Trial Outcomes & Findings for Efficacy Study With QIVc in Pediatric Subjects (NCT NCT03932682)
NCT ID: NCT03932682
Last Updated: 2025-03-04
Results Overview
First occurrence of RT-PCR confirmed influenza, due to any influenza Type A and/or B virus regardless of antigenic match to the influenza strains selected for the seasonal influenza vaccine, occurring at \>14 days after the last vaccination and until the end of the influenza season, in association with protocol-defined influenza-like illness (ILI) symptoms
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
5723 participants
Primary outcome timeframe
>14 days after last vaccination in the treatment period up to Day 181 or end of influenza season, whichever was longer (previously vaccinated subjects), or up to Day 209 or end of influenza season, whichever was longer (not previously vaccinated subjects)
Results posted on
2025-03-04
Participant Flow
Treatment period: Previously vaccinated subjects: Day of vaccination to 28 days after vaccination (Day 1-Day 29); Not previously vaccinated subjects: Day of first vaccination to 28 days after second vaccination (Day 1-Day 57) Study completion: At end of influenza season and at least 180 days after last vaccination during treatment period, whichever was longer (previously vaccinated subjects: Day 181/end of influenza season; not previously vaccinated subjects: Day 209/end of influenza season)
Participant milestones
| Measure |
QIVc
Cell-derived Quadrivalent Influenza Vaccine
QIVc: QIVc is a quadrivalent vaccine and contains 2 influenza type A strains and 2 influenza type B lineages recommended by World Health Organization (WHO) for inclusion in the quadrivalent vaccine formulation for the influenza season corresponding to the season of conduct of study.
|
Comparator
Non-influenza Comparator
Comparator: Meningococcal Group C Polysaccharide Conjugate Vaccine (NeisVac-C)
|
|---|---|---|
|
Overall Study
STARTED
|
2860
|
2863
|
|
Overall Study
COMPLETED
|
2794
|
2766
|
|
Overall Study
NOT COMPLETED
|
66
|
97
|
Reasons for withdrawal
| Measure |
QIVc
Cell-derived Quadrivalent Influenza Vaccine
QIVc: QIVc is a quadrivalent vaccine and contains 2 influenza type A strains and 2 influenza type B lineages recommended by World Health Organization (WHO) for inclusion in the quadrivalent vaccine formulation for the influenza season corresponding to the season of conduct of study.
|
Comparator
Non-influenza Comparator
Comparator: Meningococcal Group C Polysaccharide Conjugate Vaccine (NeisVac-C)
|
|---|---|---|
|
Overall Study
Death
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
37
|
45
|
|
Overall Study
Lost to Follow-up
|
19
|
25
|
|
Overall Study
Protocol Violation
|
0
|
2
|
|
Overall Study
Other
|
9
|
23
|
Baseline Characteristics
Two subjects (one subject in each vaccine group) did not have body mass index data.
Baseline characteristics by cohort
| Measure |
QIVc
n=2860 Participants
Cell-derived Quadrivalent Influenza Vaccine
QIVc: QIVc is a quadrivalent vaccine and contains 2 influenza type A strains and 2 influenza type B lineages recommended by World Health Organization (WHO) for inclusion in the quadrivalent vaccine formulation for the influenza season corresponding to the season of conduct of study.
|
Comparator
n=2863 Participants
Non-influenza Comparator
Comparator: Meningococcal Group C Polysaccharide Conjugate Vaccine (NeisVac-C)
|
Total
n=5723 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
25.8 months
STANDARD_DEVIATION 11.9 • n=2860 Participants
|
25.9 months
STANDARD_DEVIATION 11.9 • n=2863 Participants
|
25.9 months
STANDARD_DEVIATION 11.9 • n=5723 Participants
|
|
Age, Customized
6 months through 23 months
|
1268 Participants
n=2860 Participants
|
1264 Participants
n=2863 Participants
|
2532 Participants
n=5723 Participants
|
|
Age, Customized
24 months through 47 months
|
1592 Participants
n=2860 Participants
|
1599 Participants
n=2863 Participants
|
3191 Participants
n=5723 Participants
|
|
Sex: Female, Male
Female
|
1418 Participants
n=2860 Participants
|
1333 Participants
n=2863 Participants
|
2751 Participants
n=5723 Participants
|
|
Sex: Female, Male
Male
|
1442 Participants
n=2860 Participants
|
1530 Participants
n=2863 Participants
|
2972 Participants
n=5723 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
155 Participants
n=2860 Participants
|
157 Participants
n=2863 Participants
|
312 Participants
n=5723 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2696 Participants
n=2860 Participants
|
2697 Participants
n=2863 Participants
|
5393 Participants
n=5723 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=2860 Participants
|
9 Participants
n=2863 Participants
|
18 Participants
n=5723 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=2860 Participants
|
0 Participants
n=2863 Participants
|
0 Participants
n=5723 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1098 Participants
n=2860 Participants
|
1096 Participants
n=2863 Participants
|
2194 Participants
n=5723 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
348 Participants
n=2860 Participants
|
349 Participants
n=2863 Participants
|
697 Participants
n=5723 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=2860 Participants
|
1 Participants
n=2863 Participants
|
1 Participants
n=5723 Participants
|
|
Race/Ethnicity, Customized
White
|
1239 Participants
n=2860 Participants
|
1234 Participants
n=2863 Participants
|
2473 Participants
n=5723 Participants
|
|
Race/Ethnicity, Customized
Other
|
175 Participants
n=2860 Participants
|
183 Participants
n=2863 Participants
|
358 Participants
n=5723 Participants
|
|
Region of Enrollment
Romania
|
38 Participants
n=2860 Participants
|
33 Participants
n=2863 Participants
|
71 Participants
n=5723 Participants
|
|
Region of Enrollment
Czechia
|
41 Participants
n=2860 Participants
|
38 Participants
n=2863 Participants
|
79 Participants
n=5723 Participants
|
|
Region of Enrollment
Philippines
|
608 Participants
n=2860 Participants
|
609 Participants
n=2863 Participants
|
1217 Participants
n=5723 Participants
|
|
Region of Enrollment
Ukraine
|
184 Participants
n=2860 Participants
|
183 Participants
n=2863 Participants
|
367 Participants
n=5723 Participants
|
|
Region of Enrollment
Malaysia
|
31 Participants
n=2860 Participants
|
34 Participants
n=2863 Participants
|
65 Participants
n=5723 Participants
|
|
Region of Enrollment
Thailand
|
72 Participants
n=2860 Participants
|
69 Participants
n=2863 Participants
|
141 Participants
n=5723 Participants
|
|
Region of Enrollment
New Zealand
|
7 Participants
n=2860 Participants
|
7 Participants
n=2863 Participants
|
14 Participants
n=5723 Participants
|
|
Region of Enrollment
Bangladesh
|
101 Participants
n=2860 Participants
|
99 Participants
n=2863 Participants
|
200 Participants
n=5723 Participants
|
|
Region of Enrollment
Latvia
|
3 Participants
n=2860 Participants
|
2 Participants
n=2863 Participants
|
5 Participants
n=5723 Participants
|
|
Region of Enrollment
Pakistan
|
279 Participants
n=2860 Participants
|
282 Participants
n=2863 Participants
|
561 Participants
n=5723 Participants
|
|
Region of Enrollment
Poland
|
217 Participants
n=2860 Participants
|
220 Participants
n=2863 Participants
|
437 Participants
n=5723 Participants
|
|
Region of Enrollment
Honduras
|
147 Participants
n=2860 Participants
|
151 Participants
n=2863 Participants
|
298 Participants
n=5723 Participants
|
|
Region of Enrollment
South Africa
|
376 Participants
n=2860 Participants
|
380 Participants
n=2863 Participants
|
756 Participants
n=5723 Participants
|
|
Region of Enrollment
Bulgaria
|
131 Participants
n=2860 Participants
|
135 Participants
n=2863 Participants
|
266 Participants
n=5723 Participants
|
|
Region of Enrollment
Estonia
|
625 Participants
n=2860 Participants
|
621 Participants
n=2863 Participants
|
1246 Participants
n=5723 Participants
|
|
Previous influenza vaccination
Previously vaccinated
|
48 Participants
n=2860 Participants
|
62 Participants
n=2863 Participants
|
110 Participants
n=5723 Participants
|
|
Previous influenza vaccination
Not previously vaccinated
|
2812 Participants
n=2860 Participants
|
2801 Participants
n=2863 Participants
|
5613 Participants
n=5723 Participants
|
|
Participants enrolled in each influenza season
Season 1
|
344 Participants
n=2860 Participants
|
349 Participants
n=2863 Participants
|
693 Participants
n=5723 Participants
|
|
Participants enrolled in each influenza season
Season 2
|
497 Participants
n=2860 Participants
|
489 Participants
n=2863 Participants
|
986 Participants
n=5723 Participants
|
|
Participants enrolled in each influenza season
Season 3
|
525 Participants
n=2860 Participants
|
521 Participants
n=2863 Participants
|
1046 Participants
n=5723 Participants
|
|
Participants enrolled in each influenza season
Season 4
|
496 Participants
n=2860 Participants
|
504 Participants
n=2863 Participants
|
1000 Participants
n=5723 Participants
|
|
Participants enrolled in each influenza season
Season 5
|
998 Participants
n=2860 Participants
|
1000 Participants
n=2863 Participants
|
1998 Participants
n=5723 Participants
|
|
Body mass index
|
16.51 kg/m2
STANDARD_DEVIATION 2.2 • n=2859 Participants • Two subjects (one subject in each vaccine group) did not have body mass index data.
|
16.61 kg/m2
STANDARD_DEVIATION 2.9 • n=2862 Participants • Two subjects (one subject in each vaccine group) did not have body mass index data.
|
16.56 kg/m2
STANDARD_DEVIATION 2.6 • n=5721 Participants • Two subjects (one subject in each vaccine group) did not have body mass index data.
|
PRIMARY outcome
Timeframe: >14 days after last vaccination in the treatment period up to Day 181 or end of influenza season, whichever was longer (previously vaccinated subjects), or up to Day 209 or end of influenza season, whichever was longer (not previously vaccinated subjects)Population: Full Analysis Set (FAS) Efficacy, defined as all subjects in the All Enrolled Set who were randomized, received at least one dose of study vaccination, and were evaluated for efficacy at more than 14 days after the last vaccination
First occurrence of RT-PCR confirmed influenza, due to any influenza Type A and/or B virus regardless of antigenic match to the influenza strains selected for the seasonal influenza vaccine, occurring at \>14 days after the last vaccination and until the end of the influenza season, in association with protocol-defined influenza-like illness (ILI) symptoms
Outcome measures
| Measure |
QIVc
n=2856 Participants
Cell-derived Quadrivalent Influenza Vaccine
QIVc: QIVc is a quadrivalent vaccine and contains 2 influenza type A strains and 2 influenza type B lineages recommended by World Health Organization (WHO) for inclusion in the quadrivalent vaccine formulation for the influenza season corresponding to the season of conduct of study.
|
Comparator
n=2835 Participants
Non-influenza Comparator
Comparator: Meningococcal Group C Polysaccharide Conjugate Vaccine (NeisVac-C)
|
QIVc (Season 2)
QIVc immunogenicity analyses (Season 2)
|
Comparator (Season 2)
Comparator vaccine immunogenicity analyses (Season 2)
|
QIVc (Season 3)
QIVc immunogenicity analyses (Season 3)
|
Comparator (Season 3)
Comparator vaccine immunogenicity analyses (Season 3)
|
QIVc (Season 4)
QIVc immunogenicity analyses (Season 4)
|
Comparator (Season 4)
Comparator vaccine immunogenicity analyses (Season 4)
|
QIVc (Season 5)
QIVc immunogenicity analyses (Season 5)
|
Comparator (Season 5)
Comparator vaccine immunogenicity analyses (Season 5)
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Efficacy Endpoint: First Occurrence of Reverse Transcription-polymerase Chain Reaction (RT-PCR) Confirmed Influenza, Due to Any Influenza Type A and/or B Virus Regardless of Antigenic Match
|
104 Cases
|
173 Cases
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: >14 days after last vaccination in the treatment period up to Day 181 or end of influenza season, whichever was longer (previously vaccinated subjects), or up to Day 209 or end of influenza season, whichever was longer (not previously vaccinated subjects)Population: FAS Efficacy
First occurrence of culture confirmed influenza, due to influenza Type A and/or B virus antigenically matched by ferret antigenicity testing to the strains selected for the seasonal influenza vaccine, occurring at \>14 days after the last vaccination and until the end of the influenza season, in association with protocol-defined ILI symptoms
Outcome measures
| Measure |
QIVc
n=2856 Participants
Cell-derived Quadrivalent Influenza Vaccine
QIVc: QIVc is a quadrivalent vaccine and contains 2 influenza type A strains and 2 influenza type B lineages recommended by World Health Organization (WHO) for inclusion in the quadrivalent vaccine formulation for the influenza season corresponding to the season of conduct of study.
|
Comparator
n=2835 Participants
Non-influenza Comparator
Comparator: Meningococcal Group C Polysaccharide Conjugate Vaccine (NeisVac-C)
|
QIVc (Season 2)
QIVc immunogenicity analyses (Season 2)
|
Comparator (Season 2)
Comparator vaccine immunogenicity analyses (Season 2)
|
QIVc (Season 3)
QIVc immunogenicity analyses (Season 3)
|
Comparator (Season 3)
Comparator vaccine immunogenicity analyses (Season 3)
|
QIVc (Season 4)
QIVc immunogenicity analyses (Season 4)
|
Comparator (Season 4)
Comparator vaccine immunogenicity analyses (Season 4)
|
QIVc (Season 5)
QIVc immunogenicity analyses (Season 5)
|
Comparator (Season 5)
Comparator vaccine immunogenicity analyses (Season 5)
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Efficacy Endpoint: First Occurrence of Culture Confirmed Influenza, Due to Influenza Type A and/or B Virus Antigenically Matched by Ferret Antigenicity Testing to the Strains Selected for the Seasonal Influenza Vaccine
|
44 Cases
|
82 Cases
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: >14 days after last vaccination in the treatment period up to Day 181 or end of influenza season, whichever was longer (previously vaccinated subjects), or up to Day 209 or end of influenza season, whichever was longer (not previously vaccinated subjects)Population: FAS Efficacy
First occurrence of culture confirmed influenza caused by influenza virus strains antigenically dissimilar to the influenza strains selected for the seasonal vaccine occurring at \>14 days after the last vaccination and until the end of the influenza season, in association with protocol-defined ILI symptoms
Outcome measures
| Measure |
QIVc
n=2856 Participants
Cell-derived Quadrivalent Influenza Vaccine
QIVc: QIVc is a quadrivalent vaccine and contains 2 influenza type A strains and 2 influenza type B lineages recommended by World Health Organization (WHO) for inclusion in the quadrivalent vaccine formulation for the influenza season corresponding to the season of conduct of study.
|
Comparator
n=2835 Participants
Non-influenza Comparator
Comparator: Meningococcal Group C Polysaccharide Conjugate Vaccine (NeisVac-C)
|
QIVc (Season 2)
QIVc immunogenicity analyses (Season 2)
|
Comparator (Season 2)
Comparator vaccine immunogenicity analyses (Season 2)
|
QIVc (Season 3)
QIVc immunogenicity analyses (Season 3)
|
Comparator (Season 3)
Comparator vaccine immunogenicity analyses (Season 3)
|
QIVc (Season 4)
QIVc immunogenicity analyses (Season 4)
|
Comparator (Season 4)
Comparator vaccine immunogenicity analyses (Season 4)
|
QIVc (Season 5)
QIVc immunogenicity analyses (Season 5)
|
Comparator (Season 5)
Comparator vaccine immunogenicity analyses (Season 5)
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Efficacy Endpoint: First Occurrence of Culture Confirmed Influenza Caused by Influenza Virus Strains Antigenically Dissimilar to the Influenza Strains Selected for the Seasonal Influenza Vaccine
|
20 Cases
|
43 Cases
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: >14 days after last vaccination in the treatment period up to Day 181 or end of influenza season, whichever was longer (previously vaccinated subjects), or up to Day 209 or end of influenza season, whichever was longer (not previously vaccinated subjects)Population: FAS Efficacy
First occurrence of culture confirmed influenza due to any influenza Type A and/or Type B virus regardless of antigenic match to the influenza strains selected for the seasonal influenza vaccine, occurring at \>14 days after the last vaccination and until the end of the influenza season, in association with protocol-defined ILI symptoms
Outcome measures
| Measure |
QIVc
n=2856 Participants
Cell-derived Quadrivalent Influenza Vaccine
QIVc: QIVc is a quadrivalent vaccine and contains 2 influenza type A strains and 2 influenza type B lineages recommended by World Health Organization (WHO) for inclusion in the quadrivalent vaccine formulation for the influenza season corresponding to the season of conduct of study.
|
Comparator
n=2835 Participants
Non-influenza Comparator
Comparator: Meningococcal Group C Polysaccharide Conjugate Vaccine (NeisVac-C)
|
QIVc (Season 2)
QIVc immunogenicity analyses (Season 2)
|
Comparator (Season 2)
Comparator vaccine immunogenicity analyses (Season 2)
|
QIVc (Season 3)
QIVc immunogenicity analyses (Season 3)
|
Comparator (Season 3)
Comparator vaccine immunogenicity analyses (Season 3)
|
QIVc (Season 4)
QIVc immunogenicity analyses (Season 4)
|
Comparator (Season 4)
Comparator vaccine immunogenicity analyses (Season 4)
|
QIVc (Season 5)
QIVc immunogenicity analyses (Season 5)
|
Comparator (Season 5)
Comparator vaccine immunogenicity analyses (Season 5)
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Efficacy Endpoint: First Occurrence of Culture Confirmed Influenza Due to Any Influenza Type A and/or Type B Virus Regardless of Antigenic Match to the Influenza Strains Selected for the Seasonal Influenza Vaccine
|
61 Cases
|
121 Cases
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: >14 days after last vaccination in the treatment period up to Day 181 or end of influenza season, whichever was longer (previously vaccinated subjects), or up to Day 209 or end of influenza season, whichever was longer (not previously vaccinated subjects)Population: FAS Efficacy
First occurrence of RT-PCR confirmed moderate-to-severe influenza due to any influenza Type A and/or Type B virus regardless of antigenic match to the influenza strains selected for the seasonal influenza vaccine, occurring at \>14 days after the last vaccination and until the end of the influenza season
Outcome measures
| Measure |
QIVc
n=2856 Participants
Cell-derived Quadrivalent Influenza Vaccine
QIVc: QIVc is a quadrivalent vaccine and contains 2 influenza type A strains and 2 influenza type B lineages recommended by World Health Organization (WHO) for inclusion in the quadrivalent vaccine formulation for the influenza season corresponding to the season of conduct of study.
|
Comparator
n=2835 Participants
Non-influenza Comparator
Comparator: Meningococcal Group C Polysaccharide Conjugate Vaccine (NeisVac-C)
|
QIVc (Season 2)
QIVc immunogenicity analyses (Season 2)
|
Comparator (Season 2)
Comparator vaccine immunogenicity analyses (Season 2)
|
QIVc (Season 3)
QIVc immunogenicity analyses (Season 3)
|
Comparator (Season 3)
Comparator vaccine immunogenicity analyses (Season 3)
|
QIVc (Season 4)
QIVc immunogenicity analyses (Season 4)
|
Comparator (Season 4)
Comparator vaccine immunogenicity analyses (Season 4)
|
QIVc (Season 5)
QIVc immunogenicity analyses (Season 5)
|
Comparator (Season 5)
Comparator vaccine immunogenicity analyses (Season 5)
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Efficacy Endpoint: First Occurrence of RT-PCR Confirmed Moderate-to-severe Influenza Due to Any Influenza Type A and/or Type B Virus Regardless of Antigenic Match to the Influenza Strains Selected for the Seasonal Influenza Vaccine
|
0 Cases
|
9 Cases
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 29 for previously vaccinated subjects; Day 1 and Day 57 for not previously vaccinated subjectsPopulation: FAS Immunogenicity, defined as all subjects in the All Enrolled Set who were randomized, received at least one study vaccination, and provided evaluable serum samples at both baseline (Day 1) and 28 days after last vaccination (Day 29/57)
The measures for immunogenicity are determined by a hemagglutination inhibition (HI) assay prior to first vaccination and 28 days after last vaccination for all four influenza strains HI = hemagglutination inhibition Adjusted GMTs are presented
Outcome measures
| Measure |
QIVc
n=112 Participants
Cell-derived Quadrivalent Influenza Vaccine
QIVc: QIVc is a quadrivalent vaccine and contains 2 influenza type A strains and 2 influenza type B lineages recommended by World Health Organization (WHO) for inclusion in the quadrivalent vaccine formulation for the influenza season corresponding to the season of conduct of study.
|
Comparator
n=108 Participants
Non-influenza Comparator
Comparator: Meningococcal Group C Polysaccharide Conjugate Vaccine (NeisVac-C)
|
QIVc (Season 2)
n=107 Participants
QIVc immunogenicity analyses (Season 2)
|
Comparator (Season 2)
n=111 Participants
Comparator vaccine immunogenicity analyses (Season 2)
|
QIVc (Season 3)
n=111 Participants
QIVc immunogenicity analyses (Season 3)
|
Comparator (Season 3)
n=112 Participants
Comparator vaccine immunogenicity analyses (Season 3)
|
QIVc (Season 4)
n=87 Participants
QIVc immunogenicity analyses (Season 4)
|
Comparator (Season 4)
n=85 Participants
Comparator vaccine immunogenicity analyses (Season 4)
|
QIVc (Season 5)
n=108 Participants
QIVc immunogenicity analyses (Season 5)
|
Comparator (Season 5)
n=108 Participants
Comparator vaccine immunogenicity analyses (Season 5)
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (HI Assay)
A/H3N2 Day 1 HI GMT
|
NA Geometric mean titer
Not applicable due to lack of agglutination of A/H3N2 in HI assay
|
NA Geometric mean titer
Not applicable due to lack of agglutination of A/H3N2 in HI assay
|
12.21 Geometric mean titer
Interval 5.59 to 26.7
|
14.14 Geometric mean titer
Interval 6.57 to 30.41
|
NA Geometric mean titer
Not applicable due to lack of agglutination of A/H3N2 in HI assay
|
NA Geometric mean titer
Not applicable due to lack of agglutination of A/H3N2 in HI assay
|
46.38 Geometric mean titer
Interval 21.09 to 101.98
|
35.62 Geometric mean titer
Interval 16.41 to 77.3
|
82.67 Geometric mean titer
Interval 19.98 to 342.16
|
120.80 Geometric mean titer
Interval 28.47 to 512.58
|
|
Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (HI Assay)
A/H3N2 Day 29/57 HI GMT
|
NA Geometric mean titer
Not applicable due to lack of agglutination of A/H3N2 in HI assay
|
NA Geometric mean titer
Not applicable due to lack of agglutination of A/H3N2 in HI assay
|
95.36 Geometric mean titer
Interval 43.91 to 207.07
|
8.79 Geometric mean titer
Interval 4.11 to 18.77
|
NA Geometric mean titer
Not applicable due to lack of agglutination of A/H3N2 in HI assay
|
NA Geometric mean titer
Not applicable due to lack of agglutination of A/H3N2 in HI assay
|
67.88 Geometric mean titer
Interval 36.64 to 125.77
|
38.85 Geometric mean titer
Interval 21.22 to 71.1
|
440.30 Geometric mean titer
Interval 127.04 to 1526.08
|
57.87 Geometric mean titer
Interval 16.29 to 205.63
|
|
Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (HI Assay)
B/Yamagata Day 1 HI GMT
|
11.66 Geometric mean titer
Interval 8.26 to 16.46
|
11.53 Geometric mean titer
Interval 8.27 to 16.09
|
9.87 Geometric mean titer
Interval 6.86 to 14.22
|
8.22 Geometric mean titer
Interval 5.75 to 11.75
|
7.65 Geometric mean titer
Interval 4.25 to 13.79
|
7.54 Geometric mean titer
Interval 4.19 to 13.57
|
8.96 Geometric mean titer
Interval 6.78 to 11.84
|
9.49 Geometric mean titer
Interval 7.22 to 12.48
|
7.30 Geometric mean titer
Interval 4.19 to 12.73
|
7.35 Geometric mean titer
Interval 4.18 to 12.95
|
|
Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (HI Assay)
B/Yamagata Day 29/57 HI GMT
|
18.94 Geometric mean titer
Interval 13.07 to 27.46
|
6.90 Geometric mean titer
Interval 4.82 to 9.87
|
23.65 Geometric mean titer
Interval 14.04 to 39.85
|
13.57 Geometric mean titer
Interval 8.17 to 22.53
|
13.85 Geometric mean titer
Interval 6.91 to 27.77
|
5.26 Geometric mean titer
Interval 2.63 to 10.53
|
13.80 Geometric mean titer
Interval 8.95 to 21.28
|
4.70 Geometric mean titer
Interval 3.06 to 7.22
|
53.72 Geometric mean titer
Interval 20.85 to 138.4
|
8.04 Geometric mean titer
Interval 3.07 to 21.06
|
|
Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (HI Assay)
A/H1N1 Day 1 HI GMT
|
40.06 Geometric mean titer
Interval 21.41 to 74.97
|
44.28 Geometric mean titer
Interval 24.19 to 81.07
|
22.99 Geometric mean titer
Interval 9.52 to 55.49
|
27.50 Geometric mean titer
Interval 11.6 to 65.18
|
10.15 Geometric mean titer
Interval 4.45 to 23.13
|
8.72 Geometric mean titer
Interval 3.87 to 19.6
|
57.83 Geometric mean titer
Interval 34.41 to 97.19
|
58.00 Geometric mean titer
Interval 34.81 to 96.64
|
13.60 Geometric mean titer
Interval 1.97 to 93.97
|
13.94 Geometric mean titer
Interval 1.95 to 99.61
|
|
Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (HI Assay)
A/H1N1 Day 29/57 HI GMT
|
126.39 Geometric mean titer
Interval 68.37 to 233.66
|
60.33 Geometric mean titer
Interval 33.32 to 109.21
|
60.77 Geometric mean titer
Interval 33.77 to 109.38
|
11.24 Geometric mean titer
Interval 6.32 to 20.02
|
49.38 Geometric mean titer
Interval 22.92 to 106.39
|
5.45 Geometric mean titer
Interval 2.56 to 11.58
|
149.01 Geometric mean titer
Interval 96.96 to 229.01
|
81.71 Geometric mean titer
Interval 53.55 to 124.68
|
362.71 Geometric mean titer
Interval 74.42 to 1767.89
|
60.84 Geometric mean titer
Interval 12.14 to 304.84
|
|
Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (HI Assay)
B/Victoria Day 1 HI GMT
|
7.40 Geometric mean titer
Interval 5.35 to 10.24
|
8.36 Geometric mean titer
Interval 6.11 to 11.43
|
9.37 Geometric mean titer
Interval 7.46 to 11.76
|
9.31 Geometric mean titer
Interval 7.45 to 11.63
|
8.34 Geometric mean titer
Interval 5.4 to 12.9
|
9.39 Geometric mean titer
Interval 6.12 to 14.42
|
5.82 Geometric mean titer
Interval 5.18 to 6.53
|
6.08 Geometric mean titer
Interval 5.42 to 6.82
|
7.84 Geometric mean titer
Interval 1.38 to 44.61
|
5.92 Geometric mean titer
Interval 1.01 to 34.73
|
|
Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (HI Assay)
B/Victoria Day 29/57 HI GMT
|
14.97 Geometric mean titer
Interval 10.42 to 21.49
|
7.01 Geometric mean titer
Interval 4.94 to 9.95
|
16.84 Geometric mean titer
Interval 11.32 to 25.07
|
8.82 Geometric mean titer
Interval 5.97 to 13.02
|
9.54 Geometric mean titer
Interval 5.6 to 16.25
|
4.88 Geometric mean titer
Interval 2.89 to 8.26
|
23.92 Geometric mean titer
Interval 13.98 to 40.92
|
4.67 Geometric mean titer
Interval 2.73 to 7.97
|
539.53 Geometric mean titer
Interval 158.62 to 1835.19
|
45.34 Geometric mean titer
Interval 13.01 to 157.93
|
SECONDARY outcome
Timeframe: Day 1 through Day 29 for previously vaccinated subjects; Day 1 through Day 57 for not previously vaccinated subjectsPopulation: FAS Immunogenicity
The measures for immunogenicity are determined by a HI assay prior to first vaccination and 28 days after last vaccination for all four influenza strains SCR is defined as the percentage of subjects with either a prevaccination HI titer \<1:10 and a postvaccination HI titer ≥1:40, or a prevaccination HI titer ≥1:10 and a ≥4-fold increase in postvaccination HI titer
Outcome measures
| Measure |
QIVc
n=112 Participants
Cell-derived Quadrivalent Influenza Vaccine
QIVc: QIVc is a quadrivalent vaccine and contains 2 influenza type A strains and 2 influenza type B lineages recommended by World Health Organization (WHO) for inclusion in the quadrivalent vaccine formulation for the influenza season corresponding to the season of conduct of study.
|
Comparator
n=108 Participants
Non-influenza Comparator
Comparator: Meningococcal Group C Polysaccharide Conjugate Vaccine (NeisVac-C)
|
QIVc (Season 2)
n=107 Participants
QIVc immunogenicity analyses (Season 2)
|
Comparator (Season 2)
n=111 Participants
Comparator vaccine immunogenicity analyses (Season 2)
|
QIVc (Season 3)
n=111 Participants
QIVc immunogenicity analyses (Season 3)
|
Comparator (Season 3)
n=112 Participants
Comparator vaccine immunogenicity analyses (Season 3)
|
QIVc (Season 4)
n=87 Participants
QIVc immunogenicity analyses (Season 4)
|
Comparator (Season 4)
n=85 Participants
Comparator vaccine immunogenicity analyses (Season 4)
|
QIVc (Season 5)
n=108 Participants
QIVc immunogenicity analyses (Season 5)
|
Comparator (Season 5)
n=108 Participants
Comparator vaccine immunogenicity analyses (Season 5)
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Immunogenicity Endpoint: Seroconversion Rates (SCR) (HI Assay)
A/H1N1 SCR HI Titer
|
45.54 Percentage of participants
Interval 36.1 to 55.22
|
12.04 Percentage of participants
Interval 6.57 to 19.7
|
57.01 Percentage of participants
Interval 47.08 to 66.54
|
3.60 Percentage of participants
Interval 0.99 to 8.97
|
68.47 Percentage of participants
Interval 58.96 to 76.96
|
2.68 Percentage of participants
Interval 0.56 to 7.63
|
29.89 Percentage of participants
Interval 20.54 to 40.65
|
4.71 Percentage of participants
Interval 1.3 to 11.61
|
75.00 Percentage of participants
Interval 65.75 to 82.83
|
12.96 Percentage of participants
Interval 7.27 to 20.79
|
|
Immunogenicity Endpoint: Seroconversion Rates (SCR) (HI Assay)
A/H3N2 SCR HI Titer
|
NA Percentage of participants
Not applicable due to lack of agglutination of A/H3N2 in HI assay
|
NA Percentage of participants
Not applicable due to lack of agglutination of A/H3N2 in HI assay
|
70.09 Percentage of participants
Interval 60.48 to 78.56
|
6.31 Percentage of participants
Interval 2.57 to 12.56
|
NA Percentage of participants
Not applicable due to lack of agglutination of A/H3N2 in HI assay
|
NA Percentage of participants
Not applicable due to lack of agglutination of A/H3N2 in HI assay
|
44.83 Percentage of participants
Interval 34.15 to 55.87
|
28.24 Percentage of participants
Interval 19.0 to 39.04
|
84.26 Percentage of participants
Interval 76.0 to 90.55
|
15.74 Percentage of participants
Interval 9.45 to 24.0
|
|
Immunogenicity Endpoint: Seroconversion Rates (SCR) (HI Assay)
B/Yamagata SCR HI Titer
|
37.50 Percentage of participants
Interval 28.53 to 47.15
|
3.70 Percentage of participants
Interval 1.02 to 9.21
|
24.30 Percentage of participants
Interval 16.53 to 33.54
|
6.31 Percentage of participants
Interval 2.57 to 12.56
|
23.42 Percentage of participants
Interval 15.91 to 32.41
|
0.90 Percentage of participants
Interval 0.02 to 4.92
|
29.89 Percentage of participants
Interval 20.54 to 40.65
|
1.18 Percentage of participants
Interval 0.03 to 6.38
|
66.67 Percentage of participants
Interval 56.95 to 75.45
|
3.70 Percentage of participants
Interval 1.02 to 9.21
|
|
Immunogenicity Endpoint: Seroconversion Rates (SCR) (HI Assay)
B/Victoria SCR HI Titer
|
24.11 Percentage of participants
Interval 16.53 to 33.1
|
2.78 Percentage of participants
Interval 0.58 to 7.9
|
13.08 Percentage of participants
Interval 7.34 to 20.98
|
0.90 Percentage of participants
Interval 0.02 to 4.92
|
9.91 Percentage of participants
Interval 5.05 to 17.04
|
0.00 Percentage of participants
Not estimable due to insufficient number of events
|
42.53 Percentage of participants
Interval 31.99 to 53.59
|
3.53 Percentage of participants
Interval 0.73 to 9.97
|
80.56 Percentage of participants
Interval 71.83 to 87.54
|
8.33 Percentage of participants
Interval 3.88 to 15.23
|
SECONDARY outcome
Timeframe: Day 1 through Day 29 for previously vaccinated subjects; Day 1 through Day 57 for not previously vaccinated subjectsPopulation: FAS Immunogenicity
The measures for immunogenicity are determined by a hemagglutination inhibition (HI) assay prior to first vaccination and 28 days after last vaccination for all four influenza strains GMR is the geometric mean of the fold increase of postvaccination HI titer over the prevaccination HI titer Adjusted GMRs are presented
Outcome measures
| Measure |
QIVc
n=112 Participants
Cell-derived Quadrivalent Influenza Vaccine
QIVc: QIVc is a quadrivalent vaccine and contains 2 influenza type A strains and 2 influenza type B lineages recommended by World Health Organization (WHO) for inclusion in the quadrivalent vaccine formulation for the influenza season corresponding to the season of conduct of study.
|
Comparator
n=108 Participants
Non-influenza Comparator
Comparator: Meningococcal Group C Polysaccharide Conjugate Vaccine (NeisVac-C)
|
QIVc (Season 2)
n=107 Participants
QIVc immunogenicity analyses (Season 2)
|
Comparator (Season 2)
n=111 Participants
Comparator vaccine immunogenicity analyses (Season 2)
|
QIVc (Season 3)
n=111 Participants
QIVc immunogenicity analyses (Season 3)
|
Comparator (Season 3)
n=112 Participants
Comparator vaccine immunogenicity analyses (Season 3)
|
QIVc (Season 4)
n=87 Participants
QIVc immunogenicity analyses (Season 4)
|
Comparator (Season 4)
n=85 Participants
Comparator vaccine immunogenicity analyses (Season 4)
|
QIVc (Season 5)
n=108 Participants
QIVc immunogenicity analyses (Season 5)
|
Comparator (Season 5)
n=108 Participants
Comparator vaccine immunogenicity analyses (Season 5)
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (HI Assay)
A/H1N1 GMR HI Titer
|
3.36 Geometric mean ratio
Interval 1.69 to 6.66
|
1.53 Geometric mean ratio
Interval 0.79 to 2.95
|
3.71 Geometric mean ratio
Interval 2.04 to 6.73
|
0.67 Geometric mean ratio
Interval 0.37 to 1.2
|
6.28 Geometric mean ratio
Interval 2.91 to 13.56
|
0.70 Geometric mean ratio
Interval 0.33 to 1.5
|
2.59 Geometric mean ratio
Interval 1.51 to 4.45
|
1.42 Geometric mean ratio
Interval 0.83 to 2.41
|
19.20 Geometric mean ratio
Interval 3.61 to 102.12
|
3.20 Geometric mean ratio
Interval 0.58 to 17.52
|
|
Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (HI Assay)
A/H3N2 GMR HI Titer
|
NA Geometric mean ratio
Not applicable due to lack of agglutination of A/H3N2 in HI assay
|
NA Geometric mean ratio
Not applicable due to lack of agglutination of A/H3N2 in HI assay
|
7.43 Geometric mean ratio
Interval 2.95 to 18.75
|
0.62 Geometric mean ratio
Interval 0.25 to 1.54
|
NA Geometric mean ratio
Not applicable due to lack of agglutination of A/H3N2 in HI assay
|
NA Geometric mean ratio
Not applicable due to lack of agglutination of A/H3N2 in HI assay
|
1.81 Geometric mean ratio
Interval 0.86 to 3.81
|
1.19 Geometric mean ratio
Interval 0.57 to 2.48
|
7.14 Geometric mean ratio
Interval 1.81 to 28.16
|
0.80 Geometric mean ratio
Interval 0.2 to 3.24
|
|
Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (HI Assay)
B/Victoria GMR HI Titer
|
2.01 Geometric mean ratio
Interval 1.37 to 2.96
|
0.90 Geometric mean ratio
Interval 0.62 to 1.3
|
1.79 Geometric mean ratio
Interval 1.15 to 2.79
|
0.94 Geometric mean ratio
Interval 0.61 to 1.46
|
1.43 Geometric mean ratio
Interval 0.83 to 2.44
|
0.71 Geometric mean ratio
Interval 0.42 to 1.21
|
4.44 Geometric mean ratio
Interval 2.62 to 7.55
|
0.85 Geometric mean ratio
Interval 0.51 to 1.43
|
32.55 Geometric mean ratio
Interval 8.85 to 119.71
|
2.95 Geometric mean ratio
Interval 0.78 to 11.09
|
|
Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (HI Assay)
B/Yamagata GMR HI Titer
|
2.52 Geometric mean ratio
Interval 1.75 to 3.63
|
0.92 Geometric mean ratio
Interval 0.65 to 1.31
|
3.38 Geometric mean ratio
Interval 2.02 to 5.67
|
1.96 Geometric mean ratio
Interval 1.18 to 3.25
|
1.95 Geometric mean ratio
Interval 0.91 to 4.15
|
0.75 Geometric mean ratio
Interval 0.35 to 1.59
|
2.03 Geometric mean ratio
Interval 1.32 to 3.13
|
0.68 Geometric mean ratio
Interval 0.44 to 1.04
|
8.04 Geometric mean ratio
Interval 3.12 to 20.72
|
1.20 Geometric mean ratio
Interval 0.46 to 3.15
|
SECONDARY outcome
Timeframe: Day 1 and Day 29 for previously vaccinated subjects; Day 1 and Day 57 for not previously vaccinated subjectsPopulation: FAS Immunogenicity
The measures for immunogenicity are determined by a microneutralization (MN) assay prior to first vaccination and 28 days after last vaccination for all four influenza strains
Outcome measures
| Measure |
QIVc
n=112 Participants
Cell-derived Quadrivalent Influenza Vaccine
QIVc: QIVc is a quadrivalent vaccine and contains 2 influenza type A strains and 2 influenza type B lineages recommended by World Health Organization (WHO) for inclusion in the quadrivalent vaccine formulation for the influenza season corresponding to the season of conduct of study.
|
Comparator
n=108 Participants
Non-influenza Comparator
Comparator: Meningococcal Group C Polysaccharide Conjugate Vaccine (NeisVac-C)
|
QIVc (Season 2)
n=107 Participants
QIVc immunogenicity analyses (Season 2)
|
Comparator (Season 2)
n=111 Participants
Comparator vaccine immunogenicity analyses (Season 2)
|
QIVc (Season 3)
n=111 Participants
QIVc immunogenicity analyses (Season 3)
|
Comparator (Season 3)
n=112 Participants
Comparator vaccine immunogenicity analyses (Season 3)
|
QIVc (Season 4)
n=87 Participants
QIVc immunogenicity analyses (Season 4)
|
Comparator (Season 4)
n=85 Participants
Comparator vaccine immunogenicity analyses (Season 4)
|
QIVc (Season 5)
n=108 Participants
QIVc immunogenicity analyses (Season 5)
|
Comparator (Season 5)
n=108 Participants
Comparator vaccine immunogenicity analyses (Season 5)
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (MN Assay)
A/H1N1 Day 29/57 MN GMT
|
329.08 Geometric mean titer
Interval 196.16 to 552.06
|
36.24 Geometric mean titer
Interval 21.97 to 59.79
|
473.15 Geometric mean titer
Interval 247.69 to 903.85
|
66.69 Geometric mean titer
Interval 35.39 to 125.71
|
459.87 Geometric mean titer
Interval 157.55 to 1342.31
|
19.32 Geometric mean titer
Interval 6.76 to 55.21
|
86.91 Geometric mean titer
Interval 58.51 to 129.11
|
46.51 Geometric mean titer
Interval 31.53 to 68.6
|
352.09 Geometric mean titer
Interval 110.01 to 1126.9
|
86.61 Geometric mean titer
Interval 26.51 to 282.92
|
|
Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (MN Assay)
B/Yamagata Day 29/57 MN GMT
|
278.89 Geometric mean titer
Interval 202.31 to 384.46
|
88.67 Geometric mean titer
Interval 65.06 to 120.84
|
283.42 Geometric mean titer
Interval 183.07 to 438.79
|
126.59 Geometric mean titer
Interval 82.43 to 194.41
|
55.17 Geometric mean titer
Interval 27.19 to 111.92
|
19.24 Geometric mean titer
Interval 9.59 to 38.59
|
84.60 Geometric mean titer
Interval 55.74 to 128.38
|
52.11 Geometric mean titer
Interval 34.57 to 78.55
|
169.24 Geometric mean titer
Interval 75.01 to 381.86
|
49.34 Geometric mean titer
Interval 21.58 to 112.85
|
|
Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (MN Assay)
B/Victoria Day 29/57 MN GMT
|
14.23 Geometric mean titer
Interval 10.95 to 18.51
|
7.00 Geometric mean titer
Interval 5.44 to 9.02
|
5.29 Geometric mean titer
Interval 4.03 to 6.92
|
5.26 Geometric mean titer
Interval 4.04 to 6.85
|
26.81 Geometric mean titer
Interval 14.06 to 51.12
|
9.65 Geometric mean titer
Interval 5.12 to 18.2
|
121.02 Geometric mean titer
Interval 59.56 to 245.87
|
5.99 Geometric mean titer
Interval 2.99 to 11.97
|
938.65 Geometric mean titer
Interval 230.67 to 3819.51
|
39.32 Geometric mean titer
Interval 9.41 to 164.32
|
|
Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (MN Assay)
A/H1N1 Day 1 MN GMT
|
22.06 Geometric mean titer
Interval 9.53 to 51.07
|
31.10 Geometric mean titer
Interval 13.83 to 69.92
|
57.54 Geometric mean titer
Interval 18.79 to 176.16
|
55.89 Geometric mean titer
Interval 18.69 to 167.19
|
61.40 Geometric mean titer
Interval 16.51 to 228.37
|
43.43 Geometric mean titer
Interval 11.93 to 158.11
|
32.15 Geometric mean titer
Interval 19.17 to 53.9
|
35.32 Geometric mean titer
Interval 21.25 to 58.71
|
113.94 Geometric mean titer
Interval 36.64 to 354.34
|
115.49 Geometric mean titer
Interval 36.41 to 366.35
|
|
Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (MN Assay)
A/H3N2 Day 1 MN GMT
|
6.92 Geometric mean titer
Interval 4.91 to 9.76
|
6.29 Geometric mean titer
Interval 4.51 to 8.76
|
4.96 Geometric mean titer
Interval 4.19 to 5.88
|
4.80 Geometric mean titer
Interval 4.07 to 5.67
|
7.02 Geometric mean titer
Interval 3.18 to 15.51
|
8.33 Geometric mean titer
Interval 3.82 to 18.16
|
17.70 Geometric mean titer
Interval 10.34 to 30.31
|
15.77 Geometric mean titer
Interval 9.29 to 26.76
|
26.08 Geometric mean titer
Interval 7.79 to 87.37
|
25.98 Geometric mean titer
Interval 7.59 to 88.87
|
|
Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (MN Assay)
A/H3N2 Day 29/57 MN GMT
|
27.55 Geometric mean titer
Interval 18.7 to 40.58
|
10.95 Geometric mean titer
Interval 7.52 to 15.94
|
12.04 Geometric mean titer
Interval 7.6 to 19.08
|
5.31 Geometric mean titer
Interval 3.38 to 8.34
|
57.93 Geometric mean titer
Interval 28.43 to 118.06
|
10.49 Geometric mean titer
Interval 5.21 to 21.09
|
35.99 Geometric mean titer
Interval 18.52 to 69.94
|
14.78 Geometric mean titer
Interval 7.7 to 28.34
|
139.97 Geometric mean titer
Interval 41.52 to 471.84
|
30.22 Geometric mean titer
Interval 8.78 to 104.08
|
|
Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (MN Assay)
B/Yamagata Day 1 MN GMT
|
76.91 Geometric mean titer
Interval 53.5 to 110.55
|
66.14 Geometric mean titer
Interval 46.6 to 93.87
|
65.25 Geometric mean titer
Interval 35.87 to 118.7
|
60.03 Geometric mean titer
Interval 33.41 to 107.86
|
15.33 Geometric mean titer
Interval 7.73 to 30.41
|
15.26 Geometric mean titer
Interval 7.78 to 29.93
|
53.41 Geometric mean titer
Interval 32.42 to 88.0
|
54.11 Geometric mean titer
Interval 33.12 to 88.41
|
51.81 Geometric mean titer
Interval 23.27 to 115.35
|
45.20 Geometric mean titer
Interval 20.02 to 102.06
|
|
Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (MN Assay)
B/Victoria Day 1 MN GMT
|
6.07 Geometric mean titer
Interval 4.82 to 7.65
|
6.64 Geometric mean titer
Interval 5.31 to 8.3
|
4.99 Geometric mean titer
Interval 4.16 to 5.99
|
5.18 Geometric mean titer
Interval 4.33 to 6.18
|
9.09 Geometric mean titer
Interval 4.8 to 17.24
|
10.71 Geometric mean titer
Interval 5.71 to 20.09
|
8.79 Geometric mean titer
Interval 6.4 to 12.07
|
7.72 Geometric mean titer
Interval 5.66 to 10.55
|
15.97 Geometric mean titer
Interval 2.53 to 100.98
|
12.20 Geometric mean titer
Interval 1.87 to 79.68
|
SECONDARY outcome
Timeframe: Day 1 through Day 29 for previously vaccinated subjects; Day 1 through Day 57 for not previously vaccinated subjectsPopulation: FAS Immunogenicity
The measures for immunogenicity are determined by a MN assay prior to first vaccination and 28 days after last vaccination for all four influenza strains SCR is defined as the percentage of subjects with either a prevaccination MN titer \<1:10 and a postvaccination MN titer ≥1:40, or a prevaccination MN titer ≥1:10 and a ≥4-fold increase in postvaccination MN titer
Outcome measures
| Measure |
QIVc
n=112 Participants
Cell-derived Quadrivalent Influenza Vaccine
QIVc: QIVc is a quadrivalent vaccine and contains 2 influenza type A strains and 2 influenza type B lineages recommended by World Health Organization (WHO) for inclusion in the quadrivalent vaccine formulation for the influenza season corresponding to the season of conduct of study.
|
Comparator
n=108 Participants
Non-influenza Comparator
Comparator: Meningococcal Group C Polysaccharide Conjugate Vaccine (NeisVac-C)
|
QIVc (Season 2)
n=107 Participants
QIVc immunogenicity analyses (Season 2)
|
Comparator (Season 2)
n=111 Participants
Comparator vaccine immunogenicity analyses (Season 2)
|
QIVc (Season 3)
n=111 Participants
QIVc immunogenicity analyses (Season 3)
|
Comparator (Season 3)
n=112 Participants
Comparator vaccine immunogenicity analyses (Season 3)
|
QIVc (Season 4)
n=87 Participants
QIVc immunogenicity analyses (Season 4)
|
Comparator (Season 4)
n=85 Participants
Comparator vaccine immunogenicity analyses (Season 4)
|
QIVc (Season 5)
n=108 Participants
QIVc immunogenicity analyses (Season 5)
|
Comparator (Season 5)
n=108 Participants
Comparator vaccine immunogenicity analyses (Season 5)
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Immunogenicity Endpoint: Seroconversion Rates (SCR) (MN Assay)
A/H1N1 SCR (%) MN Titer
|
73.21 Percentage of participants
Interval 64.02 to 81.14
|
2.78 Percentage of participants
Interval 0.58 to 7.9
|
74.77 Percentage of participants
Interval 65.45 to 82.67
|
4.50 Percentage of participants
Interval 1.48 to 10.2
|
87.39 Percentage of participants
Interval 79.74 to 92.93
|
4.46 Percentage of participants
Interval 1.47 to 10.11
|
32.18 Percentage of participants
Interval 22.56 to 43.06
|
7.06 Percentage of participants
Interval 2.63 to 14.73
|
68.52 Percentage of participants
Interval 58.88 to 77.12
|
15.74 Percentage of participants
Interval 9.45 to 24.0
|
|
Immunogenicity Endpoint: Seroconversion Rates (SCR) (MN Assay)
A/H3N2 SCR (%) MN Titer
|
38.39 Percentage of participants
Interval 29.36 to 48.06
|
4.63 Percentage of participants
Interval 1.52 to 10.47
|
20.56 Percentage of participants
Interval 13.36 to 29.46
|
1.80 Percentage of participants
Interval 0.22 to 6.36
|
57.66 Percentage of participants
Interval 47.92 to 66.98
|
1.79 Percentage of participants
Interval 0.22 to 6.3
|
33.33 Percentage of participants
Interval 23.58 to 44.25
|
10.59 Percentage of participants
Interval 4.96 to 19.15
|
71.30 Percentage of participants
Interval 61.8 to 79.59
|
15.74 Percentage of participants
Interval 9.45 to 24.0
|
|
Immunogenicity Endpoint: Seroconversion Rates (SCR) (MN Assay)
B/Yamagata SCR (%) MN Titer
|
46.43 Percentage of participants
Interval 36.95 to 56.1
|
0.93 Percentage of participants
Interval 0.02 to 5.05
|
30.84 Percentage of participants
Interval 22.27 to 40.5
|
3.60 Percentage of participants
Interval 0.99 to 8.97
|
36.94 Percentage of participants
Interval 27.97 to 46.62
|
4.46 Percentage of participants
Interval 1.47 to 10.11
|
19.54 Percentage of participants
Interval 11.81 to 29.43
|
4.71 Percentage of participants
Interval 1.3 to 11.61
|
54.63 Percentage of participants
Interval 44.76 to 64.24
|
7.41 Percentage of participants
Interval 3.25 to 14.07
|
|
Immunogenicity Endpoint: Seroconversion Rates (SCR) (MN Assay)
B/Victoria SCR (%) MN Titer
|
20.54 Percentage of participants
Interval 13.49 to 29.2
|
0.93 Percentage of participants
Interval 0.02 to 5.05
|
0.93 Percentage of participants
Interval 0.02 to 5.1
|
2.70 Percentage of participants
Interval 0.56 to 7.7
|
25.23 Percentage of participants
Interval 17.46 to 34.35
|
0.89 Percentage of participants
Interval 0.02 to 4.87
|
87.36 Percentage of participants
Interval 78.5 to 93.52
|
7.06 Percentage of participants
Interval 2.63 to 14.73
|
94.44 Percentage of participants
Interval 88.3 to 97.93
|
9.26 Percentage of participants
Interval 4.53 to 16.37
|
SECONDARY outcome
Timeframe: Day 1 through Day 29 for previously vaccinated subjects; Day 1 through Day 57 for not previously vaccinated subjectsPopulation: FAS Immunogenicity
The measures for immunogenicity are determined by a MN assay prior to first vaccination and 28 days after last vaccination for all four influenza strains GMR is the geometric mean of the fold increase of post-vaccination MN titer over the pre-vaccination MN titer
Outcome measures
| Measure |
QIVc
n=112 Participants
Cell-derived Quadrivalent Influenza Vaccine
QIVc: QIVc is a quadrivalent vaccine and contains 2 influenza type A strains and 2 influenza type B lineages recommended by World Health Organization (WHO) for inclusion in the quadrivalent vaccine formulation for the influenza season corresponding to the season of conduct of study.
|
Comparator
n=108 Participants
Non-influenza Comparator
Comparator: Meningococcal Group C Polysaccharide Conjugate Vaccine (NeisVac-C)
|
QIVc (Season 2)
n=107 Participants
QIVc immunogenicity analyses (Season 2)
|
Comparator (Season 2)
n=111 Participants
Comparator vaccine immunogenicity analyses (Season 2)
|
QIVc (Season 3)
n=111 Participants
QIVc immunogenicity analyses (Season 3)
|
Comparator (Season 3)
n=112 Participants
Comparator vaccine immunogenicity analyses (Season 3)
|
QIVc (Season 4)
n=87 Participants
QIVc immunogenicity analyses (Season 4)
|
Comparator (Season 4)
n=85 Participants
Comparator vaccine immunogenicity analyses (Season 4)
|
QIVc (Season 5)
n=108 Participants
QIVc immunogenicity analyses (Season 5)
|
Comparator (Season 5)
n=108 Participants
Comparator vaccine immunogenicity analyses (Season 5)
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (MN Assay)
B/Victoria GMR MN Titer
|
2.17 Geometric mean ratio
Interval 1.67 to 2.82
|
1.07 Geometric mean ratio
Interval 0.83 to 1.37
|
1.04 Geometric mean ratio
Interval 0.77 to 1.4
|
1.01 Geometric mean ratio
Interval 0.75 to 1.35
|
2.74 Geometric mean ratio
Interval 1.37 to 5.47
|
0.92 Geometric mean ratio
Interval 0.47 to 1.83
|
16.90 Geometric mean ratio
Interval 8.36 to 34.19
|
0.86 Geometric mean ratio
Interval 0.43 to 1.72
|
31.51 Geometric mean ratio
Interval 7.19 to 138.05
|
1.42 Geometric mean ratio
Interval 0.31 to 6.37
|
|
Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (MN Assay)
A/H3N2 GMR MN Titer
|
3.28 Geometric mean ratio
Interval 2.23 to 4.84
|
1.32 Geometric mean ratio
Interval 0.91 to 1.92
|
2.14 Geometric mean ratio
Interval 1.35 to 3.4
|
0.93 Geometric mean ratio
Interval 0.59 to 1.46
|
5.92 Geometric mean ratio
Interval 2.79 to 12.56
|
1.01 Geometric mean ratio
Interval 0.48 to 2.13
|
2.74 Geometric mean ratio
Interval 1.39 to 5.38
|
1.16 Geometric mean ratio
Interval 0.6 to 2.26
|
4.40 Geometric mean ratio
Interval 1.3 to 14.88
|
0.95 Geometric mean ratio
Interval 0.27 to 3.28
|
|
Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (MN Assay)
B/Yamagata GMR MN Titer
|
3.93 Geometric mean ratio
Interval 2.81 to 5.49
|
1.30 Geometric mean ratio
Interval 0.94 to 1.79
|
3.05 Geometric mean ratio
Interval 1.95 to 4.75
|
1.38 Geometric mean ratio
Interval 0.89 to 2.13
|
3.15 Geometric mean ratio
Interval 1.47 to 6.71
|
1.10 Geometric mean ratio
Interval 0.52 to 2.32
|
1.82 Geometric mean ratio
Interval 1.15 to 2.88
|
1.11 Geometric mean ratio
Interval 0.71 to 1.75
|
3.81 Geometric mean ratio
Interval 1.56 to 9.33
|
1.19 Geometric mean ratio
Interval 0.48 to 2.95
|
|
Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (MN Assay)
A/H1N1 GMR MN Titer
|
16.16 Geometric mean ratio
Interval 9.52 to 27.45
|
1.70 Geometric mean ratio
Interval 1.02 to 2.83
|
8.12 Geometric mean ratio
Interval 4.19 to 15.75
|
1.15 Geometric mean ratio
Interval 0.6 to 2.2
|
17.55 Geometric mean ratio
Interval 5.72 to 53.86
|
0.81 Geometric mean ratio
Interval 0.27 to 2.44
|
2.37 Geometric mean ratio
Interval 1.54 to 3.67
|
1.23 Geometric mean ratio
Interval 0.8 to 1.88
|
3.47 Geometric mean ratio
Interval 1.07 to 11.24
|
0.85 Geometric mean ratio
Interval 0.26 to 2.81
|
SECONDARY outcome
Timeframe: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjectsPopulation: Solicited Safety Set, defined as all subjects in the All Exposed Set with any solicited AE data indicating the occurrence or lack of occurrence of solicited AEs, ie, a subject does not have to have any solicited AEs to be included in this population
Percentage of subjects with solicited local and systemic AEs assessed for 7 days following each vaccination in the QIVc group and in the comparator group
Outcome measures
| Measure |
QIVc
n=2813 Participants
Cell-derived Quadrivalent Influenza Vaccine
QIVc: QIVc is a quadrivalent vaccine and contains 2 influenza type A strains and 2 influenza type B lineages recommended by World Health Organization (WHO) for inclusion in the quadrivalent vaccine formulation for the influenza season corresponding to the season of conduct of study.
|
Comparator
n=2790 Participants
Non-influenza Comparator
Comparator: Meningococcal Group C Polysaccharide Conjugate Vaccine (NeisVac-C)
|
QIVc (Season 2)
QIVc immunogenicity analyses (Season 2)
|
Comparator (Season 2)
Comparator vaccine immunogenicity analyses (Season 2)
|
QIVc (Season 3)
QIVc immunogenicity analyses (Season 3)
|
Comparator (Season 3)
Comparator vaccine immunogenicity analyses (Season 3)
|
QIVc (Season 4)
QIVc immunogenicity analyses (Season 4)
|
Comparator (Season 4)
Comparator vaccine immunogenicity analyses (Season 4)
|
QIVc (Season 5)
QIVc immunogenicity analyses (Season 5)
|
Comparator (Season 5)
Comparator vaccine immunogenicity analyses (Season 5)
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Safety Endpoint: Percentage of Subjects With Solicited Local and Systemic Adverse Events (AEs)
Solicited AEs
|
55.8 Percentage of participants
|
60.8 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Safety Endpoint: Percentage of Subjects With Solicited Local and Systemic Adverse Events (AEs)
Solicited Local AEs
|
32.3 Percentage of participants
|
40.4 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Safety Endpoint: Percentage of Subjects With Solicited Local and Systemic Adverse Events (AEs)
Solicited Systemic AEs
|
40.9 Percentage of participants
|
42.5 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Safety Endpoint: Percentage of Subjects With Solicited Local and Systemic Adverse Events (AEs)
Analgesic/Antipyretic Use
|
14.5 Percentage of participants
|
15.0 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 28 days after each vaccination in the treatment period, ie, Day 1 to Day 29 for previously vaccinated subjects and Day 1 to Day 57 for not previously vaccinated subjectsPopulation: Unsolicited Safety Set, defined as all subjects in the All Exposed Set with unsolicited AE data
Percentage of subjects with any unsolicited AEs assessed in the QIVc group and in the comparator group until 28 days after each vaccination
Outcome measures
| Measure |
QIVc
n=2856 Participants
Cell-derived Quadrivalent Influenza Vaccine
QIVc: QIVc is a quadrivalent vaccine and contains 2 influenza type A strains and 2 influenza type B lineages recommended by World Health Organization (WHO) for inclusion in the quadrivalent vaccine formulation for the influenza season corresponding to the season of conduct of study.
|
Comparator
n=2841 Participants
Non-influenza Comparator
Comparator: Meningococcal Group C Polysaccharide Conjugate Vaccine (NeisVac-C)
|
QIVc (Season 2)
QIVc immunogenicity analyses (Season 2)
|
Comparator (Season 2)
Comparator vaccine immunogenicity analyses (Season 2)
|
QIVc (Season 3)
QIVc immunogenicity analyses (Season 3)
|
Comparator (Season 3)
Comparator vaccine immunogenicity analyses (Season 3)
|
QIVc (Season 4)
QIVc immunogenicity analyses (Season 4)
|
Comparator (Season 4)
Comparator vaccine immunogenicity analyses (Season 4)
|
QIVc (Season 5)
QIVc immunogenicity analyses (Season 5)
|
Comparator (Season 5)
Comparator vaccine immunogenicity analyses (Season 5)
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Safety Endpoint: Percentage of Subjects With Unsolicited AEs
Any AE
|
42.5 Percentage of participants
|
45.4 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Safety Endpoint: Percentage of Subjects With Unsolicited AEs
Any related AE
|
4.2 Percentage of participants
|
3.6 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 through Study Completion, ie, Day 1 to Day 181 or end of influenza season, whichever was longer, for previously vaccinated subjects and Day 1 to Day 209 or end of influenza season, whichever was longer, for not previously vaccinated subjectsPopulation: Unsolicited Safety Set
Percentage of subjects with serious adverse events (SAEs), new onset of chronic disease (NOCD), AEs leading to withdrawal from the study or vaccination, and all medications associated with these events in the QIVc group and in the comparator group Note: The time frame for assessment of these AEs was Day 1 through Study Completion as indicated below. Subjects aged 6 months through 11 months at enrollment in countries without NeisVac-C vaccine marketing authorization had an additional study visit 28 days later (ie, Day 237).
Outcome measures
| Measure |
QIVc
n=2856 Participants
Cell-derived Quadrivalent Influenza Vaccine
QIVc: QIVc is a quadrivalent vaccine and contains 2 influenza type A strains and 2 influenza type B lineages recommended by World Health Organization (WHO) for inclusion in the quadrivalent vaccine formulation for the influenza season corresponding to the season of conduct of study.
|
Comparator
n=2841 Participants
Non-influenza Comparator
Comparator: Meningococcal Group C Polysaccharide Conjugate Vaccine (NeisVac-C)
|
QIVc (Season 2)
QIVc immunogenicity analyses (Season 2)
|
Comparator (Season 2)
Comparator vaccine immunogenicity analyses (Season 2)
|
QIVc (Season 3)
QIVc immunogenicity analyses (Season 3)
|
Comparator (Season 3)
Comparator vaccine immunogenicity analyses (Season 3)
|
QIVc (Season 4)
QIVc immunogenicity analyses (Season 4)
|
Comparator (Season 4)
Comparator vaccine immunogenicity analyses (Season 4)
|
QIVc (Season 5)
QIVc immunogenicity analyses (Season 5)
|
Comparator (Season 5)
Comparator vaccine immunogenicity analyses (Season 5)
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Safety Endpoint: Percentage of Subjects With SAEs, NOCDs, AEs Leading to Withdrawal From the Study or Vaccination
Related SAE
|
0 Percentage of participants
|
0.04 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Safety Endpoint: Percentage of Subjects With SAEs, NOCDs, AEs Leading to Withdrawal From the Study or Vaccination
AE leading to study withdrawal
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Safety Endpoint: Percentage of Subjects With SAEs, NOCDs, AEs Leading to Withdrawal From the Study or Vaccination
AE leading to study vaccine withdrawal
|
0 Percentage of participants
|
0.1 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Safety Endpoint: Percentage of Subjects With SAEs, NOCDs, AEs Leading to Withdrawal From the Study or Vaccination
NOCD
|
0.7 Percentage of participants
|
0.4 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Safety Endpoint: Percentage of Subjects With SAEs, NOCDs, AEs Leading to Withdrawal From the Study or Vaccination
SAE
|
2.2 Percentage of participants
|
3.0 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: If a subject experienced an ILI during approximately 8 months of study participation, medically-attended AEs were collected for the 30-day period after onset of the ILI (defined as the first day that a subject meets the criteria for protocol-defined ILI)Population: Unsolicited Safety Set
Percentage of subjects with medically-attended AEs within 30 days after ILI onset in the QIVc group and in the comparator group
Outcome measures
| Measure |
QIVc
n=2856 Participants
Cell-derived Quadrivalent Influenza Vaccine
QIVc: QIVc is a quadrivalent vaccine and contains 2 influenza type A strains and 2 influenza type B lineages recommended by World Health Organization (WHO) for inclusion in the quadrivalent vaccine formulation for the influenza season corresponding to the season of conduct of study.
|
Comparator
n=2841 Participants
Non-influenza Comparator
Comparator: Meningococcal Group C Polysaccharide Conjugate Vaccine (NeisVac-C)
|
QIVc (Season 2)
QIVc immunogenicity analyses (Season 2)
|
Comparator (Season 2)
Comparator vaccine immunogenicity analyses (Season 2)
|
QIVc (Season 3)
QIVc immunogenicity analyses (Season 3)
|
Comparator (Season 3)
Comparator vaccine immunogenicity analyses (Season 3)
|
QIVc (Season 4)
QIVc immunogenicity analyses (Season 4)
|
Comparator (Season 4)
Comparator vaccine immunogenicity analyses (Season 4)
|
QIVc (Season 5)
QIVc immunogenicity analyses (Season 5)
|
Comparator (Season 5)
Comparator vaccine immunogenicity analyses (Season 5)
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Safety Endpoint: Percentage of Subjects With Medically-attended AEs
|
28.9 Percentage of participants
|
32.6 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
QIVc
Serious events: 64 serious events
Other events: 2050 other events
Deaths: 1 deaths
Comparator
Serious events: 84 serious events
Other events: 2126 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
QIVc
n=2856 participants at risk
Cell-derived Quadrivalent Influenza Vaccine
QIVc: QIVc is a quadrivalent vaccine and contains 2 influenza type A strains and 2 influenza type B lineages recommended by World Health Organization (WHO) for inclusion in the quadrivalent vaccine formulation for the influenza season corresponding to the season of conduct of study.
|
Comparator
n=2841 participants at risk
Non-influenza Comparator
Comparator: Meningococcal Group C Polysaccharide Conjugate Vaccine (NeisVac-C)
|
|---|---|---|
|
Infections and infestations
Pneumonia
|
0.53%
15/2856 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
0.84%
24/2841 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
|
Infections and infestations
Gastroenteritis
|
0.28%
8/2856 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
0.42%
12/2841 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
|
Infections and infestations
Dengue fever
|
0.21%
6/2856 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
0.25%
7/2841 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
|
Infections and infestations
Viral infection
|
0.14%
4/2856 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
0.00%
0/2841 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
|
Infections and infestations
Influenza
|
0.11%
3/2856 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
0.21%
6/2841 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
|
Infections and infestations
Bronchiolitis
|
0.07%
2/2856 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
0.11%
3/2841 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
|
Infections and infestations
Otitis media acute
|
0.07%
2/2856 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
0.00%
0/2841 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
|
Infections and infestations
Pneumonia viral
|
0.07%
2/2856 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
0.00%
0/2841 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
|
Infections and infestations
Respiratory syncytial virus bronchitis
|
0.07%
2/2856 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
0.07%
2/2841 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
|
Infections and infestations
Sepsis
|
0.07%
2/2856 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
0.00%
0/2841 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
|
Infections and infestations
Typhoid fever
|
0.07%
2/2856 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
0.04%
1/2841 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
|
Infections and infestations
Abscess neck
|
0.04%
1/2856 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
0.00%
0/2841 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
|
Infections and infestations
Amoebic dysentery
|
0.04%
1/2856 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
0.00%
0/2841 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
|
Infections and infestations
Bronchitis
|
0.04%
1/2856 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
0.11%
3/2841 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
|
Infections and infestations
Febrile infection
|
0.04%
1/2856 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
0.00%
0/2841 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
|
Infections and infestations
Gastroenteritis rotavirus
|
0.04%
1/2856 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
0.04%
1/2841 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
|
Infections and infestations
Gastroenteritis viral
|
0.04%
1/2856 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
0.00%
0/2841 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
|
Infections and infestations
Laryngitis
|
0.04%
1/2856 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
0.04%
1/2841 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
|
Infections and infestations
Norovirus infection
|
0.04%
1/2856 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
0.07%
2/2841 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.04%
1/2856 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
0.00%
0/2841 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
|
Infections and infestations
Pharyngitis
|
0.04%
1/2856 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
0.00%
0/2841 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
|
Infections and infestations
Pneumonia bacterial
|
0.04%
1/2856 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
0.00%
0/2841 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
|
Infections and infestations
Rotavirus infection
|
0.04%
1/2856 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
0.00%
0/2841 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
|
Infections and infestations
Urinary tract infection
|
0.04%
1/2856 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
0.07%
2/2841 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
|
Infections and infestations
Abscess limb
|
0.00%
0/2856 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
0.04%
1/2841 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
|
Infections and infestations
Adenovirus infection
|
0.00%
0/2856 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
0.07%
2/2841 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
|
Infections and infestations
Amoebiasis
|
0.00%
0/2856 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
0.04%
1/2841 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
|
Infections and infestations
Cellulitis
|
0.00%
0/2856 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
0.04%
1/2841 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
|
Infections and infestations
Gastroenteritis adenovirus
|
0.00%
0/2856 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
0.04%
1/2841 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
|
Infections and infestations
Gastroenteritis norovirus
|
0.00%
0/2856 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
0.04%
1/2841 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
|
Infections and infestations
Human herpesvirus 6 infection
|
0.00%
0/2856 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
0.04%
1/2841 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
|
Infections and infestations
Infectious mononucleosis
|
0.00%
0/2856 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
0.04%
1/2841 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
|
Infections and infestations
Meningitis bacterial
|
0.00%
0/2856 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
0.04%
1/2841 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/2856 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
0.04%
1/2841 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
|
Infections and infestations
Otitis media
|
0.00%
0/2856 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
0.04%
1/2841 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
|
Infections and infestations
Pharyngotonsillitis
|
0.00%
0/2856 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
0.04%
1/2841 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
|
Infections and infestations
Pneumonia respiratory syncytial viral
|
0.00%
0/2856 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
0.04%
1/2841 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
|
Infections and infestations
Respiratory syncytial virus bronchiolitis
|
0.00%
0/2856 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
0.04%
1/2841 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/2856 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
0.04%
1/2841 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/2856 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
0.11%
3/2841 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
|
Nervous system disorders
Febrile convulsion
|
0.18%
5/2856 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
0.11%
3/2841 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
|
Nervous system disorders
Seizure
|
0.00%
0/2856 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
0.04%
1/2841 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
|
Metabolism and nutrition disorders
Dehydration
|
0.07%
2/2856 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
0.04%
1/2841 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.04%
1/2856 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
0.00%
0/2841 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/2856 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
0.04%
1/2841 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/2856 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
0.04%
1/2841 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.07%
2/2856 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
0.04%
1/2841 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.04%
1/2856 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
0.00%
0/2841 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
|
Gastrointestinal disorders
Intussusception
|
0.04%
1/2856 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
0.00%
0/2841 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
|
Gastrointestinal disorders
Vomiting
|
0.04%
1/2856 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
0.04%
1/2841 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/2856 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
0.04%
1/2841 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/2856 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
0.04%
1/2841 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.07%
2/2856 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
0.00%
0/2841 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
|
Injury, poisoning and procedural complications
Accidental exposure to product
|
0.00%
0/2856 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
0.04%
1/2841 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
|
Injury, poisoning and procedural complications
Foreign body in gastrointestinal tract
|
0.00%
0/2856 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
0.04%
1/2841 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/2856 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
0.04%
1/2841 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
|
Injury, poisoning and procedural complications
Limb traumatic amputation
|
0.00%
0/2856 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
0.04%
1/2841 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/2856 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
0.07%
2/2841 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
|
Blood and lymphatic system disorders
Anaemia
|
0.04%
1/2856 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
0.00%
0/2841 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.04%
1/2856 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
0.00%
0/2841 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
|
Vascular disorders
Kawasaki's disease
|
0.04%
1/2856 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
0.04%
1/2841 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/2856 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
0.04%
1/2841 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
|
Cardiac disorders
Ventricular dysfunction
|
0.00%
0/2856 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
0.04%
1/2841 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
|
Congenital, familial and genetic disorders
Phimosis
|
0.00%
0/2856 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
0.04%
1/2841 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
|
Other adverse events
| Measure |
QIVc
n=2856 participants at risk
Cell-derived Quadrivalent Influenza Vaccine
QIVc: QIVc is a quadrivalent vaccine and contains 2 influenza type A strains and 2 influenza type B lineages recommended by World Health Organization (WHO) for inclusion in the quadrivalent vaccine formulation for the influenza season corresponding to the season of conduct of study.
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Comparator
n=2841 participants at risk
Non-influenza Comparator
Comparator: Meningococcal Group C Polysaccharide Conjugate Vaccine (NeisVac-C)
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Infections and infestations
Upper respiratory tract infection
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20.2%
576/2856 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
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22.3%
634/2841 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
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Infections and infestations
Rhinitis
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9.9%
282/2856 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
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10.2%
290/2841 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
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Infections and infestations
Nasopharyngitis
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8.9%
255/2856 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
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9.0%
255/2841 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
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Infections and infestations
Respiratory tract infection
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5.7%
162/2856 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
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5.6%
158/2841 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
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General disorders
Injection site pain
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28.6%
816/2856 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
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31.3%
889/2841 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
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General disorders
Injection site erythema
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25.1%
717/2856 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
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31.1%
884/2841 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
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General disorders
Injection site induration
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16.2%
464/2856 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
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25.7%
730/2841 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
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General disorders
Injection site bruising
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10.6%
303/2856 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
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11.9%
339/2841 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
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General disorders
Pyrexia
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10.7%
307/2856 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
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10.8%
307/2841 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
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Psychiatric disorders
Irritability
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23.1%
659/2856 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
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24.9%
706/2841 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
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Psychiatric disorders
Eating disorder
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15.7%
447/2856 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
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16.0%
455/2841 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
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Nervous system disorders
Somnolence
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18.0%
514/2856 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
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18.4%
522/2841 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
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Gastrointestinal disorders
Diarrhoea
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13.0%
372/2856 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
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13.1%
372/2841 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
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Gastrointestinal disorders
Vomiting
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6.6%
188/2856 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
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7.3%
207/2841 • Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set None of the deaths in the study were assessed as related to study vaccine All AEs are reported according to the intervention subjects received in the treatment period
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Any publication by Institution or Investigator shall not be made before the first multicenter publication of the entire study results. Seqirus must be notified of any intent to publish data collected from the study and prior approval from Seqirus must be obtained prior to submission for publication.
- Publication restrictions are in place
Restriction type: OTHER