Trial Outcomes & Findings for Safety and Immunogenicity of a Cell Culture-derived Influenza Vaccine in Healthy Adults and Elderly (NCT NCT00492063)
NCT ID: NCT00492063
Last Updated: 2016-01-01
Results Overview
Immunogenicity was measured as the percentage of adults (≥18 to ≤60 years) and elderly (≥61 years) achieving HI titers ≥40 at baseline (day 1) and three weeks (day 22) after one vaccination of cTIV or TIV vaccine for each of three vaccine strains, evaluated using the hemagglutination inhibition (HI) egg-derived antigen assay. In compliance with the requirements of the EMEA recommendations (CPMP/BWP/2490/00, CPMP/BWP/214/96), this criterion is met if the percentage of subjects achieving HI titers ≥40 is \>70% in the ≥18 to ≤60 years of age group or \>60% in the ≥61 years of age group.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
2654 participants
Primary outcome timeframe
Before vaccination (day 1) and three weeks after vaccination (day 22)
Results posted on
2016-01-01
Participant Flow
Subjects were enrolled at 5 sites in Poland.
All enrolled subjects were included in the trial.
Participant milestones
| Measure |
cTIV (Adults)
Subjects ≥18 to ≤60 years of age who received one vaccination of cell culture-derived influenza virus vaccine (cTIV)
|
TIV (Adults)
Subjects ≥18 to ≤60 years of age who received one vaccination of egg-derived influenza virus vaccine (TIV)
|
cTIV (Elderly)
Subjects ≥61 years of age who received one vaccination of cell culture-derived influenza virus vaccine (cTIV)
|
TIV (Elderly)
Subjects ≥61 years of age who received one vaccination of egg-derived influenza virus vaccine (TIV)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
652
|
648
|
678
|
676
|
|
Overall Study
COMPLETED
|
642
|
634
|
667
|
666
|
|
Overall Study
NOT COMPLETED
|
10
|
14
|
11
|
10
|
Reasons for withdrawal
| Measure |
cTIV (Adults)
Subjects ≥18 to ≤60 years of age who received one vaccination of cell culture-derived influenza virus vaccine (cTIV)
|
TIV (Adults)
Subjects ≥18 to ≤60 years of age who received one vaccination of egg-derived influenza virus vaccine (TIV)
|
cTIV (Elderly)
Subjects ≥61 years of age who received one vaccination of cell culture-derived influenza virus vaccine (cTIV)
|
TIV (Elderly)
Subjects ≥61 years of age who received one vaccination of egg-derived influenza virus vaccine (TIV)
|
|---|---|---|---|---|
|
Overall Study
Death
|
0
|
0
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
4
|
3
|
5
|
4
|
|
Overall Study
Lost to Follow-up
|
6
|
11
|
5
|
3
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Safety and Immunogenicity of a Cell Culture-derived Influenza Vaccine in Healthy Adults and Elderly
Baseline characteristics by cohort
| Measure |
cTIV (Adults)
n=652 Participants
Subjects ≥18 to ≤60 years of age who received one vaccination of cell culture-derived influenza virus vaccine (cTIV)
|
TIV (Adults)
n=648 Participants
Subjects ≥18 to ≤60 years of age who received one vaccination of egg-derived influenza virus vaccine (TIV)
|
cTIV (Elderly)
n=678 Participants
Subjects ≥61 years of age who received one vaccination of cell culture-derived influenza virus vaccine (cTIV)
|
TIV (Elderly)
n=676 Participants
Subjects ≥61 years of age who received one vaccination of egg-derived influenza virus vaccine (TIV)
|
Total
n=2654 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
38.7 Years
STANDARD_DEVIATION 12.7 • n=99 Participants
|
38.3 Years
STANDARD_DEVIATION 13.3 • n=107 Participants
|
69.1 Years
STANDARD_DEVIATION 5.7 • n=206 Participants
|
68.8 Years
STANDARD_DEVIATION 5.6 • n=7 Participants
|
54.0 Years
STANDARD_DEVIATION 18.2 • n=31 Participants
|
|
Sex: Female, Male
Female
|
376 Participants
n=99 Participants
|
371 Participants
n=107 Participants
|
389 Participants
n=206 Participants
|
375 Participants
n=7 Participants
|
1511 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
276 Participants
n=99 Participants
|
277 Participants
n=107 Participants
|
289 Participants
n=206 Participants
|
301 Participants
n=7 Participants
|
1143 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Before vaccination (day 1) and three weeks after vaccination (day 22)Population: Analysis was done on the per-protocol (PP) set, i.e. the subjects who received the vaccination correctly; provided evaluable data before and after vaccination; and with no major protocol violations, as defined before unblinding.
Immunogenicity was measured as the percentage of adults (≥18 to ≤60 years) and elderly (≥61 years) achieving HI titers ≥40 at baseline (day 1) and three weeks (day 22) after one vaccination of cTIV or TIV vaccine for each of three vaccine strains, evaluated using the hemagglutination inhibition (HI) egg-derived antigen assay. In compliance with the requirements of the EMEA recommendations (CPMP/BWP/2490/00, CPMP/BWP/214/96), this criterion is met if the percentage of subjects achieving HI titers ≥40 is \>70% in the ≥18 to ≤60 years of age group or \>60% in the ≥61 years of age group.
Outcome measures
| Measure |
cTIV (Adults)
n=650 Participants
Subjects ≥18 to ≤60 years of age who received one vaccination of cell culture-derived influenza virus vaccine (cTIV)
|
TIV (Adults)
n=644 Participants
Subjects ≥18 to ≤60 years of age who received one vaccination of egg-derived influenza virus vaccine (TIV)
|
cTIV (Elderly)
n=672 Participants
Subjects ≥61 years of age who received one vaccination of cell culture-derived influenza virus vaccine (cTIV)
|
TIV (Elderly)
n=674 Participants
Subjects ≥61 years of age who received one vaccination of egg-derived influenza virus vaccine (TIV)
|
|---|---|---|---|---|
|
Percentages Of Subjects Who Achieved HI Titer ≥40 After One Vaccination of Cell Culture-derived (cTIV) or Egg-derived (TIV) Influenza Subunit Vaccines
A/H1N1 (Day 1)
|
29 Percentages
Interval 26.0 to 33.0
|
33 Percentages
Interval 29.0 to 36.0
|
30 Percentages
Interval 27.0 to 34.0
|
31 Percentages
Interval 27.0 to 34.0
|
|
Percentages Of Subjects Who Achieved HI Titer ≥40 After One Vaccination of Cell Culture-derived (cTIV) or Egg-derived (TIV) Influenza Subunit Vaccines
A/H1N1 (Day 22)
|
92 Percentages
Interval 89.0 to 94.0
|
92 Percentages
Interval 89.0 to 94.0
|
85 Percentages
Interval 82.0 to 87.0
|
85 Percentages
Interval 82.0 to 88.0
|
|
Percentages Of Subjects Who Achieved HI Titer ≥40 After One Vaccination of Cell Culture-derived (cTIV) or Egg-derived (TIV) Influenza Subunit Vaccines
A/H3N2 (Day 1)
|
65 Percentages
Interval 61.0 to 69.0
|
63 Percentages
Interval 60.0 to 67.0
|
66 Percentages
Interval 63.0 to 70.0
|
59 Percentages
Interval 56.0 to 63.0
|
|
Percentages Of Subjects Who Achieved HI Titer ≥40 After One Vaccination of Cell Culture-derived (cTIV) or Egg-derived (TIV) Influenza Subunit Vaccines
A/H3N2 (Day 22)
|
99 Percentages
Interval 98.0 to 100.0
|
99 Percentages
Interval 98.0 to 99.0
|
97 Percentages
Interval 96.0 to 98.0
|
98 Percentages
Interval 97.0 to 99.0
|
|
Percentages Of Subjects Who Achieved HI Titer ≥40 After One Vaccination of Cell Culture-derived (cTIV) or Egg-derived (TIV) Influenza Subunit Vaccines
B (Day 1)
|
16 Percentages
Interval 13.0 to 19.0
|
18 Percentages
Interval 15.0 to 22.0
|
23 Percentages
Interval 20.0 to 26.0
|
20 Percentages
Interval 17.0 to 23.0
|
|
Percentages Of Subjects Who Achieved HI Titer ≥40 After One Vaccination of Cell Culture-derived (cTIV) or Egg-derived (TIV) Influenza Subunit Vaccines
B (Day 22)
|
90 Percentages
Interval 88.0 to 93.0
|
91 Percentages
Interval 88.0 to 93.0
|
90 Percentages
Interval 88.0 to 92.0
|
89 Percentages
Interval 87.0 to 91.0
|
PRIMARY outcome
Timeframe: Three weeks after vaccination (day 22)Population: Analysis was performed on the PP set.
Seroconversion or significant in HI titer is defined as the percentage of subjects with a prevaccination HI titer \<10 (negative) to a postvaccination titer ≥40; or in subjects with prevaccination HI titer ≥10, at least a 4-fold increase in postvaccination HI titer. In compliance with the requirements of the EMEA recommendations (CPMP/BWP/2490/00, CPMP/BWP/214/96), the criterion is met if the percentage of subjects achieving seroconversion/significant increase is \>40% in the ≥18 to ≤60 years of age group or \>30% in the ≥61 years of age group.
Outcome measures
| Measure |
cTIV (Adults)
n=650 Participants
Subjects ≥18 to ≤60 years of age who received one vaccination of cell culture-derived influenza virus vaccine (cTIV)
|
TIV (Adults)
n=644 Participants
Subjects ≥18 to ≤60 years of age who received one vaccination of egg-derived influenza virus vaccine (TIV)
|
cTIV (Elderly)
n=672 Participants
Subjects ≥61 years of age who received one vaccination of cell culture-derived influenza virus vaccine (cTIV)
|
TIV (Elderly)
n=674 Participants
Subjects ≥61 years of age who received one vaccination of egg-derived influenza virus vaccine (TIV)
|
|---|---|---|---|---|
|
Percentages Of Subjects Who Achieved Seroconversion Or Significant Increase In HI Titer After One Vaccination of cTIV or TIV
A/H1N1
|
69 Percentages
Interval 65.0 to 73.0
|
67 Percentages
Interval 63.0 to 71.0
|
55 Percentages
Interval 51.0 to 59.0
|
55 Percentages
Interval 51.0 to 59.0
|
|
Percentages Of Subjects Who Achieved Seroconversion Or Significant Increase In HI Titer After One Vaccination of cTIV or TIV
A/H3N2
|
63 Percentages
Interval 59.0 to 67.0
|
64 Percentages
Interval 60.0 to 68.0
|
68 Percentages
Interval 65.0 to 72.0
|
65 Percentages
Interval 61.0 to 69.0
|
|
Percentages Of Subjects Who Achieved Seroconversion Or Significant Increase In HI Titer After One Vaccination of cTIV or TIV
B
|
85 Percentages
Interval 82.0 to 87.0
|
81 Percentages
Interval 78.0 to 84.0
|
80 Percentages
Interval 77.0 to 83.0
|
73 Percentages
Interval 70.0 to 77.0
|
PRIMARY outcome
Timeframe: Three weeks after vaccination (day 22)Population: Analysis was performed on the PP set.
Immunogenicity was measured as the geometric mean ratio (GMR), calculated as the ratio of postvaccination to prevaccination HI Geometric Mean Titers (GMTs), three weeks after (day 22) one vaccination of cTIV or TIV. In compliance with the requirements of the EMEA recommendations (CPMP/BWP/2490/00, CPMP/BWP/214/96), this criterion is met if the GMR (day 22/day 1) in HI antibody titer is \>2.5 in the ≥18 to ≤60 years of age group or \>2.0 in the ≥61 years of age group.
Outcome measures
| Measure |
cTIV (Adults)
n=650 Participants
Subjects ≥18 to ≤60 years of age who received one vaccination of cell culture-derived influenza virus vaccine (cTIV)
|
TIV (Adults)
n=644 Participants
Subjects ≥18 to ≤60 years of age who received one vaccination of egg-derived influenza virus vaccine (TIV)
|
cTIV (Elderly)
n=672 Participants
Subjects ≥61 years of age who received one vaccination of cell culture-derived influenza virus vaccine (cTIV)
|
TIV (Elderly)
n=674 Participants
Subjects ≥61 years of age who received one vaccination of egg-derived influenza virus vaccine (TIV)
|
|---|---|---|---|---|
|
Geometric Mean Ratio of Subjects After One Vaccination of cTIV or TIV
A/H1N1
|
11 Ratio
Interval 10.0 to 13.0
|
11 Ratio
Interval 9.34 to 12.0
|
5.74 Ratio
Interval 5.15 to 6.41
|
5.96 Ratio
Interval 5.35 to 6.65
|
|
Geometric Mean Ratio of Subjects After One Vaccination of cTIV or TIV
A/H3N2
|
5.99 Ratio
Interval 5.37 to 6.68
|
7.08 Ratio
Interval 6.34 to 7.9
|
7.25 Ratio
Interval 6.47 to 8.12
|
8.36 Ratio
Interval 7.46 to 9.36
|
|
Geometric Mean Ratio of Subjects After One Vaccination of cTIV or TIV
B
|
13 Ratio
Interval 12.0 to 15.0
|
12 Ratio
Interval 11.0 to 13.0
|
12 Ratio
Interval 11.0 to 13.0
|
9.29 Ratio
Interval 8.42 to 10.0
|
SECONDARY outcome
Timeframe: Up to 7 days postvaccinationPopulation: Analysis was done on Safety population i.e., all subjects with vaccination and with some post-baseline safety data.
The solicited local and systemic reactions were collected from day 1 up to and including day 7 after vaccination for both the vaccine groups.
Outcome measures
| Measure |
cTIV (Adults)
n=652 Participants
Subjects ≥18 to ≤60 years of age who received one vaccination of cell culture-derived influenza virus vaccine (cTIV)
|
TIV (Adults)
n=648 Participants
Subjects ≥18 to ≤60 years of age who received one vaccination of egg-derived influenza virus vaccine (TIV)
|
cTIV (Elderly)
n=678 Participants
Subjects ≥61 years of age who received one vaccination of cell culture-derived influenza virus vaccine (cTIV)
|
TIV (Elderly)
n=676 Participants
Subjects ≥61 years of age who received one vaccination of egg-derived influenza virus vaccine (TIV)
|
|---|---|---|---|---|
|
Number of Subjects Who Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination
Stayed home due to reaction
|
14 Number of Subjects
|
16 Number of Subjects
|
19 Number of Subjects
|
14 Number of Subjects
|
|
Number of Subjects Who Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination
Ecchymosis
|
18 Number of Subjects
|
22 Number of Subjects
|
26 Number of Subjects
|
25 Number of Subjects
|
|
Number of Subjects Who Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination
Erythema
|
92 Number of Subjects
|
106 Number of Subjects
|
72 Number of Subjects
|
72 Number of Subjects
|
|
Number of Subjects Who Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination
Induration
|
38 Number of Subjects
|
42 Number of Subjects
|
37 Number of Subjects
|
29 Number of Subjects
|
|
Number of Subjects Who Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination
Swelling
|
25 Number of Subjects
|
27 Number of Subjects
|
23 Number of Subjects
|
17 Number of Subjects
|
|
Number of Subjects Who Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination
Pain
|
141 Number of Subjects
|
111 Number of Subjects
|
64 Number of Subjects
|
32 Number of Subjects
|
|
Number of Subjects Who Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination
Chills
|
25 Number of Subjects
|
29 Number of Subjects
|
23 Number of Subjects
|
26 Number of Subjects
|
|
Number of Subjects Who Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination
Malaise
|
74 Number of Subjects
|
74 Number of Subjects
|
70 Number of Subjects
|
75 Number of Subjects
|
|
Number of Subjects Who Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination
Myalgia
|
45 Number of Subjects
|
49 Number of Subjects
|
46 Number of Subjects
|
57 Number of Subjects
|
|
Number of Subjects Who Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination
Arthralgia
|
31 Number of Subjects
|
27 Number of Subjects
|
41 Number of Subjects
|
44 Number of Subjects
|
|
Number of Subjects Who Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination
Headache
|
81 Number of Subjects
|
79 Number of Subjects
|
69 Number of Subjects
|
70 Number of Subjects
|
|
Number of Subjects Who Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination
Sweating
|
28 Number of Subjects
|
27 Number of Subjects
|
44 Number of Subjects
|
48 Number of Subjects
|
|
Number of Subjects Who Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination
Fatigue
|
73 Number of Subjects
|
73 Number of Subjects
|
73 Number of Subjects
|
84 Number of Subjects
|
|
Number of Subjects Who Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination
Fever (≥38°C)
|
2 Number of Subjects
|
5 Number of Subjects
|
5 Number of Subjects
|
5 Number of Subjects
|
|
Number of Subjects Who Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination
Analgesic/antipyretic medication used
|
44 Number of Subjects
|
40 Number of Subjects
|
34 Number of Subjects
|
29 Number of Subjects
|
Adverse Events
cTIV (Adults)
Serious events: 7 serious events
Other events: 261 other events
Deaths: 0 deaths
TIV (Adults)
Serious events: 5 serious events
Other events: 257 other events
Deaths: 0 deaths
cTIV (Elderly)
Serious events: 19 serious events
Other events: 224 other events
Deaths: 0 deaths
TIV (Elderly)
Serious events: 18 serious events
Other events: 207 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
cTIV (Adults)
n=652 participants at risk
Subjects ≥18 to ≤60 years of age who received one vaccination of cell culture-derived influenza virus vaccine (cTIV)
|
TIV (Adults)
n=648 participants at risk
Subjects ≥18 to ≤60 years of age who received one vaccination of egg-derived influenza virus vaccine (TIV)
|
cTIV (Elderly)
n=678 participants at risk
Subjects ≥61 years of age who received one vaccination of cell culture-derived influenza virus vaccine (cTIV)
|
TIV (Elderly)
n=676 participants at risk
Subjects ≥61 years of age who received one vaccination of egg-derived influenza virus vaccine (TIV)
|
|---|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/652 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.15%
1/648 • Number of events 1 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.29%
2/678 • Number of events 2 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.00%
0/676 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
|
Cardiac disorders
Atrial fibrillation
|
0.15%
1/652 • Number of events 1 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.00%
0/648 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.44%
3/678 • Number of events 3 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.30%
2/676 • Number of events 2 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.31%
2/652 • Number of events 2 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.15%
1/648 • Number of events 1 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.00%
0/678 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.00%
0/676 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.15%
1/652 • Number of events 1 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.00%
0/648 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.00%
0/678 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.00%
0/676 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
|
Infections and infestations
Bronchopneumonia
|
0.15%
1/652 • Number of events 1 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.15%
1/648 • Number of events 1 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.00%
0/678 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.15%
1/676 • Number of events 1 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.15%
1/652 • Number of events 1 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.00%
0/648 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.00%
0/678 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.00%
0/676 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
|
Injury, poisoning and procedural complications
Postoperative hernia
|
0.00%
0/652 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.15%
1/648 • Number of events 1 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.00%
0/678 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.00%
0/676 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.15%
1/652 • Number of events 1 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.00%
0/648 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.00%
0/678 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.00%
0/676 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive airways disease
|
0.00%
0/652 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.15%
1/648 • Number of events 1 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.00%
0/678 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.00%
0/676 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/652 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.00%
0/648 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.00%
0/678 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.15%
1/676 • Number of events 1 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/652 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.00%
0/648 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.00%
0/678 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.30%
2/676 • Number of events 2 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/652 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.00%
0/648 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.29%
2/678 • Number of events 2 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.00%
0/676 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/652 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.00%
0/648 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.00%
0/678 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.15%
1/676 • Number of events 1 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
|
Ear and labyrinth disorders
Inner ear disorder
|
0.00%
0/652 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.00%
0/648 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.00%
0/678 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.15%
1/676 • Number of events 1 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
|
Eye disorders
Angle closure glaucoma
|
0.00%
0/652 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.00%
0/648 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.15%
1/678 • Number of events 1 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.00%
0/676 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
|
Eye disorders
Retinal detachment
|
0.00%
0/652 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.00%
0/648 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.15%
1/678 • Number of events 1 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.00%
0/676 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/652 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.00%
0/648 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.00%
0/678 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.15%
1/676 • Number of events 1 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.00%
0/652 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.00%
0/648 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.00%
0/678 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.15%
1/676 • Number of events 1 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/652 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.00%
0/648 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.15%
1/678 • Number of events 1 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.00%
0/676 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/652 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.00%
0/648 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.15%
1/678 • Number of events 1 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.00%
0/676 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/652 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.00%
0/648 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.15%
1/678 • Number of events 1 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.00%
0/676 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/652 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.00%
0/648 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.00%
0/678 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.15%
1/676 • Number of events 1 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/652 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.00%
0/648 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.00%
0/678 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.15%
1/676 • Number of events 1 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/652 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.00%
0/648 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.29%
2/678 • Number of events 2 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.15%
1/676 • Number of events 1 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
|
Injury, poisoning and procedural complications
Carbon monoxide poisoning
|
0.00%
0/652 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.00%
0/648 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.15%
1/678 • Number of events 1 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.00%
0/676 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.00%
0/652 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.00%
0/648 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.15%
1/678 • Number of events 1 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.00%
0/676 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/652 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.00%
0/648 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.15%
1/678 • Number of events 1 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.00%
0/676 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/652 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.00%
0/648 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.00%
0/678 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.15%
1/676 • Number of events 1 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign oesophageal neoplasm
|
0.00%
0/652 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.00%
0/648 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.15%
1/678 • Number of events 1 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.00%
0/676 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gallbladder cancer
|
0.00%
0/652 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.00%
0/648 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.00%
0/678 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.15%
1/676 • Number of events 1 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/652 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.00%
0/648 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.00%
0/678 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.15%
1/676 • Number of events 1 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.00%
0/652 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.00%
0/648 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.00%
0/678 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.15%
1/676 • Number of events 1 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung squamous cell carcinoma
|
0.00%
0/652 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.00%
0/648 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.15%
1/678 • Number of events 1 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.00%
0/676 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/652 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.00%
0/648 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.00%
0/678 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.15%
1/676 • Number of events 1 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/652 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.00%
0/648 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.00%
0/678 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.15%
1/676 • Number of events 1 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
|
Nervous system disorders
Sleep apnoea syndrome
|
0.00%
0/652 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.00%
0/648 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.15%
1/678 • Number of events 1 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.00%
0/676 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
|
Nervous system disorders
Syncope Vasovagal
|
0.00%
0/652 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.00%
0/648 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.15%
1/678 • Number of events 1 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.00%
0/676 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.00%
0/652 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.00%
0/648 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.15%
1/678 • Number of events 1 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.00%
0/676 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/652 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.00%
0/648 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.15%
1/678 • Number of events 1 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.00%
0/676 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
|
Vascular disorders
Atherosclerosis obliterans
|
0.00%
0/652 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.00%
0/648 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.00%
0/678 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.15%
1/676 • Number of events 1 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
|
Vascular disorders
Hypertension
|
0.00%
0/652 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.00%
0/648 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.00%
0/678 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.15%
1/676 • Number of events 1 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/652 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.00%
0/648 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.00%
0/678 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.15%
1/676 • Number of events 1 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
Other adverse events
| Measure |
cTIV (Adults)
n=652 participants at risk
Subjects ≥18 to ≤60 years of age who received one vaccination of cell culture-derived influenza virus vaccine (cTIV)
|
TIV (Adults)
n=648 participants at risk
Subjects ≥18 to ≤60 years of age who received one vaccination of egg-derived influenza virus vaccine (TIV)
|
cTIV (Elderly)
n=678 participants at risk
Subjects ≥61 years of age who received one vaccination of cell culture-derived influenza virus vaccine (cTIV)
|
TIV (Elderly)
n=676 participants at risk
Subjects ≥61 years of age who received one vaccination of egg-derived influenza virus vaccine (TIV)
|
|---|---|---|---|---|
|
General disorders
Injection site erythema
|
14.1%
92/652 • Number of events 92 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
16.4%
106/648 • Number of events 106 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
10.6%
72/678 • Number of events 72 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
10.7%
72/676 • Number of events 72 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
|
General disorders
Injection site induration
|
5.8%
38/652 • Number of events 38 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
6.5%
42/648 • Number of events 42 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
5.5%
37/678 • Number of events 37 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
4.3%
29/676 • Number of events 29 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
|
General disorders
Injection site pain
|
21.6%
141/652 • Number of events 141 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
17.1%
111/648 • Number of events 111 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
9.4%
64/678 • Number of events 64 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
4.7%
32/676 • Number of events 32 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
|
General disorders
Malaise
|
11.7%
76/652 • Number of events 76 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
11.6%
75/648 • Number of events 75 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
10.9%
74/678 • Number of events 74 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
11.2%
76/676 • Number of events 76 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.7%
37/652 • Number of events 37 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
5.6%
36/648 • Number of events 36 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
7.1%
48/678 • Number of events 48 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
7.1%
48/676 • Number of events 48 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.1%
46/652 • Number of events 46 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
7.9%
51/648 • Number of events 51 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
6.9%
47/678 • Number of events 47 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
8.6%
58/676 • Number of events 58 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
|
General disorders
Fatigue
|
11.2%
73/652 • Number of events 73 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
11.3%
73/648 • Number of events 73 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
10.9%
74/678 • Number of events 74 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
12.6%
85/676 • Number of events 85 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
|
Nervous system disorders
Headache
|
13.3%
87/652 • Number of events 87 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
13.6%
88/648 • Number of events 88 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
11.1%
75/678 • Number of events 75 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
11.1%
75/676 • Number of events 75 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/652 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
0.00%
0/648 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
6.6%
45/678 • Number of events 45 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
7.1%
48/676 • Number of events 48 • Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER