Trial Outcomes & Findings for Immune Lot Consistency, Immunogenicity, and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine (NCT NCT02842853)
NCT ID: NCT02842853
Last Updated: 2022-04-05
Results Overview
Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by serum bactericidal assay using human complement (hSBA). Data for this outcome measure were not planned to be collected and analyzed for the Menactra® reporting group.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
3344 participants
Primary outcome timeframe
Day 30 (post-vaccination)
Results posted on
2022-04-05
Participant Flow
Study participants were enrolled in 90 centers in the United States (US) from 15 July 2016 to 16 August 2016.
A total of 3344 participants who met all inclusion and none of the exclusion criteria were enrolled and randomized in the study.
Participant milestones
| Measure |
MenACYW Conjugate Vaccine Lot 1
Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 1a) and adults aged 18 to 55 years (Group 1b) received a single dose of Meningococcal Polysaccharide (Serogroups A, C, Y and W) Tetanus Toxoid (MenACYW) Conjugate vaccine from lot 1 on Day 0.
|
MenACYW Conjugate Vaccine Lot 2
Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 2a) and adults aged 18 to 55 years (Group 2b) received a single dose of MenACYW Conjugate vaccine from lot 2 on Day 0.
|
MenACYW Conjugate Vaccine Lot 3
Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 3a) and adults aged 18 to 55 years (Group 3b) received a single dose of MenACYW Conjugate vaccine from lot 3 on Day 0.
|
Menactra®
Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 4a) and adults aged 18 to 55 years (Group 4b) received a single dose of Menactra® on Day 0.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
902
|
895
|
906
|
641
|
|
Overall Study
Vaccinated
|
895
|
886
|
900
|
636
|
|
Overall Study
Safety Analysis Set (SafAS)
|
895
|
883
|
898
|
635
|
|
Overall Study
COMPLETED
|
879
|
861
|
885
|
617
|
|
Overall Study
NOT COMPLETED
|
23
|
34
|
21
|
24
|
Reasons for withdrawal
| Measure |
MenACYW Conjugate Vaccine Lot 1
Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 1a) and adults aged 18 to 55 years (Group 1b) received a single dose of Meningococcal Polysaccharide (Serogroups A, C, Y and W) Tetanus Toxoid (MenACYW) Conjugate vaccine from lot 1 on Day 0.
|
MenACYW Conjugate Vaccine Lot 2
Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 2a) and adults aged 18 to 55 years (Group 2b) received a single dose of MenACYW Conjugate vaccine from lot 2 on Day 0.
|
MenACYW Conjugate Vaccine Lot 3
Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 3a) and adults aged 18 to 55 years (Group 3b) received a single dose of MenACYW Conjugate vaccine from lot 3 on Day 0.
|
Menactra®
Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 4a) and adults aged 18 to 55 years (Group 4b) received a single dose of Menactra® on Day 0.
|
|---|---|---|---|---|
|
Overall Study
Non-compliance with the protocol
|
3
|
7
|
2
|
5
|
|
Overall Study
Subject met exclusion criteria
|
0
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
11
|
13
|
9
|
8
|
|
Overall Study
Lost to Follow-up
|
9
|
13
|
10
|
11
|
Baseline Characteristics
Immune Lot Consistency, Immunogenicity, and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine
Baseline characteristics by cohort
| Measure |
MenACYW Conjugate Vaccine Lot 1
n=902 Participants
Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 1a) and adults aged 18 to 55 years (Group 1b) received a single dose of MenACYW Conjugate vaccine from lot 1 on Day 0.
|
MenACYW Conjugate Vaccine Lot 2
n=895 Participants
Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 2a) and adults aged 18 to 55 years (Group 2b) received a single dose of MenACYW Conjugate vaccine from lot 2 on Day 0.
|
MenACYW Conjugate Vaccine Lot 3
n=906 Participants
Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 3a) and adults aged 18 to 55 years (Group 3b) received a single dose of MenACYW Conjugate vaccine from lot 3 on Day 0.
|
Menactra®
n=641 Participants
Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 4a) and adults aged 18 to 55 years (Group 4b) received a single dose of Menactra® on Day 0.
|
Total
n=3344 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
402 Participants
n=5 Participants
|
400 Participants
n=7 Participants
|
397 Participants
n=5 Participants
|
329 Participants
n=4 Participants
|
1528 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
500 Participants
n=5 Participants
|
495 Participants
n=7 Participants
|
509 Participants
n=5 Participants
|
312 Participants
n=4 Participants
|
1816 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Continuous
|
27.4 years
STANDARD_DEVIATION 15.6 • n=5 Participants
|
27.1 years
STANDARD_DEVIATION 15.7 • n=7 Participants
|
27.3 years
STANDARD_DEVIATION 15.5 • n=5 Participants
|
25.6 years
STANDARD_DEVIATION 15.4 • n=4 Participants
|
27.0 years
STANDARD_DEVIATION 15.6 • n=21 Participants
|
|
Sex: Female, Male
Female
|
535 Participants
n=5 Participants
|
531 Participants
n=7 Participants
|
496 Participants
n=5 Participants
|
357 Participants
n=4 Participants
|
1919 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
367 Participants
n=5 Participants
|
364 Participants
n=7 Participants
|
410 Participants
n=5 Participants
|
284 Participants
n=4 Participants
|
1425 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
191 Participants
n=5 Participants
|
207 Participants
n=7 Participants
|
188 Participants
n=5 Participants
|
141 Participants
n=4 Participants
|
727 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
710 Participants
n=5 Participants
|
685 Participants
n=7 Participants
|
716 Participants
n=5 Participants
|
500 Participants
n=4 Participants
|
2611 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
9 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
61 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
175 Participants
n=5 Participants
|
186 Participants
n=7 Participants
|
166 Participants
n=5 Participants
|
121 Participants
n=4 Participants
|
648 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
680 Participants
n=5 Participants
|
647 Participants
n=7 Participants
|
683 Participants
n=5 Participants
|
478 Participants
n=4 Participants
|
2488 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
30 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
110 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
902 Participants
n=5 Participants
|
895 Participants
n=7 Participants
|
906 Participants
n=5 Participants
|
641 Participants
n=4 Participants
|
3344 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Day 30 (post-vaccination)Population: Per-Protocol Analysis Set (PPAS) defined for accessing ACYW immune response data for participants who received at least one dose of study vaccine \& had a valid post-vaccination serology result. Participants who presented pre-defined protocol deviations were excluded. Here, "Number analyzed" = participants with available data for specified category.
Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by serum bactericidal assay using human complement (hSBA). Data for this outcome measure were not planned to be collected and analyzed for the Menactra® reporting group.
Outcome measures
| Measure |
MenACYW Conjugate Vaccine Lot 1
n=843 Participants
Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 1a) and adults aged 18 to 55 years (Group 1b) received a single dose of MenACYW Conjugate vaccine from lot 1 on Day 0.
|
MenACYW Conjugate Vaccine Lot 2
n=820 Participants
Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 2a) and adults aged 18 to 55 years (Group 2b) received a single dose of MenACYW Conjugate vaccine from lot 2 on Day 0.
|
MenACYW Conjugate Vaccine Lot 3
n=845 Participants
Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 3a) and adults aged 18 to 55 years (Group 3b) received a single dose of MenACYW Conjugate vaccine from lot 3 on Day 0.
|
|---|---|---|---|
|
Geometric Mean Titers (GMTs) of Meningococcal Serogroups A, C, Y, And W Antibodies Following Vaccination With 3 Lots of MenACYW Conjugate Vaccine
Serogroup A
|
84.9 Titer (1/dilution)
Interval 75.8 to 95.1
|
96.5 Titer (1/dilution)
Interval 86.4 to 108.0
|
97.9 Titer (1/dilution)
Interval 87.7 to 109.0
|
|
Geometric Mean Titers (GMTs) of Meningococcal Serogroups A, C, Y, And W Antibodies Following Vaccination With 3 Lots of MenACYW Conjugate Vaccine
Serogroup C
|
326 Titer (1/dilution)
Interval 286.0 to 372.0
|
305 Titer (1/dilution)
Interval 267.0 to 349.0
|
352 Titer (1/dilution)
Interval 307.0 to 405.0
|
|
Geometric Mean Titers (GMTs) of Meningococcal Serogroups A, C, Y, And W Antibodies Following Vaccination With 3 Lots of MenACYW Conjugate Vaccine
Serogroup Y
|
213 Titer (1/dilution)
Interval 191.0 to 238.0
|
210 Titer (1/dilution)
Interval 188.0 to 234.0
|
218 Titer (1/dilution)
Interval 194.0 to 246.0
|
|
Geometric Mean Titers (GMTs) of Meningococcal Serogroups A, C, Y, And W Antibodies Following Vaccination With 3 Lots of MenACYW Conjugate Vaccine
Serogroup W
|
84.5 Titer (1/dilution)
Interval 75.1 to 95.1
|
81.6 Titer (1/dilution)
Interval 72.7 to 91.5
|
87.2 Titer (1/dilution)
Interval 77.2 to 98.5
|
PRIMARY outcome
Timeframe: Day 30 (post-vaccination)Population: Analysis was performed on PPAS. Here, "Number analyzed"=participants with available data for specified category. Data for this outcome measure were planned to be analyzed for the pooled population of MenACYW Conjugate vaccine reporting groups.
Antibody titers against meningococcal serogroups A, C, Y, and W measured by hSBA. The hSBA vaccine seroresponse for serogroups A, C, Y, and W was defined as post-vaccination hSBA titers \>= 1:16 for participants with pre-vaccination hSBA titers \< 1:8 or at least a 4-fold increase in hSBA titers from pre- to post-vaccination for participants with pre-vaccination hSBA titers \>= 1:8.
Outcome measures
| Measure |
MenACYW Conjugate Vaccine Lot 1
n=2508 Participants
Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 1a) and adults aged 18 to 55 years (Group 1b) received a single dose of MenACYW Conjugate vaccine from lot 1 on Day 0.
|
MenACYW Conjugate Vaccine Lot 2
n=593 Participants
Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 2a) and adults aged 18 to 55 years (Group 2b) received a single dose of MenACYW Conjugate vaccine from lot 2 on Day 0.
|
MenACYW Conjugate Vaccine Lot 3
Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 3a) and adults aged 18 to 55 years (Group 3b) received a single dose of MenACYW Conjugate vaccine from lot 3 on Day 0.
|
|---|---|---|---|
|
Percentage of Participants Achieving hSBA Vaccine Seroresponse for Meningococcal Serogroups A, C, Y And W Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine
Serogroup A
|
73.8 percentage of participants
Interval 72.0 to 75.5
|
54.6 percentage of participants
Interval 50.5 to 58.7
|
—
|
|
Percentage of Participants Achieving hSBA Vaccine Seroresponse for Meningococcal Serogroups A, C, Y And W Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine
Serogroup C
|
88.8 percentage of participants
Interval 87.5 to 90.0
|
47.9 percentage of participants
Interval 43.8 to 52.0
|
—
|
|
Percentage of Participants Achieving hSBA Vaccine Seroresponse for Meningococcal Serogroups A, C, Y And W Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine
Serogroup Y
|
91.4 percentage of participants
Interval 90.3 to 92.5
|
73.4 percentage of participants
Interval 69.6 to 76.9
|
—
|
|
Percentage of Participants Achieving hSBA Vaccine Seroresponse for Meningococcal Serogroups A, C, Y And W Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine
Serogroup W
|
80.3 percentage of participants
Interval 78.7 to 81.8
|
61.2 percentage of participants
Interval 57.2 to 65.2
|
—
|
SECONDARY outcome
Timeframe: Day 30 (post-vaccination)Population: Analysis was performed on PPAS. Here, "Overall number of participants analyzed" = participants evaluable for this outcome measure; and "Number analyzed"= participants with available data for specified category. Data for this outcome measure were planned to be analyzed for the pooled population of MenACYW Conjugate vaccine reporting groups.
Antibody titers against meningococcal serogroups A, C, Y, and W measured by hSBA. The hSBA vaccine seroresponse for serogroups A, C, Y, and W was defined as post-vaccination hSBA titers \>= 1:16 for participants with pre-vaccination hSBA titers \< 1:8 or at least a 4-fold increase in hSBA titers from pre- to post-vaccination for participants with pre-vaccination hSBA titers \>= 1:8. Only adults aged 18-55 years who received a single dose of Menactra® (Group 4b) or MenACYW Conjugate vaccine (Group 1b-3b) from any of the lots 1, 2 or 3, were included in this outcome measure.
Outcome measures
| Measure |
MenACYW Conjugate Vaccine Lot 1
n=1410 Participants
Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 1a) and adults aged 18 to 55 years (Group 1b) received a single dose of MenACYW Conjugate vaccine from lot 1 on Day 0.
|
MenACYW Conjugate Vaccine Lot 2
n=293 Participants
Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 2a) and adults aged 18 to 55 years (Group 2b) received a single dose of MenACYW Conjugate vaccine from lot 2 on Day 0.
|
MenACYW Conjugate Vaccine Lot 3
Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 3a) and adults aged 18 to 55 years (Group 3b) received a single dose of MenACYW Conjugate vaccine from lot 3 on Day 0.
|
|---|---|---|---|
|
Percentage of Participants Achieving hSBA Vaccine Seroresponse for Meningococcal Serogroups A, C, Y And W Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine in Adults
Serogroup A
|
73.5 percentage of participants
Interval 71.2 to 75.8
|
53.9 percentage of participants
Interval 48.0 to 59.7
|
—
|
|
Percentage of Participants Achieving hSBA Vaccine Seroresponse for Meningococcal Serogroups A, C, Y And W Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine in Adults
Serogroup C
|
83.4 percentage of participants
Interval 81.4 to 85.3
|
42.3 percentage of participants
Interval 36.6 to 48.2
|
—
|
|
Percentage of Participants Achieving hSBA Vaccine Seroresponse for Meningococcal Serogroups A, C, Y And W Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine in Adults
Serogroup Y
|
88.1 percentage of participants
Interval 86.3 to 89.8
|
60.8 percentage of participants
Interval 54.9 to 66.4
|
—
|
|
Percentage of Participants Achieving hSBA Vaccine Seroresponse for Meningococcal Serogroups A, C, Y And W Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine in Adults
Serogroup W
|
77.0 percentage of participants
Interval 74.7 to 79.2
|
50.2 percentage of participants
Interval 44.3 to 56.0
|
—
|
SECONDARY outcome
Timeframe: Day 30 (post-vaccination)Population: Analysis performed on PPAS. Here, "Overall number of participants analyzed" = participants evaluable for this outcome measure; and "Number analyzed" = participants with available data for specified category. Data for this outcome measure were planned to be analyzed for the pooled population of MenACYW Conjugate vaccine reporting groups.
Antibody titers against meningococcal serogroups A, C, Y, and W measured by hSBA. The hSBA vaccine seroresponse for serogroups A, C, Y, and W was defined as post-vaccination hSBA titers \>= 1:16 for participants with pre-vaccination hSBA titers \< 1:8 or at least a 4-fold increase in hSBA titers from pre- to post-vaccination for participants with pre-vaccination hSBA titers \>= 1:8. Only adolescents aged 10-17 years who received a single dose of Menactra® (Group 4a) or MenACYW Conjugate vaccine (Group 1a-3a) from any of the lots 1, 2 or 3, were included in this outcome measure.
Outcome measures
| Measure |
MenACYW Conjugate Vaccine Lot 1
n=1098 Participants
Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 1a) and adults aged 18 to 55 years (Group 1b) received a single dose of MenACYW Conjugate vaccine from lot 1 on Day 0.
|
MenACYW Conjugate Vaccine Lot 2
n=300 Participants
Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 2a) and adults aged 18 to 55 years (Group 2b) received a single dose of MenACYW Conjugate vaccine from lot 2 on Day 0.
|
MenACYW Conjugate Vaccine Lot 3
Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 3a) and adults aged 18 to 55 years (Group 3b) received a single dose of MenACYW Conjugate vaccine from lot 3 on Day 0.
|
|---|---|---|---|
|
Percentage of Participants Achieving hSBA Vaccine Seroresponse for Meningococcal Serogroups A, C, Y And W Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine in Adolescents
Serogroup A
|
74.0 percentage of participants
Interval 71.3 to 76.6
|
55.3 percentage of participants
Interval 49.5 to 61.0
|
—
|
|
Percentage of Participants Achieving hSBA Vaccine Seroresponse for Meningococcal Serogroups A, C, Y And W Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine in Adolescents
Serogroup C
|
95.6 percentage of participants
Interval 94.2 to 96.8
|
53.3 percentage of participants
Interval 47.5 to 59.1
|
—
|
|
Percentage of Participants Achieving hSBA Vaccine Seroresponse for Meningococcal Serogroups A, C, Y And W Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine in Adolescents
Serogroup Y
|
95.6 percentage of participants
Interval 94.2 to 96.8
|
85.7 percentage of participants
Interval 81.2 to 89.4
|
—
|
|
Percentage of Participants Achieving hSBA Vaccine Seroresponse for Meningococcal Serogroups A, C, Y And W Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine in Adolescents
Serogroup W
|
84.5 percentage of participants
Interval 82.2 to 86.6
|
72.0 percentage of participants
Interval 66.6 to 77.0
|
—
|
SECONDARY outcome
Timeframe: Day 30 (post-vaccination)Population: Analysis was performed on PPAS. Here, "Number analyzed" = participants with available data for specified category. Data for this outcome measure were not planned to be collected and analyzed for the Menactra® reporting group.
Antibody titers against meningococcal serogroups A, C, Y, and W measured by hSBA. The hSBA vaccine seroresponse for serogroups A, C, Y, and W was defined as post-vaccination hSBA titers \>= 1:16 for participants with pre-vaccination hSBA titers \< 1:8 or at least a 4-fold increase in hSBA titers from pre- to post-vaccination for participants with pre-vaccination hSBA titers \>= 1:8.
Outcome measures
| Measure |
MenACYW Conjugate Vaccine Lot 1
n=843 Participants
Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 1a) and adults aged 18 to 55 years (Group 1b) received a single dose of MenACYW Conjugate vaccine from lot 1 on Day 0.
|
MenACYW Conjugate Vaccine Lot 2
n=820 Participants
Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 2a) and adults aged 18 to 55 years (Group 2b) received a single dose of MenACYW Conjugate vaccine from lot 2 on Day 0.
|
MenACYW Conjugate Vaccine Lot 3
n=845 Participants
Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 3a) and adults aged 18 to 55 years (Group 3b) received a single dose of MenACYW Conjugate vaccine from lot 3 on Day 0.
|
|---|---|---|---|
|
Percentage of Participants Achieving hSBA Vaccine Seroresponse for Meningococcal Serogroups A, C, Y And W Following Vaccination With 3 Lots of MenACYW Conjugate Vaccine
Serogroup A
|
71.1 percentage of participants
Interval 67.9 to 74.2
|
76.5 percentage of participants
Interval 73.5 to 79.4
|
73.7 percentage of participants
Interval 70.6 to 76.6
|
|
Percentage of Participants Achieving hSBA Vaccine Seroresponse for Meningococcal Serogroups A, C, Y And W Following Vaccination With 3 Lots of MenACYW Conjugate Vaccine
Serogroup C
|
90.5 percentage of participants
Interval 88.3 to 92.4
|
89.1 percentage of participants
Interval 86.8 to 91.2
|
86.7 percentage of participants
Interval 84.3 to 88.9
|
|
Percentage of Participants Achieving hSBA Vaccine Seroresponse for Meningococcal Serogroups A, C, Y And W Following Vaccination With 3 Lots of MenACYW Conjugate Vaccine
Serogroup Y
|
92.4 percentage of participants
Interval 90.4 to 94.1
|
91.9 percentage of participants
Interval 89.9 to 93.7
|
89.9 percentage of participants
Interval 87.7 to 91.9
|
|
Percentage of Participants Achieving hSBA Vaccine Seroresponse for Meningococcal Serogroups A, C, Y And W Following Vaccination With 3 Lots of MenACYW Conjugate Vaccine
Serogroup W
|
81.5 percentage of participants
Interval 78.7 to 84.0
|
80.7 percentage of participants
Interval 77.8 to 83.4
|
78.7 percentage of participants
Interval 75.8 to 81.4
|
SECONDARY outcome
Timeframe: Day 30 (post-vaccination)Population: Analysis performed on PPAS. Here, "Overall number of participants analyzed" = participants evaluable for this outcome measure; and "Number analyzed"= number of participants with available data for specified category. Data for this outcome measure were planned to be analyzed for the pooled population of MenACYW Conjugate vaccine reporting groups.
Antibody titers of meningococcal serogroups A, C, Y, and W were measured by hSBA.
Outcome measures
| Measure |
MenACYW Conjugate Vaccine Lot 1
n=2508 Participants
Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 1a) and adults aged 18 to 55 years (Group 1b) received a single dose of MenACYW Conjugate vaccine from lot 1 on Day 0.
|
MenACYW Conjugate Vaccine Lot 2
n=593 Participants
Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 2a) and adults aged 18 to 55 years (Group 2b) received a single dose of MenACYW Conjugate vaccine from lot 2 on Day 0.
|
MenACYW Conjugate Vaccine Lot 3
Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 3a) and adults aged 18 to 55 years (Group 3b) received a single dose of MenACYW Conjugate vaccine from lot 3 on Day 0.
|
|---|---|---|---|
|
Geometric Mean Titers (GMTs) of Meningococcal Serogroups A, C, Y, and W Antibodies Following Vaccination With MenACYW Conjugate and Menactra®
Serogroup W
|
84.4 Titer (1/dilution)
Interval 78.8 to 90.4
|
44.5 Titer (1/dilution)
Interval 38.3 to 51.7
|
—
|
|
Geometric Mean Titers (GMTs) of Meningococcal Serogroups A, C, Y, and W Antibodies Following Vaccination With MenACYW Conjugate and Menactra®
Serogroup A
|
92.9 Titer (1/dilution)
Interval 87.1 to 99.1
|
48.1 Titer (1/dilution)
Interval 41.8 to 55.2
|
—
|
|
Geometric Mean Titers (GMTs) of Meningococcal Serogroups A, C, Y, and W Antibodies Following Vaccination With MenACYW Conjugate and Menactra®
Serogroup C
|
328 Titer (1/dilution)
Interval 303.0 to 354.0
|
40.7 Titer (1/dilution)
Interval 33.8 to 49.0
|
—
|
|
Geometric Mean Titers (GMTs) of Meningococcal Serogroups A, C, Y, and W Antibodies Following Vaccination With MenACYW Conjugate and Menactra®
Serogroup Y
|
214 Titer (1/dilution)
Interval 200.0 to 228.0
|
66.4 Titer (1/dilution)
Interval 56.4 to 78.0
|
—
|
Adverse Events
MenACYW Conjugate Vaccine Lot 1
Serious events: 9 serious events
Other events: 477 other events
Deaths: 0 deaths
MenACYW Conjugate Vaccine Lot 2
Serious events: 13 serious events
Other events: 485 other events
Deaths: 0 deaths
MenACYW Conjugate Vaccine Lot 3
Serious events: 6 serious events
Other events: 489 other events
Deaths: 0 deaths
Menactra
Serious events: 5 serious events
Other events: 353 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MenACYW Conjugate Vaccine Lot 1
n=895 participants at risk
Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 1a) and adults aged 18 to 55 years (Group 1b) received a single dose of MenACYW Conjugate vaccine from lot 1 on Day 0.
|
MenACYW Conjugate Vaccine Lot 2
n=883 participants at risk
Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 2a) and adults aged 18 to 55 years (Group 2b) received a single dose of MenACYW Conjugate vaccine from lot 2 on Day 0.
|
MenACYW Conjugate Vaccine Lot 3
n=898 participants at risk
Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 3a) and adults aged 18 to 55 years (Group 3b) received a single dose of MenACYW Conjugate vaccine from lot 3 on Day 0.
|
Menactra
n=635 participants at risk
Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 4a) and adults aged 18 to 55 years (Group 4b) received a single dose of Menactra® on Day 0.
|
|---|---|---|---|---|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/895 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.11%
1/883 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/898 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/635 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Gastrointestinal disorders
Gastrointestinal ulcer perforation
|
0.00%
0/895 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/883 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.11%
1/898 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/635 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.11%
1/895 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/883 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/898 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/635 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
General disorders
Chest pain
|
0.11%
1/895 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.11%
1/883 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/898 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/635 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/895 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/883 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.11%
1/898 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/635 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/895 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/883 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.11%
1/898 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/635 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Appendicitis
|
0.11%
1/895 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.23%
2/883 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/898 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/635 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Appendicitis perforated
|
0.00%
0/895 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.11%
1/883 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/898 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/635 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Gastroenteritis norovirus
|
0.00%
0/895 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/883 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/898 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.16%
1/635 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Pneumonia pseudomonal
|
0.11%
1/895 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/883 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/898 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/635 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Pyelonephritis
|
0.11%
1/895 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/883 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/898 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/635 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.00%
0/895 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.11%
1/883 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/898 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/635 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.11%
1/895 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/883 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/898 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/635 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/895 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/883 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/898 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.16%
1/635 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.11%
1/895 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/883 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/898 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/635 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/895 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.11%
1/883 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/898 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/635 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.11%
1/895 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/883 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/898 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/635 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Nervous system disorders
Alcoholic seizure
|
0.00%
0/895 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.11%
1/883 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/898 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/635 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Nervous system disorders
Migraine
|
0.00%
0/895 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/883 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.11%
1/898 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/635 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Nervous system disorders
Multiple sclerosis
|
0.00%
0/895 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.11%
1/883 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/898 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/635 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Nervous system disorders
Paraesthesia
|
0.11%
1/895 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/883 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/898 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/635 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/895 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/883 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.11%
1/898 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/635 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Nervous system disorders
Status epilepticus
|
0.00%
0/895 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.11%
1/883 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/898 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/635 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/895 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.11%
1/883 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/898 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/635 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous incomplete
|
0.00%
0/895 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.11%
1/883 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/898 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/635 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Psychiatric disorders
Conversion disorder
|
0.00%
0/895 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/883 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.11%
1/898 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/635 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Psychiatric disorders
Depression
|
0.00%
0/895 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.11%
1/883 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/898 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/635 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Psychiatric disorders
Disruptive mood dysregulation disorder
|
0.00%
0/895 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/883 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/898 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.16%
1/635 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Psychiatric disorders
Somatic symptom disorder
|
0.00%
0/895 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.11%
1/883 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/898 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/635 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/895 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/883 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.11%
1/898 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/635 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/895 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/883 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/898 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.16%
1/635 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.11%
1/895 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/883 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/898 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/635 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.11%
1/895 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/883 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/898 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/635 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Throat tightness
|
0.00%
0/895 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/883 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/898 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.16%
1/635 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Skin and subcutaneous tissue disorders
Henoch-Schonlein purpura
|
0.00%
0/895 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/883 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/898 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.16%
1/635 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
Other adverse events
| Measure |
MenACYW Conjugate Vaccine Lot 1
n=895 participants at risk
Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 1a) and adults aged 18 to 55 years (Group 1b) received a single dose of MenACYW Conjugate vaccine from lot 1 on Day 0.
|
MenACYW Conjugate Vaccine Lot 2
n=883 participants at risk
Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 2a) and adults aged 18 to 55 years (Group 2b) received a single dose of MenACYW Conjugate vaccine from lot 2 on Day 0.
|
MenACYW Conjugate Vaccine Lot 3
n=898 participants at risk
Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 3a) and adults aged 18 to 55 years (Group 3b) received a single dose of MenACYW Conjugate vaccine from lot 3 on Day 0.
|
Menactra
n=635 participants at risk
Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 4a) and adults aged 18 to 55 years (Group 4b) received a single dose of Menactra® on Day 0.
|
|---|---|---|---|---|
|
General disorders
Injection site erythema
|
5.0%
45/895 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
4.4%
39/883 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
4.8%
43/898 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
3.9%
25/635 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
General disorders
Injection site pain
|
38.4%
344/895 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
38.4%
339/883 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
37.1%
333/898 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
37.0%
235/635 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
General disorders
Malaise
|
20.6%
184/895 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
21.1%
186/883 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
21.0%
189/898 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
20.8%
132/635 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
31.1%
278/895 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
30.7%
271/883 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
32.7%
294/898 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
30.2%
192/635 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Nervous system disorders
Headache
|
27.6%
247/895 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
28.1%
248/883 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
28.2%
253/898 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
27.6%
175/635 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable participant matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
- Publication restrictions are in place
Restriction type: OTHER