Trial Outcomes & Findings for Post-authorisation Passive Enhanced Safety Surveillance of Seasonal Influenza Vaccines (NCT NCT02893878)
NCT ID: NCT02893878
Last Updated: 2019-02-11
Results Overview
AEIs were presented by categories depending of the nature of the event. -Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia,etc); - All other presentations that were reported following vaccination (e .g., Bell's palsy, Guillain-Barre syndrome). The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Recruitment status
COMPLETED
Target enrollment
19334 participants
Primary outcome timeframe
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Results posted on
2019-02-11
Participant Flow
The study included vaccinated subjects only.
Participant milestones
| Measure |
Vaccinated_Fluarix Tetra Group
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Overall Study
STARTED
|
13861
|
2295
|
3178
|
|
Overall Study
COMPLETED
|
13861
|
2295
|
3178
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Post-authorisation Passive Enhanced Safety Surveillance of Seasonal Influenza Vaccines
Baseline characteristics by cohort
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
n=2295 Participants
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
n=3178 Participants
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
Total
n=19334 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
66 Years
STANDARD_DEVIATION 16.2 • n=99 Participants
|
24 Years
STANDARD_DEVIATION 29.7 • n=107 Participants
|
57 Years
STANDARD_DEVIATION 24.9 • n=206 Participants
|
60 Years
STANDARD_DEVIATION 24.1 • n=7 Participants
|
|
Sex: Female, Male
Female
|
7661 Participants
n=99 Participants
|
1159 Participants
n=107 Participants
|
1808 Participants
n=206 Participants
|
10628 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
6200 Participants
n=99 Participants
|
1136 Participants
n=107 Participants
|
1370 Participants
n=206 Participants
|
8706 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Asian
|
327 Participants
n=99 Participants
|
244 Participants
n=107 Participants
|
123 Participants
n=206 Participants
|
694 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Black
|
275 Participants
n=99 Participants
|
334 Participants
n=107 Participants
|
133 Participants
n=206 Participants
|
742 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
White
|
9581 Participants
n=99 Participants
|
906 Participants
n=107 Participants
|
1506 Participants
n=206 Participants
|
11993 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Mixed
|
39 Participants
n=99 Participants
|
64 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
113 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Other
|
36 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
60 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Missing
|
3603 Participants
n=99 Participants
|
728 Participants
n=107 Participants
|
1401 Participants
n=206 Participants
|
5732 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
AEIs were presented by categories depending of the nature of the event. -Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia,etc); - All other presentations that were reported following vaccination (e .g., Bell's palsy, Guillain-Barre syndrome). The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined Adverse Events of Interest (AEIs) (Any) & Onset Dates of AEIs Using a Card Based-adverse Drug Reaction (ADR) Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined Adverse Events of Interest (AEIs) (Any) & Onset Dates of AEIs Using a Card Based-adverse Drug Reaction (ADR) Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Week 38
|
67 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined Adverse Events of Interest (AEIs) (Any) & Onset Dates of AEIs Using a Card Based-adverse Drug Reaction (ADR) Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Week 39
|
169 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined Adverse Events of Interest (AEIs) (Any) & Onset Dates of AEIs Using a Card Based-adverse Drug Reaction (ADR) Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Week 40
|
164 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined Adverse Events of Interest (AEIs) (Any) & Onset Dates of AEIs Using a Card Based-adverse Drug Reaction (ADR) Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Week 41
|
112 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined Adverse Events of Interest (AEIs) (Any) & Onset Dates of AEIs Using a Card Based-adverse Drug Reaction (ADR) Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Week 42
|
85 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined Adverse Events of Interest (AEIs) (Any) & Onset Dates of AEIs Using a Card Based-adverse Drug Reaction (ADR) Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Week 43
|
29 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined Adverse Events of Interest (AEIs) (Any) & Onset Dates of AEIs Using a Card Based-adverse Drug Reaction (ADR) Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Week 44
|
31 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined Adverse Events of Interest (AEIs) (Any) & Onset Dates of AEIs Using a Card Based-adverse Drug Reaction (ADR) Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Week 45
|
28 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined Adverse Events of Interest (AEIs) (Any) & Onset Dates of AEIs Using a Card Based-adverse Drug Reaction (ADR) Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Week 46
|
13 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined Adverse Events of Interest (AEIs) (Any) & Onset Dates of AEIs Using a Card Based-adverse Drug Reaction (ADR) Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Week 47
|
3 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined Adverse Events of Interest (AEIs) (Any) & Onset Dates of AEIs Using a Card Based-adverse Drug Reaction (ADR) Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Week 48
|
2 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
AEIs were presented by categories depending of the nature of the event. -Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia,etc); - All other presentations that were reported following vaccination (e .g., Bell's palsy, Guillain-Barre syndrome). The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Week 38
|
67 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Week 39
|
236 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Week 40
|
400 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Week 41
|
512 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Week 42
|
597 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Week 43
|
626 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Week 44
|
657 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Week 45
|
685 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Week 46
|
698 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Week 47
|
701 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Week 48
|
703 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Week 38
|
4 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Week 39
|
15 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Week 40
|
8 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Week 41
|
10 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Week 42
|
9 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Week 43
|
3 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Week 44
|
2 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Week 45
|
3 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Week 46
|
4 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Week 48
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis in a (Cumulative).
Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis in a (Cumulative).
Week 38
|
4 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis in a (Cumulative).
Week 39
|
19 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis in a (Cumulative).
Week 40
|
27 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis in a (Cumulative).
Week 41
|
37 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis in a (Cumulative).
Week 42
|
46 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis in a (Cumulative).
Week 43
|
49 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis in a (Cumulative).
Week 44
|
51 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis in a (Cumulative).
Week 45
|
54 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis in a (Cumulative).
Week 46
|
58 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis in a (Cumulative).
Week 47
|
58 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis in a (Cumulative).
Week 48
|
58 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
Local symptoms include local erythema. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Week 38
|
16 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Week 39
|
20 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Week 40
|
24 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Week 41
|
28 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Week 42
|
15 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Week 43
|
6 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Week 44
|
7 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Week 45
|
8 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Week 46
|
3 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Week 48
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
Local symptoms include local erythema. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis in a (Cumulative).
Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis in a (Cumulative).
Week 38
|
16 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis in a (Cumulative).
Week 39
|
36 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis in a (Cumulative).
Week 40
|
60 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis in a (Cumulative).
Week 41
|
88 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis in a (Cumulative).
Week 42
|
103 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis in a (Cumulative).
Week 43
|
109 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis in a (Cumulative).
Week 44
|
116 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis in a (Cumulative).
Week 45
|
124 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis in a (Cumulative).
Week 46
|
127 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis in a (Cumulative).
Week 47
|
127 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis in a (Cumulative).
Week 48
|
127 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, irritability and malaise. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Any, Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Any, Week 38
|
20 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Any, Week 39
|
47 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Any, Week 40
|
43 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Any, Week 41
|
25 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Any, Week 42
|
20 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Any, Week 43
|
3 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Any, Week 44
|
6 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Any, Week 45
|
9 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Any, Week 46
|
6 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Any, Week 47
|
2 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Any, Week 48
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Drowsiness, Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Drowsiness, Week 38
|
8 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Drowsiness, Week 39
|
20 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Drowsiness, Week 40
|
18 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Drowsiness, Week 41
|
10 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Drowsiness, Week 42
|
9 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Drowsiness, Week 43
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Drowsiness, Week 44
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Drowsiness, Week 45
|
2 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Drowsiness, Week 46
|
2 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Drowsiness, Week 47
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Drowsiness, Week 48
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Fatigue, Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Fatigue, Week 38
|
20 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Fatigue, Week 39
|
40 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Fatigue, Week 40
|
35 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Fatigue, Week 41
|
20 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Fatigue, Week 42
|
13 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Fatigue, Week 43
|
3 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Fatigue, Week 44
|
6 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Fatigue, Week 45
|
9 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Fatigue, Week 46
|
6 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Fatigue, Week 47
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Fatigue, Week 48
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Irritability, Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Irritability, Week 38
|
3 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Irritability, Week 39
|
2 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Irritability, Week 40
|
6 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Irritability, Week 41
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Irritability, Week 42
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Irritability, Week 43
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Irritability, Week 44
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Irritability, Week 45
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Irritability, Week 46
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Irritability, Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Irritability, Week 48
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Malaise, Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Malaise, Week 38
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Malaise, Week 39
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Malaise, Week 40
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Malaise, Week 41
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Malaise, Week 42
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Malaise, Week 43
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Malaise, Week 44
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Malaise, Week 45
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Malaise, Week 46
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Malaise, Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Malaise, Week 48
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, irritability and malaise. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Any, Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Any, Week 38
|
20 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Any, Week 39
|
67 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Any, Week 40
|
110 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Any, Week 41
|
135 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Any, Week 42
|
155 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Any, Week 43
|
158 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Any, Week 44
|
164 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Any, Week 45
|
173 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Any, Week 46
|
179 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Any, Week 47
|
181 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Any, Week 48
|
182 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Drowsiness, Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Drowsiness, Week 38
|
8 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Drowsiness, Week 39
|
28 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Drowsiness, Week 40
|
46 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Drowsiness, Week 41
|
56 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Drowsiness, Week 42
|
65 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Drowsiness, Week 43
|
66 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Drowsiness, Week 44
|
67 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Drowsiness, Week 45
|
69 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Drowsiness, Week 46
|
71 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Drowsiness, Week 47
|
72 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Drowsiness, Week 48
|
72 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Fatigue, Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Fatigue, Week 38
|
20 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Fatigue, Week 39
|
60 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Fatigue, Week 40
|
95 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Fatigue, Week 41
|
115 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Fatigue, Week 42
|
128 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Fatigue, Week 43
|
131 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Fatigue, Week 44
|
137 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Fatigue, Week 45
|
146 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Fatigue, Week 46
|
152 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Fatigue, Week 47
|
153 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Fatigue, Week 48
|
154 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Irritability, Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Irritability, Week 38
|
3 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Irritability, Week 39
|
5 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Irritability, Week 40
|
11 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Irritability, Week 41
|
12 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Irritability, Week 42
|
13 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Irritability, Week 43
|
14 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Irritability, Week 44
|
15 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Irritability, Week 45
|
16 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Irritability, Week 46
|
16 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Irritability, Week 47
|
16 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Irritability, Week 48
|
16 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Malaise, Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Malaise, Week 38
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Malaise, Week 39
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Malaise, Week 40
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Malaise, Week 41
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Malaise, Week 42
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Malaise, Week 43
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Malaise, Week 44
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Malaise, Week 45
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Malaise, Week 46
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Malaise, Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Malaise, Week 48
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
Respiratory/Miscellaneous AE include any respiratory/miscellaneous AE, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Cough, Week 46
|
3 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Cough, Week 40
|
33 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Cough, Week 41
|
22 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Cough, Week 42
|
25 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Cough, Week 43
|
4 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Cough, Week 44
|
5 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Cough, Week 45
|
6 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Coryza, Week 42
|
20 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Coryza, Week 43
|
4 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Coryza, Week 44
|
3 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Coryza, Week 45
|
7 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Coryza, Week 46
|
2 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Coryza, Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Coryza, Week 48
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Cough, Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Cough, Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Cough, Week 48
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Epistaxis, Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Epistaxis, Week 38
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Epistaxis, Week 39
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Epistaxis, Week 40
|
2 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Epistaxis, Week 41
|
3 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Epistaxis, Week 42
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Epistaxis, Week 43
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Epistaxis, Week 44
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Epistaxis, Week 45
|
2 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Epistaxis, Week 46
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Epistaxis, Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Epistaxis, Week 48
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Hoarseness, Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Hoarseness, Week 38
|
6 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Hoarseness, Week 39
|
15 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Hoarseness, Week 40
|
16 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Hoarseness, Week 41
|
14 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Hoarseness, Week 42
|
8 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Hoarseness, Week 43
|
2 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Hoarseness, Week 44
|
2 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Hoarseness, Week 45
|
3 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Hoarseness, Week 46
|
3 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Hoarseness, Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Hoarseness, Week 48
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Nasal congestion, Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Nasal congestion, Week 38
|
21 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Nasal congestion, Week 39
|
69 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Nasal congestion, Week 40
|
54 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Nasal congestion, Week 41
|
45 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Nasal congestion, Week 42
|
33 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Nasal congestion, Week 43
|
18 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Nasal congestion, Week 44
|
7 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Nasal congestion, Week 45
|
15 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Nasal congestion, Week 46
|
4 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Nasal congestion, Week 47
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Nasal congestion, Week 48
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Oropharyngeal pain, Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Oropharyngeal pain, Week 38
|
9 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Oropharyngeal pain, Week 39
|
32 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Oropharyngeal pain, Week 40
|
38 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Oropharyngeal pain, Week 41
|
21 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Oropharyngeal pain, Week 42
|
25 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Oropharyngeal pain, Week 43
|
9 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Oropharyngeal pain, Week 44
|
5 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Oropharyngeal pain, Week 45
|
7 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Oropharyngeal pain, Week 46
|
2 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Oropharyngeal pain, Week 47
|
2 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Oropharyngeal pain, Week 48
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Rhinorrhoea, Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Rhinorrhoea, Week 38
|
17 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Rhinorrhoea, Week 39
|
58 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Rhinorrhoea, Week 40
|
53 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Cough, Week 38
|
9 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Cough, Week 39
|
29 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Rhinorrhoea, Week 41
|
44 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Rhinorrhoea, Week 42
|
27 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Rhinorrhoea, Week 43
|
17 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Rhinorrhoea, Week 44
|
5 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Rhinorrhoea, Week 45
|
14 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Rhinorrhoea, Week 46
|
4 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Rhinorrhoea, Week 47
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Rhinorrhoea, Week 48
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Wheezing, Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Wheezing, Week 38
|
2 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Wheezing, Week 39
|
9 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Wheezing, Week 40
|
11 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Wheezing, Week 41
|
7 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Wheezing, Week 42
|
12 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Wheezing, Week 43
|
2 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Wheezing, Week 44
|
5 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Wheezing, Week 45
|
3 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Wheezing, Week 46
|
2 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Wheezing, Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Wheezing, Week 48
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Any, Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Any, Week 38
|
30 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Any, Week 39
|
100 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Any, Week 40
|
95 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Any, Week 41
|
64 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Any, Week 42
|
58 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Any, Week 43
|
22 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Any, Week 44
|
13 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Any, Week 45
|
19 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Any, Week 46
|
5 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Any, Week 47
|
2 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Any, Week 48
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Conjunctivitis, Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Conjunctivitis, Week 38
|
3 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Conjunctivitis, Week 39
|
7 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Conjunctivitis, Week 40
|
2 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Conjunctivitis, Week 41
|
3 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Conjunctivitis, Week 42
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Conjunctivitis, Week 43
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Conjunctivitis, Week 44
|
3 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Conjunctivitis, Week 45
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Conjunctivitis, Week 46
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Conjunctivitis, Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Conjunctivitis, Week 48
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Coryza, Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Coryza, Week 38
|
3 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Coryza, Week 39
|
19 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Coryza, Week 40
|
26 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Coryza, Week 41
|
11 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
Respiratory/Miscellaneous AE include any respiratory/miscellaneous AE, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Rhinorrhoea, Week 42
|
199 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Any, Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Any, Week 38
|
30 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Any, Week 39
|
130 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Any, Week 40
|
225 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Any, Week 41
|
289 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Any, Week 42
|
347 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Any, Week 43
|
369 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Any, Week 44
|
382 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Any, Week 45
|
401 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Any, Week 46
|
406 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Any, Week 47
|
408 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Any, Week 48
|
408 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Conjunctivitis, Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Conjunctivitis, Week 38
|
3 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Conjunctivitis, Week 39
|
10 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Conjunctivitis, Week 40
|
12 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Conjunctivitis, Week 41
|
15 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Conjunctivitis, Week 42
|
16 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Conjunctivitis, Week 43
|
17 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Conjunctivitis, Week 44
|
20 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Conjunctivitis, Week 45
|
21 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Conjunctivitis, Week 46
|
21 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Conjunctivitis, Week 47
|
21 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Conjunctivitis, Week 48
|
21 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Coryza, Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Coryza, Week 38
|
3 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Coryza, Week 39
|
22 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Coryza, Week 40
|
48 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Coryza, Week 41
|
59 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Coryza, Week 42
|
79 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Coryza, Week 43
|
83 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Coryza, Week 44
|
86 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Coryza, Week 45
|
93 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Coryza, Week 46
|
95 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Coryza, Week 47
|
95 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Coryza, Week 48
|
95 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Cough, Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Cough, Week 38
|
9 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Cough, Week 39
|
38 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Cough, Week 40
|
71 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Cough, Week 41
|
93 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Cough, Week 42
|
118 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Cough, Week 43
|
122 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Cough, Week 44
|
127 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Cough, Week 45
|
133 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Cough, Week 46
|
136 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Cough, Week 47
|
136 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Cough, Week 48
|
136 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Epistaxis, Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Epistaxis, Week 38
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Epistaxis, Week 39
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Epistaxis, Week 40
|
3 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Epistaxis, Week 41
|
6 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Epistaxis, Week 42
|
7 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Epistaxis, Week 43
|
7 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Epistaxis, Week 44
|
7 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Epistaxis, Week 45
|
9 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Epistaxis, Week 46
|
9 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Epistaxis, Week 47
|
9 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Epistaxis, Week 48
|
9 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Hoarseness, Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Hoarseness, Week 38
|
6 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Hoarseness, Week 39
|
21 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Hoarseness, Week 40
|
37 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Hoarseness, Week 41
|
51 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Hoarseness, Week 42
|
59 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Hoarseness, Week 43
|
61 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Hoarseness, Week 44
|
63 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Hoarseness, Week 45
|
66 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Hoarseness, Week 46
|
69 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Hoarseness, Week 47
|
69 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Hoarseness, Week 48
|
69 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Nasal congestion, Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Nasal congestion, Week 38
|
21 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Nasal congestion, Week 39
|
90 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Nasal congestion, Week 40
|
144 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Nasal congestion, Week 41
|
189 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Nasal congestion, Week 42
|
222 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Nasal congestion, Week 43
|
240 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Nasal congestion, Week 44
|
247 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Nasal congestion, Week 45
|
262 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Nasal congestion, Week 46
|
266 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Nasal congestion, Week 47
|
267 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Nasal congestion, Week 48
|
267 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Oropharyngeal pain, Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Oropharyngeal pain, Week 38
|
9 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Oropharyngeal pain, Week 39
|
41 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Oropharyngeal pain, Week 40
|
79 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Oropharyngeal pain, Week 41
|
100 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Oropharyngeal pain, Week 42
|
125 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Oropharyngeal pain, Week 43
|
134 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Oropharyngeal pain, Week 44
|
139 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Oropharyngeal pain, Week 45
|
146 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Oropharyngeal pain, Week 46
|
148 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Oropharyngeal pain, Week 47
|
150 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Oropharyngeal pain, Week 48
|
150 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Rhinorrhoea, Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Rhinorrhoea, Week 38
|
17 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Rhinorrhoea, Week 39
|
75 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Rhinorrhoea, Week 40
|
128 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Rhinorrhoea, Week 41
|
172 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Rhinorrhoea, Week 43
|
216 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Rhinorrhoea, Week 44
|
221 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Rhinorrhoea, Week 45
|
235 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Rhinorrhoea, Week 46
|
239 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Rhinorrhoea, Week 47
|
240 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Rhinorrhoea, Week 48
|
240 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Wheezing, Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Wheezing, Week 38
|
2 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Wheezing, Week 39
|
11 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Wheezing, Week 40
|
22 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Wheezing, Week 41
|
29 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Wheezing, Week 42
|
41 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Wheezing, Week 43
|
43 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Wheezing, Week 44
|
48 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Wheezing, Week 45
|
51 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Wheezing, Week 46
|
53 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Wheezing, Week 47
|
53 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Wheezing, Week 48
|
53 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
Gastrointestinal AEs include any gastrointestinal AEs, decreased appetite, diarrhoea, nausea and vomiting. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Decreased appetite, Week 40
|
11 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Any, Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Any, Week 38
|
15 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Any, Week 39
|
29 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Any, Week 40
|
29 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Any, Week 41
|
21 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Any, Week 42
|
18 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Any, Week 43
|
6 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Any, Week 44
|
4 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Any, Week 45
|
5 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Any, Week 46
|
3 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Any, Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Any, Week 48
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Decreased appetite, Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Decreased appetite, Week 38
|
7 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Decreased appetite, Week 39
|
11 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Decreased appetite, Week 41
|
7 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Decreased appetite, Week 42
|
6 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Decreased appetite, Week 43
|
2 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Decreased appetite, Week 44
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Decreased appetite, Week 45
|
2 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Decreased appetite, Week 46
|
2 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Decreased appetite, Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Decreased appetite, Week 48
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Diarrhoea, Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Diarrhoea, Week 38
|
5 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Diarrhoea, Week 39
|
10 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Diarrhoea, Week 40
|
12 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Diarrhoea, Week 41
|
8 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Diarrhoea, Week 42
|
5 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Diarrhoea, Week 43
|
3 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Diarrhoea, Week 44
|
3 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Diarrhoea, Week 45
|
2 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Diarrhoea, Week 46
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Diarrhoea, Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Diarrhoea, Week 48
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Nausea, Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Nausea, Week 38
|
11 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Nausea, Week 39
|
17 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Nausea, Week 40
|
14 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Nausea, Week 41
|
8 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Nausea, Week 42
|
9 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Nausea, Week 43
|
2 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Nausea, Week 44
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Nausea, Week 45
|
4 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Nausea, Week 46
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Nausea, Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Nausea, Week 48
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Vomiting, Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Vomiting, Week 38
|
2 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Vomiting, Week 39
|
2 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Vomiting, Week 40
|
6 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Vomiting, Week 41
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Vomiting, Week 42
|
3 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Vomiting, Week 43
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Vomiting, Week 44
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Vomiting, Week 45
|
2 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Vomiting, Week 46
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Vomiting, Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Vomiting, Week 48
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
Gastrointestinal AEs include any gastrointestinal AEs, decreased appetite, diarrhoea, nausea and vomiting. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Diarrhoea, Week 38
|
5 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Diarrhoea, Week 43
|
43 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Any, Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Any, Week 38
|
15 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Any, Week 39
|
44 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Any, Week 40
|
73 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Any, Week 41
|
94 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Any, Week 42
|
112 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Any, Week 43
|
118 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Any, Week 44
|
122 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Any, Week 45
|
127 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Any, Week 46
|
130 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Any, Week 47
|
130 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Any, Week 48
|
131 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Decreased appetite, Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Decreased appetite, Week 38
|
7 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Decreased appetite, Week 39
|
18 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Decreased appetite, Week 40
|
29 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Decreased appetite, Week 41
|
36 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Decreased appetite, Week 42
|
42 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Decreased appetite, Week 43
|
44 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Decreased appetite, Week 44
|
45 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Decreased appetite, Week 45
|
47 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Decreased appetite, Week 46
|
49 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Decreased appetite, Week 47
|
49 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Decreased appetite, Week 48
|
49 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Diarrhoea, Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Diarrhoea, Week 39
|
15 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Diarrhoea, Week 40
|
27 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Diarrhoea, Week 41
|
35 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Diarrhoea, Week 42
|
40 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Diarrhoea, Week 44
|
46 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Diarrhoea, Week 45
|
48 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Diarrhoea, Week 46
|
48 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Diarrhoea, Week 47
|
48 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Diarrhoea, Week 48
|
48 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Nausea, Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Nausea, Week 38
|
11 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Nausea, Week 39
|
28 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Nausea, Week 40
|
42 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Nausea, Week 41
|
50 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Nausea, Week 42
|
59 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Nausea, Week 43
|
61 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Nausea, Week 44
|
61 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Nausea, Week 45
|
65 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Nausea, Week 46
|
66 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Nausea, Week 47
|
66 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Nausea, Week 48
|
67 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Vomiting, Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Vomiting, Week 38
|
2 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Vomiting, Week 39
|
4 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Vomiting, Week 40
|
10 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Vomiting, Week 41
|
11 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Vomiting, Week 42
|
14 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Vomiting, Week 43
|
14 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Vomiting, Week 44
|
14 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Vomiting, Week 45
|
16 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Vomiting, Week 46
|
16 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Vomiting, Week 47
|
16 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Vomiting, Week 48
|
16 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
Sensitivity/anaphylaxis AEs include any sensitivity/anaphylaxis AEs, anaphylactic reactions, facial oedema and hypersensitivity reactions. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Anaphylactic reactions, Week 38
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Anaphylactic reactions, Week 39
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Anaphylactic reactions, Week 40
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Anaphylactic reactions, Week 41
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Anaphylactic reactions, Week 42
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Hypersensitivity reactions, Week 43
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Hypersensitivity reactions, Week 44
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Hypersensitivity reactions, Week 45
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Hypersensitivity reactions, Week 46
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Hypersensitivity reactions, Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Hypersensitivity reactions, Week 48
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Any, Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Any, Week 38
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Any, Week 39
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Any, Week 40
|
3 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Any, Week 41
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Any, Week 42
|
2 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Any, Week 43
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Any, Week 44
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Any, Week 45
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Any, Week 46
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Any, Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Any, Week 48
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Anaphylactic reactions, Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Anaphylactic reactions, Week 43
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Anaphylactic reactions, Week 44
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Anaphylactic reactions, Week 45
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Anaphylactic reactions, Week 46
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Anaphylactic reactions, Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Anaphylactic reactions, Week 48
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Facial oedema, Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Facial oedema, Week 38
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Facial oedema, Week 39
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Facial oedema, Week 40
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Facial oedema, Week 41
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Facial oedema, Week 42
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Facial oedema, Week 43
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Facial oedema, Week 44
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Facial oedema, Week 45
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Facial oedema, Week 46
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Facial oedema, Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Facial oedema, Week 48
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Hypersensitivity reactions, Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Hypersensitivity reactions, Week 38
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Hypersensitivity reactions, Week 39
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Hypersensitivity reactions, Week 40
|
2 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Hypersensitivity reactions, Week 41
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Hypersensitivity reactions, Week 42
|
2 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
Sensitivity/anaphylaxis AEs include any sensitivity/anaphylaxis AEs, anaphylactic reactions, facial oedema and hypersensitivity reactions. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Any, Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Any, Week 38
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Any, Week 39
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Any, Week 40
|
3 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Any, Week 41
|
3 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Any, Week 42
|
5 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Any, Week 43
|
5 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Any, Week 44
|
6 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Any, Week 45
|
7 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Any, Week 46
|
7 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Any, Week 47
|
7 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Any, Week 48
|
7 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Anaphylactic reactions, Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Anaphylactic reactions, Week 38
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Anaphylactic reactions, Week 39
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Anaphylactic reactions, Week 40
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Anaphylactic reactions, Week 41
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Anaphylactic reactions, Week 42
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Anaphylactic reactions, Week 43
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Anaphylactic reactions, Week 44
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Anaphylactic reactions, Week 45
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Anaphylactic reactions, Week 46
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Anaphylactic reactions, Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Anaphylactic reactions, Week 48
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Facial oedema, Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Facial oedema, Week 38
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Facial oedema, Week 39
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Facial oedema, Week 40
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Facial oedema, Week 41
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Facial oedema, Week 42
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Facial oedema, Week 43
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Facial oedema, Week 44
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Facial oedema, Week 45
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Facial oedema, Week 46
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Facial oedema, Week 47
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Facial oedema, Week 48
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Hypersensitivity reactions, Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Hypersensitivity reactions, Week 38
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Hypersensitivity reactions, Week 39
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Hypersensitivity reactions, Week 40
|
2 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Hypersensitivity reactions, Week 41
|
2 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Hypersensitivity reactions, Week 42
|
4 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Hypersensitivity reactions, Week 43
|
4 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Hypersensitivity reactions, Week 44
|
5 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Hypersensitivity reactions, Week 45
|
6 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Hypersensitivity reactions, Week 46
|
6 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Hypersensitivity reactions, Week 47
|
6 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Hypersensitivity reactions, Week 48
|
6 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
Rash AEs include any rash AEs, generalised rash and rash. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Any, Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Any, Week 38
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Any, Week 39
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Any, Week 40
|
5 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Any, Week 41
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Any, Week 42
|
3 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Any, Week 43
|
3 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Any, Week 44
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Any, Week 45
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Any, Week 46
|
2 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Any, Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Any, Week 48
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Generalised rash, Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Generalised rash, Week 38
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Generalised rash, Week 39
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Generalised rash, Week 40
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Generalised rash, Week 41
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Generalised rash, Week 42
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Generalised rash, Week 43
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Generalised rash, Week 44
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Generalised rash, Week 45
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Generalised rash, Week 46
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Generalised rash, Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Generalised rash, Week 48
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Rash, Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Rash, Week 38
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Rash, Week 39
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Rash, Week 40
|
4 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Rash, Week 41
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Rash, Week 42
|
3 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Rash, Week 43
|
3 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Rash, Week 44
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Rash, Week 45
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Rash, Week 46
|
2 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Rash, Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Rash, Week 48
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
Rash AEs include any rash AEs, generalised rash and rash. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Any, Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Any, Week 38
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Any, Week 39
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Any, Week 40
|
6 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Any, Week 41
|
7 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Any, Week 42
|
10 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Any, Week 43
|
13 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Any, Week 44
|
14 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Any, Week 45
|
15 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Any, Week 46
|
17 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Any, Week 47
|
17 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Any, Week 48
|
17 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Generalised rash, Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Generalised rash, Week 38
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Generalised rash, Week 39
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Generalised rash, Week 40
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Generalised rash, Week 41
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Generalised rash, Week 42
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Generalised rash, Week 43
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Generalised rash, Week 44
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Generalised rash, Week 45
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Generalised rash, Week 46
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Generalised rash, Week 47
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Generalised rash, Week 48
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Rash, Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Rash, Week 38
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Rash, Week 39
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Rash, Week 40
|
5 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Rash, Week 41
|
6 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Rash, Week 42
|
9 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Rash, Week 43
|
12 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Rash, Week 44
|
13 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Rash, Week 45
|
14 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Rash, Week 46
|
16 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Rash, Week 47
|
16 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Rash, Week 48
|
16 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
Musculoskeletal AEs include any musculoskeletal AEs, arthropathy and muscle aches/myalgia. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Any, Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Any, Week 38
|
27 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Any, Week 39
|
60 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Any, Week 40
|
64 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Any, Week 41
|
32 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Any, Week 42
|
33 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Any, Week 43
|
7 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Any, Week 44
|
9 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Any, Week 45
|
13 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Any, Week 46
|
7 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Any, Week 47
|
2 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Any, Week 48
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Arthropathy, Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Arthropathy, Week 38
|
8 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Arthropathy, Week 39
|
17 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Arthropathy, Week 40
|
24 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Arthropathy, Week 41
|
9 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Arthropathy, Week 42
|
11 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Arthropathy, Week 43
|
2 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Arthropathy, Week 44
|
2 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Arthropathy, Week 45
|
5 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Arthropathy, Week 46
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Arthropathy, Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Arthropathy, Week 48
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Muscle aches/myalgia, Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Muscle aches/myalgia, Week 38
|
25 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Muscle aches/myalgia, Week 39
|
58 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Muscle aches/myalgia, Week 40
|
57 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Muscle aches/myalgia, Week 41
|
30 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Muscle aches/myalgia, Week 42
|
29 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Muscle aches/myalgia, Week 43
|
7 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Muscle aches/myalgia, Week 44
|
7 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Muscle aches/myalgia, Week 45
|
13 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Muscle aches/myalgia, Week 46
|
6 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Muscle aches/myalgia, Week 47
|
2 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Muscle aches/myalgia, Week 48
|
1 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
Musculoskeletal AEs include any musculoskeletal AEs, arthropathy and muscle aches/myalgia. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Any, Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Any, Week 38
|
27 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Any, Week 39
|
87 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Any, Week 40
|
151 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Any, Week 41
|
183 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Any, Week 42
|
216 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Any, Week 43
|
223 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Any, Week 44
|
232 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Any, Week 45
|
245 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Any, Week 46
|
252 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Any, Week 47
|
254 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Any, Week 48
|
255 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Arthropathy, Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Arthropathy, Week 38
|
8 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Arthropathy, Week 39
|
25 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Arthropathy, Week 40
|
49 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Arthropathy, Week 41
|
58 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Arthropathy, Week 42
|
69 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Arthropathy, Week 43
|
71 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Arthropathy, Week 44
|
73 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Arthropathy, Week 45
|
78 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Arthropathy, Week 46
|
79 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Arthropathy, Week 47
|
79 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Arthropathy, Week 48
|
79 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Muscle aches/myalgia, Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Muscle aches/myalgia, Week 38
|
25 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Muscle aches/myalgia, Week 39
|
83 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Muscle aches/myalgia, Week 40
|
140 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Muscle aches/myalgia, Week 41
|
170 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Muscle aches/myalgia, Week 42
|
199 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Muscle aches/myalgia, Week 43
|
206 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Muscle aches/myalgia, Week 44
|
213 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Muscle aches/myalgia, Week 45
|
226 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Muscle aches/myalgia, Week 46
|
232 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Muscle aches/myalgia, Week 47
|
234 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Muscle aches/myalgia, Week 48
|
235 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
Neurological AEs include any neurological AEs, Bell's palsy, Guillain-Barre syndrome, headache, peripheral tremor and seizure/febrile convulsions. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Bell's palsy, Week 46
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Bell's palsy, Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Any, Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Any, Week 38
|
19 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Any, Week 39
|
48 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Any, Week 40
|
42 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Any, Week 41
|
25 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Any, Week 42
|
15 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Any, Week 43
|
10 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Any, Week 44
|
5 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Any, Week 45
|
10 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Any, Week 46
|
3 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Any, Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Any, Week 48
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Bell's palsy, Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Bell's palsy, Week 38
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Bell's palsy, Week 39
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Bell's palsy, Week 40
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Bell's palsy, Week 41
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Bell's palsy, Week 42
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Bell's palsy, Week 43
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Bell's palsy, Week 44
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Bell's palsy, Week 45
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Bell's palsy, Week 48
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Guillain-Barre Syndrome, Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Guillain-Barre Syndrome, Week 38
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Guillain-Barre Syndrome, Week 39
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Guillain-Barre Syndrome, Week 40
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Guillain-Barre Syndrome, Week 41
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Guillain-Barre Syndrome, Week 42
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Guillain-Barre Syndrome, Week 43
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Guillain-Barre Syndrome, Week 44
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Guillain-Barre Syndrome, Week 45
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Guillain-Barre Syndrome, Week 46
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Guillain-Barre Syndrome, Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Guillain-Barre Syndrome, Week 48
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Headache, Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Headache, Week 38
|
17 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Headache, Week 39
|
48 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Headache, Week 40
|
40 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Headache, Week 41
|
23 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Headache, Week 42
|
13 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Headache, Week 43
|
8 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Headache, Week 44
|
5 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Headache, Week 45
|
9 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Headache, Week 46
|
3 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Headache, Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Headache, Week 48
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Peripheral tremor, Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Peripheral tremor, Week 38
|
3 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Peripheral tremor, Week 39
|
5 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Peripheral tremor, Week 40
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Peripheral tremor, Week 41
|
7 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Peripheral tremor, Week 42
|
3 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Peripheral tremor, Week 43
|
2 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Peripheral tremor, Week 44
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Peripheral tremor, Week 45
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Peripheral tremor, Week 46
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Peripheral tremor, Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Peripheral tremor, Week 48
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Seizure/Febrile convulsions, Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Seizure/Febrile convulsions, Week 38
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Seizure/Febrile convulsions, Week 39
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Seizure/Febrile convulsions, Week 40
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Seizure/Febrile convulsions, Week 41
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Seizure/Febrile convulsions, Week 42
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Seizure/Febrile convulsions, Week 43
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Seizure/Febrile convulsions, Week 44
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Seizure/Febrile convulsions, Week 45
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Seizure/Febrile convulsions, Week 46
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Seizure/Febrile convulsions, Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Seizure/Febrile convulsions, Week 48
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
Neurological AEs include any neurological AEs, Bell's palsy, Guillain-Barre syndrome, headache, peripheral tremor and seizure/febrile convulsions. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Guillain-Barre Syndrome, Week 41
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Guillain-Barre Syndrome, Week 42
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Any, Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Any, Week 38
|
19 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Any, Week 39
|
67 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Any, Week 40
|
109 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Any, Week 41
|
134 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Any, Week 42
|
149 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Any, Week 43
|
159 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Any, Week 44
|
164 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Any, Week 45
|
174 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Any, Week 46
|
177 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Any, Week 47
|
177 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Any, Week 48
|
178 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Bell's palsy, Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Bell's palsy, Week 38
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Bell's palsy, Week 39
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Bell's palsy, Week 40
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Bell's palsy, Week 41
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Bell's palsy, Week 42
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Bell's palsy, Week 43
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Bell's palsy, Week 44
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Bell's palsy, Week 45
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Bell's palsy, Week 46
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Bell's palsy, Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Bell's palsy, Week 48
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Guillain-Barre Syndrome, Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Guillain-Barre Syndrome, Week 38
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Guillain-Barre Syndrome, Week 39
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Guillain-Barre Syndrome, Week 40
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Guillain-Barre Syndrome, Week 43
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Guillain-Barre Syndrome, Week 44
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Guillain-Barre Syndrome, Week 45
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Guillain-Barre Syndrome, Week 46
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Guillain-Barre Syndrome, Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Guillain-Barre Syndrome, Week 48
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Headache, Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Headache, Week 38
|
17 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Headache, Week 39
|
65 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Headache, Week 40
|
105 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Headache, Week 41
|
128 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Headache, Week 42
|
141 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Headache, Week 43
|
149 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Headache, Week 44
|
154 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Headache, Week 45
|
163 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Headache, Week 46
|
166 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Headache, Week 47
|
166 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Headache, Week 48
|
167 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Peripheral tremor, Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Peripheral tremor, Week 38
|
3 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Peripheral tremor, Week 39
|
8 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Peripheral tremor, Week 40
|
9 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Peripheral tremor, Week 41
|
16 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Peripheral tremor, Week 42
|
19 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Peripheral tremor, Week 43
|
21 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Peripheral tremor, Week 44
|
21 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Peripheral tremor, Week 45
|
22 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Peripheral tremor, Week 46
|
22 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Peripheral tremor, Week 47
|
22 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Peripheral tremor, Week 48
|
22 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Seizure/Febrile convulsions, Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Seizure/Febrile convulsions, Week 38
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Seizure/Febrile convulsions, Week 39
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Seizure/Febrile convulsions, Week 40
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Seizure/Febrile convulsions, Week 41
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Seizure/Febrile convulsions, Week 42
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Seizure/Febrile convulsions, Week 43
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Seizure/Febrile convulsions, Week 44
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Seizure/Febrile convulsions, Week 45
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Seizure/Febrile convulsions, Week 46
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Seizure/Febrile convulsions, Week 47
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Seizure/Febrile convulsions, Week 48
|
1 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years, Week 48
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years, Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years, Week 38
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years, Week 39
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years, Week 40
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years, Week 41
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years, Week 42
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years, Week 43
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years, Week 44
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years, Week 45
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years, Week 46
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years, Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years, Week 48
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years, Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years, Week 38
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years, Week 39
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years, Week 40
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years, Week 41
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years, Week 42
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years, Week 43
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years, Week 44
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years, Week 45
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years, Week 46
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years, Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years, Week 48
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years, Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years, Week 38
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years, Week 39
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years, Week 40
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years, Week 41
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years, Week 42
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years, Week 43
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years, Week 44
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years, Week 45
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years, Week 46
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years, Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years, Week 48
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years, Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years, Week 38
|
21 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years, Week 39
|
45 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years, Week 40
|
57 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years, Week 41
|
36 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years, Week 42
|
38 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years, Week 43
|
10 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years, Week 44
|
12 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years, Week 45
|
12 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years, Week 46
|
5 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years, Week 47
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years, Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years, Week 38
|
46 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years, Week 39
|
124 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years, Week 40
|
107 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years, Week 41
|
76 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years, Week 42
|
46 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years, Week 43
|
19 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years, Week 44
|
19 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years, Week 45
|
16 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years, Week 46
|
8 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years, Week 47
|
2 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years, Week 48
|
1 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e . cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years, Week 47
|
463 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years, Week 48
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years, Week 47
|
237 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years, Week 45
|
453 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 39
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 38
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 40
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 41
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 42
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 43
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 44
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 45
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 46
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 48
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years, Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years, Week 38
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years, Week 39
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years, Week 40
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years, Week 41
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years, Week 42
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years, Week 43
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years, Week 44
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years, Week 45
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years, Week 46
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years, Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years, Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years, Week 38
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years, Week 39
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years, Week 40
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years, Week 41
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years, Week 42
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years, Week 43
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years, Week 44
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years, Week 45
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years, Week 46
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years, Week 47
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years, Week 48
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years, Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years, Week 38
|
21 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years, Week 39
|
66 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years, Week 40
|
123 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years, Week 41
|
159 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years, Week 42
|
197 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years, Week 43
|
207 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years, Week 44
|
219 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years, Week 45
|
231 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years, Week 46
|
236 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years, Week 48
|
238 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years, Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years, Week 38
|
46 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years, Week 39
|
170 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years, Week 40
|
277 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years, Week 41
|
353 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years, Week 42
|
399 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years, Week 43
|
418 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years, Week 44
|
437 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years, Week 46
|
461 Participants
|
—
|
—
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years, Week 48
|
464 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016).Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR .
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years, Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years, Week 38
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years, Week 45
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years, Week 46
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years, Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years, Week 38
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years, Week 40
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years, Week 42
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years, Week 44
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years, Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years, Week 40
|
3 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years, Week 43
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years, Week 46
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years, Week40
|
5 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years, Week 41
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years, Week 42
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years, Week 43
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years, Week 44
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years, Week 39
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years, Week 40
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years, Week 48
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years, Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years, Week 38
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years, Week 39
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years, Week 41
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years, Week 39
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years, Week 43
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years, Week 45
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years, Week 46
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years, Week 48
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years, Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years, Week 38
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years, Week 39
|
6 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years, Week 41
|
4 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years, Week 42
|
5 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years, Week 44
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years, Week 45
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years, Week 40
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years, Week 41
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years, Week 42
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years, Week 43
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years, Week 44
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years, Week 45
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years, Week 46
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years, Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years, Week 48
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years, Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years, Week 48
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years, Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years, Week 38
|
3 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years, Week 39
|
9 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years, Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years, Week 41
|
6 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years, Week 42
|
4 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years, Week 43
|
2 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years, Week 44
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years, Week 45
|
2 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years, Week 46
|
3 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years, Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years, Week 48
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016).Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e . cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who receive d the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR .
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 41
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 44
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 45
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 46
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years, Week 39
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years, Week 39
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years, Week 45
|
22 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years, Week 46
|
23 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years, Week 47
|
23 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years, Week 48
|
23 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years, Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years, Week 38
|
3 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years, Week 39
|
12 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years, Week 40
|
17 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years, Week 41
|
23 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years, Week 42
|
27 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years, Week 43
|
29 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years, Week 44
|
30 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years, Week 45
|
32 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years, Week 46
|
35 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years, Week 47
|
35 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years, Week 48
|
35 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 38
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 39
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 40
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 42
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 43
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 48
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years, Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years, Week 38
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years, Week 40
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years, Week 41
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years, Week 42
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years, Week 43
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years, Week 44
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years, Week 45
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years, Week 46
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years, Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years, Week 48
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years, Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years, Week 38
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years, Week 40
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years, Week 41
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years, Week 42
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years, Week 43
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years, Week 44
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years, Week 45
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years, Week 46
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years, Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years, Week 48
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years, Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years, Week 38
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years, Week 39
|
7 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years, Week 40
|
10 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years, Week 41
|
14 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years, Week 42
|
19 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years, Week 43
|
20 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years, Week 44
|
21 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
Local symptoms included local erythema. The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years: Week 41
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years: Week 40
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years: Week 42
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years: Week 45
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years: Week 46
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years: Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years: Week 39
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years: Week 44
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years: Week 45
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years: Week 46
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years: Week 48
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years: Week 39
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years: Week 40
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years: Week 41
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years: Week 42
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years: Week 43
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years: Week 44
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years: Week 45
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years: Week 38
|
9 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years: Week 43
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years: Week 44
|
4 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years: Week 38
|
7 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years: Week 39
|
12 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years: Week 40
|
14 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years: Week 41
|
16 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years: Week 43
|
5 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years: Week 44
|
3 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years: Week 45
|
5 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years: Week 46
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years: Week 38
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years: Week 39
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years: Week 43
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years: Week 44
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years: Week 48
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years: Week 38
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years: Week 40
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years: Week 41
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years: Week 42
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years: Week 43
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years: Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years: Week 38
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years: Week 46
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years: Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years: Week 48
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years: Week 39
|
8 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years: Week 40
|
10 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years: Week 41
|
12 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years: Week 42
|
9 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years: Week 45
|
3 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years: Week 46
|
3 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years: Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years: Week 48
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years: Week 42
|
6 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years: Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years: Week 48
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
Local symptoms included local erythema. The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR .
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years: Week 44
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years: Week 39
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years: Week 40
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years: Week 41
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years: Week 44
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years: Week 45
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years: Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years: Week 48
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years: Week 40
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years: Week 41
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years: Week 42
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years: Week 44
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years: Week 45
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years: Week 46
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years: Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years: Week 48
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years: Week 41
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years: Week 42
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years: Week 43
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years: Week 45
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years: Week 46
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years: Week 48
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years: Week 38
|
9 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years: Week 39
|
17 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years: Week 40
|
27 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years: Week 41
|
39 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years: Week 42
|
48 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years: Week 43
|
49 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years: Week 44
|
53 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years: Week 45
|
56 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years: Week 46
|
59 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years: Week 47
|
59 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years: Week 48
|
59 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years: Week 45
|
68 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years: Week 46
|
68 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years: Week 47
|
68 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years: Week 38
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years: Week 42
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years: Week 43
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years: Week 46
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years: Week 38
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years: Week 39
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years: Week 43
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years: Week 38
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years: Week 39
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years: Week 40
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years: Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years: Week 38
|
7 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years: Week 39
|
19 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years: Week 40
|
33 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years: Week 41
|
49 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years: Week 42
|
55 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years: Week 43
|
60 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years: Week 44
|
63 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years: Week 48
|
68 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR .
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years: Week 38
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years: Week 39
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years: Week 40
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years: Week 41
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years: Week 43
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years: Week 45
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years: Week 46
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years: Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years: Week 48
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years: Week 39
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years: Week 40
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years: Week 41
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years: Week 42
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years: Week 44
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years: Week 45
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years: Week 48
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years: Week 38
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years: Week 42
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years: Week 43
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years: Week 44
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years: Week 45
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years: Week 46
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years: Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years: Week 38
|
6 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years: Week 39
|
15 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years: Week 40
|
17 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years: Week 41
|
3 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years: Week 42
|
9 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years: Week 43
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years: Week 46
|
2 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years: Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years: Week 38
|
14 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years: Week 39
|
32 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years: Week 40
|
26 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years: Week 41
|
22 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years: Week 46
|
4 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years: Week 47
|
2 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years: Week 48
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years: Week 42
|
10 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years: Week 43
|
3 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years: Week 44
|
4 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years: Week 45
|
4 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years: Week 42
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years: Week 44
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years: Week 38
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years: Week 43
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years: Week 46
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years: Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years: Week 39
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years: Week 40
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years: Week 41
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years: Week 48
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years: Week 44
|
2 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years: Week 45
|
5 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years: Week 48
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years: Week 37
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years: Week 38
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years: Week 39
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years: Week 40
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years: Week 43
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years: Week 46
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years: Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years: Week 38
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years: Week 38
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years: Week 40
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years: Week 41
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years: Week 43
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years: Week 44
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years: Week 45
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years: Week 46
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years: Week 40
|
38 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years: Week 43
|
50 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years: Week 38
|
14 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years: Week 39
|
46 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years: Week 43
|
107 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years: Week 44
|
111 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years: Week 45
|
115 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years: Week 41
|
41 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years: Week 41
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years: Week 42
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years: Week 44
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years: Week 45
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years: Week 48
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years: Week 39
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years: Week 40
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years: Week 41
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years: Week 42
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years: Week 43
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years: Week 44
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years: Week 45
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years: Week 46
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years: Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years: Week 48
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years: Week 39
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years: Week 42
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years: Week 47
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years: Week 48
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years: Week 38
|
6 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years: Week 39
|
21 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years: Week 42
|
50 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years: Week 44
|
52 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years: Week 45
|
57 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years: Week 46
|
59 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years: Week 47
|
59 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years: Week 48
|
60 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years: Week 40
|
72 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years: Week 41
|
94 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years: Week 42
|
104 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years: Week 46
|
119 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years: Week 47
|
121 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years: Week 48
|
121 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years: Week 39
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years: Week 40
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years: Week 41
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years: Week 42
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years: Week 43
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years: Week 44
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years: Week 46
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years: Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years: Week 43
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years: Week 44
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years: Week 45
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years: Week 46
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years: Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years: Week 48
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years: Week 38
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years: Week 39
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years: Week 40
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years: Week 41
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years: Week 42
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years: Week 43
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years: Week 44
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years: Week 45
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years: Week 46
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years: Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years: Week 48
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years: Week 39
|
25 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years: Week 41
|
17 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years: Week 43
|
9 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years: Week 47
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years: Week 48
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years: Week 38
|
22 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years: Week 39
|
75 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years: Week 38
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years: Week 45
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years: Week 48
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years: Week 38
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years: Week 39
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years: Week 40
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years: Week 41
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years: Week 42
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years: Week 38
|
8 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years: Week 40
|
32 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years: Week 42
|
27 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years: Week 44
|
4 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years: Week 45
|
10 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years: Week 46
|
2 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years: Week 40
|
63 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years: Week 41
|
47 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years: Week 42
|
30 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years: Week 43
|
13 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years: Week 44
|
9 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years: Week 45
|
9 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years: Week 46
|
3 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years: Week 47
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years: Week 48
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years: Week 43
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years: Week 38
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years: Week 48
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years: Week 38
|
8 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years: Week 42
|
237 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years: Week 43
|
250 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years: Week 38
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years: Week 39
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years: Week 40
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years: Week 41
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years: Week 42
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years: Week 43
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years: Week 44
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years: Week 45
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years: Week 46
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years: Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years: Week 48
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years: Week 38
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years: Week 39
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years: Week 40
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years: Week 41
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years: Week 42
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years: Week 44
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years: Week 45
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years: Week 46
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years: Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years: Week 48
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years: Week 39
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years: Week 40
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years: Week 41
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years: Week 42
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years: Week 43
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years: Week 44
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years: Week 45
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years: Week 46
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years: Week 47
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years: Week 39
|
33 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years: Week 40
|
65 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years: Week 41
|
82 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years: Week 42
|
109 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years: Week 43
|
118 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years: Week 44
|
122 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years: Week 45
|
132 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years: Week 46
|
134 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years: Week 47
|
135 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years: Week 48
|
135 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years: Week 38
|
22 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years: Week 39
|
97 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years: Week 40
|
160 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years: Week 41
|
207 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years: Week 44
|
259 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years: Week 45
|
268 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years: Week 46
|
271 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years: Week 47
|
272 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years: Week 48
|
272 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years: Week 48
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years: Week 40
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years: Week 38
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years: Week 39
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years: Week 40
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years: Week 41
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years: Week 42
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years: Week 43
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years: Week 44
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years: Week 45
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years: Week 46
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years: Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years: Week 48
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years: Week 38
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years: Week 39
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years: Week 40
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years: Week 41
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years: Week 42
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years: Week 43
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years: Week 44
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years: Week 45
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years: Week 46
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years: Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years: Week 38
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years: Week 39
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years: Week 41
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years: Week 42
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years: Week 43
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years: Week 44
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years: Week 45
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years: Week 46
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years: Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years: Week 48
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years: Week 38
|
7 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years: Week 39
|
9 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years: Week 40
|
10 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years: Week 41
|
7 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years: Week 42
|
7 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years: Week 43
|
3 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years: Week 44
|
2 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years: Week 45
|
3 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years: Week 46
|
2 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years: Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years: Week 48
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years: Week 38
|
8 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years: Week 39
|
20 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years: Week 40
|
19 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years: Week 41
|
14 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years: Week 42
|
11 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years: Week 43
|
3 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years: Week 44
|
2 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years: Week 45
|
2 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years: Week 46
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years: Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years: Week 48
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years: Week 41
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years: Week 38
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years: Week 39
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years: Week 40
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years: Week 42
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years: Week 43
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years: Week 44
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years: Week 45
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years: Week 46
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years: Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years: Week 48
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years: Week 38
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years: Week 39
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years: Week 40
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years: Week 41
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years: Week 42
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years: Week 43
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years: Week 44
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years: Week 45
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years: Week 46
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years: Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years: Week 48
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years: Week 38
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years: Week 39
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years: Week 40
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years: Week 41
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years: Week 42
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years: Week 43
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years: Week 44
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years: Week 45
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years: Week 46
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years: Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years: Week 48
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years: Week 38
|
7 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years: Week 39
|
16 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years: Week 40
|
26 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years: Week 41
|
33 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years: Week 42
|
40 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years: Week 43
|
43 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years: Week 44
|
45 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years: Week 45
|
48 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years: Week 46
|
50 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years: Week 47
|
50 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years: Week 48
|
51 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years: Week 38
|
8 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years: Week 39
|
28 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years: Week 40
|
47 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years: Week 41
|
61 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years: Week 42
|
72 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years: Week 43
|
75 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years: Week 44
|
77 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years: Week 45
|
79 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years: Week 46
|
80 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years: Week 47
|
80 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years: Week 48
|
80 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years: Week 42
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years: Week 45
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years: Week 46
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years: Week 38
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years: Week 38
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years: Week 39
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years: Week 40
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years: Week 41
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years: Week 42
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years: Week 43
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years: Week 44
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years: Week 45
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years: Week 46
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years: Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years: Week 48
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years: Week 38
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years: Week 39
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years: Week 40
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years: Week 41
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years: Week 43
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years: Week 44
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years: Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years: Week 48
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years: Week 38
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years: Week 39
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years: Week 40
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years: Week 41
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years: Week 42
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years: Week 43
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years: Week 44
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years: Week 45
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years: Week 46
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years: Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years: Week 48
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years: Week 38
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years: Week 39
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years: Week 40
|
2 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years: Week 41
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years: Week 42
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years: Week 43
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years: Week 44
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years: Week 45
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years: Week 46
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years: Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years: Week 48
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years: Week 39
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years: Week 40
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years: Week 41
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years: Week 42
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years: Week 43
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years: Week 44
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years: Week 45
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years: Week 46
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years: Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years: Week 48
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years: Week 42
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years: Week 46
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years: Week 38
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years: Week 39
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years: Week 42
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years: Week 43
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years: Week 44
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years: Week 38
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years: Week 39
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years: Week 40
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years: Week 41
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years: Week 43
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years: Week 44
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years: Week 45
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years: Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years: Week 48
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years: Week 38
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years: Week 39
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years: Week 40
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years: Week 41
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years: Week 42
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years: Week 43
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years: Week 44
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years: Week 45
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years: Week 46
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years: Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years: Week 48
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years: Week 39
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years: Week 40
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years: Week 41
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years: Week 45
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years: Week 46
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years: Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years: Week 48
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years: Week 38
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years: Week 40
|
2 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years: Week 41
|
2 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years: Week 42
|
3 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years: Week 43
|
3 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years: Week 44
|
4 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years: Week 45
|
4 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years: Week 46
|
4 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years: Week 47
|
4 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years: Week 48
|
4 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years: Week 38
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years: Week 39
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years: Week 40
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years: Week 41
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years: Week 42
|
2 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years: Week 43
|
2 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years: Week 44
|
2 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years: Week 45
|
3 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years: Week 46
|
3 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years: Week 47
|
3 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years: Week 48
|
3 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years: Week 38
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years: Week 39
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years: Week 40
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years: Week 41
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years: Week 42
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years: Week 43
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years: Week 44
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years: Week 45
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years: Week 46
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years: Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years: Week 48
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years: Week 38
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years: Week 39
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years: Week 40
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years: Week 41
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years: Week 42
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years: Week 43
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years: Week 44
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years: Week 45
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years: Week 46
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years: Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years: Week 48
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years: Week 38
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years: Week 39
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years: Week 40
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years: Week 41
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years: Week 42
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years: Week 43
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years: Week 44
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years: Week 45
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years: Week 46
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years: Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years: Week 48
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years: Week 38
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years: Week 39
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years: Week 40
|
2 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years: Week 41
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years: Week 42
|
2 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years: Week 43
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years: Week 44
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years: Week 45
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years: Week 46
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years: Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years: Week 48
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years: Week 38
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years: Week 39
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years: Week 40
|
3 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years: Week 41
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years: Week 42
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years: Week 43
|
2 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years: Week 44
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years: Week 45
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years: Week 46
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years: Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years: Week 48
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years: Week 41
|
2 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years: Week 42
|
4 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years: Week 45
|
10 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years: Week 38
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years: Week 39
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years: Week 40
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years: Week 41
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years: Week 42
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years: Week 43
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years: Week 44
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years: Week 45
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years: Week 46
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years: Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years: Week 48
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years: Week 38
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years: Week 39
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years: Week 40
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years: Week 41
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years: Week 42
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years: Week 43
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years: Week 44
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years: Week 45
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years: Week 46
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years: Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years: Week 48
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years: Week 38
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years: Week 39
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years: Week 40
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years: Week 41
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years: Week 42
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years: Week 43
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years: Week 44
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years: Week 45
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years: Week 46
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years: Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years: Week 48
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years: Week 38
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years: Week 39
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years: Week 40
|
2 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years: Week 43
|
5 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years: Week 44
|
5 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years: Week 45
|
5 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years: Week 46
|
6 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years: Week 47
|
6 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years: Week 48
|
6 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years: Week 38
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years: Week 39
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years: Week 40
|
4 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years: Week 41
|
5 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years: Week 42
|
6 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years: Week 43
|
8 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years: Week 44
|
9 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years: Week 46
|
11 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years: Week 47
|
11 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years: Week 48
|
11 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years: Week 39
|
18 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years: Week 40
|
22 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years: Week 41
|
12 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years: Week 42
|
18 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years: Week 43
|
5 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years: Week 44
|
3 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years: Week 45
|
7 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years: Week 46
|
3 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years: Week 47
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years: Week 48
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years: Week 38
|
11 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years: Week 41
|
20 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years: Week 42
|
15 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years: Week 38
|
16 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years: Week 39
|
42 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years: Week 40
|
42 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years: Week 46
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years: Week 43
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years: Week 44
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years: Week 45
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years: Week 46
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years: Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years: Week 48
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years: Week 38
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years: Week 39
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years: Week 40
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years: Week 41
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years: Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years: Week 48
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years: Week 38
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years: Week 42
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years: Week 39
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years: Week 40
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years: Week 41
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years: Week 42
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years: Week 43
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years: Week 44
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years: Week 45
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years: Week 46
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years: Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years: Week 48
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years: Week 38
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years: Week 39
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years: Week 40
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years: Week 41
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years: Week 42
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years: Week 43
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years: Week 44
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years: Week 45
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years: Week 43
|
2 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years: Week 44
|
6 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years: Week 45
|
6 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years: Week 46
|
4 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years: Week 47
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years: Week 48
|
1 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years: Week 38
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years: Week 39
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years: Week 40
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years: Week 41
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years: Week 42
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years: Week 43
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years: Week 44
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years: Week 45
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years: Week 46
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years: Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years: Week 48
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years: Week 38
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years: Week 39
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years: Week 40
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years: Week 41
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years: Week 42
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years: Week 43
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years: Week 44
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years: Week 45
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years: Week 46
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years: Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years: Week 48
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years: Week 38
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years: Week 39
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years: Week 40
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years: Week 41
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years: Week 42
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years: Week 43
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years: Week 44
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years: Week 45
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years: Week 46
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years: Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years: Week 48
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years: Week 38
|
11 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years: Week 39
|
29 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years: Week 40
|
51 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years: Week 41
|
63 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years: Week 42
|
81 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years: Week 43
|
86 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years: Week 44
|
89 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years: Week 45
|
96 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years: Week 46
|
99 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years: Week 47
|
100 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years: Week 48
|
100 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years: Week 38
|
16 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years: Week 39
|
58 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years: Week 40
|
100 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years: Week 41
|
120 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years: Week 42
|
135 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years: Week 43
|
137 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years: Week 44
|
143 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years: Week 45
|
149 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years: Week 46
|
153 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years: Week 47
|
154 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years: Week 48
|
155 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years: Week 39
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years: Week 42
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years: Week 44
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years: Week 45
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years: Week 46
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years: Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years: Week 40
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years: Week 41
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years: Week 45
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years: Week 48
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years: Week 41
|
8 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years: Week 38
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years: Week 40
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years: Week 41
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years: Week 42
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years: Week 43
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years: Week 42
|
8 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years: Week 44
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years: Week 45
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years: Week 46
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years: Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6 months - 5 years: Week 48
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years: Week 43
|
6 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years: Week 44
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years: Week 38
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years: Week 39
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years: Week 40
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years: Week 41
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years: Week 45
|
7 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years: Week 46
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years: Week 43
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
6-12 years: Week 48
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years: Week 38
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years: Week 39
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years: Week 42
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years: Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years: Week 48
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years: Week 43
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years: Week 44
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years: Week 38
|
10 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years: Week 39
|
28 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years: Week 40
|
25 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years: Week 41
|
17 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years: Week 42
|
7 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years: Week 43
|
4 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years: Week 46
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
13-17 years: Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years: Week 44
|
4 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years: Week 45
|
3 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years: Week 38
|
9 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years: Week 39
|
20 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
18-65 years: Week 40
|
17 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years: Week 46
|
2 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years: Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
>65 years: Week 48
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years: Week 45
|
98 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years: Week 38
|
10 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years: Week 38
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years: Week 39
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years: Week 40
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years: Week 41
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years: Week 42
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years: Week 43
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years: Week 44
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years: Week 45
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years: Week 46
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years: Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6 months - 5 years: Week 48
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years: Week 38
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years: Week 39
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years: Week 40
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years: Week 41
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years: Week 42
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years: Week 43
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years: Week 44
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years: Week 45
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years: Week 46
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years: Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
6-12 years: Week 48
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years: Week 38
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years: Week 39
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years: Week 40
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years: Week 41
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years: Week 42
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years: Week 43
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years: Week 44
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years: Week 45
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years: Week 46
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years: Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
13-17 years: Week 48
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years: Week 38
|
9 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years: Week 39
|
29 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years: Week 40
|
46 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years: Week 41
|
54 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years: Week 42
|
62 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years: Week 43
|
68 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years: Week 44
|
69 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years: Week 45
|
76 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years: Week 46
|
77 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years: Week 47
|
77 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
18-65 years: Week 48
|
78 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years: Week 39
|
38 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years: Week 40
|
63 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years: Week 41
|
80 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years: Week 42
|
87 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years: Week 43
|
91 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years: Week 44
|
95 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years: Week 46
|
100 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years: Week 47
|
100 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
>65 years: Week 48
|
100 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At Risk: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At Risk: Week 38
|
62 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At Risk: Week 39
|
159 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At Risk: Week 40
|
151 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At Risk: Week 41
|
102 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At Risk: Week 42
|
74 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At Risk: Week 43
|
29 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At Risk: Week 44
|
28 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At Risk: Week 45
|
25 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At Risk: Week 46
|
11 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At Risk: Week 47
|
2 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At Risk: Week 48
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk: Week 38
|
5 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk: Week 39
|
10 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk: Week 40
|
13 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk: Week 41
|
10 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk: Week 42
|
11 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk: Week 43
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk: Week 44
|
3 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk: Week 45
|
3 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk: Week 46
|
2 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk: Week 47
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk: Week 48
|
1 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 38
|
62 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 39
|
221 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 40
|
372 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 41
|
474 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 42
|
548 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 43
|
577 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 44
|
605 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 45
|
630 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 46
|
641 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 47
|
643 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 48
|
644 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 38
|
5 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 39
|
15 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 40
|
28 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 41
|
38 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 42
|
49 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 43
|
49 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 44
|
52 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 45
|
55 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 46
|
57 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 47
|
58 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 48
|
59 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk: Week 38
|
4 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk: Week 39
|
15 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk: Week 40
|
8 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk: Week 41
|
8 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk: Week 42
|
8 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk: Week 43
|
3 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk: Week 44
|
2 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk: Week 45
|
3 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk: Week 46
|
4 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk: Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk: Week 48
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk: Week 38
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk: Week 39
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk: Week 40
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk: Week 41
|
2 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk: Week 42
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk: Week 43
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk: Week 44
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk: Week 45
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk: Week 46
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk: Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk: Week 48
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 38
|
4 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 39
|
19 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 40
|
27 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 41
|
35 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 42
|
43 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 43
|
46 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 44
|
48 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 45
|
51 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 46
|
55 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 47
|
55 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 48
|
55 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 38
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 39
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 40
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 41
|
2 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 42
|
3 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 43
|
3 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 44
|
3 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 45
|
3 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 46
|
3 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 47
|
3 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 48
|
3 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk: Week 38
|
14 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk: Week 39
|
19 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk: Week 40
|
21 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk: Week 41
|
26 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk: Week 42
|
13 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk: Week 43
|
6 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk: Week 44
|
5 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk: Week 45
|
8 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk: Week 46
|
2 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk: Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk: Week 48
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk: Week 38
|
2 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk: Week 39
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk: Week 40
|
3 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk: Week 41
|
2 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk: Week 42
|
2 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk: Week 43
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk: Week 44
|
2 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk: Week 45
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk: Week 46
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk: Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk: Week 48
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 38
|
14 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 39
|
33 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 40
|
54 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 41
|
80 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 42
|
93 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 43
|
99 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 44
|
104 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 45
|
112 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 46
|
114 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 47
|
114 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 48
|
114 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 38
|
2 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 39
|
3 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 40
|
6 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 41
|
8 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 42
|
10 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 43
|
10 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 44
|
12 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 45
|
12 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 46
|
13 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 47
|
13 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 48
|
13 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk: Week 46
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk: Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk: Week 48
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk: Week 38
|
18 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk: Week 39
|
42 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk: Week 40
|
41 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk: Week 41
|
25 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk: Week 42
|
18 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk: Week 43
|
3 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk: Week 44
|
6 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk: Week 45
|
7 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk: Week 46
|
5 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk: Week 47
|
2 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk: Week 48
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk: Week 38
|
2 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk: Week 39
|
5 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk: Week 40
|
2 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk: Week 41
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk: Week 42
|
2 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk: Week 43
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk: Week 44
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk: Week 45
|
2 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative)
At risk: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative)
At risk: Week 38
|
18 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative)
At risk: Week 39
|
60 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative)
At risk: Week 40
|
101 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative)
At risk: Week 41
|
126 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative)
At risk: Week 42
|
144 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative)
At risk: Week 43
|
147 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative)
At risk: Week 44
|
153 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative)
At risk: Week 45
|
160 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative)
At risk: Week 46
|
165 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative)
At risk: Week 47
|
167 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative)
At risk: Week 48
|
167 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative)
Not at risk: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative)
Not at risk: Week 38
|
2 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative)
Not at risk: Week 39
|
7 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative)
Not at risk: Week 40
|
9 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative)
Not at risk: Week 41
|
9 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative)
Not at risk: Week 42
|
11 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative)
Not at risk: Week 43
|
11 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative)
Not at risk: Week 44
|
11 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative)
Not at risk: Week 45
|
13 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative)
Not at risk: Week 46
|
14 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative)
Not at risk: Week 47
|
14 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative)
Not at risk: Week 48
|
15 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
At risk: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
At risk: Week 38
|
28 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
At risk: Week 39
|
94 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
At risk: Week 40
|
88 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
At risk: Week 41
|
62 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
At risk: Week 42
|
49 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
At risk: Week 43
|
22 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
At risk: Week 44
|
12 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
At risk: Week 45
|
16 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
At risk: Week 46
|
5 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
At risk: Week 47
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
At risk: Week 48
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
Not at risk: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
Not at risk: Week 38
|
2 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
Not at risk: Week 39
|
6 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
Not at risk: Week 40
|
7 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
Not at risk: Week 41
|
2 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
Not at risk: Week 42
|
9 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
Not at risk: Week 43
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
Not at risk: Week 44
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
Not at risk: Week 45
|
3 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
Not at risk: Week 46
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
Not at risk: Week 47
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
Not at risk: Week 48
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 38
|
28 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 39
|
122 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 40
|
210 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 41
|
272 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 42
|
321 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 43
|
343 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 44
|
355 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 45
|
371 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 46
|
376 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 47
|
377 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 48
|
377 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 38
|
2 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 39
|
8 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 40
|
15 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 41
|
17 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 42
|
26 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 43
|
26 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 44
|
27 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 45
|
30 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 46
|
30 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 47
|
31 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 48
|
31 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
At risk: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
At risk: Week 38
|
13 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
At risk: Week 39
|
27 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
At risk: Week 40
|
28 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
At risk: Week 41
|
18 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
At risk: Week 42
|
17 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
At risk: Week 43
|
6 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
At risk: Week 44
|
4 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
At risk: Week 45
|
5 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
At risk: Week 46
|
3 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
At risk: Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
At risk: Week 48
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
Not at risk: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
Not at risk: Week 38
|
2 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
Not at risk: Week 39
|
2 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
Not at risk: Week 40
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
Not at risk: Week 41
|
3 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
Not at risk: Week 42
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
Not at risk: Week 43
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
Not at risk: Week 44
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
Not at risk: Week 45
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
Not at risk: Week 46
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
Not at risk: Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
Not at risk: Week 48
|
1 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 40
|
5 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 38
|
13 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 39
|
40 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 40
|
68 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 41
|
86 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 42
|
103 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 43
|
109 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 44
|
113 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 45
|
118 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 46
|
121 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 47
|
121 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 48
|
121 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 38
|
2 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 39
|
4 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 41
|
8 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 42
|
9 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 43
|
9 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 44
|
9 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 45
|
9 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 46
|
9 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 47
|
9 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 48
|
10 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
At risk: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
At risk: Week 38
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
At risk: Week 39
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
At risk: Week 40
|
3 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
At risk: Week 41
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
At risk: Week 42
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
At risk: Week 43
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
At risk: Week 44
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
At risk: Week 45
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
At risk: Week 46
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
At risk: Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
At risk: Week 48
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
Not at risk: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
Not at risk: Week 38
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
Not at risk: Week 39
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
Not at risk: Week 40
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
Not at risk: Week 41
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
Not at risk: Week 42
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
Not at risk: Week 43
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
Not at risk: Week 44
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
Not at risk: Week 45
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
Not at risk: Week 46
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
Not at risk: Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
Not at risk: Week 48
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 38
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 39
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 40
|
3 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 41
|
3 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 42
|
4 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 43
|
4 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 44
|
5 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 45
|
6 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 46
|
6 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 47
|
6 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 48
|
6 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 38
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 39
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 40
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 41
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 42
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 43
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 44
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 45
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 46
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 47
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 48
|
1 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
At risk: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
At risk: Week 38
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
At risk: Week 39
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
At risk: Week 40
|
5 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
At risk: Week 41
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
At risk: Week 42
|
2 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
At risk: Week 43
|
3 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
At risk: Week 44
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
At risk: Week 45
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
At risk: Week 46
|
2 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
At risk: Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
At risk: Week 48
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
Not at risk: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
Not at risk: Week 38
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
Not at risk: Week 39
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
Not at risk: Week 40
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
Not at risk: Week 41
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
Not at risk: Week 42
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
Not at risk: Week 43
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
Not at risk: Week 44
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
Not at risk: Week 45
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
Not at risk: Week 46
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
Not at risk: Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
Not at risk: Week 48
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 39
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 40
|
6 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 42
|
9 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 43
|
12 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 43
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 38
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 41
|
7 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 44
|
13 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 45
|
14 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 46
|
16 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 47
|
16 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 48
|
16 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 38
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 39
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 40
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 41
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 42
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 44
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 45
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 46
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 47
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 48
|
1 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
At risk: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
At risk: Week 38
|
24 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
At risk: Week 39
|
54 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
At risk: Week 40
|
61 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
At risk: Week 41
|
29 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
At risk: Week 42
|
31 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
At risk: Week 43
|
7 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
At risk: Week 44
|
9 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
At risk: Week 45
|
11 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
At risk: Week 46
|
5 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
At risk: Week 47
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
At risk: Week 48
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
Not at risk: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
Not at risk: Week 38
|
3 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
Not at risk: Week 39
|
6 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
Not at risk: Week 40
|
3 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
Not at risk: Week 41
|
3 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
Not at risk: Week 42
|
2 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
Not at risk: Week 43
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
Not at risk: Week 44
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
Not at risk: Week 45
|
2 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
Not at risk: Week 46
|
2 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
Not at risk: Week 47
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
Not at risk: Week 48
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 38
|
24 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 39
|
78 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 40
|
139 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 41
|
168 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 42
|
199 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 43
|
206 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 44
|
215 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 45
|
226 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 46
|
231 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 47
|
232 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 48
|
233 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 38
|
3 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 39
|
9 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 40
|
12 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 41
|
15 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 42
|
17 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 43
|
17 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 44
|
17 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 45
|
19 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 46
|
21 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 47
|
22 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 48
|
22 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
Not at risk: Week 48
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
At risk: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
At risk: Week 38
|
17 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
At risk: Week 39
|
44 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
At risk: Week 40
|
37 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
At risk: Week 41
|
24 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
At risk: Week 42
|
13 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
At risk: Week 43
|
10 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
At risk: Week 44
|
5 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
At risk: Week 45
|
8 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
At risk: Week 46
|
3 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
At risk: Week 47
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
At risk: Week 48
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
Not at risk: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
Not at risk: Week 38
|
2 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
Not at risk: Week 39
|
4 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
Not at risk: Week 40
|
5 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
Not at risk: Week 41
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
Not at risk: Week 42
|
2 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
Not at risk: Week 43
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
Not at risk: Week 44
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
Not at risk: Week 45
|
2 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
Not at risk: Week 46
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
Not at risk: Week 47
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 38
|
17 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 39
|
61 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 40
|
98 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 41
|
122 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 42
|
135 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 43
|
145 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 44
|
150 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 45
|
158 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 46
|
161 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 47
|
161 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
At risk: Week 48
|
161 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 37
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 38
|
2 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 39
|
6 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 40
|
11 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 41
|
12 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 42
|
14 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 43
|
14 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 44
|
14 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 45
|
16 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 46
|
16 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 47
|
16 Participants
|
—
|
—
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk: Week 48
|
17 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
AEIs were presented by categories depending of the nature of the event. - Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia, etc.); - All other presentations that were reported following vaccination (e.g., Bell's palsy, Guillain-Barre syndrome).
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
n=2295 Participants
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
n=3178 Participants
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Week 41
|
172 Participants
|
5 Participants
|
7 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Week 42
|
118 Participants
|
10 Participants
|
8 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Week 43
|
57 Participants
|
4 Participants
|
10 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Week 44
|
52 Participants
|
6 Participants
|
4 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Week 45
|
54 Participants
|
2 Participants
|
4 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Week 46
|
37 Participants
|
6 Participants
|
2 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Week 47
|
14 Participants
|
2 Participants
|
3 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Week 48
|
13 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Week 38
|
87 Participants
|
4 Participants
|
7 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Week 39
|
227 Participants
|
10 Participants
|
3 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Week 40
|
218 Participants
|
11 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
AEIs were presented by categories depending of the nature of the event. - Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia, etc.); - All other presentations that were reported following vaccination (e.g., Bell's palsy, Guillain-Barre syndrome).
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
n=2295 Participants
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
n=3178 Participants
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Week 38
|
87 Participants
|
4 Participants
|
7 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Week 40
|
532 Participants
|
25 Participants
|
14 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Week 41
|
704 Participants
|
30 Participants
|
21 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Week 42
|
822 Participants
|
40 Participants
|
29 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Week 43
|
879 Participants
|
44 Participants
|
39 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Week 44
|
931 Participants
|
50 Participants
|
43 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Week 45
|
985 Participants
|
52 Participants
|
47 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Week 46
|
1022 Participants
|
58 Participants
|
49 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Week 47
|
1036 Participants
|
60 Participants
|
52 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Week 48
|
1049 Participants
|
62 Participants
|
54 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Week 39
|
314 Participants
|
14 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
AEIs were presented by categories depending of the nature of the event. - Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia, etc.); - All other presentations that were reported following vaccination (e.g., Bell's palsy, Guillain-Barre syndrome).
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
n=2295 Participants
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
n=3178 Participants
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Week 44
|
6 Participants
|
2 Participants
|
3 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Week 45
|
8 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Week 38
|
8 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Week 39
|
23 Participants
|
5 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Week 40
|
22 Participants
|
5 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Week 41
|
20 Participants
|
3 Participants
|
1 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Week 42
|
15 Participants
|
4 Participants
|
2 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Week 43
|
13 Participants
|
0 Participants
|
3 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Week 46
|
11 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Week 47
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Week 48
|
5 Participants
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
AEIs were presented by categories depending of the nature of the event. - Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia, etc.); - All other presentations that were reported following vaccination (e.g., Bell's palsy, Guillain-Barre syndrome).
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
n=2295 Participants
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
n=3178 Participants
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative).
Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative).
Week 38
|
8 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative).
Week 39
|
31 Participants
|
7 Participants
|
2 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative).
Week 40
|
53 Participants
|
12 Participants
|
2 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative).
Week 41
|
73 Participants
|
15 Participants
|
3 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative).
Week 42
|
88 Participants
|
19 Participants
|
5 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative).
Week 43
|
101 Participants
|
19 Participants
|
8 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative).
Week 44
|
107 Participants
|
21 Participants
|
11 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative).
Week 45
|
115 Participants
|
23 Participants
|
13 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative).
Week 46
|
126 Participants
|
24 Participants
|
13 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative).
Week 47
|
128 Participants
|
24 Participants
|
14 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative).
Week 48
|
133 Participants
|
25 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
AEIs were presented by categories depending of the nature of the event. - Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia, etc.); - All other presentations that were reported following vaccination (e.g., Bell's palsy, Guillain-Barre syndrome).
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
n=2295 Participants
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
n=3178 Participants
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Week 38
|
16 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Week 39
|
20 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Week 40
|
24 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Week 41
|
28 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Week 42
|
15 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Week 43
|
6 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Week 44
|
7 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Week 45
|
8 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Week 46
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Week 47
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Week 48
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
AEIs were presented by categories depending of the nature of the event. - Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia, etc.); - All other presentations that were reported following vaccination (e.g., Bell's palsy, Guillain-Barre syndrome).
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
n=2295 Participants
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
n=3178 Participants
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative).
Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative).
Week 39
|
36 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative).
Week 40
|
60 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative).
Week 42
|
103 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative).
Week 43
|
109 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative).
Week 44
|
116 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative).
Week 45
|
124 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative).
Week 46
|
127 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative).
Week 47
|
127 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative).
Week 48
|
127 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative).
Week 38
|
16 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative).
Week 41
|
88 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
AEIs were presented by categories depending of the nature of the event. - Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia, etc.); - All other presentations that were reported following vaccination (e.g., Bell's palsy, Guillain-Barre syndrome).
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
n=2295 Participants
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
n=3178 Participants
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Any, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Any, Week 38
|
21 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Any, Week 39
|
51 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Any, Week 40
|
48 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Any, Week 43
|
5 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Any, Week 44
|
7 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Any, Week 45
|
10 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Any, Week 46
|
7 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Any, Week 47
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Any, Week 48
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Drowsiness, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Drowsiness, Week 38
|
8 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Drowsiness, Week 39
|
20 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Drowsiness, Week 40
|
18 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Drowsiness, Week 41
|
10 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Drowsiness, Week 42
|
9 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Drowsiness, Week 43
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Drowsiness, Week 44
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Drowsiness, Week 45
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Drowsiness, Week 46
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Drowsiness, Week 47
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Drowsiness, Week 48
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Fatigue, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Fatigue, Week 38
|
20 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Fatigue, Week 39
|
44 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Fatigue, Week 41
|
22 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Fatigue, Week 42
|
15 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Irritability, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Irritability, Week 38
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Irritability, Week 40
|
7 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Irritability, Week 42
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Irritability, Week 47
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Irritability, Week 48
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Malaise, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Malaise, Week 38
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Malaise, Week 39
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Malaise, Week 40
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Malaise, Week 41
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Malaise, Week 42
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Malaise, Week 43
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Malaise, Week 47
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Malaise, Week 48
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Any, Week 41
|
28 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Any, Week 42
|
22 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Fatigue, Week 40
|
39 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Fatigue, Week 43
|
5 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Fatigue, Week 44
|
6 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Fatigue, Week 45
|
9 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Fatigue, Week 46
|
7 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Fatigue, Week 47
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Fatigue, Week 48
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Irritability, Week 39
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Irritability, Week 41
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Irritability, Week 43
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Irritability, Week 44
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Irritability, Week 45
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Irritability, Week 46
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Malaise, Week 44
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Malaise, Week 45
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Malaise, Week 46
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
AEIs were presented by categories depending of the nature of the event. - Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia, etc.); - All other presentations that were reported following vaccination (e.g., Bell's palsy, Guillain-Barre syndrome).
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
n=2295 Participants
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
n=3178 Participants
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Any, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Any, Week 38
|
21 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Any, Week 40
|
120 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Any, Week 42
|
170 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Any, Week 43
|
175 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Any, Week 45
|
192 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Any, Week 46
|
199 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Drowsiness, Week 39
|
28 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Drowsiness, Week 42
|
65 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Drowsiness, Week 43
|
66 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Drowsiness, Week 44
|
67 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Fatigue, Week 39
|
64 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Fatigue, Week 40
|
103 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Fatigue, Week 41
|
125 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Fatigue, Week 42
|
140 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Fatigue, Week 45
|
160 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Fatigue, Week 46
|
167 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Fatigue, Week 47
|
168 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Fatigue, Week 48
|
169 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Irritability, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Irritability, Week 38
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Irritability, Week 39
|
5 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Irritability, Week 40
|
12 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Irritability, Week 41
|
13 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Irritability, Week 42
|
14 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Irritability, Week 43
|
15 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Irritability, Week 44
|
16 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Irritability, Week 45
|
17 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Irritability, Week 46
|
17 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Malaise, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Malaise, Week 38
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Malaise, Week 39
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Malaise, Week 40
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Malaise, Week 44
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Malaise, Week 45
|
4 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Malaise, Week 46
|
4 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Malaise, Week 47
|
4 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Malaise, Week 48
|
4 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Any, Week 47
|
201 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Any, Week 48
|
202 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Drowsiness, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Drowsiness, Week 38
|
8 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Drowsiness, Week 40
|
46 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Drowsiness, Week 41
|
56 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Drowsiness, Week 45
|
69 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Drowsiness, Week 46
|
71 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Drowsiness, Week 47
|
72 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Drowsiness, Week 48
|
72 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Fatigue, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Fatigue, Week 38
|
20 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Fatigue, Week 43
|
145 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Fatigue, Week 44
|
151 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Irritability, Week 47
|
17 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Irritability, Week 48
|
17 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Malaise, Week 41
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Malaise, Week 42
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Malaise, Week 43
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Any, Week 39
|
72 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Any, Week 41
|
148 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Any, Week 44
|
182 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
Respiratory/Miscellaneous AE include any respiratory/miscellaneous AE, conjunctivitis, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing.
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
n=2295 Participants
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
n=3178 Participants
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Any, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Any, Week 39
|
120 Participants
|
3 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Any, Week 40
|
111 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Any, Week 43
|
29 Participants
|
1 Participants
|
5 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Any, Week 44
|
20 Participants
|
4 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Any, Week 45
|
29 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Any, Week 46
|
14 Participants
|
3 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Any, Week 47
|
7 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Any, Week 48
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Conjunctivitis, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Conjunctivitis, Week 40
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Conjunctivitis, Week 41
|
5 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Conjunctivitis, Week 44
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Conjunctivitis, Week 45
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Conjunctivitis, Week 46
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Conjunctivitis, Week 47
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Conjunctivitis, Week 48
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Coryza, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Coryza, Week 38
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Coryza, Week 39
|
19 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Coryza, Week 40
|
26 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Coryza, Week 41
|
11 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Coryza, Week 42
|
20 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Coryza, Week 43
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Coryza, Week 44
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Coryza, Week 45
|
7 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Coryza, Week 46
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Cough, Week 41
|
33 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Cough, Week 42
|
30 Participants
|
2 Participants
|
3 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Cough, Week 43
|
8 Participants
|
1 Participants
|
5 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Cough, Week 44
|
12 Participants
|
4 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Cough, Week 45
|
14 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Cough, Week 46
|
10 Participants
|
3 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Cough, Week 47
|
3 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Cough, Week 48
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Epistaxis, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Epistaxis, Week 38
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Epistaxis, Week 39
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Epistaxis, Week 40
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Epistaxis, Week 41
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Epistaxis, Week 42
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Epistaxis, Week 43
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Epistaxis, Week 44
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Epistaxis, Week 45
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Epistaxis, Week 46
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Epistaxis, Week 47
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Epistaxis, Week 48
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Hoarseness, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Hoarseness, Week 38
|
6 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Hoarseness, Week 39
|
15 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Hoarseness, Week 42
|
8 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Hoarseness, Week 43
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Hoarseness, Week 44
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Hoarseness, Week 45
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Nasal congestion, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Nasal congestion, Week 38
|
22 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Nasal congestion, Week 39
|
70 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Nasal congestion, Week 40
|
57 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Nasal congestion, Week 42
|
33 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Nasal congestion, Week 43
|
19 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Nasal congestion, Week 44
|
7 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Nasal congestion, Week 45
|
15 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Nasal congestion, Week 46
|
5 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Nasal congestion, Week 47
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Nasal congestion, Week 48
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Oropharyngeal pain, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Oropharyngeal pain, Week 40
|
39 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Oropharyngeal pain, Week 43
|
10 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Oropharyngeal pain, Week 45
|
8 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Oropharyngeal pain, Week 46
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Oropharyngeal pain, Week 47
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Oropharyngeal pain, Week 48
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Rhinorrhoea, Week 40
|
54 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Rhinorrhoea, Week 41
|
45 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Rhinorrhoea, Week 42
|
27 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Rhinorrhoea, Week 43
|
17 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Rhinorrhoea, Week 44
|
5 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Rhinorrhoea, Week 45
|
15 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Rhinorrhoea, Week 46
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Rhinorrhoea, Week 47
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Rhinorrhoea, Week 48
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Wheezing, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Wheezing, Week 38
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Wheezing, Week 42
|
12 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Wheezing, Week 45
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Wheezing, Week 47
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Wheezing, Week 48
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Any, Week 38
|
34 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Any, Week 41
|
82 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Any, Week 42
|
65 Participants
|
4 Participants
|
3 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Conjunctivitis, Week 38
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Conjunctivitis, Week 39
|
10 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Conjunctivitis, Week 42
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Conjunctivitis, Week 43
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Coryza, Week 47
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Coryza, Week 48
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Cough, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Cough, Week 38
|
11 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Cough, Week 39
|
43 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Cough, Week 40
|
45 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Hoarseness, Week 40
|
16 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Hoarseness, Week 41
|
15 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Hoarseness, Week 46
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Hoarseness, Week 47
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Hoarseness, Week 48
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Nasal congestion, Week 41
|
46 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Oropharyngeal pain, Week 38
|
9 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Oropharyngeal pain, Week 39
|
33 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Oropharyngeal pain, Week 41
|
21 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Oropharyngeal pain, Week 42
|
25 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Oropharyngeal pain, Week 44
|
5 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Rhinorrhoea, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Rhinorrhoea, Week 38
|
17 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Rhinorrhoea, Week 39
|
58 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Wheezing, Week 39
|
11 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Wheezing, Week 40
|
13 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Wheezing, Week 41
|
10 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Wheezing, Week 43
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Wheezing, Week 44
|
6 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Wheezing, Week 46
|
4 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
Respiratory/Miscellaneous AE include any respiratory/miscellaneous AE, conjunctivitis, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing.
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
n=2295 Participants
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
n=3178 Participants
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Rhinorrhoea, Week 41
|
174 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Rhinorrhoea, Week 42
|
201 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Any, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Any, Week 38
|
34 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Any, Week 39
|
154 Participants
|
4 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Any, Week 40
|
265 Participants
|
6 Participants
|
2 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Any, Week 42
|
412 Participants
|
12 Participants
|
7 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Any, Week 43
|
441 Participants
|
13 Participants
|
12 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Any, Week 44
|
461 Participants
|
17 Participants
|
13 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Any, Week 45
|
490 Participants
|
17 Participants
|
13 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Any, Week 46
|
504 Participants
|
20 Participants
|
13 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Any, Week 47
|
511 Participants
|
22 Participants
|
13 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Any, Week 48
|
513 Participants
|
23 Participants
|
13 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Conjunctivitis, Week 40
|
16 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Conjunctivitis, Week 41
|
21 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Conjunctivitis, Week 43
|
24 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Conjunctivitis, Week 44
|
27 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Conjunctivitis, Week 45
|
28 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Conjunctivitis, Week 46
|
28 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Coryza, Week 42
|
79 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Coryza, Week 43
|
83 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Cough, Week 44
|
182 Participants
|
12 Participants
|
13 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Cough, Week 45
|
196 Participants
|
12 Participants
|
13 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Cough, Week 46
|
206 Participants
|
15 Participants
|
13 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Epistaxis, Week 39
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Epistaxis, Week 43
|
10 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Epistaxis, Week 44
|
10 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Epistaxis, Week 45
|
12 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Epistaxis, Week 48
|
12 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Hoarseness, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Hoarseness, Week 38
|
6 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Hoarseness, Week 39
|
21 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Hoarseness, Week 42
|
60 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Hoarseness, Week 43
|
63 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Hoarseness, Week 44
|
65 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Hoarseness, Week 45
|
68 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Hoarseness, Week 46
|
71 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Hoarseness, Week 47
|
71 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Hoarseness, Week 48
|
71 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Nasal congestion, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Nasal congestion, Week 38
|
22 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Nasal congestion, Week 39
|
92 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Nasal congestion, Week 40
|
149 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Nasal congestion, Week 42
|
228 Participants
|
3 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Nasal congestion, Week 43
|
247 Participants
|
3 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Nasal congestion, Week 46
|
274 Participants
|
3 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Nasal congestion, Week 47
|
276 Participants
|
3 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Oropharyngeal pain, Week 38
|
9 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Oropharyngeal pain, Week 39
|
42 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Oropharyngeal pain, Week 41
|
102 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Oropharyngeal pain, Week 42
|
127 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Oropharyngeal pain, Week 43
|
137 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Rhinorrhoea, Week 39
|
75 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Rhinorrhoea, Week 40
|
129 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Rhinorrhoea, Week 45
|
238 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Wheezing, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Wheezing, Week 47
|
63 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Wheezing, Week 48
|
63 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Conjunctivitis, Week 47
|
28 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Conjunctivitis, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Conjunctivitis, Week 38
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Conjunctivitis, Week 39
|
14 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Conjunctivitis, Week 42
|
23 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Conjunctivitis, Week 48
|
28 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Coryza, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Coryza, Week 38
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Coryza, Week 39
|
22 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Coryza, Week 40
|
48 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Coryza, Week 41
|
59 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Coryza, Week 44
|
86 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Coryza, Week 45
|
93 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Coryza, Week 46
|
95 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Coryza, Week 47
|
95 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Coryza, Week 48
|
96 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Cough, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Cough, Week 38
|
11 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Cough, Week 39
|
54 Participants
|
3 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Cough, Week 40
|
99 Participants
|
3 Participants
|
2 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Cough, Week 41
|
132 Participants
|
5 Participants
|
4 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Cough, Week 42
|
162 Participants
|
7 Participants
|
7 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Cough, Week 43
|
170 Participants
|
8 Participants
|
12 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Cough, Week 47
|
209 Participants
|
17 Participants
|
13 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Cough, Week 48
|
210 Participants
|
17 Participants
|
13 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Epistaxis, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Epistaxis, Week 38
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Epistaxis, Week 40
|
4 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Epistaxis, Week 41
|
8 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Epistaxis, Week 42
|
10 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Epistaxis, Week 46
|
12 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Epistaxis, Week 47
|
12 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Hoarseness, Week 40
|
37 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Hoarseness, Week 41
|
52 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Nasal congestion, Week 41
|
195 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Nasal congestion, Week 44
|
254 Participants
|
3 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Nasal congestion, Week 45
|
269 Participants
|
3 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Nasal congestion, Week 48
|
276 Participants
|
3 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Oropharyngeal pain, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Oropharyngeal pain, Week 40
|
81 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Oropharyngeal pain, Week 44
|
142 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Oropharyngeal pain, Week 45
|
150 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Oropharyngeal pain, Week 46
|
152 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Oropharyngeal pain, Week 47
|
155 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Oropharyngeal pain, Week 48
|
155 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Rhinorrhoea, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Rhinorrhoea, Week 38
|
17 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Rhinorrhoea, Week 43
|
218 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Rhinorrhoea, Week 44
|
223 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Rhinorrhoea, Week 46
|
242 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Rhinorrhoea, Week 47
|
243 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Rhinorrhoea, Week 48
|
243 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Wheezing, Week 38
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Wheezing, Week 39
|
13 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Wheezing, Week 40
|
26 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Wheezing, Week 41
|
36 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Wheezing, Week 42
|
48 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Wheezing, Week 43
|
50 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Wheezing, Week 44
|
56 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Wheezing, Week 45
|
59 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Wheezing, Week 46
|
63 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Any, Week 41
|
347 Participants
|
8 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
Gastrointestinal AEs include any gastrointestinal AEs, decreased appetite, diarrhoea, nausea and vomiting.
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
n=2295 Participants
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
n=3178 Participants
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Any, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Any, Week 43
|
9 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Any, Week 44
|
5 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Any, Week 45
|
6 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Decreased appetite, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Decreased appetite, Week 38
|
7 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Decreased appetite, Week 43
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Decreased appetite, Week 44
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Decreased appetite, Week 48
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Diarrhoea, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Diarrhoea, Week 45
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Diarrhoea, Week 46
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Vomiting, Week 46
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Vomiting, Week 47
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Vomiting, Week 48
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Any, Week 38
|
18 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Any, Week 39
|
32 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Any, Week 40
|
34 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Any, Week 41
|
25 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Any, Week 42
|
19 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Any, Week 46
|
4 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Any, Week 47
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Any, Week 48
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Decreased appetite, Week 39
|
11 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Decreased appetite, Week 40
|
12 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Decreased appetite, Week 41
|
7 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Decreased appetite, Week 42
|
6 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Decreased appetite, Week 45
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Decreased appetite, Week 46
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Decreased appetite, Week 47
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Diarrhoea, Week 38
|
6 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Diarrhoea, Week 39
|
12 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Diarrhoea, Week 40
|
14 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Diarrhoea, Week 41
|
12 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Diarrhoea, Week 42
|
6 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Diarrhoea, Week 43
|
5 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Diarrhoea, Week 44
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Diarrhoea, Week 47
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Diarrhoea, Week 48
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Nausea, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Nausea, Week 38
|
12 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Nausea, Week 39
|
18 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Nausea, Week 40
|
15 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Nausea, Week 41
|
8 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Nausea, Week 42
|
9 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Nausea, Week 43
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Nausea, Week 44
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Nausea, Week 45
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Nausea, Week 46
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Nausea, Week 47
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Nausea, Week 48
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Vomiting, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Vomiting, Week 38
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Vomiting, Week 39
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Vomiting, Week 40
|
7 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Vomiting, Week 41
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Vomiting, Week 42
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Vomiting, Week 43
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Vomiting, Week 44
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Vomiting, Week 45
|
2 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
Gastrointestinal AEs include any gastrointestinal AEs, decreased appetite, diarrhoea, nausea and vomiting.
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
n=2295 Participants
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
n=3178 Participants
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Nausea, Week 38
|
12 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Nausea, Week 39
|
30 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Any, Week 43
|
137 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Any, Week 44
|
142 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Any, Week 45
|
148 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Any, Week 48
|
154 Participants
|
2 Participants
|
3 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Decreased appetite, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Diarrhoea, Week 39
|
18 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Diarrhoea, Week 40
|
32 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Nausea, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Nausea, Week 42
|
62 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Nausea, Week 43
|
65 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Nausea, Week 44
|
65 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Nausea, Week 45
|
69 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Nausea, Week 48
|
71 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Vomiting, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Vomiting, Week 38
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Vomiting, Week 39
|
5 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Vomiting, Week 40
|
12 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Vomiting, Week 41
|
13 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Any, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Any, Week 38
|
18 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Any, Week 39
|
50 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Any, Week 40
|
84 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Any, Week 41
|
109 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Any, Week 42
|
128 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Any, Week 46
|
152 Participants
|
2 Participants
|
3 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Any, Week 47
|
153 Participants
|
2 Participants
|
3 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Decreased appetite, Week 38
|
7 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Decreased appetite, Week 39
|
18 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Decreased appetite, Week 40
|
30 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Decreased appetite, Week 41
|
37 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Decreased appetite, Week 42
|
43 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Decreased appetite, Week 43
|
45 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Decreased appetite, Week 44
|
46 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Decreased appetite, Week 45
|
48 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Decreased appetite, Week 46
|
50 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Decreased appetite, Week 47
|
50 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Decreased appetite, Week 48
|
50 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Diarrhoea, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Diarrhoea, Week 38
|
6 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Diarrhoea, Week 41
|
44 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Diarrhoea, Week 42
|
50 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Diarrhoea, Week 43
|
55 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Diarrhoea, Week 44
|
59 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Diarrhoea, Week 45
|
62 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Diarrhoea, Week 46
|
63 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Diarrhoea, Week 47
|
64 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Diarrhoea, Week 48
|
64 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Nausea, Week 40
|
45 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Nausea, Week 41
|
53 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Nausea, Week 46
|
70 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Nausea, Week 47
|
70 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Vomiting, Week 42
|
16 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Vomiting, Week 43
|
17 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Vomiting, Week 44
|
17 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Vomiting, Week 45
|
19 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Vomiting, Week 46
|
19 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Vomiting, Week 47
|
19 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Vomiting, Week 48
|
19 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
Sensitivity/anaphylaxis AEs include any sensitivity/anaphylaxis AEs, anaphylactic reactions, facial oedema and hypersensitivity reactions.
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
n=2295 Participants
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
n=3178 Participants
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Any, Week 39
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Any, Week 40
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Any, Week 43
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Any, Week 44
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Any, Week 45
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Any, Week 47
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Anaphylactic reactions, Week 44
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Anaphylactic reactions, Week 45
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Anaphylactic reactions, Week 46
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Facial oedema, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Facial oedema, Week 38
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Facial oedema, Week 39
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Facial oedema, Week 40
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Facial oedema, Week 41
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Facial oedema, Week 42
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Facial oedema, Week 43
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Facial oedema, Week 44
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Facial oedema, Week 45
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Facial oedema, Week 46
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Hypersensitivity reactions, Week 38
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Hypersensitivity reactions, Week 39
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Hypersensitivity reactions, Week 43
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Hypersensitivity reactions, Week 44
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Hypersensitivity reactions, Week 45
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Hypersensitivity reactions, Week 46
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Any, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Any, Week 38
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Any, Week 41
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Any, Week 42
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Any, Week 46
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Any, Week 48
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Anaphylactic reactions, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Anaphylactic reactions, Week 38
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Anaphylactic reactions, Week 39
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Anaphylactic reactions, Week 40
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Anaphylactic reactions, Week 41
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Anaphylactic reactions, Week 42
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Anaphylactic reactions, Week 43
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Anaphylactic reactions, Week 47
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Anaphylactic reactions, Week 48
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Facial oedema, Week 47
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Facial oedema, Week 48
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Hypersensitivity reactions, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Hypersensitivity reactions, Week 40
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Hypersensitivity reactions, Week 41
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Hypersensitivity reactions, Week 42
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Hypersensitivity reactions, Week 47
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Hypersensitivity reactions, Week 48
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
Sensitivity/anaphylaxis AEs include any sensitivity/anaphylaxis AEs, anaphylactic reactions, facial oedema and hypersensitivity reactions.
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
n=2295 Participants
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
n=3178 Participants
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Facial oedema, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Facial oedema, Week 38
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Any, Week 44
|
12 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Hypersensitivity reactions, Week 45
|
12 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Hypersensitivity reactions, Week 46
|
13 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Any, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Any, Week 38
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Any, Week 39
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Any, Week 40
|
6 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Any, Week 41
|
6 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Any, Week 42
|
9 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Any, Week 43
|
11 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Any, Week 45
|
13 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Any, Week 46
|
14 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Any, Week 47
|
14 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Any, Week 48
|
15 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Anaphylactic reactions, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Anaphylactic reactions, Week 38
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Anaphylactic reactions, Week 39
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Anaphylactic reactions, Week 40
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Anaphylactic reactions, Week 41
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Anaphylactic reactions, Week 42
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Anaphylactic reactions, Week 43
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Anaphylactic reactions, Week 44
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Anaphylactic reactions, Week 45
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Anaphylactic reactions, Week 46
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Anaphylactic reactions, Week 47
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Anaphylactic reactions, Week 48
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Facial oedema, Week 39
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Facial oedema, Week 40
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Facial oedema, Week 41
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Facial oedema, Week 42
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Facial oedema, Week 43
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Facial oedema, Week 44
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Facial oedema, Week 45
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Facial oedema, Week 46
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Facial oedema, Week 47
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Facial oedema, Week 48
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Hypersensitivity reactions, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Hypersensitivity reactions, Week 38
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Hypersensitivity reactions, Week 39
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Hypersensitivity reactions, Week 40
|
5 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Hypersensitivity reactions, Week 41
|
5 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Hypersensitivity reactions, Week 42
|
8 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Hypersensitivity reactions, Week 43
|
10 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Hypersensitivity reactions, Week 44
|
11 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Hypersensitivity reactions, Week 47
|
13 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Hypersensitivity reactions, Week 48
|
14 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
Rash AEs include any rash AEs, generalised rash and rash.
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
n=2295 Participants
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
n=3178 Participants
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Any, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Any, Week 38
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Any, Week 39
|
10 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Any, Week 40
|
7 Participants
|
3 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Any, Week 41
|
7 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Any, Week 42
|
5 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Any, Week 43
|
4 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Any, Week 44
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Any, Week 45
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Any, Week 46
|
4 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Any, Week 47
|
3 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Any, Week 48
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Generalised rash, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Generalised rash, Week 38
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Generalised rash, Week 39
|
10 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Generalised rash, Week 40
|
3 Participants
|
3 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Generalised rash, Week 41
|
6 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Generalised rash, Week 42
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Generalised rash, Week 43
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Generalised rash, Week 44
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Generalised rash, Week 45
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Generalised rash, Week 46
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Generalised rash, Week 47
|
3 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Generalised rash, Week 48
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Rash, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Rash, Week 38
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Rash, Week 39
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Rash, Week 40
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Rash, Week 41
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Rash, Week 42
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Rash, Week 43
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Rash, Week 44
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Rash, Week 45
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Rash, Week 46
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Rash, Week 47
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Rash, Week 48
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
Rash AEs include any rash AEs, generalised rash and rash.
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
n=2295 Participants
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
n=3178 Participants
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative)
Generalised rash, Week 42
|
22 Participants
|
5 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative)
Generalised rash, Week 43
|
23 Participants
|
6 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative)
Generalised rash, Week 44
|
25 Participants
|
6 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative)
Generalised rash, Week 45
|
26 Participants
|
6 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative)
Generalised rash, Week 48
|
31 Participants
|
6 Participants
|
2 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative)
Rash, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative)
Rash, Week 38
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative)
Rash, Week 39
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative)
Rash, Week 40
|
5 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative)
Rash, Week 41
|
6 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative)
Rash, Week 42
|
9 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative)
Rash, Week 43
|
12 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative)
Generalised rash, Week 46
|
28 Participants
|
6 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative)
Generalised rash, Week 47
|
31 Participants
|
6 Participants
|
2 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative)
Any, Week 41
|
26 Participants
|
3 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative)
Any, Week 42
|
31 Participants
|
5 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative)
Any, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative)
Any, Week 38
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative)
Any, Week 39
|
12 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative)
Any, Week 40
|
19 Participants
|
3 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative)
Any, Week 43
|
35 Participants
|
6 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative)
Any, Week 44
|
38 Participants
|
6 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative)
Any, Week 45
|
40 Participants
|
6 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative)
Any, Week 46
|
44 Participants
|
6 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative)
Any, Week 47
|
47 Participants
|
6 Participants
|
2 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative)
Any, Week 48
|
47 Participants
|
6 Participants
|
2 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative)
Generalised rash, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative)
Generalised rash, Week 38
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative)
Generalised rash, Week 39
|
11 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative)
Generalised rash, Week 40
|
14 Participants
|
3 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative)
Generalised rash, Week 41
|
20 Participants
|
3 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative)
Rash, Week 44
|
13 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative)
Rash, Week 45
|
14 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative)
Rash, Week 46
|
16 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative)
Rash, Week 47
|
16 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative)
Rash, Week 48
|
16 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
Musculoskeletal AEs include any musculoskeletal AEs, arthropathy and muscle aches/myalgia.
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
n=2295 Participants
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
n=3178 Participants
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Any, Week 45
|
18 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Any, Week 46
|
12 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Any, Week 47
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Any, Week 48
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Arthropathy, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Arthropathy, Week 38
|
8 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Arthropathy, Week 40
|
24 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Arthropathy, Week 41
|
9 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Arthropathy, Week 42
|
11 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Arthropathy, Week 43
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Arthropathy, Week 44
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Arthropathy, Week 45
|
5 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Arthropathy, Week 46
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Arthropathy, Week 47
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Arthropathy, Week 48
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Muscle aches/myalgia, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Muscle aches/myalgia, Week 38
|
30 Participants
|
1 Participants
|
4 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Muscle aches/myalgia, Week 39
|
69 Participants
|
2 Participants
|
3 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Muscle aches/myalgia, Week 40
|
68 Participants
|
1 Participants
|
3 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Muscle aches/myalgia, Week 41
|
46 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Muscle aches/myalgia, Week 42
|
42 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Muscle aches/myalgia, Week 43
|
8 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Muscle aches/myalgia, Week 45
|
18 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Muscle aches/myalgia, Week 46
|
11 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Muscle aches/myalgia, Week 47
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Muscle aches/myalgia, Week 48
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Any, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Any, Week 38
|
32 Participants
|
1 Participants
|
4 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Any, Week 39
|
71 Participants
|
2 Participants
|
3 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Any, Week 40
|
75 Participants
|
1 Participants
|
3 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Any, Week 41
|
48 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Any, Week 42
|
46 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Any, Week 43
|
8 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Any, Week 44
|
15 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Arthropathy, Week 39
|
17 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Muscle aches/myalgia, Week 44
|
13 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
Musculoskeletal AEs include any musculoskeletal AEs, arthropathy and muscle aches/myalgia.
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
n=2295 Participants
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
n=3178 Participants
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Any, Week 38
|
32 Participants
|
1 Participants
|
4 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Any, Week 39
|
103 Participants
|
3 Participants
|
7 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Any, Week 40
|
178 Participants
|
4 Participants
|
10 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Any, Week 46
|
325 Participants
|
7 Participants
|
14 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Any, Week 47
|
327 Participants
|
7 Participants
|
15 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Any, Week 48
|
331 Participants
|
7 Participants
|
15 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Arthropathy, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Arthropathy, Week 38
|
8 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Arthropathy, Week 39
|
25 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Arthropathy, Week 40
|
49 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Arthropathy, Week 41
|
58 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Arthropathy, Week 42
|
69 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Arthropathy, Week 43
|
71 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Arthropathy, Week 44
|
73 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Arthropathy, Week 45
|
78 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Arthropathy, Week 46
|
79 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Arthropathy, Week 47
|
79 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Arthropathy, Week 48
|
79 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Muscle aches/myalgia, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Muscle aches/myalgia, Week 39
|
99 Participants
|
3 Participants
|
7 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Muscle aches/myalgia, Week 40
|
167 Participants
|
4 Participants
|
10 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Muscle aches/myalgia, Week 41
|
213 Participants
|
5 Participants
|
10 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Muscle aches/myalgia, Week 42
|
255 Participants
|
5 Participants
|
12 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Muscle aches/myalgia, Week 46
|
305 Participants
|
7 Participants
|
14 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Muscle aches/myalgia, Week 47
|
307 Participants
|
7 Participants
|
15 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Muscle aches/myalgia, Week 48
|
311 Participants
|
7 Participants
|
15 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Any, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Any, Week 41
|
226 Participants
|
5 Participants
|
10 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Any, Week 42
|
272 Participants
|
5 Participants
|
12 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Any, Week 43
|
280 Participants
|
6 Participants
|
12 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Any, Week 44
|
295 Participants
|
6 Participants
|
12 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Any, Week 45
|
313 Participants
|
6 Participants
|
14 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Muscle aches/myalgia, Week 38
|
30 Participants
|
1 Participants
|
4 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Muscle aches/myalgia, Week 43
|
263 Participants
|
6 Participants
|
12 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Muscle aches/myalgia, Week 44
|
276 Participants
|
6 Participants
|
12 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Muscle aches/myalgia, Week 45
|
294 Participants
|
6 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
Neurological AEs include any neurological AEs, Bell's palsy, Guillain-Barre syndrome, headache, peripheral tremor and seizure/febrile convulsions.
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
n=2295 Participants
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
n=3178 Participants
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Any, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Any, Week 38
|
22 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Any, Week 39
|
52 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Any, Week 40
|
46 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Any, Week 45
|
13 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Any, Week 46
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Any, Week 48
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Bell's palsy, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Bell's palsy, Week 38
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Bell's palsy, Week 39
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Bell's palsy, Week 44
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Bell's palsy, Week 45
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Bell's palsy, Week 47
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Guillain-Barre Syndrome, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Headache, Week 38
|
20 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Headache, Week 39
|
52 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Headache, Week 41
|
28 Participants
|
0 Participants
|
3 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Peripheral tremor, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Peripheral tremor, Week 39
|
5 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Peripheral tremor, Week 40
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Seizure/Febrile convulsions, Week 39
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Seizure/Febrile convulsions, Week 40
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Seizure/Febrile convulsions, Week 41
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Seizure/Febrile convulsions, Week 42
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Seizure/Febrile convulsions, Week 45
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Seizure/Febrile convulsions, Week 47
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Seizure/Febrile convulsions, Week 48
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Any, Week 41
|
31 Participants
|
0 Participants
|
3 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Any, Week 42
|
17 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Any, Week 43
|
13 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Any, Week 44
|
7 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Any, Week 47
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Bell's palsy, Week 40
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Bell's palsy, Week 41
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Bell's palsy, Week 42
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Bell's palsy, Week 43
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Bell's palsy, Week 46
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Bell's palsy, Week 48
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Guillain-Barre Syndrome, Week 38
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Guillain-Barre Syndrome, Week 39
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Guillain-Barre Syndrome, Week 40
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Guillain-Barre Syndrome, Week 41
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Guillain-Barre Syndrome, Week 42
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Guillain-Barre Syndrome, Week 43
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Guillain-Barre Syndrome, Week 44
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Guillain-Barre Syndrome, Week 45
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Guillain-Barre Syndrome, Week 46
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Guillain-Barre Syndrome, Week 47
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Guillain-Barre Syndrome, Week 48
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Headache, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Headache, Week 40
|
44 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Headache, Week 42
|
15 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Headache, Week 43
|
11 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Headache, Week 44
|
6 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Headache, Week 45
|
11 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Headache, Week 46
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Headache, Week 47
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Headache, Week 48
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Peripheral tremor, Week 38
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Peripheral tremor, Week 41
|
8 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Peripheral tremor, Week 42
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Peripheral tremor, Week 43
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Peripheral tremor, Week 44
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Peripheral tremor, Week 45
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Peripheral tremor, Week 46
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Peripheral tremor, Week 47
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Peripheral tremor, Week 48
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Seizure/Febrile convulsions, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Seizure/Febrile convulsions, Week 38
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Seizure/Febrile convulsions, Week 43
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Seizure/Febrile convulsions, Week 44
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Seizure/Febrile convulsions, Week 46
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
Neurological AEs include any neurological AEs, Bell's palsy, Guillain-Barre syndrome, headache, peripheral tremor and seizure/febrile convulsions.
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
n=2295 Participants
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
n=3178 Participants
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative),
Peripheral tremor, Week 43
|
22 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative),
Bell's palsy, Week 48
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative),
Bell's palsy, Week 40
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative),
Bell's palsy, Week 41
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative),
Bell's palsy, Week 42
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative),
Bell's palsy, Week 43
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative),
Bell's palsy, Week 44
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative),
Bell's palsy, Week 45
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative),
Bell's palsy, Week 46
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative),
Bell's palsy, Week 47
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative),
Guillain-Barre Syndrome, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative),
Guillain-Barre Syndrome, Week 38
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative),
Any, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative),
Guillain-Barre Syndrome, Week 39
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative),
Guillain-Barre Syndrome, Week 40
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative),
Any, Week 38
|
22 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative),
Guillain-Barre Syndrome, Week 41
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative),
Any, Week 39
|
74 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative),
Guillain-Barre Syndrome, Week 42
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative),
Guillain-Barre Syndrome, Week 43
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative),
Guillain-Barre Syndrome, Week 44
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative),
Any, Week 40
|
120 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative),
Guillain-Barre Syndrome, Week 45
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative),
Guillain-Barre Syndrome, Week 46
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative),
Any, Week 41
|
151 Participants
|
2 Participants
|
3 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative),
Guillain-Barre Syndrome, Week 47
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative),
Guillain-Barre Syndrome, Week 48
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative),
Any, Week 42
|
168 Participants
|
3 Participants
|
3 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative),
Headache, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative),
Any, Week 43
|
181 Participants
|
4 Participants
|
5 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative),
Headache, Week 38
|
20 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative),
Headache, Week 39
|
72 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative),
Any, Week 44
|
188 Participants
|
5 Participants
|
5 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative),
Headache, Week 40
|
116 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative),
Headache, Week 41
|
144 Participants
|
2 Participants
|
3 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative),
Headache, Week 42
|
159 Participants
|
3 Participants
|
3 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative),
Any, Week 45
|
201 Participants
|
5 Participants
|
5 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative),
Headache, Week 43
|
170 Participants
|
4 Participants
|
5 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative),
Headache, Week 44
|
176 Participants
|
5 Participants
|
5 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative),
Any, Week 46
|
204 Participants
|
6 Participants
|
5 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative),
Headache, Week 45
|
187 Participants
|
5 Participants
|
5 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative),
Any, Week 47
|
205 Participants
|
6 Participants
|
5 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative),
Headache, Week 46
|
190 Participants
|
6 Participants
|
5 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative),
Any, Week 48
|
206 Participants
|
6 Participants
|
5 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative),
Headache, Week 47
|
191 Participants
|
6 Participants
|
5 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative),
Bell's palsy, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative),
Headache, Week 48
|
192 Participants
|
6 Participants
|
5 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative),
Peripheral tremor, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative),
Peripheral tremor, Week 38
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative),
Bell's palsy, Week 38
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative),
Bell's palsy, Week 39
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative),
Peripheral tremor, Week 41
|
17 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative),
Peripheral tremor, Week 42
|
20 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative),
Peripheral tremor, Week 44
|
23 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative),
Peripheral tremor, Week 45
|
24 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative),
Peripheral tremor, Week 39
|
8 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative),
Peripheral tremor, Week 40
|
9 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative),
Peripheral tremor, Week 46
|
24 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative),
Peripheral tremor, Week 47
|
24 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative),
Peripheral tremor, Week 48
|
24 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative),
Seizure / Febrile convulsions, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative),
Seizure / Febrile convulsions, Week 38
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative),
Seizure / Febrile convulsions, Week 39
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative),
Seizure / Febrile convulsions, Week 40
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative),
Seizure / Febrile convulsions, Week 41
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative),
Seizure / Febrile convulsions, Week 42
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative),
Seizure / Febrile convulsions, Week 43
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative),
Seizure / Febrile convulsions, Week 44
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative),
Seizure / Febrile convulsions, Week 45
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative),
Seizure / Febrile convulsions, Week 46
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative),
Seizure / Febrile convulsions, Week 47
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative),
Seizure / Febrile convulsions, Week 48
|
2 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years.
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
n=2295 Participants
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
n=3178 Participants
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 45
|
27 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 40
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 42
|
1 Participants
|
6 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 47
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 48
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 40
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 41
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 42
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 46
|
21 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 43
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 38
|
59 Participants
|
1 Participants
|
5 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 39
|
160 Participants
|
4 Participants
|
2 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 40
|
140 Participants
|
2 Participants
|
3 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 41
|
112 Participants
|
1 Participants
|
3 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 44
|
21 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 42
|
67 Participants
|
1 Participants
|
5 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 43
|
33 Participants
|
2 Participants
|
5 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 44
|
31 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 45
|
27 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 47
|
5 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 48
|
6 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 46
|
15 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 47
|
8 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 48
|
7 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 43
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 39
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 44
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 45
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 46
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 47
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 48
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 44
|
0 Participants
|
4 Participants
|
1 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 38
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 38
|
28 Participants
|
3 Participants
|
2 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 39
|
67 Participants
|
6 Participants
|
1 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 40
|
77 Participants
|
5 Participants
|
1 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 41
|
60 Participants
|
1 Participants
|
3 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 45
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 46
|
0 Participants
|
4 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 47
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 48
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 42
|
49 Participants
|
1 Participants
|
3 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 43
|
23 Participants
|
1 Participants
|
4 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 38
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 39
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 40
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 41
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 42
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 43
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 44
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 45
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 46
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 38
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 39
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 41
|
0 Participants
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years.
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
n=2295 Participants
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
n=3178 Participants
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 39
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 43
|
1 Participants
|
11 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 43
|
2 Participants
|
3 Participants
|
2 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 42
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 43
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 44
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 42
|
281 Participants
|
16 Participants
|
10 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 45
|
352 Participants
|
17 Participants
|
16 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 42
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 41
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 44
|
2 Participants
|
4 Participants
|
2 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 44
|
602 Participants
|
12 Participants
|
24 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 47
|
378 Participants
|
18 Participants
|
18 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 45
|
2 Participants
|
4 Participants
|
2 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 46
|
3 Participants
|
4 Participants
|
3 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 48
|
384 Participants
|
18 Participants
|
18 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 47
|
3 Participants
|
6 Participants
|
2 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 48
|
3 Participants
|
6 Participants
|
6 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 38
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 38
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 39
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 38
|
59 Participants
|
1 Participants
|
5 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 40
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 39
|
219 Participants
|
5 Participants
|
7 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 40
|
359 Participants
|
7 Participants
|
10 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 41
|
471 Participants
|
8 Participants
|
13 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 41
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 42
|
538 Participants
|
9 Participants
|
18 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 43
|
571 Participants
|
11 Participants
|
23 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 40
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 41
|
0 Participants
|
5 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 45
|
629 Participants
|
12 Participants
|
26 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 46
|
644 Participants
|
12 Participants
|
26 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 47
|
652 Participants
|
12 Participants
|
26 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 48
|
659 Participants
|
12 Participants
|
26 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 45
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 46
|
1 Participants
|
3 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 47
|
1 Participants
|
3 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 48
|
1 Participants
|
3 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 38
|
28 Participants
|
3 Participants
|
2 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 39
|
95 Participants
|
9 Participants
|
3 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 42
|
1 Participants
|
11 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 44
|
1 Participants
|
15 Participants
|
1 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 45
|
1 Participants
|
17 Participants
|
3 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 46
|
1 Participants
|
21 Participants
|
3 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 47
|
2 Participants
|
21 Participants
|
4 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 48
|
2 Participants
|
23 Participants
|
4 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 38
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 40
|
172 Participants
|
14 Participants
|
4 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 41
|
232 Participants
|
15 Participants
|
7 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 43
|
304 Participants
|
17 Participants
|
14 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 44
|
325 Participants
|
17 Participants
|
16 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 46
|
373 Participants
|
18 Participants
|
17 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 39
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 40
|
1 Participants
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years.
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
n=2295 Participants
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
n=3178 Participants
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 46
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 47
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 47
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 39
|
13 Participants
|
4 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 46
|
6 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 38
|
5 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 40
|
14 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 41
|
12 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 42
|
7 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 43
|
8 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 47
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 38
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 39
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 40
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 41
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 42
|
1 Participants
|
3 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 43
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 44
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 45
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 47
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 48
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 38
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 39
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 40
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 41
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 42
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 43
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 44
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 45
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 46
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 48
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 42
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 43
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 44
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 45
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 46
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 48
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 38
|
3 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 43
|
5 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 38
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 39
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 40
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 44
|
4 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 45
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 47
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 48
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 39
|
10 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 41
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 40
|
7 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 41
|
8 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 44
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 45
|
5 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 46
|
5 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 48
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 42
|
7 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years.
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
n=2295 Participants
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
n=3178 Participants
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 42
|
1 Participants
|
8 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 43
|
1 Participants
|
8 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 46
|
1 Participants
|
12 Participants
|
3 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 47
|
1 Participants
|
12 Participants
|
4 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 48
|
1 Participants
|
13 Participants
|
4 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 40
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 41
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 44
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 47
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 41
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 47
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 48
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 38
|
3 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 39
|
16 Participants
|
6 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 40
|
23 Participants
|
8 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 42
|
38 Participants
|
8 Participants
|
2 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 43
|
43 Participants
|
8 Participants
|
3 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 45
|
50 Participants
|
8 Participants
|
5 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 46
|
56 Participants
|
8 Participants
|
5 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 38
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 39
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 40
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 41
|
0 Participants
|
4 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 44
|
1 Participants
|
9 Participants
|
1 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 45
|
1 Participants
|
11 Participants
|
3 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 38
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 39
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 42
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 43
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 44
|
58 Participants
|
3 Participants
|
5 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 45
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 46
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 48
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 38
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 39
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 40
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 42
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 43
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 44
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 45
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 46
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 41
|
31 Participants
|
8 Participants
|
1 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 44
|
47 Participants
|
8 Participants
|
5 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 47
|
57 Participants
|
8 Participants
|
5 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 48
|
60 Participants
|
8 Participants
|
5 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 38
|
5 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 45
|
63 Participants
|
3 Participants
|
5 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 39
|
15 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 40
|
29 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 41
|
41 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 42
|
48 Participants
|
2 Participants
|
3 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 43
|
56 Participants
|
2 Participants
|
5 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 46
|
68 Participants
|
3 Participants
|
5 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 47
|
69 Participants
|
3 Participants
|
5 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 48
|
71 Participants
|
3 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years.
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
n=2295 Participants
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
n=3178 Participants
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 46
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 47
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 48
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 39
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 40
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 41
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 42
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 47
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 48
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 38
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 40
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 43
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 45
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 45
|
5 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 40
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 38
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 39
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 41
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 42
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 43
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 44
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 38
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 45
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 43
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 44
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 45
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 46
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 39
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 41
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 42
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 44
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 46
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 47
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 48
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 38
|
9 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 39
|
8 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 40
|
10 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 41
|
12 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 42
|
9 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 43
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 44
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 45
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 46
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 47
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 48
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 38
|
7 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 39
|
12 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 40
|
14 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 41
|
16 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 42
|
6 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 43
|
5 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 44
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 46
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 47
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 48
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years.
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
n=2295 Participants
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
n=3178 Participants
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 40
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 41
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 38
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 40
|
27 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 43
|
49 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 44
|
53 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 40
|
33 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 41
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 42
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 43
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 44
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 45
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 46
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 47
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 48
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 38
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 39
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 42
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 43
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 44
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 45
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 46
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 47
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 48
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 39
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 40
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 41
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 42
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 43
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 44
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 45
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 46
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 47
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 48
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 38
|
9 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 39
|
17 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 41
|
39 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 42
|
48 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 45
|
56 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 46
|
59 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 47
|
59 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 48
|
59 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 38
|
7 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 39
|
19 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 41
|
49 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 42
|
55 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 43
|
60 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 44
|
63 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 45
|
68 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 38
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 39
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 40
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 46
|
68 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 47
|
68 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 48
|
68 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years.
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
n=2295 Participants
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
n=3178 Participants
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 42
|
10 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 43
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 39
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 40
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 48
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 38
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 41
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 42
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 43
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 44
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 45
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 46
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 47
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 48
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 38
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 39
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 40
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 41
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 42
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 43
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 44
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 45
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 46
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 47
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 38
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 39
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 40
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 41
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 42
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 43
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 44
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 45
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 46
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 47
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 48
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 38
|
6 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 39
|
18 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 40
|
20 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 41
|
6 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 44
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 45
|
5 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 46
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 47
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 48
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 38
|
15 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 39
|
33 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 40
|
28 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 41
|
22 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 42
|
11 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 43
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 44
|
5 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 45
|
5 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 46
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 47
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 48
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years.
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
n=2295 Participants
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
n=3178 Participants
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 47
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 38
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 39
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 40
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 41
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 46
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 48
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 38
|
6 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 39
|
24 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 42
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 43
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 44
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 45
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 46
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 47
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 48
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 38
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 39
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 40
|
44 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 41
|
50 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 42
|
60 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 43
|
61 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 44
|
63 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 45
|
68 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 46
|
71 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 47
|
71 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 48
|
72 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 38
|
15 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 39
|
48 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 40
|
76 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 41
|
98 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 40
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 41
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 42
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 43
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 44
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 45
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 46
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 47
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 48
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 38
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 39
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 40
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 41
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 42
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 43
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 44
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 45
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 42
|
109 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 43
|
113 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 44
|
118 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 45
|
123 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 46
|
127 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 47
|
129 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 48
|
129 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years.
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
n=2295 Participants
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
n=3178 Participants
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 40
|
36 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 40
|
75 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 45
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 38
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 39
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 40
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 41
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 42
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 43
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 44
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 46
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 47
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 48
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 38
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 39
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 40
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 41
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 42
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 43
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 44
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 45
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 46
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 47
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 48
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 38
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 39
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 40
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 41
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 42
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 43
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 44
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 45
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 46
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 47
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 48
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 38
|
8 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 39
|
32 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 41
|
24 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 42
|
28 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 43
|
12 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 44
|
7 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 45
|
18 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 46
|
9 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 47
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 48
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 38
|
26 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 39
|
88 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 41
|
58 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 42
|
36 Participants
|
0 Participants
|
3 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 43
|
17 Participants
|
1 Participants
|
3 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 44
|
13 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 45
|
11 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 46
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 47
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 48
|
2 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years.
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
n=2295 Participants
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
n=3178 Participants
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 42
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 45
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 46
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 47
|
178 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 38
|
26 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 39
|
114 Participants
|
3 Participants
|
1 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 38
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 39
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 40
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 41
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 42
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 43
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 44
|
0 Participants
|
4 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 45
|
0 Participants
|
4 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 46
|
0 Participants
|
7 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 47
|
0 Participants
|
7 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 48
|
0 Participants
|
8 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 38
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 39
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 40
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 41
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 43
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 44
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 47
|
1 Participants
|
4 Participants
|
1 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 48
|
1 Participants
|
4 Participants
|
1 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 38
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 39
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 40
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 41
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 42
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 43
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 44
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 45
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 46
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 47
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 48
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 38
|
8 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 39
|
40 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 40
|
76 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 41
|
100 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 42
|
128 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 43
|
140 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 44
|
147 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 45
|
165 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 46
|
174 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 48
|
178 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 40
|
189 Participants
|
4 Participants
|
1 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 41
|
247 Participants
|
5 Participants
|
3 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 42
|
283 Participants
|
5 Participants
|
6 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 43
|
300 Participants
|
6 Participants
|
9 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 44
|
313 Participants
|
7 Participants
|
10 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 45
|
324 Participants
|
7 Participants
|
10 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 46
|
328 Participants
|
7 Participants
|
10 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 47
|
331 Participants
|
7 Participants
|
10 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 48
|
333 Participants
|
7 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years.
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
n=2295 Participants
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
n=3178 Participants
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 43
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 48
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 38
|
11 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 39
|
23 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 40
|
22 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 41
|
17 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 42
|
12 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 43
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 44
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 45
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 46
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 47
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 48
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 38
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 39
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 38
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 39
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 40
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 41
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 42
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 40
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 41
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 42
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 43
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 44
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 45
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 46
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 47
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 48
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 38
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 39
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 40
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 41
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 42
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 44
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 45
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 46
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 47
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 48
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 43
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 44
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 45
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 46
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 47
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 48
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 38
|
7 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 39
|
9 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 40
|
12 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 41
|
8 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 42
|
7 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 43
|
5 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 44
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 45
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 46
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 47
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years.
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
n=2295 Participants
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
n=3178 Participants
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 39
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 38
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 38
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 39
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 40
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 41
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 42
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 43
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 44
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 45
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 46
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 47
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 48
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 40
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 41
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 42
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 43
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 44
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 45
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 46
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 47
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 48
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 38
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 39
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 40
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 41
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 42
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 43
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 44
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 45
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 46
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 47
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 48
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 38
|
7 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 39
|
16 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 40
|
28 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 41
|
36 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 42
|
43 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 43
|
48 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 44
|
50 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 45
|
53 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 46
|
55 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 47
|
55 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 48
|
56 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 38
|
11 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 39
|
34 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 40
|
56 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 41
|
73 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 42
|
85 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 43
|
89 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 44
|
92 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 45
|
95 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 46
|
97 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 47
|
98 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 48
|
98 Participants
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years.
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
n=2295 Participants
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
n=3178 Participants
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 40
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 41
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 48
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 38
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 39
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 42
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 43
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 44
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 46
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 47
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 48
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 38
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 39
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 40
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 41
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 42
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 43
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 45
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 46
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 47
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 48
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 38
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 39
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 40
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 41
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 42
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 43
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 44
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 45
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 44
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 45
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 46
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 47
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 48
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 38
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 39
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 40
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 41
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 42
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 43
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 44
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 45
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 46
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 47
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 48
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 38
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 39
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 40
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 41
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 42
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 43
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 44
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 45
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 46
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 47
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years.
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
n=2295 Participants
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
n=3178 Participants
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 38
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 39
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 40
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 41
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 42
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 43
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 44
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 45
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 46
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 47
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 48
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 38
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 39
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 40
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 41
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 42
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 43
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 44
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 45
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 46
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 47
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 48
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 38
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 39
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 40
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 41
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 42
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 43
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 44
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 38
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 45
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 46
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 47
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 48
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 38
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 39
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 40
|
4 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 41
|
4 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 42
|
6 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 43
|
7 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 44
|
8 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 45
|
8 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 46
|
9 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 47
|
9 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 48
|
9 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 39
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 40
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 41
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 42
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 43
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 44
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 45
|
5 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 46
|
5 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 47
|
5 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 48
|
6 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years.
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
n=2295 Participants
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
n=3178 Participants
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 38
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 39
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 40
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 41
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 42
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 43
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 44
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 45
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 46
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 47
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 48
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 38
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 39
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 40
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 41
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 42
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 43
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 44
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 45
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 46
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 47
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 48
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 38
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 39
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 40
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 41
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 42
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 43
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 44
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 45
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 46
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 47
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 48
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 38
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 39
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 40
|
4 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 41
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 42
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 43
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 44
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 45
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 46
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 47
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 48
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 38
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 39
|
8 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 40
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 41
|
5 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 42
|
5 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 43
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 44
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 45
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 46
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 47
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 48
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years.
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
n=2295 Participants
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
n=3178 Participants
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 43
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 44
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 45
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 46
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 47
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 48
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 38
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 39
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 40
|
6 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 41
|
8 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 42
|
10 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 43
|
12 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 44
|
13 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 45
|
14 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 46
|
16 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 47
|
16 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 48
|
16 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 38
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 39
|
10 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 40
|
13 Participants
|
6 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 41
|
18 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 42
|
21 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 43
|
23 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 44
|
25 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 45
|
26 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 46
|
28 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 47
|
30 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 48
|
30 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 38
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 39
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 40
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 41
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 42
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 43
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 44
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 45
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 46
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 47
|
1 Participants
|
3 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 48
|
1 Participants
|
3 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 38
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 39
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 40
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 41
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 42
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 43
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 44
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 45
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 46
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 47
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 48
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 38
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 39
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 40
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 41
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 42
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years.
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
n=2295 Participants
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
n=3178 Participants
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 38
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 39
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 40
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 47
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 41
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 42
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 43
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 44
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 45
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 46
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 48
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 38
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 39
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 40
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 41
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 42
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 43
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 44
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 45
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 46
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 47
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 48
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 38
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 39
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 40
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 41
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 42
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 43
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 44
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 45
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 46
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 47
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 48
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 38
|
13 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 39
|
19 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 40
|
25 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 41
|
15 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 42
|
23 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 43
|
5 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 44
|
5 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 45
|
9 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 46
|
6 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 47
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 48
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 38
|
19 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 39
|
52 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 40
|
50 Participants
|
0 Participants
|
3 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 41
|
33 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 42
|
23 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 43
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 44
|
10 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 45
|
9 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 46
|
6 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 47
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 48
|
2 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years.
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
n=2295 Participants
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
n=3178 Participants
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 41
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 44
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 45
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 46
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 39
|
71 Participants
|
1 Participants
|
4 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 38
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 39
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 40
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 41
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 42
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 43
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 44
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 45
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 46
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 47
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 48
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 38
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 39
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 40
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 42
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 43
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 46
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 47
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 48
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 38
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 39
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 40
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 41
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 42
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 43
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 44
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 45
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 47
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 48
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 38
|
13 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 39
|
32 Participants
|
2 Participants
|
3 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 40
|
57 Participants
|
3 Participants
|
3 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 41
|
72 Participants
|
4 Participants
|
3 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 42
|
95 Participants
|
4 Participants
|
4 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 43
|
100 Participants
|
4 Participants
|
4 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 44
|
105 Participants
|
4 Participants
|
4 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 45
|
114 Participants
|
4 Participants
|
4 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 46
|
120 Participants
|
4 Participants
|
4 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 47
|
121 Participants
|
4 Participants
|
5 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 48
|
123 Participants
|
4 Participants
|
5 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 38
|
19 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 40
|
121 Participants
|
1 Participants
|
7 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 41
|
154 Participants
|
1 Participants
|
7 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 42
|
177 Participants
|
1 Participants
|
8 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 43
|
180 Participants
|
2 Participants
|
8 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 44
|
190 Participants
|
2 Participants
|
8 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 45
|
199 Participants
|
2 Participants
|
10 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 46
|
205 Participants
|
2 Participants
|
10 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 47
|
206 Participants
|
2 Participants
|
10 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 48
|
208 Participants
|
2 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years.
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
n=2295 Participants
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
n=3178 Participants
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 38
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 40
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 39
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 41
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 42
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 43
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 44
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 45
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 46
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 47
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6 months - 5 years, Week 48
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 38
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 39
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 40
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 41
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 42
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 43
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 44
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 45
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 46
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 47
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
6-12 years, Week 48
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 38
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 39
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 40
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 41
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 42
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 43
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 44
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 45
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 46
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 47
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
13-17 years, Week 48
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 38
|
12 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 39
|
22 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 40
|
20 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 41
|
13 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 42
|
9 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 43
|
8 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 44
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 45
|
9 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 46
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 47
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
18-65 years, Week 48
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 38
|
10 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 39
|
30 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 40
|
26 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 41
|
18 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 42
|
8 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 43
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 44
|
5 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 45
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 46
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 47
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
>65 years, Week 48
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years.
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
n=2295 Participants
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
n=3178 Participants
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 38
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 39
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 40
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 41
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 42
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 43
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 44
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 45
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 46
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 47
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6 months - 5 years, Week 48
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 38
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 39
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 40
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 41
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 42
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 43
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 44
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 45
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 46
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 47
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
6-12 years, Week 48
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 38
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 39
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 40
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 41
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 42
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 43
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 44
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 45
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 46
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 47
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
13-17 years, Week 48
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 38
|
12 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 39
|
34 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 40
|
54 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 41
|
67 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 42
|
76 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 43
|
84 Participants
|
3 Participants
|
4 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 44
|
86 Participants
|
3 Participants
|
4 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 45
|
95 Participants
|
3 Participants
|
4 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 46
|
96 Participants
|
4 Participants
|
4 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 47
|
97 Participants
|
4 Participants
|
4 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
18-65 years, Week 48
|
98 Participants
|
4 Participants
|
4 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 38
|
10 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 39
|
40 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 40
|
66 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 41
|
84 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 42
|
92 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 43
|
96 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 44
|
101 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 45
|
105 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 46
|
107 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 47
|
107 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
>65 years, Week 48
|
107 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
AEIs were presented by categories depending of the nature of the event. -Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia,etc); - All other presentations that were reported following vaccination (e .g., Bell's palsy, Guillain-Barre syndrome).
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
n=2295 Participants
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
n=3178 Participants
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk, Week 38
|
81 Participants
|
4 Participants
|
7 Participants
|
|
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk, Week 39
|
216 Participants
|
8 Participants
|
2 Participants
|
|
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk, Week 40
|
203 Participants
|
10 Participants
|
4 Participants
|
|
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk, Week 41
|
155 Participants
|
4 Participants
|
6 Participants
|
|
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk, Week 42
|
105 Participants
|
7 Participants
|
7 Participants
|
|
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk, Week 43
|
49 Participants
|
4 Participants
|
9 Participants
|
|
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk, Week 44
|
47 Participants
|
4 Participants
|
3 Participants
|
|
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk, Week 45
|
49 Participants
|
1 Participants
|
3 Participants
|
|
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk, Week 46
|
29 Participants
|
5 Participants
|
2 Participants
|
|
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk, Week 47
|
11 Participants
|
2 Participants
|
3 Participants
|
|
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk, Week 48
|
11 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk, Week 38
|
6 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk, Week 39
|
11 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk, Week 40
|
15 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk, Week 41
|
17 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk, Week 42
|
13 Participants
|
3 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk, Week 43
|
8 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk, Week 44
|
5 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk, Week 45
|
5 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk, Week 46
|
8 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk, Week 47
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk, Week 48
|
2 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
AEIs were presented by categories depending of the nature of the event. -Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia,etc); - All other presentations that were reported following vaccination (e .g., Bell's palsy, Guillain-Barre syndrome).
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
n=2295 Participants
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
n=3178 Participants
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk, Week 46
|
934 Participants
|
47 Participants
|
43 Participants
|
|
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk, Week 47
|
945 Participants
|
49 Participants
|
46 Participants
|
|
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk, Week 48
|
956 Participants
|
50 Participants
|
47 Participants
|
|
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk, Week 43
|
70 Participants
|
7 Participants
|
4 Participants
|
|
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk, Week 38
|
6 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk, Week 40
|
32 Participants
|
3 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk, Week 44
|
75 Participants
|
9 Participants
|
5 Participants
|
|
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk, Week 41
|
49 Participants
|
4 Participants
|
2 Participants
|
|
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk, Week 42
|
62 Participants
|
7 Participants
|
3 Participants
|
|
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk, Week 39
|
17 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk, Week 38
|
81 Participants
|
4 Participants
|
7 Participants
|
|
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk, Week 39
|
297 Participants
|
12 Participants
|
9 Participants
|
|
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk, Week 40
|
500 Participants
|
22 Participants
|
13 Participants
|
|
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk, Week 41
|
655 Participants
|
26 Participants
|
19 Participants
|
|
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk, Week 42
|
760 Participants
|
33 Participants
|
26 Participants
|
|
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk, Week 43
|
809 Participants
|
37 Participants
|
35 Participants
|
|
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk, Week 44
|
856 Participants
|
41 Participants
|
38 Participants
|
|
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk, Week 45
|
905 Participants
|
42 Participants
|
41 Participants
|
|
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk, Week 45
|
80 Participants
|
10 Participants
|
6 Participants
|
|
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk, Week 46
|
88 Participants
|
11 Participants
|
6 Participants
|
|
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk, Week 47
|
91 Participants
|
11 Participants
|
6 Participants
|
|
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk, Week 48
|
93 Participants
|
12 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
AEIs were presented by categories depending of the nature of the event. -Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia,etc); - All other presentations that were reported following vaccination (e .g., Bell's palsy, Guillain-Barre syndrome).
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
n=2295 Participants
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
n=3178 Participants
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk, Week 38
|
8 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk, Week 39
|
23 Participants
|
3 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk, Week 40
|
21 Participants
|
5 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk, Week 41
|
18 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk, Week 42
|
13 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk, Week 43
|
11 Participants
|
0 Participants
|
3 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk, Week 44
|
6 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk, Week 45
|
7 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk, Week 46
|
9 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk, Week 47
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk, Week 48
|
4 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk, Week 38
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk, Week 39
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk, Week 40
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk, Week 41
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk, Week 42
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk, Week 43
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk, Week 44
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk, Week 45
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk, Week 46
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk, Week 47
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk, Week 48
|
1 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
AEIs were presented by categories depending of the nature of the event. -Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia,etc); - All other presentations that were reported following vaccination (e .g., Bell's palsy, Guillain-Barre syndrome).
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
n=2295 Participants
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
n=3178 Participants
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk, Week 38
|
8 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk, Week 39
|
31 Participants
|
5 Participants
|
2 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk, Week 40
|
52 Participants
|
10 Participants
|
2 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk, Week 41
|
70 Participants
|
12 Participants
|
3 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk, Week 42
|
83 Participants
|
14 Participants
|
4 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk, Week 43
|
94 Participants
|
14 Participants
|
7 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk, Week 44
|
100 Participants
|
16 Participants
|
9 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk, Week 45
|
107 Participants
|
17 Participants
|
10 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk, Week 46
|
116 Participants
|
18 Participants
|
10 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk, Week 47
|
117 Participants
|
18 Participants
|
11 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk, Week 48
|
121 Participants
|
18 Participants
|
12 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk, Week 38
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk, Week 39
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk, Week 40
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk, Week 41
|
3 Participants
|
3 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk, Week 42
|
5 Participants
|
5 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk, Week 43
|
7 Participants
|
5 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk, Week 44
|
7 Participants
|
5 Participants
|
2 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk, Week 45
|
8 Participants
|
6 Participants
|
3 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk, Week 46
|
10 Participants
|
6 Participants
|
3 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk, Week 47
|
11 Participants
|
6 Participants
|
3 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk, Week 48
|
12 Participants
|
7 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
AEIs were presented by categories depending of the nature of the event. -Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia,etc); - All other presentations that were reported following vaccination (e .g., Bell's palsy, Guillain-Barre syndrome).
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
n=2295 Participants
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
n=3178 Participants
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk, Week 42
|
13 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk, Week 38
|
14 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk, Week 39
|
19 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk, Week 40
|
21 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk, Week 41
|
26 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk, Week 43
|
6 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk, Week 44
|
5 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk, Week 45
|
8 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk, Week 46
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk, Week 47
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk, Week 48
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk, Week 38
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk, Week 39
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk, Week 40
|
3 Participants
|
0 Participants
|
3 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk, Week 41
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk, Week 42
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk, Week 43
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk, Week 44
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk, Week 45
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk, Week 46
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk, Week 47
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk, Week 48
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
AEIs were presented by categories depending of the nature of the event. -Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia,etc); - All other presentations that were reported following vaccination (e .g., Bell's palsy, Guillain-Barre syndrome).
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
n=2295 Participants
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
n=3178 Participants
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk, Week 39
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk, Week 40
|
6 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk, Week 41
|
8 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk, Week 42
|
10 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk, Week 43
|
10 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk, Week 44
|
12 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk, Week 45
|
12 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk, Week 46
|
13 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk, Week 47
|
13 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk, Week 48
|
13 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk, Week 41
|
80 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk, Week 38
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk, Week 38
|
14 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk, Week 39
|
33 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk, Week 40
|
54 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk, Week 42
|
93 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk, Week 43
|
99 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk, Week 44
|
104 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk, Week 45
|
112 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk, Week 46
|
114 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk, Week 47
|
114 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk, Week 48
|
114 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
AEIs were presented by categories depending of the nature of the event. -Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia,etc); - All other presentations that were reported following vaccination (e .g., Bell's palsy, Guillain-Barre syndrome).
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
n=2295 Participants
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
n=3178 Participants
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk, Week 38
|
19 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk, Week 39
|
46 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk, Week 40
|
46 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk, Week 41
|
26 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk, Week 42
|
20 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk, Week 43
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk, Week 44
|
7 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk, Week 45
|
8 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk, Week 46
|
5 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk, Week 47
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk, Week 48
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk, Week 38
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk, Week 39
|
5 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk, Week 40
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk, Week 41
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk, Week 42
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk, Week 43
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk, Week 44
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk, Week 45
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk, Week 46
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk, Week 47
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk, Week 48
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
AEIs were presented by categories depending of the nature of the event. -Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia,etc); - All other presentations that were reported following vaccination (e .g., Bell's palsy, Guillain-Barre syndrome).
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
n=2295 Participants
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
n=3178 Participants
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk, Week 38
|
19 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk, Week 39
|
65 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk, Week 40
|
111 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk, Week 41
|
137 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk, Week 42
|
157 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk, Week 43
|
161 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk, Week 44
|
168 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk, Week 45
|
176 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk, Week 46
|
181 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk, Week 47
|
183 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk, Week 48
|
183 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk, Week 38
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk, Week 39
|
7 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk, Week 40
|
9 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk, Week 41
|
11 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk, Week 42
|
13 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk, Week 43
|
14 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk, Week 44
|
14 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk, Week 45
|
16 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk, Week 46
|
18 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk, Week 47
|
18 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk, Week 48
|
19 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
Respiratory/Miscellaneous AE include any respiratory/miscellaneous AE, conjunctivitis, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing.
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
n=2295 Participants
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
n=3178 Participants
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk, Week 38
|
32 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk, Week 39
|
114 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk, Week 40
|
103 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk, Week 41
|
77 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk, Week 42
|
56 Participants
|
3 Participants
|
3 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk, Week 43
|
27 Participants
|
1 Participants
|
4 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk, Week 44
|
18 Participants
|
3 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk, Week 45
|
26 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk, Week 46
|
12 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk, Week 47
|
5 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk, Week 48
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk, Week 38
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk, Week 39
|
6 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk, Week 40
|
8 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk, Week 41
|
5 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk, Week 42
|
9 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk, Week 43
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk, Week 44
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk, Week 45
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk, Week 46
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk, Week 47
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk, Week 48
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
Respiratory/Miscellaneous AE include any respiratory/miscellaneous AE, conjunctivitis, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing.
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
n=2295 Participants
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
n=3178 Participants
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk, Week 38
|
32 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk, Week 39
|
146 Participants
|
3 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk, Week 40
|
249 Participants
|
5 Participants
|
2 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk, Week 41
|
326 Participants
|
7 Participants
|
4 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk, Week 42
|
382 Participants
|
10 Participants
|
7 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk, Week 43
|
409 Participants
|
11 Participants
|
11 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk, Week 44
|
427 Participants
|
14 Participants
|
12 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk, Week 45
|
453 Participants
|
14 Participants
|
12 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk, Week 46
|
465 Participants
|
16 Participants
|
12 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk, Week 47
|
470 Participants
|
18 Participants
|
12 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk, Week 48
|
472 Participants
|
19 Participants
|
12 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk, Week 38
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk, Week 39
|
8 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk, Week 40
|
16 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk, Week 41
|
21 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk, Week 42
|
30 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk, Week 43
|
32 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk, Week 44
|
34 Participants
|
3 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk, Week 45
|
37 Participants
|
3 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk, Week 46
|
39 Participants
|
4 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk, Week 47
|
41 Participants
|
4 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk, Week 48
|
41 Participants
|
4 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
Gastrointestinal AEs include any gastrointestinal AEs, decreased appetite, diarrhoea, nausea and vomiting.
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
n=2295 Participants
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
n=3178 Participants
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk, Week 41
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk, Week 39
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk, Week 40
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk, Week 38
|
16 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk, Week 39
|
30 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk, Week 40
|
33 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk, Week 41
|
22 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk, Week 42
|
18 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk, Week 38
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk, Week 43
|
7 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk, Week 44
|
5 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk, Week 45
|
6 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk, Week 46
|
4 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk, Week 47
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
At risk, Week 48
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk, Week 42
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk, Week 43
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk, Week 44
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk, Week 45
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk, Week 46
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk, Week 47
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Not at risk, Week 48
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
Gastrointestinal AEs include any gastrointestinal AEs, decreased appetite, diarrhoea, nausea and vomiting.
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
n=2295 Participants
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
n=3178 Participants
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk, Week 38
|
16 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk, Week 39
|
46 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk, Week 40
|
79 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk, Week 41
|
101 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk, Week 42
|
119 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk, Week 43
|
126 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk, Week 44
|
131 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk, Week 45
|
137 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk, Week 46
|
141 Participants
|
1 Participants
|
3 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk, Week 47
|
142 Participants
|
1 Participants
|
3 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk, Week 48
|
142 Participants
|
1 Participants
|
3 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk, Week 38
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk, Week 39
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk, Week 40
|
5 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk, Week 41
|
8 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk, Week 42
|
9 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk, Week 43
|
11 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk, Week 44
|
11 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk, Week 45
|
11 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk, Week 46
|
11 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk, Week 47
|
11 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk, Week 48
|
12 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
Sensitivity/anaphylaxis AEs include any sensitivity/anaphylaxis AEs, anaphylactic reactions, facial oedema and hypersensitivity reactions.
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
n=2295 Participants
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
n=3178 Participants
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
At risk, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
At risk, Week 38
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
At risk, Week 39
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
At risk, Week 40
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
At risk, Week 41
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
At risk, Week 42
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
At risk, Week 43
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
At risk, Week 44
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
At risk, Week 45
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
At risk, Week 46
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
At risk, Week 47
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
At risk, Week 48
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
Not at risk, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
Not at risk, Week 38
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
Not at risk, Week 39
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
Not at risk, Week 40
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
Not at risk, Week 41
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
Not at risk, Week 42
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
Not at risk, Week 43
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
Not at risk, Week 44
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
Not at risk, Week 45
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
Not at risk, Week 46
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
Not at risk, Week 47
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
Not at risk, Week 48
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
Sensitivity/anaphylaxis AEs include any sensitivity/anaphylaxis AEs, anaphylactic reactions, facial oedema and hypersensitivity reactions.
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
n=2295 Participants
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
n=3178 Participants
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk, Week 38
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk, Week 39
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk, Week 40
|
6 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk, Week 41
|
6 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk, Week 42
|
7 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk, Week 43
|
9 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk, Week 44
|
10 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk, Week 45
|
11 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk, Week 46
|
11 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk, Week 47
|
11 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk, Week 48
|
12 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk, Week 38
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk, Week 39
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk, Week 40
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk, Week 41
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk, Week 42
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk, Week 43
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk, Week 44
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk, Week 45
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk, Week 46
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk, Week 47
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk, Week 48
|
3 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
Rash AEs include any rash AEs, generalised rash and rash.
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
n=2295 Participants
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
n=3178 Participants
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
At risk, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
At risk, Week 38
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
At risk, Week 39
|
10 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
At risk, Week 40
|
7 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
At risk, Week 41
|
7 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
At risk, Week 42
|
4 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
At risk, Week 43
|
4 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
At risk, Week 44
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
At risk, Week 45
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
At risk, Week 46
|
3 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
At risk, Week 47
|
3 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
At risk, Week 48
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
Not at risk, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
Not at risk, Week 38
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
Not at risk, Week 39
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
Not at risk, Week 40
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
Not at risk, Week 41
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
Not at risk, Week 42
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
Not at risk, Week 43
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
Not at risk, Week 44
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
Not at risk, Week 45
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
Not at risk, Week 46
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
Not at risk, Week 47
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
Not at risk, Week 48
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
Rash AEs include any rash AEs, generalised rash and rash.
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
n=2295 Participants
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
n=3178 Participants
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative)
Not at risk, Week 47
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative)
Not at risk, Week 48
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative)
At risk, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative)
At risk, Week 38
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative)
At risk, Week 39
|
12 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative)
At risk, Week 40
|
19 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative)
At risk, Week 41
|
26 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative)
At risk, Week 42
|
30 Participants
|
4 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative)
At risk, Week 43
|
34 Participants
|
5 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative)
At risk, Week 44
|
37 Participants
|
5 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative)
At risk, Week 45
|
39 Participants
|
5 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative)
At risk, Week 46
|
42 Participants
|
5 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative)
At risk, Week 47
|
45 Participants
|
5 Participants
|
2 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative)
At risk, Week 48
|
45 Participants
|
5 Participants
|
2 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative)
Not at risk, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative)
Not at risk, Week 38
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative)
Not at risk, Week 39
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative)
Not at risk, Week 40
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative)
Not at risk, Week 41
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative)
Not at risk, Week 42
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative)
Not at risk, Week 43
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative)
Not at risk, Week 44
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative)
Not at risk, Week 45
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative)
Not at risk, Week 46
|
2 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
Musculoskeletal AEs include any musculoskeletal AEs, arthropathy and muscle aches/myalgia.
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
n=2295 Participants
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
n=3178 Participants
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
Not at risk, Week 47
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
Not at risk, Week 48
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
At risk, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
At risk, Week 38
|
29 Participants
|
1 Participants
|
4 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
At risk, Week 39
|
64 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
At risk, Week 40
|
72 Participants
|
1 Participants
|
3 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
At risk, Week 41
|
43 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
At risk, Week 42
|
44 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
At risk, Week 43
|
8 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
At risk, Week 44
|
15 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
At risk, Week 45
|
15 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
At risk, Week 46
|
9 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
At risk, Week 47
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
At risk, Week 48
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
Not at risk, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
Not at risk, Week 38
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
Not at risk, Week 39
|
7 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
Not at risk, Week 40
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
Not at risk, Week 41
|
5 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
Not at risk, Week 42
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
Not at risk, Week 43
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
Not at risk, Week 44
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
Not at risk, Week 45
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
Not at risk, Week 46
|
3 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
Musculoskeletal AEs include any musculoskeletal AEs, arthropathy and muscle aches/myalgia.
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
n=2295 Participants
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
n=3178 Participants
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative)
At risk, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative)
At risk, Week 38
|
29 Participants
|
1 Participants
|
4 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative)
At risk, Week 39
|
93 Participants
|
3 Participants
|
6 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative)
At risk, Week 40
|
165 Participants
|
4 Participants
|
9 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative)
At risk, Week 41
|
208 Participants
|
5 Participants
|
9 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative)
At risk, Week 42
|
252 Participants
|
5 Participants
|
11 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative)
At risk, Week 43
|
260 Participants
|
6 Participants
|
11 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative)
At risk, Week 44
|
275 Participants
|
6 Participants
|
11 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative)
At risk, Week 45
|
290 Participants
|
6 Participants
|
13 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative)
At risk, Week 46
|
299 Participants
|
7 Participants
|
13 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative)
At risk, Week 47
|
300 Participants
|
7 Participants
|
14 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative)
At risk, Week 48
|
304 Participants
|
7 Participants
|
14 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative)
Not at risk, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative)
Not at risk, Week 38
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative)
Not at risk, Week 39
|
10 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative)
Not at risk, Week 40
|
13 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative)
Not at risk, Week 41
|
18 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative)
Not at risk, Week 42
|
20 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative)
Not at risk, Week 43
|
20 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative)
Not at risk, Week 44
|
20 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative)
Not at risk, Week 45
|
23 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative)
Not at risk, Week 46
|
26 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative)
Not at risk, Week 47
|
27 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative)
Not at risk, Week 48
|
27 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
Neurological AEs include any neurological AEs, Bell's palsy, Guillain-Barre syndrome, headache, peripheral tremor and seizure/febrile convulsions.
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
n=2295 Participants
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
n=3178 Participants
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
At risk, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
At risk, Week 38
|
19 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
At risk, Week 39
|
48 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
At risk, Week 40
|
40 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
At risk, Week 41
|
30 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
At risk, Week 42
|
15 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
At risk, Week 43
|
11 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
At risk, Week 44
|
6 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
At risk, Week 45
|
11 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
At risk, Week 46
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
At risk, Week 47
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
At risk, Week 48
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
Not at risk, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
Not at risk, Week 38
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
Not at risk, Week 39
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
Not at risk, Week 40
|
6 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
Not at risk, Week 41
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
Not at risk, Week 42
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
Not at risk, Week 43
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
Not at risk, Week 44
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
Not at risk, Week 45
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
Not at risk, Week 46
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
Not at risk, Week 47
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
Not at risk, Week 48
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
Neurological AEs include any neurological AEs, Bell's palsy, Guillain-Barre syndrome, headache, peripheral tremor and seizure/febrile convulsions.
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
n=2295 Participants
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
n=3178 Participants
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk, Week 38
|
19 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk, Week 39
|
67 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk, Week 40
|
107 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk, Week 41
|
137 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk, Week 42
|
152 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk, Week 43
|
163 Participants
|
3 Participants
|
4 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk, Week 44
|
169 Participants
|
3 Participants
|
4 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk, Week 45
|
180 Participants
|
3 Participants
|
4 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk, Week 46
|
183 Participants
|
4 Participants
|
4 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk, Week 47
|
183 Participants
|
4 Participants
|
4 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
At risk, Week 48
|
183 Participants
|
4 Participants
|
4 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk, Week 37
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk, Week 38
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk, Week 39
|
7 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk, Week 40
|
13 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk, Week 41
|
14 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk, Week 42
|
16 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk, Week 43
|
18 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk, Week 44
|
19 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk, Week 45
|
21 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk, Week 46
|
21 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk, Week 47
|
22 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Not at risk, Week 48
|
23 Participants
|
2 Participants
|
1 Participants
|
Adverse Events
Vaccinated_Fluarix Tetra Group
Serious events: 0 serious events
Other events: 1049 other events
Deaths: 0 deaths
Vaccinated_Non GSK Group
Serious events: 0 serious events
Other events: 62 other events
Deaths: 0 deaths
Vaccinated_Unknown Group
Serious events: 0 serious events
Other events: 54 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Vaccinated_Fluarix Tetra Group
n=13861 participants at risk
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices.
|
Vaccinated_Non GSK Group
n=2295 participants at risk
Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices.
|
Vaccinated_Unknown Group
n=3178 participants at risk
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices.
|
|---|---|---|---|
|
General disorders
Fever/pyrexia
|
0.96%
133/13861 • Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Subjects who did not report an event were considered as subjects without the event.
|
1.1%
25/2295 • Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Subjects who did not report an event were considered as subjects without the event.
|
0.50%
16/3178 • Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Subjects who did not report an event were considered as subjects without the event.
|
|
General disorders
Local erythema
|
0.92%
127/13861 • Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Subjects who did not report an event were considered as subjects without the event.
|
0.00%
0/2295 • Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Subjects who did not report an event were considered as subjects without the event.
|
0.00%
0/3178 • Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Subjects who did not report an event were considered as subjects without the event.
|
|
General disorders
Drowsiness
|
0.52%
72/13861 • Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Subjects who did not report an event were considered as subjects without the event.
|
0.00%
0/2295 • Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Subjects who did not report an event were considered as subjects without the event.
|
0.00%
0/3178 • Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Subjects who did not report an event were considered as subjects without the event.
|
|
General disorders
Fatigue
|
1.2%
169/13861 • Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Subjects who did not report an event were considered as subjects without the event.
|
0.00%
0/2295 • Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Subjects who did not report an event were considered as subjects without the event.
|
0.03%
1/3178 • Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Subjects who did not report an event were considered as subjects without the event.
|
|
General disorders
Irritability
|
0.12%
17/13861 • Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Subjects who did not report an event were considered as subjects without the event.
|
0.00%
0/2295 • Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Subjects who did not report an event were considered as subjects without the event.
|
0.00%
0/3178 • Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Subjects who did not report an event were considered as subjects without the event.
|
|
General disorders
Malaise
|
0.03%
4/13861 • Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Subjects who did not report an event were considered as subjects without the event.
|
0.04%
1/2295 • Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Subjects who did not report an event were considered as subjects without the event.
|
0.00%
0/3178 • Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Subjects who did not report an event were considered as subjects without the event.
|
|
General disorders
Conjunctivitis
|
0.20%
28/13861 • Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Subjects who did not report an event were considered as subjects without the event.
|
0.09%
2/2295 • Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Subjects who did not report an event were considered as subjects without the event.
|
0.00%
0/3178 • Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Subjects who did not report an event were considered as subjects without the event.
|
|
General disorders
Coryza
|
0.69%
96/13861 • Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Subjects who did not report an event were considered as subjects without the event.
|
0.00%
0/2295 • Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Subjects who did not report an event were considered as subjects without the event.
|
0.00%
0/3178 • Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Subjects who did not report an event were considered as subjects without the event.
|
|
General disorders
Cough
|
1.5%
210/13861 • Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Subjects who did not report an event were considered as subjects without the event.
|
0.74%
17/2295 • Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Subjects who did not report an event were considered as subjects without the event.
|
0.41%
13/3178 • Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Subjects who did not report an event were considered as subjects without the event.
|
|
General disorders
Epistaxis
|
0.09%
12/13861 • Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Subjects who did not report an event were considered as subjects without the event.
|
0.04%
1/2295 • Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Subjects who did not report an event were considered as subjects without the event.
|
0.00%
0/3178 • Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Subjects who did not report an event were considered as subjects without the event.
|
|
General disorders
Hoarseness
|
0.51%
71/13861 • Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Subjects who did not report an event were considered as subjects without the event.
|
0.00%
0/2295 • Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Subjects who did not report an event were considered as subjects without the event.
|
0.00%
0/3178 • Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Subjects who did not report an event were considered as subjects without the event.
|
|
General disorders
Nasal congestion
|
2.0%
276/13861 • Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Subjects who did not report an event were considered as subjects without the event.
|
0.13%
3/2295 • Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Subjects who did not report an event were considered as subjects without the event.
|
0.00%
0/3178 • Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Subjects who did not report an event were considered as subjects without the event.
|
|
General disorders
Oropharyngeal pain
|
1.1%
155/13861 • Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Subjects who did not report an event were considered as subjects without the event.
|
0.09%
2/2295 • Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Subjects who did not report an event were considered as subjects without the event.
|
0.00%
0/3178 • Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Subjects who did not report an event were considered as subjects without the event.
|
|
General disorders
Rhinorrhoea
|
1.8%
243/13861 • Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Subjects who did not report an event were considered as subjects without the event.
|
0.09%
2/2295 • Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Subjects who did not report an event were considered as subjects without the event.
|
0.00%
0/3178 • Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Subjects who did not report an event were considered as subjects without the event.
|
|
General disorders
Wheezing
|
0.45%
63/13861 • Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Subjects who did not report an event were considered as subjects without the event.
|
0.00%
0/2295 • Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Subjects who did not report an event were considered as subjects without the event.
|
0.03%
1/3178 • Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Subjects who did not report an event were considered as subjects without the event.
|
|
Gastrointestinal disorders
Decreased appetite
|
0.36%
50/13861 • Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Subjects who did not report an event were considered as subjects without the event.
|
0.04%
1/2295 • Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Subjects who did not report an event were considered as subjects without the event.
|
0.03%
1/3178 • Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Subjects who did not report an event were considered as subjects without the event.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.46%
64/13861 • Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Subjects who did not report an event were considered as subjects without the event.
|
0.00%
0/2295 • Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Subjects who did not report an event were considered as subjects without the event.
|
0.06%
2/3178 • Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Subjects who did not report an event were considered as subjects without the event.
|
|
Gastrointestinal disorders
Nausea
|
0.51%
71/13861 • Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Subjects who did not report an event were considered as subjects without the event.
|
0.00%
0/2295 • Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Subjects who did not report an event were considered as subjects without the event.
|
0.00%
0/3178 • Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Subjects who did not report an event were considered as subjects without the event.
|
|
Gastrointestinal disorders
Vomiting
|
0.14%
19/13861 • Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Subjects who did not report an event were considered as subjects without the event.
|
0.04%
1/2295 • Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Subjects who did not report an event were considered as subjects without the event.
|
0.00%
0/3178 • Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Subjects who did not report an event were considered as subjects without the event.
|
|
General disorders
Anaphylactic reactions
|
0.00%
0/13861 • Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Subjects who did not report an event were considered as subjects without the event.
|
0.00%
0/2295 • Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Subjects who did not report an event were considered as subjects without the event.
|
0.00%
0/3178 • Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Subjects who did not report an event were considered as subjects without the event.
|
|
General disorders
Facial oedema
|
0.01%
1/13861 • Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Subjects who did not report an event were considered as subjects without the event.
|
0.00%
0/2295 • Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Subjects who did not report an event were considered as subjects without the event.
|
0.00%
0/3178 • Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Subjects who did not report an event were considered as subjects without the event.
|
|
General disorders
Hypersensitivity reactions
|
0.10%
14/13861 • Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Subjects who did not report an event were considered as subjects without the event.
|
0.04%
1/2295 • Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Subjects who did not report an event were considered as subjects without the event.
|
0.00%
0/3178 • Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Subjects who did not report an event were considered as subjects without the event.
|
|
General disorders
Generalised rash
|
0.22%
31/13861 • Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Subjects who did not report an event were considered as subjects without the event.
|
0.26%
6/2295 • Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Subjects who did not report an event were considered as subjects without the event.
|
0.06%
2/3178 • Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Subjects who did not report an event were considered as subjects without the event.
|
|
General disorders
Rash
|
0.12%
16/13861 • Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Subjects who did not report an event were considered as subjects without the event.
|
0.00%
0/2295 • Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Subjects who did not report an event were considered as subjects without the event.
|
0.00%
0/3178 • Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Subjects who did not report an event were considered as subjects without the event.
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.57%
79/13861 • Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Subjects who did not report an event were considered as subjects without the event.
|
0.00%
0/2295 • Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Subjects who did not report an event were considered as subjects without the event.
|
0.00%
0/3178 • Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Subjects who did not report an event were considered as subjects without the event.
|
|
Musculoskeletal and connective tissue disorders
Muscle aches/myalgia
|
2.2%
311/13861 • Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Subjects who did not report an event were considered as subjects without the event.
|
0.31%
7/2295 • Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Subjects who did not report an event were considered as subjects without the event.
|
0.47%
15/3178 • Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Subjects who did not report an event were considered as subjects without the event.
|
|
Nervous system disorders
Bell's palsy
|
0.00%
0/13861 • Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Subjects who did not report an event were considered as subjects without the event.
|
0.00%
0/2295 • Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Subjects who did not report an event were considered as subjects without the event.
|
0.00%
0/3178 • Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Subjects who did not report an event were considered as subjects without the event.
|
|
Nervous system disorders
Guillain-Barre Syndrome
|
0.00%
0/13861 • Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Subjects who did not report an event were considered as subjects without the event.
|
0.00%
0/2295 • Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Subjects who did not report an event were considered as subjects without the event.
|
0.00%
0/3178 • Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Subjects who did not report an event were considered as subjects without the event.
|
|
General disorders
Headache
|
1.4%
192/13861 • Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Subjects who did not report an event were considered as subjects without the event.
|
0.26%
6/2295 • Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Subjects who did not report an event were considered as subjects without the event.
|
0.16%
5/3178 • Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Subjects who did not report an event were considered as subjects without the event.
|
|
General disorders
Peripheral tremor
|
0.17%
24/13861 • Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Subjects who did not report an event were considered as subjects without the event.
|
0.00%
0/2295 • Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Subjects who did not report an event were considered as subjects without the event.
|
0.00%
0/3178 • Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Subjects who did not report an event were considered as subjects without the event.
|
|
General disorders
Seizure / Febrile convulsions
|
0.01%
2/13861 • Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Subjects who did not report an event were considered as subjects without the event.
|
0.00%
0/2295 • Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Subjects who did not report an event were considered as subjects without the event.
|
0.00%
0/3178 • Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Subjects who did not report an event were considered as subjects without the event.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER