Trial Outcomes & Findings for Phase 2, Observer-Blind, Placebo-Controlled, Randomized, Multi-Center Extension Study to Evaluate the Safety and Immunogenicity of a Booster Dose of a MenABCWY Vaccine Administered 24 Months Following the Primary Series to Adolescents and Young Adults Who Participated in V102_03 (NCT01272180) (NCT NCT01992536)
NCT ID: NCT01992536
Last Updated: 2016-10-25
Results Overview
Percentages of subjects having HT-hSBA seroresponse against N. meningitidis serogroups A, C, W and Y, following administration of a booster dose of MenABCWY, in the present study, in subjects who previously received the same MenABCWY vaccine formulation in study V102\_03 (NCT01272180). Seroresponse to N. meningitidis serogroups A, C, W and Y is defined as: for subjects with a pre-vaccination HT-hSBA titer \< 1:4, a post-vaccination hSBA titer ≥ 1:8; for subjects with a pre-vaccination hSBA titer ≥ 1:4, an increase in hSBA titer of at least four times the pre-vaccination titer.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
194 participants
Primary outcome timeframe
Day 30
Results posted on
2016-10-25
Participant Flow
Subjects were recruited from 5 study sites in Poland and from 8 study sites in United States.
All enrolled subjects were included in the study.
Participant milestones
| Measure |
2OMV_OMV
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
|
2OMV_Pbo
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
|
2qOMV_qOMV
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
|
2qOMV_Pbo
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study.
|
2B_OMV
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study.
|
2B_qOMV
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼ OMV in this study.
|
2B_Pbo
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of Placebo in this study.
|
1M_OMV
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
|
1M_qOMV
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼ OMV in this study.
|
1M_Pbo
Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
26
|
25
|
17
|
24
|
11
|
21
|
7
|
21
|
19
|
19
|
|
Overall Study
COMPLETED
|
22
|
22
|
16
|
22
|
11
|
20
|
0
|
21
|
18
|
18
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
1
|
2
|
0
|
1
|
7
|
0
|
1
|
1
|
Reasons for withdrawal
| Measure |
2OMV_OMV
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
|
2OMV_Pbo
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
|
2qOMV_qOMV
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
|
2qOMV_Pbo
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study.
|
2B_OMV
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study.
|
2B_qOMV
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼ OMV in this study.
|
2B_Pbo
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of Placebo in this study.
|
1M_OMV
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
|
1M_qOMV
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼ OMV in this study.
|
1M_Pbo
Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Administrative Reason
|
0
|
0
|
0
|
0
|
0
|
0
|
7
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
4
|
2
|
1
|
0
|
0
|
1
|
0
|
0
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Phase 2, Observer-Blind, Placebo-Controlled, Randomized, Multi-Center Extension Study to Evaluate the Safety and Immunogenicity of a Booster Dose of a MenABCWY Vaccine Administered 24 Months Following the Primary Series to Adolescents and Young Adults Who Participated in V102_03 (NCT01272180)
Baseline characteristics by cohort
| Measure |
2OMV_OMV
n=26 Participants
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
|
2OMV_Pbo
n=25 Participants
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
|
2qOMV_qOMV
n=17 Participants
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
|
2qOMV_Pbo
n=24 Participants
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study.
|
2B_OMV
n=11 Participants
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study.
|
2B_qOMV
n=21 Participants
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼ OMV in this study.
|
2B_Pbo
n=7 Participants
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of Placebo in this study.
|
1M_OMV
n=21 Participants
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
|
1M_qOMV
n=19 Participants
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼ OMV in this study.
|
1M_Pbo
n=19 Participants
Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
|
Total
n=190 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
18.8 Years
STANDARD_DEVIATION 5.19 • n=99 Participants
|
17.1 Years
STANDARD_DEVIATION 4.31 • n=107 Participants
|
18 Years
STANDARD_DEVIATION 5.05 • n=206 Participants
|
19 Years
STANDARD_DEVIATION 5.4 • n=7 Participants
|
20.9 Years
STANDARD_DEVIATION 3.99 • n=31 Participants
|
19.7 Years
STANDARD_DEVIATION 5.36 • n=30 Participants
|
17.9 Years
STANDARD_DEVIATION 4.67 • n=3 Participants
|
16.8 Years
STANDARD_DEVIATION 4.65 • n=6 Participants
|
19.2 Years
STANDARD_DEVIATION 6.1 • n=114 Participants
|
17.6 Years
STANDARD_DEVIATION 5.19
|
18.4 Years
STANDARD_DEVIATION 5.08 • n=19 Participants
|
|
Sex/Gender, Customized
Female
|
8 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
14 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
15 Participants
n=30 Participants
|
3 Participants
n=3 Participants
|
12 Participants
n=6 Participants
|
12 Participants
n=114 Participants
|
11 Participants
|
99 Participants
n=19 Participants
|
|
Sex/Gender, Customized
Male
|
18 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
10 Participants
n=7 Participants
|
9 Participants
n=31 Participants
|
6 Participants
n=30 Participants
|
4 Participants
n=3 Participants
|
9 Participants
n=6 Participants
|
7 Participants
n=114 Participants
|
8 Participants
|
91 Participants
n=19 Participants
|
PRIMARY outcome
Timeframe: Day 30Population: Analysis was done on FAS Day 30 (Booster) population.. All subjects in the enrolled population who were randomized, actually received the study vaccination in V102\_03E1 and provided an evaluable serum sample at Day 30 (for seroresponse, Day 1 and Day 30 samples were required).
Percentages of subjects having HT-hSBA seroresponse against N. meningitidis serogroups A, C, W and Y, following administration of a booster dose of MenABCWY, in the present study, in subjects who previously received the same MenABCWY vaccine formulation in study V102\_03 (NCT01272180). Seroresponse to N. meningitidis serogroups A, C, W and Y is defined as: for subjects with a pre-vaccination HT-hSBA titer \< 1:4, a post-vaccination hSBA titer ≥ 1:8; for subjects with a pre-vaccination hSBA titer ≥ 1:4, an increase in hSBA titer of at least four times the pre-vaccination titer.
Outcome measures
| Measure |
2OMV_OMV
n=25 Participants
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
|
2qOMV_qOMV
n=16 Participants
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
|
rMenB+OMV
Subjects received two doses of rMenB + OMV, administered two months apart.
|
Menveo
Subjects received a dose of placebo followed by one dose of MenACWY administered two months later.
|
2B_OMV
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study
|
2B_qOMV
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study
|
1M_OMV
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
|
1M_qOMV
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
|
1M_Pbo
Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
|
1M_Pbo
Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
|
Total
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
1. Percentages of Subjects With HT-hSBA (High-throughput Human Serum Bactericidal Assay) Seroresponse Against N. Meningitidis Serogroups A, C, W and Y.
Men A
|
96 Percentages of Subjects
Interval 79.6 to 99.9
|
94 Percentages of Subjects
Interval 69.8 to 99.84
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
1. Percentages of Subjects With HT-hSBA (High-throughput Human Serum Bactericidal Assay) Seroresponse Against N. Meningitidis Serogroups A, C, W and Y.
Men C (N=20,10)
|
85 Percentages of Subjects
Interval 62.1 to 96.8
|
100 Percentages of Subjects
Interval 69.2 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
1. Percentages of Subjects With HT-hSBA (High-throughput Human Serum Bactericidal Assay) Seroresponse Against N. Meningitidis Serogroups A, C, W and Y.
Men W (N=20,13)
|
85 Percentages of Subjects
Interval 62.1 to 96.8
|
85 Percentages of Subjects
Interval 54.6 to 98.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
1. Percentages of Subjects With HT-hSBA (High-throughput Human Serum Bactericidal Assay) Seroresponse Against N. Meningitidis Serogroups A, C, W and Y.
Men Y (N=25,14)
|
96 Percentages of Subjects
Interval 79.6 to 99.9
|
100 Percentages of Subjects
Interval 76.8 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 and Day 30Population: Analysis was done on FAS Day 30 (Booster) population. All subjects in the enrolled population who were randomized, actually received the study vaccination in V102\_03E1 and provided an evaluable serum sample at Day 30 (for seroresponse, Day 1 and Day 30 samples were required).
Percentage of subjects reporting HT-hSBA titers ≥ 1:5 against strains of N. meningitidis serogroups B at baseline (Day 1) and one month (Day 30) following administration of a booster dose of MenABCWY, in the present study, in subjects who previously received the same MenABCWY vaccine formulation in study V102\_03 (NCT01272180).
Outcome measures
| Measure |
2OMV_OMV
n=25 Participants
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
|
2qOMV_qOMV
n=17 Participants
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
|
rMenB+OMV
Subjects received two doses of rMenB + OMV, administered two months apart.
|
Menveo
Subjects received a dose of placebo followed by one dose of MenACWY administered two months later.
|
2B_OMV
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study
|
2B_qOMV
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study
|
1M_OMV
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
|
1M_qOMV
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
|
1M_Pbo
Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
|
1M_Pbo
Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
|
Total
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
2. Percentage of Subjects With HT-hSBA Titers ≥ 1:5 Against Strains of N. Meningitidis Serogroups B.
5/99 (Day 1, N= 25,15)
|
76 Percentages of Subjects
Interval 54.9 to 90.6
|
87 Percentages of Subjects
Interval 59.5 to 98.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
2. Percentage of Subjects With HT-hSBA Titers ≥ 1:5 Against Strains of N. Meningitidis Serogroups B.
5/99 (Day 30, N=25,17)
|
100 Percentages of Subjects
Interval 86.3 to 100.0
|
100 Percentages of Subjects
Interval 80.5 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
2. Percentage of Subjects With HT-hSBA Titers ≥ 1:5 Against Strains of N. Meningitidis Serogroups B.
H44/76 (Day 1, N=25,16)
|
16 Percentages of Subjects
Interval 4.5 to 36.1
|
13 Percentages of Subjects
Interval 1.6 to 38.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
2. Percentage of Subjects With HT-hSBA Titers ≥ 1:5 Against Strains of N. Meningitidis Serogroups B.
H44/76 (Day 30, N=25,17)
|
96 Percentages of Subjects
Interval 79.6 to 99.9
|
100 Percentages of Subjects
Interval 80.5 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
2. Percentage of Subjects With HT-hSBA Titers ≥ 1:5 Against Strains of N. Meningitidis Serogroups B.
M01-0240364 (Day 1, N=24,15)
|
25 Percentages of Subjects
Interval 9.8 to 46.7
|
20 Percentages of Subjects
Interval 4.3 to 48.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
2. Percentage of Subjects With HT-hSBA Titers ≥ 1:5 Against Strains of N. Meningitidis Serogroups B.
M01-0240364 (Day 30, N=25,17)
|
100 Percentages of Subjects
Interval 86.3 to 100.0
|
100 Percentages of Subjects
Interval 80.5 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
2. Percentage of Subjects With HT-hSBA Titers ≥ 1:5 Against Strains of N. Meningitidis Serogroups B.
M07-0241084 (Day 1,N=25,15)
|
36 Percentages of Subjects
Interval 18.0 to 57.5
|
27 Percentages of Subjects
Interval 7.8 to 55.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
2. Percentage of Subjects With HT-hSBA Titers ≥ 1:5 Against Strains of N. Meningitidis Serogroups B.
M07-0241084 (Day 30, N=25,17)
|
100 Percentages of Subjects
Interval 86.3 to 100.0
|
88 Percentages of Subjects
Interval 63.6 to 98.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
2. Percentage of Subjects With HT-hSBA Titers ≥ 1:5 Against Strains of N. Meningitidis Serogroups B.
M14459 (Day 1, N=25,15)
|
24 Percentages of Subjects
Interval 9.4 to 45.1
|
7 Percentages of Subjects
Interval 0.17 to 31.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
2. Percentage of Subjects With HT-hSBA Titers ≥ 1:5 Against Strains of N. Meningitidis Serogroups B.
M14459 (Day 30, N=25,17)
|
92 Percentages of Subjects
Interval 74.0 to 99.0
|
88 Percentages of Subjects
Interval 63.6 to 98.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
2. Percentage of Subjects With HT-hSBA Titers ≥ 1:5 Against Strains of N. Meningitidis Serogroups B.
NZ98/254 (Day 1, N=25,15)
|
16 Percentages of Subjects
Interval 4.5 to 36.1
|
7 Percentages of Subjects
Interval 0.17 to 31.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
2. Percentage of Subjects With HT-hSBA Titers ≥ 1:5 Against Strains of N. Meningitidis Serogroups B.
NZ98/254 (Day 30, N=25,17)
|
92 Percentages of Subjects
Interval 74.0 to 99.0
|
71 Percentages of Subjects
Interval 44.0 to 89.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (Pre vaccination)Population: Analysis was done on FAS Day 1 (Persistence) population. All subjects in the enrolled population who provided an evaluable serum sample at Day 1.
Percentage of subjects with HT-hSBA titer ≥ 1:8 in serogroups A, C, W, Y against N. meningitides assessed prior to the administration of MenABCWY booster vaccination or placebo. Pre vaccination is 24 months after completion of the primary vaccination series, in subjects who previously received the same vaccine formulation in study V102\_03 (NCT01272180).
Outcome measures
| Measure |
2OMV_OMV
n=51 Participants
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
|
2qOMV_qOMV
n=40 Participants
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
|
rMenB+OMV
n=38 Participants
Subjects received two doses of rMenB + OMV, administered two months apart.
|
Menveo
n=59 Participants
Subjects received a dose of placebo followed by one dose of MenACWY administered two months later.
|
2B_OMV
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study
|
2B_qOMV
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study
|
1M_OMV
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
|
1M_qOMV
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
|
1M_Pbo
Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
|
1M_Pbo
Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
|
Total
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
3. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitides Serogroups A, C, W, Y.
Men A (N=51,40,38,58)
|
27 Percentages of Subjects
Interval 15.9 to 41.7
|
28 Percentages of Subjects
Interval 14.6 to 43.9
|
29 Percentages of Subjects
Interval 15.4 to 45.9
|
31 Percentages of Subjects
Interval 19.5 to 44.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
3. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitides Serogroups A, C, W, Y.
Men C (N=48,38,38,58)
|
67 Percentages of Subjects
Interval 51.6 to 79.6
|
68 Percentages of Subjects
Interval 51.3 to 82.5
|
45 Percentages of Subjects
Interval 28.6 to 61.7
|
57 Percentages of Subjects
Interval 43.2 to 69.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
3. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitides Serogroups A, C, W, Y.
Men W (N=50,36,38,56)
|
92 Percentages of Subjects
Interval 80.8 to 97.8
|
75 Percentages of Subjects
Interval 57.8 to 87.9
|
76 Percentages of Subjects
Interval 59.8 to 88.6
|
68 Percentages of Subjects
Interval 54.0 to 79.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
3. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitides Serogroups A, C, W, Y.
Men Y (N=51,38,38,59)
|
65 Percentages of Subjects
Interval 50.1 to 77.6
|
50 Percentages of Subjects
Interval 33.4 to 66.6
|
16 Percentages of Subjects
Interval 6.0 to 31.3
|
46 Percentages of Subjects
Interval 32.7 to 59.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (Pre vaccination)Population: Analysis was done on the FAS Day 1 (Persistence) population. All subjects in the enrolled population who provided an evaluable serum sample at Day 1.
Percentage of subjects with HT-hSBA titer ≥ 1:5 against N. meningitidis strains of serogroup B assessed prior to the administration of MenABCWY booster vaccination or placebo. Pre vaccination is 24 months after completion of the primary vaccination series, in subjects who previously received the same vaccine formulation in study V102\_03 (NCT01272180).
Outcome measures
| Measure |
2OMV_OMV
n=51 Participants
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
|
2qOMV_qOMV
n=39 Participants
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
|
rMenB+OMV
n=38 Participants
Subjects received two doses of rMenB + OMV, administered two months apart.
|
Menveo
n=59 Participants
Subjects received a dose of placebo followed by one dose of MenACWY administered two months later.
|
2B_OMV
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study
|
2B_qOMV
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study
|
1M_OMV
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
|
1M_qOMV
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
|
1M_Pbo
Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
|
1M_Pbo
Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
|
Total
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
4. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B.
5/99 (N=51,38,36,59)
|
76 Percentages of Subjects
Interval 62.5 to 87.2
|
87 Percentages of Subjects
Interval 71.9 to 95.6
|
94 Percentages of Subjects
Interval 81.3 to 99.3
|
19 Percentages of Subjects
Interval 9.7 to 30.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
4. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B.
H44/76 (N=51,39,38,59)
|
22 Percentages of Subjects
Interval 11.3 to 35.3
|
18 Percentages of Subjects
Interval 7.5 to 33.5
|
34 Percentages of Subjects
Interval 19.6 to 51.4
|
3 Percentages of Subjects
Interval 0.41 to 11.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
4. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B.
M01-0240364 (N=50,37,37,58)
|
24 Percentages of Subjects
Interval 13.1 to 38.2
|
16 Percentages of Subjects
Interval 6.2 to 32.0
|
35 Percentages of Subjects
Interval 20.2 to 52.5
|
7 Percentages of Subjects
Interval 1.9 to 16.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
4. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B.
M07-0241084 (N=51,38,38,59)
|
37 Percentages of Subjects
Interval 24.1 to 51.9
|
29 Percentages of Subjects
Interval 15.4 to 45.9
|
50 Percentages of Subjects
Interval 33.4 to 66.6
|
22 Percentages of Subjects
Interval 12.3 to 34.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
4. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B.
M14459 (N=51,39,38,59)
|
29 Percentages of Subjects
Interval 17.5 to 43.8
|
13 Percentages of Subjects
Interval 4.3 to 27.4
|
26 Percentages of Subjects
Interval 13.4 to 43.1
|
14 Percentages of Subjects
Interval 6.0 to 25.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
4. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B.
NZ98/254 (N=51,39,38,59)
|
24 Percentages of Subjects
Interval 12.8 to 37.5
|
8 Percentages of Subjects
Interval 1.6 to 20.9
|
16 Percentages of Subjects
Interval 6.0 to 31.3
|
3 Percentages of Subjects
Interval 0.41 to 11.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (Pre-vaccination)Population: Analysis was done on FAS Day 1 (Persistence) population. All subjects in the enrolled population who provided an evaluable serum sample at Day 1.
The HT-hSBA GMTs against N. meningitidis serogroup A, C, W, Y prior the administration of MenABCWY booster vaccination or placebo. Pre vaccination is 24 months after completion of the primary vaccination series, in subjects who previously received the same vaccine formulation in study V102\_03 (NCT01272180).
Outcome measures
| Measure |
2OMV_OMV
n=51 Participants
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
|
2qOMV_qOMV
n=40 Participants
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
|
rMenB+OMV
n=38 Participants
Subjects received two doses of rMenB + OMV, administered two months apart.
|
Menveo
n=59 Participants
Subjects received a dose of placebo followed by one dose of MenACWY administered two months later.
|
2B_OMV
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study
|
2B_qOMV
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study
|
1M_OMV
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
|
1M_qOMV
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
|
1M_Pbo
Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
|
1M_Pbo
Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
|
Total
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
5. The HT-hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroups A, C, W,Y.
Men A (N=51,40,38,58)
|
3.34 Titers
Interval 2.19 to 5.08
|
3.3 Titers
Interval 1.95 to 5.6
|
2.96 Titers
Interval 1.7 to 5.17
|
4.14 Titers
Interval 2.75 to 6.23
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
5. The HT-hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroups A, C, W,Y.
Men C (N=48,38,38,58)
|
18 Titers
Interval 11.0 to 30.0
|
13 Titers
Interval 8.0 to 20.0
|
6.05 Titers
Interval 4.28 to 8.55
|
10 Titers
Interval 6.36 to 17.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
5. The HT-hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroups A, C, W,Y.
Men W (N=50,36,38,56)
|
35 Titers
Interval 24.0 to 52.0
|
23 Titers
Interval 12.0 to 45.0
|
20 Titers
Interval 11.0 to 34.0
|
17 Titers
Interval 9.65 to 29.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
5. The HT-hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroups A, C, W,Y.
Men Y (N=51,38,38,59)
|
13 Titers
Interval 7.01 to 23.0
|
8.85 Titers
Interval 4.24 to 18.0
|
1.8 Titers
Interval 1.25 to 2.6
|
6.49 Titers
Interval 3.72 to 11.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (Pre-vaccination)Population: Analysis was done on the FAS Day 1 (Persistence) population. All subjects in the enrolled population who provided an evaluable serum sample at Day 1.
The HT-hSBA GMTs against N. meningitidis strains of serogroup B prior the administration of MenABCWY booster vaccination or placebo. Pre vaccination is 24 months after completion of the primary vaccination series, in subjects who previously received the same vaccine formulation in study V102\_03 (NCT01272180).
Outcome measures
| Measure |
2OMV_OMV
n=50 Participants
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
|
2qOMV_qOMV
n=38 Participants
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
|
rMenB+OMV
n=36 Participants
Subjects received two doses of rMenB + OMV, administered two months apart.
|
Menveo
n=17 Participants
Subjects received a dose of placebo followed by one dose of MenACWY administered two months later.
|
2B_OMV
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study
|
2B_qOMV
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study
|
1M_OMV
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
|
1M_qOMV
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
|
1M_Pbo
Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
|
1M_Pbo
Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
|
Total
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
6. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroup B.
M07-0241084 (N=51,38,38,59)
|
3.76 Titers
Interval 2.55 to 5.56
|
2.42 Titers
Interval 1.7 to 3.45
|
4.56 Titers
Interval 2.97 to 7.01
|
2.35 Titers
Interval 1.68 to 3.28
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
6. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroup B.
M14459 (N=51,39,38,59)
|
2.67 Titers
Interval 1.92 to 3.7
|
1.94 Titers
Interval 1.48 to 2.56
|
2.82 Titers
Interval 2.0 to 3.96
|
1.87 Titers
Interval 1.43 to 2.43
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
6. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroup B.
NZ98/254 (N=51,39,38,59)
|
2.03 Titers
Interval 1.43 to 2.89
|
1.46 Titers
Interval 1.15 to 1.85
|
1.75 Titers
Interval 1.24 to 2.47
|
1.16 Titers
Interval 1.0 to 1.34
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
6. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroup B.
5/99 (N=51,38,36,59)
|
16 Titers
Interval 11.0 to 24.0
|
33 Titers
Interval 19.0 to 54.0
|
39 Titers
Interval 25.0 to 62.0
|
2.46 Titers
Interval 1.73 to 3.51
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
6. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroup B.
H44/76 (N=51,39,38,59)
|
2.54 Titers
Interval 1.69 to 3.82
|
1.78 Titers
Interval 1.26 to 2.53
|
3.22 Titers
Interval 2.18 to 4.76
|
1.32 Titers
Interval 1.06 to 1.65
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
6. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroup B.
M01-0240364 (N=50,37,37,58)
|
2.67 Titers
Interval 1.7 to 4.2
|
2.1 Titers
Interval 1.21 to 3.65
|
4.72 Titers
Interval 2.44 to 9.13
|
1.37 Titers
Interval 1.06 to 1.78
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 30Population: Analysis was done on FAS Day 30 (Booster) population. All subjects in the enrolled population who were randomized, actually received the study vaccination in V102\_03E1 and provided an evaluable serum sample at Day 30 (for seroresponse, Day 1 and Day 30 samples were required).
The HT-hSBA GMTs against N. meningitidis serogroup A, C, W, Y at Day 1 and Day 30 (one month) after the administration of MenABCWY booster vaccination or placebo.
Outcome measures
| Measure |
2OMV_OMV
n=25 Participants
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
|
2qOMV_qOMV
n=25 Participants
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
|
rMenB+OMV
n=16 Participants
Subjects received two doses of rMenB + OMV, administered two months apart.
|
Menveo
n=23 Participants
Subjects received a dose of placebo followed by one dose of MenACWY administered two months later.
|
2B_OMV
n=11 Participants
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study
|
2B_qOMV
n=21 Participants
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study
|
1M_OMV
n=21 Participants
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
|
1M_qOMV
n=18 Participants
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
|
1M_Pbo
n=18 Participants
Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
|
1M_Pbo
Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
|
Total
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
7. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y.
Men A (Day 1, N=25,25,16,22,11,21,19,16,18)
|
3.41 Titers
Interval 1.87 to 6.22
|
2.92 Titers
Interval 1.59 to 5.36
|
2.86 Titers
Interval 1.23 to 6.63
|
2.73 Titers
Interval 1.41 to 5.27
|
2.26 Titers
Interval 0.96 to 5.31
|
3.94 Titers
Interval 1.58 to 9.85
|
6.62 Titers
Interval 2.85 to 15.0
|
2.09 Titers
Interval 1.28 to 3.41
|
5.02 Titers
Interval 2.06 to 12.0
|
—
|
—
|
|
7. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y.
Men A (Day 30, N=25,25,16,22,11,21,19,17,18)
|
259 Titers
Interval 174.0 to 383.0
|
4.28 Titers
Interval 2.03 to 9.03
|
333 Titers
Interval 199.0 to 559.0
|
3.07 Titers
Interval 1.51 to 6.25
|
438 Titers
Interval 287.0 to 670.0
|
416 Titers
Interval 198.0 to 871.0
|
138 Titers
Interval 84.0 to 229.0
|
46 Titers
Interval 24.0 to 87.0
|
4.91 Titers
Interval 2.0 to 12.0
|
—
|
—
|
|
7. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y.
Men C (Day 1, N=20,23,10,22,7,16,21,18,17)
|
23 Titers
Interval 9.45 to 57.0
|
16 Titers
Interval 7.06 to 36.0
|
17 Titers
Interval 5.98 to 51.0
|
11 Titers
Interval 6.24 to 19.0
|
5.45 Titers
Interval 2.41 to 12.0
|
9.02 Titers
Interval 5.24 to 16.0
|
7.75 Titers
Interval 4.19 to 14.0
|
7.53 Titers
Interval 2.38 to 24.0
|
17 Titers
Interval 6.6 to 44.0
|
—
|
—
|
|
7. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y.
Men C (Day 30, N=21,24,11,23,7,16,21,18,18)
|
660 Titers
Interval 401.0 to 1084.0
|
17 Titers
Interval 7.6 to 38.0
|
612 Titers
Interval 245.0 to 1524.0
|
11 Titers
Interval 5.51 to 22.0
|
292 Titers
Interval 75.0 to 1142.0
|
135 Titers
Interval 69.0 to 261.0
|
338 Titers
Interval 205.0 to 558.0
|
304 Titers
Interval 124.0 to 742.0
|
20 Titers
Interval 7.2 to 56.0
|
—
|
—
|
|
7. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y.
Men W (Day 1, N=20,24,13,21,11,19,18,17,15)
|
34 Titers
Interval 20.0 to 59.0
|
33 Titers
Interval 17.0 to 65.0
|
30 Titers
Interval 8.9 to 101.0
|
18 Titers
Interval 7.3 to 46.0
|
25 Titers
Interval 7.98 to 79.0
|
29 Titers
Interval 13.0 to 64.0
|
28 Titers
Interval 12.0 to 66.0
|
9.37 Titers
Interval 2.85 to 31.0
|
9.42 Titers
Interval 3.03 to 29.0
|
—
|
—
|
|
7. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y.
Men W (Day 30, N=20,24,16,22,11,19,19,17,16)
|
792 Titers
Interval 516.0 to 1216.0
|
34 Titers
Interval 16.0 to 71.0
|
880 Titers
Interval 671.0 to 1154.0
|
26 Titers
Interval 11.0 to 59.0
|
392 Titers
Interval 252.0 to 610.0
|
363 Titers
Interval 278.0 to 473.0
|
629 Titers
Interval 384.0 to 1032.0
|
364 Titers
Interval 180.0 to 736.0
|
16 Titers
Interval 4.87 to 53.0
|
—
|
—
|
|
7. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y.
Men Y (Day 1, N=25,25,14,22,11,21,21,18,18)
|
10 Titers
Interval 4.89 to 21.0
|
15 Titers
Interval 5.5 to 43.0
|
15 Titers
Interval 4.33 to 53.0
|
5.66 Titers
Interval 2.25 to 14.0
|
2.4 Titers
Interval 1.05 to 5.47
|
1.84 Titers
Interval 1.07 to 3.14
|
6.43 Titers
Interval 2.86 to 14.0
|
5.79 Titers
Interval 1.77 to 19.0
|
5.32 Titers
Interval 1.81 to 16.0
|
—
|
—
|
|
7. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y.
Men Y (Day 30, N=25,25,16,23,11,21,21,18,18)
|
464 Titers
Interval 294.0 to 734.0
|
16 Titers
Interval 5.65 to 48.0
|
697 Titers
Interval 435.0 to 1116.0
|
5.17 Titers
Interval 2.16 to 12.0
|
48 Titers
Interval 14.0 to 157.0
|
39 Titers
Interval 13.0 to 120.0
|
658 Titers
Interval 431.0 to 1003.0
|
419 Titers
Interval 217.0 to 809.0
|
6.36 Titers
Interval 1.91 to 21.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 30Population: Analysis was done on FAS Day 30 (Booster) population.. All subjects in the enrolled population who were randomized, actually received the study vaccination in V102\_03E1 and provided an evaluable serum sample at Day 30 (for seroresponse, Day 1 and Day 30 samples were required).
The HT-hSBA GMTs against N. meningitidis strains of serogroups B at Day 1 and Day 30 (one month) after the administration of MenABCWY booster vaccination or placebo.
Outcome measures
| Measure |
2OMV_OMV
n=25 Participants
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
|
2qOMV_qOMV
n=25 Participants
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
|
rMenB+OMV
n=17 Participants
Subjects received two doses of rMenB + OMV, administered two months apart.
|
Menveo
n=23 Participants
Subjects received a dose of placebo followed by one dose of MenACWY administered two months later.
|
2B_OMV
n=11 Participants
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study
|
2B_qOMV
n=21 Participants
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study
|
1M_OMV
n=21 Participants
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
|
1M_qOMV
n=19 Participants
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
|
1M_Pbo
n=18 Participants
Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
|
1M_Pbo
Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
|
Total
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B.
5/99 (Day 30, N=25,25,17,23,11,21,21,19,18)
|
1131 Titers
Interval 716.0 to 1787.0
|
20 Titers
Interval 10.0 to 42.0
|
1598 Titers
Interval 900.0 to 2840.0
|
34 Titers
Interval 20.0 to 59.0
|
2205 Titers
Interval 1560.0 to 3117.0
|
2576 Titers
Interval 1716.0 to 3867.0
|
28 Titers
Interval 11.0 to 67.0
|
30 Titers
Interval 11.0 to 78.0
|
3.41 Titers
Interval 1.2 to 9.73
|
—
|
—
|
|
8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B.
NZ98/254 (Day 30, N= 25,25,17,23,11,21,21,19,18)
|
29 Titers
Interval 18.0 to 47.0
|
2.03 Titers
Interval 1.21 to 3.4
|
12 Titers
Interval 5.04 to 31.0
|
1.87 Titers
Interval 1.11 to 3.16
|
17 Titers
Interval 6.22 to 45.0
|
28 Titers
Interval 17.0 to 44.0
|
2.48 Titers
Interval 1.31 to 4.69
|
1.58 Titers
Interval 0.96 to 2.59
|
1.71 Titers
Interval 0.84 to 3.5
|
—
|
—
|
|
8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B.
5/99 (Day 1, N=25,25,15,22,9,21,21,19,18)
|
17 Titers
Interval 9.56 to 29.0
|
16 Titers
Interval 8.32 to 30.0
|
35 Titers
Interval 14.0 to 92.0
|
30 Titers
Interval 15.0 to 60.0
|
27 Titers
Interval 8.61 to 86.0
|
43 Titers
Interval 24.0 to 77.0
|
2.97 Titers
Interval 1.58 to 5.59
|
1.74 Titers
Interval 1.01 to 3.03
|
2.81 Titers
Interval 1.3 to 6.06
|
—
|
—
|
|
8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B.
H44/76 (Day 1, N= 25,25,16,22,11,21,19,19,18)
|
2.92 Titers
Interval 1.5 to 5.67
|
2.03 Titers
Interval 1.23 to 3.34
|
1.46 Titers
Interval 0.96 to 2.21
|
1.92 Titers
Interval 1.11 to 3.32
|
3.45 Titers
Interval 1.81 to 6.57
|
3.24 Titers
Interval 1.76 to 5.94
|
1.09 Titers
Interval 0.96 to 1.22
|
1.47 Titers
Interval 0.92 to 2.36
|
1.18 Titers
Interval 0.97 to 1.44
|
—
|
—
|
|
8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B.
H44/76 (Day 30, 25,25,17,23,11,21,19,19,18)
|
97 Titers
Interval 60.0 to 157.0
|
2.36 Titers
Interval 1.39 to 4.01
|
56 Titers
Interval 32.0 to 97.0
|
2.54 Titers
Interval 1.42 to 4.53
|
132 Titers
Interval 64.0 to 271.0
|
79 Titers
Interval 42.0 to 149.0
|
5.27 Titers
Interval 2.54 to 11.0
|
3.85 Titers
Interval 1.85 to 8.02
|
1.63 Titers
Interval 0.75 to 3.52
|
—
|
—
|
|
8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B.
M01-0240364 (Day 1, N=24,25,15,20,10,21,20,18,18)
|
2.28 Titers
Interval 1.3 to 3.98
|
3.11 Titers
Interval 1.44 to 6.68
|
2.67 Titers
Interval 0.87 to 8.24
|
1.36 Titers
Interval 0.83 to 2.23
|
2.46 Titers
Interval 0.72 to 8.4
|
6.81 Titers
Interval 2.47 to 19.0
|
1.34 Titers
Interval 0.84 to 2.13
|
1.23 Titers
Interval 0.88 to 1.71
|
1.63 Titers
Interval 0.86 to 3.11
|
—
|
—
|
|
8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B.
M01-0240364 (Day 30, N=25,25,17,22,11,21,20,19,18)
|
685 Titers
Interval 397.0 to 1182.0
|
3.21 Titers
Interval 1.4 to 7.37
|
856 Titers
Interval 454.0 to 1614.0
|
1.94 Titers
Interval 1.02 to 3.69
|
1336 Titers
Interval 810.0 to 2202.0
|
1275 Titers
Interval 794.0 to 2048.0
|
3.5 Titers
Interval 1.32 to 9.3
|
3.42 Titers
Interval 1.19 to 9.8
|
1.76 Titers
Interval 0.75 to 4.09
|
—
|
—
|
|
8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B.
M07-0241084 (Day 1, N= 25,25,15,22,11,21,21,19,18)
|
3.53 Titers
Interval 2.09 to 5.95
|
3.54 Titers
Interval 1.98 to 6.31
|
2.16 Titers
Interval 1.15 to 4.08
|
2.52 Titers
Interval 1.58 to 4.03
|
4.10 Titers
Interval 1.89 to 8.9
|
6.08 Titers
Interval 3.18 to 12.0
|
2.08 Titers
Interval 1.26 to 3.42
|
2.06 Titers
Interval 1.13 to 3.77
|
3.01 Titers
Interval 1.38 to 6.56
|
—
|
—
|
|
8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B.
M07-0241084 (Day 30, N=25,25,17,23,11,21,21,19,18)
|
50 Titers
Interval 31.0 to 79.0
|
3.66 Titers
Interval 2.02 to 6.64
|
29 Titers
Interval 14.0 to 58.0
|
2.48 Titers
Interval 1.55 to 3.96
|
68 Titers
Interval 33.0 to 142.0
|
69 Titers
Interval 36.0 to 129.0
|
3.26 Titers
Interval 1.75 to 6.06
|
2.15 Titers
Interval 1.13 to 4.07
|
3.86 Titers
Interval 1.4 to 11.0
|
—
|
—
|
|
8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B.
M14459 (Day 1, N=25,25,15,23,11,21,20,19,18)
|
2.57 Titers
Interval 1.57 to 4.22
|
2.58 Titers
Interval 1.62 to 4.12
|
1.6 Titers
Interval 0.97 to 2.65
|
2.27 Titers
Interval 1.61 to 3.2
|
3.11 Titers
Interval 1.74 to 5.56
|
3.18 Titers
Interval 1.87 to 5.41
|
1.91 Titers
Interval 1.14 to 3.2
|
1.45 Titers
Interval 1.03 to 2.05
|
2.37 Titers
Interval 1.31 to 4.29
|
—
|
—
|
|
8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B.
M14459 (Day 30, N=25,25,17,23,11,21,20,19,18)
|
31 Titers
Interval 18.0 to 54.0
|
2.18 Titers
Interval 1.39 to 3.42
|
20 Titers
Interval 11.0 to 37.0
|
2.33 Titers
Interval 1.62 to 3.35
|
56 Titers
Interval 27.0 to 117.0
|
35 Titers
Interval 21.0 to 58.0
|
3.44 Titers
Interval 2.05 to 5.75
|
2.57 Titers
Interval 1.51 to 4.37
|
2.93 Titers
Interval 1.14 to 7.53
|
—
|
—
|
|
8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B.
NZ98/254 (Day 1, N= 25,25,15,23,11,21,21,19,18)
|
1.65 Titers
Interval 1.09 to 2.48
|
2.11 Titers
Interval 1.28 to 3.49
|
1.32 Titers
Interval 0.94 to 1.84
|
1.58 Titers
Interval 1.11 to 2.27
|
1.72 Titers
Interval 0.99 to 2.98
|
2.07 Titers
Interval 1.17 to 3.66
|
1.18 Titers
Interval 0.84 to 1.66
|
1.18 Titers
Interval 0.9 to 1.54
|
1.12 Titers
Interval 0.94 to 1.34
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 30Population: Analysis was done on FAS Day 30 (Booster) population. All subjects in the enrolled population who were randomized, actually received the study vaccination in V102\_03E1 and provided an evaluable serum sample at Day 30 (for seroresponse, Day 1 and Day 30 samples were required).
Percentage of subjects with four-fold rise in HT-hSBA titers against N. meningitidis serogroup B strains, from Day 1 (baseline) to Day 30 (one month) after the administration of MenABCWY booster vaccination or placebo. Four-fold rise is defined as follows: for subjects with a pre-vaccination titer \< 1:2, a post-titer of ≥ 1:8; for subjects with a pre-vaccination titer ≥ 1:2 at least a four-fold increase.
Outcome measures
| Measure |
2OMV_OMV
n=25 Participants
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
|
2qOMV_qOMV
n=25 Participants
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
|
rMenB+OMV
n=16 Participants
Subjects received two doses of rMenB + OMV, administered two months apart.
|
Menveo
n=22 Participants
Subjects received a dose of placebo followed by one dose of MenACWY administered two months later.
|
2B_OMV
n=11 Participants
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study
|
2B_qOMV
n=21 Participants
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study
|
1M_OMV
n=21 Participants
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
|
1M_qOMV
n=19 Participants
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
|
1M_Pbo
n=18 Participants
Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
|
1M_Pbo
Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
|
Total
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains.
5/99 (Day 1, N= 24,24,16,22,11,20,6,5,5)
|
96 Percentages of Subjects
Interval 78.9 to 99.89
|
100 Percentages of Subjects
Interval 85.8 to 100.0
|
94 Percentages of Subjects
Interval 69.8 to 99.84
|
100 Percentages of Subjects
Interval 84.6 to 100.0
|
91 Percentages of Subjects
Interval 58.7 to 99.77
|
95 Percentages of Subjects
Interval 75.1 to 99.87
|
0 Percentages of Subjects
Interval 0.0 to 45.9
|
0 Percentages of Subjects
Interval 0.0 to 52.2
|
0 Percentages of Subjects
Interval 0.0 to 52.2
|
—
|
—
|
|
9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains.
5/99 (Day 30, N=25,25,15,22,9,21,21,19,18)
|
100 Percentages of Subjects
Interval 86.3 to 100.0
|
4 Percentages of Subjects
Interval 0.1 to 20.4
|
93 Percentages of Subjects
Interval 68.1 to 99.83
|
0 Percentages of Subjects
Interval 0.0 to 15.4
|
100 Percentages of Subjects
Interval 66.4 to 100.0
|
95 Percentages of Subjects
Interval 76.2 to 99.88
|
57 Percentages of Subjects
Interval 34.0 to 78.2
|
79 Percentages of Subjects
Interval 54.4 to 93.9
|
6 Percentages of Subjects
Interval 0.14 to 27.3
|
—
|
—
|
|
9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains.
H44/76 (Day 1, N=24,25,16,23,11,20,6,5,5)
|
100 Percentages of Subjects
Interval 85.8 to 100.0
|
96 Percentages of Subjects
Interval 79.6 to 99.9
|
100 Percentages of Subjects
Interval 79.4 to 100.0
|
96 Percentages of Subjects
Interval 78.1 to 99.89
|
91 Percentages of Subjects
Interval 58.7 to 99.77
|
90 Percentages of Subjects
Interval 68.3 to 98.8
|
0 Percentages of Subjects
Interval 0.0 to 45.9
|
0 Percentages of Subjects
Interval 0.0 to 52.2
|
0 Percentages of Subjects
Interval 0.0 to 52.2
|
—
|
—
|
|
9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains.
H44/76 (Day 30, N=25,25,16,22,11,21,19,19,18)
|
84 Percentages of Subjects
Interval 63.9 to 95.5
|
4 Percentages of Subjects
Interval 0.1 to 20.4
|
94 Percentages of Subjects
Interval 69.8 to 99.84
|
0 Percentages of Subjects
Interval 0.0 to 15.4
|
100 Percentages of Subjects
Interval 71.5 to 100.0
|
76 Percentages of Subjects
Interval 52.8 to 91.8
|
37 Percentages of Subjects
Interval 16.3 to 61.6
|
26 Percentages of Subjects
Interval 9.1 to 51.2
|
6 Percentages of Subjects
Interval 0.14 to 27.3
|
—
|
—
|
|
9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains.
M01-0240364 (Day 1, N=23,23,16,20,11,20,6,5,4)
|
78 Percentages of Subjects
Interval 56.3 to 92.5
|
74 Percentages of Subjects
Interval 51.6 to 89.8
|
63 Percentages of Subjects
Interval 35.4 to 84.8
|
75 Percentages of Subjects
Interval 50.9 to 91.3
|
82 Percentages of Subjects
Interval 48.2 to 97.7
|
85 Percentages of Subjects
Interval 62.1 to 96.8
|
0 Percentages of Subjects
Interval 0.0 to 45.9
|
0 Percentages of Subjects
Interval 0.0 to 52.2
|
0 Percentages of Subjects
Interval 0.0 to 60.2
|
—
|
—
|
|
9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains.
M01-0240364 (Day30,N=24,25,15,20,10,21,20,18,18)
|
100 Percentages of Subjects
Interval 85.8 to 100.0
|
4 Percentages of Subjects
Interval 0.1 to 20.4
|
93 Percentages of Subjects
Interval 68.1 to 99.83
|
5 Percentages of Subjects
Interval 0.13 to 24.9
|
100 Percentages of Subjects
Interval 69.2 to 100.0
|
90 Percentages of Subjects
Interval 69.6 to 98.8
|
20 Percentages of Subjects
Interval 5.7 to 43.7
|
22 Percentages of Subjects
Interval 6.4 to 47.6
|
6 Percentages of Subjects
Interval 0.14 to 27.3
|
—
|
—
|
|
9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains.
M07-0241084 (Day 1, N=24,23,16,21,11,20,6,5,4)
|
25 Percentages of Subjects
Interval 9.8 to 46.7
|
17 Percentages of Subjects
Interval 5.0 to 38.8
|
31 Percentages of Subjects
Interval 11.0 to 58.7
|
19 Percentages of Subjects
Interval 5.4 to 41.9
|
45 Percentages of Subjects
Interval 16.7 to 76.6
|
55 Percentages of Subjects
Interval 31.5 to 76.9
|
0 Percentages of Subjects
Interval 0.0 to 45.9
|
0 Percentages of Subjects
Interval 0.0 to 52.2
|
0 Percentages of Subjects
Interval 0.0 to 60.2
|
—
|
—
|
|
9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains.
M07-0241084 (Day 30,N=25,25,15,22,11,21,21,19,18)
|
76 Percentages of Subjects
Interval 54.9 to 90.6
|
0 Percentages of Subjects
Interval 0.0 to 13.7
|
87 Percentages of Subjects
Interval 59.5 to 98.3
|
0 Percentages of Subjects
Interval 0.0 to 15.4
|
82 Percentages of Subjects
Interval 48.2 to 97.7
|
62 Percentages of Subjects
Interval 38.4 to 81.9
|
14 Percentages of Subjects
Interval 3.0 to 36.3
|
0 Percentages of Subjects
Interval 0.0 to 17.6
|
6 Percentages of Subjects
Interval 0.14 to 27.3
|
—
|
—
|
|
9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains.
M14459 (Day 1, N=24,25,16,22,11,20,6,5,5)
|
54 Percentages of Subjects
Interval 32.8 to 74.4
|
48 Percentages of Subjects
Interval 27.8 to 68.7
|
63 Percentages of Subjects
Interval 35.4 to 84.8
|
59 Percentages of Subjects
Interval 36.4 to 79.3
|
91 Percentages of Subjects
Interval 58.7 to 99.77
|
60 Percentages of Subjects
Interval 36.1 to 80.9
|
0 Percentages of Subjects
Interval 0.0 to 45.9
|
0 Percentages of Subjects
Interval 0.0 to 52.2
|
0 Percentages of Subjects
Interval 0.0 to 52.2
|
—
|
—
|
|
9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains.
M14459 (Day 30, N=25,25,15,23,11,21,5,20,19,18)
|
72 Percentages of Subjects
Interval 50.6 to 87.9
|
0 Percentages of Subjects
Interval 0.0 to 13.7
|
87 Percentages of Subjects
Interval 59.5 to 98.3
|
0 Percentages of Subjects
Interval 0.0 to 14.8
|
100 Percentages of Subjects
Interval 71.5 to 100.0
|
76 Percentages of Subjects
Interval 52.8 to 91.8
|
15 Percentages of Subjects
Interval 3.2 to 37.9
|
5 Percentages of Subjects
Interval 0.13 to 26.0
|
6 Percentages of Subjects
Interval 0.14 to 27.3
|
—
|
—
|
|
9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains.
NZ98/254 (Day 1, N=24,24,16,22,11,20,6,5,5)
|
50 Percentages of Subjects
Interval 29.1 to 70.9
|
46 Percentages of Subjects
Interval 25.6 to 67.2
|
50 Percentages of Subjects
Interval 24.7 to 75.3
|
59 Percentages of Subjects
Interval 36.4 to 79.3
|
55 Percentages of Subjects
Interval 23.4 to 83.3
|
70 Percentages of Subjects
Interval 45.7 to 88.1
|
0 Percentages of Subjects
Interval 0.0 to 45.9
|
0 Percentages of Subjects
Interval 0.0 to 52.2
|
0 Percentages of Subjects
Interval 0.0 to 52.2
|
—
|
—
|
|
9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains.
NZ98/254 (Day 30, N=25,25,15,23,11,21,21,19,18)
|
76 Percentages of Subjects
Interval 54.9 to 90.6
|
0 Percentages of Subjects
Interval 0.0 to 13.7
|
67 Percentages of Subjects
Interval 38.4 to 88.2
|
4 Percentages of Subjects
Interval 0.11 to 21.9
|
82 Percentages of Subjects
Interval 48.2 to 97.7
|
67 Percentages of Subjects
Interval 43.0 to 85.4
|
19 Percentages of Subjects
Interval 5.4 to 41.9
|
5 Percentages of Subjects
Interval 0.13 to 26.0
|
6 Percentages of Subjects
Interval 0.14 to 27.3
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 30Population: Analysis was done on FAS Day 30 (Booster) population.. All subjects in the enrolled population who were randomized, actually received the study vaccination in V102\_03E1 and provided an evaluable serum sample at Day 30 (for seroresponse, Day 1 and Day 30 samples were required).
Percentage of subjects with HT-hSBA titer ≥ 1:8 to N. meningitidis serogroups A,C,W,Y at Day 1 and Day 30 (one month) after the administration of a booster dose of MenABCWY vaccine or placebo in this study, versus baseline.
Outcome measures
| Measure |
2OMV_OMV
n=25 Participants
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
|
2qOMV_qOMV
n=25 Participants
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
|
rMenB+OMV
n=16 Participants
Subjects received two doses of rMenB + OMV, administered two months apart.
|
Menveo
n=23 Participants
Subjects received a dose of placebo followed by one dose of MenACWY administered two months later.
|
2B_OMV
n=11 Participants
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study
|
2B_qOMV
n=21 Participants
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study
|
1M_OMV
n=21 Participants
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
|
1M_qOMV
n=18 Participants
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
|
1M_Pbo
n=18 Participants
Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
|
1M_Pbo
Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
|
Total
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
10. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 Against N. Meningitidis Serogroups A,C,W,Y.
Men W (Day 1, N=20,24,13,21,11,19,18,17,15)
|
95 Percentages of Subjects
Interval 75.1 to 99.87
|
88 Percentages of Subjects
Interval 67.6 to 97.3
|
77 Percentages of Subjects
Interval 46.2 to 95.0
|
71 Percentages of Subjects
Interval 47.8 to 88.7
|
82 Percentages of Subjects
Interval 48.2 to 97.7
|
79 Percentages of Subjects
Interval 54.4 to 93.9
|
83 Percentages of Subjects
Interval 58.6 to 96.4
|
53 Percentages of Subjects
Interval 27.8 to 77.0
|
53 Percentages of Subjects
Interval 26.6 to 78.7
|
—
|
—
|
|
10. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 Against N. Meningitidis Serogroups A,C,W,Y.
Men W (Day 30, N=20,24,16,22,11,19,19,17,16)
|
100 Percentages of Subjects
Interval 83.2 to 100.0
|
79 Percentages of Subjects
Interval 57.8 to 92.9
|
100 Percentages of Subjects
Interval 79.4 to 100.0
|
77 Percentages of Subjects
Interval 54.6 to 92.9
|
100 Percentages of Subjects
Interval 71.5 to 100.0
|
100 Percentages of Subjects
Interval 82.4 to 100.0
|
100 Percentages of Subjects
Interval 82.4 to 100.0
|
100 Percentages of Subjects
Interval 80.5 to 100.0
|
63 Percentages of Subjects
Interval 35.4 to 84.8
|
—
|
—
|
|
10. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 Against N. Meningitidis Serogroups A,C,W,Y.
Men Y (Day 1, N=25,25,14,22,11,21,21,18,18)
|
64 Percentages of Subjects
Interval 42.5 to 82.0
|
64 Percentages of Subjects
Interval 42.5 to 82.0
|
64 Percentages of Subjects
Interval 35.1 to 87.2
|
41 Percentages of Subjects
Interval 20.7 to 63.6
|
36 Percentages of Subjects
Interval 10.9 to 69.2
|
10 Percentages of Subjects
Interval 1.2 to 30.4
|
52 Percentages of Subjects
Interval 29.8 to 74.3
|
39 Percentages of Subjects
Interval 17.3 to 64.3
|
39 Percentages of Subjects
Interval 17.3 to 64.3
|
—
|
—
|
|
10. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 Against N. Meningitidis Serogroups A,C,W,Y.
Men Y (Day 30, N=25,25,16,23,11,21,21,18,18)
|
100 Percentages of Subjects
Interval 86.3 to 100.0
|
60 Percentages of Subjects
Interval 38.7 to 78.9
|
100 Percentages of Subjects
Interval 79.4 to 100.0
|
39 Percentages of Subjects
Interval 19.7 to 61.5
|
82 Percentages of Subjects
Interval 48.2 to 97.7
|
76 Percentages of Subjects
Interval 52.8 to 91.8
|
100 Percentages of Subjects
Interval 83.9 to 100.0
|
100 Percentages of Subjects
Interval 81.5 to 100.0
|
39 Percentages of Subjects
Interval 17.3 to 64.3
|
—
|
—
|
|
10. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 Against N. Meningitidis Serogroups A,C,W,Y.
Men A (Day 1, N=25,25,16,22,11,21,19,16,18)
|
32 Percentages of Subjects
Interval 14.9 to 53.5
|
20 Percentages of Subjects
Interval 6.8 to 40.7
|
19 Percentages of Subjects
Interval 4.0 to 45.6
|
27 Percentages of Subjects
Interval 10.7 to 50.2
|
27 Percentages of Subjects
Interval 6.0 to 61.0
|
33 Percentages of Subjects
Interval 14.6 to 57.0
|
47 Percentages of Subjects
Interval 24.4 to 71.1
|
6 Percentages of Subjects
Interval 0.16 to 30.2
|
39 Percentages of Subjects
Interval 17.3 to 64.3
|
—
|
—
|
|
10. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 Against N. Meningitidis Serogroups A,C,W,Y.
Men A (Day 30, N=25,25,16,22,11,21,19,17,18)
|
100 Percentages of Subjects
Interval 86.3 to 100.0
|
36 Percentages of Subjects
Interval 18.0 to 57.5
|
100 Percentages of Subjects
Interval 79.4 to 100.0
|
27 Percentages of Subjects
Interval 10.7 to 50.2
|
100 Percentages of Subjects
Interval 71.5 to 100.0
|
95 Percentages of Subjects
Interval 76.2 to 99.88
|
100 Percentages of Subjects
Interval 82.4 to 100.0
|
94 Percentages of Subjects
Interval 71.3 to 99.85
|
39 Percentages of Subjects
Interval 17.3 to 64.3
|
—
|
—
|
|
10. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 Against N. Meningitidis Serogroups A,C,W,Y.
Men C (Day 1, N=20,23,10,22,7,16,21,18,17)
|
70 Percentages of Subjects
Interval 45.7 to 88.1
|
65 Percentages of Subjects
Interval 42.7 to 83.6
|
70 Percentages of Subjects
Interval 34.8 to 93.3
|
68 Percentages of Subjects
Interval 45.1 to 86.1
|
43 Percentages of Subjects
Interval 9.9 to 81.6
|
63 Percentages of Subjects
Interval 35.4 to 84.8
|
57 Percentages of Subjects
Interval 34.0 to 78.2
|
44 Percentages of Subjects
Interval 21.5 to 69.2
|
65 Percentages of Subjects
Interval 38.3 to 85.8
|
—
|
—
|
|
10. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 Against N. Meningitidis Serogroups A,C,W,Y.
Men C (Day 30, N=21,24,11,23,7,16,21,18,18)
|
100 Percentages of Subjects
Interval 83.9 to 100.0
|
63 Percentages of Subjects
Interval 40.6 to 81.2
|
100 Percentages of Subjects
Interval 71.5 to 100.0
|
61 Percentages of Subjects
Interval 38.5 to 80.3
|
100 Percentages of Subjects
Interval 59.0 to 100.0
|
100 Percentages of Subjects
Interval 79.4 to 100.0
|
100 Percentages of Subjects
Interval 83.9 to 100.0
|
89 Percentages of Subjects
Interval 65.3 to 98.6
|
61 Percentages of Subjects
Interval 35.7 to 82.7
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 30Population: Analysis was done on FAS Day 30 (Booster) population.. All subjects in the enrolled population who were randomized, actually received the study vaccination in V102\_03E1 and provided an evaluable serum sample at Day 30 (for seroresponse, Day 1 and Day 30 samples were required).
Percentage of subjects with HT-hSBA titer ≥ 1:5 to N. meningitidis serogroup B strains at Day 1 and Day 30 (one month) after the administration of a booster dose of MenABCWY vaccine or placebo in this study, versus baseline.
Outcome measures
| Measure |
2OMV_OMV
n=25 Participants
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
|
2qOMV_qOMV
n=25 Participants
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
|
rMenB+OMV
n=17 Participants
Subjects received two doses of rMenB + OMV, administered two months apart.
|
Menveo
n=23 Participants
Subjects received a dose of placebo followed by one dose of MenACWY administered two months later.
|
2B_OMV
n=11 Participants
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study
|
2B_qOMV
n=21 Participants
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study
|
1M_OMV
n=21 Participants
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
|
1M_qOMV
n=19 Participants
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
|
1M_Pbo
n=18 Participants
Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
|
1M_Pbo
Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
|
Total
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains.
5/99 (Day 1, N=25,25,15,22,9,21,21,19,18)
|
76 Percentages of Subjects
Interval 54.9 to 90.6
|
76 Percentages of Subjects
Interval 54.9 to 90.6
|
87 Percentages of Subjects
Interval 59.5 to 98.3
|
86 Percentages of Subjects
Interval 65.1 to 97.1
|
89 Percentages of Subjects
Interval 51.8 to 99.72
|
95 Percentages of Subjects
Interval 76.2 to 99.88
|
19 Percentages of Subjects
Interval 5.4 to 41.9
|
16 Percentages of Subjects
Interval 3.4 to 39.6
|
22 Percentages of Subjects
Interval 6.4 to 47.6
|
—
|
—
|
|
11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains.
5/99 (Day 30, N=25,25,17,23,11,21,21,19,18)
|
100 Percentages of Subjects
Interval 86.3 to 100.0
|
84 Percentages of Subjects
Interval 63.9 to 95.5
|
100 Percentages of Subjects
Interval 80.5 to 100.0
|
91 Percentages of Subjects
Interval 72.0 to 98.6
|
100 Percentages of Subjects
Interval 71.5 to 100.0
|
100 Percentages of Subjects
Interval 83.9 to 100.0
|
76 Percentages of Subjects
Interval 52.8 to 91.8
|
84 Percentages of Subjects
Interval 60.4 to 96.6
|
22 Percentages of Subjects
Interval 6.4 to 47.6
|
—
|
—
|
|
11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains.
H44/76 (Day 1, N=25,25,16,22,11,21,19,19,18)
|
16 Percentages of Subjects
Interval 4.5 to 36.1
|
24 Percentages of Subjects
Interval 9.4 to 45.1
|
13 Percentages of Subjects
Interval 1.6 to 38.3
|
18 Percentages of Subjects
Interval 5.2 to 40.3
|
45 Percentages of Subjects
Interval 16.7 to 76.6
|
29 Percentages of Subjects
Interval 11.3 to 52.2
|
0 Percentages of Subjects
Interval 0.0 to 17.6
|
5 Percentages of Subjects
Interval 0.13 to 26.0
|
0 Percentages of Subjects
Interval 0.0 to 18.5
|
—
|
—
|
|
11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains.
H44/76 (Day 30, N=25,25,17,23,11,21,19,19,18)
|
96 Percentages of Subjects
Interval 79.6 to 99.9
|
24 Percentages of Subjects
Interval 9.4 to 45.1
|
100 Percentages of Subjects
Interval 80.5 to 100.0
|
26 Percentages of Subjects
Interval 10.2 to 48.4
|
100 Percentages of Subjects
Interval 71.5 to 100.0
|
100 Percentages of Subjects
Interval 83.9 to 100.0
|
58 Percentages of Subjects
Interval 33.5 to 79.7
|
32 Percentages of Subjects
Interval 12.6 to 56.6
|
6 Percentages of Subjects
Interval 0.14 to 27.3
|
—
|
—
|
|
11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains.
M01-0240364 (Day 1, N=24,25,15,20,10,21,20,18,18)
|
25 Percentages of Subjects
Interval 9.8 to 46.7
|
24 Percentages of Subjects
Interval 9.4 to 45.1
|
20 Percentages of Subjects
Interval 4.3 to 48.1
|
5 Percentages of Subjects
Interval 0.13 to 24.9
|
20 Percentages of Subjects
Interval 2.5 to 55.6
|
43 Percentages of Subjects
Interval 21.8 to 66.0
|
5 Percentages of Subjects
Interval 0.13 to 24.9
|
6 Percentages of Subjects
Interval 0.14 to 27.3
|
11 Percentages of Subjects
Interval 1.4 to 34.7
|
—
|
—
|
|
11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains.
M01-0240364 (Day 30, N=25,25,17,22,11,21,20,19,18)
|
100 Percentages of Subjects
Interval 86.3 to 100.0
|
24 Percentages of Subjects
Interval 9.4 to 45.1
|
100 Percentages of Subjects
Interval 80.5 to 100.0
|
18 Percentages of Subjects
Interval 5.2 to 40.3
|
100 Percentages of Subjects
Interval 71.5 to 100.0
|
100 Percentages of Subjects
Interval 83.9 to 100.0
|
25 Percentages of Subjects
Interval 8.7 to 49.1
|
26 Percentages of Subjects
Interval 9.1 to 51.2
|
11 Percentages of Subjects
Interval 1.4 to 34.7
|
—
|
—
|
|
11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains.
M07-0241084 (Day 1,N=25,25,15,22,11,21,21,19,18)
|
36 Percentages of Subjects
Interval 18.0 to 57.5
|
36 Percentages of Subjects
Interval 18.0 to 57.5
|
27 Percentages of Subjects
Interval 7.8 to 55.1
|
27 Percentages of Subjects
Interval 10.7 to 50.2
|
64 Percentages of Subjects
Interval 30.8 to 89.1
|
52 Percentages of Subjects
Interval 29.8 to 74.3
|
19 Percentages of Subjects
Interval 5.4 to 41.9
|
16 Percentages of Subjects
Interval 3.4 to 39.6
|
33 Percentages of Subjects
Interval 13.3 to 59.0
|
—
|
—
|
|
11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains.
M07-0241084 (Day 30,N=25,25,17,23,11,21,21,19,18)
|
100 Percentages of Subjects
Interval 86.3 to 100.0
|
40 Percentages of Subjects
Interval 21.1 to 61.3
|
88 Percentages of Subjects
Interval 63.6 to 98.5
|
30 Percentages of Subjects
Interval 13.2 to 52.9
|
91 Percentages of Subjects
Interval 58.7 to 99.77
|
95 Percentages of Subjects
Interval 76.2 to 99.88
|
33 Percentages of Subjects
Interval 14.6 to 57.0
|
21 Percentages of Subjects
Interval 6.1 to 45.6
|
33 Percentages of Subjects
Interval 13.3 to 59.0
|
—
|
—
|
|
11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains.
M14459 (Day 1, N=25,25,15,23,11,21,20,19,18)
|
24 Percentages of Subjects
Interval 9.4 to 45.1
|
32 Percentages of Subjects
Interval 14.9 to 53.5
|
7 Percentages of Subjects
Interval 0.17 to 31.9
|
17 Percentages of Subjects
Interval 5.0 to 38.8
|
36 Percentages of Subjects
Interval 10.9 to 69.2
|
29 Percentages of Subjects
Interval 11.3 to 52.2
|
10 Percentages of Subjects
Interval 1.2 to 31.7
|
11 Percentages of Subjects
Interval 1.3 to 33.1
|
22 Percentages of Subjects
Interval 6.4 to 47.6
|
—
|
—
|
|
11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains.
M14459 (Day 30, N=25,25,17,23,11,21,20,19,18)
|
92 Percentages of Subjects
Interval 74.0 to 99.0
|
28 Percentages of Subjects
Interval 12.1 to 49.4
|
88 Percentages of Subjects
Interval 63.6 to 98.5
|
30 Percentages of Subjects
Interval 13.2 to 52.9
|
100 Percentages of Subjects
Interval 71.5 to 100.0
|
95 Percentages of Subjects
Interval 76.2 to 99.88
|
35 Percentages of Subjects
Interval 15.4 to 59.2
|
32 Percentages of Subjects
Interval 12.6 to 56.6
|
22 Percentages of Subjects
Interval 6.4 to 47.6
|
—
|
—
|
|
11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains.
NZ98/254 (Day 1, N=25,25,15,23,11,21,21,19,18)
|
16 Percentages of Subjects
Interval 4.5 to 36.1
|
28 Percentages of Subjects
Interval 12.1 to 49.4
|
7 Percentages of Subjects
Interval 0.17 to 31.9
|
9 Percentages of Subjects
Interval 1.1 to 28.0
|
9 Percentages of Subjects
Interval 0.23 to 41.3
|
24 Percentages of Subjects
Interval 8.2 to 47.2
|
5 Percentages of Subjects
Interval 0.12 to 23.8
|
5 Percentages of Subjects
Interval 0.13 to 26.0
|
0 Percentages of Subjects
Interval 0.0 to 18.5
|
—
|
—
|
|
11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains.
NZ98/254 (Day 30, N=25,25,17,23,11,21,21,19,18)
|
92 Percentages of Subjects
Interval 74.0 to 99.0
|
20 Percentages of Subjects
Interval 6.8 to 40.7
|
71 Percentages of Subjects
Interval 44.0 to 89.7
|
13 Percentages of Subjects
Interval 2.8 to 33.6
|
82 Percentages of Subjects
Interval 48.2 to 97.7
|
95 Percentages of Subjects
Interval 76.2 to 99.88
|
19 Percentages of Subjects
Interval 5.4 to 41.9
|
16 Percentages of Subjects
Interval 3.4 to 39.6
|
6 Percentages of Subjects
Interval 0.14 to 27.3
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 30Population: Analysis was done on FAS Day 30 (Booster) population. All subjects in the enrolled population who were randomized, actually received the study vaccination in V102\_03E1 and provided an evaluable serum sample at Day 30 (for seroresponse, Day 1 and Day 30 samples were required).
Percentage of subjects with seroresponse to N. meningitidis serogroup A, C, W and Y, at Day 30 after the administration of a booster dose of MenABCWY vaccine or placebo in this study, versus baseline.
Outcome measures
| Measure |
2OMV_OMV
n=25 Participants
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
|
2qOMV_qOMV
n=25 Participants
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
|
rMenB+OMV
n=16 Participants
Subjects received two doses of rMenB + OMV, administered two months apart.
|
Menveo
n=22 Participants
Subjects received a dose of placebo followed by one dose of MenACWY administered two months later.
|
2B_OMV
n=11 Participants
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study
|
2B_qOMV
n=21 Participants
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study
|
1M_OMV
n=21 Participants
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
|
1M_qOMV
n=18 Participants
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
|
1M_Pbo
n=18 Participants
Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
|
1M_Pbo
Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
|
Total
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
12. Percentage of Subjects With Seroresponse to N. Meningitidis Serogroups A, C, W and Y, at Day 30 After Booster Vaccination in This Study.
Men A Overall
|
96 Percentages of Subjects
Interval 79.6 to 99.9
|
12 Percentages of Subjects
Interval 2.5 to 31.2
|
94 Percentages of Subjects
Interval 69.8 to 99.84
|
0 Percentages of Subjects
Interval 0.0 to 15.4
|
100 Percentages of Subjects
Interval 71.5 to 100.0
|
86 Percentages of Subjects
Interval 63.7 to 97.0
|
84 Percentages of Subjects
Interval 60.4 to 96.6
|
94 Percentages of Subjects
Interval 69.8 to 99.84
|
0 Percentages of Subjects
Interval 0.0 to 18.5
|
—
|
—
|
|
12. Percentage of Subjects With Seroresponse to N. Meningitidis Serogroups A, C, W and Y, at Day 30 After Booster Vaccination in This Study.
Men C Overall
|
85 Percentages of Subjects
Interval 62.1 to 96.8
|
4 Percentages of Subjects
Interval 0.11 to 21.9
|
100 Percentages of Subjects
Interval 69.2 to 100.0
|
0 Percentages of Subjects
Interval 0.0 to 15.4
|
100 Percentages of Subjects
Interval 59.0 to 100.0
|
81 Percentages of Subjects
Interval 54.4 to 96.0
|
95 Percentages of Subjects
Interval 76.2 to 99.88
|
78 Percentages of Subjects
Interval 52.4 to 93.6
|
6 Percentages of Subjects
Interval 0.15 to 28.7
|
—
|
—
|
|
12. Percentage of Subjects With Seroresponse to N. Meningitidis Serogroups A, C, W and Y, at Day 30 After Booster Vaccination in This Study.
Men W Overall
|
85 Percentages of Subjects
Interval 62.1 to 96.8
|
4 Percentages of Subjects
Interval 0.11 to 21.1
|
85 Percentages of Subjects
Interval 54.6 to 98.1
|
5 Percentages of Subjects
Interval 0.12 to 23.8
|
82 Percentages of Subjects
Interval 48.2 to 97.7
|
68 Percentages of Subjects
Interval 43.4 to 87.4
|
83 Percentages of Subjects
Interval 58.6 to 96.4
|
76 Percentages of Subjects
Interval 50.1 to 93.2
|
20 Percentages of Subjects
Interval 4.3 to 48.1
|
—
|
—
|
|
12. Percentage of Subjects With Seroresponse to N. Meningitidis Serogroups A, C, W and Y, at Day 30 After Booster Vaccination in This Study.
Men Y Overall
|
96 Percentages of Subjects
Interval 79.6 to 99.9
|
4 Percentages of Subjects
Interval 0.1 to 20.4
|
100 Percentages of Subjects
Interval 76.8 to 100.0
|
0 Percentages of Subjects
Interval 0.0 to 15.4
|
73 Percentages of Subjects
Interval 39.0 to 94.0
|
62 Percentages of Subjects
Interval 38.4 to 81.9
|
95 Percentages of Subjects
Interval 76.2 to 99.88
|
89 Percentages of Subjects
Interval 65.3 to 98.6
|
6 Percentages of Subjects
Interval 0.14 to 27.3
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 365Population: Analysis was done on the FAS Day 365 (Persistence of Booster) population. All subjects in the enrolled population who were randomized, actually received the study vaccination in V102\_03E1 and provided an evaluable serum sample at Day 365.
Percentage of subjects with HT-hSBA titer ≥ 1:8 against N. meningitidis serogroups A, C, W, Y, at 24 and 36 months after the primary vaccination.
Outcome measures
| Measure |
2OMV_OMV
n=21 Participants
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
|
2qOMV_qOMV
n=22 Participants
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
|
rMenB+OMV
n=16 Participants
Subjects received two doses of rMenB + OMV, administered two months apart.
|
Menveo
n=20 Participants
Subjects received a dose of placebo followed by one dose of MenACWY administered two months later.
|
2B_OMV
n=11 Participants
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study
|
2B_qOMV
n=20 Participants
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study
|
1M_OMV
n=20 Participants
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
|
1M_qOMV
n=18 Participants
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
|
1M_Pbo
n=17 Participants
Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
|
1M_Pbo
Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
|
Total
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
13. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y.
Men A (Day 1, N= 21,22,15,20,10,20,20,17,17)
|
38 Percentages of Subjects
Interval 18.1 to 61.6
|
18 Percentages of Subjects
Interval 5.2 to 40.3
|
20 Percentages of Subjects
Interval 4.3 to 48.1
|
30 Percentages of Subjects
Interval 11.9 to 54.3
|
30 Percentages of Subjects
Interval 6.7 to 65.2
|
35 Percentages of Subjects
Interval 15.4 to 59.2
|
45 Percentages of Subjects
Interval 23.1 to 68.5
|
12 Percentages of Subjects
Interval 1.5 to 36.4
|
41 Percentages of Subjects
Interval 18.4 to 67.1
|
—
|
—
|
|
13. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y.
Men A (Day 365, N= 21,22,16,20,10,20,20,18,17)
|
67 Percentages of Subjects
Interval 43.0 to 85.4
|
23 Percentages of Subjects
Interval 7.8 to 45.4
|
88 Percentages of Subjects
Interval 61.7 to 98.4
|
25 Percentages of Subjects
Interval 8.7 to 49.1
|
90 Percentages of Subjects
Interval 55.5 to 99.75
|
85 Percentages of Subjects
Interval 62.1 to 96.8
|
85 Percentages of Subjects
Interval 62.1 to 96.8
|
50 Percentages of Subjects
Interval 26.0 to 74.0
|
35 Percentages of Subjects
Interval 14.2 to 61.7
|
—
|
—
|
|
13. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y.
Men C (Day 1, N= 20,19,14,20,11,19,19,18,16)
|
65 Percentages of Subjects
Interval 40.8 to 84.6
|
68 Percentages of Subjects
Interval 43.4 to 87.4
|
71 Percentages of Subjects
Interval 41.9 to 91.6
|
65 Percentages of Subjects
Interval 40.8 to 84.6
|
36 Percentages of Subjects
Interval 10.9 to 69.2
|
58 Percentages of Subjects
Interval 33.5 to 79.7
|
58 Percentages of Subjects
Interval 33.5 to 79.7
|
50 Percentages of Subjects
Interval 26.0 to 74.0
|
75 Percentages of Subjects
Interval 47.6 to 92.7
|
—
|
—
|
|
13. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y.
Men C (Day 365, N= 21,21,16,20,11,19,19,18,17)
|
100 Percentages of Subjects
Interval 83.9 to 100.0
|
62 Percentages of Subjects
Interval 38.4 to 81.9
|
100 Percentages of Subjects
Interval 79.4 to 100.0
|
50 Percentages of Subjects
Interval 27.2 to 72.8
|
82 Percentages of Subjects
Interval 48.2 to 97.7
|
95 Percentages of Subjects
Interval 74.0 to 99.87
|
100 Percentages of Subjects
Interval 82.4 to 100.0
|
89 Percentages of Subjects
Interval 65.3 to 98.6
|
65 Percentages of Subjects
Interval 38.3 to 85.8
|
—
|
—
|
|
13. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y.
Men W (Day 1, N= 20,22,12,20,11,20,17,18,16)
|
95 Percentages of Subjects
Interval 75.1 to 99.87
|
95 Percentages of Subjects
Interval 77.2 to 99.88
|
75 Percentages of Subjects
Interval 42.8 to 94.5
|
70 Percentages of Subjects
Interval 45.7 to 88.1
|
82 Percentages of Subjects
Interval 48.2 to 97.7
|
75 Percentages of Subjects
Interval 50.9 to 91.3
|
82 Percentages of Subjects
Interval 56.6 to 96.2
|
61 Percentages of Subjects
Interval 35.7 to 82.7
|
56 Percentages of Subjects
Interval 29.9 to 80.2
|
—
|
—
|
|
13. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y.
Men W (Day 365, N= 21,22,16,20,11,20,19,18,17)
|
100 Percentages of Subjects
Interval 83.9 to 100.0
|
82 Percentages of Subjects
Interval 59.7 to 94.8
|
100 Percentages of Subjects
Interval 79.4 to 100.0
|
65 Percentages of Subjects
Interval 40.8 to 84.6
|
91 Percentages of Subjects
Interval 58.7 to 99.77
|
100 Percentages of Subjects
Interval 83.2 to 100.0
|
100 Percentages of Subjects
Interval 82.4 to 100.0
|
100 Percentages of Subjects
Interval 81.5 to 100.0
|
65 Percentages of Subjects
Interval 38.3 to 85.8
|
—
|
—
|
|
13. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y.
Men Y (Day 1, N= 21,21,14,20,11,18,20,18,17)
|
62 Percentages of Subjects
Interval 38.4 to 81.9
|
62 Percentages of Subjects
Interval 38.4 to 81.9
|
71 Percentages of Subjects
Interval 41.9 to 91.6
|
40 Percentages of Subjects
Interval 19.1 to 63.9
|
36 Percentages of Subjects
Interval 10.9 to 69.2
|
11 Percentages of Subjects
Interval 1.4 to 34.7
|
55 Percentages of Subjects
Interval 31.5 to 76.9
|
44 Percentages of Subjects
Interval 21.5 to 69.2
|
41 Percentages of Subjects
Interval 18.4 to 67.1
|
—
|
—
|
|
13. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y.
Men Y (Day 365, N= 21,21,16,20,11,18,20,18,17)
|
95 Percentages of Subjects
Interval 76.2 to 99.88
|
52 Percentages of Subjects
Interval 29.8 to 74.3
|
100 Percentages of Subjects
Interval 79.4 to 100.0
|
40 Percentages of Subjects
Interval 19.1 to 63.9
|
45 Percentages of Subjects
Interval 16.7 to 76.6
|
72 Percentages of Subjects
Interval 46.5 to 90.3
|
100 Percentages of Subjects
Interval 83.2 to 100.0
|
89 Percentages of Subjects
Interval 65.3 to 98.6
|
47 Percentages of Subjects
Interval 23.0 to 72.2
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1, Day 30 and Day 365Population: Analysis was done on FAS Day 365 (Persistence of Booster) population. All subjects in the enrolled population who were randomized, actually received the study vaccination in V102\_03E1 and provided an evaluable serum sample at Day 365.
Percentage of subjects with HT-hSBA titer ≥ 1:5 against N. meningitidis strains of serogroup B, at 24 and 36 months after the primary vaccination.
Outcome measures
| Measure |
2OMV_OMV
n=21 Participants
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
|
2qOMV_qOMV
n=22 Participants
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
|
rMenB+OMV
n=16 Participants
Subjects received two doses of rMenB + OMV, administered two months apart.
|
Menveo
n=20 Participants
Subjects received a dose of placebo followed by one dose of MenACWY administered two months later.
|
2B_OMV
n=11 Participants
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study
|
2B_qOMV
n=20 Participants
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study
|
1M_OMV
n=21 Participants
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
|
1M_qOMV
n=18 Participants
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
|
1M_Pbo
n=17 Participants
Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
|
1M_Pbo
Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
|
Total
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B
NZ98/254 (Day 365, N=21,22,16,20,11,19,21,18,17)
|
29 Percentages of Subjects
Interval 11.3 to 52.2
|
14 Percentages of Subjects
Interval 2.9 to 34.9
|
31 Percentages of Subjects
Interval 11.0 to 58.7
|
5 Percentages of Subjects
Interval 0.13 to 24.9
|
45 Percentages of Subjects
Interval 16.7 to 76.6
|
42 Percentages of Subjects
Interval 20.3 to 66.5
|
19 Percentages of Subjects
Interval 5.4 to 41.9
|
6 Percentages of Subjects
Interval 0.14 to 27.3
|
6 Percentages of Subjects
Interval 0.15 to 28.7
|
—
|
—
|
|
14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B
5/99 (Day 1, N=21,22,14,20,9,19,21,18,17)
|
76 Percentages of Subjects
Interval 52.8 to 91.8
|
82 Percentages of Subjects
Interval 59.7 to 94.8
|
86 Percentages of Subjects
Interval 57.2 to 98.2
|
85 Percentages of Subjects
Interval 62.1 to 96.8
|
89 Percentages of Subjects
Interval 51.8 to 99.72
|
95 Percentages of Subjects
Interval 74.0 to 99.87
|
19 Percentages of Subjects
Interval 5.4 to 41.9
|
17 Percentages of Subjects
Interval 3.6 to 41.4
|
24 Percentages of Subjects
Interval 6.8 to 49.9
|
—
|
—
|
|
14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B
5/99 (Day 30, N=21,22,16,20,11,19,21,18,16)
|
100 Percentages of Subjects
Interval 83.9 to 100.0
|
86 Percentages of Subjects
Interval 65.1 to 97.1
|
100 Percentages of Subjects
Interval 79.4 to 100.0
|
90 Percentages of Subjects
Interval 68.3 to 98.8
|
100 Percentages of Subjects
Interval 71.5 to 100.0
|
100 Percentages of Subjects
Interval 82.4 to 100.0
|
76 Percentages of Subjects
Interval 52.8 to 91.8
|
83 Percentages of Subjects
Interval 58.6 to 96.4
|
25 Percentages of Subjects
Interval 7.3 to 52.4
|
—
|
—
|
|
14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B
5/99 (Day 365, N=21,22,16,20,11,19,21,18,17)
|
95 Percentages of Subjects
Interval 76.2 to 99.88
|
77 Percentages of Subjects
Interval 54.6 to 92.2
|
100 Percentages of Subjects
Interval 79.4 to 100.0
|
80 Percentages of Subjects
Interval 56.3 to 94.3
|
100 Percentages of Subjects
Interval 71.5 to 100.0
|
100 Percentages of Subjects
Interval 82.4 to 100.0
|
43 Percentages of Subjects
Interval 21.8 to 66.0
|
33 Percentages of Subjects
Interval 13.3 to 59.0
|
18 Percentages of Subjects
Interval 3.8 to 43.4
|
—
|
—
|
|
14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B
H44/76 (Day 1, N=21,22,15,20,11,20,21,18,17)
|
19 Percentages of Subjects
Interval 5.4 to 41.9
|
27 Percentages of Subjects
Interval 10.7 to 50.2
|
13 Percentages of Subjects
Interval 1.7 to 40.5
|
15 Percentages of Subjects
Interval 3.2 to 37.9
|
45 Percentages of Subjects
Interval 16.7 to 76.6
|
30 Percentages of Subjects
Interval 11.9 to 54.3
|
5 Percentages of Subjects
Interval 0.12 to 23.8
|
6 Percentages of Subjects
Interval 0.14 to 27.3
|
0 Percentages of Subjects
Interval 0.0 to 19.5
|
—
|
—
|
|
14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B
H44/76 (Day 30, N=21,22,16,20,11,20,19,18,16)
|
95 Percentages of Subjects
Interval 76.2 to 99.88
|
27 Percentages of Subjects
Interval 10.7 to 50.2
|
100 Percentages of Subjects
Interval 79.4 to 100.0
|
15 Percentages of Subjects
Interval 3.2 to 37.9
|
100 Percentages of Subjects
Interval 71.5 to 100.0
|
100 Percentages of Subjects
Interval 83.2 to 100.0
|
58 Percentages of Subjects
Interval 33.5 to 79.7
|
33 Percentages of Subjects
Interval 13.3 to 59.0
|
6 Percentages of Subjects
Interval 0.16 to 30.2
|
—
|
—
|
|
14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B
H44/76 (Day 365, N=21,22,16,20,11,20,21,18,17)
|
76 Percentages of Subjects
Interval 52.8 to 91.8
|
18 Percentages of Subjects
Interval 5.2 to 40.3
|
44 Percentages of Subjects
Interval 19.8 to 70.1
|
10 Percentages of Subjects
Interval 1.2 to 31.7
|
82 Percentages of Subjects
Interval 48.2 to 97.7
|
65 Percentages of Subjects
Interval 40.8 to 84.6
|
19 Percentages of Subjects
Interval 5.4 to 41.9
|
11 Percentages of Subjects
Interval 1.4 to 34.7
|
6 Percentages of Subjects
Interval 0.15 to 28.7
|
—
|
—
|
|
14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B
M01-0240364 (Day 1, N=21,22,14,18,10,19,20,17,17)
|
24 Percentages of Subjects
Interval 8.2 to 47.2
|
27 Percentages of Subjects
Interval 10.7 to 50.2
|
21 Percentages of Subjects
Interval 4.7 to 50.8
|
6 Percentages of Subjects
Interval 0.14 to 27.3
|
20 Percentages of Subjects
Interval 2.5 to 55.6
|
42 Percentages of Subjects
Interval 20.3 to 66.5
|
5 Percentages of Subjects
Interval 0.13 to 24.9
|
6 Percentages of Subjects
Interval 0.15 to 28.7
|
12 Percentages of Subjects
Interval 1.5 to 36.4
|
—
|
—
|
|
14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B
M01-0240364 (Day 30, N=21,22,16,17,11,19,19,18,16)
|
100 Percentages of Subjects
Interval 83.9 to 100.0
|
27 Percentages of Subjects
Interval 10.7 to 50.2
|
100 Percentages of Subjects
Interval 79.4 to 100.0
|
6 Percentages of Subjects
Interval 0.15 to 28.7
|
100 Percentages of Subjects
Interval 71.5 to 100.0
|
100 Percentages of Subjects
Interval 82.4 to 100.0
|
21 Percentages of Subjects
Interval 6.1 to 45.6
|
28 Percentages of Subjects
Interval 9.7 to 53.5
|
13 Percentages of Subjects
Interval 1.6 to 38.3
|
—
|
—
|
|
14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B
M01-0240364(Day 365, N=21,22,16,18,11,19,20,18,17)
|
71 Percentages of Subjects
Interval 47.8 to 88.7
|
32 Percentages of Subjects
Interval 13.9 to 54.9
|
75 Percentages of Subjects
Interval 47.6 to 92.7
|
6 Percentages of Subjects
Interval 0.14 to 27.3
|
100 Percentages of Subjects
Interval 71.5 to 100.0
|
95 Percentages of Subjects
Interval 74.0 to 99.87
|
15 Percentages of Subjects
Interval 3.2 to 37.9
|
11 Percentages of Subjects
Interval 1.4 to 34.7
|
18 Percentages of Subjects
Interval 3.8 to 43.4
|
—
|
—
|
|
14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B
M07-0241084 (Day 1, N=21,22,14,20,11,19,21,18,17)
|
38 Percentages of Subjects
Interval 18.1 to 61.6
|
41 Percentages of Subjects
Interval 20.7 to 63.6
|
29 Percentages of Subjects
Interval 8.4 to 58.1
|
25 Percentages of Subjects
Interval 8.7 to 49.1
|
64 Percentages of Subjects
Interval 30.8 to 89.1
|
58 Percentages of Subjects
Interval 33.5 to 79.7
|
19 Percentages of Subjects
Interval 5.4 to 41.9
|
17 Percentages of Subjects
Interval 3.6 to 41.4
|
35 Percentages of Subjects
Interval 14.2 to 61.7
|
—
|
—
|
|
14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B
M07-0241084 (Day 30, N=21,22,16,20,11,19,21,18,16)
|
100 Percentages of Subjects
Interval 83.9 to 100.0
|
45 Percentages of Subjects
Interval 24.4 to 67.8
|
94 Percentages of Subjects
Interval 69.8 to 99.84
|
25 Percentages of Subjects
Interval 8.7 to 49.1
|
91 Percentages of Subjects
Interval 58.7 to 99.77
|
95 Percentages of Subjects
Interval 74.0 to 99.87
|
33 Percentages of Subjects
Interval 14.6 to 57.0
|
22 Percentages of Subjects
Interval 6.4 to 47.6
|
38 Percentages of Subjects
Interval 15.2 to 64.6
|
—
|
—
|
|
14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B
M07-0241084(Day 365, N=21,22,16,20,11,19,21,18,17)
|
62 Percentages of Subjects
Interval 38.4 to 81.9
|
32 Percentages of Subjects
Interval 13.9 to 54.9
|
50 Percentages of Subjects
Interval 24.7 to 75.3
|
20 Percentages of Subjects
Interval 5.7 to 43.7
|
82 Percentages of Subjects
Interval 48.2 to 97.7
|
74 Percentages of Subjects
Interval 48.8 to 90.9
|
29 Percentages of Subjects
Interval 11.3 to 52.2
|
17 Percentages of Subjects
Interval 3.6 to 41.4
|
35 Percentages of Subjects
Interval 14.2 to 61.7
|
—
|
—
|
|
14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B
M14459 (Day 1, N=21,22,14,20,11,20,21,18,17)
|
24 Percentages of Subjects
Interval 8.2 to 47.2
|
36 Percentages of Subjects
Interval 17.2 to 59.3
|
7 Percentages of Subjects
Interval 0.18 to 33.9
|
15 Percentages of Subjects
Interval 3.2 to 37.9
|
36 Percentages of Subjects
Interval 10.9 to 69.2
|
30 Percentages of Subjects
Interval 11.9 to 54.3
|
10 Percentages of Subjects
Interval 1.2 to 30.4
|
11 Percentages of Subjects
Interval 1.4 to 34.7
|
24 Percentages of Subjects
Interval 6.8 to 49.9
|
—
|
—
|
|
14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B
M14459 (Day 30, N=21,22,16,20,11,20,20,18,16)
|
95 Percentages of Subjects
Interval 76.2 to 99.88
|
32 Percentages of Subjects
Interval 13.9 to 54.9
|
88 Percentages of Subjects
Interval 61.7 to 98.4
|
20 Percentages of Subjects
Interval 5.7 to 43.7
|
100 Percentages of Subjects
Interval 71.5 to 100.0
|
95 Percentages of Subjects
Interval 75.1 to 99.87
|
35 Percentages of Subjects
Interval 15.4 to 59.2
|
33 Percentages of Subjects
Interval 13.3 to 59.0
|
25 Percentages of Subjects
Interval 7.3 to 52.4
|
—
|
—
|
|
14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B
M14459 (Day 365, N=21,22,16,20,11,20,21,18,17)
|
57 Percentages of Subjects
Interval 34.0 to 78.2
|
18 Percentages of Subjects
Interval 5.2 to 40.3
|
38 Percentages of Subjects
Interval 15.2 to 64.6
|
5 Percentages of Subjects
Interval 0.13 to 24.9
|
82 Percentages of Subjects
Interval 48.2 to 97.7
|
60 Percentages of Subjects
Interval 36.1 to 80.9
|
14 Percentages of Subjects
Interval 3.0 to 36.3
|
11 Percentages of Subjects
Interval 1.4 to 34.7
|
24 Percentages of Subjects
Interval 6.8 to 49.9
|
—
|
—
|
|
14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B
NZ98/254 (Day 1, N=21,22,14,20,11,19,21,18,17)
|
19 Percentages of Subjects
Interval 5.4 to 41.9
|
32 Percentages of Subjects
Interval 13.9 to 54.9
|
7 Percentages of Subjects
Interval 0.18 to 33.9
|
5 Percentages of Subjects
Interval 0.13 to 24.9
|
9 Percentages of Subjects
Interval 0.23 to 41.3
|
26 Percentages of Subjects
Interval 9.1 to 51.2
|
5 Percentages of Subjects
Interval 0.12 to 23.8
|
6 Percentages of Subjects
Interval 0.14 to 27.3
|
0 Percentages of Subjects
Interval 0.0 to 19.5
|
—
|
—
|
|
14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B
NZ98/254 (Day 30, N=21,22,16,20,11,19,21,18,16)
|
95 Percentages of Subjects
Interval 76.2 to 99.88
|
23 Percentages of Subjects
Interval 7.8 to 45.4
|
75 Percentages of Subjects
Interval 47.6 to 92.7
|
10 Percentages of Subjects
Interval 1.2 to 31.7
|
82 Percentages of Subjects
Interval 48.2 to 97.7
|
95 Percentages of Subjects
Interval 74.0 to 99.87
|
19 Percentages of Subjects
Interval 5.4 to 41.9
|
17 Percentages of Subjects
Interval 3.6 to 41.4
|
6 Percentages of Subjects
Interval 0.16 to 30.2
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1, Day 30 and Day 365Population: Analysis was done on FAS Day 365 (Persistence of Booster). All subjects in the enrolled population who were randomized, actually received the study vaccination in V102\_03E1 and provided an evaluable serum sample at Day 365.
Percentage of subjects with four-fold rise in HT-hSBA titers against N. meningitidis serogroup B strains, at 24 and 36 months after the primary vaccination. Four-fold rise is defined as follows: for subjects with a pre-vaccination titer \< 1:2, a post-titer of ≥ 1:8; for subjects with a pre-vaccination titer ≥ 1:2 at least a four-fold increase.
Outcome measures
| Measure |
2OMV_OMV
n=21 Participants
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
|
2qOMV_qOMV
n=22 Participants
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
|
rMenB+OMV
n=15 Participants
Subjects received two doses of rMenB + OMV, administered two months apart.
|
Menveo
n=20 Participants
Subjects received a dose of placebo followed by one dose of MenACWY administered two months later.
|
2B_OMV
n=11 Participants
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study
|
2B_qOMV
n=19 Participants
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study
|
1M_OMV
n=21 Participants
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
|
1M_qOMV
n=18 Participants
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
|
1M_Pbo
n=17 Participants
Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
|
1M_Pbo
Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
|
Total
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains.
5/99 (Day 1, N= 20,21,15,19,11,18,6,4,5)
|
95 Percentages of Subjects
Interval 75.1 to 99.87
|
100 Percentages of Subjects
Interval 83.9 to 100.0
|
100 Percentages of Subjects
Interval 78.2 to 100.0
|
100 Percentages of Subjects
Interval 82.4 to 100.0
|
91 Percentages of Subjects
Interval 58.7 to 99.77
|
94 Percentages of Subjects
Interval 72.7 to 99.86
|
0 Percentages of Subjects
Interval 0.0 to 45.9
|
0 Percentages of Subjects
Interval 0.0 to 60.2
|
0 Percentages of Subjects
Interval 0.0 to 52.2
|
—
|
—
|
|
15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains.
5/99 (Day 30, N=21,22,14,20,9,19,21,18,16)
|
100 Percentages of Subjects
Interval 83.9 to 100.0
|
5 Percentages of Subjects
Interval 0.12 to 22.8
|
93 Percentages of Subjects
Interval 66.1 to 99.82
|
0 Percentages of Subjects
Interval 0.0 to 16.8
|
100 Percentages of Subjects
Interval 66.4 to 100.0
|
100 Percentages of Subjects
Interval 82.4 to 100.0
|
57 Percentages of Subjects
Interval 34.0 to 78.2
|
78 Percentages of Subjects
Interval 52.4 to 93.6
|
6 Percentages of Subjects
Interval 0.16 to 30.2
|
—
|
—
|
|
15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains.
5/99 (Day 365, N=21,22,14,20,9,19,21,18,17)
|
67 Percentages of Subjects
Interval 43.0 to 85.4
|
5 Percentages of Subjects
Interval 0.12 to 22.8
|
86 Percentages of Subjects
Interval 57.2 to 98.2
|
0 Percentages of Subjects
Interval 0.0 to 16.8
|
89 Percentages of Subjects
Interval 51.8 to 99.72
|
74 Percentages of Subjects
Interval 48.8 to 90.9
|
29 Percentages of Subjects
Interval 11.3 to 52.2
|
28 Percentages of Subjects
Interval 9.7 to 53.5
|
6 Percentages of Subjects
Interval 0.15 to 28.7
|
—
|
—
|
|
15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains.
H44/76 (Day 1, N=20,22,15,20,11,19,6,4,5)
|
100 Percentages of Subjects
Interval 83.2 to 100.0
|
95 Percentages of Subjects
Interval 77.2 to 99.88
|
100 Percentages of Subjects
Interval 78.2 to 100.0
|
95 Percentages of Subjects
Interval 75.1 to 99.87
|
91 Percentages of Subjects
Interval 58.7 to 99.77
|
89 Percentages of Subjects
Interval 66.9 to 98.7
|
0 Percentages of Subjects
Interval 0.0 to 45.9
|
0 Percentages of Subjects
Interval 0.0 to 60.2
|
0 Percentages of Subjects
Interval 0.0 to 52.2
|
—
|
—
|
|
15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains.
H44/76 (Day 30, N=21,22,15,20,11,20,19,18,16)
|
81 Percentages of Subjects
Interval 58.1 to 94.6
|
5 Percentages of Subjects
Interval 0.12 to 22.8
|
93 Percentages of Subjects
Interval 68.1 to 99.83
|
0 Percentages of Subjects
Interval 0.0 to 16.8
|
100 Percentages of Subjects
Interval 71.5 to 100.0
|
75 Percentages of Subjects
Interval 50.9 to 91.3
|
37 Percentages of Subjects
Interval 16.3 to 61.6
|
28 Percentages of Subjects
Interval 9.7 to 53.5
|
6 Percentages of Subjects
Interval 0.16 to 30.2
|
—
|
—
|
|
15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains.
H44/76 (Day 365, N=21,22,15,20,11,20,21,18,17)
|
38 Percentages of Subjects
Interval 18.1 to 61.6
|
0 Percentages of Subjects
Interval 0.0 to 15.4
|
20 Percentages of Subjects
Interval 4.3 to 48.1
|
0 Percentages of Subjects
Interval 0.0 to 16.8
|
64 Percentages of Subjects
Interval 30.8 to 89.1
|
30 Percentages of Subjects
Interval 11.9 to 54.3
|
10 Percentages of Subjects
Interval 1.2 to 30.4
|
0 Percentages of Subjects
Interval 0.0 to 18.5
|
6 Percentages of Subjects
Interval 0.15 to 28.7
|
—
|
—
|
|
15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains.
M01-0240364 (Day 1, N=19,21,15,15,11,18,6,4,4)
|
79 Percentages of Subjects
Interval 54.4 to 93.9
|
76 Percentages of Subjects
Interval 52.8 to 91.8
|
67 Percentages of Subjects
Interval 38.4 to 88.2
|
67 Percentages of Subjects
Interval 38.4 to 88.2
|
82 Percentages of Subjects
Interval 48.2 to 97.7
|
89 Percentages of Subjects
Interval 65.3 to 98.6
|
0 Percentages of Subjects
Interval 0.0 to 45.9
|
0 Percentages of Subjects
Interval 0.0 to 60.2
|
0 Percentages of Subjects
Interval 0.0 to 60.2
|
—
|
—
|
|
15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains.
M01-0240364 (Day 30, N=21,22,14,17,10,19,19,17,16)
|
100 Percentages of Subjects
Interval 83.9 to 100.0
|
5 Percentages of Subjects
Interval 0.12 to 22.8
|
93 Percentages of Subjects
Interval 66.1 to 99.82
|
6 Percentages of Subjects
Interval 0.15 to 28.7
|
100 Percentages of Subjects
Interval 69.2 to 100.0
|
89 Percentages of Subjects
Interval 66.9 to 98.7
|
16 Percentages of Subjects
Interval 3.4 to 39.6
|
24 Percentages of Subjects
Interval 6.8 to 49.9
|
6 Percentages of Subjects
Interval 0.16 to 30.2
|
—
|
—
|
|
15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains.
M01-0240364 (Day 365,N=21,22,14,18,10,19,20,17,17)
|
62 Percentages of Subjects
Interval 38.4 to 81.9
|
5 Percentages of Subjects
Interval 0.12 to 22.8
|
64 Percentages of Subjects
Interval 35.1 to 87.2
|
6 Percentages of Subjects
Interval 0.14 to 27.3
|
90 Percentages of Subjects
Interval 55.5 to 99.75
|
79 Percentages of Subjects
Interval 54.4 to 93.9
|
15 Percentages of Subjects
Interval 3.2 to 37.9
|
6 Percentages of Subjects
Interval 0.15 to 28.7
|
6 Percentages of Subjects
Interval 0.15 to 28.7
|
—
|
—
|
|
15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains.
M07-0241084 (Day 1, N=20,20,15,18,11,18,6,4,4)
|
30 Percentages of Subjects
Interval 11.9 to 54.3
|
20 Percentages of Subjects
Interval 5.7 to 43.7
|
33 Percentages of Subjects
Interval 11.8 to 61.6
|
17 Percentages of Subjects
Interval 3.6 to 41.4
|
45 Percentages of Subjects
Interval 16.7 to 76.6
|
56 Percentages of Subjects
Interval 30.8 to 78.5
|
0 Percentages of Subjects
Interval 0.0 to 45.9
|
0 Percentages of Subjects
Interval 0.0 to 60.2
|
0 Percentages of Subjects
Interval 0.0 to 60.2
|
—
|
—
|
|
15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains.
M07-0241084 (Day 30, N=21,22,14,20,11,19,21,18,16)
|
81 Percentages of Subjects
Interval 58.1 to 94.6
|
0 Percentages of Subjects
Interval 0.0 to 15.4
|
93 Percentages of Subjects
Interval 66.1 to 99.82
|
0 Percentages of Subjects
Interval 0.0 to 16.8
|
82 Percentages of Subjects
Interval 48.2 to 97.7
|
58 Percentages of Subjects
Interval 33.5 to 79.7
|
14 Percentages of Subjects
Interval 3.0 to 36.3
|
0 Percentages of Subjects
Interval 0.0 to 18.5
|
6 Percentages of Subjects
Interval 0.16 to 30.2
|
—
|
—
|
|
15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains.
M07-0241084 (Day 365,N=21,22,14,20,11,19,21,18,17)
|
19 Percentages of Subjects
Interval 5.4 to 41.9
|
0 Percentages of Subjects
Interval 0.0 to 15.4
|
0 Percentages of Subjects
Interval 0.0 to 23.2
|
0 Percentages of Subjects
Interval 0.0 to 16.8
|
27 Percentages of Subjects
Interval 6.0 to 61.0
|
5 Percentages of Subjects
Interval 0.13 to 26.0
|
0 Percentages of Subjects
Interval 0.0 to 16.1
|
0 Percentages of Subjects
Interval 0.0 to 18.5
|
6 Percentages of Subjects
Interval 0.15 to 28.7
|
—
|
—
|
|
15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains.
M14459 (Day 1, N=20,22,15,19,11,19,6,4,5)
|
55 Percentages of Subjects
Interval 31.5 to 76.9
|
55 Percentages of Subjects
Interval 32.2 to 75.6
|
67 Percentages of Subjects
Interval 38.4 to 88.2
|
58 Percentages of Subjects
Interval 33.5 to 79.7
|
91 Percentages of Subjects
Interval 58.7 to 99.77
|
63 Percentages of Subjects
Interval 38.4 to 83.7
|
0 Percentages of Subjects
Interval 0.0 to 45.9
|
0 Percentages of Subjects
Interval 0.0 to 60.2
|
0 Percentages of Subjects
Interval 0.0 to 52.2
|
—
|
—
|
|
15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains.
M14459 (Day 30, N=21,22,14,20,11,20,20,18,16)
|
76 Percentages of Subjects
Interval 52.8 to 91.8
|
0 Percentages of Subjects
Interval 0.0 to 15.4
|
86 Percentages of Subjects
Interval 57.2 to 98.2
|
0 Percentages of Subjects
Interval 0.0 to 16.8
|
100 Percentages of Subjects
Interval 71.5 to 100.0
|
75 Percentages of Subjects
Interval 50.9 to 91.3
|
15 Percentages of Subjects
Interval 3.2 to 37.9
|
6 Percentages of Subjects
Interval 0.14 to 27.3
|
6 Percentages of Subjects
Interval 0.16 to 30.2
|
—
|
—
|
|
15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains.
M14459 (Day 365, N=21,22,14,20,11,20,21,18,17)
|
24 Percentages of Subjects
Interval 8.2 to 47.2
|
0 Percentages of Subjects
Interval 0.0 to 15.4
|
0 Percentages of Subjects
Interval 0.0 to 23.2
|
0 Percentages of Subjects
Interval 0.0 to 16.8
|
36 Percentages of Subjects
Interval 10.9 to 69.2
|
25 Percentages of Subjects
Interval 8.7 to 49.1
|
10 Percentages of Subjects
Interval 1.2 to 30.4
|
0 Percentages of Subjects
Interval 0.0 to 18.5
|
6 Percentages of Subjects
Interval 0.15 to 28.7
|
—
|
—
|
|
15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains.
NZ98/254 (Day 1, N=20,21,15,19,11,18,6,4,5)
|
60 Percentages of Subjects
Interval 36.1 to 80.9
|
52 Percentages of Subjects
Interval 29.8 to 74.3
|
53 Percentages of Subjects
Interval 26.6 to 78.7
|
58 Percentages of Subjects
Interval 33.5 to 79.7
|
55 Percentages of Subjects
Interval 23.4 to 83.3
|
67 Percentages of Subjects
Interval 41.0 to 86.7
|
0 Percentages of Subjects
Interval 0.0 to 45.9
|
0 Percentages of Subjects
Interval 0.0 to 60.2
|
0 Percentages of Subjects
Interval 0.0 to 52.2
|
—
|
—
|
|
15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains.
NZ98/254 (Day 30, N=21,22,14,20,11,19,21,18,16)
|
81 Percentages of Subjects
Interval 58.1 to 94.6
|
0 Percentages of Subjects
Interval 0.0 to 15.4
|
71 Percentages of Subjects
Interval 41.9 to 91.6
|
5 Percentages of Subjects
Interval 0.13 to 24.9
|
82 Percentages of Subjects
Interval 48.2 to 97.7
|
63 Percentages of Subjects
Interval 38.4 to 83.7
|
19 Percentages of Subjects
Interval 5.4 to 41.9
|
6 Percentages of Subjects
Interval 0.14 to 27.3
|
6 Percentages of Subjects
Interval 0.16 to 30.2
|
—
|
—
|
|
15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains.
NZ98/254 (Day 365, N=21,22,14,20,11,19,21,18,17)
|
10 Percentages of Subjects
Interval 1.2 to 30.4
|
0 Percentages of Subjects
Interval 0.0 to 15.4
|
14 Percentages of Subjects
Interval 1.8 to 42.8
|
0 Percentages of Subjects
Interval 0.0 to 16.8
|
9 Percentages of Subjects
Interval 0.23 to 41.3
|
5 Percentages of Subjects
Interval 0.13 to 26.0
|
10 Percentages of Subjects
Interval 1.2 to 30.4
|
0 Percentages of Subjects
Interval 0.0 to 18.5
|
6 Percentages of Subjects
Interval 0.15 to 28.7
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 365Population: Analysis was done on FAS Day 365 (Persistence of Booster). All subjects in the enrolled population who were randomized, actually received the study vaccination in V102\_03E1 and provided an evaluable serum sample at Day 365.
The HT-hSBA GMTs against N. meningitidis serogroup A, C, W, Y, at 24 and 36 months after the primary vaccination.
Outcome measures
| Measure |
2OMV_OMV
n=21 Participants
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
|
2qOMV_qOMV
n=22 Participants
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
|
rMenB+OMV
n=16 Participants
Subjects received two doses of rMenB + OMV, administered two months apart.
|
Menveo
n=20 Participants
Subjects received a dose of placebo followed by one dose of MenACWY administered two months later.
|
2B_OMV
n=11 Participants
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study
|
2B_qOMV
n=20 Participants
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study
|
1M_OMV
n=20 Participants
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
|
1M_qOMV
n=18 Participants
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
|
1M_Pbo
n=17 Participants
Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
|
1M_Pbo
Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
|
Total
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
16. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y.
Men A (Day 1, N=21,22,15,20,10,20,20,17,17)
|
3.98 Titers
Interval 1.98 to 8.0
|
2.73 Titers
Interval 1.44 to 5.15
|
3.07 Titers
Interval 1.26 to 7.47
|
2.98 Titers
Interval 1.38 to 6.42
|
2.27 Titers
Interval 0.87 to 5.94
|
4.22 Titers
Interval 1.63 to 11.0
|
6.31 Titers
Interval 2.82 to 14.0
|
2.49 Titers
Interval 1.52 to 4.09
|
5.48 Titers
Interval 2.18 to 14.0
|
—
|
—
|
|
16. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y.
Men A (Day 365, N=21,22,16,20,10,20,20,18,17)
|
25 Titers
Interval 11.0 to 59.0
|
2.62 Titers
Interval 1.39 to 4.94
|
44 Titers
Interval 18.0 to 105.0
|
3.03 Titers
Interval 1.3 to 7.06
|
54 Titers
Interval 17.0 to 174.0
|
53 Titers
Interval 22.0 to 130.0
|
34 Titers
Interval 16.0 to 69.0
|
6.52 Titers
Interval 2.71 to 16.0
|
3.54 Titers
Interval 1.4 to 8.92
|
—
|
—
|
|
16. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y.
Men C (Day 1, N=20,19,14,20,11,19,19,18,16)
|
18 Titers
Interval 8.21 to 39.0
|
19 Titers
Interval 7.54 to 49.0
|
19 Titers
Interval 8.13 to 44.0
|
10 Titers
Interval 5.52 to 19.0
|
5.20 Titers
Interval 2.8 to 9.65
|
7.83 Titers
Interval 4.51 to 14.0
|
7.89 Titers
Interval 4.26 to 15.0
|
8.45 Titers
Interval 2.64 to 27.0
|
24 Titers
Interval 9.34 to 61.0
|
—
|
—
|
|
16. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y.
Men C (Day 365, N=21,21,16,20,11,19,19,18,17)
|
128 Titers
Interval 75.0 to 217.0
|
15 Titers
Interval 5.82 to 39.0
|
177 Titers
Interval 102.0 to 305.0
|
9.14 Titers
Interval 4.07 to 21.0
|
29 Titers
Interval 10.0 to 82.0
|
32 Titers
Interval 16.0 to 67.0
|
81 Titers
Interval 46.0 to 141.0
|
72 Titers
Interval 27.0 to 191.0
|
24 Titers
Interval 8.98 to 66.0
|
—
|
—
|
|
16. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y.
Men W (Day 1, N=20,22,12,20,11,20,17,18,16)
|
36 Titers
Interval 21.0 to 62.0
|
43 Titers
Interval 24.0 to 79.0
|
30 Titers
Interval 7.82 to 112.0
|
17 Titers
Interval 6.88 to 43.0
|
25 Titers
Interval 7.98 to 79.0
|
23 Titers
Interval 9.81 to 52.0
|
28 Titers
Interval 11.0 to 70.0
|
15 Titers
Interval 4.54 to 47.0
|
10 Titers
Interval 3.53 to 30.0
|
—
|
—
|
|
16. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y.
Men W (Day 365, N=21,22,16,20,11,20,19,18,17)
|
190 Titers
Interval 133.0 to 272.0
|
28 Titers
Interval 13.0 to 59.0
|
213 Titers
Interval 135.0 to 337.0
|
16 Titers
Interval 5.58 to 47.0
|
80 Titers
Interval 26.0 to 246.0
|
96 Titers
Interval 72.0 to 127.0
|
172 Titers
Interval 97.0 to 306.0
|
104 Titers
Interval 49.0 to 221.0
|
16 Titers
Interval 5.27 to 49.0
|
—
|
—
|
|
16. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y.
Men Y (Day 1, N=21,21,14,20,11,18,20,18,17)
|
10 Titers
Interval 4.39 to 24.0
|
16 Titers
Interval 4.85 to 54.0
|
24 Titers
Interval 6.62 to 90.0
|
5.39 Titers
Interval 2.06 to 14.0
|
2.40 Titers
Interval 1.05 to 5.47
|
1.90 Titers
Interval 1.02 to 3.55
|
7.05 Titers
Interval 3.08 to 16.0
|
6.83 Titers
Interval 2.11 to 22.0
|
7.03 Titers
Interval 1.99 to 25.0
|
—
|
—
|
|
16. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y.
Men Y (Day 365, N=21,21,16,20,11,18,20,18,17)
|
116 Titers
Interval 58.0 to 231.0
|
18 Titers
Interval 5.05 to 62.0
|
235 Titers
Interval 147.0 to 376.0
|
5.93 Titers
Interval 1.97 to 18.0
|
7.17 Titers
Interval 1.91 to 27.0
|
20 Titers
Interval 6.92 to 58.0
|
193 Titers
Interval 123.0 to 301.0
|
101 Titers
Interval 36.0 to 280.0
|
9.56 Titers
Interval 2.44 to 37.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 365Population: Analysis was done on FAS Day 365 (Persistence of Booster) population. All subjects in the enrolled population who were randomized, actually received the study vaccination in V102\_03E1 and provided an evaluable serum sample at Day 365.
The HT-hSBA GMTs against N. meningitidis strains of serogroups B, at 24 and 36 months after the primary vaccination.
Outcome measures
| Measure |
2OMV_OMV
n=21 Participants
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
|
2qOMV_qOMV
n=22 Participants
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
|
rMenB+OMV
n=16 Participants
Subjects received two doses of rMenB + OMV, administered two months apart.
|
Menveo
n=20 Participants
Subjects received a dose of placebo followed by one dose of MenACWY administered two months later.
|
2B_OMV
n=11 Participants
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study
|
2B_qOMV
n=20 Participants
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study
|
1M_OMV
n=21 Participants
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
|
1M_qOMV
n=18 Participants
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
|
1M_Pbo
n=17 Participants
Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
|
1M_Pbo
Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
|
Total
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B.
5/99 (Day 1, N= 21,22,14,20,9,19,21,18,17)
|
18 Titers
Interval 9.47 to 34.0
|
18 Titers
Interval 9.5 to 34.0
|
31 Titers
Interval 12.0 to 85.0
|
31 Titers
Interval 15.0 to 65.0
|
27 Titers
Interval 8.61 to 86.0
|
39 Titers
Interval 21.0 to 74.0
|
2.97 Titers
Interval 1.58 to 5.59
|
1.80 Titers
Interval 1.01 to 3.22
|
3.20 Titers
Interval 1.44 to 7.09
|
—
|
—
|
|
17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B.
5/99 (Day 365, N= 21,22,16,20,11,19,21,18,17)
|
175 Titers
Interval 79.0 to 385.0
|
13 Titers
Interval 6.07 to 29.0
|
305 Titers
Interval 149.0 to 625.0
|
23 Titers
Interval 11.0 to 47.0
|
587 Titers
Interval 351.0 to 983.0
|
491 Titers
Interval 258.0 to 936.0
|
6.05 Titers
Interval 3.1 to 12.0
|
4.23 Titers
Interval 1.48 to 12.0
|
2.45 Titers
Interval 1.0 to 5.99
|
—
|
—
|
|
17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B.
H44/76 (Day 1, N= 21,22,15,20,11,20,21,18,17)
|
3.58 Titers
Interval 1.66 to 7.71
|
2.23 Titers
Interval 1.28 to 3.9
|
1.49 Titers
Interval 0.96 to 2.33
|
1.73 Titers
Interval 0.97 to 3.1
|
3.45 Titers
Interval 1.81 to 6.57
|
3.43 Titers
Interval 1.83 to 6.43
|
1.34 Titers
Interval 0.85 to 2.13
|
1.51 Titers
Interval 0.91 to 2.48
|
1.19 Titers
Interval 0.97 to 1.47
|
—
|
—
|
|
17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B.
H44/76 (Day 365, N= 21,22,16,20,11,20,21,18,17)
|
12 Titers
Interval 5.18 to 26.0
|
1.93 Titers
Interval 1.2 to 3.1
|
4.19 Titers
Interval 1.93 to 9.11
|
1.83 Titers
Interval 1.07 to 3.15
|
21 Titers
Interval 6.0 to 71.0
|
11 Titers
Interval 4.68 to 25.0
|
1.96 Titers
Interval 1.21 to 3.19
|
1.92 Titers
Interval 1.17 to 3.17
|
1.49 Titers
Interval 0.9 to 2.48
|
—
|
—
|
|
17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B.
M01-0240364 (Day 1, N= 21,22,14,18,10,19,20,17,17)
|
2.33 Titers
Interval 1.25 to 4.36
|
3.39 Titers
Interval 1.43 to 8.05
|
2.87 Titers
Interval 0.86 to 9.59
|
1.26 Titers
Interval 0.89 to 1.8
|
2.46 Titers
Interval 0.72 to 8.4
|
6.29 Titers
Interval 2.22 to 18.0
|
1.24 Titers
Interval 0.79 to 1.94
|
1.24 Titers
Interval 0.88 to 1.77
|
1.68 Titers
Interval 0.85 to 3.33
|
—
|
—
|
|
17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B.
M01-0240364(Day 365,N= 21,22,16,18,11,19,20,18,17)
|
30 Titers
Interval 9.54 to 93.0
|
3.55 Titers
Interval 1.56 to 8.07
|
74 Titers
Interval 18.0 to 300.0
|
1.23 Titers
Interval 0.91 to 1.68
|
303 Titers
Interval 174.0 to 527.0
|
155 Titers
Interval 69.0 to 350.0
|
1.61 Titers
Interval 0.99 to 2.63
|
1.71 Titers
Interval 0.86 to 3.42
|
2.03 Titers
Interval 0.9 to 4.58
|
—
|
—
|
|
17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B.
M07-0241084 (Day 1, N= 21,22,14,20,11,19,21,18,17)
|
3.68 Titers
Interval 2.07 to 6.54
|
4.20 Titers
Interval 2.25 to 7.85
|
2.28 Titers
Interval 1.16 to 4.48
|
2.36 Titers
Interval 1.51 to 3.7
|
4.10 Titers
Interval 1.89 to 8.9
|
7.35 Titers
Interval 3.82 to 14.0
|
2.08 Titers
Interval 1.26 to 3.42
|
2.15 Titers
Interval 1.14 to 4.05
|
3.50 Titers
Interval 1.57 to 7.8
|
—
|
—
|
|
17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B.
M07-0241084 (Day 365,N=21,22,16,20,11,19,21,18,17)
|
7.96 Titers
Interval 4.6 to 14.0
|
3.28 Titers
Interval 2.16 to 4.97
|
4.09 Titers
Interval 2.3 to 7.25
|
2.04 Titers
Interval 1.43 to 2.92
|
10 Titers
Interval 4.51 to 24.0
|
11 Titers
Interval 6.35 to 18.0
|
2.45 Titers
Interval 1.59 to 3.79
|
1.91 Titers
Interval 1.14 to 3.23
|
3.92 Titers
Interval 1.9 to 8.07
|
—
|
—
|
|
17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B.
M14459 (Day 1, N= 21,22,14,20,11,20,21,18,16)
|
2.69 Titers
Interval 1.51 to 4.78
|
2.94 Titers
Interval 1.77 to 4.89
|
1.54 Titers
Interval 0.9 to 2.63
|
2.01 Titers
Interval 1.4 to 2.88
|
3.11 Titers
Interval 1.74 to 5.56
|
3.37 Titers
Interval 1.95 to 5.81
|
1.85 Titers
Interval 1.13 to 3.04
|
1.48 Titers
Interval 1.03 to 2.13
|
2.55 Titers
Interval 1.37 to 4.77
|
—
|
—
|
|
17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B.
M14459 (Day 365, N= 21,22,16,20,11,20,21,18,17)
|
7.19 Titers
Interval 3.89 to 13.0
|
1.67 Titers
Interval 1.07 to 2.6
|
2.94 Titers
Interval 1.49 to 5.8
|
1.47 Titers
Interval 1.07 to 2.03
|
11 Titers
Interval 4.41 to 28.0
|
7.12 Titers
Interval 3.59 to 14.0
|
2.09 Titers
Interval 1.33 to 3.29
|
1.38 Titers
Interval 0.98 to 1.93
|
2.17 Titers
Interval 1.07 to 4.41
|
—
|
—
|
|
17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B.
NZ98/254 (Day 1, N= 21,22,14,20,11,19,21,18,17)
|
1.73 Titers
Interval 1.06 to 2.81
|
2.34 Titers
Interval 1.33 to 4.1
|
1.34 Titers
Interval 0.94 to 1.93
|
1.48 Titers
Interval 1.01 to 2.17
|
1.72 Titers
Interval 0.99 to 2.98
|
2.24 Titers
Interval 1.2 to 4.17
|
1.18 Titers
Interval 0.84 to 1.66
|
1.19 Titers
Interval 0.9 to 1.58
|
1.13 Titers
Interval 0.94 to 1.37
|
—
|
—
|
|
17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B.
NZ98/254 (Day 365, N= 21,22,16,20,11,19,21,18,17)
|
3.49 Titers
Interval 2.12 to 5.74
|
1.71 Titers
Interval 1.41 to 2.57
|
2.67 Titers
Interval 1.27 to 5.61
|
1.23 Titers
Interval 0.9 to 1.69
|
3.28 Titers
Interval 1.66 to 6.49
|
3.77 Titers
Interval 1.98 to 7.18
|
1.65 Titers
Interval 1.04 to 2.61
|
1.19 Titers
Interval 0.91 to 1.54
|
1.28 Titers
Interval 0.85 to 1.92
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1, Day 30 and Day 365Population: Analysis was done on FAS Day 365 (Persistence of Booster). All subjects in the enrolled population who were randomized, actually received the study vaccination in V102\_03E1 and provided an evaluable serum sample at Day 365.
Percentage of subjects with HT-hSBA titer ≥ 1:8 against N. meningitidis serogroups A, C, W, Y at Day 1, Day 30 (one month) and Day 365 (12 months) after the administration of MenABCWY booster vaccination.
Outcome measures
| Measure |
2OMV_OMV
n=21 Participants
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
|
2qOMV_qOMV
n=22 Participants
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
|
rMenB+OMV
n=16 Participants
Subjects received two doses of rMenB + OMV, administered two months apart.
|
Menveo
n=20 Participants
Subjects received a dose of placebo followed by one dose of MenACWY administered two months later.
|
2B_OMV
n=11 Participants
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study
|
2B_qOMV
n=20 Participants
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study
|
1M_OMV
n=20 Participants
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
|
1M_qOMV
n=18 Participants
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
|
1M_Pbo
n=17 Participants
Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
|
1M_Pbo
Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
|
Total
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y.
Men A (Day 1,N=21,22,15,20,10,20,20,17,17)
|
38 Percentages of Subjects
Interval 18.1 to 61.6
|
18 Percentages of Subjects
Interval 5.2 to 40.3
|
20 Percentages of Subjects
Interval 4.3 to 48.1
|
30 Percentages of Subjects
Interval 11.9 to 54.3
|
30 Percentages of Subjects
Interval 6.7 to 65.2
|
35 Percentages of Subjects
Interval 15.4 to 59.2
|
45 Percentages of Subjects
Interval 23.1 to 68.5
|
12 Percentages of Subjects
Interval 1.5 to 36.4
|
41 Percentages of Subjects
Interval 18.4 to 67.1
|
—
|
—
|
|
18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y.
Men A (Day 30, N=21,22,15,19,10,20,18,16,16)
|
100 Percentages of Subjects
Interval 83.9 to 100.0
|
32 Percentages of Subjects
Interval 13.9 to 54.9
|
100 Percentages of Subjects
Interval 78.2 to 100.0
|
26 Percentages of Subjects
Interval 9.1 to 51.2
|
100 Percentages of Subjects
Interval 69.2 to 100.0
|
95 Percentages of Subjects
Interval 75.1 to 99.87
|
100 Percentages of Subjects
Interval 81.5 to 100.0
|
94 Percentages of Subjects
Interval 69.8 to 99.84
|
44 Percentages of Subjects
Interval 19.8 to 70.1
|
—
|
—
|
|
18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y.
Men A (Day 365, N=21,22,16,20,10,20,20,18,17)
|
67 Percentages of Subjects
Interval 43.0 to 85.4
|
23 Percentages of Subjects
Interval 7.8 to 45.4
|
88 Percentages of Subjects
Interval 61.7 to 98.4
|
25 Percentages of Subjects
Interval 8.7 to 49.1
|
90 Percentages of Subjects
Interval 55.5 to 99.75
|
85 Percentages of Subjects
Interval 62.1 to 96.8
|
85 Percentages of Subjects
Interval 62.1 to 96.8
|
50 Percentages of Subjects
Interval 26.0 to 74.0
|
35 Percentages of Subjects
Interval 14.2 to 61.7
|
—
|
—
|
|
18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y.
Men C (Day 1, N=20,19,14,20,11,19,19,18,16)
|
65 Percentages of Subjects
Interval 40.8 to 84.6
|
68 Percentages of Subjects
Interval 43.4 to 87.4
|
71 Percentages of Subjects
Interval 41.9 to 91.6
|
65 Percentages of Subjects
Interval 40.8 to 84.6
|
36 Percentages of Subjects
Interval 10.9 to 69.2
|
58 Percentages of Subjects
Interval 33.5 to 79.7
|
58 Percentages of Subjects
Interval 33.5 to 79.7
|
50 Percentages of Subjects
Interval 26.0 to 74.0
|
75 Percentages of Subjects
Interval 47.6 to 92.7
|
—
|
—
|
|
18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y.
Men C (Day 30, N=17,20,10,20,7,14,19,17,16)
|
100 Percentages of Subjects
Interval 80.5 to 100.0
|
65 Percentages of Subjects
Interval 40.8 to 84.6
|
100 Percentages of Subjects
Interval 69.2 to 100.0
|
55 Percentages of Subjects
Interval 31.5 to 76.9
|
100 Percentages of Subjects
Interval 59.0 to 100.0
|
100 Percentages of Subjects
Interval 76.8 to 100.0
|
100 Percentages of Subjects
Interval 82.4 to 100.0
|
88 Percentages of Subjects
Interval 63.6 to 98.5
|
69 Percentages of Subjects
Interval 41.3 to 89.0
|
—
|
—
|
|
18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y.
Men C (Day 365, N=21,21,16,20,11,19,19,18,17)
|
100 Percentages of Subjects
Interval 83.9 to 100.0
|
62 Percentages of Subjects
Interval 38.4 to 81.9
|
100 Percentages of Subjects
Interval 79.4 to 100.0
|
50 Percentages of Subjects
Interval 27.2 to 72.8
|
82 Percentages of Subjects
Interval 48.2 to 97.7
|
95 Percentages of Subjects
Interval 74.0 to 99.87
|
100 Percentages of Subjects
Interval 82.4 to 100.0
|
89 Percentages of Subjects
Interval 65.3 to 98.6
|
65 Percentages of Subjects
Interval 38.3 to 85.8
|
—
|
—
|
|
18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y.
Men W (Day 1,N=20,22,12,20,11,20,17,18,16)
|
95 Percentages of Subjects
Interval 75.1 to 99.87
|
95 Percentages of Subjects
Interval 77.2 to 99.88
|
75 Percentages of Subjects
Interval 42.8 to 94.5
|
70 Percentages of Subjects
Interval 45.7 to 88.1
|
82 Percentages of Subjects
Interval 48.2 to 97.7
|
75 Percentages of Subjects
Interval 50.9 to 91.3
|
82 Percentages of Subjects
Interval 56.6 to 96.2
|
61 Percentages of Subjects
Interval 35.7 to 82.7
|
56 Percentages of Subjects
Interval 29.9 to 80.2
|
—
|
—
|
|
18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y.
Men W (Day 30, N=18,22,15,19,11,18,17,16,14)
|
100 Percentages of Subjects
Interval 81.5 to 100.0
|
86 Percentages of Subjects
Interval 65.1 to 97.1
|
100 Percentages of Subjects
Interval 78.2 to 100.0
|
74 Percentages of Subjects
Interval 48.8 to 90.9
|
100 Percentages of Subjects
Interval 71.5 to 100.0
|
100 Percentages of Subjects
Interval 81.5 to 100.0
|
100 Percentages of Subjects
Interval 80.5 to 100.0
|
100 Percentages of Subjects
Interval 79.4 to 100.0
|
57 Percentages of Subjects
Interval 28.9 to 82.3
|
—
|
—
|
|
18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y.
Men W (Day 365, N=21,22,16,20,11,20,19,18,17)
|
100 Percentages of Subjects
Interval 83.9 to 100.0
|
82 Percentages of Subjects
Interval 59.7 to 94.8
|
100 Percentages of Subjects
Interval 79.4 to 100.0
|
65 Percentages of Subjects
Interval 40.8 to 84.6
|
91 Percentages of Subjects
Interval 58.7 to 99.77
|
100 Percentages of Subjects
Interval 83.2 to 100.0
|
100 Percentages of Subjects
Interval 82.4 to 100.0
|
100 Percentages of Subjects
Interval 81.5 to 100.0
|
65 Percentages of Subjects
Interval 38.3 to 85.8
|
—
|
—
|
|
18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y.
Men Y (Day 1, N=21,21,14,20,11,18,20,18,17)
|
62 Percentages of Subjects
Interval 38.4 to 81.9
|
62 Percentages of Subjects
Interval 38.4 to 81.9
|
71 Percentages of Subjects
Interval 41.9 to 91.6
|
40 Percentages of Subjects
Interval 19.1 to 63.9
|
36 Percentages of Subjects
Interval 10.9 to 69.2
|
11 Percentages of Subjects
Interval 1.4 to 34.7
|
55 Percentages of Subjects
Interval 31.5 to 76.9
|
44 Percentages of Subjects
Interval 21.5 to 69.2
|
41 Percentages of Subjects
Interval 18.4 to 67.1
|
—
|
—
|
|
18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y.
Men Y (Day 30, N=21,21,15,20,11,18,20,17,16)
|
100 Percentages of Subjects
Interval 83.9 to 100.0
|
57 Percentages of Subjects
Interval 34.0 to 78.2
|
100 Percentages of Subjects
Interval 78.2 to 100.0
|
40 Percentages of Subjects
Interval 19.1 to 63.9
|
82 Percentages of Subjects
Interval 48.2 to 97.7
|
83 Percentages of Subjects
Interval 58.6 to 96.4
|
100 Percentages of Subjects
Interval 83.2 to 100.0
|
100 Percentages of Subjects
Interval 80.5 to 100.0
|
38 Percentages of Subjects
Interval 15.2 to 64.6
|
—
|
—
|
|
18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y.
Men Y (Day 365, N=21,21,16,20,11,18,20,18,17)
|
95 Percentages of Subjects
Interval 76.2 to 99.88
|
52 Percentages of Subjects
Interval 29.8 to 74.3
|
100 Percentages of Subjects
Interval 79.4 to 100.0
|
40 Percentages of Subjects
Interval 19.1 to 63.9
|
45 Percentages of Subjects
Interval 16.7 to 76.6
|
72 Percentages of Subjects
Interval 46.5 to 90.3
|
100 Percentages of Subjects
Interval 83.2 to 100.0
|
89 Percentages of Subjects
Interval 65.3 to 98.6
|
47 Percentages of Subjects
Interval 23.0 to 72.2
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1, Day 30 and Day 365Population: Analysis was done on FAS Day 365 (Persistence of Booster). All subjects in the enrolled population who were randomized, actually received the study vaccination in V102\_03E1 and provided an evaluable serum sample at Day 365.
Percentage of subjects with HT-hSBA titer ≥ 1:5 against N. meningitides strains of serogroups B at Day 1, Day 30 (one month) and Day 365 (12 months) after the administration of MenABCWY booster vaccination.
Outcome measures
| Measure |
2OMV_OMV
n=21 Participants
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
|
2qOMV_qOMV
n=16 Participants
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
|
rMenB+OMV
n=11 Participants
Subjects received two doses of rMenB + OMV, administered two months apart.
|
Menveo
n=20 Participants
Subjects received a dose of placebo followed by one dose of MenACWY administered two months later.
|
2B_OMV
n=21 Participants
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study
|
2B_qOMV
n=18 Participants
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study
|
1M_OMV
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
|
1M_qOMV
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
|
1M_Pbo
Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
|
1M_Pbo
Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
|
Total
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B.
5/99 (Day 1,N= 21,14,9,19,21,18)
|
76 Percentages of Subjects
Interval 52.8 to 91.8
|
86 Percentages of Subjects
Interval 57.2 to 98.2
|
89 Percentages of Subjects
Interval 51.8 to 99.72
|
95 Percentages of Subjects
Interval 74.0 to 99.87
|
19 Percentages of Subjects
Interval 5.4 to 41.9
|
17 Percentages of Subjects
Interval 3.6 to 41.4
|
—
|
—
|
—
|
—
|
—
|
|
19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B.
5/99 (Day 30, N= 21,16,11,19,21,18)
|
100 Percentages of Subjects
Interval 83.9 to 100.0
|
100 Percentages of Subjects
Interval 79.4 to 100.0
|
100 Percentages of Subjects
Interval 71.5 to 100.0
|
100 Percentages of Subjects
Interval 82.4 to 100.0
|
76 Percentages of Subjects
Interval 52.8 to 91.8
|
83 Percentages of Subjects
Interval 58.6 to 96.4
|
—
|
—
|
—
|
—
|
—
|
|
19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B.
5/99 (Day 365, 21,16,11,19,21,18)
|
95 Percentages of Subjects
Interval 76.2 to 99.88
|
100 Percentages of Subjects
Interval 79.4 to 100.0
|
100 Percentages of Subjects
Interval 71.5 to 100.0
|
100 Percentages of Subjects
Interval 82.4 to 100.0
|
43 Percentages of Subjects
Interval 21.8 to 66.0
|
33 Percentages of Subjects
Interval 13.3 to 59.0
|
—
|
—
|
—
|
—
|
—
|
|
19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B.
H44/76 (Day 1, N= 21,15,11,20,21,18)
|
19 Percentages of Subjects
Interval 5.4 to 41.9
|
13 Percentages of Subjects
Interval 1.7 to 40.5
|
45 Percentages of Subjects
Interval 16.7 to 76.6
|
30 Percentages of Subjects
Interval 11.9 to 54.3
|
5 Percentages of Subjects
Interval 0.12 to 23.8
|
6 Percentages of Subjects
Interval 0.14 to 27.3
|
—
|
—
|
—
|
—
|
—
|
|
19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B.
H44/76 (Day 30, N= 21,16,11,20,19,18)
|
95 Percentages of Subjects
Interval 76.2 to 99.88
|
100 Percentages of Subjects
Interval 79.4 to 100.0
|
100 Percentages of Subjects
Interval 71.5 to 100.0
|
100 Percentages of Subjects
Interval 83.2 to 100.0
|
58 Percentages of Subjects
Interval 33.5 to 79.7
|
33 Percentages of Subjects
Interval 13.3 to 59.0
|
—
|
—
|
—
|
—
|
—
|
|
19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B.
H44/76 (Day 365, N= 21,16,11,20,21,18)
|
76 Percentages of Subjects
Interval 52.8 to 91.8
|
44 Percentages of Subjects
Interval 19.8 to 70.1
|
82 Percentages of Subjects
Interval 48.2 to 97.7
|
65 Percentages of Subjects
Interval 40.8 to 84.6
|
19 Percentages of Subjects
Interval 5.4 to 41.9
|
11 Percentages of Subjects
Interval 1.4 to 34.7
|
—
|
—
|
—
|
—
|
—
|
|
19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B.
M01-0240364 (Day 1, N= 21,14,10,19,20,17)
|
24 Percentages of Subjects
Interval 8.2 to 47.2
|
21 Percentages of Subjects
Interval 4.7 to 50.8
|
20 Percentages of Subjects
Interval 2.5 to 55.6
|
42 Percentages of Subjects
Interval 20.3 to 66.5
|
5 Percentages of Subjects
Interval 0.13 to 24.9
|
6 Percentages of Subjects
Interval 0.15 to 28.7
|
—
|
—
|
—
|
—
|
—
|
|
19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B.
M01-0240364(Day 30, N= 21,16,11,19,19,18)
|
100 Percentages of Subjects
Interval 83.9 to 100.0
|
100 Percentages of Subjects
Interval 79.4 to 100.0
|
100 Percentages of Subjects
Interval 71.5 to 100.0
|
100 Percentages of Subjects
Interval 82.4 to 100.0
|
21 Percentages of Subjects
Interval 6.1 to 45.6
|
28 Percentages of Subjects
Interval 9.7 to 53.5
|
—
|
—
|
—
|
—
|
—
|
|
19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B.
M01-0240364 (Day 365, N= 21,16,11,19,20,18)
|
71 Percentages of Subjects
Interval 47.8 to 88.7
|
75 Percentages of Subjects
Interval 47.6 to 92.7
|
100 Percentages of Subjects
Interval 71.5 to 100.0
|
95 Percentages of Subjects
Interval 74.0 to 99.87
|
15 Percentages of Subjects
Interval 3.2 to 37.9
|
11 Percentages of Subjects
Interval 1.4 to 34.7
|
—
|
—
|
—
|
—
|
—
|
|
19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B.
M07-0241084 (Day 1, N= 21,14,11,19,21,18)
|
38 Percentages of Subjects
Interval 18.1 to 61.6
|
29 Percentages of Subjects
Interval 8.4 to 58.1
|
64 Percentages of Subjects
Interval 30.8 to 89.1
|
58 Percentages of Subjects
Interval 33.5 to 79.7
|
19 Percentages of Subjects
Interval 5.4 to 41.9
|
17 Percentages of Subjects
Interval 3.6 to 41.4
|
—
|
—
|
—
|
—
|
—
|
|
19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B.
M07-0241084 (Day 30, N= 21,16,11,19,21,18)
|
100 Percentages of Subjects
Interval 83.9 to 100.0
|
94 Percentages of Subjects
Interval 69.8 to 99.84
|
91 Percentages of Subjects
Interval 58.7 to 99.77
|
95 Percentages of Subjects
Interval 74.0 to 99.87
|
33 Percentages of Subjects
Interval 14.6 to 57.0
|
22 Percentages of Subjects
Interval 6.4 to 47.6
|
—
|
—
|
—
|
—
|
—
|
|
19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B.
M07-0241084(Day 365, N=21,16,11,19,21,18)
|
62 Percentages of Subjects
Interval 38.4 to 81.9
|
50 Percentages of Subjects
Interval 24.7 to 75.3
|
82 Percentages of Subjects
Interval 48.2 to 97.7
|
74 Percentages of Subjects
Interval 48.8 to 90.9
|
29 Percentages of Subjects
Interval 11.3 to 52.2
|
17 Percentages of Subjects
Interval 3.6 to 41.4
|
—
|
—
|
—
|
—
|
—
|
|
19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B.
M14459 (Day 1, N= 21,14,11,20,21,18)
|
24 Percentages of Subjects
Interval 8.2 to 47.2
|
7 Percentages of Subjects
Interval 0.18 to 33.9
|
36 Percentages of Subjects
Interval 10.9 to 69.2
|
30 Percentages of Subjects
Interval 11.9 to 54.3
|
10 Percentages of Subjects
Interval 1.2 to 30.4
|
11 Percentages of Subjects
Interval 1.4 to 34.7
|
—
|
—
|
—
|
—
|
—
|
|
19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B.
M14459 (Day 365, N= 21,16,11,20,21,18)
|
57 Percentages of Subjects
Interval 34.0 to 78.2
|
38 Percentages of Subjects
Interval 15.2 to 64.6
|
82 Percentages of Subjects
Interval 48.2 to 97.7
|
60 Percentages of Subjects
Interval 36.1 to 80.9
|
14 Percentages of Subjects
Interval 3.0 to 36.3
|
11 Percentages of Subjects
Interval 1.4 to 34.7
|
—
|
—
|
—
|
—
|
—
|
|
19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B.
NZ98/254 (Day 1,N= 21,14,11,19,21,18)
|
19 Percentages of Subjects
Interval 5.4 to 41.9
|
7 Percentages of Subjects
Interval 0.18 to 33.9
|
9 Percentages of Subjects
Interval 0.23 to 41.3
|
26 Percentages of Subjects
Interval 9.1 to 51.2
|
5 Percentages of Subjects
Interval 0.12 to 23.8
|
6 Percentages of Subjects
Interval 0.14 to 27.3
|
—
|
—
|
—
|
—
|
—
|
|
19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B.
M14459 (Day 30, N= 21,16,11,20,20,18)
|
95 Percentages of Subjects
Interval 76.2 to 99.88
|
88 Percentages of Subjects
Interval 61.7 to 98.4
|
100 Percentages of Subjects
Interval 71.5 to 100.0
|
95 Percentages of Subjects
Interval 75.1 to 99.87
|
35 Percentages of Subjects
Interval 15.4 to 59.2
|
33 Percentages of Subjects
Interval 13.3 to 59.0
|
—
|
—
|
—
|
—
|
—
|
|
19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B.
NZ98/254 (Day 30, N= 21,16,11,19,21,18)
|
95 Percentages of Subjects
Interval 76.2 to 99.88
|
75 Percentages of Subjects
Interval 47.6 to 92.7
|
82 Percentages of Subjects
Interval 48.2 to 97.7
|
95 Percentages of Subjects
Interval 74.0 to 99.87
|
19 Percentages of Subjects
Interval 5.4 to 41.9
|
17 Percentages of Subjects
Interval 3.6 to 41.4
|
—
|
—
|
—
|
—
|
—
|
|
19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B.
NZ98/254 (Day 365, N= 21,16,11,19,21,18)
|
29 Percentages of Subjects
Interval 11.3 to 52.2
|
31 Percentages of Subjects
Interval 11.0 to 58.7
|
45 Percentages of Subjects
Interval 16.7 to 76.6
|
42 Percentages of Subjects
Interval 20.3 to 66.5
|
19 Percentages of Subjects
Interval 5.4 to 41.9
|
6 Percentages of Subjects
Interval 0.14 to 27.3
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1, Day 30 and Day 365Population: Analysis was done on FAS Day 365 (Persistence of Booster). All subjects in the enrolled population who were randomized, actually received the study vaccination in V102\_03E1 and provided an evaluable serum sample at Day 365.
The HT-hSBA GMTs against Neisseria meningitidis serogroup A, C, W, Y and strains of serogroups B at Day 1, Day 30 (one month) and Day 365 (12 months) after the administration of MenABCWY booster vaccination.
Outcome measures
| Measure |
2OMV_OMV
n=21 Participants
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
|
2qOMV_qOMV
n=22 Participants
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
|
rMenB+OMV
n=16 Participants
Subjects received two doses of rMenB + OMV, administered two months apart.
|
Menveo
n=20 Participants
Subjects received a dose of placebo followed by one dose of MenACWY administered two months later.
|
2B_OMV
n=11 Participants
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study
|
2B_qOMV
n=20 Participants
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study
|
1M_OMV
n=20 Participants
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
|
1M_qOMV
n=18 Participants
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
|
1M_Pbo
n=17 Participants
Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
|
1M_Pbo
Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
|
Total
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B.
Men A (Day 30, N= 21,22,15,19,10,20,18,16,16)
|
275 Titers
Interval 174.0 to 435.0
|
3.88 Titers
Interval 1.74 to 8.66
|
348 Titers
Interval 202.0 to 601.0
|
2.95 Titers
Interval 1.41 to 6.17
|
445 Titers
Interval 277.0 to 715.0
|
428 Titers
Interval 196.0 to 931.0
|
140 Titers
Interval 82.0 to 239.0
|
46 Titers
Interval 23.0 to 91.0
|
5.99 Titers
Interval 2.27 to 16.0
|
—
|
—
|
|
20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B.
Men W (Day 365, N= 21,22,16,20,11,20,19,18,17)
|
190 Titers
Interval 133.0 to 272.0
|
28 Titers
Interval 13.0 to 59.0
|
213 Titers
Interval 135.0 to 337.0
|
16 Titers
Interval 5.58 to 47.0
|
80 Titers
Interval 26.0 to 246.0
|
96 Titers
Interval 72.0 to 127.0
|
172 Titers
Interval 97.0 to 306.0
|
104 Titers
Interval 49.0 to 221.0
|
16 Titers
Interval 5.27 to 49.0
|
—
|
—
|
|
20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B.
Men C (Day 365, N= 21,21,16,20,11,19,19,18,17)
|
128 Titers
Interval 75.0 to 217.0
|
15 Titers
Interval 5.82 to 39.0
|
177 Titers
Interval 102.0 to 305.0
|
9.14 Titers
Interval 4.07 to 21.0
|
29 Titers
Interval 10.0 to 82.0
|
32 Titers
Interval 16.0 to 67.0
|
81 Titers
Interval 46.0 to 141.0
|
72 Titers
Interval 27.0 to 191.0
|
24 Titers
Interval 8.98 to 66.0
|
—
|
—
|
|
20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B.
Men Y (Day 1, N= 21,21,14,20,11,18,20,18,17)
|
10 Titers
Interval 4.39 to 24.0
|
16 Titers
Interval 4.85 to 54.0
|
24 Titers
Interval 6.62 to 90.0
|
5.39 Titers
Interval 2.06 to 14.0
|
2.40 Titers
Interval 1.05 to 5.47
|
1.90 Titers
Interval 1.02 to 3.55
|
7.05 Titers
Interval 3.08 to 16.0
|
6.83 Titers
Interval 2.11 to 22.0
|
7.03 Titers
Interval 1.99 to 25.0
|
—
|
—
|
|
20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B.
Men Y (Day 30, N= 21,21,15,20,11,18,20,17,16)
|
444 Titers
Interval 257.0 to 768.0
|
17 Titers
Interval 4.77 to 57.0
|
748 Titers
Interval 463.0 to 1208.0
|
4.86 Titers
Interval 1.86 to 13.0
|
48 Titers
Interval 14.0 to 157.0
|
54 Titers
Interval 17.0 to 171.0
|
662 Titers
Interval 424.0 to 1032.0
|
404 Titers
Interval 201.0 to 811.0
|
6.84 Titers
Interval 1.78 to 26.0
|
—
|
—
|
|
20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B.
Men Y (Day 365, N= 21,21,16,20,11,18,20,18,17)
|
116 Titers
Interval 58.0 to 231.0
|
18 Titers
Interval 5.05 to 62.0
|
235 Titers
Interval 147.0 to 376.0
|
5.93 Titers
Interval 1.97 to 18.0
|
7.17 Titers
Interval 1.91 to 27.0
|
20 Titers
Interval 6.92 to 58.0
|
193 Titers
Interval 123.0 to 301.0
|
101 Titers
Interval 36.0 to 280.0
|
9.56 Titers
Interval 2.44 to 37.0
|
—
|
—
|
|
20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B.
Men W (Day 1, N= 20,22,12,20,11,20,17,18,16)
|
36 Titers
Interval 21.0 to 62.0
|
43 Titers
Interval 24.0 to 79.0
|
30 Titers
Interval 7.82 to 112.0
|
17 Titers
Interval 6.88 to 43.0
|
25 Titers
Interval 7.98 to 79.0
|
23 Titers
Interval 9.81 to 52.0
|
28 Titers
Interval 11.0 to 70.0
|
15 Titers
Interval 4.54 to 47.0
|
10 Titers
Interval 3.53 to 30.0
|
—
|
—
|
|
20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B.
Men W (Day 30, N= 18,22,15,19,11,18,17,16,14)
|
844 Titers
Interval 535.0 to 1333.0
|
46 Titers
Interval 23.0 to 89.0
|
890 Titers
Interval 665.0 to 1190.0
|
22 Titers
Interval 8.89 to 52.0
|
392 Titers
Interval 252.0 to 610.0
|
395 Titers
Interval 321.0 to 487.0
|
620 Titers
Interval 354.0 to 1085.0
|
360 Titers
Interval 169.0 to 765.0
|
13 Titers
Interval 3.5 to 52.0
|
—
|
—
|
|
20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B.
Men A (Day 365, N= 21,22,16,20,10,20,20,18,17)
|
25 Titers
Interval 11.0 to 59.0
|
2.62 Titers
Interval 1.39 to 4.94
|
44 Titers
Interval 18.0 to 105.0
|
3.03 Titers
Interval 1.3 to 7.06
|
54 Titers
Interval 17.0 to 174.0
|
53 Titers
Interval 22.0 to 130.0
|
34 Titers
Interval 16.0 to 69.0
|
6.52 Titers
Interval 2.71 to 16.0
|
3.54 Titers
Interval 1.4 to 8.92
|
—
|
—
|
|
20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B.
Men A (Day 1, N= 21,22,15,20,10,20,20,17,17)
|
3.98 Titers
Interval 1.98 to 8.0
|
2.73 Titers
Interval 1.44 to 5.15
|
3.07 Titers
Interval 1.26 to 7.47
|
2.98 Titers
Interval 1.38 to 6.42
|
2.27 Titers
Interval 0.87 to 5.94
|
4.22 Titers
Interval 1.63 to 11.0
|
6.31 Titers
Interval 2.82 to 14.0
|
2.49 Titers
Interval 1.52 to 4.09
|
5.48 Titers
Interval 2.18 to 14.0
|
—
|
—
|
|
20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B.
Men C (Day 1, N= 20,19,14,20,11,19,19,18,16)
|
18 Titers
Interval 8.21 to 39.0
|
19 Titers
Interval 7.54 to 49.0
|
19 Titers
Interval 8.13 to 44.0
|
10 Titers
Interval 5.52 to 19.0
|
5.20 Titers
Interval 2.8 to 9.65
|
7.83 Titers
Interval 4.51 to 14.0
|
7.89 Titers
Interval 4.26 to 15.0
|
8.45 Titers
Interval 2.64 to 27.0
|
24 Titers
Interval 9.34 to 61.0
|
—
|
—
|
|
20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B.
Men C (Day 30, N= 17,20,10,20,7,14,19,17,16)
|
737 Titers
Interval 459.0 to 1183.0
|
21 Titers
Interval 8.38 to 52.0
|
766 Titers
Interval 325.0 to 1804.0
|
8.43 Titers
Interval 4.37 to 16.0
|
292 Titers
Interval 75.0 to 1142.0
|
102 Titers
Interval 57.0 to 181.0
|
322 Titers
Interval 186.0 to 556.0
|
307 Titers
Interval 118.0 to 795.0
|
27 Titers
Interval 9.15 to 78.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1, Day 30 and Day 365Population: Analysis was done on FAS Day 365 (Persistence of Booster). All subjects in the enrolled population who were randomized, actually received the study vaccination in V102\_03E1 and provided an evaluable serum sample at Day 365.
The HT-hSBA GMTs against Neisseria meningitidis strains of serogroups B at Day 1, Day 30 (one month) and Day 365 (12 months) after the administration of MenABCWY booster vaccination.
Outcome measures
| Measure |
2OMV_OMV
n=21 Participants
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
|
2qOMV_qOMV
n=22 Participants
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
|
rMenB+OMV
n=16 Participants
Subjects received two doses of rMenB + OMV, administered two months apart.
|
Menveo
n=20 Participants
Subjects received a dose of placebo followed by one dose of MenACWY administered two months later.
|
2B_OMV
n=11 Participants
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study
|
2B_qOMV
n=20 Participants
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study
|
1M_OMV
n=21 Participants
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
|
1M_qOMV
n=18 Participants
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
|
1M_Pbo
n=17 Participants
Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
|
1M_Pbo
Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
|
Total
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B.
M01-0240364 (Day 1, N=21,22,14,18,10,19,20,17,17)
|
2.33 Titers
Interval 1.25 to 4.36
|
3.39 Titers
Interval 1.43 to 8.05
|
2.87 Titers
Interval 0.86 to 9.59
|
1.26 Titers
Interval 0.89 to 1.8
|
2.46 Titers
Interval 0.72 to 8.4
|
6.29 Titers
Interval 2.22 to 18.0
|
1.24 Titers
Interval 0.79 to 1.94
|
1.24 Titers
Interval 0.88 to 1.77
|
1.68 Titers
Interval 0.85 to 3.33
|
—
|
—
|
|
21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B.
M01-0240364 (Day 30, N=21,22,16,17,11,19,19,18,16)
|
679 Titers
Interval 352.0 to 1310.0
|
3.57 Titers
Interval 1.39 to 9.14
|
903 Titers
Interval 463.0 to 1761.0
|
1.23 Titers
Interval 0.89 to 1.7
|
1336 Titers
Interval 810.0 to 2202.0
|
1261 Titers
Interval 746.0 to 2131.0
|
2.68 Titers
Interval 1.15 to 6.25
|
3.66 Titers
Interval 1.21 to 11.0
|
1.89 Titers
Interval 0.72 to 4.91
|
—
|
—
|
|
21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B.
5/99 (Day 1, N=21,22,14,20,9,19,21,18,17)
|
18 Titers
Interval 9.47 to 34.0
|
18 Titers
Interval 9.5 to 34.0
|
31 Titers
Interval 12.0 to 85.0
|
31 Titers
Interval 15.0 to 65.0
|
27 Titers
Interval 8.61 to 86.0
|
39 Titers
Interval 21.0 to 74.0
|
2.97 Titers
Interval 1.58 to 5.59
|
1.8 Titers
Interval 1.01 to 3.22
|
3.2 Titers
Interval 1.44 to 7.09
|
—
|
—
|
|
21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B.
5/99 (Day 30, N=21,22,16,20,11,19,21,18,16)
|
1147 Titers
Interval 665.0 to 1980.0
|
23 Titers
Interval 11.0 to 48.0
|
1598 Titers
Interval 864.0 to 2956.0
|
35 Titers
Interval 19.0 to 65.0
|
2205 Titers
Interval 1560.0 to 3117.0
|
2816 Titers
Interval 1856.0 to 4273.0
|
28 Titers
Interval 11.0 to 67.0
|
29 Titers
Interval 10.0 to 80.0
|
3.98 Titers
Interval 1.24 to 13.0
|
—
|
—
|
|
21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B.
5/99 (Day 365, N=21,22,16,20,11,19,21,18,17)
|
175 Titers
Interval 79.0 to 385.0
|
13 Titers
Interval 6.07 to 29.0
|
305 Titers
Interval 149.0 to 625.0
|
23 Titers
Interval 11.0 to 47.0
|
587 Titers
Interval 351.0 to 983.0
|
491 Titers
Interval 258.0 to 936.0
|
6.05 Titers
Interval 3.1 to 12.0
|
4.23 Titers
Interval 1.48 to 12.0
|
2.45 Titers
Interval 1.0 to 5.99
|
—
|
—
|
|
21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B.
H44/76 (Day 1, N=21,22,15,20,11,20,21,18,17)
|
3.58 Titers
Interval 1.66 to 7.71
|
2.23 Titers
Interval 1.28 to 3.9
|
1.49 Titers
Interval 0.96 to 2.33
|
1.73 Titers
Interval 0.97 to 3.1
|
3.45 Titers
Interval 1.81 to 6.57
|
3.43 Titers
Interval 1.83 to 6.43
|
1.34 Titers
Interval 0.85 to 2.13
|
1.51 Titers
Interval 0.91 to 2.48
|
1.19 Titers
Interval 0.97 to 1.47
|
—
|
—
|
|
21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B.
H44/76 (Day 30, N=21,22,16,20,11,20,19,18,16)
|
104 Titers
Interval 59.0 to 184.0
|
2.65 Titers
Interval 1.48 to 4.78
|
57 Titers
Interval 32.0 to 102.0
|
2.03 Titers
Interval 1.11 to 3.73
|
132 Titers
Interval 64.0 to 271.0
|
79 Titers
Interval 40.0 to 153.0
|
5.27 Titers
Interval 2.54 to 11.0
|
3.89 Titers
Interval 1.79 to 8.47
|
1.6 Titers
Interval 0.67 to 3.83
|
—
|
—
|
|
21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B.
H44/76 (Day 365, N=21,22,16,20,11,20,21,18,17)
|
12 Titers
Interval 5.18 to 26.0
|
1.93 Titers
Interval 1.2 to 3.1
|
4.19 Titers
Interval 1.93 to 9.11
|
1.83 Titers
Interval 1.07 to 3.15
|
21 Titers
Interval 6.0 to 71.0
|
11 Titers
Interval 4.68 to 25.0
|
1.96 Titers
Interval 1.21 to 3.19
|
1.92 Titers
Interval 1.17 to 3.17
|
1.49 Titers
Interval 0.9 to 2.48
|
—
|
—
|
|
21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B.
M07-0241084 (Day 1, N=21,22,14,20,11,19,21,18,17)
|
3.68 Titers
Interval 2.07 to 6.54
|
4.2 Titers
Interval 2.25 to 7.85
|
2.28 Titers
Interval 1.16 to 4.48
|
2.36 Titers
Interval 1.51 to 3.7
|
4.1 Titers
Interval 1.89 to 8.9
|
7.35 Titers
Interval 3.82 to 14.0
|
2.08 Titers
Interval 1.26 to 3.42
|
2.15 Titers
Interval 1.14 to 4.05
|
3.5 Titers
Interval 1.57 to 7.8
|
—
|
—
|
|
21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B.
M07-0241084 (Day 30, N=21,22,16,20,11,19,21,18,16)
|
59 Titers
Interval 36.0 to 98.0
|
4.37 Titers
Interval 2.29 to 8.31
|
36 Titers
Interval 20.0 to 64.0
|
2.2 Titers
Interval 1.38 to 3.49
|
68 Titers
Interval 33.0 to 142.0
|
66 Titers
Interval 35.0 to 124.0
|
3.26 Titers
Interval 1.75 to 6.06
|
2.24 Titers
Interval 1.14 to 4.38
|
4.57 Titers
Interval 1.48 to 14.0
|
—
|
—
|
|
21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B.
M07-0241084 (Day 365,N=21,22,16,20,11,19,21,18,17)
|
7.96 Titers
Interval 4.6 to 14.0
|
3.28 Titers
Interval 2.16 to 4.97
|
4.09 Titers
Interval 2.3 to 7.25
|
2.04 Titers
Interval 1.43 to 2.92
|
10 Titers
Interval 4.51 to 24.0
|
11 Titers
Interval 6.35 to 18.0
|
2.45 Titers
Interval 1.59 to 3.79
|
1.91 Titers
Interval 1.14 to 3.23
|
3.92 Titers
Interval 1.9 to 8.07
|
—
|
—
|
|
21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B.
M14459 (Day 1, N=21,22,14,20,11,20,21,18,17)
|
2.69 Titers
Interval 1.51 to 4.78
|
2.94 Titers
Interval 1.77 to 4.89
|
1.54 Titers
Interval 0.9 to 2.63
|
2.01 Titers
Interval 1.4 to 2.88
|
3.11 Titers
Interval 1.74 to 5.56
|
3.37 Titers
Interval 1.95 to 5.81
|
1.85 Titers
Interval 1.13 to 3.04
|
1.48 Titers
Interval 1.03 to 2.13
|
2.55 Titers
Interval 1.37 to 4.77
|
—
|
—
|
|
21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B.
M14459 (Day 30, N=21,22,16,20,11,20,20,18,16)
|
39 Titers
Interval 21.0 to 70.0
|
2.31 Titers
Interval 1.39 to 3.82
|
20 Titers
Interval 10.0 to 39.0
|
2.03 Titers
Interval 1.38 to 2.98
|
56 Titers
Interval 27.0 to 117.0
|
35 Titers
Interval 21.0 to 60.0
|
3.44 Titers
Interval 2.05 to 5.75
|
2.71 Titers
Interval 1.56 to 4.7
|
3.05 Titers
Interval 1.05 to 8.83
|
—
|
—
|
|
21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B.
M14459 (Day 365, N=21,22,16,20,11,20,21,18,17)
|
7.19 Titers
Interval 3.89 to 13.0
|
1.67 Titers
Interval 1.07 to 2.6
|
2.94 Titers
Interval 1.49 to 5.8
|
1.47 Titers
Interval 1.07 to 2.03
|
11 Titers
Interval 4.41 to 28.0
|
7.12 Titers
Interval 3.59 to 14.0
|
2.09 Titers
Interval 1.33 to 3.29
|
1.38 Titers
Interval 0.98 to 1.93
|
2.17 Titers
Interval 1.07 to 4.41
|
—
|
—
|
|
21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B.
NZ98/254 (Day 1, N=21,22,14,20,11,19,21,18,17)
|
1.73 Titers
Interval 1.06 to 2.81
|
2.34 Titers
Interval 1.33 to 4.1
|
1.34 Titers
Interval 0.94 to 1.93
|
1.48 Titers
Interval 1.01 to 2.17
|
1.72 Titers
Interval 0.99 to 2.98
|
2.24 Titers
Interval 1.2 to 4.17
|
1.18 Titers
Interval 0.84 to 1.66
|
1.19 Titers
Interval 0.9 to 1.58
|
1.13 Titers
Interval 0.94 to 1.37
|
—
|
—
|
|
21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B.
NZ98/254 (Day 30, N=21,22,16,20,11,19,21,18,16)
|
32 Titers
Interval 19.0 to 52.0
|
2.23 Titers
Interval 1.25 to 3.99
|
15 Titers
Interval 5.93 to 36.0
|
1.75 Titers
Interval 0.98 to 3.14
|
17 Titers
Interval 6.22 to 45.0
|
28 Titers
Interval 17.0 to 47.0
|
2.48 Titers
Interval 1.31 to 4.69
|
1.62 Titers
Interval 0.96 to 2.74
|
1.73 Titers
Interval 0.77 to 3.9
|
—
|
—
|
|
21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B.
NZ98/254 (Day 365, N=21,22,16,20,11,19,21,18,17)
|
3.49 Titers
Interval 2.12 to 5.74
|
1.71 Titers
Interval 1.14 to 2.57
|
2.67 Titers
Interval 1.27 to 5.61
|
1.23 Titers
Interval 0.9 to 1.69
|
3.28 Titers
Interval 1.66 to 6.49
|
3.77 Titers
Interval 1.98 to 7.18
|
1.65 Titers
Interval 1.04 to 2.61
|
1.19 Titers
Interval 0.91 to 1.54
|
1.28 Titers
Interval 0.85 to 1.92
|
—
|
—
|
|
21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B.
M01-0240364 (Day 365,N=21,22,16,18,11,19,20,18,17)
|
30 Titers
Interval 9.54 to 93.0
|
3.55 Titers
Interval 1.56 to 8.07
|
74 Titers
Interval 18.0 to 300.0
|
1.23 Titers
Interval 0.91 to 1.68
|
303 Titers
Interval 174.0 to 527.0
|
155 Titers
Interval 69.0 to 350.0
|
1.61 Titers
Interval 0.99 to 2.63
|
1.71 Titers
Interval 0.86 to 3.42
|
2.03 Titers
Interval 0.9 to 4.58
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1, Day 30 and Day 365Population: Analysis was done on FAS Day 365 (Persistence of Booster). All subjects in the enrolled population who were randomized, actually received the study vaccination in V102\_03E1 and provided an evaluable serum sample at Day 365.
Percentage of subjects with HT-hSBA titer ≥ 1:8 to N. meningitidis serogroups A,C,W,Y at Day 1, Day 30 (one month) and Day 365 (12 months) after the administration of MenABCWY booster vaccination in this study.
Outcome measures
| Measure |
2OMV_OMV
n=21 Participants
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
|
2qOMV_qOMV
n=22 Participants
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
|
rMenB+OMV
n=16 Participants
Subjects received two doses of rMenB + OMV, administered two months apart.
|
Menveo
n=20 Participants
Subjects received a dose of placebo followed by one dose of MenACWY administered two months later.
|
2B_OMV
n=11 Participants
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study
|
2B_qOMV
n=20 Participants
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study
|
1M_OMV
n=20 Participants
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
|
1M_qOMV
n=18 Participants
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
|
1M_Pbo
n=17 Participants
Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
|
1M_Pbo
Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
|
Total
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination.
Men A (Day 30, N= 21,22,15,19,10,20,18,16,16)
|
100 Percentages of Subjects
Interval 83.9 to 100.0
|
32 Percentages of Subjects
Interval 13.9 to 54.9
|
100 Percentages of Subjects
Interval 78.2 to 100.0
|
26 Percentages of Subjects
Interval 9.1 to 51.2
|
100 Percentages of Subjects
Interval 69.2 to 100.0
|
95 Percentages of Subjects
Interval 75.1 to 99.87
|
100 Percentages of Subjects
Interval 81.5 to 100.0
|
94 Percentages of Subjects
Interval 69.8 to 99.84
|
44 Percentages of Subjects
Interval 19.8 to 70.1
|
—
|
—
|
|
22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination.
Men A (Day 365, N= 21,22,16,20,10,20,20,18,17)
|
67 Percentages of Subjects
Interval 43.0 to 85.4
|
23 Percentages of Subjects
Interval 7.8 to 45.4
|
88 Percentages of Subjects
Interval 61.7 to 98.4
|
25 Percentages of Subjects
Interval 8.7 to 49.1
|
90 Percentages of Subjects
Interval 55.5 to 99.75
|
85 Percentages of Subjects
Interval 62.1 to 96.8
|
85 Percentages of Subjects
Interval 62.1 to 96.8
|
50 Percentages of Subjects
Interval 26.0 to 74.0
|
35 Percentages of Subjects
Interval 14.2 to 61.7
|
—
|
—
|
|
22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination.
Men C (Day 1, N= 20,19,14,20,11,19,19,18,16)
|
65 Percentages of Subjects
Interval 40.8 to 84.6
|
68 Percentages of Subjects
Interval 43.4 to 87.4
|
71 Percentages of Subjects
Interval 41.9 to 91.6
|
65 Percentages of Subjects
Interval 40.8 to 84.6
|
36 Percentages of Subjects
Interval 10.9 to 69.2
|
58 Percentages of Subjects
Interval 33.5 to 79.7
|
58 Percentages of Subjects
Interval 33.5 to 79.7
|
50 Percentages of Subjects
Interval 26.0 to 74.0
|
75 Percentages of Subjects
Interval 47.6 to 92.7
|
—
|
—
|
|
22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination.
Men C (Day 30, N= 17,20,10,20,7,14,19,17,16)
|
100 Percentages of Subjects
Interval 80.5 to 100.0
|
65 Percentages of Subjects
Interval 40.8 to 84.6
|
100 Percentages of Subjects
Interval 69.2 to 100.0
|
55 Percentages of Subjects
Interval 31.5 to 76.9
|
100 Percentages of Subjects
Interval 59.0 to 100.0
|
100 Percentages of Subjects
Interval 76.8 to 100.0
|
100 Percentages of Subjects
Interval 82.4 to 100.0
|
88 Percentages of Subjects
Interval 63.6 to 98.5
|
69 Percentages of Subjects
Interval 41.3 to 89.0
|
—
|
—
|
|
22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination.
Men W (Day 365, N= 21,22,16,20,11,20,19,18,17)
|
100 Percentages of Subjects
Interval 83.9 to 100.0
|
82 Percentages of Subjects
Interval 59.7 to 94.8
|
100 Percentages of Subjects
Interval 79.4 to 100.0
|
65 Percentages of Subjects
Interval 40.8 to 84.6
|
91 Percentages of Subjects
Interval 58.7 to 99.77
|
100 Percentages of Subjects
Interval 83.2 to 100.0
|
100 Percentages of Subjects
Interval 82.4 to 100.0
|
100 Percentages of Subjects
Interval 81.5 to 100.0
|
65 Percentages of Subjects
Interval 38.3 to 85.8
|
—
|
—
|
|
22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination.
Men Y (Day 1, N= 21,21,14,20,11,18,20,18,17)
|
62 Percentages of Subjects
Interval 38.4 to 81.9
|
62 Percentages of Subjects
Interval 38.4 to 81.9
|
71 Percentages of Subjects
Interval 41.9 to 91.6
|
40 Percentages of Subjects
Interval 19.1 to 63.9
|
36 Percentages of Subjects
Interval 10.9 to 69.2
|
11 Percentages of Subjects
Interval 1.4 to 34.7
|
55 Percentages of Subjects
Interval 31.5 to 76.9
|
44 Percentages of Subjects
Interval 21.5 to 69.2
|
41 Percentages of Subjects
Interval 18.4 to 67.1
|
—
|
—
|
|
22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination.
Men A (Day 1, N= 21,22,15,20,10,20,20,17,17)
|
38 Percentages of Subjects
Interval 18.1 to 61.6
|
18 Percentages of Subjects
Interval 5.2 to 40.3
|
20 Percentages of Subjects
Interval 4.3 to 48.1
|
30 Percentages of Subjects
Interval 11.9 to 54.3
|
30 Percentages of Subjects
Interval 6.7 to 65.2
|
35 Percentages of Subjects
Interval 15.4 to 59.2
|
45 Percentages of Subjects
Interval 23.1 to 68.5
|
12 Percentages of Subjects
Interval 1.5 to 36.4
|
41 Percentages of Subjects
Interval 18.4 to 67.1
|
—
|
—
|
|
22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination.
Men C (Day 365, N= 21,21,16,20,11,19,19,18,17)
|
100 Percentages of Subjects
Interval 83.9 to 100.0
|
62 Percentages of Subjects
Interval 38.4 to 81.9
|
100 Percentages of Subjects
Interval 79.4 to 100.0
|
50 Percentages of Subjects
Interval 27.2 to 72.8
|
82 Percentages of Subjects
Interval 48.2 to 97.7
|
95 Percentages of Subjects
Interval 74.0 to 99.87
|
100 Percentages of Subjects
Interval 82.4 to 100.0
|
89 Percentages of Subjects
Interval 65.3 to 98.6
|
65 Percentages of Subjects
Interval 38.3 to 85.8
|
—
|
—
|
|
22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination.
Men W (Day 1, 20,22,12,20,11,20,17,18,16)
|
95 Percentages of Subjects
Interval 75.1 to 99.87
|
95 Percentages of Subjects
Interval 77.2 to 99.88
|
75 Percentages of Subjects
Interval 42.8 to 94.5
|
70 Percentages of Subjects
Interval 45.7 to 88.1
|
82 Percentages of Subjects
Interval 48.2 to 97.7
|
75 Percentages of Subjects
Interval 50.9 to 91.3
|
82 Percentages of Subjects
Interval 56.6 to 96.2
|
61 Percentages of Subjects
Interval 35.7 to 82.7
|
56 Percentages of Subjects
Interval 29.9 to 80.2
|
—
|
—
|
|
22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination.
Men W (Day 30, N= 18,22,15,19,11,18,17,16,14)
|
100 Percentages of Subjects
Interval 81.5 to 100.0
|
86 Percentages of Subjects
Interval 65.1 to 97.1
|
100 Percentages of Subjects
Interval 78.2 to 100.0
|
74 Percentages of Subjects
Interval 48.8 to 90.9
|
100 Percentages of Subjects
Interval 71.5 to 100.0
|
100 Percentages of Subjects
Interval 81.5 to 100.0
|
100 Percentages of Subjects
Interval 80.5 to 100.0
|
100 Percentages of Subjects
Interval 79.4 to 100.0
|
57 Percentages of Subjects
Interval 28.9 to 82.3
|
—
|
—
|
|
22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination.
Men Y (Day 30, N= 21,21,15,20,11,18,20,17,16)
|
100 Percentages of Subjects
Interval 83.9 to 100.0
|
57 Percentages of Subjects
Interval 34.0 to 78.2
|
100 Percentages of Subjects
Interval 78.2 to 100.0
|
40 Percentages of Subjects
Interval 19.1 to 63.9
|
82 Percentages of Subjects
Interval 48.2 to 97.7
|
83 Percentages of Subjects
Interval 58.6 to 96.4
|
100 Percentages of Subjects
Interval 83.2 to 100.0
|
100 Percentages of Subjects
Interval 80.5 to 100.0
|
38 Percentages of Subjects
Interval 15.2 to 64.6
|
—
|
—
|
|
22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination.
Men Y (Day 365, N= 21,21,16,20,11,18,20,18,17)
|
95 Percentages of Subjects
Interval 76.2 to 99.88
|
52 Percentages of Subjects
Interval 29.8 to 74.3
|
100 Percentages of Subjects
Interval 79.4 to 100.0
|
40 Percentages of Subjects
Interval 19.1 to 63.9
|
45 Percentages of Subjects
Interval 16.7 to 76.6
|
72 Percentages of Subjects
Interval 46.5 to 90.3
|
100 Percentages of Subjects
Interval 83.2 to 100.0
|
89 Percentages of Subjects
Interval 65.3 to 98.6
|
47 Percentages of Subjects
Interval 23.0 to 72.2
|
—
|
—
|
SECONDARY outcome
Timeframe: From day 1 (6 hours) through day 7 after any vaccinationPopulation: Analysis was done on the Solicited Safety Set, i.e. all exposed subjects who provide post vaccination solicited adverse event data.
Number of subjects reporting solicited local and systemic adverse events after receiving a booster dose of MenABCWY vaccine or placebo. the below reported events are Erythema- Injection site erythema, Induration- Injection site induration, Pain-injection site pain, Arthralgia, Chills, Fatigue, Headache, Loss of Appetite, Myalgia, Nausea, Rash, Fever, Prevention- Prevention of Pain and/or Fever, Treatment- Treatment of Pain and/or Fever and Analgesic/Antipyr.: use of Analgesic/Antipyretics in pain and fever.
Outcome measures
| Measure |
2OMV_OMV
n=26 Participants
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
|
2qOMV_qOMV
n=24 Participants
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
|
rMenB+OMV
n=17 Participants
Subjects received two doses of rMenB + OMV, administered two months apart.
|
Menveo
n=23 Participants
Subjects received a dose of placebo followed by one dose of MenACWY administered two months later.
|
2B_OMV
n=11 Participants
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study
|
2B_qOMV
n=21 Participants
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study
|
1M_OMV
n=6 Participants
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
|
1M_qOMV
n=21 Participants
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
|
1M_Pbo
n=19 Participants
Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
|
1M_Pbo
n=19 Participants
Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
|
Total
n=187 Participants
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study.
Any AEs (N=26,24,17,23,11,21,6,21,19,19,187)
|
23 Participants
|
10 Participants
|
15 Participants
|
13 Participants
|
11 Participants
|
18 Participants
|
2 Participants
|
20 Participants
|
17 Participants
|
8 Participants
|
137 Participants
|
|
23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study.
Erythema (N=26,23,17,23,11,21,6,21,19,19,186)
|
11 Participants
|
2 Participants
|
7 Participants
|
3 Participants
|
6 Participants
|
7 Participants
|
0 Participants
|
6 Participants
|
9 Participants
|
2 Participants
|
53 Participants
|
|
23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study.
Any Local (N=26,24,17,23,11,21,6,21,19,19,187)
|
23 Participants
|
7 Participants
|
15 Participants
|
8 Participants
|
11 Participants
|
18 Participants
|
1 Participants
|
19 Participants
|
17 Participants
|
5 Participants
|
124 Participants
|
|
23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study.
Pain (N=26,24,17,23,11,21,6,21,19,19,187)
|
20 Participants
|
6 Participants
|
14 Participants
|
7 Participants
|
11 Participants
|
17 Participants
|
1 Participants
|
19 Participants
|
17 Participants
|
4 Participants
|
116 Participants
|
|
23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study.
Induration (N=26,23,17,23,11,21,6,21,19,18,185)
|
7 Participants
|
2 Participants
|
5 Participants
|
2 Participants
|
9 Participants
|
6 Participants
|
0 Participants
|
11 Participants
|
9 Participants
|
1 Participants
|
52 Participants
|
|
23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study.
Any Systemic (N=26,24,17,23,11,21,6,21,19,19,187)
|
12 Participants
|
9 Participants
|
12 Participants
|
6 Participants
|
6 Participants
|
10 Participants
|
1 Participants
|
15 Participants
|
10 Participants
|
5 Participants
|
86 Participants
|
|
23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study.
Arthralgia(N=25,23,17,23,10,21,6,21,19,19,184)
|
3 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
4 Participants
|
2 Participants
|
3 Participants
|
20 Participants
|
|
23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study.
Chills(N=26,23,17,23,11,21,6,21,19,19,186)
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
5 Participants
|
1 Participants
|
1 Participants
|
14 Participants
|
|
23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study.
Fatigue(N=26,23,17,23,11,21,6,21,19,19,186)
|
9 Participants
|
6 Participants
|
8 Participants
|
2 Participants
|
5 Participants
|
8 Participants
|
0 Participants
|
11 Participants
|
6 Participants
|
5 Participants
|
60 Participants
|
|
23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study.
Headache(N=26,23,17,23,11,21,6,21,19,19,186)
|
7 Participants
|
6 Participants
|
8 Participants
|
3 Participants
|
5 Participants
|
4 Participants
|
1 Participants
|
12 Participants
|
5 Participants
|
2 Participants
|
53 Participants
|
|
23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study.
Loss ofAppetite(N=26,23,17,23,11,21,6,21,19,19,186
|
2 Participants
|
1 Participants
|
4 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
8 Participants
|
3 Participants
|
2 Participants
|
26 Participants
|
|
23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study.
Myalgia(N=26,23,17,23,10,21,6,21,19,19,185)
|
6 Participants
|
2 Participants
|
5 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
8 Participants
|
4 Participants
|
1 Participants
|
31 Participants
|
|
23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study.
Nausea(N=26,23,17,23,11,21,6,21,19,19,186)
|
0 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
5 Participants
|
0 Participants
|
4 Participants
|
5 Participants
|
1 Participants
|
24 Participants
|
|
23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study.
Rash (N=26,23,17,23,11,21,6,21,18,19,185)
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
5 Participants
|
|
23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study.
Fever >38 °C (N=25,24,17,23,11,21,6,21,19,18,185)
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
|
23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study.
Prevention (N=25,23,17,23,11,21,6,21,19,19,185)
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
|
23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study.
Treatment (N=25,23,17,23,11,21,6,21,19,19,185)
|
2 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
5 Participants
|
0 Participants
|
6 Participants
|
2 Participants
|
0 Participants
|
22 Participants
|
|
23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study.
Analgesic/Antipyr. Pain (N=0,0,1,0,0,0,0,0,0,0,1)
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study.
Analgesic/Antipyr. Fever (N=0,0,1,0,0,0,0,0,0,0,1)
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 30Population: Analysis was done on the Unsolicited Safety Set. All subjects in the exposed population who provided information about post-vaccination AEs or safety records at Day 30.
Number of subjects reporting unsolicited AEs (any AEs and at least possibly related AEs) after receiving a booster dose of MenABCWY vaccine or placebo from Day 1 to Day 30. Analysis was done on the Unsolicited Safety Set. All subjects in the exposed population who provided information about post-vaccination AEs or safety records at Day 30.
Outcome measures
| Measure |
2OMV_OMV
n=26 Participants
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
|
2qOMV_qOMV
n=24 Participants
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
|
rMenB+OMV
n=17 Participants
Subjects received two doses of rMenB + OMV, administered two months apart.
|
Menveo
n=23 Participants
Subjects received a dose of placebo followed by one dose of MenACWY administered two months later.
|
2B_OMV
n=11 Participants
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study
|
2B_qOMV
n=21 Participants
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study
|
1M_OMV
n=6 Participants
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
|
1M_qOMV
n=21 Participants
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
|
1M_Pbo
n=19 Participants
Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
|
1M_Pbo
n=19 Participants
Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
|
Total
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
24. Number of Subjects With Unsolicited (Any AEs and Possibly Related AEs) Following Booster Vaccination in This Study.
Any AEs
|
6 Participants
|
4 Participants
|
5 Participants
|
2 Participants
|
3 Participants
|
7 Participants
|
1 Participants
|
6 Participants
|
5 Participants
|
4 Participants
|
—
|
|
24. Number of Subjects With Unsolicited (Any AEs and Possibly Related AEs) Following Booster Vaccination in This Study.
At least possibly related
|
3 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 1 to Day 365Population: Analysis was done on the Unsolicited Safety Set. All subjects in the exposed population who provided information about post-vaccination AEs or safety records at Day 30.
Number of subjects reporting any serious unsolicited AEs (SAEs), possibly related SAEs, medically attended AEs, unsolicited AEs leading to withdrawal and deaths after receiving a booster dose of MenABCWY vaccine or placebo, are reported for the entire study period.
Outcome measures
| Measure |
2OMV_OMV
n=26 Participants
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
|
2qOMV_qOMV
n=24 Participants
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
|
rMenB+OMV
n=17 Participants
Subjects received two doses of rMenB + OMV, administered two months apart.
|
Menveo
n=23 Participants
Subjects received a dose of placebo followed by one dose of MenACWY administered two months later.
|
2B_OMV
n=11 Participants
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study
|
2B_qOMV
n=21 Participants
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study
|
1M_OMV
n=6 Participants
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
|
1M_qOMV
n=21 Participants
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
|
1M_Pbo
n=19 Participants
Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
|
1M_Pbo
n=19 Participants
Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
|
Total
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
25. Number of Subjects With Unsolicited Adverse Events Following Booster Vaccination in This Study.
Any SAEs
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
|
25. Number of Subjects With Unsolicited Adverse Events Following Booster Vaccination in This Study.
At Least Possibly related SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
25. Number of Subjects With Unsolicited Adverse Events Following Booster Vaccination in This Study.
NOCD
|
0 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
|
25. Number of Subjects With Unsolicited Adverse Events Following Booster Vaccination in This Study.
Medically attended AEs
|
12 Participants
|
10 Participants
|
12 Participants
|
9 Participants
|
6 Participants
|
9 Participants
|
1 Participants
|
13 Participants
|
11 Participants
|
11 Participants
|
—
|
|
25. Number of Subjects With Unsolicited Adverse Events Following Booster Vaccination in This Study.
AEs leading to withdrawal
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
25. Number of Subjects With Unsolicited Adverse Events Following Booster Vaccination in This Study.
Deaths
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: From primary parent study completion up to Day 1 in this study.Population: Analysis was done on the all enrolled set population. All screened subjects who have been enrolled (ie, attended the first clinic visit and received a subject ID).
Number of subjects reporting New Onset Chronic Disease (NOCD),from the end of the primary parental study V102\_03 (NCT01272180) up to Day 1 visit in V102\_03E1 study, is reported. (Any NOCD AEs: NOCD V102\_03 (NCT01272180) vs. NOCD- Day 1, V102\_03E1)
Outcome measures
| Measure |
2OMV_OMV
n=26 Participants
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
|
2qOMV_qOMV
n=25 Participants
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
|
rMenB+OMV
n=17 Participants
Subjects received two doses of rMenB + OMV, administered two months apart.
|
Menveo
n=24 Participants
Subjects received a dose of placebo followed by one dose of MenACWY administered two months later.
|
2B_OMV
n=11 Participants
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study
|
2B_qOMV
n=21 Participants
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study
|
1M_OMV
n=7 Participants
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
|
1M_qOMV
n=21 Participants
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
|
1M_Pbo
n=19 Participants
Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
|
1M_Pbo
n=19 Participants
Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
|
Total
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
26. Number of Subjects With Unsolicited Adverse Leading to New Onset Chronic Disease (NOCD) Before Study Vaccination.
|
2 Participants
|
4 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
—
|
Adverse Events
2OMV_OMV
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
2OMV_Pbo
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
2qOMV_qOMV
Serious events: 1 serious events
Other events: 16 other events
Deaths: 0 deaths
2qOMV_Pbo
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
2B_OMV
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
2B_qOMV
Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths
2B_Pbo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
1M_OMV
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
1M_qOMV
Serious events: 1 serious events
Other events: 17 other events
Deaths: 0 deaths
1M_Pbo
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Total
Serious events: 5 serious events
Other events: 158 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
2OMV_OMV
n=26 participants at risk
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
|
2OMV_Pbo
n=24 participants at risk
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
|
2qOMV_qOMV
n=17 participants at risk
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
|
2qOMV_Pbo
n=23 participants at risk
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study.
|
2B_OMV
n=11 participants at risk
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study.
|
2B_qOMV
n=21 participants at risk
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼ OMV in this study.
|
2B_Pbo
n=6 participants at risk
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of Placebo in this study.
|
1M_OMV
n=21 participants at risk
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
|
1M_qOMV
n=19 participants at risk
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼ OMV in this study.
|
1M_Pbo
n=19 participants at risk
Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
|
Total
n=188 participants at risk
Total
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Appendicitis
|
0.00%
0/26 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/24 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/17 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/23 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/11 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
4.8%
1/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/6 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.53%
1/188 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/26 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/24 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/17 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
4.3%
1/23 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/11 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/6 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.53%
1/188 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/26 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/24 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/17 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/23 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/11 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/6 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
5.3%
1/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.53%
1/188 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
|
Nervous system disorders
Syncope
|
0.00%
0/26 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/24 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
5.9%
1/17 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/23 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/11 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/6 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.53%
1/188 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/26 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/24 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/17 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/23 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/11 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/6 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
5.3%
1/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.53%
1/188 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
Other adverse events
| Measure |
2OMV_OMV
n=26 participants at risk
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
|
2OMV_Pbo
n=24 participants at risk
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
|
2qOMV_qOMV
n=17 participants at risk
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
|
2qOMV_Pbo
n=23 participants at risk
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study.
|
2B_OMV
n=11 participants at risk
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study.
|
2B_qOMV
n=21 participants at risk
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼ OMV in this study.
|
2B_Pbo
n=6 participants at risk
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of Placebo in this study.
|
1M_OMV
n=21 participants at risk
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
|
1M_qOMV
n=19 participants at risk
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼ OMV in this study.
|
1M_Pbo
n=19 participants at risk
Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
|
Total
n=188 participants at risk
Total
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/26 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/24 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/17 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/23 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/11 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/6 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
5.3%
1/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.53%
1/188 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
|
General disorders
Vaccination site erythema
|
0.00%
0/26 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/24 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
5.9%
1/17 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/23 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/11 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/6 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.53%
1/188 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
|
Eye disorders
Myopia
|
3.8%
1/26 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/24 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/17 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/23 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/11 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/6 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
5.3%
1/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
1.1%
2/188 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
|
Eye disorders
Photophobia
|
0.00%
0/26 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/24 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
5.9%
1/17 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/23 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/11 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/6 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.53%
1/188 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/26 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/24 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/17 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/23 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/11 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/6 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
5.3%
1/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.53%
1/188 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/26 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
8.3%
2/24 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/17 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/23 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/11 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/6 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
1.1%
2/188 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
|
Gastrointestinal disorders
Nausea
|
3.8%
1/26 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
8.3%
2/24 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
17.6%
3/17 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
4.3%
1/23 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
27.3%
3/11 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
23.8%
5/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/6 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
19.0%
4/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
26.3%
5/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
5.3%
1/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
13.3%
25/188 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
|
Gastrointestinal disorders
Tooth impacted
|
0.00%
0/26 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/24 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
5.9%
1/17 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/23 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/11 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/6 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.53%
1/188 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
|
General disorders
Chills
|
11.5%
3/26 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
4.2%
1/24 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/17 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/23 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
9.1%
1/11 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
9.5%
2/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/6 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
28.6%
6/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
5.3%
1/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
5.3%
1/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
8.0%
15/188 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
|
General disorders
Fatigue
|
34.6%
9/26 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
33.3%
8/24 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
47.1%
8/17 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
8.7%
2/23 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
45.5%
5/11 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
38.1%
8/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/6 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
52.4%
11/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
31.6%
6/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
26.3%
5/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
33.0%
62/188 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
|
General disorders
Induration
|
0.00%
0/26 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/24 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
5.9%
1/17 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/23 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
9.1%
1/11 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/6 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
1.1%
2/188 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
|
General disorders
Injection site erythema
|
42.3%
11/26 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
8.3%
2/24 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
41.2%
7/17 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
13.0%
3/23 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
63.6%
7/11 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
33.3%
7/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/6 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
33.3%
7/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
47.4%
9/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
10.5%
2/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
29.3%
55/188 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
|
General disorders
Injection site induration
|
26.9%
7/26 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
8.3%
2/24 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
35.3%
6/17 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
13.0%
3/23 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
90.9%
10/11 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
33.3%
7/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/6 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
52.4%
11/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
47.4%
9/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
5.3%
1/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
29.8%
56/188 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
|
General disorders
Injection site pain
|
80.8%
21/26 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
29.2%
7/24 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
82.4%
14/17 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
30.4%
7/23 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
100.0%
11/11 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
85.7%
18/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
16.7%
1/6 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
90.5%
19/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
89.5%
17/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
31.6%
6/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
64.4%
121/188 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
|
General disorders
Injection site pruritus
|
3.8%
1/26 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/24 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/17 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/23 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/11 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/6 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
5.3%
1/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
1.1%
2/188 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
|
General disorders
Pyrexia
|
7.7%
2/26 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
4.2%
1/24 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/17 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
4.3%
1/23 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/11 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/6 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
2.1%
4/188 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
|
General disorders
Vaccination site pain
|
0.00%
0/26 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/24 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/17 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/23 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
9.1%
1/11 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/6 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.53%
1/188 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/26 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/24 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/17 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/23 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/11 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/6 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
5.3%
1/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.53%
1/188 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
|
Infections and infestations
Acute sinusitis
|
3.8%
1/26 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/24 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/17 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/23 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/11 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/6 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
5.3%
1/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
1.1%
2/188 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/26 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
8.3%
2/24 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
11.8%
2/17 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/23 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/11 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/6 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
5.3%
1/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
2.7%
5/188 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/26 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/24 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/17 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/23 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/11 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/6 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
9.5%
2/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
5.3%
1/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
1.6%
3/188 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
|
Infections and infestations
Croup infectious
|
0.00%
0/26 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/24 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/17 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/23 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/11 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/6 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
5.3%
1/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.53%
1/188 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
|
Infections and infestations
Herpes virus infection
|
0.00%
0/26 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/24 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/17 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
4.3%
1/23 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
9.1%
1/11 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/6 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
1.1%
2/188 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
|
Infections and infestations
Influenza
|
0.00%
0/26 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/24 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
5.9%
1/17 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/23 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/11 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
9.5%
2/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/6 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
1.6%
3/188 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
|
Infections and infestations
Laryngitis
|
3.8%
1/26 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/24 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
5.9%
1/17 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/23 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/11 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/6 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
1.1%
2/188 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
|
Infections and infestations
Lice infestation
|
0.00%
0/26 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/24 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
5.9%
1/17 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/23 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/11 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/6 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
5.3%
1/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
1.1%
2/188 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/26 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
8.3%
2/24 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/17 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
4.3%
1/23 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
9.1%
1/11 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
9.5%
2/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/6 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
4.8%
1/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
5.3%
1/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
4.3%
8/188 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/26 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/24 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/17 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/23 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/11 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/6 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
5.3%
1/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.53%
1/188 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
|
Infections and infestations
Otitis media
|
0.00%
0/26 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/24 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/17 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/23 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/11 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/6 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
5.3%
1/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.53%
1/188 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
|
Infections and infestations
Pharyngitis
|
3.8%
1/26 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
8.3%
2/24 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
11.8%
2/17 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/23 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
9.1%
1/11 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
4.8%
1/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/6 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
9.5%
2/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
5.3%
1/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
5.3%
10/188 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
|
Infections and infestations
Pharyngitis streptococcal
|
3.8%
1/26 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/24 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/17 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/23 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/11 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/6 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
9.5%
2/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
5.3%
1/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
2.1%
4/188 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
|
Infections and infestations
Pneumonia
|
7.7%
2/26 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/24 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/17 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/23 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/11 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/6 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
4.8%
1/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
1.6%
3/188 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
|
Infections and infestations
Pneumonia mycoplasmal
|
3.8%
1/26 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/24 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
5.9%
1/17 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/23 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/11 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/6 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
1.1%
2/188 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/26 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/24 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/17 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/23 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
9.1%
1/11 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/6 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.53%
1/188 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/26 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/24 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
5.9%
1/17 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
4.3%
1/23 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/11 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/6 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
4.8%
1/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
1.6%
3/188 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
|
Infections and infestations
Tonsillitis
|
7.7%
2/26 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/24 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
5.9%
1/17 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
4.3%
1/23 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/11 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/6 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
2.1%
4/188 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/26 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/24 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/17 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/23 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/11 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/6 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
5.3%
1/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
5.3%
1/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
1.1%
2/188 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
|
Infections and infestations
Viral pharyngitis
|
0.00%
0/26 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/24 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/17 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/23 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/11 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/6 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
4.8%
1/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
5.3%
1/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
5.3%
1/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
1.6%
3/188 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/26 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/24 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
11.8%
2/17 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
4.3%
1/23 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
9.1%
1/11 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
4.8%
1/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/6 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
9.5%
2/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
10.5%
2/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
5.3%
1/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
5.3%
10/188 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
|
Infections and infestations
Viral infection
|
7.7%
2/26 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/24 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/17 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/23 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/11 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/6 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
1.1%
2/188 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/26 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/24 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/17 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/23 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/11 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/6 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
4.8%
1/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
5.3%
1/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
1.1%
2/188 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/26 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/24 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/17 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/23 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/11 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/6 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
5.3%
1/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.53%
1/188 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/26 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/24 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/17 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/23 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/11 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/6 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
5.3%
1/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.53%
1/188 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
|
Injury, poisoning and procedural complications
Limb injury
|
7.7%
2/26 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
4.2%
1/24 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/17 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/23 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/11 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
4.8%
1/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/6 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
4.8%
1/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
5.3%
1/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
3.2%
6/188 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
|
Injury, poisoning and procedural complications
Post vaccination syndrome
|
0.00%
0/26 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/24 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
5.9%
1/17 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/23 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/11 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/6 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.53%
1/188 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
|
Investigations
Blood iron decreased
|
0.00%
0/26 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/24 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/17 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/23 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/11 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/6 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
5.3%
1/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.53%
1/188 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
|
Investigations
Body temperature increased
|
0.00%
0/26 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/24 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/17 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/23 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/11 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
16.7%
1/6 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.53%
1/188 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
|
Metabolism and nutrition disorders
Abnormal weight gain
|
0.00%
0/26 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/24 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
5.9%
1/17 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/23 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/11 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/6 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.53%
1/188 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
7.7%
2/26 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
4.2%
1/24 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
23.5%
4/17 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
8.7%
2/23 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
9.1%
1/11 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
14.3%
3/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
16.7%
1/6 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
38.1%
8/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
21.1%
4/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
10.5%
2/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
14.9%
28/188 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/26 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
8.3%
2/24 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/17 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/23 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/11 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/6 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
1.1%
2/188 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/26 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/24 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
5.9%
1/17 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/23 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/11 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/6 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.53%
1/188 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
15.4%
4/26 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
8.3%
2/24 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
17.6%
3/17 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
4.3%
1/23 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/11 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
9.5%
2/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/6 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
19.0%
4/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
10.5%
2/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
15.8%
3/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
11.2%
21/188 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.8%
1/26 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/24 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/17 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/23 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/11 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/6 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
5.3%
1/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
1.1%
2/188 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/26 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/24 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/17 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/23 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/11 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/6 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
10.5%
2/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
1.1%
2/188 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.00%
0/26 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/24 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/17 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/23 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/11 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/6 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
5.3%
1/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.53%
1/188 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
23.1%
6/26 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
8.3%
2/24 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
29.4%
5/17 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/23 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
9.1%
1/11 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
19.0%
4/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/6 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
38.1%
8/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
21.1%
4/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
5.3%
1/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
16.5%
31/188 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/26 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/24 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
5.9%
1/17 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/23 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/11 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/6 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.53%
1/188 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
0.00%
0/26 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/24 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
11.8%
2/17 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/23 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/11 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/6 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
1.1%
2/188 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
|
Musculoskeletal and connective tissue disorders
Temporomandibular joint syndrome
|
0.00%
0/26 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/24 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/17 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/23 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/11 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/6 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
5.3%
1/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.53%
1/188 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/26 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/24 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/17 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/23 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/11 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/6 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
5.3%
1/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.53%
1/188 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/26 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/24 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
5.9%
1/17 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/23 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/11 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/6 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.53%
1/188 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
|
Nervous system disorders
Headache
|
30.8%
8/26 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
25.0%
6/24 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
47.1%
8/17 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
13.0%
3/23 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
45.5%
5/11 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
19.0%
4/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
16.7%
1/6 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
66.7%
14/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
26.3%
5/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
10.5%
2/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
29.8%
56/188 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
|
Nervous system disorders
Syncope
|
0.00%
0/26 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/24 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/17 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/23 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
9.1%
1/11 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/6 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.53%
1/188 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
|
Renal and urinary disorders
Proteinuria
|
3.8%
1/26 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/24 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/17 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/23 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/11 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/6 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
5.3%
1/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
1.1%
2/188 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
|
Reproductive system and breast disorders
Breast mass
|
0.00%
0/26 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/24 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/17 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/23 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/11 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/6 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
5.3%
1/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.53%
1/188 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/26 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/24 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/17 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/23 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/11 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
4.8%
1/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
16.7%
1/6 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
4.8%
1/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
1.6%
3/188 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/26 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/24 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
5.9%
1/17 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/23 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/11 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
16.7%
1/6 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
1.1%
2/188 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.7%
2/26 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/24 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
5.9%
1/17 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
4.3%
1/23 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/11 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/6 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
4.8%
1/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
2.7%
5/188 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/26 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/24 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/17 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/23 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/11 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
4.8%
1/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
16.7%
1/6 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
1.1%
2/188 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
|
Skin and subcutaneous tissue disorders
Acne
|
7.7%
2/26 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
4.2%
1/24 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/17 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/23 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/11 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/6 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
4.8%
1/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
5.3%
1/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
2.7%
5/188 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/26 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/24 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/17 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/23 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
9.1%
1/11 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/6 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.53%
1/188 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/26 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/24 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
5.9%
1/17 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/23 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/11 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/6 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
5.3%
1/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
1.1%
2/188 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/26 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/24 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/17 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/23 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
9.1%
1/11 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/6 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
5.3%
1/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
1.1%
2/188 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/26 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/24 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
5.9%
1/17 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/23 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/11 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
4.8%
1/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/6 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
14.3%
3/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
10.5%
2/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
3.7%
7/188 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/26 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/24 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/17 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/23 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
18.2%
2/11 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/6 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
1.1%
2/188 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
|
Vascular disorders
Essential hypertension
|
0.00%
0/26 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/24 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/17 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/23 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/11 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/6 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/21 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.00%
0/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
5.3%
1/19 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
0.53%
1/188 • Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place