Trial Outcomes & Findings for Safety and Immunogenicity of Three Influenza Vaccines Adults Ages 18 and Older (NCT NCT01992094)
NCT ID: NCT01992094
Last Updated: 2015-12-10
Results Overview
Immunogenicity of QIVc to comparator TIVc (For H1N1, H3N2 and B1 strain, the comparison is between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison is between QIVc and TIV2c) was assessed in terms of GMT in subjects measured by hemagglutination inhibition (HI) assay, three weeks after vaccination with one dose of either QIVc or TIV1c and TIV2c. Non-inferiority was established if the upper bound of the two-sided 95% confidence interval (CI) for the ratio of GMTs (GMT TIV1c or TIV2c /GMT QIVc) for HI antibody does not exceed the non-inferiority margin of 1.5.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
2680 participants
Primary outcome timeframe
Three weeks post vaccination (Day 22)
Results posted on
2015-12-10
Participant Flow
Subjects were enrolled from 40 centers in US
All enrolled subjects were included in the trial
Participant milestones
| Measure |
QIVc (≥18 Years)
Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
|
TIV1c (≥18 Years)
Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1,H3N2, B1) recommended for 2013-2014 season
|
TIV2c (≥18 Years)
Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
|
|---|---|---|---|
|
Overall Study
STARTED
|
1335
|
676
|
669
|
|
Overall Study
COMPLETED
|
1285
|
652
|
648
|
|
Overall Study
NOT COMPLETED
|
50
|
24
|
21
|
Reasons for withdrawal
| Measure |
QIVc (≥18 Years)
Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
|
TIV1c (≥18 Years)
Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1,H3N2, B1) recommended for 2013-2014 season
|
TIV2c (≥18 Years)
Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
|
|---|---|---|---|
|
Overall Study
ADMINISTRATIVE REASON
|
6
|
7
|
1
|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
|
Overall Study
Death
|
5
|
5
|
2
|
|
Overall Study
Lost to Follow-up
|
26
|
9
|
13
|
|
Overall Study
OTHER
|
4
|
0
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
7
|
3
|
4
|
Baseline Characteristics
Safety and Immunogenicity of Three Influenza Vaccines Adults Ages 18 and Older
Baseline characteristics by cohort
| Measure |
QIVc (≥18 Years)
n=1335 Participants
Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
|
TIV1c (≥18 Years)
n=676 Participants
Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1,H3N2, B1) recommended for 2013-2014 season
|
TIV2c (≥18 Years)
n=669 Participants
Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
|
Total
n=2680 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
57.4 year
STANDARD_DEVIATION 17.8 • n=5 Participants
|
57.2 year
STANDARD_DEVIATION 18.0 • n=7 Participants
|
57.1 year
STANDARD_DEVIATION 18.1 • n=5 Participants
|
57.3 year
STANDARD_DEVIATION 17.9 • n=4 Participants
|
|
Sex: Female, Male
Female
|
732 Participants
n=5 Participants
|
392 Participants
n=7 Participants
|
392 Participants
n=5 Participants
|
1516 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
603 Participants
n=5 Participants
|
284 Participants
n=7 Participants
|
277 Participants
n=5 Participants
|
1164 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Three weeks post vaccination (Day 22)Population: Analysis was done on Per Protocol (PP) Population i.e. all subjects in the Full Analysis Set (FAS) efficacy/immunogenicity population correctly receive the vaccine, have no major protocol deviations leading to exclusion as defined prior to unblinding/analysis and are not excluded due to other reasons defined prior to unblinding or analysis
Immunogenicity of QIVc to comparator TIVc (For H1N1, H3N2 and B1 strain, the comparison is between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison is between QIVc and TIV2c) was assessed in terms of GMT in subjects measured by hemagglutination inhibition (HI) assay, three weeks after vaccination with one dose of either QIVc or TIV1c and TIV2c. Non-inferiority was established if the upper bound of the two-sided 95% confidence interval (CI) for the ratio of GMTs (GMT TIV1c or TIV2c /GMT QIVc) for HI antibody does not exceed the non-inferiority margin of 1.5.
Outcome measures
| Measure |
QIVc (≥18 Years)
n=1335 Participants
Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
|
TIV1c (≥18 Years)
n=676 Participants
Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
|
TIV2c (≥18 Years)
n=669 Participants
Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
|
TIV1c (≥ 65 Years)
Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1,H3N2, B1)recommended for 2013-2014 season
|
TIV2c (18 to <65 Years)
Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
|
TIV2c (≥ 65 Years)
Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
|
|---|---|---|---|---|---|---|
|
1.Geometric Mean Titres (GMT) in Subjects After Receiving One Dose of Either QIVc, TIV1c or TIV2c
H3N2: Day 22(N=1250,635,NA)
|
372.3 Titer
Interval 349.2 to 396.9
|
378.4 Titer
Interval 345.1 to 414.8
|
NA Titer
antigen not immunized
|
—
|
—
|
—
|
|
1.Geometric Mean Titres (GMT) in Subjects After Receiving One Dose of Either QIVc, TIV1c or TIV2c
B2:Day 1(N=1250,NA,639)
|
59.2 Titer
Interval 56.0 to 62.7
|
NA Titer
antigen not immunized
|
58.0 Titer
Interval 53.4 to 63.0
|
—
|
—
|
—
|
|
1.Geometric Mean Titres (GMT) in Subjects After Receiving One Dose of Either QIVc, TIV1c or TIV2c
B2:Day 22(N=1250,NA,639)
|
177.2 Titer
Interval 167.6 to 187.5
|
NA Titer
antigen not immunized
|
164.0 Titer
Interval 151.4 to 177.7
|
—
|
—
|
—
|
|
1.Geometric Mean Titres (GMT) in Subjects After Receiving One Dose of Either QIVc, TIV1c or TIV2c
H1N1: Day 1(N=1250,635,NA)
|
60.7 Titer
Interval 56.0 to 65.9
|
59.6 Titer
Interval 53.0 to 67.0
|
NA Titer
antigen not immunized
|
—
|
—
|
—
|
|
1.Geometric Mean Titres (GMT) in Subjects After Receiving One Dose of Either QIVc, TIV1c or TIV2c
H1N1: Day 22(N=1250,635,NA)
|
302.8 Titer
Interval 281.8 to 325.5
|
298.9 Titer
Interval 270.3 to 330.5
|
NA Titer
antigen not immunized
|
—
|
—
|
—
|
|
1.Geometric Mean Titres (GMT) in Subjects After Receiving One Dose of Either QIVc, TIV1c or TIV2c
H3N2: Day 1(N=1250,635,NA)
|
122.5 Titer
Interval 112.7 to 133.1
|
128.1 Titer
Interval 113.6 to 144.6
|
NA Titer
antigen not immunized
|
—
|
—
|
—
|
|
1.Geometric Mean Titres (GMT) in Subjects After Receiving One Dose of Either QIVc, TIV1c or TIV2c
B1:Day 1(N=1250,635,NA)
|
45.3 Titer
Interval 42.6 to 48.1
|
43.8 Titer
Interval 40.2 to 47.7
|
NA Titer
antigen not immunized
|
—
|
—
|
—
|
|
1.Geometric Mean Titres (GMT) in Subjects After Receiving One Dose of Either QIVc, TIV1c or TIV2c
B1:Day 22(N=1250,635,NA)
|
133.2 Titer
Interval 125.3 to 141.7
|
115.6 Titer
Interval 106.4 to 125.6
|
NA Titer
antigen not immunized
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Three weeks post vaccination (Day 22)Population: Analysis was done on PP population
Immunogenicity of QIVc to comparator TIVc (For H1N1, H3N2 and B1 strain, the comparison is between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison is between QIVc and TIV2c) was assessed in terms of percentages of subjects showing seroconversion or significant increase in HI antibody titers, three weeks (day 22) after vaccination with one dose of either QIVc,TIV1c or TIV2c Seroconversion is defined in subjects seronegative at baseline (i.e., HI titer \<1:10 at Day 1) as post-vaccination HI titer ≥1:40, and defined in subjects sero-positive at baseline (i.e., HI titer ≥1:10 at Day 1) as a minimum of a 4-fold increase in post-vaccination HI titer
Outcome measures
| Measure |
QIVc (≥18 Years)
n=1335 Participants
Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
|
TIV1c (≥18 Years)
n=676 Participants
Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
|
TIV2c (≥18 Years)
n=669 Participants
Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
|
TIV1c (≥ 65 Years)
Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1,H3N2, B1)recommended for 2013-2014 season
|
TIV2c (18 to <65 Years)
Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
|
TIV2c (≥ 65 Years)
Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
|
|---|---|---|---|---|---|---|
|
2. Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV1c or TIV2c
H3N2: Day 22(N=1250, 635,NA)
|
38.3 percentage of subjects
Interval 35.6 to 41.1
|
35.6 percentage of subjects
Interval 31.9 to 39.5
|
NA percentage of subjects
antigen not immunized
|
—
|
—
|
—
|
|
2. Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV1c or TIV2c
B1: Day 22(N=1250, 635,NA)
|
36.6 percentage of subjects
Interval 33.9 to 39.3
|
34.8 percentage of subjects
Interval 31.1 to 38.7
|
NA percentage of subjects
antigen not immunized
|
—
|
—
|
—
|
|
2. Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV1c or TIV2c
H1N1: Day 22(N=1250, 635,NA)
|
49.2 percentage of subjects
Interval 46.4 to 52.0
|
48.7 percentage of subjects
Interval 44.7 to 52.6
|
NA percentage of subjects
antigen not immunized
|
—
|
—
|
—
|
|
2. Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV1c or TIV2c
B2: Day 22(N=1250,NA, 639)
|
39.8 percentage of subjects
Interval 37.0 to 42.5
|
NA percentage of subjects
antigen not immunized
|
35.4 percentage of subjects
Interval 31.7 to 39.2
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Three weeks post vaccination (Day 22)Population: Analysis was done on FAS immunogenicity set i.e. all subjects in the enrolled set who receive the study vaccination and provide immunogenicity data at visit 1 and visit 2
Immunogenicity was assessed in terms of percentages of subjects showing seroconversion or significant increase in HI antibody titers, against each vaccine strains, three weeks (day 22) after vaccination with ether QIVc, TIV1c or TIV2c Seroconversion is defined in subjects seronegative at baseline (i.e., HI titer \<1:10 at Day 1) as post-vaccination HI titer ≥1:40, and defined in subjects sero-positive at baseline (i.e., HI titer ≥1:10 at Day 1) as a minimum of a 4-fold increase in post-vaccination HI titer.The CBER criterion for 18 to \<65 years age group is that the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroconversion for HI antibody should meet or exceed 40% and that for the ≥ 65 years age group should meet or exceed 30%
Outcome measures
| Measure |
QIVc (≥18 Years)
n=661 Participants
Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
|
TIV1c (≥18 Years)
n=650 Participants
Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
|
TIV2c (≥18 Years)
n=328 Participants
Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
|
TIV1c (≥ 65 Years)
n=336 Participants
Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1,H3N2, B1)recommended for 2013-2014 season
|
TIV2c (18 to <65 Years)
n=326 Participants
Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
|
TIV2c (≥ 65 Years)
n=332 Participants
Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
|
|---|---|---|---|---|---|---|
|
3. Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV1c or TIV2c in 18 to <65 and ≥ 65 Years Age Cohorts
H3N2: Day 22(N=661, 650, 328, 336,NA,NA)
|
49.2 percentages of subjects
Interval 45.3 to 53.1
|
27.2 percentages of subjects
Interval 23.8 to 30.8
|
47.3 percentages of subjects
Interval 41.7 to 52.8
|
24.7 percentages of subjects
Interval 20.2 to 29.7
|
NA percentages of subjects
antigen not immunized
|
NA percentages of subjects
antigen not immunized
|
|
3. Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV1c or TIV2c in 18 to <65 and ≥ 65 Years Age Cohorts
B1: Day 22(N=661, 650, 328, 336,NA,NA)
|
52.0 percentages of subjects
Interval 48.2 to 55.9
|
20.9 percentages of subjects
Interval 17.9 to 24.3
|
50.3 percentages of subjects
Interval 44.8 to 55.8
|
19.3 percentages of subjects
Interval 15.3 to 24.0
|
NA percentages of subjects
antigen not immunized
|
NA percentages of subjects
antigen not immunized
|
|
3. Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV1c or TIV2c in 18 to <65 and ≥ 65 Years Age Cohorts
B2: Day 22(N=661, 650,NA,NA, 326, 332)
|
52.8 percentages of subjects
Interval 48.9 to 56.7
|
26.3 percentages of subjects
Interval 23.0 to 29.9
|
NA percentages of subjects
antigen not immunized
|
NA percentages of subjects
antigen not immunized
|
50.3 percentages of subjects
Interval 44.7 to 55.9
|
20.8 percentages of subjects
Interval 16.5 to 25.6
|
|
3. Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV1c or TIV2c in 18 to <65 and ≥ 65 Years Age Cohorts
H1N1: Day 22(N=661, 650, 328, 336,NA,NA)
|
63.1 percentages of subjects
Interval 59.3 to 66.8
|
34.5 percentages of subjects
Interval 30.8 to 38.3
|
60.4 percentages of subjects
Interval 54.8 to 65.7
|
36.9 percentages of subjects
Interval 31.7 to 42.3
|
NA percentages of subjects
antigen not immunized
|
NA percentages of subjects
antigen not immunized
|
SECONDARY outcome
Timeframe: Three weeks post vaccination (Day 22)Population: Analysis was done on FAS immunogenicity set.
Immunogenicity was assessed in terms of percentages of subjects showing HI titer ≥1:40, three weeks (day 22) after vaccination with either QIVc, TIV1c or TIV2c The CBER criterion for 18 to \<65 years age group is that the lower bound of the two-sided 95% CI for the percentage of subjects achieving an HI antibody titer ≥ 1:40 should meet or exceed 70% and that for the ≥ 65 years age group should meet or exceed 60%
Outcome measures
| Measure |
QIVc (≥18 Years)
n=661 Participants
Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
|
TIV1c (≥18 Years)
n=650 Participants
Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
|
TIV2c (≥18 Years)
n=328 Participants
Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
|
TIV1c (≥ 65 Years)
n=336 Participants
Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1,H3N2, B1)recommended for 2013-2014 season
|
TIV2c (18 to <65 Years)
n=326 Participants
Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
|
TIV2c (≥ 65 Years)
n=332 Participants
Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
|
|---|---|---|---|---|---|---|
|
4. Percentages of Subjects Achieving HI Titer ≥1:40 After One Dose of Either QIVc, TIV1c or TIV2c in 18 to <65 and ≥ 65 Years Age-cohorts
H3N2: Day 1(N=661, 650, 328, 336,NA,NA)
|
78.2 percentages of subjects
Interval 74.9 to 81.3
|
89.5 percentages of subjects
Interval 86.9 to 91.8
|
80.5 percentages of subjects
Interval 75.8 to 84.6
|
88.4 percentages of subjects
Interval 84.5 to 91.6
|
NA percentages of subjects
antigen not immunized
|
NA percentages of subjects
antigen not immunized
|
|
4. Percentages of Subjects Achieving HI Titer ≥1:40 After One Dose of Either QIVc, TIV1c or TIV2c in 18 to <65 and ≥ 65 Years Age-cohorts
B1: Day 1(N=661, 650, 328, 336,NA,NA)
|
64.6 percentages of subjects
Interval 60.8 to 68.2
|
72.3 percentages of subjects
Interval 68.7 to 75.7
|
62.8 percentages of subjects
Interval 57.3 to 68.1
|
67.9 percentages of subjects
Interval 62.6 to 72.8
|
NA percentages of subjects
antigen not immunized
|
NA percentages of subjects
antigen not immunized
|
|
4. Percentages of Subjects Achieving HI Titer ≥1:40 After One Dose of Either QIVc, TIV1c or TIV2c in 18 to <65 and ≥ 65 Years Age-cohorts
B1: Day 22(N=661, 650, 328, 336,NA,NA)
|
95.6 percentages of subjects
Interval 93.8 to 97.0
|
92.2 percentages of subjects
Interval 89.8 to 94.1
|
95.7 percentages of subjects
Interval 92.9 to 97.6
|
87.8 percentages of subjects
Interval 83.8 to 91.1
|
NA percentages of subjects
antigen not immunized
|
NA percentages of subjects
antigen not immunized
|
|
4. Percentages of Subjects Achieving HI Titer ≥1:40 After One Dose of Either QIVc, TIV1c or TIV2c in 18 to <65 and ≥ 65 Years Age-cohorts
B2: Day 1(N=661, 650,NA,NA, 326, 332)
|
74.9 percentages of subjects
Interval 71.4 to 78.2
|
81.2 percentages of subjects
Interval 78.0 to 84.2
|
NA percentages of subjects
antigen not immunized
|
NA percentages of subjects
antigen not immunized
|
73.3 percentages of subjects
Interval 68.2 to 78.0
|
81.0 percentages of subjects
Interval 76.4 to 85.1
|
|
4. Percentages of Subjects Achieving HI Titer ≥1:40 After One Dose of Either QIVc, TIV1c or TIV2c in 18 to <65 and ≥ 65 Years Age-cohorts
H1N1: Day 1(N=661, 650, 328, 336,NA,NA)
|
63.8 percentages of subjects
Interval 60.0 to 67.5
|
79.2 percentages of subjects
Interval 75.9 to 82.3
|
64.6 percentages of subjects
Interval 59.2 to 69.8
|
76.5 percentages of subjects
Interval 71.6 to 80.9
|
NA percentages of subjects
antigen not immunized
|
NA percentages of subjects
antigen not immunized
|
|
4. Percentages of Subjects Achieving HI Titer ≥1:40 After One Dose of Either QIVc, TIV1c or TIV2c in 18 to <65 and ≥ 65 Years Age-cohorts
H1N1: Day 22(N=661, 650, 328, 336,NA,NA)
|
98.5 percentages of subjects
Interval 97.2 to 99.3
|
94.3 percentages of subjects
Interval 92.2 to 96.0
|
97.0 percentages of subjects
Interval 94.5 to 98.5
|
96.1 percentages of subjects
Interval 93.5 to 97.9
|
NA percentages of subjects
antigen not immunized
|
NA percentages of subjects
antigen not immunized
|
|
4. Percentages of Subjects Achieving HI Titer ≥1:40 After One Dose of Either QIVc, TIV1c or TIV2c in 18 to <65 and ≥ 65 Years Age-cohorts
H3N2: Day 22(N=661, 650, 328, 336,NA,NA)
|
98.6 percentages of subjects
Interval 97.4 to 99.4
|
98.3 percentages of subjects
Interval 97.0 to 99.2
|
99.1 percentages of subjects
Interval 97.4 to 99.8
|
98.2 percentages of subjects
Interval 96.2 to 99.3
|
NA percentages of subjects
antigen not immunized
|
NA percentages of subjects
antigen not immunized
|
|
4. Percentages of Subjects Achieving HI Titer ≥1:40 After One Dose of Either QIVc, TIV1c or TIV2c in 18 to <65 and ≥ 65 Years Age-cohorts
B2: Day 22(N=661, 650,NA,NA, 326, 332)
|
99.1 percentages of subjects
Interval 98.0 to 99.7
|
96.2 percentages of subjects
Interval 94.4 to 97.5
|
NA percentages of subjects
antigen not immunized
|
NA percentages of subjects
antigen not immunized
|
98.8 percentages of subjects
Interval 96.9 to 99.7
|
95.2 percentages of subjects
Interval 92.3 to 97.2
|
SECONDARY outcome
Timeframe: Three weeks post vaccination (Day 22)Population: Analysis was done on FAS immunogenicity set.
Immunogenicity was measured as the geometric mean ratio (GMR). The ratio of post-vaccination to pre-vaccination HI GMTs, three weeks (day 22) after vaccination with either QIVc, TIV1c or TIV2c Committee for Medicinal Products for Human Use (CHMP) criterion for 18 to ≤60 years age group is \>2.5 and that for ≥ 61 years age group is \>2.0
Outcome measures
| Measure |
QIVc (≥18 Years)
n=606 Participants
Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
|
TIV1c (≥18 Years)
n=705 Participants
Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
|
TIV2c (≥18 Years)
n=306 Participants
Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
|
TIV1c (≥ 65 Years)
n=358 Participants
Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1,H3N2, B1)recommended for 2013-2014 season
|
TIV2c (18 to <65 Years)
n=297 Participants
Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
|
TIV2c (≥ 65 Years)
n=361 Participants
Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
|
|---|---|---|---|---|---|---|
|
5.Geometric Mean Ratios (GMR) in Subjects After One Dose of Either QIVc, TIV1c or TIV2c in 18 to ≤60 Years and ≥ 61 Years Age Cohorts
B2 (Day 22/Day1)(N=606,705,NA,NA,297,361)
|
4.3 Ratio
Interval 3.9 to 4.8
|
2.2 Ratio
Interval 2.0 to 2.3
|
NA Ratio
antigen not immunized
|
NA Ratio
antigen not immunized
|
4.1 Ratio
Interval 3.5 to 4.7
|
2.1 Ratio
Interval 1.9 to 2.3
|
|
5.Geometric Mean Ratios (GMR) in Subjects After One Dose of Either QIVc, TIV1c or TIV2c in 18 to ≤60 Years and ≥ 61 Years Age Cohorts
A/H1N1(Day 22/Day1)(N=606,705,306,358,NA,NA)
|
9.2 Ratio
Interval 8.0 to 10.6
|
3.0 Ratio
Interval 2.7 to 3.2
|
9.1 Ratio
Interval 7.5 to 11.1
|
3.0 Ratio
Interval 2.7 to 3.4
|
NA Ratio
antigen not immunized
|
NA Ratio
antigen not immunized
|
|
5.Geometric Mean Ratios (GMR) in Subjects After One Dose of Either QIVc, TIV1c or TIV2c in 18 to ≤60 Years and ≥ 61 Years Age Cohorts
A/H3N2 (Day 22/Day1)(N=606,705,306,358,NA,NA)
|
4.2 Ratio
Interval 3.8 to 4.7
|
2.3 Ratio
Interval 2.1 to 2.5
|
4.2 Ratio
Interval 3.6 to 4.9
|
2.2 Ratio
Interval 2.0 to 2.5
|
NA Ratio
antigen not immunized
|
NA Ratio
antigen not immunized
|
|
5.Geometric Mean Ratios (GMR) in Subjects After One Dose of Either QIVc, TIV1c or TIV2c in 18 to ≤60 Years and ≥ 61 Years Age Cohorts
B1 (Day 22/Day1)(N=606,705,306,358,NA,NA)
|
4.5 Ratio
Interval 4.0 to 5.0
|
2.1 Ratio
Interval 1.9 to 2.2
|
4.1 Ratio
Interval 3.5 to 4.8
|
1.8 Ratio
Interval 1.7 to 2.0
|
NA Ratio
antigen not immunized
|
NA Ratio
antigen not immunized
|
SECONDARY outcome
Timeframe: Three weeks post vaccination (Day 22)Population: Analysis was done on FAS immunogenicity set.
Immunogenicity was assessed in terms of percentages of subjects showing seroconversion or significant increase in HI antibody titers, three weeks (day 22) after vaccination with either QIVc, TIV1c or TIV2c Seroconversion is defined in subjects seronegative at baseline (i.e., HI titer \<1:10 at Day 1) as post-vaccination HI titer ≥1:40, and defined in subjects sero-positive at baseline (i.e., HI titer ≥1:10 at Day 1) as a minimum of a 4-fold increase in post-vaccination HI titer The CHMP criterion for 18 to ≤60 years age group is that the percentage of subjects achieving seroconversion or significant increase in HI titer is \>40% and that for ≥ 61 years age group is \>30%
Outcome measures
| Measure |
QIVc (≥18 Years)
n=606 Participants
Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
|
TIV1c (≥18 Years)
n=705 Participants
Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
|
TIV2c (≥18 Years)
n=306 Participants
Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
|
TIV1c (≥ 65 Years)
n=358 Participants
Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1,H3N2, B1)recommended for 2013-2014 season
|
TIV2c (18 to <65 Years)
n=297 Participants
Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
|
TIV2c (≥ 65 Years)
n=361 Participants
Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
|
|---|---|---|---|---|---|---|
|
6. Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV1c or TIV2c in 18 to ≤60 Years and ≥ 61 Years Age Cohorts
H1N1: Day 22(N=606,705,306,358,NA,NA)
|
63.5 percentages of subjects
Interval 59.6 to 67.4
|
36.3 percentages of subjects
Interval 32.8 to 40.4
|
62.1 percentages of subjects
Interval 56.4 to 67.6
|
36.9 percentages of subjects
Interval 31.9 to 42.1
|
NA percentages of subjects
antigen not immunized
|
NA percentages of subjects
antigen not immunized
|
|
6. Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV1c or TIV2c in 18 to ≤60 Years and ≥ 61 Years Age Cohorts
H3N2: Day 22(N=606,705,306,358,NA,NA)
|
49.8 percentages of subjects
Interval 45.8 to 53.9
|
28.4 percentages of subjects
Interval 25.1 to 31.9
|
48.7 percentages of subjects
Interval 43.0 to 54.4
|
24.9 percentages of subjects
Interval 20.5 to 29.7
|
NA percentages of subjects
antigen not immunized
|
NA percentages of subjects
antigen not immunized
|
|
6. Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV1c or TIV2c in 18 to ≤60 Years and ≥ 61 Years Age Cohorts
B1: Day 22(N=606,705,306,358,NA,NA)
|
53.3 percentages of subjects
Interval 49.2 to 57.3
|
22.3 percentages of subjects
Interval 19.2 to 25.5
|
52.3 percentages of subjects
Interval 46.5 to 58.0
|
19.6 percentages of subjects
Interval 15.6 to 24.0
|
NA percentages of subjects
antigen not immunized
|
NA percentages of subjects
antigen not immunized
|
|
6. Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV1c or TIV2c in 18 to ≤60 Years and ≥ 61 Years Age Cohorts
B2: Day 22(N=606,705,NA,NA,297,361)
|
53.8 percentages of subjects
Interval 49.7 to 57.8
|
27.5 percentages of subjects
Interval 24.3 to 31.0
|
NA percentages of subjects
antigen not immunized
|
NA percentages of subjects
antigen not immunized
|
51.2 percentages of subjects
Interval 45.3 to 57.0
|
22.4 percentages of subjects
Interval 18.2 to 27.1
|
SECONDARY outcome
Timeframe: Three weeks post vaccination (Day 22)Population: Analysis was done on FAS immunogenicity set.
Immunogenicity was assessed in terms of percentages of subjects showing HI titer ≥1:40, three weeks (day 22) after vaccination with either QIVc, TIV1c and TIV2c The CHMP criterion for 18 to ≤60 years age group is that the percentage of subjects achieving an HI titer ≥1:40 is \>70% and that for ≥ 61 years age group is \>60%
Outcome measures
| Measure |
QIVc (≥18 Years)
n=606 Participants
Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
|
TIV1c (≥18 Years)
n=705 Participants
Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
|
TIV2c (≥18 Years)
n=306 Participants
Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
|
TIV1c (≥ 65 Years)
n=358 Participants
Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1,H3N2, B1)recommended for 2013-2014 season
|
TIV2c (18 to <65 Years)
n=297 Participants
Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
|
TIV2c (≥ 65 Years)
n=361 Participants
Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
|
|---|---|---|---|---|---|---|
|
7. Percentages of Subjects Achieving HI Titer ≥1:40 After One Dose of Either QIVc, TIV1c or TIV2c in 18 to ≤60 Years and ≥ 61 Years Age Cohorts
H1N1: Day 1(N=606,705,306,358,NA,NA)
|
64.4 percentages of subjects
Interval 60.4 to 68.2
|
77.6 percentages of subjects
Interval 74.3 to 80.6
|
65.0 percentages of subjects
Interval 59.4 to 70.4
|
75.4 percentages of subjects
Interval 70.6 to 79.8
|
NA percentages of subjects
antigen not immunized
|
NA percentages of subjects
Interval 0.0 to 0.0
antigen not immunized
|
|
7. Percentages of Subjects Achieving HI Titer ≥1:40 After One Dose of Either QIVc, TIV1c or TIV2c in 18 to ≤60 Years and ≥ 61 Years Age Cohorts
H3N2: Day 22(N=606,705,306,358,NA,NA)
|
98.7 percentages of subjects
Interval 97.4 to 99.4
|
98.3 percentages of subjects
Interval 97.0 to 99.1
|
99.0 percentages of subjects
Interval 97.2 to 99.8
|
98.3 percentages of subjects
Interval 96.4 to 99.4
|
NA percentages of subjects
antigen not immunized
|
NA percentages of subjects
antigen not immunized
|
|
7. Percentages of Subjects Achieving HI Titer ≥1:40 After One Dose of Either QIVc, TIV1c or TIV2c in 18 to ≤60 Years and ≥ 61 Years Age Cohorts
B1: Day 1(N=606,705,306,358,NA,NA)
|
65.5 percentages of subjects
Interval 61.6 to 69.3
|
70.9 percentages of subjects
Interval 67.4 to 74.3
|
62.4 percentages of subjects
Interval 56.7 to 67.9
|
67.9 percentages of subjects
Interval 62.8 to 72.7
|
NA percentages of subjects
antigen not immunized
|
NA percentages of subjects
antigen not immunized
|
|
7. Percentages of Subjects Achieving HI Titer ≥1:40 After One Dose of Either QIVc, TIV1c or TIV2c in 18 to ≤60 Years and ≥ 61 Years Age Cohorts
B2: Day 1(N=606,705,NA,NA,297,361)
|
73.8 percentages of subjects
Interval 70.1 to 77.2
|
81.7 percentages of subjects
Interval 78.6 to 84.5
|
NA percentages of subjects
antigen not immunized
|
NA percentages of subjects
antigen not immunized
|
72.7 percentages of subjects
Interval 67.3 to 77.7
|
80.9 percentages of subjects
Interval 76.4 to 84.8
|
|
7. Percentages of Subjects Achieving HI Titer ≥1:40 After One Dose of Either QIVc, TIV1c or TIV2c in 18 to ≤60 Years and ≥ 61 Years Age Cohorts
B1: Day 22(N=606,705,306,358,NA,NA)
|
96.4 percentages of subjects
Interval 94.6 to 97.7
|
91.8 percentages of subjects
Interval 89.5 to 93.7
|
96.4 percentages of subjects
Interval 93.7 to 98.2
|
87.7 percentages of subjects
Interval 83.9 to 90.9
|
NA percentages of subjects
antigen not immunized
|
NA percentages of subjects
antigen not immunized
|
|
7. Percentages of Subjects Achieving HI Titer ≥1:40 After One Dose of Either QIVc, TIV1c or TIV2c in 18 to ≤60 Years and ≥ 61 Years Age Cohorts
H1N1: Day 22(N=606,705,306,358,NA,NA)
|
98.3 percentages of subjects
Interval 97.0 to 99.2
|
94.8 percentages of subjects
Interval 92.8 to 96.3
|
97.4 percentages of subjects
Interval 94.9 to 98.9
|
95.8 percentages of subjects
Interval 93.2 to 97.6
|
NA percentages of subjects
antigen not immunized
|
NA percentages of subjects
antigen not immunized
|
|
7. Percentages of Subjects Achieving HI Titer ≥1:40 After One Dose of Either QIVc, TIV1c or TIV2c in 18 to ≤60 Years and ≥ 61 Years Age Cohorts
H3N2: Day 1(N=606,705,306,358,NA,NA)
|
77.6 percentages of subjects
Interval 74.0 to 80.8
|
89.2 percentages of subjects
Interval 86.7 to 91.4
|
80.4 percentages of subjects
Interval 75.5 to 84.7
|
88.0 percentages of subjects
Interval 84.2 to 91.2
|
NA percentages of subjects
antigen not immunized
|
NA percentages of subjects
antigen not immunized
|
|
7. Percentages of Subjects Achieving HI Titer ≥1:40 After One Dose of Either QIVc, TIV1c or TIV2c in 18 to ≤60 Years and ≥ 61 Years Age Cohorts
B2: Day 22(N=606,705,NA,NA,297,361)
|
99.3 percentages of subjects
Interval 98.3 to 99.8
|
96.2 percentages of subjects
Interval 94.5 to 97.5
|
NA percentages of subjects
antigen not immunized
|
NA percentages of subjects
antigen not immunized
|
99.0 percentages of subjects
Interval 97.1 to 99.8
|
95.3 percentages of subjects
Interval 92.6 to 97.2
|
SECONDARY outcome
Timeframe: Three weeks post vaccination (Day 22)Population: Analysis was done on FAS population
Immunogenicity of QIVc to TIV1c was assessed by GMT in subjects measured by HI assay, three weeks after vaccination with one dose of either QIVc or TIV1c. Superiority was established if the upper bound of the two-sided 95% CI for the ratio of GMTs (GMT TIV1c /GMT QIVc) for HI antibody does not exceed the superiority margin of 1.
Outcome measures
| Measure |
QIVc (≥18 Years)
n=1311 Participants
Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
|
TIV1c (≥18 Years)
n=664 Participants
Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
|
TIV2c (≥18 Years)
Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
|
TIV1c (≥ 65 Years)
Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1,H3N2, B1)recommended for 2013-2014 season
|
TIV2c (18 to <65 Years)
Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
|
TIV2c (≥ 65 Years)
Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
|
|---|---|---|---|---|---|---|
|
8.Geometric Mean Titres (GMT) in Subjects After Receiving One Dose of Either QIVc, TIV1c Against B2 Strain
Day 1(N=1311,664)
|
45.9 Titers
Interval 43.3 to 48.8
|
55.7 Titers
Interval 51.6 to 60.2
|
—
|
—
|
—
|
—
|
|
8.Geometric Mean Titres (GMT) in Subjects After Receiving One Dose of Either QIVc, TIV1c Against B2 Strain
Day 22(N=1311,664)
|
135.4 Titers
Interval 127.6 to 143.7
|
91.7 Titers
Interval 85.7 to 98.2
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Three weeks post vaccination (Day 22)Population: Analysis was done on FAS population
Immunogenicity of QIVc to TIV1c was assessed in terms of percentages of subjects showing seroconversion or significant increase in HI antibody titers, against influenza strain B2, three weeks (day 22) after vaccination with QIVc or TIV1c Superiority was established if the upper bound of the two-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV1c - % seroconversion QIVc) for HI antibody in ≥ 18 years age group does not exceed the margin of 0 points
Outcome measures
| Measure |
QIVc (≥18 Years)
n=1311 Participants
Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
|
TIV1c (≥18 Years)
n=664 Participants
Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
|
TIV2c (≥18 Years)
Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
|
TIV1c (≥ 65 Years)
Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1,H3N2, B1)recommended for 2013-2014 season
|
TIV2c (18 to <65 Years)
Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
|
TIV2c (≥ 65 Years)
Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
|
|---|---|---|---|---|---|---|
|
9.Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV1c Against B2 Strain
|
36.6 percentages of subjects
Interval 34.0 to 39.3
|
17.2 percentages of subjects
Interval 14.4 to 20.3
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Three weeks post vaccination (Day 22)Population: Analysis was done on FAS population
Immunogenicity of QIVc to TIV2c was assessed by GMT in subjects measured by HI assay, three weeks after vaccination with one dose of either QIVc or TIV2c. Superiority was established if the upper bound of the two-sided 95% CI for the ratio of GMTs (GMT TIV2c /GMT QIVc) for HI antibody does not exceed the superiority margin of 1
Outcome measures
| Measure |
QIVc (≥18 Years)
n=1311 Participants
Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
|
TIV1c (≥18 Years)
n=658 Participants
Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
|
TIV2c (≥18 Years)
Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
|
TIV1c (≥ 65 Years)
Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1,H3N2, B1)recommended for 2013-2014 season
|
TIV2c (18 to <65 Years)
Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
|
TIV2c (≥ 65 Years)
Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
|
|---|---|---|---|---|---|---|
|
10.GMT in Subjects After Receiving One Dose of Either QIVc, TIV2c Against B1 Strain
Day 1(N=1311,658)
|
59.7 Titers
Interval 56.4 to 63.0
|
43.8 Titers
Interval 40.3 to 47.6
|
—
|
—
|
—
|
—
|
|
10.GMT in Subjects After Receiving One Dose of Either QIVc, TIV2c Against B1 Strain
Day 22(N=1311,657)
|
177.1 Titers
Interval 167.8 to 187.1
|
76.3 Titers
Interval 70.4 to 82.7
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Three weeks post vaccination (Day 22)Population: Analysis was done on FAS population
Immunogenicity of QIVc to TIV2c in terms of percentages of subjects showing seroconversion or significant increase in HI antibody titers, against influenza strain B1, three weeks (day 22) after vaccination with QIVc or TIV2c Superiority was established if the upper bound of the two-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV2c - % seroconversion QIVc) for HI antibody in ≥ 18 years age group does not exceed the margin of 0 points
Outcome measures
| Measure |
QIVc (≥18 Years)
n=1311 Participants
Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
|
TIV1c (≥18 Years)
n=657 Participants
Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
|
TIV2c (≥18 Years)
Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
|
TIV1c (≥ 65 Years)
Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1,H3N2, B1)recommended for 2013-2014 season
|
TIV2c (18 to <65 Years)
Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
|
TIV2c (≥ 65 Years)
Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
|
|---|---|---|---|---|---|---|
|
11.Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV2c Against B1 Strain
|
39.7 percentages of subjects
Interval 37.0 to 42.4
|
18.0 percentages of subjects
Interval 15.1 to 21.1
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 to 7 post vaccinationPopulation: Analysis was done on solicited safety data set i.e. all subjects in the exposed set with solicited adverse event data
Safety was assessed in terms of number (%) of subjects reporting solicited local and systemic reactions, day 1 to 7 after vaccination with one dose of either four (4) strain inactivated quadrivalent cell based influenza vaccine (QIVc) or trivalent inactivated influenza vaccine (TIV1c or TIV2c)
Outcome measures
| Measure |
QIVc (≥18 Years)
n=1319 Participants
Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
|
TIV1c (≥18 Years)
n=670 Participants
Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
|
TIV2c (≥18 Years)
n=663 Participants
Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
|
TIV1c (≥ 65 Years)
Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1,H3N2, B1)recommended for 2013-2014 season
|
TIV2c (18 to <65 Years)
Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
|
TIV2c (≥ 65 Years)
Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
|
|---|---|---|---|---|---|---|
|
12.Number of Subjects Reporting Solicited Adverse Events (AEs) After One Dose of Either QIVc, TIV1c or TIV2c by Overall Age Group
Any local
|
551 Subjects
|
240 Subjects
|
242 Subjects
|
—
|
—
|
—
|
|
12.Number of Subjects Reporting Solicited Adverse Events (AEs) After One Dose of Either QIVc, TIV1c or TIV2c by Overall Age Group
Injection site ecchymosis(bruising)
|
56 Subjects
|
26 Subjects
|
35 Subjects
|
—
|
—
|
—
|
|
12.Number of Subjects Reporting Solicited Adverse Events (AEs) After One Dose of Either QIVc, TIV1c or TIV2c by Overall Age Group
Vomiting
|
23 Subjects
|
6 Subjects
|
5 Subjects
|
—
|
—
|
—
|
|
12.Number of Subjects Reporting Solicited Adverse Events (AEs) After One Dose of Either QIVc, TIV1c or TIV2c by Overall Age Group
Use of analgesics / antipyretics for prophylasis
|
6 Subjects
|
2 Subjects
|
1 Subjects
|
—
|
—
|
—
|
|
12.Number of Subjects Reporting Solicited Adverse Events (AEs) After One Dose of Either QIVc, TIV1c or TIV2c by Overall Age Group
Injection site induration(hardness)
|
134 Subjects
|
55 Subjects
|
60 Subjects
|
—
|
—
|
—
|
|
12.Number of Subjects Reporting Solicited Adverse Events (AEs) After One Dose of Either QIVc, TIV1c or TIV2c by Overall Age Group
Injection site erythema (redness)
|
167 Subjects
|
80 Subjects
|
68 Subjects
|
—
|
—
|
—
|
|
12.Number of Subjects Reporting Solicited Adverse Events (AEs) After One Dose of Either QIVc, TIV1c or TIV2c by Overall Age Group
Injection site pain
|
443 Subjects
|
186 Subjects
|
195 Subjects
|
—
|
—
|
—
|
|
12.Number of Subjects Reporting Solicited Adverse Events (AEs) After One Dose of Either QIVc, TIV1c or TIV2c by Overall Age Group
Any systemic
|
376 Subjects
|
192 Subjects
|
194 Subjects
|
—
|
—
|
—
|
|
12.Number of Subjects Reporting Solicited Adverse Events (AEs) After One Dose of Either QIVc, TIV1c or TIV2c by Overall Age Group
Chills
|
70 Subjects
|
35 Subjects
|
36 Subjects
|
—
|
—
|
—
|
|
12.Number of Subjects Reporting Solicited Adverse Events (AEs) After One Dose of Either QIVc, TIV1c or TIV2c by Overall Age Group
Nausea
|
89 Subjects
|
38 Subjects
|
43 Subjects
|
—
|
—
|
—
|
|
12.Number of Subjects Reporting Solicited Adverse Events (AEs) After One Dose of Either QIVc, TIV1c or TIV2c by Overall Age Group
Myalgia
|
156 Subjects
|
80 Subjects
|
77 Subjects
|
—
|
—
|
—
|
|
12.Number of Subjects Reporting Solicited Adverse Events (AEs) After One Dose of Either QIVc, TIV1c or TIV2c by Overall Age Group
Arthralgia
|
90 Subjects
|
44 Subjects
|
54 Subjects
|
—
|
—
|
—
|
|
12.Number of Subjects Reporting Solicited Adverse Events (AEs) After One Dose of Either QIVc, TIV1c or TIV2c by Overall Age Group
Headache
|
185 Subjects
|
90 Subjects
|
89 Subjects
|
—
|
—
|
—
|
|
12.Number of Subjects Reporting Solicited Adverse Events (AEs) After One Dose of Either QIVc, TIV1c or TIV2c by Overall Age Group
Fatigue
|
178 Subjects
|
109 Subjects
|
81 Subjects
|
—
|
—
|
—
|
|
12.Number of Subjects Reporting Solicited Adverse Events (AEs) After One Dose of Either QIVc, TIV1c or TIV2c by Overall Age Group
Diarrhea
|
77 Subjects
|
42 Subjects
|
42 Subjects
|
—
|
—
|
—
|
|
12.Number of Subjects Reporting Solicited Adverse Events (AEs) After One Dose of Either QIVc, TIV1c or TIV2c by Overall Age Group
Loss of appetite
|
81 Subjects
|
45 Subjects
|
39 Subjects
|
—
|
—
|
—
|
|
12.Number of Subjects Reporting Solicited Adverse Events (AEs) After One Dose of Either QIVc, TIV1c or TIV2c by Overall Age Group
Any other
|
66 Subjects
|
20 Subjects
|
30 Subjects
|
—
|
—
|
—
|
|
12.Number of Subjects Reporting Solicited Adverse Events (AEs) After One Dose of Either QIVc, TIV1c or TIV2c by Overall Age Group
Use of analgesics / antipyretics for treatment
|
8 Subjects
|
2 Subjects
|
3 Subjects
|
—
|
—
|
—
|
|
12.Number of Subjects Reporting Solicited Adverse Events (AEs) After One Dose of Either QIVc, TIV1c or TIV2c by Overall Age Group
Body temperature
|
7 Subjects
|
5 Subjects
|
3 Subjects
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 to 181 post vaccinationPopulation: Analysis was done on unsolicited safety data set i.e. all subjects in the exposed set with unsolicited adverse event data
Safety was assessed in terms of number (%) of subjects reporting unsolicited AEs (day 1 to 22 after vaccination), serious adverse events (SAEs), medically attended AEs, AEs leading to withdrawal from the study, new onset of chronic diseases (NOCDs), and concomitant medications (day 1 to day 181 post vaccination) after receiving one dose of either four (4) strain inactivated quadrivalent cell based influenza vaccine (QIVc) or trivalent inactivated influenza vaccine (TIV1c or TIV2c)
Outcome measures
| Measure |
QIVc (≥18 Years)
n=1324 Participants
Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
|
TIV1c (≥18 Years)
n=673 Participants
Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
|
TIV2c (≥18 Years)
n=665 Participants
Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
|
TIV1c (≥ 65 Years)
Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1,H3N2, B1)recommended for 2013-2014 season
|
TIV2c (18 to <65 Years)
Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
|
TIV2c (≥ 65 Years)
Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
|
|---|---|---|---|---|---|---|
|
13.Number of Subjects Reporting Unsolicited Adverse Events (AEs) After One Dose of Either QIVc, TIV1c or TIV2c by Overall Age Group
AE leading to study withdrawal
|
2 Subjects
|
1 Subjects
|
1 Subjects
|
—
|
—
|
—
|
|
13.Number of Subjects Reporting Unsolicited Adverse Events (AEs) After One Dose of Either QIVc, TIV1c or TIV2c by Overall Age Group
Any AE
|
213 Subjects
|
99 Subjects
|
110 Subjects
|
—
|
—
|
—
|
|
13.Number of Subjects Reporting Unsolicited Adverse Events (AEs) After One Dose of Either QIVc, TIV1c or TIV2c by Overall Age Group
Any possibly related AE
|
57 Subjects
|
22 Subjects
|
30 Subjects
|
—
|
—
|
—
|
|
13.Number of Subjects Reporting Unsolicited Adverse Events (AEs) After One Dose of Either QIVc, TIV1c or TIV2c by Overall Age Group
SAE
|
52 Subjects
|
22 Subjects
|
21 Subjects
|
—
|
—
|
—
|
|
13.Number of Subjects Reporting Unsolicited Adverse Events (AEs) After One Dose of Either QIVc, TIV1c or TIV2c by Overall Age Group
Possibly/probably related SAE
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
—
|
—
|
|
13.Number of Subjects Reporting Unsolicited Adverse Events (AEs) After One Dose of Either QIVc, TIV1c or TIV2c by Overall Age Group
Medically attended AE
|
344 Subjects
|
172 Subjects
|
166 Subjects
|
—
|
—
|
—
|
|
13.Number of Subjects Reporting Unsolicited Adverse Events (AEs) After One Dose of Either QIVc, TIV1c or TIV2c by Overall Age Group
NOCD
|
62 Subjects
|
25 Subjects
|
29 Subjects
|
—
|
—
|
—
|
|
13.Number of Subjects Reporting Unsolicited Adverse Events (AEs) After One Dose of Either QIVc, TIV1c or TIV2c by Overall Age Group
Death(N=1355,676,669)
|
5 Subjects
|
5 Subjects
|
2 Subjects
|
—
|
—
|
—
|
Adverse Events
QIVc (≥18 Years)
Serious events: 52 serious events
Other events: 681 other events
Deaths: 0 deaths
TIV1c (≥ 18 Years)
Serious events: 22 serious events
Other events: 332 other events
Deaths: 0 deaths
TIV2c (≥18 Years)
Serious events: 21 serious events
Other events: 335 other events
Deaths: 0 deaths
Total
Serious events: 95 serious events
Other events: 1348 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
QIVc (≥18 Years)
n=1324 participants at risk
Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
|
TIV1c (≥ 18 Years)
n=673 participants at risk
Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
|
TIV2c (≥18 Years)
n=665 participants at risk
Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
|
Total
n=2662 participants at risk
Total Number of Subjects
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
HISTIOCYTOSIS HAEMATOPHAGIC
|
0.08%
1/1324 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/673 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/665 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.04%
1/2662 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
|
Blood and lymphatic system disorders
IRON DEFICIENCY ANAEMIA
|
0.08%
1/1324 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/673 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/665 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.04%
1/2662 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
|
Cardiac disorders
ANGINA PECTORIS
|
0.08%
1/1324 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/673 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/665 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.04%
1/2662 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
|
Cardiac disorders
ARTERIOSCLEROSIS CORONARY ARTERY
|
0.00%
0/1324 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.15%
1/673 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/665 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.04%
1/2662 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.23%
3/1324 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.15%
1/673 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.15%
1/665 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.19%
5/2662 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
|
Cardiac disorders
CARDIAC ARREST
|
0.00%
0/1324 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.30%
2/673 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.15%
1/665 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.11%
3/2662 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
|
Cardiac disorders
CARDIAC FAILURE ACUTE
|
0.08%
1/1324 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/673 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/665 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.04%
1/2662 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
|
Cardiac disorders
CARDIAC FAILURE CONGESTIVE
|
0.38%
5/1324 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/673 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.30%
2/665 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.26%
7/2662 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
|
Cardiac disorders
CORONARY ARTERY DISEASE
|
0.15%
2/1324 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.30%
2/673 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.15%
1/665 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.19%
5/2662 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
|
Cardiac disorders
MITRAL VALVE INCOMPETENCE
|
0.08%
1/1324 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/673 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/665 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.04%
1/2662 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
0.30%
4/1324 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/673 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.15%
1/665 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.19%
5/2662 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
|
Cardiac disorders
MYOCARDIAL ISCHAEMIA
|
0.08%
1/1324 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.15%
1/673 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/665 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.08%
2/2662 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
|
Cardiac disorders
VENTRICULAR FIBRILLATION
|
0.08%
1/1324 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/673 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/665 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.04%
1/2662 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.08%
1/1324 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/673 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/665 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.04%
1/2662 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
|
Gastrointestinal disorders
GASTROINTESTINAL HAEMORRHAGE
|
0.08%
1/1324 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/673 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/665 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.04%
1/2662 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
|
Gastrointestinal disorders
LOWER GASTROINTESTINAL HAEMORRHAGE
|
0.08%
1/1324 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/673 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/665 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.04%
1/2662 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
|
Gastrointestinal disorders
SMALL INTESTINAL OBSTRUCTION
|
0.00%
0/1324 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/673 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.30%
2/665 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.08%
2/2662 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
|
General disorders
CHEST DISCOMFORT
|
0.00%
0/1324 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/673 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.15%
1/665 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.04%
1/2662 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
|
General disorders
CHEST PAIN
|
0.08%
1/1324 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/673 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/665 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.04%
1/2662 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
|
General disorders
CORONARY ARTERY RESTENOSIS
|
0.00%
0/1324 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/673 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.15%
1/665 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.04%
1/2662 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
|
General disorders
DEATH
|
0.00%
0/1324 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.15%
1/673 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/665 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.04%
1/2662 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
0.08%
1/1324 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.15%
1/673 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/665 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.08%
2/2662 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
|
General disorders
STRANGULATED HERNIA
|
0.08%
1/1324 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/673 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/665 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.04%
1/2662 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
|
Immune system disorders
ANAPHYLACTIC REACTION
|
0.00%
0/1324 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/673 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.15%
1/665 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.04%
1/2662 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
|
Infections and infestations
APPENDICITIS
|
0.00%
0/1324 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.15%
1/673 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/665 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.04%
1/2662 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
|
Infections and infestations
BRONCHITIS
|
0.08%
1/1324 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/673 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/665 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.04%
1/2662 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
|
Infections and infestations
CELLULITIS
|
0.23%
3/1324 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.15%
1/673 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/665 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.15%
4/2662 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
|
Infections and infestations
DIVERTICULITIS
|
0.15%
2/1324 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/673 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/665 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.08%
2/2662 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
|
Infections and infestations
ESCHERICHIA SEPSIS
|
0.08%
1/1324 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/673 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/665 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.04%
1/2662 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
|
Infections and infestations
GASTROENTERITIS
|
0.08%
1/1324 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/673 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/665 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.04%
1/2662 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
|
Infections and infestations
GASTROENTERITIS VIRAL
|
0.08%
1/1324 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/673 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/665 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.04%
1/2662 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
|
Infections and infestations
MENINGITIS VIRAL
|
0.08%
1/1324 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/673 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/665 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.04%
1/2662 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
|
Infections and infestations
PNEUMONIA
|
0.15%
2/1324 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/673 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.45%
3/665 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.19%
5/2662 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
|
Infections and infestations
PNEUMONIA LEGIONELLA
|
0.00%
0/1324 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/673 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.15%
1/665 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.04%
1/2662 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
|
Infections and infestations
PYELONEPHRITIS
|
0.15%
2/1324 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/673 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/665 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.08%
2/2662 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
|
Infections and infestations
SEPSIS
|
0.08%
1/1324 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.15%
1/673 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/665 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.08%
2/2662 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.08%
1/1324 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/673 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/665 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.04%
1/2662 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
|
Injury, poisoning and procedural complications
HEAD INJURY
|
0.00%
0/1324 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.15%
1/673 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/665 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.04%
1/2662 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
|
Injury, poisoning and procedural complications
HIP FRACTURE
|
0.00%
0/1324 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/673 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.15%
1/665 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.04%
1/2662 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
|
Injury, poisoning and procedural complications
LUMBAR VERTEBRAL FRACTURE
|
0.08%
1/1324 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/673 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/665 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.04%
1/2662 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
|
Injury, poisoning and procedural complications
POSTOPERATIVE ILEUS
|
0.00%
0/1324 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/673 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.15%
1/665 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.04%
1/2662 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
|
Injury, poisoning and procedural complications
SUBDURAL HAEMATOMA
|
0.08%
1/1324 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/673 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/665 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.04%
1/2662 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
|
Injury, poisoning and procedural complications
TENDON RUPTURE
|
0.00%
0/1324 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.15%
1/673 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/665 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.04%
1/2662 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS
|
0.00%
0/1324 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/673 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.15%
1/665 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.04%
1/2662 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
0.08%
1/1324 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/673 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/665 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.04%
1/2662 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
|
Metabolism and nutrition disorders
HYPOVOLAEMIA
|
0.08%
1/1324 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/673 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/665 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.04%
1/2662 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.00%
0/1324 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.15%
1/673 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/665 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.04%
1/2662 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE HAEMORRHAGE
|
0.00%
0/1324 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.15%
1/673 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/665 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.04%
1/2662 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
0.08%
1/1324 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/673 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/665 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.04%
1/2662 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
0.23%
3/1324 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/673 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/665 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.11%
3/2662 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
0.00%
0/1324 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.15%
1/673 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/665 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.04%
1/2662 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
|
Musculoskeletal and connective tissue disorders
ROTATOR CUFF SYNDROME
|
0.08%
1/1324 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/673 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/665 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.04%
1/2662 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ACUTE MYELOID LEUKAEMIA
|
0.08%
1/1324 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/673 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/665 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.04%
1/2662 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BASAL CELL CARCINOMA
|
0.08%
1/1324 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/673 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/665 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.04%
1/2662 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CERVIX CARCINOMA
|
0.00%
0/1324 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.15%
1/673 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/665 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.04%
1/2662 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ENDOMETRIAL ADENOCARCINOMA
|
0.00%
0/1324 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.15%
1/673 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/665 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.04%
1/2662 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ENDOMETRIAL CANCER
|
0.08%
1/1324 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/673 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/665 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.04%
1/2662 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO LUNG
|
0.08%
1/1324 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/673 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/665 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.04%
1/2662 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
OVARIAN ADENOMA
|
0.08%
1/1324 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/673 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/665 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.04%
1/2662 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SQUAMOUS CELL CARCINOMA
|
0.08%
1/1324 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/673 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.15%
1/665 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.08%
2/2662 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
TRANSITIONAL CELL CARCINOMA
|
0.00%
0/1324 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/673 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.15%
1/665 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.04%
1/2662 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
|
Nervous system disorders
AMYOTROPHIC LATERAL SCLEROSIS
|
0.08%
1/1324 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/673 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/665 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.04%
1/2662 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
|
Nervous system disorders
DIZZINESS
|
0.00%
0/1324 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/673 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.15%
1/665 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.04%
1/2662 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
|
Nervous system disorders
GENERALISED TONIC-CLONIC SEIZURE
|
0.00%
0/1324 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.15%
1/673 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.15%
1/665 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.08%
2/2662 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
|
Nervous system disorders
PRESYNCOPE
|
0.00%
0/1324 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/673 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.15%
1/665 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.04%
1/2662 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
|
Nervous system disorders
TRANSIENT ISCHAEMIC ATTACK
|
0.00%
0/1324 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.15%
1/673 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/665 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.04%
1/2662 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
|
Psychiatric disorders
ALCOHOLISM
|
0.00%
0/1324 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.15%
1/673 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/665 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.04%
1/2662 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
|
Psychiatric disorders
BIPOLAR DISORDER
|
0.08%
1/1324 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/673 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/665 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.04%
1/2662 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
|
Psychiatric disorders
DEPRESSION
|
0.00%
0/1324 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/673 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.15%
1/665 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.04%
1/2662 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
|
Reproductive system and breast disorders
BENIGN PROSTATIC HYPERPLASIA
|
0.15%
2/1324 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/673 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/665 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.08%
2/2662 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
|
Reproductive system and breast disorders
ENDOMETRIOSIS
|
0.00%
0/1324 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.15%
1/673 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/665 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.04%
1/2662 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY FAILURE
|
0.08%
1/1324 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.15%
1/673 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/665 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.08%
2/2662 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
0.08%
1/1324 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/673 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/665 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.04%
1/2662 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
0.00%
0/1324 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/673 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.15%
1/665 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.04%
1/2662 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.08%
1/1324 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.15%
1/673 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/665 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.08%
2/2662 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
0.00%
0/1324 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.30%
2/673 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/665 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.08%
2/2662 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
|
Surgical and medical procedures
IMPLANTABLE DEFIBRILLATOR INSERTION
|
0.00%
0/1324 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/673 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.15%
1/665 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.04%
1/2662 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
|
Vascular disorders
ARTERIOSCLEROSIS
|
0.00%
0/1324 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/673 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.15%
1/665 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.04%
1/2662 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
|
Vascular disorders
HYPERTENSION
|
0.15%
2/1324 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.00%
0/673 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.15%
1/665 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
0.11%
3/2662 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
Other adverse events
| Measure |
QIVc (≥18 Years)
n=1324 participants at risk
Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
|
TIV1c (≥ 18 Years)
n=673 participants at risk
Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
|
TIV2c (≥18 Years)
n=665 participants at risk
Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
|
Total
n=2662 participants at risk
Total Number of Subjects
|
|---|---|---|---|---|
|
Gastrointestinal disorders
DIARRHOEA
|
6.9%
91/1324 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
7.3%
49/673 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
7.2%
48/665 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
7.1%
188/2662 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
|
Gastrointestinal disorders
NAUSEA
|
7.3%
96/1324 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
5.8%
39/673 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
6.9%
46/665 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
6.8%
181/2662 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
|
General disorders
CHILLS
|
5.4%
72/1324 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
5.2%
35/673 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
5.6%
37/665 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
5.4%
144/2662 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
|
General disorders
FATIGUE
|
13.8%
183/1324 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
16.8%
113/673 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
12.2%
81/665 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
14.2%
377/2662 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
|
General disorders
INJECTION SITE ERYTHEMA
|
12.6%
167/1324 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
11.9%
80/673 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
10.2%
68/665 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
11.8%
315/2662 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
|
General disorders
INJECTION SITE HAEMORRHAGE
|
4.2%
56/1324 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
3.9%
26/673 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
5.3%
35/665 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
4.4%
117/2662 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
|
General disorders
INJECTION SITE INDURATION
|
10.1%
134/1324 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
8.2%
55/673 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
9.0%
60/665 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
9.4%
249/2662 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
|
General disorders
INJECTION SITE PAIN
|
33.5%
444/1324 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
27.8%
187/673 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
29.3%
195/665 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
31.0%
826/2662 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
6.2%
82/1324 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
6.7%
45/673 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
6.0%
40/665 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
6.3%
167/2662 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
7.4%
98/1324 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
8.3%
56/673 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
8.7%
58/665 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
8.0%
212/2662 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
12.1%
160/1324 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
12.3%
83/673 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
11.9%
79/665 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
12.1%
322/2662 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
|
Nervous system disorders
HEADACHE
|
14.4%
191/1324 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
13.8%
93/673 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
14.0%
93/665 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
14.2%
377/2662 • Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment. For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial
- Publication restrictions are in place
Restriction type: OTHER