Trial Outcomes & Findings for Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Toddlers (NCT NCT02955797)
NCT ID: NCT02955797
Last Updated: 2022-04-05
Results Overview
Antibody titers against Meningococcal Serogroups A, C, Y, and W were measured by serum bactericidal assay using human complement (hSBA). Data for this outcome measure were planned to be analyzed for the pooled population of MenACYW Conjugate vaccine and Nimenrix® reporting groups.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
918 participants
Primary outcome timeframe
Day 30 (post-vaccination)
Results posted on
2022-04-05
Participant Flow
Study participants were enrolled in 34 centers in Spain, Hungary, Germany and Finland from 24 February 2017 to 21 September 2017.
A total of 918 participants were enrolled and randomized in the study.
Participant milestones
| Measure |
Group 1(Meningococcal Vaccine-Naive):MenACYW Conjugate Vaccine
Healthy, meningococcal vaccine naive toddlers aged 12 to 23 months received a single dose of Meningococcal Polysaccharide (Serogroups A, C, Y and W) Tetanus Toxoid (MenACYW) Conjugate vaccine on Day 0.
|
Group 2 (Meningococcal Vaccine-Naive): Nimenrix®
Healthy, meningococcal vaccine naive toddlers aged 12 to 23 months received a single dose of Meningococcal polysaccharide groups A, C, W-135 and Y (Nimenrix®) Conjugate vaccine on Day 0.
|
Group 3 (MenC-Primed) MenACYW Conjugate Vaccine
Healthy, meningococcal C (MenC) vaccine primed toddlers aged 12 to 23 months received a single dose of MenACYW Conjugate vaccine on Day 0.
|
Group 4 (MenC-Primed): Nimenrix®
Healthy, meningococcal C vaccine primed toddlers aged 12 to 23 months received a single dose of Nimenrix® vaccine on Day 0.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
306
|
306
|
203
|
103
|
|
Overall Study
Safety Analysis Set (SafAS)
|
303
|
306
|
203
|
102
|
|
Overall Study
Per Protocol Analysis Set (PPAS)
|
293
|
296
|
198
|
99
|
|
Overall Study
COMPLETED
|
303
|
303
|
203
|
101
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
0
|
2
|
Reasons for withdrawal
| Measure |
Group 1(Meningococcal Vaccine-Naive):MenACYW Conjugate Vaccine
Healthy, meningococcal vaccine naive toddlers aged 12 to 23 months received a single dose of Meningococcal Polysaccharide (Serogroups A, C, Y and W) Tetanus Toxoid (MenACYW) Conjugate vaccine on Day 0.
|
Group 2 (Meningococcal Vaccine-Naive): Nimenrix®
Healthy, meningococcal vaccine naive toddlers aged 12 to 23 months received a single dose of Meningococcal polysaccharide groups A, C, W-135 and Y (Nimenrix®) Conjugate vaccine on Day 0.
|
Group 3 (MenC-Primed) MenACYW Conjugate Vaccine
Healthy, meningococcal C (MenC) vaccine primed toddlers aged 12 to 23 months received a single dose of MenACYW Conjugate vaccine on Day 0.
|
Group 4 (MenC-Primed): Nimenrix®
Healthy, meningococcal C vaccine primed toddlers aged 12 to 23 months received a single dose of Nimenrix® vaccine on Day 0.
|
|---|---|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Toddlers
Baseline characteristics by cohort
| Measure |
Group 1(Meningococcal Vaccine-Naive):MenACYW Conjugate Vaccine
n=306 Participants
Healthy, meningococcal vaccine naive toddlers aged 12 to 23 months received a single dose of MenACYW Conjugate vaccine on Day 0.
|
Group 2 (Meningococcal Vaccine-Naive): Nimenrix®
n=306 Participants
Healthy, meningococcal vaccine naive toddlers aged 12 to 23 months received a single dose of Nimenrix® vaccine on Day 0.
|
Group 3 (MenC-Primed): MenACYW Conjugate Vaccine
n=203 Participants
Healthy, meningococcal C vaccine primed toddlers aged 12 to 23 months received a single dose of MenACYW Conjugate vaccine on Day 0.
|
Group 4 (MenC-Primed): Nimenrix®
n=103 Participants
Healthy, meningococcal C vaccine primed toddlers aged 12 to 23 months received a single dose of Nimenrix® vaccine on Day 0.
|
Total
n=918 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
16.1 months
STANDARD_DEVIATION 3.32 • n=99 Participants
|
16.2 months
STANDARD_DEVIATION 3.19 • n=107 Participants
|
14.0 months
STANDARD_DEVIATION 3.01 • n=206 Participants
|
13.8 months
STANDARD_DEVIATION 2.72 • n=7 Participants
|
15.4 months
STANDARD_DEVIATION 3.31 • n=31 Participants
|
|
Sex: Female, Male
Female
|
140 Participants
n=99 Participants
|
145 Participants
n=107 Participants
|
97 Participants
n=206 Participants
|
53 Participants
n=7 Participants
|
435 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
166 Participants
n=99 Participants
|
161 Participants
n=107 Participants
|
106 Participants
n=206 Participants
|
50 Participants
n=7 Participants
|
483 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
115 Participants
n=99 Participants
|
132 Participants
n=107 Participants
|
197 Participants
n=206 Participants
|
99 Participants
n=7 Participants
|
543 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
12 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
188 Participants
n=99 Participants
|
168 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
356 Participants
n=31 Participants
|
|
Region of Enrollment
Hungary
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
95 Participants
n=206 Participants
|
50 Participants
n=7 Participants
|
145 Participants
n=31 Participants
|
|
Region of Enrollment
Finland
|
188 Participants
n=99 Participants
|
168 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
356 Participants
n=31 Participants
|
|
Region of Enrollment
Germany
|
118 Participants
n=99 Participants
|
138 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
256 Participants
n=31 Participants
|
|
Region of Enrollment
Spain
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
108 Participants
n=206 Participants
|
53 Participants
n=7 Participants
|
161 Participants
n=31 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 and had a valid post-vaccination serology result. Participants with pre-defined protocol deviations were excluded. Here, "Number analyzed" = participants with available data for each specified category.
Antibody titers against Meningococcal Serogroups A, C, Y, and W were measured by serum bactericidal assay using human complement (hSBA). Data for this outcome measure were planned to be analyzed for the pooled population of MenACYW Conjugate vaccine and Nimenrix® reporting groups.
Outcome measures
| Measure |
MenACYW Conjugate Vaccine (Groups 1 and 3)
n=491 Participants
All healthy meningococcal-vaccine naive and meningococcal C vaccine primed toddlers aged 12 to 23 months who received a single dose of MenACYW Conjugate vaccine on Day 0.
|
Nimenrix® (Groups 2 and 4)
n=395 Participants
All meningococcal-vaccine naive and meningococcal C vaccine primed participants who a single dose of Nimenrix® vaccine on Day 0.
|
|---|---|---|
|
Percentage of Participants With Antibody Titers Greater Than or Equal to (>=) 1:8 Against Meningococcal Serogroups A, C, Y, and W in Toddlers Who Either Were Meningococcal Vaccine Naïve or Had Received Monovalent MenC Vaccination During Infancy
Serogroup A
|
90.4 percentage of participants
Interval 87.4 to 92.9
|
91.6 percentage of participants
Interval 88.4 to 94.2
|
|
Percentage of Participants With Antibody Titers Greater Than or Equal to (>=) 1:8 Against Meningococcal Serogroups A, C, Y, and W in Toddlers Who Either Were Meningococcal Vaccine Naïve or Had Received Monovalent MenC Vaccination During Infancy
Serogroup C
|
99.2 percentage of participants
Interval 97.9 to 99.8
|
85.5 percentage of participants
Interval 81.7 to 88.9
|
|
Percentage of Participants With Antibody Titers Greater Than or Equal to (>=) 1:8 Against Meningococcal Serogroups A, C, Y, and W in Toddlers Who Either Were Meningococcal Vaccine Naïve or Had Received Monovalent MenC Vaccination During Infancy
Serogroup Y
|
94.3 percentage of participants
Interval 91.8 to 96.2
|
91.6 percentage of participants
Interval 88.5 to 94.2
|
|
Percentage of Participants With Antibody Titers Greater Than or Equal to (>=) 1:8 Against Meningococcal Serogroups A, C, Y, and W in Toddlers Who Either Were Meningococcal Vaccine Naïve or Had Received Monovalent MenC Vaccination During Infancy
Serogroup W
|
84.9 percentage of participants
Interval 81.4 to 87.9
|
84.0 percentage of participants
Interval 80.0 to 87.5
|
PRIMARY outcome
Timeframe: Day 30 (post-vaccination)Population: Analysis was performed on PPAS. Here, "Number analyzed" = participants with available data for each specified category. Data for this outcome measure were not planned to be collected and analyzed for MenC-primed reporting groups (Groups 3 and 4).
Antibody titers against Meningococcal Serogroups A, C, Y, and W were measured by hSBA.
Outcome measures
| Measure |
MenACYW Conjugate Vaccine (Groups 1 and 3)
n=293 Participants
All healthy meningococcal-vaccine naive and meningococcal C vaccine primed toddlers aged 12 to 23 months who received a single dose of MenACYW Conjugate vaccine on Day 0.
|
Nimenrix® (Groups 2 and 4)
n=296 Participants
All meningococcal-vaccine naive and meningococcal C vaccine primed participants who a single dose of Nimenrix® vaccine on Day 0.
|
|---|---|---|
|
Percentage of Participants With Antibody Titers >=1:8 Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® in Meningococcal Vaccine Naïve Toddlers
Serogroup A
|
90.8 percentage of participants
Interval 86.9 to 93.8
|
89.5 percentage of participants
Interval 85.4 to 92.7
|
|
Percentage of Participants With Antibody Titers >=1:8 Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® in Meningococcal Vaccine Naïve Toddlers
Serogroup C
|
99.3 percentage of participants
Interval 97.6 to 99.9
|
81.4 percentage of participants
Interval 76.4 to 85.6
|
|
Percentage of Participants With Antibody Titers >=1:8 Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® in Meningococcal Vaccine Naïve Toddlers
Serogroup Y
|
93.2 percentage of participants
Interval 89.7 to 95.8
|
91.6 percentage of participants
Interval 87.8 to 94.5
|
|
Percentage of Participants With Antibody Titers >=1:8 Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® in Meningococcal Vaccine Naïve Toddlers
Serogroup W
|
83.6 percentage of participants
Interval 78.9 to 87.7
|
83.4 percentage of participants
Interval 78.7 to 87.5
|
SECONDARY outcome
Timeframe: Day 30 (post-vaccination)Population: Analysis was performed on PPAS. Here, "Number analyzed" = participants with available data for each specified category. Data for this outcome measure were planned to be analyzed for the pooled population of MenACYW Conjugate vaccine and Nimenrix® reporting groups.
Antibody titers against Meningococcal Serogroups A, C, Y, and W were measured by hSBA.
Outcome measures
| Measure |
MenACYW Conjugate Vaccine (Groups 1 and 3)
n=491 Participants
All healthy meningococcal-vaccine naive and meningococcal C vaccine primed toddlers aged 12 to 23 months who received a single dose of MenACYW Conjugate vaccine on Day 0.
|
Nimenrix® (Groups 2 and 4)
n=395 Participants
All meningococcal-vaccine naive and meningococcal C vaccine primed participants who a single dose of Nimenrix® vaccine on Day 0.
|
|---|---|---|
|
Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W in Toddlers Who Either Were Meningococcal Vaccine Naïve or Had Received Monovalent MenC Vaccination During Infancy
Serogroup W
|
24.4 titers (1/dilution)
Interval 21.8 to 27.5
|
17.7 titers (1/dilution)
Interval 15.8 to 19.8
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W in Toddlers Who Either Were Meningococcal Vaccine Naïve or Had Received Monovalent MenC Vaccination During Infancy
Serogroup A
|
29.9 titers (1/dilution)
Interval 26.9 to 33.2
|
34.5 titers (1/dilution)
Interval 30.5 to 39.0
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W in Toddlers Who Either Were Meningococcal Vaccine Naïve or Had Received Monovalent MenC Vaccination During Infancy
Serogroup C
|
880 titers (1/dilution)
Interval 748.0 to 1035.0
|
77.1 titers (1/dilution)
Interval 60.7 to 98.0
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W in Toddlers Who Either Were Meningococcal Vaccine Naïve or Had Received Monovalent MenC Vaccination During Infancy
Serogroup Y
|
41.7 titers (1/dilution)
Interval 37.5 to 46.5
|
31.9 titers (1/dilution)
Interval 28.4 to 36.0
|
SECONDARY outcome
Timeframe: Day 30 (post-vaccination)Population: Analysis was performed on PPAS. Here, "Number analyzed" = participants with available data for each specified category.
Antibody titers against Meningococcal Serogroups A, C, Y, and W were measured by hSBA.
Outcome measures
| Measure |
MenACYW Conjugate Vaccine (Groups 1 and 3)
n=293 Participants
All healthy meningococcal-vaccine naive and meningococcal C vaccine primed toddlers aged 12 to 23 months who received a single dose of MenACYW Conjugate vaccine on Day 0.
|
Nimenrix® (Groups 2 and 4)
n=296 Participants
All meningococcal-vaccine naive and meningococcal C vaccine primed participants who a single dose of Nimenrix® vaccine on Day 0.
|
|---|---|---|
|
Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® in Vaccine Naive Toddlers
Serogroup A
|
28.7 titers (1/dilution)
Interval 25.2 to 32.6
|
28.0 titers (1/dilution)
Interval 24.4 to 32.1
|
|
Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® in Vaccine Naive Toddlers
Serogroup C
|
436 titers (1/dilution)
Interval 380.0 to 500.0
|
26.4 titers (1/dilution)
Interval 22.5 to 31.0
|
|
Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® in Vaccine Naive Toddlers
Serogroup Y
|
38.0 titers (1/dilution)
Interval 33.0 to 43.9
|
32.2 titers (1/dilution)
Interval 28.0 to 37.0
|
|
Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® in Vaccine Naive Toddlers
Serogroup W
|
22.0 titers (1/dilution)
Interval 18.9 to 25.5
|
16.4 titers (1/dilution)
Interval 14.4 to 18.6
|
SECONDARY outcome
Timeframe: Day 30 (post-vaccination)Population: Analysis was performed on PPAS. Here, "Number analyzed" = participants with available data for each specified category.
Antibody titers against Meningococcal Serogroups A, C, Y, and W were measured by hSBA.
Outcome measures
| Measure |
MenACYW Conjugate Vaccine (Groups 1 and 3)
n=198 Participants
All healthy meningococcal-vaccine naive and meningococcal C vaccine primed toddlers aged 12 to 23 months who received a single dose of MenACYW Conjugate vaccine on Day 0.
|
Nimenrix® (Groups 2 and 4)
n=99 Participants
All meningococcal-vaccine naive and meningococcal C vaccine primed participants who a single dose of Nimenrix® vaccine on Day 0.
|
|---|---|---|
|
Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® in Toddlers Who Had Received Monovalent MenC Vaccination During Infancy
Serogroup Y
|
48.0 titers (1/dilution)
Interval 40.6 to 56.7
|
31.3 titers (1/dilution)
Interval 24.8 to 39.5
|
|
Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® in Toddlers Who Had Received Monovalent MenC Vaccination During Infancy
Serogroup W
|
28.7 titers (1/dilution)
Interval 23.8 to 34.5
|
22.3 titers (1/dilution)
Interval 17.7 to 28.2
|
|
Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® in Toddlers Who Had Received Monovalent MenC Vaccination During Infancy
Serogroup A
|
31.8 titers (1/dilution)
Interval 26.5 to 38.1
|
64.0 titers (1/dilution)
Interval 50.9 to 80.5
|
|
Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® in Toddlers Who Had Received Monovalent MenC Vaccination During Infancy
Serogroup C
|
2514 titers (1/dilution)
Interval 1875.0 to 3372.0
|
1883 titers (1/dilution)
Interval 1276.0 to 2779.0
|
Adverse Events
Group 1(Meningococcal Vaccine-Naive):MenACYW Conjugate Vaccine
Serious events: 2 serious events
Other events: 261 other events
Deaths: 0 deaths
Group 2 (Meningococcal Vaccine-Naive): Nimenrix®
Serious events: 1 serious events
Other events: 266 other events
Deaths: 0 deaths
Group 3 (MenC-Primed): MenACYW Conjugate Vaccine
Serious events: 2 serious events
Other events: 151 other events
Deaths: 0 deaths
Group 4 (MenC-Primed): Nimenrix®
Serious events: 2 serious events
Other events: 65 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1(Meningococcal Vaccine-Naive):MenACYW Conjugate Vaccine
n=303 participants at risk
Healthy, meningococcal vaccine naive toddlers aged 12 to 23 months received a single dose of MenACYW Conjugate vaccine on Day 0.
|
Group 2 (Meningococcal Vaccine-Naive): Nimenrix®
n=306 participants at risk
Healthy, meningococcal vaccine naive toddlers aged 12 to 23 months received a single dose of Nimenrix® vaccine on Day 0.
|
Group 3 (MenC-Primed): MenACYW Conjugate Vaccine
n=203 participants at risk
Healthy, meningococcal C vaccine primed toddlers aged 12 to 23 months received a single dose of MenACYW Conjugate vaccine on Day 0.
|
Group 4 (MenC-Primed): Nimenrix®
n=102 participants at risk
Healthy, meningococcal C vaccine primed toddlers aged 12 to 23 months received a single dose of Nimenrix® vaccine on Day 0.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Haemolytic Uraemic Syndrome
|
0.33%
1/303 • Number of events 1 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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%
0/306 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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%
0/203 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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%
0/102 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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.
|
|
Congenital, familial and genetic disorders
Intestinal Malrotation
|
0.33%
1/303 • Number of events 1 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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%
0/306 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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%
0/203 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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%
0/102 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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
Bronchitis
|
0.00%
0/303 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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%
0/306 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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%
0/203 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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.
|
0.98%
1/102 • Number of events 1 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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
Campylobacter Gastroenteritis
|
0.00%
0/303 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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%
0/306 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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.
|
0.49%
1/203 • Number of events 1 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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%
0/102 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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 Escherichia Coli
|
0.33%
1/303 • Number of events 1 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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%
0/306 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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%
0/203 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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%
0/102 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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
Contusion
|
0.00%
0/303 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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.
|
0.33%
1/306 • Number of events 1 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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%
0/203 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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%
0/102 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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%
0/303 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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%
0/306 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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.
|
0.49%
1/203 • Number of events 1 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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%
0/102 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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.
|
|
Investigations
Blood Immunoglobulin A Decreased
|
0.00%
0/303 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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%
0/306 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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%
0/203 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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.
|
0.98%
1/102 • Number of events 1 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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
Febrile Convulsion
|
0.33%
1/303 • Number of events 1 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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%
0/306 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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%
0/203 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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%
0/102 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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
Seizure
|
0.00%
0/303 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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%
0/306 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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.
|
0.49%
1/203 • Number of events 1 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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%
0/102 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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
Bronchospasm
|
0.00%
0/303 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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%
0/306 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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%
0/203 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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.
|
0.98%
1/102 • Number of events 1 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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 |
Group 1(Meningococcal Vaccine-Naive):MenACYW Conjugate Vaccine
n=303 participants at risk
Healthy, meningococcal vaccine naive toddlers aged 12 to 23 months received a single dose of MenACYW Conjugate vaccine on Day 0.
|
Group 2 (Meningococcal Vaccine-Naive): Nimenrix®
n=306 participants at risk
Healthy, meningococcal vaccine naive toddlers aged 12 to 23 months received a single dose of Nimenrix® vaccine on Day 0.
|
Group 3 (MenC-Primed): MenACYW Conjugate Vaccine
n=203 participants at risk
Healthy, meningococcal C vaccine primed toddlers aged 12 to 23 months received a single dose of MenACYW Conjugate vaccine on Day 0.
|
Group 4 (MenC-Primed): Nimenrix®
n=102 participants at risk
Healthy, meningococcal C vaccine primed toddlers aged 12 to 23 months received a single dose of Nimenrix® vaccine on Day 0.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
7.6%
23/303 • Number of events 23 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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.
|
5.2%
16/306 • Number of events 16 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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%
8/203 • Number of events 8 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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%
4/102 • Number of events 4 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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
Teething
|
5.3%
16/303 • Number of events 18 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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.
|
4.2%
13/306 • Number of events 19 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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.
|
5.9%
12/203 • Number of events 15 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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.
|
5.9%
6/102 • Number of events 7 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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
Vomiting
|
7.6%
23/303 • Number of events 24 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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.
|
4.2%
13/306 • Number of events 13 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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.
|
10.3%
21/203 • Number of events 21 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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.
|
7.8%
8/102 • Number of events 8 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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
Crying
|
35.0%
106/303 • Number of events 109 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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.
|
36.3%
111/306 • Number of events 112 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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.
|
23.6%
48/203 • Number of events 48 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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.
|
22.5%
23/102 • Number of events 23 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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 Erythema
|
40.3%
122/303 • Number of events 123 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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.
|
37.9%
116/306 • Number of events 116 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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.
|
25.6%
52/203 • Number of events 52 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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.
|
20.6%
21/102 • Number of events 21 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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
|
40.3%
122/303 • Number of events 122 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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.
|
36.9%
113/306 • Number of events 113 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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.
|
27.1%
55/203 • Number of events 55 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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.
|
19.6%
20/102 • Number of events 21 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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 Swelling
|
20.8%
63/303 • Number of events 63 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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.
|
17.0%
52/306 • Number of events 52 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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.
|
17.2%
35/203 • Number of events 35 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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.
|
8.8%
9/102 • Number of events 9 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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
Pyrexia
|
13.2%
40/303 • Number of events 42 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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.
|
15.7%
48/306 • Number of events 48 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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.
|
14.3%
29/203 • Number of events 29 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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.
|
13.7%
14/102 • Number of events 15 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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
Bronchitis
|
0.99%
3/303 • Number of events 4 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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.
|
0.65%
2/306 • Number of events 2 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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.
|
5.4%
11/203 • Number of events 11 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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.
|
0.98%
1/102 • Number of events 1 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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
Nasopharyngitis
|
5.0%
15/303 • Number of events 19 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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.
|
5.9%
18/306 • Number of events 18 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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.
|
0.99%
2/203 • Number of events 2 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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%
0/102 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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
Rhinitis
|
6.9%
21/303 • Number of events 22 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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.
|
8.2%
25/306 • Number of events 27 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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.
|
2.5%
5/203 • Number of events 5 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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%
0/102 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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
Upper Respiratory Tract Infection
|
16.2%
49/303 • Number of events 55 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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.
|
12.7%
39/306 • Number of events 43 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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.
|
6.9%
14/203 • Number of events 14 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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.
|
6.9%
7/102 • Number of events 8 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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
Decreased Appetite
|
30.0%
91/303 • Number of events 93 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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%
94/306 • Number of events 94 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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%
56/203 • Number of events 56 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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.
|
27.5%
28/102 • Number of events 28 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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
Somnolence
|
21.1%
64/303 • Number of events 64 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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.
|
18.0%
55/306 • Number of events 55 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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.
|
25.1%
51/203 • Number of events 51 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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.
|
18.6%
19/102 • Number of events 19 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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
Irritability
|
47.5%
144/303 • Number of events 145 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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.
|
41.5%
127/306 • Number of events 128 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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.
|
37.4%
76/203 • Number of events 76 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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.
|
35.3%
36/102 • Number of events 36 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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
Cough
|
3.6%
11/303 • Number of events 11 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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.
|
4.2%
13/306 • Number of events 16 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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.
|
6.4%
13/203 • Number of events 13 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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.
|
4.9%
5/102 • Number of events 5 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reactions (SRs) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 30 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 The 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