Trial Outcomes & Findings for Safety and Immunogenicity of MF59C.1 Adjuvanted Trivalent Subunit Influenza Vaccine in Elderly Subjects (NCT NCT01162122)
NCT ID: NCT01162122
Last Updated: 2014-06-26
Results Overview
Immunologic equivalence of 3 consecutive production lots of aTIV (Lot 1, Lot 2 and Lot 3), was assessed in terms of Hemagglutination Inhibition (HI) Geometric Mean Titers (GMTs) in subjects, at three weeks after vaccination, against each vaccine strain.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
7109 participants
Primary outcome timeframe
Day 22 post vaccination
Results posted on
2014-06-26
Participant Flow
Subjects were enrolled from 4 sites in Columbia, 2 sites in Panama, 11 sites in Philippines, 21 sites in USA.
Five enrolled subjects were not randomized and did not receive study vaccination, hence were discontinued.
Participant milestones
| Measure |
aTIV (Pooled)
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
|
Licensed TIV
Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
|
|---|---|---|
|
Overall Study
STARTED
|
3552
|
3552
|
|
Overall Study
Vaccinated
|
3541
|
3541
|
|
Overall Study
COMPLETED
|
3361
|
3356
|
|
Overall Study
NOT COMPLETED
|
191
|
196
|
Reasons for withdrawal
| Measure |
aTIV (Pooled)
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
|
Licensed TIV
Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
52
|
43
|
|
Overall Study
Lost to Follow-up
|
73
|
91
|
|
Overall Study
Adverse Event
|
3
|
2
|
|
Overall Study
Death
|
51
|
46
|
|
Overall Study
Protocol Violation
|
2
|
2
|
|
Overall Study
Inappropriate enrollment
|
5
|
4
|
|
Overall Study
Administrative reason
|
1
|
1
|
|
Overall Study
Unable to classify
|
3
|
7
|
|
Overall Study
Missing primary reason
|
1
|
0
|
Baseline Characteristics
Safety and Immunogenicity of MF59C.1 Adjuvanted Trivalent Subunit Influenza Vaccine in Elderly Subjects
Baseline characteristics by cohort
| Measure |
aTIV (Pooled)
n=3545 Participants
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
|
Licensed TIV
n=3537 Participants
Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
|
Total
n=7082 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
72.0 years
STANDARD_DEVIATION 5.3 • n=5 Participants
|
71.8 years
STANDARD_DEVIATION 5.3 • n=7 Participants
|
71.9 years
STANDARD_DEVIATION 5.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2272 Participants
n=5 Participants
|
2342 Participants
n=7 Participants
|
4614 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1273 Participants
n=5 Participants
|
1195 Participants
n=7 Participants
|
2468 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 22 post vaccinationPopulation: Analysis was done on the per protocol set population (PPS) i.e all randomised subjects who received the correct vaccine, provided evaluable serum samples, and had no major protocol deviation prior to unblinding.
Immunologic equivalence of 3 consecutive production lots of aTIV (Lot 1, Lot 2 and Lot 3), was assessed in terms of Hemagglutination Inhibition (HI) Geometric Mean Titers (GMTs) in subjects, at three weeks after vaccination, against each vaccine strain.
Outcome measures
| Measure |
aTIV_Lot 1
n=1073 Participants
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from Lot 1
|
aTIV_Lot 2
n=1078 Participants
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from Lot 2
|
aTIV_Lot 3
n=1076 Participants
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from Lot 3
|
|---|---|---|---|
|
Geometric Mean Titers in Subjects After Receiving One Dose of Lot 1 or Lot 2 or Lot 3 of aTIV
H1N1 strain (N=1072,1078,1075)
|
209 Titers
Interval 189.0 to 231.0
|
187 Titers
Interval 170.0 to 207.0
|
199 Titers
Interval 180.0 to 220.0
|
|
Geometric Mean Titers in Subjects After Receiving One Dose of Lot 1 or Lot 2 or Lot 3 of aTIV
H3N2 strain (N=1072,1078,1075)
|
548 Titers
Interval 502.0 to 598.0
|
542 Titers
Interval 498.0 to 591.0
|
556 Titers
Interval 510.0 to 606.0
|
|
Geometric Mean Titers in Subjects After Receiving One Dose of Lot 1 or Lot 2 or Lot 3 of aTIV
B strain
|
56 Titers
Interval 51.0 to 61.0
|
56 Titers
Interval 51.0 to 61.0
|
58 Titers
Interval 53.0 to 64.0
|
PRIMARY outcome
Timeframe: Day 22 post vaccinationPopulation: Analysis was done on PPS.
The non-inferiority of HI antibody responses of aTIV compared to TIV assessed in terms of post vaccination GMTs at three weeks after vaccination against the three homologous vaccine strains.
Outcome measures
| Measure |
aTIV_Lot 1
n=3227 Participants
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from Lot 1
|
aTIV_Lot 2
n=3259 Participants
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from Lot 2
|
aTIV_Lot 3
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from Lot 3
|
|---|---|---|---|
|
Comparison of aTIV Versus TIV in Terms of Geometric Mean Titers (GMTs) Against Homologous Strains - PPS
H1N1 strain (N=3225,3257)
|
198 Titers
Interval 185.0 to 211.0
|
141 Titers
Interval 132.0 to 150.0
|
—
|
|
Comparison of aTIV Versus TIV in Terms of Geometric Mean Titers (GMTs) Against Homologous Strains - PPS
H3N2 strain (N=3225,3256)
|
544 Titers
Interval 513.0 to 575.0
|
337 Titers
Interval 319.0 to 357.0
|
—
|
|
Comparison of aTIV Versus TIV in Terms of Geometric Mean Titers (GMTs) Against Homologous Strains - PPS
B strain
|
55 Titers
Interval 52.0 to 58.0
|
48 Titers
Interval 46.0 to 51.0
|
—
|
PRIMARY outcome
Timeframe: Day 22 post vaccinationPopulation: Analysis was done on PPS.
The non-inferiority of HI antibody responses of aTIV compared to TIV assessed in terms of percentage of subjects achieving seroconversion at three weeks after vaccination against the three homologous vaccine strains. Seroconversion defined as prevaccination HI titer \<10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10.
Outcome measures
| Measure |
aTIV_Lot 1
n=3227 Participants
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from Lot 1
|
aTIV_Lot 2
n=3259 Participants
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from Lot 2
|
aTIV_Lot 3
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from Lot 3
|
|---|---|---|---|
|
Comparison of aTIV Versus TIV in Terms of Percentage of Subjects Achieving Seroconversion Against Homologous Strains-PPS
H1N1 strain (N=3225,3257)
|
77.4 Percentage of subjects
Interval 75.9 to 78.9
|
67.6 Percentage of subjects
Interval 65.9 to 69.2
|
—
|
|
Comparison of aTIV Versus TIV in Terms of Percentage of Subjects Achieving Seroconversion Against Homologous Strains-PPS
H3N2 strain (N=3225,3256)
|
74.0 Percentage of subjects
Interval 72.4 to 75.5
|
60.7 Percentage of subjects
Interval 59.0 to 62.3
|
—
|
|
Comparison of aTIV Versus TIV in Terms of Percentage of Subjects Achieving Seroconversion Against Homologous Strains-PPS
B strain
|
47.0 Percentage of subjects
Interval 45.2 to 48.7
|
41.2 Percentage of subjects
Interval 39.5 to 43.0
|
—
|
PRIMARY outcome
Timeframe: Day 22 post vaccinationPopulation: Analysis was done on FAS i.e all randomized subjects who received a study vaccination and provided evaluable serum samples both at day 1 and at day 22
The superiority of HI antibody responses of aTIV compared to TIV assessed in terms of post vaccination GMTs at three weeks after vaccination against the three homologous vaccine strains.
Outcome measures
| Measure |
aTIV_Lot 1
n=3479 Participants
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from Lot 1
|
aTIV_Lot 2
n=3482 Participants
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from Lot 2
|
aTIV_Lot 3
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from Lot 3
|
|---|---|---|---|
|
Comparison of aTIV Versus TIV in Terms of GMTs Against Homologous Strains-Full Analysis Set (FAS)
H1N1 strain (N=3477,3480)
|
196 Titers
Interval 184.0 to 208.0
|
142 Titers
Interval 134.0 to 151.0
|
—
|
|
Comparison of aTIV Versus TIV in Terms of GMTs Against Homologous Strains-Full Analysis Set (FAS)
H3N2 strain (N=3477,3479)
|
534 Titers
Interval 506.0 to 563.0
|
334 Titers
Interval 317.0 to 353.0
|
—
|
|
Comparison of aTIV Versus TIV in Terms of GMTs Against Homologous Strains-Full Analysis Set (FAS)
B strain
|
54 Titers
Interval 51.0 to 57.0
|
48 Titers
Interval 45.0 to 50.0
|
—
|
PRIMARY outcome
Timeframe: Day 22 post vaccinationPopulation: Analysis was done on FAS.
The superiority of HI antibody responses of aTIV compared to TIV assessed in terms of percentage of subjects achieving seroconversion at three weeks after vaccination against the three homologous vaccine strains. Seroconversion defined as prevaccination HI titer \<10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10.
Outcome measures
| Measure |
aTIV_Lot 1
n=3479 Participants
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from Lot 1
|
aTIV_Lot 2
n=3482 Participants
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from Lot 2
|
aTIV_Lot 3
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from Lot 3
|
|---|---|---|---|
|
Comparison of aTIV Versus TIV in Terms of Percentage of Subjects Achieving Seroconversion Against Homologous Strains-FAS
H1N1 strain (N=3477, 3480)
|
77.3 Percentage of subjects
Interval 75.8 to 78.6
|
67.8 Percentage of subjects
Interval 66.2 to 69.3
|
—
|
|
Comparison of aTIV Versus TIV in Terms of Percentage of Subjects Achieving Seroconversion Against Homologous Strains-FAS
H3N2 strain (N=3477,3479)
|
73.7 Percentage of subjects
Interval 72.2 to 75.1
|
60.6 Percentage of subjects
Interval 59.0 to 62.2
|
—
|
|
Comparison of aTIV Versus TIV in Terms of Percentage of Subjects Achieving Seroconversion Against Homologous Strains-FAS
B strain
|
46.9 Percentage of subjects
Interval 45.3 to 48.6
|
41.5 Percentage of subjects
Interval 39.8 to 43.1
|
—
|
PRIMARY outcome
Timeframe: Day 22 post vaccinationPopulation: Analysis was done on the FAS.
The percentage of subjects demonstrating HI titers ≥40, in overall group and in subjects with pre-defined co-morbidities (high risk group), against homologous strains, three weeks after vaccination with aTIV or TIV.
Outcome measures
| Measure |
aTIV_Lot 1
n=3479 Participants
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from Lot 1
|
aTIV_Lot 2
n=3482 Participants
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from Lot 2
|
aTIV_Lot 3
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from Lot 3
|
|---|---|---|---|
|
Percentage of Subjects With HI Titers ≥40 Against Homologous Strains
H1N1 strain (N=3477,3480) overall
|
91.1 Percentage of subjects
Interval 90.1 to 92.0
|
84.5 Percentage of subjects
Interval 83.3 to 85.7
|
—
|
|
Percentage of Subjects With HI Titers ≥40 Against Homologous Strains
H3N2 strain (N=3477,3479) overall
|
99.0 Percentage of subjects
Interval 98.6 to 99.3
|
97.0 Percentage of subjects
Interval 96.4 to 97.6
|
—
|
|
Percentage of Subjects With HI Titers ≥40 Against Homologous Strains
B strain, overall
|
64.6 Percentage of subjects
Interval 62.9 to 66.2
|
58.9 Percentage of subjects
Interval 57.3 to 60.6
|
—
|
|
Percentage of Subjects With HI Titers ≥40 Against Homologous Strains
H1N1 strain (N=1299,1273), high risk group
|
91.9 Percentage of subjects
Interval 90.3 to 93.3
|
85.8 Percentage of subjects
Interval 83.7 to 87.7
|
—
|
|
Percentage of Subjects With HI Titers ≥40 Against Homologous Strains
H3N2 strain (N=1299,1273), high risk group
|
98.7 Percentage of subjects
Interval 97.9 to 99.2
|
96.7 Percentage of subjects
Interval 95.6 to 97.6
|
—
|
|
Percentage of Subjects With HI Titers ≥40 Against Homologous Strains
B strain (N=1300,1273), high risk group
|
66.3 Percentage of subjects
Interval 63.7 to 68.9
|
61.4 Percentage of subjects
Interval 58.7 to 64.1
|
—
|
PRIMARY outcome
Timeframe: Day 22 post vaccinationPopulation: Analysis was done on the FAS.
The percentage of subjects achieving seroconversion in HI titers from baseline, in overall group and in subjects with pre-defined co-morbidities (high risk group), against homologous strains, three weeks after vaccination with aTIV or TIV. Seroconversion is defined as prevaccination HI titer \<10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10.
Outcome measures
| Measure |
aTIV_Lot 1
n=3479 Participants
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from Lot 1
|
aTIV_Lot 2
n=3482 Participants
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from Lot 2
|
aTIV_Lot 3
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from Lot 3
|
|---|---|---|---|
|
Percentage of Subjects Achieving Seroconversion in HI Titers, Against Homologous Strains
H1N1 strain ( N= 3477,3480), overall
|
77.3 Percentage of subjects
Interval 75.8 to 78.6
|
67.8 Percentage of subjects
Interval 66.2 to 69.3
|
—
|
|
Percentage of Subjects Achieving Seroconversion in HI Titers, Against Homologous Strains
H3N2 strain ( N= 3477,3479), overall
|
73.7 Percentage of subjects
Interval 72.2 to 75.1
|
60.6 Percentage of subjects
Interval 59.0 to 62.2
|
—
|
|
Percentage of Subjects Achieving Seroconversion in HI Titers, Against Homologous Strains
B strain, overall
|
46.9 Percentage of subjects
Interval 45.3 to 48.6
|
41.5 Percentage of subjects
Interval 39.8 to 43.1
|
—
|
|
Percentage of Subjects Achieving Seroconversion in HI Titers, Against Homologous Strains
H1N1 strain ( N= 1299,1273), high risk group
|
72.6 Percentage of subjects
Interval 70.1 to 75.0
|
62.0 Percentage of subjects
Interval 59.3 to 64.7
|
—
|
|
Percentage of Subjects Achieving Seroconversion in HI Titers, Against Homologous Strains
H3N2 strain ( N= 1299,1273), high risk group
|
68.9 Percentage of subjects
Interval 66.3 to 71.4
|
55.2 Percentage of subjects
Interval 52.4 to 58.0
|
—
|
|
Percentage of Subjects Achieving Seroconversion in HI Titers, Against Homologous Strains
B strain (N= 1299,1273), high risk group
|
40.0 Percentage of subjects
Interval 37.3 to 42.7
|
34.3 Percentage of subjects
Interval 31.6 to 36.9
|
—
|
PRIMARY outcome
Timeframe: Day 22 post vaccinationPopulation: Analysis was done on the FAS
The GMR of post-vaccination versus pre-vaccination HI titers (day 22/day 1) in overall group and in subjects with pre-defined co-morbidities (high risk group), against homologous strains, three weeks after vaccination with aTIV or TIV.
Outcome measures
| Measure |
aTIV_Lot 1
n=3479 Participants
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from Lot 1
|
aTIV_Lot 2
n=3482 Participants
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from Lot 2
|
aTIV_Lot 3
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from Lot 3
|
|---|---|---|---|
|
Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination HI Titers Against Homologous Strains
H1N1 strain (N=3477, 3480), overall
|
13 Ratio
Interval 13.0 to 14.0
|
9.77 Ratio
Interval 9.14 to 10.0
|
—
|
|
Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination HI Titers Against Homologous Strains
H3N2 strain (N=3477, 3479), overall
|
10 Ratio
Interval 9.48 to 11.0
|
6.54 Ratio
Interval 6.06 to 7.06
|
—
|
|
Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination HI Titers Against Homologous Strains
B strain , overall
|
4.85 Ratio
Interval 4.59 to 5.13
|
4.27 Ratio
Interval 4.04 to 4.52
|
—
|
|
Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination HI Titers Against Homologous Strains
H1N1 strain (N=1299, 1273), high risk group
|
12 Ratio
Interval 11.0 to 14.0
|
9.17 Ratio
Interval 8.28 to 10.0
|
—
|
|
Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination HI Titers Against Homologous Strains
H3N2 strain (N=1299, 1273), high risk group
|
9.26 Ratio
Interval 8.31 to 10.0
|
6.24 Ratio
Interval 5.59 to 6.96
|
—
|
|
Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination HI Titers Against Homologous Strains
B strain (N=1300, 1273), high risk group
|
4.48 Ratio
Interval 4.14 to 4.84
|
3.99 Ratio
Interval 3.68 to 4.31
|
—
|
PRIMARY outcome
Timeframe: Day 22 post vaccinationPopulation: Analysis was done on the FAS.
The percentage of subjects demonstrating HI titers ≥40, in overall group and in subjects with pre-defined co-morbidities (high risk group), against heterologous strains, three weeks after vaccination with aTIV or TIV.
Outcome measures
| Measure |
aTIV_Lot 1
n=887 Participants
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from Lot 1
|
aTIV_Lot 2
n=881 Participants
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from Lot 2
|
aTIV_Lot 3
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from Lot 3
|
|---|---|---|---|
|
Percentage of Subjects With HI Titers ≥40 Against Heterologous Strains
B strain (N=330, 333), high risk group
|
83.3 Percentage of subjects
Interval 78.9 to 87.2
|
78.4 Percentage of subjects
Interval 73.6 to 82.7
|
—
|
|
Percentage of Subjects With HI Titers ≥40 Against Heterologous Strains
H3N2/Brisbane strain(N=887,880), overall
|
95.8 Percentage of subjects
Interval 94.3 to 97.1
|
94.0 Percentage of subjects
Interval 92.2 to 95.5
|
—
|
|
Percentage of Subjects With HI Titers ≥40 Against Heterologous Strains
H3N2/Wisconsin strain, overall
|
99.6 Percentage of subjects
Interval 98.9 to 99.9
|
98.4 Percentage of subjects
Interval 97.4 to 99.1
|
—
|
|
Percentage of Subjects With HI Titers ≥40 Against Heterologous Strains
B strain (N=887,880), overall
|
76.2 Percentage of subjects
Interval 73.3 to 79.0
|
72.4 Percentage of subjects
Interval 69.3 to 75.3
|
—
|
|
Percentage of Subjects With HI Titers ≥40 Against Heterologous Strains
H3N2/Brisbane (N=330, 333), high risk group
|
94.9 Percentage of subjects
Interval 91.9 to 97.0
|
94.0 Percentage of subjects
Interval 90.9 to 96.3
|
—
|
|
Percentage of Subjects With HI Titers ≥40 Against Heterologous Strains
H3N2/Wisconsin (N=330, 333), high risk group
|
99.7 Percentage of subjects
Interval 98.3 to 100.0
|
98.5 Percentage of subjects
Interval 96.5 to 99.5
|
—
|
PRIMARY outcome
Timeframe: Day 22 post vaccinationPopulation: Analysis was done on the FAS.
The GMR of post-vaccination versus pre-vaccination HI titers (day 22/day 1) in overall group and in subjects with pre-defined co-morbidities (high risk group), against heterologous strains, three weeks after vaccination with aTIV or TIV.
Outcome measures
| Measure |
aTIV_Lot 1
n=887 Participants
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from Lot 1
|
aTIV_Lot 2
n=881 Participants
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from Lot 2
|
aTIV_Lot 3
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from Lot 3
|
|---|---|---|---|
|
Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination HI Titers, Against Heterologous Strains
H3N2/Brisbane strain (N=887,880), overall
|
5.76 Ratio
Interval 5.02 to 6.6
|
3.87 Ratio
Interval 3.37 to 4.44
|
—
|
|
Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination HI Titers, Against Heterologous Strains
H3N2/Wisconsin strain, overall
|
4.95 Ratio
Interval 4.36 to 5.62
|
3.54 Ratio
Interval 3.12 to 4.03
|
—
|
|
Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination HI Titers, Against Heterologous Strains
B strain (N=887,880), overall
|
5.76 Ratio
Interval 5.2 to 6.38
|
5.28 Ratio
Interval 4.76 to 5.85
|
—
|
|
Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination HI Titers, Against Heterologous Strains
H3N2/Brisbane strain (N=330,333), high risk group
|
5.42 Ratio
Interval 4.47 to 6.57
|
4.15 Ratio
Interval 3.43 to 5.03
|
—
|
|
Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination HI Titers, Against Heterologous Strains
H3N2/Wisconsin strain (N=330,333), high risk group
|
4.67 Ratio
Interval 3.87 to 5.62
|
3.73 Ratio
Interval 3.1 to 4.49
|
—
|
|
Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination HI Titers, Against Heterologous Strains
B strain (N=330,333), high risk group
|
5.41 Ratio
Interval 4.66 to 6.28
|
4.77 Ratio
Interval 4.11 to 5.53
|
—
|
PRIMARY outcome
Timeframe: Day 22 post vaccinationPopulation: Analysis was done on the FAS.
The percentage of subjects achieving seroconversion in HI titers from baseline, in overall group and in subjects with pre-defined co-morbidities (high risk group), against heterologous strains, three weeks after vaccination with aTIV or TIV. Seroconversion is defined as prevaccination HI titer \<10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10.
Outcome measures
| Measure |
aTIV_Lot 1
n=887 Participants
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from Lot 1
|
aTIV_Lot 2
n=881 Participants
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from Lot 2
|
aTIV_Lot 3
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from Lot 3
|
|---|---|---|---|
|
Percentage of Subjects Achieving Seroconversion in HI Titers, Against Heterologous Strains
H3N2/Brisbane, overall (N=887, 880)
|
60.4 Percentage of subjects
Interval 57.1 to 63.7
|
48.4 Percentage of subjects
Interval 45.1 to 51.8
|
—
|
|
Percentage of Subjects Achieving Seroconversion in HI Titers, Against Heterologous Strains
H3N2/Wisconsin, overall
|
57.5 Percentage of subjects
Interval 54.2 to 60.8
|
45.5 Percentage of subjects
Interval 42.2 to 48.9
|
—
|
|
Percentage of Subjects Achieving Seroconversion in HI Titers, Against Heterologous Strains
B strain, overall (N=887, 880)
|
53.3 Percentage of subjects
Interval 50.0 to 56.7
|
49.8 Percentage of subjects
Interval 46.4 to 53.1
|
—
|
|
Percentage of Subjects Achieving Seroconversion in HI Titers, Against Heterologous Strains
H3N2/Brisbane (N= 330,333), high risk group
|
54.2 Percentage of subjects
Interval 48.7 to 59.7
|
41.4 Percentage of subjects
Interval 36.1 to 46.9
|
—
|
|
Percentage of Subjects Achieving Seroconversion in HI Titers, Against Heterologous Strains
H3N2/Wisconsin ( N= 330,333), high risk group
|
52.1 Percentage of subjects
Interval 46.6 to 57.6
|
38.7 Percentage of subjects
Interval 33.5 to 44.2
|
—
|
|
Percentage of Subjects Achieving Seroconversion in HI Titers, Against Heterologous Strains
B strain (N= 330, 333), high risk group
|
46.4 Percentage of subjects
Interval 40.9 to 51.9
|
41.7 Percentage of subjects
Interval 36.4 to 47.2
|
—
|
SECONDARY outcome
Timeframe: Day 22 post vaccinationPopulation: Analysis was done on PPS.
The non-inferiority of HI antibody responses of ATIV compared to TIV, in subjects with pre-defined co-morbidities (high risk subjects), was assessed in terms of post vaccination GMTs at three weeks after vaccination against the three homologous vaccine strains.
Outcome measures
| Measure |
aTIV_Lot 1
n=1195 Participants
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from Lot 1
|
aTIV_Lot 2
n=1190 Participants
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from Lot 2
|
aTIV_Lot 3
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from Lot 3
|
|---|---|---|---|
|
Comparison of aTIV Versus TIV in High Risk Group in Terms of GMTs Against Homologous Strains-PPS
B strain
|
61 Titers
Interval 56.0 to 66.0
|
54 Titers
Interval 50.0 to 59.0
|
—
|
|
Comparison of aTIV Versus TIV in High Risk Group in Terms of GMTs Against Homologous Strains-PPS
H1N1 strain (1194, 1190)
|
221 Titers
Interval 201.0 to 243.0
|
161 Titers
Interval 146.0 to 177.0
|
—
|
|
Comparison of aTIV Versus TIV in High Risk Group in Terms of GMTs Against Homologous Strains-PPS
H3N2 strain (1194, 1190)
|
519 Titers
Interval 477.0 to 565.0
|
331 Titers
Interval 304.0 to 360.0
|
—
|
SECONDARY outcome
Timeframe: Day 22 post vaccinationPopulation: Analysis was done on PPS.
The non-inferiority of HI antibody responses of ATIV compared to TIV, in subjects with pre-defined co-morbidities (high risk group), assessed in terms of percentage of subjects achieving seroconversion at three weeks after vaccination against the homologous vaccine strains. Seroconversion is defined as prevaccination HI titer \<10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10.
Outcome measures
| Measure |
aTIV_Lot 1
n=1195 Participants
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from Lot 1
|
aTIV_Lot 2
n=1190 Participants
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from Lot 2
|
aTIV_Lot 3
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from Lot 3
|
|---|---|---|---|
|
Comparison of HI Antibody Responses of aTIV Versus TIV, in High Risk Group in Terms of Percentage of Subjects Achieving Seroconversion Against Homologous Strains-PPS
H1N1 strain (N=1194, 1190)
|
73.6 Percentage of subjects
Interval 71.0 to 76.1
|
61.7 Percentage of subjects
Interval 58.9 to 64.5
|
—
|
|
Comparison of HI Antibody Responses of aTIV Versus TIV, in High Risk Group in Terms of Percentage of Subjects Achieving Seroconversion Against Homologous Strains-PPS
H3N2 strain (N=1194, 1190)
|
69.1 Percentage of subjects
Interval 66.4 to 71.7
|
54.8 Percentage of subjects
Interval 51.9 to 57.6
|
—
|
|
Comparison of HI Antibody Responses of aTIV Versus TIV, in High Risk Group in Terms of Percentage of Subjects Achieving Seroconversion Against Homologous Strains-PPS
B strain
|
40.0 Percentage of subjects
Interval 37.2 to 42.8
|
34.0 Percentage of subjects
Interval 31.3 to 36.7
|
—
|
SECONDARY outcome
Timeframe: Day 22 post vaccinationPopulation: Analysis was done on FAS population.
The superiority of HI antibody responses of aTIV compared to TIV, in subjects with predefined co-morbidities (high risk group) assessed in terms of post vaccination GMTs at three weeks after vaccination against the three homologous vaccine strains.
Outcome measures
| Measure |
aTIV_Lot 1
n=1300 Participants
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from Lot 1
|
aTIV_Lot 2
n=1273 Participants
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from Lot 2
|
aTIV_Lot 3
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from Lot 3
|
|---|---|---|---|
|
Comparison of aTIV Versus TIV in High Risk Group in Terms of GMTs Against Homologous Strains-FAS
H1N1 strain (N=1299,1273)
|
212 Titers
Interval 194.0 to 232.0
|
160 Titers
Interval 147.0 to 176.0
|
—
|
|
Comparison of aTIV Versus TIV in High Risk Group in Terms of GMTs Against Homologous Strains-FAS
H3N2 strain (N=1299,1273)
|
499 Titers
Interval 460.0 to 540.0
|
324 Titers
Interval 299.0 to 351.0
|
—
|
|
Comparison of aTIV Versus TIV in High Risk Group in Terms of GMTs Against Homologous Strains-FAS
B strain
|
60 Titers
Interval 55.0 to 64.0
|
54 Titers
Interval 50.0 to 58.0
|
—
|
SECONDARY outcome
Timeframe: Day 22 postvaccinationPopulation: Analysis was done on FAS.
The superiority of HI antibody responses of aTIV compared to TIV, in subjects with pre-defined co-morbidities (high risk group), assessed in terms of percentage of subjects achieving seroconversion at three weeks after vaccination against the homologous vaccine strains. Seroconversion is defined as prevaccination HI titer \<10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10.
Outcome measures
| Measure |
aTIV_Lot 1
n=1300 Participants
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from Lot 1
|
aTIV_Lot 2
n=1273 Participants
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from Lot 2
|
aTIV_Lot 3
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from Lot 3
|
|---|---|---|---|
|
Comparison of HI Antibody Responses of aTIV Versus TIV, in High Risk Group in Terms of Percentage of Subjects Achieving Seroconversion Against Homologous Strains-FAS
H1N1 strain (N=1299,1273)
|
72.6 Percentage of subjects
Interval 70.1 to 75.0
|
62.0 Percentage of subjects
Interval 59.3 to 64.7
|
—
|
|
Comparison of HI Antibody Responses of aTIV Versus TIV, in High Risk Group in Terms of Percentage of Subjects Achieving Seroconversion Against Homologous Strains-FAS
H3N2 strain (N=1299,1273)
|
68.9 Percentage of subjects
Interval 66.3 to 71.4
|
55.2 Percentage of subjects
Interval 52.4 to 58.0
|
—
|
|
Comparison of HI Antibody Responses of aTIV Versus TIV, in High Risk Group in Terms of Percentage of Subjects Achieving Seroconversion Against Homologous Strains-FAS
B strain
|
40.0 Percentage of subjects
Interval 37.3 to 42.7
|
34.3 Percentage of subjects
Interval 31.6 to 36.9
|
—
|
SECONDARY outcome
Timeframe: Day 22 post vaccinationPopulation: Analysis was done on PPS.
The non-inferiority of HI antibody responses of aTIV compared to TIV against the heterologous vaccine strains, in overall group and in subjects with pre-defined co-morbidities (high risk subjects), was assessed in terms of post vaccination GMTs at three weeks after vaccination .
Outcome measures
| Measure |
aTIV_Lot 1
n=834 Participants
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from Lot 1
|
aTIV_Lot 2
n=815 Participants
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from Lot 2
|
aTIV_Lot 3
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from Lot 3
|
|---|---|---|---|
|
Comparison of aTIV Versus TIV in Terms of GMTs Against Heterologous Strains-PPS
H3N2/Brisbane (overall) (N=834,814)
|
369 Titers
Interval 329.0 to 414.0
|
255 Titers
Interval 227.0 to 287.0
|
—
|
|
Comparison of aTIV Versus TIV in Terms of GMTs Against Heterologous Strains-PPS
H3N2/Wisconsin (overall)
|
1037 Titers
Interval 940.0 to 1144.0
|
764 Titers
Interval 691.0 to 846.0
|
—
|
|
Comparison of aTIV Versus TIV in Terms of GMTs Against Heterologous Strains-PPS
B strain (overall) (N=834,814)
|
89 Titers
Interval 80.0 to 99.0
|
82 Titers
Interval 73.0 to 91.0
|
—
|
|
Comparison of aTIV Versus TIV in Terms of GMTs Against Heterologous Strains-PPS
H3N2/Brisbane (high risk) (N=302,307)
|
377 Titers
Interval 319.0 to 445.0
|
279 Titers
Interval 236.0 to 330.0
|
—
|
|
Comparison of aTIV Versus TIV in Terms of GMTs Against Heterologous Strains-PPS
H3N2/Wisconsin (high risk) (N=302,307)
|
965 Titers
Interval 831.0 to 1121.0
|
751 Titers
Interval 646.0 to 873.0
|
—
|
|
Comparison of aTIV Versus TIV in Terms of GMTs Against Heterologous Strains-PPS
B strain (high risk) (N=302,307)
|
117 Titers
Interval 100.0 to 136.0
|
105 Titers
Interval 90.0 to 123.0
|
—
|
SECONDARY outcome
Timeframe: Day 22 post vaccinationPopulation: Analysis was done on FAS.
The superiority of HI antibody responses of aTIV compared to TIV against the heterologous vaccine strains, in overall group and in subjects with pre-defined co-morbidities (high risk subjects), was assessed in terms of post vaccination GMTs at three weeks after vaccination.
Outcome measures
| Measure |
aTIV_Lot 1
n=887 Participants
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from Lot 1
|
aTIV_Lot 2
n=881 Participants
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from Lot 2
|
aTIV_Lot 3
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from Lot 3
|
|---|---|---|---|
|
Comparison of aTIV Versus TIV in Terms of GMTs Against Heterologous Strains-FAS
H3N2/Brisbane (overall) (N=887,880)
|
362 Titers
Interval 325.0 to 404.0
|
243 Titers
Interval 218.0 to 271.0
|
—
|
|
Comparison of aTIV Versus TIV in Terms of GMTs Against Heterologous Strains-FAS
H3N2/Wisconsin (overall)
|
1016 Titers
Interval 926.0 to 1115.0
|
738 Titers
Interval 672.0 to 811.0
|
—
|
|
Comparison of aTIV Versus TIV in Terms of GMTs Against Heterologous Strains-FAS
B strain (overall) (N=887,880)
|
87 Titers
Interval 79.0 to 97.0
|
80 Titers
Interval 72.0 to 88.0
|
—
|
|
Comparison of aTIV Versus TIV in Terms of GMTs Against Heterologous Strains-FAS
H3N2/Brisbane (high risk) (N=302,307)
|
364 Titers
Interval 312.0 to 425.0
|
267 Titers
Interval 229.0 to 312.0
|
—
|
|
Comparison of aTIV Versus TIV in Terms of GMTs Against Heterologous Strains-FAS
H3N2/Wisconsin (high risk) (N=302,307)
|
927 Titers
Interval 807.0 to 1065.0
|
724 Titers
Interval 631.0 to 831.0
|
—
|
|
Comparison of aTIV Versus TIV in Terms of GMTs Against Heterologous Strains-FAS
B strain (high risk) (N=302,307)
|
112 Titers
Interval 97.0 to 129.0
|
99 Titers
Interval 87.0 to 114.0
|
—
|
SECONDARY outcome
Timeframe: Day 22 postvaccinationPopulation: Analysis was done on PPS.
The non-inferiority of HI antibody responses of aTIV compared to TIV against the heterologous strains, in overall group and in subjects with pre-defined co-morbidities (high risk group), assessed in terms of percentage of subjects achieving seroconversion at three weeks after vaccination. Seroconversion is defined as prevaccination HI titer \<10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10.
Outcome measures
| Measure |
aTIV_Lot 1
n=834 Participants
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from Lot 1
|
aTIV_Lot 2
n=815 Participants
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from Lot 2
|
aTIV_Lot 3
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from Lot 3
|
|---|---|---|---|
|
Comparison of HI Antibody Responses of aTIV Versus TIV, in Terms of Percentage of Subjects Achieving Seroconversion Against Heterologous Strains-PPS
H3N2/Brisbane (overall) (N=834,814)
|
60.0 Percentage of subjects
Interval 56.5 to 63.3
|
49.1 Percentage of subjects
Interval 45.7 to 52.6
|
—
|
|
Comparison of HI Antibody Responses of aTIV Versus TIV, in Terms of Percentage of Subjects Achieving Seroconversion Against Heterologous Strains-PPS
H3N2/Wisconsin (overall)
|
57.0 Percentage of subjects
Interval 53.5 to 60.4
|
45.9 Percentage of subjects
Interval 42.4 to 49.4
|
—
|
|
Comparison of HI Antibody Responses of aTIV Versus TIV, in Terms of Percentage of Subjects Achieving Seroconversion Against Heterologous Strains-PPS
B strain (overall) (N=834,814)
|
52.8 Percentage of subjects
Interval 49.3 to 56.2
|
49.3 Percentage of subjects
Interval 45.8 to 52.8
|
—
|
|
Comparison of HI Antibody Responses of aTIV Versus TIV, in Terms of Percentage of Subjects Achieving Seroconversion Against Heterologous Strains-PPS
H3N2/Brisbane (high risk) (N=302,307)
|
54.3 Percentage of subjects
Interval 48.5 to 60.0
|
41.7 Percentage of subjects
Interval 36.1 to 47.4
|
—
|
|
Comparison of HI Antibody Responses of aTIV Versus TIV, in Terms of Percentage of Subjects Achieving Seroconversion Against Heterologous Strains-PPS
H3N2/Wisconsin (high risk) (N=302,307)
|
51.7 Percentage of subjects
Interval 45.9 to 57.4
|
38.8 Percentage of subjects
Interval 33.3 to 44.5
|
—
|
|
Comparison of HI Antibody Responses of aTIV Versus TIV, in Terms of Percentage of Subjects Achieving Seroconversion Against Heterologous Strains-PPS
B strain (high risk) (N=302,307)
|
45.7 Percentage of subjects
Interval 40.0 to 51.5
|
41.4 Percentage of subjects
Interval 35.8 to 47.1
|
—
|
SECONDARY outcome
Timeframe: Day 22 post vaccinationPopulation: Analysis was done on FAS
The superiority of HI antibody responses of aTIV compared to TIV against the heterologous vaccine strains, in overall group and in subjects with pre-defined co-morbidities (high risk subjects), was assessed in terms of percentage of subjects achieving seroconversion, at three weeks after vaccination. Seroconversion is defined as prevaccination HI titer \<10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10.
Outcome measures
| Measure |
aTIV_Lot 1
n=887 Participants
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from Lot 1
|
aTIV_Lot 2
n=881 Participants
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from Lot 2
|
aTIV_Lot 3
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from Lot 3
|
|---|---|---|---|
|
Comparison of aTIV Versus TIV in Terms of Percentage of Subjects Achieving Seroconversion Against Heterologous Strains-FAS
H3N2/Brisbane (overall) (N=887,880)
|
60.4 Percentage of subjects
Interval 57.1 to 63.7
|
48.4 Percentage of subjects
Interval 45.1 to 51.8
|
—
|
|
Comparison of aTIV Versus TIV in Terms of Percentage of Subjects Achieving Seroconversion Against Heterologous Strains-FAS
H3N2/Wisconsin (overall)
|
57.5 Percentage of subjects
Interval 54.2 to 60.8
|
45.5 Percentage of subjects
Interval 42.2 to 48.9
|
—
|
|
Comparison of aTIV Versus TIV in Terms of Percentage of Subjects Achieving Seroconversion Against Heterologous Strains-FAS
B strain (overall) (N=887,880)
|
53.3 Percentage of subjects
Interval 50.0 to 56.7
|
49.8 Percentage of subjects
Interval 46.4 to 53.1
|
—
|
|
Comparison of aTIV Versus TIV in Terms of Percentage of Subjects Achieving Seroconversion Against Heterologous Strains-FAS
H3N2/Brisbane (high risk) (N=330, 333)
|
54.2 Percentage of subjects
Interval 48.7 to 59.7
|
41.4 Percentage of subjects
Interval 36.1 to 46.9
|
—
|
|
Comparison of aTIV Versus TIV in Terms of Percentage of Subjects Achieving Seroconversion Against Heterologous Strains-FAS
H3N2/Wisconsin (high risk) (N=330,333)
|
52.1 Percentage of subjects
Interval 46.6 to 57.6
|
38.7 Percentage of subjects
Interval 33.5 to 44.2
|
—
|
|
Comparison of aTIV Versus TIV in Terms of Percentage of Subjects Achieving Seroconversion Against Heterologous Strains-FAS
B strain (high risk) (N=330, 333)
|
46.4 Percentage of subjects
Interval 40.9 to 51.9
|
41.7 Percentage of subjects
Interval 36.4 to 47.2
|
—
|
SECONDARY outcome
Timeframe: Day 181, Day 366 post vaccinationPopulation: The analysis was done on the FAS (persistence) subset population i.e all randomized population only from US sites who received a study vaccination, provided evaluable blood samples at day 1, day 22, day 181, and day 366.
The GMTs against homologous and heterologous strains, persisting in subjects at six months (day 181) and one year (day 366) after vaccination with either aTIV or TIV.
Outcome measures
| Measure |
aTIV_Lot 1
n=189 Participants
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from Lot 1
|
aTIV_Lot 2
n=191 Participants
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from Lot 2
|
aTIV_Lot 3
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from Lot 3
|
|---|---|---|---|
|
Persistence of GMTs Against Homologous and Heterologous Strains
H3N2/Wisconsin (heterologous) Day 181
|
228 Titers
Interval 189.0 to 275.0
|
194 Titers
Interval 161.0 to 233.0
|
—
|
|
Persistence of GMTs Against Homologous and Heterologous Strains
H1N1 (homologous) Day 181
|
71 Titers
Interval 60.0 to 84.0
|
68 Titers
Interval 57.0 to 80.0
|
—
|
|
Persistence of GMTs Against Homologous and Heterologous Strains
H1N1 (homologous) Day 366
|
49 Titers
Interval 41.0 to 59.0
|
52 Titers
Interval 44.0 to 63.0
|
—
|
|
Persistence of GMTs Against Homologous and Heterologous Strains
H3N2 (homologous) Day 181
|
123 Titers
Interval 104.0 to 146.0
|
91 Titers
Interval 77.0 to 108.0
|
—
|
|
Persistence of GMTs Against Homologous and Heterologous Strains
H3N2 (homologous) Day 366
|
70 Titers
Interval 59.0 to 84.0
|
54 Titers
Interval 45.0 to 64.0
|
—
|
|
Persistence of GMTs Against Homologous and Heterologous Strains
B (homologous) Day 181
|
25 Titers
Interval 21.0 to 29.0
|
22 Titers
Interval 19.0 to 26.0
|
—
|
|
Persistence of GMTs Against Homologous and Heterologous Strains
B (homologous) Day 366
|
21 Titers
Interval 18.0 to 24.0
|
20 Titers
Interval 17.0 to 23.0
|
—
|
|
Persistence of GMTs Against Homologous and Heterologous Strains
B (heterologous) Day 181
|
39 Titers
Interval 33.0 to 45.0
|
38 Titers
Interval 33.0 to 44.0
|
—
|
|
Persistence of GMTs Against Homologous and Heterologous Strains
B (heterologous) Day 366
|
38 Titers
Interval 33.0 to 44.0
|
40 Titers
Interval 35.0 to 46.0
|
—
|
|
Persistence of GMTs Against Homologous and Heterologous Strains
H3N2/Brisbane (heterologous) Day 181
|
100 Titers
Interval 84.0 to 120.0
|
81 Titers
Interval 68.0 to 97.0
|
—
|
|
Persistence of GMTs Against Homologous and Heterologous Strains
H3N2/Brisbane(heterologous) Day 366
|
75 Titers
Interval 63.0 to 90.0
|
72 Titers
Interval 60.0 to 86.0
|
—
|
|
Persistence of GMTs Against Homologous and Heterologous Strains
H3N2/Wisconsin (heterologous) Day 366
|
190 Titers
Interval 157.0 to 231.0
|
182 Titers
Interval 150.0 to 221.0
|
—
|
SECONDARY outcome
Timeframe: Day 181, Day 366 post vaccinationPopulation: The analysis was done on the FAS (persistence) subset.
The percentage of subjects demonstrating seroconversion in HI titers against homologous and heterologous strains, at six months (day 181) and one year (day 366) after vaccination with either aTIV or TIV. Seroconversion is defined as prevaccination HI titer \<10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10.
Outcome measures
| Measure |
aTIV_Lot 1
n=189 Participants
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from Lot 1
|
aTIV_Lot 2
n=191 Participants
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from Lot 2
|
aTIV_Lot 3
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from Lot 3
|
|---|---|---|---|
|
Percentage of Subjects With Seroconversion Upto One Year After Vaccination, Against Homologous and Heterologous Strains
B (homologous) Day 366
|
2.1 Percentage of subjects
Interval 0.6 to 5.3
|
3.1 Percentage of subjects
Interval 1.2 to 6.7
|
—
|
|
Percentage of Subjects With Seroconversion Upto One Year After Vaccination, Against Homologous and Heterologous Strains
B (heterologous) Day 181
|
2.65 Percentage of subjects
Interval 0.86 to 6.07
|
3.14 Percentage of subjects
Interval 1.16 to 6.71
|
—
|
|
Percentage of Subjects With Seroconversion Upto One Year After Vaccination, Against Homologous and Heterologous Strains
B (heterologous) Day 366
|
4.23 Percentage of subjects
Interval 1.84 to 8.17
|
3.14 Percentage of subjects
Interval 1.16 to 6.71
|
—
|
|
Percentage of Subjects With Seroconversion Upto One Year After Vaccination, Against Homologous and Heterologous Strains
H3N2/Brisbane (heterologous) Day 181
|
15.34 Percentage of subjects
Interval 10.52 to 21.29
|
8.38 Percentage of subjects
Interval 4.86 to 13.25
|
—
|
|
Percentage of Subjects With Seroconversion Upto One Year After Vaccination, Against Homologous and Heterologous Strains
H3N2/Brisbane(heterologous) Day 366
|
7.94 Percentage of subjects
Interval 4.51 to 12.75
|
5.24 Percentage of subjects
Interval 2.54 to 9.42
|
—
|
|
Percentage of Subjects With Seroconversion Upto One Year After Vaccination, Against Homologous and Heterologous Strains
H3N2/Wisconsin (heterologous) Day 181
|
12.17 Percentage of subjects
Interval 7.87 to 17.7
|
8.90 Percentage of subjects
Interval 5.27 to 13.87
|
—
|
|
Percentage of Subjects With Seroconversion Upto One Year After Vaccination, Against Homologous and Heterologous Strains
H3N2/Wisconsin (heterologous) Day 366
|
8.99 Percentage of subjects
Interval 5.33 to 14.01
|
6.28 Percentage of subjects
Interval 3.29 to 10.72
|
—
|
|
Percentage of Subjects With Seroconversion Upto One Year After Vaccination, Against Homologous and Heterologous Strains
H1N1 (homologous) Day 181
|
28.6 Percentage of subjects
Interval 22.3 to 35.6
|
26.2 Percentage of subjects
Interval 20.1 to 33.0
|
—
|
|
Percentage of Subjects With Seroconversion Upto One Year After Vaccination, Against Homologous and Heterologous Strains
H1N1 (homologous) Day 366
|
18.5 Percentage of subjects
Interval 13.3 to 24.8
|
19.4 Percentage of subjects
Interval 14.0 to 25.7
|
—
|
|
Percentage of Subjects With Seroconversion Upto One Year After Vaccination, Against Homologous and Heterologous Strains
H3N2 (homologous) Day 181
|
36.0 Percentage of subjects
Interval 29.1 to 43.3
|
24.6 Percentage of subjects
Interval 18.7 to 31.4
|
—
|
|
Percentage of Subjects With Seroconversion Upto One Year After Vaccination, Against Homologous and Heterologous Strains
H3N2 (homologous) Day 366
|
16.9 Percentage of subjects
Interval 11.9 to 23.1
|
12.6 Percentage of subjects
Interval 8.2 to 18.1
|
—
|
|
Percentage of Subjects With Seroconversion Upto One Year After Vaccination, Against Homologous and Heterologous Strains
B (homologous) Day 181
|
3.7 Percentage of subjects
Interval 1.5 to 7.5
|
2.6 Percentage of subjects
Interval 0.9 to 6.0
|
—
|
SECONDARY outcome
Timeframe: Day 22 through Day 366 post vaccinationPopulation: Analysis was done on the modified full analysis set (mFAS; effectiveness) population i.e all subjects in the randomized population who received a study vaccination but excluding those who received a non-study vaccine during the follow-up phase.
The number of subjects reporting ILI from three weeks after vaccination to up to one year in aTIV group compared to TIV group, by country.
Outcome measures
| Measure |
aTIV_Lot 1
n=3497 Participants
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from Lot 1
|
aTIV_Lot 2
n=3498 Participants
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from Lot 2
|
aTIV_Lot 3
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from Lot 3
|
|---|---|---|---|
|
Number of Subjects Reporting Influenza Like Illness (ILI) Across Vaccine Groups
Columbia (N=516, 506)
|
119 participants
|
97 participants
|
—
|
|
Number of Subjects Reporting Influenza Like Illness (ILI) Across Vaccine Groups
Panama (N=108, 102)
|
20 participants
|
21 participants
|
—
|
|
Number of Subjects Reporting Influenza Like Illness (ILI) Across Vaccine Groups
Philippines (N=1836,1835)
|
102 participants
|
113 participants
|
—
|
|
Number of Subjects Reporting Influenza Like Illness (ILI) Across Vaccine Groups
United states (N=1037,1055)
|
72 participants
|
76 participants
|
—
|
SECONDARY outcome
Timeframe: Day 1 through Day 366 post vaccinationPopulation: Analysis was done on the mFAS (effectiveness) population.
The number of high risk subjects reporting exacerbation of preexisting chronic conditions (i.e.congestive heart failure, Chronic Obstructive Pulmonary disease (COPD), asthma, hepatic disease, renal insufficiency, and neurological/neuromuscular or metabolic disorders including diabetes mellitus) in aTIV group compared to TIV group.
Outcome measures
| Measure |
aTIV_Lot 1
n=1307 Participants
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from Lot 1
|
aTIV_Lot 2
n=1281 Participants
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from Lot 2
|
aTIV_Lot 3
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from Lot 3
|
|---|---|---|---|
|
Number of High Risk Subjects With Exacerbation of Preexisting Chronic Disease, Across Vaccine Groups
|
55 participants
|
48 participants
|
—
|
SECONDARY outcome
Timeframe: Day 1 through Day 366 post vaccinationPopulation: Analysis was done on the mFAS (effectiveness).
The number of subjects with emergency room visits, unscheduled physician visits, and hospitalizations due to community acquired influenza or pneumonia, cardiopulmonary disease, cardiac disease, respiratory or pulmonary disease,in aTIV group compared to TIV group.
Outcome measures
| Measure |
aTIV_Lot 1
n=3499 Participants
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from Lot 1
|
aTIV_Lot 2
n=3502 Participants
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from Lot 2
|
aTIV_Lot 3
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from Lot 3
|
|---|---|---|---|
|
Number of Subjects Reporting Healthcare Utilization Across Vaccine Groups
|
275 participants
|
289 participants
|
—
|
SECONDARY outcome
Timeframe: Day 1 through Day 366 post vaccinationPopulation: Analysis was done on the mFAS (effectiveness).
The all-cause mortality rate (excluding injury)reported in aTIV group compared to TIV group, by country.
Outcome measures
| Measure |
aTIV_Lot 1
n=3540 Participants
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from Lot 1
|
aTIV_Lot 2
n=3541 Participants
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from Lot 2
|
aTIV_Lot 3
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from Lot 3
|
|---|---|---|---|
|
All Cause Mortality Rate, Across Vaccine Groups
Columbia (N=519, 509)
|
7 participants
|
7 participants
|
—
|
|
All Cause Mortality Rate, Across Vaccine Groups
Panama (N=109, 105)
|
0 participants
|
0 participants
|
—
|
|
All Cause Mortality Rate, Across Vaccine Groups
Philippines (N=1873,1867)
|
39 participants
|
34 participants
|
—
|
|
All Cause Mortality Rate, Across Vaccine Groups
United states (N=1039,1060)
|
6 participants
|
5 participants
|
—
|
SECONDARY outcome
Timeframe: Day 1 through Day 7 post vaccinationPopulation: Analysis was done on the safety set i.e all randomized subjects who received a study vaccination and provided postvaccination safety data.
The number of subjects reporting solicited local and systemic adverse events and other adverse events in aTIV group compared to TIV group.
Outcome measures
| Measure |
aTIV_Lot 1
n=3505 Participants
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from Lot 1
|
aTIV_Lot 2
n=3495 Participants
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from Lot 2
|
aTIV_Lot 3
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from Lot 3
|
|---|---|---|---|
|
Number of Subjects Reporting Solicited Adverse Events Following Vaccination
Any Local
|
1137 participants
|
593 participants
|
—
|
|
Number of Subjects Reporting Solicited Adverse Events Following Vaccination
Injection site erythema (N=3492, 3485)
|
43 participants
|
18 participants
|
—
|
|
Number of Subjects Reporting Solicited Adverse Events Following Vaccination
Injection site induration (N=3494, 3488)
|
45 participants
|
17 participants
|
—
|
|
Number of Subjects Reporting Solicited Adverse Events Following Vaccination
Injection site tenderness (N=3495,3483)
|
739 participants
|
391 participants
|
—
|
|
Number of Subjects Reporting Solicited Adverse Events Following Vaccination
Injection site swelling (N=3495,3488)
|
43 participants
|
15 participants
|
—
|
|
Number of Subjects Reporting Solicited Adverse Events Following Vaccination
Injection site pain (N=3495,3485)
|
875 participants
|
425 participants
|
—
|
|
Number of Subjects Reporting Solicited Adverse Events Following Vaccination
Any sytemic
|
1120 participants
|
902 participants
|
—
|
|
Number of Subjects Reporting Solicited Adverse Events Following Vaccination
Chills (N=3495,3485)
|
235 participants
|
163 participants
|
—
|
|
Number of Subjects Reporting Solicited Adverse Events Following Vaccination
Myalgia (N=3496,3487)
|
515 participants
|
339 participants
|
—
|
|
Number of Subjects Reporting Solicited Adverse Events Following Vaccination
Arthralgia (N=3492,3486)
|
296 participants
|
272 participants
|
—
|
|
Number of Subjects Reporting Solicited Adverse Events Following Vaccination
Headache (N= 3495,3486)
|
463 participants
|
391 participants
|
—
|
|
Number of Subjects Reporting Solicited Adverse Events Following Vaccination
Fatigue (N= 3494, 3484)
|
466 participants
|
361 participants
|
—
|
|
Number of Subjects Reporting Solicited Adverse Events Following Vaccination
Nausea (N=3492,3482)
|
101 participants
|
98 participants
|
—
|
|
Number of Subjects Reporting Solicited Adverse Events Following Vaccination
Vomiting (N=3494,3483)
|
48 participants
|
59 participants
|
—
|
|
Number of Subjects Reporting Solicited Adverse Events Following Vaccination
Diarrhea (N=3494,3485)
|
168 participants
|
158 participants
|
—
|
|
Number of Subjects Reporting Solicited Adverse Events Following Vaccination
Fever (≥ 38°C)
|
122 participants
|
116 participants
|
—
|
|
Number of Subjects Reporting Solicited Adverse Events Following Vaccination
Any other
|
210 participants
|
165 participants
|
—
|
|
Number of Subjects Reporting Solicited Adverse Events Following Vaccination
Oral Temperature (≥ 40°C)
|
3 participants
|
0 participants
|
—
|
|
Number of Subjects Reporting Solicited Adverse Events Following Vaccination
Analgesic/Antipyretic used
|
158 participants
|
122 participants
|
—
|
Adverse Events
aTIV (Pooled)
Serious events: 264 serious events
Other events: 1678 other events
Deaths: 0 deaths
Licensed TIV
Serious events: 243 serious events
Other events: 1257 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
aTIV (Pooled)
n=3545 participants at risk
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
|
Licensed TIV
n=3537 participants at risk
Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.06%
2/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.14%
5/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.00%
0/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Blood and lymphatic system disorders
Idiopathic Thrombocytopenic coagulation
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.00%
0/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Blood and lymphatic system disorders
Sideroblastic anaemia
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.00%
0/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.06%
2/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.00%
0/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.31%
11/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.20%
7/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Cardiac disorders
Angina pectoris
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.06%
2/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Cardiac disorders
Angina unstable
|
0.08%
3/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.06%
2/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.06%
2/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.00%
0/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.11%
4/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.23%
8/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Cardiac disorders
Atrial tachycardia
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.00%
0/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Cardiac disorders
Bradycardia
|
0.06%
2/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.00%
0/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.06%
2/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Cardiac disorders
Cardiac disorder
|
0.06%
2/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.00%
0/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Cardiac disorders
Cardiac failure
|
0.08%
3/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.11%
4/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.23%
8/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.45%
16/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.08%
3/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Cardiac disorders
Coronary artery disease
|
0.20%
7/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.17%
6/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Cardiac disorders
Dressler's syndrome
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.00%
0/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Cardiac disorders
Hypertensive heart disease
|
0.06%
2/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Cardiac disorders
Hypertrophic cardiomyopathy
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Cardiac disorders
Myocardial infarction
|
0.28%
10/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.25%
9/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Cardiac disorders
Myocardial Ischemia
|
0.08%
3/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.06%
2/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Cardiac disorders
Nodal arrythmia
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.00%
0/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Cardiac disorders
Pericarditis
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.00%
0/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Cardiac disorders
Sinus Tachycardia
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.00%
0/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.06%
2/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.00%
0/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Ear and labyrinth disorders
Vertigo
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.06%
2/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Eye disorders
Blindness unilateral
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Eye disorders
Corneal degeneration
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Eye disorders
Retinal neovascularisation
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Eye disorders
Viterous hemorrhage
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.00%
0/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Gastrointestinal disorders
Abdominal wall hematoma
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Gastrointestinal disorders
Ascites
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.00%
0/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Gastrointestinal disorders
Diverticulum
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.06%
2/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Gastrointestinal disorders
Duodenal ulcer perforation
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Gastrointestinal disorders
Erosive oesophagitis
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.00%
0/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Gastrointestinal disorders
Femoral hernia,obstructive
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.00%
0/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Gastrointestinal disorders
Gastric ulcer perforation
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Gastrointestinal disorders
Gastritis
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.06%
2/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Gastrointestinal disorders
Inguinal hernia, obstructive
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.00%
0/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.00%
0/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.00%
0/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.00%
0/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Gastrointestinal disorders
Pancreatic mass
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.00%
0/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.11%
4/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.00%
0/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.11%
4/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Gastrointestinal disorders
Peptic ulcer perforation
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.00%
0/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Gastrointestinal disorders
Pneumoperitonium
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.11%
4/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.11%
4/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.20%
7/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Gastrointestinal disorders
Volvulus
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.00%
0/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
General disorders
Chest pain
|
0.20%
7/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.08%
3/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
General disorders
Hernia obstructive
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
General disorders
Multi-organ failure
|
0.08%
3/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
General disorders
Non-cardiac chest pain
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
General disorders
Pyrexia
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.06%
2/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.00%
0/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.20%
7/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.06%
2/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.00%
0/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.11%
4/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.11%
4/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Hepatobiliary disorders
Chronic hepatic failure
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.00%
0/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.00%
0/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Immune system disorders
Drug hypersensitivity
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.00%
0/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Infections and infestations
Appendicitis
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.06%
2/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Infections and infestations
Arthritis infective
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Infections and infestations
Bronchitis
|
0.14%
5/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Infections and infestations
Cellulitis
|
0.06%
2/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.08%
3/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Infections and infestations
Cellulitis staphylococcal
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.00%
0/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Infections and infestations
Cystitis
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Infections and infestations
Diverticulitis
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.06%
2/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Infections and infestations
Escherichia sepsis
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.00%
0/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Infections and infestations
Gastroenteritis
|
0.14%
5/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.17%
6/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Infections and infestations
Incision site infection
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Infections and infestations
Infected skin ulcer
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.00%
0/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Infections and infestations
Infectious peritonitis
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Infections and infestations
Laryngitis
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.00%
0/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Infections and infestations
Leptospirosis
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.00%
0/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Infections and infestations
Lobar pneumonia
|
0.06%
2/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Infections and infestations
Meningitis aseptic
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Infections and infestations
Peritonsillar abscess
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Infections and infestations
Pneumonia
|
0.90%
32/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.99%
35/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Infections and infestations
Pneumonia viral
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.00%
0/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Infections and infestations
Pulmonary Tuberculosis
|
0.06%
2/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.06%
2/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Infections and infestations
Sepsis
|
0.08%
3/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.06%
2/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Infections and infestations
Septic shock
|
0.08%
3/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.08%
3/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Infections and infestations
Streptococcal sepsis
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Infections and infestations
Tetanus
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Infections and infestations
Tracheobronchitis
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.00%
0/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Infections and infestations
Tuberculosis
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.00%
0/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.00%
0/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Infections and infestations
Urinary tract infection
|
0.23%
8/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.17%
6/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Infections and infestations
Wound abscess
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Injury, poisoning and procedural complications
Back injury
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.00%
0/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Injury, poisoning and procedural complications
Brain herniation
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.00%
0/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Injury, poisoning and procedural complications
Fall
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.00%
0/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.06%
2/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.08%
3/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.11%
4/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Injury, poisoning and procedural complications
Forearm Fracture
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.08%
3/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Injury, poisoning and procedural complications
Humerus Fracture
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Injury, poisoning and procedural complications
Jaw fracture
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.00%
0/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.00%
0/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Injury, poisoning and procedural complications
Nerve injury
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.00%
0/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Injury, poisoning and procedural complications
Perirenal haematoma
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.00%
0/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Injury, poisoning and procedural complications
Postoperative adhesion
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Injury, poisoning and procedural complications
Seroma
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.00%
0/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Injury, poisoning and procedural complications
Spinal cord injury
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.00%
0/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.00%
0/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Injury, poisoning and procedural complications
Traumatic liver injury
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.06%
2/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.00%
0/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
0.14%
5/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.06%
2/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.06%
2/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.06%
2/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Metabolism and nutrition disorders
Diabetic foot
|
0.06%
2/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.00%
0/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.06%
2/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.06%
2/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.00%
0/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.08%
3/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.00%
0/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.08%
3/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.08%
3/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.08%
3/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.00%
0/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Metabolism and nutrition disorders
Arthropathy
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.00%
0/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.00%
0/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.00%
0/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.08%
3/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.20%
7/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.34%
12/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.00%
0/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.00%
0/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute leukaemia
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.00%
0/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.00%
0/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder adenocarcinoma stage unspecified
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.00%
0/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.06%
2/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.00%
0/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm malignant
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.00%
0/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.08%
3/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer stage II
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.00%
0/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic myeloid leukaemia
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.00%
0/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.06%
2/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal stromal tumor
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.00%
0/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung carcinoma cell type unspecified stage IV
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.00%
0/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung squamous cell carcinoma stage unspecified
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.00%
0/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.00%
0/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.00%
0/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.00%
0/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian adenoma
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Nervous system disorders
Ovarian cancer
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Nervous system disorders
Pancreatic carcinoma
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic neoplasm
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.06%
2/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prolymphocytic leukaemia
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostrate cancer
|
0.06%
2/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.11%
4/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.00%
0/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Sarcoma
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.00%
0/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the cervix
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.06%
2/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.00%
0/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Nervous system disorders
Carotid artery disease
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Nervous system disorders
Cerebellar infraction
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.08%
3/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.06%
2/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Nervous system disorders
Cerebral infraction
|
0.08%
3/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.06%
2/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.11%
4/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.28%
10/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Nervous system disorders
Cerebrovascular disorder
|
0.23%
8/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.08%
3/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Nervous system disorders
Cervical myelopathy
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Nervous system disorders
Cervicobrachial syndrome
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Nervous system disorders
Convulsion
|
0.06%
2/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.00%
0/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Nervous system disorders
Dementia alzheimer's type
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Nervous system disorders
Dementia with lewy bodies
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.00%
0/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Nervous system disorders
Embolic stroke
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Nervous system disorders
Guillain-barre syndrome
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Nervous system disorders
Headcahe
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Nervous system disorders
Hemiplegia
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.00%
0/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Nervous system disorders
Ishaemic stroke
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.08%
3/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Nervous system disorders
Radiculopathy
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.00%
0/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Nervous system disorders
Ruptured cerebral aneurysm
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.00%
0/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Nervous system disorders
Stroke in evolution
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Nervous system disorders
Subarachnoid hemorrhage
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Nervous system disorders
Syncope
|
0.11%
4/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.11%
4/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Nervous system disorders
Transient ischemic attack
|
0.08%
3/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.06%
2/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Nervous system disorders
Vertebrobasilar insufficiency
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Nervous system disorders
VIIth nerve paralysis
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.00%
0/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Nervous system disorders
Confusional state
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Psychiatric disorders
Mental status change
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.00%
0/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Renal and urinary disorders
Azotemia
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.00%
0/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Renal and urinary disorders
Calculus ureteric
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.00%
0/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Renal and urinary disorders
Nephropathy
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.00%
0/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Renal and urinary disorders
Obstructive uropathy
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.00%
0/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Renal and urinary disorders
Renal Failure
|
0.06%
2/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.00%
0/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Renal and urinary disorders
Renal Failure acute
|
0.08%
3/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.06%
2/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Renal and urinary disorders
Renal failure chronic
|
0.06%
2/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.06%
2/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Reproductive system and breast disorders
Endometriosis
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.00%
0/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Reproductive system and breast disorders
Uterovaginal prolapse
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.00%
0/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Respiratory, thoracic and mediastinal disorders
Asthmatic crisis
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.28%
10/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.40%
14/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.06%
2/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.06%
2/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.00%
0/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.00%
0/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.06%
2/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.06%
2/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.00%
0/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.08%
3/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.00%
0/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.00%
0/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.00%
0/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.00%
0/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.06%
2/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.08%
3/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Respiratory, thoracic and mediastinal disorders
Upper airway obstruction
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.00%
0/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Respiratory, thoracic and mediastinal disorders
Angioedema
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.00%
0/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Vascular disorders
Aneurysm ruptured
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Vascular disorders
Aortic aneurysm
|
0.08%
3/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Vascular disorders
Aortic dissection
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Vascular disorders
Arteriosclerosis
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Vascular disorders
Hypertension
|
0.23%
8/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.23%
8/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Vascular disorders
Hypertensive crisis
|
0.11%
4/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.06%
2/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Vascular disorders
Hypotension
|
0.06%
2/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Vascular disorders
Peripheral artery aneurysm
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.03%
1/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Vascular disorders
Varicose ulceration
|
0.03%
1/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
0.00%
0/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
Other adverse events
| Measure |
aTIV (Pooled)
n=3545 participants at risk
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
|
Licensed TIV
n=3537 participants at risk
Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
|
|---|---|---|
|
General disorders
Chills
|
7.3%
258/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
5.0%
176/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
General disorders
Fatigue
|
13.5%
480/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
10.7%
379/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
General disorders
Injection site erythema
|
8.2%
292/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
7.2%
255/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
General disorders
Injection site pain
|
33.1%
1172/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
18.2%
643/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.9%
315/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
8.3%
293/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
15.1%
536/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
10.2%
360/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Nervous system disorders
Headache
|
13.9%
492/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
12.0%
426/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.2%
186/3545 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
4.9%
172/3537 • Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60