Trial Outcomes & Findings for Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine in Infants and Toddlers When Administered Concomitantly With Routine Pediatric Vaccines in the United Kingdom (NCT NCT03632720)
NCT ID: NCT03632720
Last Updated: 2023-11-07
Results Overview
Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by serum bactericidal assay using human complement (hSBA) assay. Percentage of participants with antibody titers \>=1:8 for meningococcal serogroups A, C, Y, and W were reported in this outcome measure. Data for this outcome measure was not planned to be collected and analyzed for Group 3.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
788 participants
Primary outcome timeframe
30 days post-vaccination at the age of 12 to 13 months (i.e., at the age of 13 to 14 months)
Results posted on
2023-11-07
Participant Flow
Study was conducted at 16 sites in United Kingdom from 10 October 2018 to 05 December 2022.
A total of 788 participants were enrolled and randomized in the study.
Participant milestones
| Measure |
Group 1: MenACYW Conjugate Vaccine + Bexsero® (2, 4, and 12 to 13 Months)
Participants aged 2 months (at the time of enrollment) received Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus toxoid (MenACYW) Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
Group 2: MenACYW Conjugate Vaccine + Bexsero® (2 and 4 Months)
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2 and 4 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
Group 3: Bexsero® (2, 4, and 12 to 13 Months)
Participants aged 2 months (at the time of enrollment) received Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
|---|---|---|---|
|
Overall Study
STARTED
|
314
|
316
|
158
|
|
Overall Study
Safety Analysis Set
|
314
|
314
|
157
|
|
Overall Study
COMPLETED
|
301
|
305
|
150
|
|
Overall Study
NOT COMPLETED
|
13
|
11
|
8
|
Reasons for withdrawal
| Measure |
Group 1: MenACYW Conjugate Vaccine + Bexsero® (2, 4, and 12 to 13 Months)
Participants aged 2 months (at the time of enrollment) received Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus toxoid (MenACYW) Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
Group 2: MenACYW Conjugate Vaccine + Bexsero® (2 and 4 Months)
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2 and 4 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
Group 3: Bexsero® (2, 4, and 12 to 13 Months)
Participants aged 2 months (at the time of enrollment) received Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by parent/legally acceptable representative
|
11
|
9
|
8
|
|
Overall Study
Screen failure
|
0
|
1
|
0
|
Baseline Characteristics
Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine in Infants and Toddlers When Administered Concomitantly With Routine Pediatric Vaccines in the United Kingdom
Baseline characteristics by cohort
| Measure |
Group 1: MenACYW Conjugate Vaccine + Bexsero® (2, 4, and 12 to 13 Months)
n=314 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
Group 2: MenACYW Conjugate Vaccine + Bexsero® (2 and 4 Months)
n=316 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2 and 4 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
Group 3: Bexsero® (2, 4, and 12 to 13 Months)
n=158 Participants
Participants aged 2 months (at the time of enrollment) received Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
Total
n=788 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
64.7 days
STANDARD_DEVIATION 6.88 • n=5 Participants
|
63.9 days
STANDARD_DEVIATION 6.73 • n=7 Participants
|
64.8 days
STANDARD_DEVIATION 7.03 • n=5 Participants
|
64.4 days
STANDARD_DEVIATION 6.85 • n=4 Participants
|
|
Sex/Gender, Customized
Male
|
166 Participants
n=5 Participants
|
161 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
404 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Female
|
148 Participants
n=5 Participants
|
154 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
383 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Missing
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
300 Participants
n=5 Participants
|
296 Participants
n=7 Participants
|
148 Participants
n=5 Participants
|
744 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 30 days post-vaccination at the age of 12 to 13 months (i.e., at the age of 13 to 14 months)Population: Analysis was performed on Per-Protocol Analysis Set 3 (PPAS3) defined for accessing ACYW immune response data for participants who received at least 1 dose of study vaccine and had valid post-vaccination serology results of 2nd year of life, with no relevant protocol deviation. Here, 'number analyzed' = participants with available data for each specified category.
Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by serum bactericidal assay using human complement (hSBA) assay. Percentage of participants with antibody titers \>=1:8 for meningococcal serogroups A, C, Y, and W were reported in this outcome measure. Data for this outcome measure was not planned to be collected and analyzed for Group 3.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine + Bexsero® (2, 4, and 12 to 13 Months)
n=178 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
Group 2: MenACYW Conjugate Vaccine + Bexsero® (2 and 4 Months)
n=169 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2 and 4 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
Group 3: Bexsero® (2, 4, and 12 to 13 Months)
Participants aged 2 months (at the time of enrollment) received Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
|---|---|---|---|
|
Percentage of Participants With Antibody Titers Greater Than or Equal to (>=) 1:8 Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA After Vaccination: Groups 1 and 2 - PPAS3
Serogroup A
|
100 percentage of participants
Interval 97.7 to 100.0
|
99.4 percentage of participants
Interval 96.5 to 100.0
|
—
|
|
Percentage of Participants With Antibody Titers Greater Than or Equal to (>=) 1:8 Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA After Vaccination: Groups 1 and 2 - PPAS3
Serogroup C
|
100 percentage of participants
Interval 97.8 to 100.0
|
100 percentage of participants
Interval 97.8 to 100.0
|
—
|
|
Percentage of Participants With Antibody Titers Greater Than or Equal to (>=) 1:8 Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA After Vaccination: Groups 1 and 2 - PPAS3
Serogroup Y
|
100 percentage of participants
Interval 97.7 to 100.0
|
100 percentage of participants
Interval 97.7 to 100.0
|
—
|
|
Percentage of Participants With Antibody Titers Greater Than or Equal to (>=) 1:8 Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA After Vaccination: Groups 1 and 2 - PPAS3
Serogroup W
|
99.4 percentage of participants
Interval 96.8 to 100.0
|
100 percentage of participants
Interval 97.7 to 100.0
|
—
|
SECONDARY outcome
Timeframe: 30 days post-vaccination at the age of 12 to 13 months (i.e., at the age of 13 to 14 months)Population: Analysis was performed on PPAS3. Here, 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Group 3.
GMTs of antibody against meningococcal serogroups A, C, Y, and W were measured by hSBA. Titers were expressed in terms of 1/dilution.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine + Bexsero® (2, 4, and 12 to 13 Months)
n=178 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
Group 2: MenACYW Conjugate Vaccine + Bexsero® (2 and 4 Months)
n=169 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2 and 4 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
Group 3: Bexsero® (2, 4, and 12 to 13 Months)
Participants aged 2 months (at the time of enrollment) received Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
|---|---|---|---|
|
Geometric Mean Titers (GMTs) of Antibodies Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS3
Serogroup A
|
1214 titers
Interval 993.0 to 1484.0
|
205 titers
Interval 168.0 to 250.0
|
—
|
|
Geometric Mean Titers (GMTs) of Antibodies Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS3
Serogroup C
|
963 titers
Interval 784.0 to 1182.0
|
744 titers
Interval 608.0 to 911.0
|
—
|
|
Geometric Mean Titers (GMTs) of Antibodies Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS3
Serogroup Y
|
454 titers
Interval 374.0 to 551.0
|
434 titers
Interval 359.0 to 525.0
|
—
|
|
Geometric Mean Titers (GMTs) of Antibodies Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS3
Serogroup W
|
578 titers
Interval 478.0 to 698.0
|
528 titers
Interval 439.0 to 635.0
|
—
|
SECONDARY outcome
Timeframe: Before vaccination at the age of 3 monthsPopulation: Analysis was performed on per-protocol analysis set 1 (PPAS1) defined for accessing ACYW immune response data for participants who received at least 1 dose of study vaccine and had valid post-vaccination serology result of infancy (up to 4 months age) vaccination stage, with no relevant protocol deviations. Here, 'number analyzed' = participants with available data for each specified category.
GMTs of antibody against meningococcal serogroups A, C, Y, and W were measured by hSBA. Infancy was defined as up to 4 months of age. Titers were expressed in terms of 1/dilution. Data for this outcome measure was not planned to be collected and analyzed for Group 3.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine + Bexsero® (2, 4, and 12 to 13 Months)
n=78 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
Group 2: MenACYW Conjugate Vaccine + Bexsero® (2 and 4 Months)
n=77 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2 and 4 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
Group 3: Bexsero® (2, 4, and 12 to 13 Months)
Participants aged 2 months (at the time of enrollment) received Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
|---|---|---|---|
|
Geometric Mean Titers of Antibodies Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W Before Vaccination: Group 1 and 2 - PPAS1
Serogroup A
|
8.52 titers
Interval 5.16 to 14.1
|
7.22 titers
Interval 4.39 to 11.9
|
—
|
|
Geometric Mean Titers of Antibodies Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W Before Vaccination: Group 1 and 2 - PPAS1
Serogroup C
|
3.70 titers
Interval 2.84 to 4.84
|
3.84 titers
Interval 2.49 to 5.92
|
—
|
|
Geometric Mean Titers of Antibodies Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W Before Vaccination: Group 1 and 2 - PPAS1
Serogroup Y
|
3.26 titers
Interval 2.23 to 4.76
|
2.58 titers
Interval 2.17 to 3.07
|
—
|
|
Geometric Mean Titers of Antibodies Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W Before Vaccination: Group 1 and 2 - PPAS1
Serogroup W
|
2.52 titers
Interval 1.93 to 3.3
|
2.15 titers
Interval 1.98 to 2.33
|
—
|
SECONDARY outcome
Timeframe: 30 days post-vaccination at the age of 3 months (i.e., at the age of 4 months)Population: Analysis was performed PPAS1. Here, 'number analyzed' = participants with available data for each specified category.
GMTs of antibody against meningococcal serogroups A, C, Y, and W were measured by hSBA. Infancy was defined as up to 4 months of age. Titers were expressed in terms of 1/dilution. Data for this outcome measure was not planned to be collected and analyzed for Group 3.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine + Bexsero® (2, 4, and 12 to 13 Months)
n=78 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
Group 2: MenACYW Conjugate Vaccine + Bexsero® (2 and 4 Months)
n=77 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2 and 4 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
Group 3: Bexsero® (2, 4, and 12 to 13 Months)
Participants aged 2 months (at the time of enrollment) received Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
|---|---|---|---|
|
Geometric Mean Titers of Antibodies Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS1
Serogroup A
|
10.8 titers
Interval 8.4 to 14.0
|
9.63 titers
Interval 7.46 to 12.4
|
—
|
|
Geometric Mean Titers of Antibodies Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS1
Serogroup C
|
78.0 titers
Interval 52.9 to 115.0
|
61.2 titers
Interval 41.3 to 90.7
|
—
|
|
Geometric Mean Titers of Antibodies Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS1
Serogroup Y
|
9.44 titers
Interval 7.16 to 12.5
|
6.33 titers
Interval 4.93 to 8.13
|
—
|
|
Geometric Mean Titers of Antibodies Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS1
Serogroup W
|
4.67 titers
Interval 3.74 to 5.83
|
3.81 titers
Interval 3.12 to 4.66
|
—
|
SECONDARY outcome
Timeframe: Before vaccination at the age of 12 to 13 monthsPopulation: Analysis was performed on PPAS3. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Group 3.
GMTs of antibodies against meningococcal serogroups A, C, Y, and W were measured by hSBA. Infancy was defined as up to 4 months of age. Titers were expressed in terms of 1/dilution.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine + Bexsero® (2, 4, and 12 to 13 Months)
n=35 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
Group 2: MenACYW Conjugate Vaccine + Bexsero® (2 and 4 Months)
n=26 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2 and 4 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
Group 3: Bexsero® (2, 4, and 12 to 13 Months)
Participants aged 2 months (at the time of enrollment) received Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
|---|---|---|---|
|
Geometric Mean Titers of Antibodies Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W Before Vaccination: Group 1 and 2 - PPAS3
Serogroup A
|
45.8 titers
Interval 28.4 to 73.8
|
22.6 titers
Interval 13.5 to 37.9
|
—
|
|
Geometric Mean Titers of Antibodies Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W Before Vaccination: Group 1 and 2 - PPAS3
Serogroup C
|
30.2 titers
Interval 19.0 to 47.9
|
8.44 titers
Interval 5.18 to 13.7
|
—
|
|
Geometric Mean Titers of Antibodies Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W Before Vaccination: Group 1 and 2 - PPAS3
Serogroup Y
|
25.2 titers
Interval 16.8 to 37.8
|
9.90 titers
Interval 6.43 to 15.3
|
—
|
|
Geometric Mean Titers of Antibodies Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W Before Vaccination: Group 1 and 2 - PPAS3
Serogroup W
|
34.6 titers
Interval 21.4 to 56.1
|
10.4 titers
Interval 6.58 to 16.6
|
—
|
SECONDARY outcome
Timeframe: 30 days post-vaccination at the age of 12 to 13 months (i.e., at the age of 13 to 14 months)Population: Analysis was performed on PPAS3. Here, 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Group 3.
GMTs of antibodies against meningococcal serogroups A, C, Y, and W were measured by hSBA. Titers were expressed in terms of 1/dilution.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine + Bexsero® (2, 4, and 12 to 13 Months)
n=178 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
Group 2: MenACYW Conjugate Vaccine + Bexsero® (2 and 4 Months)
n=169 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2 and 4 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
Group 3: Bexsero® (2, 4, and 12 to 13 Months)
Participants aged 2 months (at the time of enrollment) received Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
|---|---|---|---|
|
Geometric Mean Titers of Antibodies Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS3
Serogroup A
|
1214 titers
Interval 993.0 to 1484.0
|
205 titers
Interval 168.0 to 250.0
|
—
|
|
Geometric Mean Titers of Antibodies Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS3
Serogroup C
|
963 titers
Interval 784.0 to 1182.0
|
744 titers
Interval 608.0 to 911.0
|
—
|
|
Geometric Mean Titers of Antibodies Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS3
Serogroup Y
|
454 titers
Interval 374.0 to 551.0
|
434 titers
Interval 359.0 to 525.0
|
—
|
|
Geometric Mean Titers of Antibodies Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS3
Serogroup W
|
578 titers
Interval 478.0 to 698.0
|
528 titers
Interval 439.0 to 635.0
|
—
|
SECONDARY outcome
Timeframe: Before vaccination at the age of 3 monthsPopulation: Analysis was performed on PPAS1. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Group 3.
GMTs of antibodies against meningococcal serogroups A, C, Y, and W were measured by serum bactericidal assay using baby rabbit complement (rSBA). Infancy was defined as up to 4 months of age. Titers were expressed in terms of 1/dilution.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine + Bexsero® (2, 4, and 12 to 13 Months)
n=47 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
Group 2: MenACYW Conjugate Vaccine + Bexsero® (2 and 4 Months)
n=51 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2 and 4 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
Group 3: Bexsero® (2, 4, and 12 to 13 Months)
Participants aged 2 months (at the time of enrollment) received Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
|---|---|---|---|
|
Geometric Mean Titers of Antibodies Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W Before Vaccination: Group 1 and 2 - PPAS1
Serogroup A
|
2.00 titers
95% confidence interval (CI) was not computable as the standard deviation (SD) of the sample was 0, since all participants had the same value.
|
2.00 titers
95% CI was not computable as the SD of the sample was 0, since all participants had the same value.
|
—
|
|
Geometric Mean Titers of Antibodies Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W Before Vaccination: Group 1 and 2 - PPAS1
Serogroup C
|
2.88 titers
Interval 1.84 to 4.52
|
3.77 titers
Interval 2.01 to 7.04
|
—
|
|
Geometric Mean Titers of Antibodies Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W Before Vaccination: Group 1 and 2 - PPAS1
Serogroup Y
|
2.68 titers
Interval 1.76 to 4.08
|
2.70 titers
Interval 1.87 to 3.92
|
—
|
|
Geometric Mean Titers of Antibodies Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W Before Vaccination: Group 1 and 2 - PPAS1
Serogroup W
|
2.89 titers
Interval 1.69 to 4.94
|
2.00 titers
95% CI was not computable as the SD of the sample was 0, since all participants had the same value.
|
—
|
SECONDARY outcome
Timeframe: 30 days post-vaccination at the age of 3 months (i.e., at the age of 4 months)Population: Analysis was performed on PPAS1. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Group 3.
GMTs of antibodies against meningococcal serogroups A, C, Y, and W were measured by rSBA. Infancy was defined as up to 4 months of age. Titers were expressed in terms of 1/dilution.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine + Bexsero® (2, 4, and 12 to 13 Months)
n=47 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
Group 2: MenACYW Conjugate Vaccine + Bexsero® (2 and 4 Months)
n=51 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2 and 4 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
Group 3: Bexsero® (2, 4, and 12 to 13 Months)
Participants aged 2 months (at the time of enrollment) received Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
|---|---|---|---|
|
Geometric Mean Titers of Antibodies Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS1
Serogroup A
|
13.7 titers
Interval 6.89 to 27.3
|
20.7 titers
Interval 9.96 to 43.2
|
—
|
|
Geometric Mean Titers of Antibodies Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS1
Serogroup C
|
251 titers
Interval 147.0 to 430.0
|
347 titers
Interval 230.0 to 523.0
|
—
|
|
Geometric Mean Titers of Antibodies Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS1
Serogroup Y
|
152 titers
Interval 84.2 to 275.0
|
124 titers
Interval 56.3 to 276.0
|
—
|
|
Geometric Mean Titers of Antibodies Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS1
Serogroup W
|
87.1 titers
Interval 41.1 to 185.0
|
50.8 titers
Interval 19.4 to 133.0
|
—
|
SECONDARY outcome
Timeframe: Before vaccination at the age of 12 to 13 monthsPopulation: Analysis was performed on PPAS3. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Group 3.
GMTs of antibody against meningococcal serogroups A, C, Y, and W were measured by rSBA. Titers were expressed in terms of 1/dilution.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine + Bexsero® (2, 4, and 12 to 13 Months)
n=7 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
Group 2: MenACYW Conjugate Vaccine + Bexsero® (2 and 4 Months)
n=5 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2 and 4 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
Group 3: Bexsero® (2, 4, and 12 to 13 Months)
Participants aged 2 months (at the time of enrollment) received Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
|---|---|---|---|
|
Geometric Mean Titers of Antibodies Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W Before Vaccination: Group 1 and 2 - PPAS3
Serogroup A
|
32.0 titers
Interval 1.2 to 855.0
|
169 titers
95% CI was not computable as the sample size was too small to compute valid data.
|
—
|
|
Geometric Mean Titers of Antibodies Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W Before Vaccination: Group 1 and 2 - PPAS3
Serogroup C
|
58.0 titers
Interval 18.6 to 181.0
|
3.48 titers
95% CI was not computable as the sample size was too small to compute valid data.
|
—
|
|
Geometric Mean Titers of Antibodies Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W Before Vaccination: Group 1 and 2 - PPAS3
Serogroup Y
|
58.0 titers
Interval 6.82 to 493.0
|
6.96 titers
95% CI was not computable as the sample size was too small to compute valid data.
|
—
|
|
Geometric Mean Titers of Antibodies Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W Before Vaccination: Group 1 and 2 - PPAS3
Serogroup W
|
8.00 titers
95% CI was not computable as the sample size was too small to compute valid data.
|
8.00 titers
95% CI was not computable as the sample size was too small to compute valid data.
|
—
|
SECONDARY outcome
Timeframe: 30 days post-vaccination at the age of 12 to 13 months (i.e., at the age of 13 to 14 months)Population: Analysis was performed on PPAS3. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Group 3.
GMTs of antibody against meningococcal serogroups A, C, Y, and W were measured by rSBA. Titers were expressed in terms of 1/dilution.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine + Bexsero® (2, 4, and 12 to 13 Months)
n=54 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
Group 2: MenACYW Conjugate Vaccine + Bexsero® (2 and 4 Months)
n=54 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2 and 4 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
Group 3: Bexsero® (2, 4, and 12 to 13 Months)
Participants aged 2 months (at the time of enrollment) received Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
|---|---|---|---|
|
Geometric Mean Titers of Antibodies Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS3
Serogroup A
|
1741 titers
Interval 1354.0 to 2240.0
|
1508 titers
Interval 1073.0 to 2118.0
|
—
|
|
Geometric Mean Titers of Antibodies Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS3
Serogroup C
|
1396 titers
Interval 1047.0 to 1860.0
|
1532 titers
Interval 1061.0 to 2212.0
|
—
|
|
Geometric Mean Titers of Antibodies Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS3
Serogroup Y
|
2620 titers
Interval 1999.0 to 3435.0
|
1414 titers
Interval 997.0 to 2005.0
|
—
|
|
Geometric Mean Titers of Antibodies Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS3
Serogroup W
|
2491 titers
Interval 1852.0 to 3351.0
|
2566 titers
Interval 1780.0 to 3700.0
|
—
|
SECONDARY outcome
Timeframe: Before vaccination at the age of 3 monthsPopulation: Analysis was performed on PPAS1. Here, 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Group 3.
Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by hSBA assay. Infancy was defined as up to 4 months of age. Percentage of participants with antibody titers \>=1.4 and \>=1:8 for meningococcal serogroups A, C, Y, and W were reported in this outcome measure.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine + Bexsero® (2, 4, and 12 to 13 Months)
n=78 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
Group 2: MenACYW Conjugate Vaccine + Bexsero® (2 and 4 Months)
n=77 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2 and 4 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
Group 3: Bexsero® (2, 4, and 12 to 13 Months)
Participants aged 2 months (at the time of enrollment) received Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
|---|---|---|---|
|
Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W Before Vaccination: Group 1 and 2 - PPAS1
Serogroup A: >= 1:4
|
81.8 percentage of participants
Interval 59.7 to 94.8
|
74.1 percentage of participants
Interval 53.7 to 88.9
|
—
|
|
Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W Before Vaccination: Group 1 and 2 - PPAS1
Serogroup A: >= 1:8
|
59.1 percentage of participants
Interval 36.4 to 79.3
|
48.1 percentage of participants
Interval 28.7 to 68.1
|
—
|
|
Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W Before Vaccination: Group 1 and 2 - PPAS1
Serogroup C: >= 1:4
|
55.6 percentage of participants
Interval 35.3 to 74.5
|
38.2 percentage of participants
Interval 22.2 to 56.4
|
—
|
|
Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W Before Vaccination: Group 1 and 2 - PPAS1
Serogroup C: >= 1:8
|
25.9 percentage of participants
Interval 11.1 to 46.3
|
20.6 percentage of participants
Interval 8.7 to 37.9
|
—
|
|
Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W Before Vaccination: Group 1 and 2 - PPAS1
Serogroup Y: >= 1:4
|
29.6 percentage of participants
Interval 13.8 to 50.2
|
26.7 percentage of participants
Interval 12.3 to 45.9
|
—
|
|
Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W Before Vaccination: Group 1 and 2 - PPAS1
Serogroup Y: >= 1:8
|
22.2 percentage of participants
Interval 8.6 to 42.3
|
10.0 percentage of participants
Interval 2.1 to 26.5
|
—
|
|
Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W Before Vaccination: Group 1 and 2 - PPAS1
Serogroup W: >= 1:4
|
16.7 percentage of participants
Interval 4.7 to 37.4
|
10.3 percentage of participants
Interval 2.2 to 27.4
|
—
|
|
Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W Before Vaccination: Group 1 and 2 - PPAS1
Serogroup W: >= 1:8
|
8.3 percentage of participants
Interval 1.0 to 27.0
|
0 percentage of participants
Interval 0.0 to 11.9
|
—
|
SECONDARY outcome
Timeframe: 30 days post-vaccination at the age of 3 months (i.e., at the age of 4 months)Population: Analysis was performed on PPAS1. Here, 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Group 3.
Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by hSBA assay. Infancy was defined as up to 4 months of age. Percentage of participants with antibody titers \>=1.4 and \>=1:8 for meningococcal serogroups A, C, Y, and W were reported in this outcome measure.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine + Bexsero® (2, 4, and 12 to 13 Months)
n=78 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
Group 2: MenACYW Conjugate Vaccine + Bexsero® (2 and 4 Months)
n=77 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2 and 4 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
Group 3: Bexsero® (2, 4, and 12 to 13 Months)
Participants aged 2 months (at the time of enrollment) received Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
|---|---|---|---|
|
Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS1
Serogroup W: >= 1:8
|
35.5 percentage of participants
Interval 24.9 to 47.3
|
27.4 percentage of participants
Interval 17.6 to 39.1
|
—
|
|
Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS1
Serogroup A: >= 1:4
|
87.5 percentage of participants
Interval 76.8 to 94.4
|
85.9 percentage of participants
Interval 75.6 to 93.0
|
—
|
|
Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS1
Serogroup A: >= 1:8
|
73.4 percentage of participants
Interval 60.9 to 83.7
|
66.2 percentage of participants
Interval 54.0 to 77.0
|
—
|
|
Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS1
Serogroup C: >= 1:4
|
93.5 percentage of participants
Interval 85.5 to 97.9
|
90.9 percentage of participants
Interval 82.2 to 96.3
|
—
|
|
Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS1
Serogroup C: >= 1:8
|
87.0 percentage of participants
Interval 77.4 to 93.6
|
88.3 percentage of participants
Interval 79.0 to 94.5
|
—
|
|
Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS1
Serogroup Y: >= 1:4
|
81.7 percentage of participants
Interval 70.7 to 89.9
|
69.1 percentage of participants
Interval 56.7 to 79.8
|
—
|
|
Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS1
Serogroup Y: >= 1:8
|
66.2 percentage of participants
Interval 54.0 to 77.0
|
54.4 percentage of participants
Interval 41.9 to 66.5
|
—
|
|
Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS1
Serogroup W: >= 1:4
|
56.6 percentage of participants
Interval 44.7 to 67.9
|
46.6 percentage of participants
Interval 34.8 to 58.6
|
—
|
SECONDARY outcome
Timeframe: Before vaccination at the age of 12 to 13 monthsPopulation: Analysis was performed on PPAS3. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Group 3.
Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by hSBA assay. Infancy was defined as up to 4 months of age. Percentage of participants with antibody titers \>=1.4 and \>=1:8 for meningococcal serogroups A, C, Y, and W were reported in this outcome measure.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine + Bexsero® (2, 4, and 12 to 13 Months)
n=35 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
Group 2: MenACYW Conjugate Vaccine + Bexsero® (2 and 4 Months)
n=26 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2 and 4 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
Group 3: Bexsero® (2, 4, and 12 to 13 Months)
Participants aged 2 months (at the time of enrollment) received Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
|---|---|---|---|
|
Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W Before Vaccination: Group 1 and 2 - PPAS3
Serogroup A: >= 1:4
|
100 percentage of participants
Interval 88.8 to 100.0
|
96.2 percentage of participants
Interval 80.4 to 99.9
|
—
|
|
Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W Before Vaccination: Group 1 and 2 - PPAS3
Serogroup A: >= 1:8
|
93.5 percentage of participants
Interval 78.6 to 99.2
|
76.9 percentage of participants
Interval 56.4 to 91.0
|
—
|
|
Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W Before Vaccination: Group 1 and 2 - PPAS3
Serogroup C: >= 1:4
|
94.3 percentage of participants
Interval 80.8 to 99.3
|
73.1 percentage of participants
Interval 52.2 to 88.4
|
—
|
|
Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W Before Vaccination: Group 1 and 2 - PPAS3
Serogroup C: >= 1:8
|
85.7 percentage of participants
Interval 69.7 to 95.2
|
53.8 percentage of participants
Interval 33.4 to 73.4
|
—
|
|
Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W Before Vaccination: Group 1 and 2 - PPAS3
Serogroup Y: >= 1:4
|
96.9 percentage of participants
Interval 83.8 to 99.9
|
88.5 percentage of participants
Interval 69.8 to 97.6
|
—
|
|
Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W Before Vaccination: Group 1 and 2 - PPAS3
Serogroup Y: >= 1:8
|
93.8 percentage of participants
Interval 79.2 to 99.2
|
73.1 percentage of participants
Interval 52.2 to 88.4
|
—
|
|
Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W Before Vaccination: Group 1 and 2 - PPAS3
Serogroup W: >= 1:4
|
97.1 percentage of participants
Interval 85.1 to 99.9
|
84.6 percentage of participants
Interval 65.1 to 95.6
|
—
|
|
Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W Before Vaccination: Group 1 and 2 - PPAS3
Serogroup W: >= 1:8
|
88.6 percentage of participants
Interval 73.3 to 96.8
|
69.2 percentage of participants
Interval 48.2 to 85.7
|
—
|
SECONDARY outcome
Timeframe: 30 days post-vaccination at the age of 12 to 13 months (i.e., at the age of 13 to 14 months)Population: Analysis was performed on PPAS3. Here, 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Group 3.
Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by hSBA assay. Percentage of participants with antibody titers \>=1.4 and \>=1:8 for meningococcal serogroups A, C, Y, and W were reported in this outcome measure.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine + Bexsero® (2, 4, and 12 to 13 Months)
n=178 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
Group 2: MenACYW Conjugate Vaccine + Bexsero® (2 and 4 Months)
n=169 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2 and 4 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
Group 3: Bexsero® (2, 4, and 12 to 13 Months)
Participants aged 2 months (at the time of enrollment) received Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
|---|---|---|---|
|
Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS3
Serogroup A: >= 1:4
|
100 percentage of participants
Interval 97.7 to 100.0
|
100 percentage of participants
Interval 97.7 to 100.0
|
—
|
|
Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS3
Serogroup A: >= 1:8
|
100 percentage of participants
Interval 97.7 to 100.0
|
99.4 percentage of participants
Interval 96.5 to 100.0
|
—
|
|
Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS3
Serogroup C: >= 1:4
|
100 percentage of participants
Interval 97.8 to 100.0
|
100 percentage of participants
Interval 97.8 to 100.0
|
—
|
|
Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS3
Serogroup C: >= 1:8
|
100 percentage of participants
Interval 97.8 to 100.0
|
100 percentage of participants
Interval 97.8 to 100.0
|
—
|
|
Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS3
Serogroup Y: >= 1:4
|
100 percentage of participants
Interval 97.7 to 100.0
|
100 percentage of participants
Interval 97.7 to 100.0
|
—
|
|
Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS3
Serogroup Y: >= 1:8
|
100 percentage of participants
Interval 97.7 to 100.0
|
100 percentage of participants
Interval 97.7 to 100.0
|
—
|
|
Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS3
Serogroup W: >= 1:4
|
99.4 percentage of participants
Interval 96.8 to 100.0
|
100 percentage of participants
Interval 97.7 to 100.0
|
—
|
|
Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS3
Serogroup W: >= 1:8
|
99.4 percentage of participants
Interval 96.8 to 100.0
|
100 percentage of participants
Interval 97.7 to 100.0
|
—
|
SECONDARY outcome
Timeframe: Before vaccination at the age of 3 monthsPopulation: Analysis was performed on PPAS1. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Group 3.
Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by rSBA assay. Infancy was defined as up to 4 months of age. Percentage of participants with antibody titers \>=1.8 and \>=1:128 for meningococcal serogroups A, C, Y, and W were reported in this outcome measure.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine + Bexsero® (2, 4, and 12 to 13 Months)
n=47 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
Group 2: MenACYW Conjugate Vaccine + Bexsero® (2 and 4 Months)
n=51 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2 and 4 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
Group 3: Bexsero® (2, 4, and 12 to 13 Months)
Participants aged 2 months (at the time of enrollment) received Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
|---|---|---|---|
|
Percentage of Participants With rSBA Antibody Titers >=1:8 and >=1:128 Against Meningococcal Serogroups A, C, Y, and W Before Vaccination: Group 1 and 2 - PPAS1
Serogroup C: >= 1:8
|
15.8 percentage of participants
Interval 3.4 to 39.6
|
17.4 percentage of participants
Interval 5.0 to 38.8
|
—
|
|
Percentage of Participants With rSBA Antibody Titers >=1:8 and >=1:128 Against Meningococcal Serogroups A, C, Y, and W Before Vaccination: Group 1 and 2 - PPAS1
Serogroup C: >= 1:128
|
0 percentage of participants
Interval 0.0 to 17.6
|
4.3 percentage of participants
Interval 0.1 to 21.9
|
—
|
|
Percentage of Participants With rSBA Antibody Titers >=1:8 and >=1:128 Against Meningococcal Serogroups A, C, Y, and W Before Vaccination: Group 1 and 2 - PPAS1
Serogroup Y: >= 1:8
|
10.5 percentage of participants
Interval 1.3 to 33.1
|
13.0 percentage of participants
Interval 2.8 to 33.6
|
—
|
|
Percentage of Participants With rSBA Antibody Titers >=1:8 and >=1:128 Against Meningococcal Serogroups A, C, Y, and W Before Vaccination: Group 1 and 2 - PPAS1
Serogroup Y: >= 1:128
|
0 percentage of participants
Interval 0.0 to 17.6
|
0 percentage of participants
Interval 0.0 to 14.8
|
—
|
|
Percentage of Participants With rSBA Antibody Titers >=1:8 and >=1:128 Against Meningococcal Serogroups A, C, Y, and W Before Vaccination: Group 1 and 2 - PPAS1
Serogroup W: >= 1:8
|
11.8 percentage of participants
Interval 1.5 to 36.4
|
0 percentage of participants
Interval 0.0 to 14.8
|
—
|
|
Percentage of Participants With rSBA Antibody Titers >=1:8 and >=1:128 Against Meningococcal Serogroups A, C, Y, and W Before Vaccination: Group 1 and 2 - PPAS1
Serogroup A: >= 1:8
|
0 percentage of participants
Interval 0.0 to 20.6
|
0 percentage of participants
Interval 0.0 to 15.4
|
—
|
|
Percentage of Participants With rSBA Antibody Titers >=1:8 and >=1:128 Against Meningococcal Serogroups A, C, Y, and W Before Vaccination: Group 1 and 2 - PPAS1
Serogroup A: >= 1:128
|
0 percentage of participants
Interval 0.0 to 20.6
|
0 percentage of participants
Interval 0.0 to 15.4
|
—
|
|
Percentage of Participants With rSBA Antibody Titers >=1:8 and >=1:128 Against Meningococcal Serogroups A, C, Y, and W Before Vaccination: Group 1 and 2 - PPAS1
Serogroup W: >= 1:128
|
0 percentage of participants
Interval 0.0 to 19.5
|
0 percentage of participants
Interval 0.0 to 14.8
|
—
|
SECONDARY outcome
Timeframe: 30 days post-vaccination at the age of 3 months (i.e., at the age of 4 months)Population: Analysis was performed on PPAS1. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Group 3.
Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by rSBA assay. Infancy was defined as up to 4 months of age. Percentage of participants with antibody titers \>=1.8 and \>=1:128 for meningococcal serogroups A, C, Y, and W were reported in this outcome measure.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine + Bexsero® (2, 4, and 12 to 13 Months)
n=47 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
Group 2: MenACYW Conjugate Vaccine + Bexsero® (2 and 4 Months)
n=51 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2 and 4 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
Group 3: Bexsero® (2, 4, and 12 to 13 Months)
Participants aged 2 months (at the time of enrollment) received Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
|---|---|---|---|
|
Percentage of Participants With rSBA Antibody Titers >=1:8 and >=1:128 Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS1
Serogroup A: >= 1:8
|
52.8 percentage of participants
Interval 35.5 to 69.6
|
65.6 percentage of participants
Interval 46.8 to 81.4
|
—
|
|
Percentage of Participants With rSBA Antibody Titers >=1:8 and >=1:128 Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS1
Serogroup A: >= 1:128
|
19.4 percentage of participants
Interval 8.2 to 36.0
|
28.1 percentage of participants
Interval 13.7 to 46.7
|
—
|
|
Percentage of Participants With rSBA Antibody Titers >=1:8 and >=1:128 Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS1
Serogroup C: >= 1:8
|
97.4 percentage of participants
Interval 86.2 to 99.9
|
100 percentage of participants
Interval 89.1 to 100.0
|
—
|
|
Percentage of Participants With rSBA Antibody Titers >=1:8 and >=1:128 Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS1
Serogroup C: >= 1:128
|
78.9 percentage of participants
Interval 62.7 to 90.4
|
96.9 percentage of participants
Interval 83.8 to 99.9
|
—
|
|
Percentage of Participants With rSBA Antibody Titers >=1:8 and >=1:128 Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS1
Serogroup Y: >= 1:8
|
91.7 percentage of participants
Interval 77.5 to 98.2
|
92.0 percentage of participants
Interval 74.0 to 99.0
|
—
|
|
Percentage of Participants With rSBA Antibody Titers >=1:8 and >=1:128 Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS1
Serogroup Y: >= 1:128
|
80.6 percentage of participants
Interval 64.0 to 91.8
|
68.0 percentage of participants
Interval 46.5 to 85.1
|
—
|
|
Percentage of Participants With rSBA Antibody Titers >=1:8 and >=1:128 Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS1
Serogroup W: >= 1:8
|
77.8 percentage of participants
Interval 60.8 to 89.9
|
63.3 percentage of participants
Interval 43.9 to 80.1
|
—
|
|
Percentage of Participants With rSBA Antibody Titers >=1:8 and >=1:128 Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS1
Serogroup W: >= 1:128
|
75.0 percentage of participants
Interval 57.8 to 87.9
|
53.3 percentage of participants
Interval 34.3 to 71.7
|
—
|
SECONDARY outcome
Timeframe: Before vaccination at the age of 12 to 13 monthsPopulation: Analysis was performed on PPAS3. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Group 3.
Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by rSBA assay. Infancy was defined as up to 4 months of age. Percentage of participants with antibody titers \>=1.8 and \>=1:128 for meningococcal serogroups A, C, Y, and W were reported in this outcome measure.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine + Bexsero® (2, 4, and 12 to 13 Months)
n=7 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
Group 2: MenACYW Conjugate Vaccine + Bexsero® (2 and 4 Months)
n=5 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2 and 4 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
Group 3: Bexsero® (2, 4, and 12 to 13 Months)
Participants aged 2 months (at the time of enrollment) received Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
|---|---|---|---|
|
Percentage of Participants With rSBA Antibody Titers >=1:8 and >=1:128 Against Meningococcal Serogroups A, C, Y, and W Before Vaccination: Group 1 and 2 - PPAS3
Serogroup A: >= 1:8
|
50.0 percentage of participants
Interval 11.8 to 88.2
|
80.0 percentage of participants
Interval 28.4 to 99.5
|
—
|
|
Percentage of Participants With rSBA Antibody Titers >=1:8 and >=1:128 Against Meningococcal Serogroups A, C, Y, and W Before Vaccination: Group 1 and 2 - PPAS3
Serogroup A: >= 1:128
|
50.0 percentage of participants
Interval 11.8 to 88.2
|
80.0 percentage of participants
Interval 28.4 to 99.5
|
—
|
|
Percentage of Participants With rSBA Antibody Titers >=1:8 and >=1:128 Against Meningococcal Serogroups A, C, Y, and W Before Vaccination: Group 1 and 2 - PPAS3
Serogroup C: >= 1:8
|
100 percentage of participants
Interval 59.0 to 100.0
|
20.0 percentage of participants
Interval 0.5 to 71.6
|
—
|
|
Percentage of Participants With rSBA Antibody Titers >=1:8 and >=1:128 Against Meningococcal Serogroups A, C, Y, and W Before Vaccination: Group 1 and 2 - PPAS3
Serogroup C: >= 1:128
|
42.9 percentage of participants
Interval 9.9 to 81.6
|
0 percentage of participants
Interval 0.0 to 52.2
|
—
|
|
Percentage of Participants With rSBA Antibody Titers >=1:8 and >=1:128 Against Meningococcal Serogroups A, C, Y, and W Before Vaccination: Group 1 and 2 - PPAS3
Serogroup Y: >= 1:8
|
85.7 percentage of participants
Interval 42.1 to 99.6
|
40.0 percentage of participants
Interval 5.3 to 85.3
|
—
|
|
Percentage of Participants With rSBA Antibody Titers >=1:8 and >=1:128 Against Meningococcal Serogroups A, C, Y, and W Before Vaccination: Group 1 and 2 - PPAS3
Serogroup Y: >= 1:128
|
28.6 percentage of participants
Interval 3.7 to 71.0
|
0 percentage of participants
Interval 0.0 to 52.2
|
—
|
|
Percentage of Participants With rSBA Antibody Titers >=1:8 and >=1:128 Against Meningococcal Serogroups A, C, Y, and W Before Vaccination: Group 1 and 2 - PPAS3
Serogroup W: >= 1:8
|
40.0 percentage of participants
Interval 5.3 to 85.3
|
60.0 percentage of participants
Interval 14.7 to 94.7
|
—
|
|
Percentage of Participants With rSBA Antibody Titers >=1:8 and >=1:128 Against Meningococcal Serogroups A, C, Y, and W Before Vaccination: Group 1 and 2 - PPAS3
Serogroup W: >= 1:128
|
20.0 percentage of participants
Interval 0.5 to 71.6
|
0 percentage of participants
Interval 0.0 to 52.2
|
—
|
SECONDARY outcome
Timeframe: 30 days post-vaccination at the age of 12 to 13 months (i.e., at the age of 13 to 14 months)Population: Analysis was performed on PPAS3. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Group 3.
Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by rSBA assay. Percentage of participants with antibody titers \>=1.8 and \>=1:128 for meningococcal serogroups A, C, Y, and W were reported in this outcome measure.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine + Bexsero® (2, 4, and 12 to 13 Months)
n=54 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
Group 2: MenACYW Conjugate Vaccine + Bexsero® (2 and 4 Months)
n=54 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2 and 4 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
Group 3: Bexsero® (2, 4, and 12 to 13 Months)
Participants aged 2 months (at the time of enrollment) received Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
|---|---|---|---|
|
Percentage of Participants With rSBA Antibody Titers >=1:8 and >=1:128 Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS3
Serogroup A: >= 1:8
|
100 percentage of participants
Interval 92.5 to 100.0
|
100 percentage of participants
Interval 91.8 to 100.0
|
—
|
|
Percentage of Participants With rSBA Antibody Titers >=1:8 and >=1:128 Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS3
Serogroup A: >= 1:128
|
100 percentage of participants
Interval 92.5 to 100.0
|
97.7 percentage of participants
Interval 87.7 to 99.9
|
—
|
|
Percentage of Participants With rSBA Antibody Titers >=1:8 and >=1:128 Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS3
Serogroup C: >= 1:8
|
100 percentage of participants
Interval 92.5 to 100.0
|
100 percentage of participants
Interval 91.8 to 100.0
|
—
|
|
Percentage of Participants With rSBA Antibody Titers >=1:8 and >=1:128 Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS3
Serogroup C: >= 1:128
|
100 percentage of participants
Interval 92.5 to 100.0
|
100 percentage of participants
Interval 91.8 to 100.0
|
—
|
|
Percentage of Participants With rSBA Antibody Titers >=1:8 and >=1:128 Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS3
Serogroup Y: >= 1:8
|
100 percentage of participants
Interval 92.1 to 100.0
|
100 percentage of participants
Interval 91.8 to 100.0
|
—
|
|
Percentage of Participants With rSBA Antibody Titers >=1:8 and >=1:128 Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS3
Serogroup Y: >= 1:128
|
100 percentage of participants
Interval 92.1 to 100.0
|
97.7 percentage of participants
Interval 87.7 to 99.9
|
—
|
|
Percentage of Participants With rSBA Antibody Titers >=1:8 and >=1:128 Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS3
Serogroup W: >= 1:8
|
100 percentage of participants
Interval 92.3 to 100.0
|
100 percentage of participants
Interval 91.8 to 100.0
|
—
|
|
Percentage of Participants With rSBA Antibody Titers >=1:8 and >=1:128 Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS3
Serogroup W: >= 1:128
|
100 percentage of participants
Interval 92.3 to 100.0
|
97.7 percentage of participants
Interval 87.7 to 99.9
|
—
|
SECONDARY outcome
Timeframe: Before vaccination at the age of 3 months, 30 days post-vaccination at the age of 3 months (i.e., at the age of 4 months)Population: Analysis was performed on PPAS1. Here, 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Group 3.
Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by hSBA assay. Fold-rise was calculated as ratio of post-vaccination titer (i.e., 30 days post-vaccination at the age of 3 months) to pre-dose titer at the age of 3 months. Infancy was defined as up to 4 months of age.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine + Bexsero® (2, 4, and 12 to 13 Months)
n=78 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
Group 2: MenACYW Conjugate Vaccine + Bexsero® (2 and 4 Months)
n=77 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2 and 4 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
Group 3: Bexsero® (2, 4, and 12 to 13 Months)
Participants aged 2 months (at the time of enrollment) received Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
|---|---|---|---|
|
Percentage of Participants With >= 4-Fold Rise in hSBA Antibody Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS1
Serogroup Y
|
45.8 percentage of participants
Interval 25.6 to 67.2
|
53.8 percentage of participants
Interval 33.4 to 73.4
|
—
|
|
Percentage of Participants With >= 4-Fold Rise in hSBA Antibody Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS1
Serogroup W
|
29.2 percentage of participants
Interval 12.6 to 51.1
|
18.5 percentage of participants
Interval 6.3 to 38.1
|
—
|
|
Percentage of Participants With >= 4-Fold Rise in hSBA Antibody Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS1
Serogroup A
|
5.9 percentage of participants
Interval 0.1 to 28.7
|
25.0 percentage of participants
Interval 9.8 to 46.7
|
—
|
|
Percentage of Participants With >= 4-Fold Rise in hSBA Antibody Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS1
Serogroup C
|
70.4 percentage of participants
Interval 49.8 to 86.2
|
82.4 percentage of participants
Interval 65.5 to 93.2
|
—
|
SECONDARY outcome
Timeframe: Before vaccination at the age of 3 months, 30 days post-vaccination at the age of 12 to 13 months (i.e., at the age of 13 to 14 months)Population: Analysis was performed on PPAS3. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Group 3.
Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by hSBA assay. Fold-rise was calculated as ratio of post-vaccination titer (i.e., 30 days post-vaccination at the age of 12 to 13 months) to pre-dose titer before vaccination at the age of 3 months.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine + Bexsero® (2, 4, and 12 to 13 Months)
n=28 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
Group 2: MenACYW Conjugate Vaccine + Bexsero® (2 and 4 Months)
n=32 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2 and 4 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
Group 3: Bexsero® (2, 4, and 12 to 13 Months)
Participants aged 2 months (at the time of enrollment) received Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
|---|---|---|---|
|
Percentage of Participants With >= 4-Fold Rise in hSBA Antibody Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS3
Serogroup A
|
100 percentage of participants
Interval 84.6 to 100.0
|
91.7 percentage of participants
Interval 73.0 to 99.0
|
—
|
|
Percentage of Participants With >= 4-Fold Rise in hSBA Antibody Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS3
Serogroup C
|
92.9 percentage of participants
Interval 76.5 to 99.1
|
93.8 percentage of participants
Interval 79.2 to 99.2
|
—
|
|
Percentage of Participants With >= 4-Fold Rise in hSBA Antibody Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS3
Serogroup Y
|
96.3 percentage of participants
Interval 81.0 to 99.9
|
100 percentage of participants
Interval 88.1 to 100.0
|
—
|
|
Percentage of Participants With >= 4-Fold Rise in hSBA Antibody Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS3
Serogroup W
|
100 percentage of participants
Interval 86.8 to 100.0
|
100 percentage of participants
Interval 86.8 to 100.0
|
—
|
SECONDARY outcome
Timeframe: Before vaccination at the age of 12 to 13 months, 30 days post-vaccination at the age of 12 to 13 months (i.e., at the age of 13 to 14 months)Population: Analysis was performed on PPAS3. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Group 3.
Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by hSBA assay. Fold-rise was calculated as ratio of post-vaccination titer (i.e., 30 days post-vaccination at the age of 12 to 13 months) to pre-dose titer before vaccination at the age of 12 to 13 months.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine + Bexsero® (2, 4, and 12 to 13 Months)
n=34 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
Group 2: MenACYW Conjugate Vaccine + Bexsero® (2 and 4 Months)
n=26 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2 and 4 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
Group 3: Bexsero® (2, 4, and 12 to 13 Months)
Participants aged 2 months (at the time of enrollment) received Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
|---|---|---|---|
|
Percentage of Participants With >= 4-Fold Rise in hSBA Antibody Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS3
Serogroup A
|
100 percentage of participants
Interval 87.2 to 100.0
|
53.8 percentage of participants
Interval 33.4 to 73.4
|
—
|
|
Percentage of Participants With >= 4-Fold Rise in hSBA Antibody Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS3
Serogroup C
|
100 percentage of participants
Interval 89.4 to 100.0
|
100 percentage of participants
Interval 86.8 to 100.0
|
—
|
|
Percentage of Participants With >= 4-Fold Rise in hSBA Antibody Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS3
Serogroup Y
|
89.7 percentage of participants
Interval 72.6 to 97.8
|
96.0 percentage of participants
Interval 79.6 to 99.9
|
—
|
|
Percentage of Participants With >= 4-Fold Rise in hSBA Antibody Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS3
Serogroup W
|
85.3 percentage of participants
Interval 68.9 to 95.0
|
100 percentage of participants
Interval 86.3 to 100.0
|
—
|
SECONDARY outcome
Timeframe: Before vaccination at the age of 3 months, 30 days post-vaccination at the age of 3 months (i.e., at the age of 4 months)Population: Analysis was performed on PPAS1. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Group 3.
Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by rSBA assay. Fold-rise was calculated as ratio of post-vaccination titer (i.e., 30 days post-vaccination at the age of 3 months) to pre-dose titer at the age of 3 months. Infancy was defined as up to 4 months of age.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine + Bexsero® (2, 4, and 12 to 13 Months)
n=47 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
Group 2: MenACYW Conjugate Vaccine + Bexsero® (2 and 4 Months)
n=51 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2 and 4 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
Group 3: Bexsero® (2, 4, and 12 to 13 Months)
Participants aged 2 months (at the time of enrollment) received Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
|---|---|---|---|
|
Percentage of Participants With >= 4-Fold Rise in rSBA Antibody Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS1
Serogroup A
|
46.2 percentage of participants
Interval 19.2 to 74.9
|
62.5 percentage of participants
Interval 35.4 to 84.8
|
—
|
|
Percentage of Participants With >= 4-Fold Rise in rSBA Antibody Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS1
Serogroup C
|
86.7 percentage of participants
Interval 59.5 to 98.3
|
87.5 percentage of participants
Interval 61.7 to 98.4
|
—
|
|
Percentage of Participants With >= 4-Fold Rise in rSBA Antibody Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS1
Serogroup Y
|
78.6 percentage of participants
Interval 49.2 to 95.3
|
90.9 percentage of participants
Interval 58.7 to 99.8
|
—
|
|
Percentage of Participants With >= 4-Fold Rise in rSBA Antibody Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS1
Serogroup W
|
57.1 percentage of participants
Interval 28.9 to 82.3
|
53.3 percentage of participants
Interval 26.6 to 78.7
|
—
|
SECONDARY outcome
Timeframe: Before vaccination at the age of 3 months, 30 days post-vaccination at the age of 12 to 13 months (i.e., at the age of 13 to 14 months)Population: Analysis was performed on PPAS3. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Group 3.
Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by rSBA assay. Fold-rise was calculated as ratio of post-vaccination titer (i.e., 30 days post-vaccination at the age of 12 to 13 months) to pre-dose titer before vaccination at the age of 3 months.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine + Bexsero® (2, 4, and 12 to 13 Months)
n=54 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
Group 2: MenACYW Conjugate Vaccine + Bexsero® (2 and 4 Months)
n=54 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2 and 4 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
Group 3: Bexsero® (2, 4, and 12 to 13 Months)
Participants aged 2 months (at the time of enrollment) received Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
|---|---|---|---|
|
Percentage of Participants With >= 4-Fold Rise in rSBA Antibody Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS3
Serogroup A
|
100 percentage of participants
Interval 75.3 to 100.0
|
100 percentage of participants
Interval 80.5 to 100.0
|
—
|
|
Percentage of Participants With >= 4-Fold Rise in rSBA Antibody Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS3
Serogroup C
|
100 percentage of participants
Interval 80.5 to 100.0
|
100 percentage of participants
Interval 80.5 to 100.0
|
—
|
|
Percentage of Participants With >= 4-Fold Rise in rSBA Antibody Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS3
Serogroup Y
|
100 percentage of participants
Interval 79.4 to 100.0
|
100 percentage of participants
Interval 80.5 to 100.0
|
—
|
|
Percentage of Participants With >= 4-Fold Rise in rSBA Antibody Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS3
Serogroup W
|
100 percentage of participants
Interval 78.2 to 100.0
|
100 percentage of participants
Interval 80.5 to 100.0
|
—
|
SECONDARY outcome
Timeframe: Before vaccination at the age of 12 to 13 months, 30 days post-vaccination at the age of 12 to 13 months (i.e., at the age of 13 to 14 months)Population: Analysis was performed on PPAS3. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Group 3.
Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by rSBA assay. Fold-rise was calculated as ratio of post-vaccination titer (i.e., 30 days post-vaccination at the age of 12 to 13 months) to pre-dose titer before vaccination at the age of 12 to 13 months.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine + Bexsero® (2, 4, and 12 to 13 Months)
n=7 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
Group 2: MenACYW Conjugate Vaccine + Bexsero® (2 and 4 Months)
n=5 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2 and 4 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
Group 3: Bexsero® (2, 4, and 12 to 13 Months)
Participants aged 2 months (at the time of enrollment) received Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
|---|---|---|---|
|
Percentage of Participants With >= 4-Fold Rise in rSBA Antibody Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS3
Serogroup A
|
83.3 percentage of participants
Interval 35.9 to 99.6
|
100 percentage of participants
Interval 47.8 to 100.0
|
—
|
|
Percentage of Participants With >= 4-Fold Rise in rSBA Antibody Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS3
Serogroup C
|
100 percentage of participants
Interval 59.0 to 100.0
|
100 percentage of participants
Interval 47.8 to 100.0
|
—
|
|
Percentage of Participants With >= 4-Fold Rise in rSBA Antibody Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS3
Serogroup Y
|
71.4 percentage of participants
Interval 29.0 to 96.3
|
100 percentage of participants
Interval 47.8 to 100.0
|
—
|
|
Percentage of Participants With >= 4-Fold Rise in rSBA Antibody Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS3
Serogroup W
|
100 percentage of participants
Interval 47.8 to 100.0
|
100 percentage of participants
Interval 47.8 to 100.0
|
—
|
SECONDARY outcome
Timeframe: Before vaccination at the age of 3 months up to 30 days post-vaccination at the age of 3 months (i.e., at the age of 4 months)Population: Analysis was performed on PPAS1. Here, 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Group 3.
The hSBA vaccine seroresponse against serogroups A, C, Y, and W was defined as post-vaccination hSBA titer \>=1:16 for participants with pre-vaccination hSBA titer \<1:8 or at least a 4-fold increase in hSBA titers from pre to post-vaccination for participants with pre-vaccination hSBA titers \>=1:8. Infancy was defined as up to 4 months of age.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine + Bexsero® (2, 4, and 12 to 13 Months)
n=78 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
Group 2: MenACYW Conjugate Vaccine + Bexsero® (2 and 4 Months)
n=77 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2 and 4 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
Group 3: Bexsero® (2, 4, and 12 to 13 Months)
Participants aged 2 months (at the time of enrollment) received Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
|---|---|---|---|
|
Percentage of Participants With Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS1
Serogroup W
|
25.0 percentage of participants
Interval 9.8 to 46.7
|
11.1 percentage of participants
Interval 2.4 to 29.2
|
—
|
|
Percentage of Participants With Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS1
Serogroup A
|
0 percentage of participants
Interval 0.0 to 19.5
|
20.8 percentage of participants
Interval 7.1 to 42.2
|
—
|
|
Percentage of Participants With Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS1
Serogroup C
|
66.7 percentage of participants
Interval 46.0 to 83.5
|
79.4 percentage of participants
Interval 62.1 to 91.3
|
—
|
|
Percentage of Participants With Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS1
Serogroup Y
|
33.3 percentage of participants
Interval 15.6 to 55.3
|
30.8 percentage of participants
Interval 14.3 to 51.8
|
—
|
SECONDARY outcome
Timeframe: Before vaccination at the age of 3 months up to 30 days post-vaccination at the age of 12 to 13 months (i.e., at the age of 13 to 14 months)Population: Analysis was performed on PPAS3. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Group 3.
The hSBA vaccine seroresponse against serogroups A, C, Y, and W was defined as post-vaccination hSBA titer \>=1:16 for participants with pre-vaccination hSBA titer \<1:8 or at least a 4-fold increase in hSBA titers from pre to post-vaccination for participants with pre-vaccination hSBA titers \>=1:8.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine + Bexsero® (2, 4, and 12 to 13 Months)
n=28 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
Group 2: MenACYW Conjugate Vaccine + Bexsero® (2 and 4 Months)
n=32 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2 and 4 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
Group 3: Bexsero® (2, 4, and 12 to 13 Months)
Participants aged 2 months (at the time of enrollment) received Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
|---|---|---|---|
|
Percentage of Participants With Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS3
Serogroup A
|
100 percentage of participants
Interval 84.6 to 100.0
|
91.7 percentage of participants
Interval 73.0 to 99.0
|
—
|
|
Percentage of Participants With Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS3
Serogroup C
|
92.9 percentage of participants
Interval 76.5 to 99.1
|
93.8 percentage of participants
Interval 79.2 to 99.2
|
—
|
|
Percentage of Participants With Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS3
Serogroup Y
|
96.3 percentage of participants
Interval 81.0 to 99.9
|
96.6 percentage of participants
Interval 82.2 to 99.9
|
—
|
|
Percentage of Participants With Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS3
Serogroup W
|
100 percentage of participants
Interval 86.8 to 100.0
|
100 percentage of participants
Interval 86.8 to 100.0
|
—
|
SECONDARY outcome
Timeframe: Before vaccination at the age of 12 to 13 months up to 30 days post-vaccination at the age of 12 to 13 months (i.e., at the age of 13 to 14 months)Population: Analysis was performed on PPAS3. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Group 3.
The hSBA vaccine seroresponse against serogroups A, C, Y, and W was defined as post-vaccination hSBA titer \>=1:16 for participants with pre-vaccination hSBA titer \<1:8 or at least a 4-fold increase in hSBA titers from pre to post-vaccination for participants with pre-vaccination hSBA titers \>=1:8.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine + Bexsero® (2, 4, and 12 to 13 Months)
n=34 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
Group 2: MenACYW Conjugate Vaccine + Bexsero® (2 and 4 Months)
n=26 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2 and 4 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
Group 3: Bexsero® (2, 4, and 12 to 13 Months)
Participants aged 2 months (at the time of enrollment) received Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
|---|---|---|---|
|
Percentage of Participants With Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS3
Serogroup A
|
100 percentage of participants
Interval 87.2 to 100.0
|
53.8 percentage of participants
Interval 33.4 to 73.4
|
—
|
|
Percentage of Participants With Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS3
Serogroup C
|
100 percentage of participants
Interval 89.4 to 100.0
|
96.2 percentage of participants
Interval 80.4 to 99.9
|
—
|
|
Percentage of Participants With Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS3
Serogroup Y
|
89.7 percentage of participants
Interval 72.6 to 97.8
|
96.0 percentage of participants
Interval 79.6 to 99.9
|
—
|
|
Percentage of Participants With Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS3
Serogroup W
|
85.3 percentage of participants
Interval 68.9 to 95.0
|
100 percentage of participants
Interval 86.3 to 100.0
|
—
|
SECONDARY outcome
Timeframe: Before vaccination at the age of 3 months up to 30 days post-vaccination at the age of 3 months (i.e., at the age of 4 months)Population: Analysis was performed on PPAS1. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Group 3.
The rSBA vaccine seroresponse against serogroups A, C, Y, and W was defined as post-vaccination rSBA titer \>=1:32 for participants with pre-vaccination rSBA titer \<1:8 or at least a 4-fold increase in hSBA titers from pre to post-vaccination for participants with pre-vaccination hSBA titers \>=1:8. Infancy was defined as up to 4 months of age.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine + Bexsero® (2, 4, and 12 to 13 Months)
n=47 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
Group 2: MenACYW Conjugate Vaccine + Bexsero® (2 and 4 Months)
n=51 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2 and 4 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
Group 3: Bexsero® (2, 4, and 12 to 13 Months)
Participants aged 2 months (at the time of enrollment) received Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
|---|---|---|---|
|
Percentage of Participants With Vaccine Seroresponse Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS1
Serogroup A
|
30.8 percentage of participants
Interval 9.1 to 61.4
|
50.0 percentage of participants
Interval 24.7 to 75.3
|
—
|
|
Percentage of Participants With Vaccine Seroresponse Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS1
Serogroup C
|
86.7 percentage of participants
Interval 59.5 to 98.3
|
87.5 percentage of participants
Interval 61.7 to 98.4
|
—
|
|
Percentage of Participants With Vaccine Seroresponse Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS1
Serogroup Y
|
71.4 percentage of participants
Interval 41.9 to 91.6
|
72.7 percentage of participants
Interval 39.0 to 94.0
|
—
|
|
Percentage of Participants With Vaccine Seroresponse Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS1
Serogroup W
|
57.1 percentage of participants
Interval 28.9 to 82.3
|
53.3 percentage of participants
Interval 26.6 to 78.7
|
—
|
SECONDARY outcome
Timeframe: Before vaccination at the age of 3 months up to 30 days post-vaccination at the age of 12 to 13 months (i.e., at the age of 13 to 14 months)Population: Analysis was performed on PPAS3. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Group 3.
The rSBA vaccine seroresponse against serogroups A, C, Y, and W was defined as post-vaccination rSBA titer \>=1:32 for participants with pre-vaccination rSBA titer \<1:8 or at least a 4-fold increase in hSBA titers from pre to post-vaccination for participants with pre-vaccination hSBA titers \>=1:8.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine + Bexsero® (2, 4, and 12 to 13 Months)
n=54 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
Group 2: MenACYW Conjugate Vaccine + Bexsero® (2 and 4 Months)
n=54 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2 and 4 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
Group 3: Bexsero® (2, 4, and 12 to 13 Months)
Participants aged 2 months (at the time of enrollment) received Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
|---|---|---|---|
|
Percentage of Participants With Vaccine Seroresponse Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS3
Serogroup A
|
100 percentage of participants
Interval 75.3 to 100.0
|
100 percentage of participants
Interval 80.5 to 100.0
|
—
|
|
Percentage of Participants With Vaccine Seroresponse Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS3
Serogroup C
|
100 percentage of participants
Interval 80.5 to 100.0
|
100 percentage of participants
Interval 80.5 to 100.0
|
—
|
|
Percentage of Participants With Vaccine Seroresponse Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS3
Serogroup Y
|
100 percentage of participants
Interval 79.4 to 100.0
|
94.1 percentage of participants
Interval 71.3 to 99.9
|
—
|
|
Percentage of Participants With Vaccine Seroresponse Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS3
Serogroup W
|
100 percentage of participants
Interval 78.2 to 100.0
|
100 percentage of participants
Interval 80.5 to 100.0
|
—
|
SECONDARY outcome
Timeframe: Before vaccination at the age of 12 to 13 months up to 30 days post-vaccination at the age of 12 to 13 months (i.e., at the age of 13 to 14 months)Population: Analysis was performed on PPAS3. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Group 3.
The rSBA vaccine seroresponse against serogroups A, C, Y, and W was defined as post-vaccination rSBA titer \>=1:32 for participants with pre-vaccination rSBA titer \<1:8 or at least a 4-fold increase in hSBA titers from pre to post-vaccination for participants with pre-vaccination hSBA titers \>=1:8.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine + Bexsero® (2, 4, and 12 to 13 Months)
n=7 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
Group 2: MenACYW Conjugate Vaccine + Bexsero® (2 and 4 Months)
n=5 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2 and 4 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
Group 3: Bexsero® (2, 4, and 12 to 13 Months)
Participants aged 2 months (at the time of enrollment) received Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
|---|---|---|---|
|
Percentage of Participants With Vaccine Seroresponse Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS3
Serogroup A
|
83.3 percentage of participants
Interval 35.9 to 99.6
|
100 percentage of participants
Interval 47.8 to 100.0
|
—
|
|
Percentage of Participants With Vaccine Seroresponse Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS3
Serogroup C
|
100 percentage of participants
Interval 59.0 to 100.0
|
100 percentage of participants
Interval 47.8 to 100.0
|
—
|
|
Percentage of Participants With Vaccine Seroresponse Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS3
Serogroup Y
|
71.4 percentage of participants
Interval 29.0 to 96.3
|
100 percentage of participants
Interval 47.8 to 100.0
|
—
|
|
Percentage of Participants With Vaccine Seroresponse Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS3
Serogroup W
|
100 percentage of participants
Interval 47.8 to 100.0
|
100 percentage of participants
Interval 47.8 to 100.0
|
—
|
SECONDARY outcome
Timeframe: Before vaccination at the age of 3 monthsPopulation: Analysis was performed on PPAS1. Here, 'number analyzed' = participants with available data for each specified category and '0' in the number analyzed field denotes that no participant had available data for the specified titer category.
Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by hSBA assay. Percentage of participants with hSBA antibody titers distribution \<1:4, \>=1:4, \>=1:8, \>=1:16; \>=1:32; \>=1:64, \>=1:128, \>=1:256; \>=1:512; \>=1:1024 for meningococcal serogroups A, C, Y, and W were reported in this outcome measure.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine + Bexsero® (2, 4, and 12 to 13 Months)
n=78 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
Group 2: MenACYW Conjugate Vaccine + Bexsero® (2 and 4 Months)
n=77 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2 and 4 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
Group 3: Bexsero® (2, 4, and 12 to 13 Months)
n=84 Participants
Participants aged 2 months (at the time of enrollment) received Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
|---|---|---|---|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS1
Serogroup W: >=1:4
|
16.7 percentage of participants
|
10.3 percentage of participants
|
12.5 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS1
Serogroup A: <1:4
|
18.2 percentage of participants
|
25.9 percentage of participants
|
24.1 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS1
Serogroup A: >=1:4
|
81.8 percentage of participants
|
74.1 percentage of participants
|
75.9 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS1
Serogroup A: >=1:8
|
59.1 percentage of participants
|
48.1 percentage of participants
|
48.3 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS1
Serogroup A: >=1:16
|
36.4 percentage of participants
|
33.3 percentage of participants
|
27.6 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS1
Serogroup A: >=1:32
|
22.7 percentage of participants
|
11.1 percentage of participants
|
20.7 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS1
Serogroup W: >=1:8
|
8.3 percentage of participants
|
0 percentage of participants
|
3.1 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS1
Serogroup W: >=1:16
|
4.2 percentage of participants
|
0 percentage of participants
|
3.1 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS1
Serogroup W: >=1:32
|
4.2 percentage of participants
|
0 percentage of participants
|
3.1 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS1
Serogroup W: >=1:64
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS1
Serogroup W: >=1:128
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS1
Serogroup W: >=1:256
|
0 percentage of participants
|
0 percentage of participants
|
—
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS1
Serogroup W: >=1:512
|
0 percentage of participants
|
0 percentage of participants
|
—
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS1
Serogroup W: >=1:1024
|
0 percentage of participants
|
0 percentage of participants
|
—
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS1
Serogroup A: >=1:64
|
4.5 percentage of participants
|
7.4 percentage of participants
|
10.3 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS1
Serogroup A: >=1:128
|
4.5 percentage of participants
|
7.4 percentage of participants
|
3.4 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS1
Serogroup A: >=1:256
|
0 percentage of participants
|
3.7 percentage of participants
|
—
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS1
Serogroup A: >=1:512
|
0 percentage of participants
|
0 percentage of participants
|
—
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS1
Serogroup A: >=1:1024
|
0 percentage of participants
|
0 percentage of participants
|
—
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS1
Serogroup C: <1:4
|
44.4 percentage of participants
|
61.8 percentage of participants
|
62.9 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS1
Serogroup C: >=1:4
|
55.6 percentage of participants
|
38.2 percentage of participants
|
37.1 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS1
Serogroup C: >=1:8
|
25.9 percentage of participants
|
20.6 percentage of participants
|
14.3 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS1
Serogroup C: >=1:16
|
7.4 percentage of participants
|
11.8 percentage of participants
|
11.4 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS1
Serogroup C: >=1:32
|
0 percentage of participants
|
5.9 percentage of participants
|
2.9 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS1
Serogroup C: >=1:64
|
0 percentage of participants
|
5.9 percentage of participants
|
2.9 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS1
Serogroup C: >=1:128
|
0 percentage of participants
|
5.9 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS1
Serogroup C: >=1:256
|
0 percentage of participants
|
2.9 percentage of participants
|
—
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS1
Serogroup C: >=1:512
|
0 percentage of participants
|
2.9 percentage of participants
|
—
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS1
Serogroup C: >=1:1024
|
0 percentage of participants
|
0 percentage of participants
|
—
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS1
Serogroup Y: <1:4
|
70.4 percentage of participants
|
73.3 percentage of participants
|
84.8 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS1
Serogroup Y: >=1:4
|
29.6 percentage of participants
|
26.7 percentage of participants
|
15.2 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS1
Serogroup Y: >=1:8
|
22.2 percentage of participants
|
10.0 percentage of participants
|
12.1 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS1
Serogroup Y: >=1:16
|
7.4 percentage of participants
|
0 percentage of participants
|
3.0 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS1
Serogroup Y: >=1:32
|
3.7 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS1
Serogroup Y: >=1:64
|
3.7 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS1
Serogroup Y: >=1:128
|
3.7 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS1
Serogroup Y: >=1:256
|
0 percentage of participants
|
0 percentage of participants
|
—
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS1
Serogroup Y: >=1:512
|
0 percentage of participants
|
0 percentage of participants
|
—
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS1
Serogroup Y: >=1:1024
|
0 percentage of participants
|
0 percentage of participants
|
—
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS1
Serogroup W: <1:4
|
83.3 percentage of participants
|
89.7 percentage of participants
|
87.5 percentage of participants
|
SECONDARY outcome
Timeframe: 30 days post-vaccination at the age of 3 months (i.e., at the age of 4 months)Population: Analysis was performed on PPAS1. Here, 'number analyzed' = participants with available data for each specified category and '0' in the number analyzed field denotes that no participant had available data for the specified titer category.
Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by hSBA assay. Infancy was defined as up to 4 months of age. Percentage of participants with hSBA antibody titers distribution \<1:4, \>=1:4, \>=1:8, \>=1:16; \>=1:32; \>=1:64, \>=1:128, \>=1:256; \>=1:512; \>=1:1024 for meningococcal serogroups A, C, Y, and W were reported in this outcome measure.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine + Bexsero® (2, 4, and 12 to 13 Months)
n=78 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
Group 2: MenACYW Conjugate Vaccine + Bexsero® (2 and 4 Months)
n=77 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2 and 4 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
Group 3: Bexsero® (2, 4, and 12 to 13 Months)
n=84 Participants
Participants aged 2 months (at the time of enrollment) received Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
|---|---|---|---|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS1
Serogroup W: >=1:8
|
35.5 percentage of participants
|
27.4 percentage of participants
|
2.6 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS1
Serogroup A: <1:4
|
12.5 percentage of participants
|
14.1 percentage of participants
|
21.2 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS1
Serogroup A: >=1:4
|
87.5 percentage of participants
|
85.9 percentage of participants
|
78.8 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS1
Serogroup A: >=1:8
|
73.4 percentage of participants
|
66.2 percentage of participants
|
51.5 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS1
Serogroup A: >=1:16
|
51.6 percentage of participants
|
42.3 percentage of participants
|
34.8 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS1
Serogroup A: >=1:32
|
21.9 percentage of participants
|
19.7 percentage of participants
|
16.7 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS1
Serogroup A: >=1:64
|
7.8 percentage of participants
|
9.9 percentage of participants
|
9.1 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS1
Serogroup A: >=1:128
|
1.6 percentage of participants
|
2.8 percentage of participants
|
3.0 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS1
Serogroup A: >=1:256
|
0 percentage of participants
|
0 percentage of participants
|
—
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS1
Serogroup A: >=1:512
|
0 percentage of participants
|
0 percentage of participants
|
—
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS1
Serogroup A: >=1:1024
|
0 percentage of participants
|
0 percentage of participants
|
—
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS1
Serogroup C: <1:4
|
6.5 percentage of participants
|
9.1 percentage of participants
|
78.6 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS1
Serogroup C: >=1:4
|
93.5 percentage of participants
|
90.9 percentage of participants
|
21.4 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS1
Serogroup C: >=1:8
|
87.0 percentage of participants
|
88.3 percentage of participants
|
7.1 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS1
Serogroup C: >=1:16
|
85.7 percentage of participants
|
80.5 percentage of participants
|
6.0 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS1
Serogroup C: >=1:32
|
81.8 percentage of participants
|
71.4 percentage of participants
|
3.6 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS1
Serogroup C: >=1:64
|
66.2 percentage of participants
|
66.2 percentage of participants
|
1.2 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS1
Serogroup C: >=1:128
|
54.5 percentage of participants
|
49.4 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS1
Serogroup C: >=1:256
|
32.5 percentage of participants
|
28.6 percentage of participants
|
—
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS1
Serogroup C: >=1:512
|
20.8 percentage of participants
|
13.0 percentage of participants
|
—
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS1
Serogroup C: >=1:1024
|
6.5 percentage of participants
|
5.2 percentage of participants
|
—
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS1
Serogroup Y: <1:4
|
18.3 percentage of participants
|
30.9 percentage of participants
|
89.0 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS1
Serogroup Y: >=1:4
|
81.7 percentage of participants
|
69.1 percentage of participants
|
11.0 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS1
Serogroup Y: >=1:8
|
66.2 percentage of participants
|
54.4 percentage of participants
|
2.7 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS1
Serogroup Y: >=1:16
|
40.8 percentage of participants
|
25.0 percentage of participants
|
2.7 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS1
Serogroup Y: >=1:32
|
21.1 percentage of participants
|
11.8 percentage of participants
|
1.4 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS1
Serogroup Y: >=1:64
|
7.0 percentage of participants
|
4.4 percentage of participants
|
1.4 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS1
Serogroup Y: >=1:128
|
4.2 percentage of participants
|
1.5 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS1
Serogroup Y: >=1:256
|
1.4 percentage of participants
|
0 percentage of participants
|
—
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS1
Serogroup Y: >=1:512
|
1.4 percentage of participants
|
0 percentage of participants
|
—
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS1
Serogroup Y: >=1:1024
|
0 percentage of participants
|
0 percentage of participants
|
—
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS1
Serogroup W: <1:4
|
43.4 percentage of participants
|
53.4 percentage of participants
|
94.8 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS1
Serogroup W: >=1:4
|
56.6 percentage of participants
|
46.6 percentage of participants
|
5.2 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS1
Serogroup W: >=1:16
|
21.1 percentage of participants
|
13.7 percentage of participants
|
1.3 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS1
Serogroup W: >=1:32
|
5.3 percentage of participants
|
4.1 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS1
Serogroup W: >=1:64
|
2.6 percentage of participants
|
1.4 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS1
Serogroup W: >=1:128
|
1.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS1
Serogroup W: >=1:256
|
0 percentage of participants
|
0 percentage of participants
|
—
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS1
Serogroup W: >=1:512
|
0 percentage of participants
|
0 percentage of participants
|
—
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS1
Serogroup W: >=1:1024
|
0 percentage of participants
|
0 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Before vaccination at the age of 12 to 13 monthsPopulation: Analysis was performed on PPAS3. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified category. Here, '0' in the number analyzed field denotes that no participant had available data for the specified titer category.
Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by hSBA assay. Infancy was defined as up to 4 months of age. Percentage of participants with hSBA antibody titers distribution \<1:4, \>=1:4, \>=1:8, \>=1:16; \>=1:32; \>=1:64, \>=1:128, \>=1:256; \>=1:512; \>=1:1024; \>=1:2048; \>=1:4096; \>=1:8192; \>=1:16384; \>=1:32768; \>=1:65536 for meningococcal serogroups A, C, Y, and W were reported in this outcome measure.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine + Bexsero® (2, 4, and 12 to 13 Months)
n=35 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
Group 2: MenACYW Conjugate Vaccine + Bexsero® (2 and 4 Months)
n=26 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2 and 4 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
Group 3: Bexsero® (2, 4, and 12 to 13 Months)
n=35 Participants
Participants aged 2 months (at the time of enrollment) received Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
|---|---|---|---|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup Y: >=1:32
|
50.0 percentage of participants
|
19.2 percentage of participants
|
2.9 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup Y: >=1:1024
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup Y: >=1:2048
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup Y: >=1:4096
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup Y: >=1:8192
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup Y: >=1:64
|
28.1 percentage of participants
|
11.5 percentage of participants
|
2.9 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup Y: >=1:128
|
12.5 percentage of participants
|
3.8 percentage of participants
|
2.9 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup Y: >=1:256
|
6.3 percentage of participants
|
0 percentage of participants
|
2.9 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup Y: >=1:512
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup Y: >=1:16384
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup Y: >=1:32768
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup Y: >=1:65536
|
—
|
—
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup W: <1:4
|
2.9 percentage of participants
|
15.4 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup W: >=1:4
|
97.1 percentage of participants
|
84.6 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup W: >=1:32
|
60.0 percentage of participants
|
23.1 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup W: >=1:64
|
45.7 percentage of participants
|
11.5 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup W: >=1:8
|
88.6 percentage of participants
|
69.2 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup W: >=1:16
|
77.1 percentage of participants
|
46.2 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup C: >=1:16
|
71.4 percentage of participants
|
42.3 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup C: >=1:32
|
65.7 percentage of participants
|
34.6 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup C: >=1:64
|
48.6 percentage of participants
|
3.8 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup C: >=1:128
|
20.0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup C: >=1:256
|
5.7 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup C: >=1:512
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup C: >=1:1024
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup C: >=1:2048
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup C: >=1:4096
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup C: >=1:8192
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup C: >=1:16384
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup Y: <1:4
|
3.1 percentage of participants
|
11.5 percentage of participants
|
94.3 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup Y: >=1:4
|
96.9 percentage of participants
|
88.5 percentage of participants
|
5.7 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup Y: >=1:8
|
93.8 percentage of participants
|
73.1 percentage of participants
|
5.7 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup A: <1:4
|
0 percentage of participants
|
3.8 percentage of participants
|
11.8 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup A: >=1:4
|
100 percentage of participants
|
96.2 percentage of participants
|
88.2 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup A: >=1:8
|
93.5 percentage of participants
|
76.9 percentage of participants
|
73.5 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup A: >=1:16
|
90.3 percentage of participants
|
73.1 percentage of participants
|
55.9 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup A: >=1:32
|
64.5 percentage of participants
|
61.5 percentage of participants
|
41.2 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup A: >=1:64
|
48.4 percentage of participants
|
23.1 percentage of participants
|
29.4 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup A: >=1:128
|
29.0 percentage of participants
|
15.4 percentage of participants
|
23.5 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup A: >=1:256
|
22.6 percentage of participants
|
3.8 percentage of participants
|
5.9 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup A: >=1:512
|
3.2 percentage of participants
|
0 percentage of participants
|
2.9 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup A: >=1:1024
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup A: >=1:2048
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup A: >=1:4096
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup A: >=1:8192
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup A: >=1:16384
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup A: >=1:32768
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup A: >=1:65536
|
—
|
—
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup C: <1:4
|
5.7 percentage of participants
|
26.9 percentage of participants
|
94.3 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup C: >=1:4
|
94.3 percentage of participants
|
73.1 percentage of participants
|
5.7 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup C: >=1:8
|
85.7 percentage of participants
|
53.8 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup Y: >=1:16
|
78.1 percentage of participants
|
34.6 percentage of participants
|
2.9 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup C: >=1:32768
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup C: >=1:65536
|
—
|
—
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup W: >=1:128
|
28.6 percentage of participants
|
3.8 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup W: >=1:256
|
8.6 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup W: >=1:512
|
5.7 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup W: >=1:1024
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup W: >=1:2048
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup W: >=1:4096
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup W: >=1:8192
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup W: >=1:16384
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup W: >=1:32768
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup W: >=1:65536
|
—
|
—
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: 30 days post-vaccination at the age of 12 to 13 months (i.e., at the age of 13 to 14 months)Population: Analysis was performed on PPAS3. Here, 'number analyzed' = participants with available data for each specified category and '0' in the number analyzed field denotes that no participant had available data for the specified titer category.
Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by hSBA assay. Percentage of participants with hSBA antibody titers distribution \<1:4, \>=1:4, \>=1:8, \>=1:16; \>=1:32; \>=1:64, \>=1:128, \>=1:256; \>=1:512; \>=1:1024; \>=1:2048; \>=1:4096; \>=1:8192; \>=1:16384; \>=1:32768; \>=1:65536 for meningococcal serogroups A, C, Y, and W were reported in this outcome measure.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine + Bexsero® (2, 4, and 12 to 13 Months)
n=178 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
Group 2: MenACYW Conjugate Vaccine + Bexsero® (2 and 4 Months)
n=169 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2 and 4 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
Group 3: Bexsero® (2, 4, and 12 to 13 Months)
n=86 Participants
Participants aged 2 months (at the time of enrollment) received Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
|---|---|---|---|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup A: <1:4
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup A: >=1:4
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup A: >=1:8
|
100 percentage of participants
|
99.4 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup A: >=1:16
|
100 percentage of participants
|
98.7 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup A: >=1:32
|
100 percentage of participants
|
94.2 percentage of participants
|
97.5 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup A: >=1:64
|
99.4 percentage of participants
|
87.2 percentage of participants
|
93.8 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup A: >=1:128
|
97.5 percentage of participants
|
75.0 percentage of participants
|
90.0 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup A: >=1:256
|
94.3 percentage of participants
|
58.3 percentage of participants
|
83.8 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup A: >=1:512
|
83.6 percentage of participants
|
35.3 percentage of participants
|
76.3 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup A: >=1:1024
|
68.6 percentage of participants
|
17.9 percentage of participants
|
52.5 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup A: >=1:2048
|
39.0 percentage of participants
|
1.9 percentage of participants
|
26.3 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup A: >=1:4096
|
25.2 percentage of participants
|
0 percentage of participants
|
15.0 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup A: >=1:8192
|
10.1 percentage of participants
|
0 percentage of participants
|
5.0 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup A: >=1:16384
|
6.3 percentage of participants
|
0 percentage of participants
|
2.5 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup A: >=1:32768
|
0.6 percentage of participants
|
0 percentage of participants
|
1.3 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup A: >=1:65536
|
—
|
—
|
1.3 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup C: <1:4
|
0 percentage of participants
|
0 percentage of participants
|
10.6 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup C: >=1:4
|
100 percentage of participants
|
100 percentage of participants
|
89.4 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup C: >=1:8
|
100 percentage of participants
|
100 percentage of participants
|
78.8 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup C: >=1:16
|
99.4 percentage of participants
|
99.4 percentage of participants
|
69.4 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup C: >=1:32
|
98.2 percentage of participants
|
99.4 percentage of participants
|
56.5 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup C: >=1:64
|
97.6 percentage of participants
|
98.2 percentage of participants
|
30.6 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup C: >=1:128
|
95.2 percentage of participants
|
92.7 percentage of participants
|
22.4 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup C: >=1:256
|
90.5 percentage of participants
|
86.1 percentage of participants
|
7.1 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup C: >=1:512
|
78.6 percentage of participants
|
73.3 percentage of participants
|
4.7 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup C: >=1:1024
|
64.9 percentage of participants
|
58.2 percentage of participants
|
2.4 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup C: >=1:2048
|
35.7 percentage of participants
|
25.5 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup C: >=1:4096
|
22.0 percentage of participants
|
14.5 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup C: >=1:8192
|
8.3 percentage of participants
|
5.5 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup C: >=1:16384
|
0.6 percentage of participants
|
0.6 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup C: >=1:32768
|
0 percentage of participants
|
0.6 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup C: >=1:65536
|
—
|
—
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup Y: <1:4
|
0 percentage of participants
|
0 percentage of participants
|
46.3 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup Y: >=1:4
|
100 percentage of participants
|
100 percentage of participants
|
53.7 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup Y: >=1:8
|
100 percentage of participants
|
100 percentage of participants
|
35.4 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup Y: >=1:16
|
99.4 percentage of participants
|
99.4 percentage of participants
|
23.2 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup Y: >=1:32
|
98.8 percentage of participants
|
98.1 percentage of participants
|
6.1 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup Y: >=1:64
|
94.4 percentage of participants
|
95.6 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup Y: >=1:128
|
89.4 percentage of participants
|
89.9 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup Y: >=1:256
|
77.6 percentage of participants
|
81.1 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup Y: >=1:512
|
65.2 percentage of participants
|
61.0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup Y: >=1:1024
|
39.1 percentage of participants
|
32.7 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup Y: >=1:2048
|
11.2 percentage of participants
|
9.4 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup Y: >=1:4096
|
5.6 percentage of participants
|
5.7 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup Y: >=1:8192
|
1.9 percentage of participants
|
3.1 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup Y: >=1:16384
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup Y: >=1:32768
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup Y: >=1:65536
|
—
|
—
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup W: <1:4
|
0.6 percentage of participants
|
0 percentage of participants
|
96.5 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup W: >=1:4
|
99.4 percentage of participants
|
100 percentage of participants
|
3.5 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup W: >=1:8
|
99.4 percentage of participants
|
100 percentage of participants
|
2.3 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup W: >=1:16
|
98.8 percentage of participants
|
99.4 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup W: >=1:32
|
98.3 percentage of participants
|
98.8 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup W: >=1:64
|
98.3 percentage of participants
|
98.1 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup W: >=1:128
|
93.6 percentage of participants
|
93.1 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup W: >=1:256
|
84.9 percentage of participants
|
85.0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup W: >=1:512
|
70.3 percentage of participants
|
64.4 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup W: >=1:1024
|
45.9 percentage of participants
|
43.8 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup W: >=1:2048
|
15.7 percentage of participants
|
13.1 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup W: >=1:4096
|
9.3 percentage of participants
|
4.4 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup W: >=1:8192
|
2.3 percentage of participants
|
1.9 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup W: >=1:16384
|
1.2 percentage of participants
|
1.3 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup W: >=1:32768
|
0 percentage of participants
|
1.3 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup W: >=1:65536
|
—
|
—
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Before vaccination at the age of 3 monthsPopulation: Analysis was performed on PPAS1. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified category. Here, '0' in the number analyzed field denotes that no participant had available data for the specified titer category.
Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by rSBA assay. Infancy was defined as up to 4 months of age. Percentage of participants with rSBA antibody titers distribution \<1:4, \>=1:4, \>=1:8, \>=1:16; \>=1:32; \>=1:64, \>=1:128, \>=1:256; \>=1:512; \>=1:1024; \>=1:2048; \>=1:4096; \>=1:8192 for meningococcal serogroups A, C, Y, and W were reported in this outcome measure.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine + Bexsero® (2, 4, and 12 to 13 Months)
n=47 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
Group 2: MenACYW Conjugate Vaccine + Bexsero® (2 and 4 Months)
n=51 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2 and 4 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
Group 3: Bexsero® (2, 4, and 12 to 13 Months)
n=56 Participants
Participants aged 2 months (at the time of enrollment) received Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
|---|---|---|---|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS1
Serogroup A: <1:4
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS1
Serogroup A: >=1:4
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS1
Serogroup A: >=1:8
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS1
Serogroup A: >=1:16
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS1
Serogroup A: >=1:32
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS1
Serogroup A: >=1:64
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS1
Serogroup A: >=1:128
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS1
Serogroup A: >=1:256
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS1
Serogroup A: >=1:512
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS1
Serogroup A: >=1:1024
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS1
Serogroup A: >=1:2048
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS1
Serogroup A: >=1:4096
|
0 percentage of participants
|
0 percentage of participants
|
—
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS1
Serogroup A: >=1:8192
|
0 percentage of participants
|
0 percentage of participants
|
—
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS1
Serogroup C: <1:4
|
84.2 percentage of participants
|
82.6 percentage of participants
|
84.6 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS1
Serogroup C: >=1:4
|
15.8 percentage of participants
|
17.4 percentage of participants
|
15.4 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS1
Serogroup C: >=1:8
|
15.8 percentage of participants
|
17.4 percentage of participants
|
11.5 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS1
Serogroup C: >=1:16
|
10.5 percentage of participants
|
17.4 percentage of participants
|
7.7 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS1
Serogroup C: >=1:32
|
5.3 percentage of participants
|
17.4 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS1
Serogroup C: >=1:64
|
5.3 percentage of participants
|
13.0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS1
Serogroup C: >=1:128
|
0 percentage of participants
|
4.3 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS1
Serogroup C: >=1:256
|
0 percentage of participants
|
4.3 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS1
Serogroup C: >=1:512
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS1
Serogroup C: >=1:1024
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS1
Serogroup C: >=1:2048
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS1
Serogroup C: >=1:4096
|
0 percentage of participants
|
0 percentage of participants
|
—
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS1
Serogroup C: >=1:8192
|
0 percentage of participants
|
0 percentage of participants
|
—
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS1
Serogroup Y: <1:4
|
89.5 percentage of participants
|
87.0 percentage of participants
|
84.6 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS1
Serogroup Y: >=1:4
|
10.5 percentage of participants
|
13.0 percentage of participants
|
15.4 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS1
Serogroup Y: >=1:8
|
10.5 percentage of participants
|
13.0 percentage of participants
|
15.4 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS1
Serogroup Y: >=1:16
|
10.5 percentage of participants
|
8.7 percentage of participants
|
7.7 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS1
Serogroup Y: >=1:32
|
10.5 percentage of participants
|
4.3 percentage of participants
|
3.8 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS1
Serogroup Y: >=1:64
|
0 percentage of participants
|
4.3 percentage of participants
|
3.8 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS1
Serogroup Y: >=1:128
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS1
Serogroup Y: >=1:256
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS1
Serogroup Y: >=1:512
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS1
Serogroup Y: >=1:1024
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS1
Serogroup Y: >=1:2048
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS1
Serogroup Y: >=1:4096
|
0 percentage of participants
|
0 percentage of participants
|
—
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS1
Serogroup Y: >=1:8192
|
0 percentage of participants
|
0 percentage of participants
|
—
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS1
Serogroup W: <1:4
|
88.2 percentage of participants
|
100 percentage of participants
|
96.2 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS1
Serogroup W: >=1:4
|
11.8 percentage of participants
|
0 percentage of participants
|
3.8 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS1
Serogroup W: >=1:8
|
11.8 percentage of participants
|
0 percentage of participants
|
3.8 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS1
Serogroup W: >=1:16
|
11.8 percentage of participants
|
0 percentage of participants
|
3.8 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS1
Serogroup W: >=1:32
|
11.8 percentage of participants
|
0 percentage of participants
|
3.8 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS1
Serogroup W: >=1:64
|
5.9 percentage of participants
|
0 percentage of participants
|
3.8 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS1
Serogroup W: >=1:128
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS1
Serogroup W: >=1:256
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS1
Serogroup W: >=1:512
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS1
Serogroup W: >=1:1024
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS1
Serogroup W: >=1:2048
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS1
Serogroup W: >=1:4096
|
0 percentage of participants
|
0 percentage of participants
|
—
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS1
Serogroup W: >=1:8192
|
0 percentage of participants
|
0 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: 30 days post-vaccination at the age of 3 months (i.e., at the age of 4 months)Population: Analysis was performed on PPAS1. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified category. Here, '0' in the number analyzed field denotes that no participant had available data for the specified titer category.
Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by rSBA assay. Infancy was defined as up to 4 months of age. Percentage of participants with rSBA antibody titers distribution \<1:4, \>=1:4, \>=1:8, \>=1:16; \>=1:32; \>=1:64, \>=1:128, \>=1:256; \>=1:512; \>=1:1024; \>=1:2048; \>=1:4096; \>=1:8192 for meningococcal serogroups A, C, Y, and W were reported in this outcome measure.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine + Bexsero® (2, 4, and 12 to 13 Months)
n=47 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
Group 2: MenACYW Conjugate Vaccine + Bexsero® (2 and 4 Months)
n=51 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2 and 4 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
Group 3: Bexsero® (2, 4, and 12 to 13 Months)
n=56 Participants
Participants aged 2 months (at the time of enrollment) received Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
|---|---|---|---|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS1
Serogroup C: >=1:8192
|
0 percentage of participants
|
3.1 percentage of participants
|
—
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS1
Serogroup Y: <1:4
|
8.3 percentage of participants
|
8.0 percentage of participants
|
90.3 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS1
Serogroup Y: >=1:4
|
91.7 percentage of participants
|
92.0 percentage of participants
|
9.7 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS1
Serogroup Y: >=1:8
|
91.7 percentage of participants
|
92.0 percentage of participants
|
9.7 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS1
Serogroup Y: >=1:16
|
88.9 percentage of participants
|
88.0 percentage of participants
|
9.7 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS1
Serogroup Y: >=1:32
|
83.3 percentage of participants
|
80.0 percentage of participants
|
6.5 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS1
Serogroup Y: >=1:64
|
80.6 percentage of participants
|
72.0 percentage of participants
|
3.2 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS1
Serogroup Y: >=1:128
|
80.6 percentage of participants
|
68.0 percentage of participants
|
3.2 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS1
Serogroup Y: >=1:256
|
63.9 percentage of participants
|
48.0 percentage of participants
|
3.2 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS1
Serogroup Y: >=1:512
|
36.1 percentage of participants
|
36.0 percentage of participants
|
3.2 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS1
Serogroup Y: >=1:1024
|
5.6 percentage of participants
|
12.0 percentage of participants
|
3.2 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS1
Serogroup Y: >=1:2048
|
2.8 percentage of participants
|
4.0 percentage of participants
|
3.2 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS1
Serogroup Y: >=1:4096
|
0 percentage of participants
|
4.0 percentage of participants
|
—
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS1
Serogroup Y: >=1:8192
|
0 percentage of participants
|
0 percentage of participants
|
—
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS1
Serogroup W: <1:4
|
22.2 percentage of participants
|
33.3 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS1
Serogroup W: >=1:4
|
77.8 percentage of participants
|
66.7 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS1
Serogroup W: >=1:8
|
77.8 percentage of participants
|
63.3 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS1
Serogroup W: >=1:16
|
77.8 percentage of participants
|
63.3 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS1
Serogroup W: >=1:32
|
75.0 percentage of participants
|
63.3 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS1
Serogroup W: >=1:64
|
75.0 percentage of participants
|
63.3 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS1
Serogroup W: >=1:128
|
75.0 percentage of participants
|
53.3 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS1
Serogroup W: >=1:256
|
50.0 percentage of participants
|
50.0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS1
Serogroup W: >=1:512
|
19.4 percentage of participants
|
26.7 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS1
Serogroup W: >=1:1024
|
11.1 percentage of participants
|
13.3 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS1
Serogroup W: >=1:2048
|
5.6 percentage of participants
|
3.3 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS1
Serogroup W: >=1:4096
|
0 percentage of participants
|
0 percentage of participants
|
—
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS1
Serogroup W: >=1:8192
|
0 percentage of participants
|
0 percentage of participants
|
—
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS1
Serogroup A: <1:4
|
38.9 percentage of participants
|
21.9 percentage of participants
|
97.2 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS1
Serogroup A: >=1:4
|
61.1 percentage of participants
|
78.1 percentage of participants
|
2.8 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS1
Serogroup A: >=1:8
|
52.8 percentage of participants
|
65.6 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS1
Serogroup A: >=1:16
|
44.4 percentage of participants
|
53.1 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS1
Serogroup A: >=1:32
|
41.7 percentage of participants
|
43.8 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS1
Serogroup A: >=1:64
|
36.1 percentage of participants
|
31.3 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS1
Serogroup A: >=1:128
|
19.4 percentage of participants
|
28.1 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS1
Serogroup A: >=1:256
|
8.3 percentage of participants
|
21.9 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS1
Serogroup A: >=1:512
|
5.6 percentage of participants
|
9.4 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS1
Serogroup A: >=1:1024
|
5.6 percentage of participants
|
3.1 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS1
Serogroup A: >=1:2048
|
2.8 percentage of participants
|
3.1 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS1
Serogroup A: >=1:4096
|
0 percentage of participants
|
0 percentage of participants
|
—
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS1
Serogroup A: >=1:8192
|
0 percentage of participants
|
0 percentage of participants
|
—
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS1
Serogroup C: <1:4
|
2.6 percentage of participants
|
0 percentage of participants
|
86.5 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS1
Serogroup C: >=1:4
|
97.4 percentage of participants
|
100 percentage of participants
|
13.5 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS1
Serogroup C: >=1:8
|
97.4 percentage of participants
|
100 percentage of participants
|
8.1 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS1
Serogroup C: >=1:16
|
94.7 percentage of participants
|
100 percentage of participants
|
5.4 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS1
Serogroup C: >=1:32
|
89.5 percentage of participants
|
100 percentage of participants
|
5.4 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS1
Serogroup C: >=1:64
|
81.6 percentage of participants
|
96.9 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS1
Serogroup C: >=1:128
|
78.9 percentage of participants
|
96.9 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS1
Serogroup C: >=1:256
|
71.1 percentage of participants
|
65.6 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS1
Serogroup C: >=1:512
|
55.3 percentage of participants
|
40.6 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS1
Serogroup C: >=1:1024
|
23.7 percentage of participants
|
28.1 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS1
Serogroup C: >=1:2048
|
5.3 percentage of participants
|
9.4 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS1
Serogroup C: >=1:4096
|
2.6 percentage of participants
|
3.1 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Before vaccination at the age of 12 to 13 monthsPopulation: Analysis was performed on PPAS3. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified category. Here, '0' in the number analyzed field denotes that no participant had available data for the specified titer category.
Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by rSBA assay. Infancy was defined as up to 4 months of age. Percentage of participants with rSBA antibody titers distribution \<1:4, \>=1:4, \>=1:8, \>=1:16; \>=1:32; \>=1:64, \>=1:128, \>=1:256; \>=1:512; \>=1:1024; \>=1:2048; \>=1:4096; \>=1:8192; \>=1:16384; \>=1:32768 for meningococcal serogroups A, C, Y, and W were reported in this outcome measure.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine + Bexsero® (2, 4, and 12 to 13 Months)
n=7 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
Group 2: MenACYW Conjugate Vaccine + Bexsero® (2 and 4 Months)
n=5 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2 and 4 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
Group 3: Bexsero® (2, 4, and 12 to 13 Months)
n=6 Participants
Participants aged 2 months (at the time of enrollment) received Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
|---|---|---|---|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup A: <1:4
|
50.0 percentage of participants
|
20.0 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup A: >=1:4
|
50.0 percentage of participants
|
80.0 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup A: >=1:8
|
50.0 percentage of participants
|
80.0 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup A: >=1:16
|
50.0 percentage of participants
|
80.0 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup A: >=1:32
|
50.0 percentage of participants
|
80.0 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup A: >=1:64
|
50.0 percentage of participants
|
80.0 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup A: >=1:128
|
50.0 percentage of participants
|
80.0 percentage of participants
|
33.3 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup A: >=1:256
|
33.3 percentage of participants
|
60.0 percentage of participants
|
33.3 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup A: >=1:512
|
33.3 percentage of participants
|
40.0 percentage of participants
|
33.3 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup A: >=1:1024
|
33.3 percentage of participants
|
40.0 percentage of participants
|
16.7 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup A: >=1:2048
|
0 percentage of participants
|
20.0 percentage of participants
|
16.7 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup A: >=1:4096
|
0 percentage of participants
|
0 percentage of participants
|
16.7 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup A: >=1:8192
|
0 percentage of participants
|
0 percentage of participants
|
—
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup A: >=1:16384
|
0 percentage of participants
|
0 percentage of participants
|
—
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup A: >=1:32768
|
0 percentage of participants
|
0 percentage of participants
|
—
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup C: <1:4
|
0 percentage of participants
|
80.0 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup C: >=1:4
|
100 percentage of participants
|
20.0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup C: >=1:8
|
100 percentage of participants
|
20.0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup C: >=1:16
|
85.7 percentage of participants
|
20.0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup C: >=1:32
|
71.4 percentage of participants
|
20.0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup C: >=1:64
|
71.4 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup C: >=1:128
|
42.9 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup C: >=1:256
|
14.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup C: >=1:512
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup C: >=1:1024
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup C: >=1:2048
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup C: >=1:4096
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup C: >=1:8192
|
0 percentage of participants
|
0 percentage of participants
|
—
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup C: >=1:16384
|
0 percentage of participants
|
0 percentage of participants
|
—
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup C: >=1:32768
|
0 percentage of participants
|
0 percentage of participants
|
—
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup Y: <1:4
|
14.3 percentage of participants
|
40.0 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup Y: >=1:4
|
85.7 percentage of participants
|
60.0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup Y: >=1:8
|
85.7 percentage of participants
|
40.0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup Y: >=1:16
|
85.7 percentage of participants
|
40.0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup Y: >=1:32
|
71.4 percentage of participants
|
20.0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup Y: >=1:64
|
57.1 percentage of participants
|
20.0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup Y: >=1:128
|
28.6 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup Y: >=1:256
|
14.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup Y: >=1:512
|
14.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup Y: >=1:1024
|
14.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup Y: >=1:2048
|
14.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup Y: >=1:4096
|
14.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup Y: >=1:8192
|
0 percentage of participants
|
0 percentage of participants
|
—
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup Y: >=1:16384
|
0 percentage of participants
|
0 percentage of participants
|
—
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup Y: >=1:32768
|
0 percentage of participants
|
0 percentage of participants
|
—
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup W: <1:4
|
40.0 percentage of participants
|
40.0 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup W: >=1:4
|
60.0 percentage of participants
|
60.0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup W: >=1:8
|
40.0 percentage of participants
|
60.0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup W: >=1:16
|
40.0 percentage of participants
|
40.0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup W: >=1:32
|
20.0 percentage of participants
|
20.0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup W: >=1:64
|
20.0 percentage of participants
|
20.0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup W: >=1:128
|
20.0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup W: >=1:256
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup W: >=1:512
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup W: >=1:1024
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup W: >=1:2048
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup W: >=1:4096
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup W: >=1:8192
|
0 percentage of participants
|
0 percentage of participants
|
—
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup W: >=1:16384
|
0 percentage of participants
|
0 percentage of participants
|
—
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Serogroup W: >=1:32768
|
0 percentage of participants
|
0 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: 30 days post-vaccination at the age of 12 to 13 months (i.e., at the age of 13 to 14 months)Population: Analysis was performed on PPAS3. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified category. Here, '0' in the number analyzed field denotes that no participant had available data for the specified titer category.
Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by rSBA assay. Percentage of participants with rSBA antibody titers distribution \<1:4, \>=1:4, \>=1:8, \>=1:16; \>=1:32; \>=1:64, \>=1:128, \>=1:256; \>=1:512; \>=1:1024; \>=1:2048; \>=1:4096; \>=1:8192; \>=1:16384; \>=1:32768 for meningococcal serogroups A, C, Y, and W were reported in this outcome measure.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine + Bexsero® (2, 4, and 12 to 13 Months)
n=54 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
Group 2: MenACYW Conjugate Vaccine + Bexsero® (2 and 4 Months)
n=54 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2 and 4 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
Group 3: Bexsero® (2, 4, and 12 to 13 Months)
n=52 Participants
Participants aged 2 months (at the time of enrollment) received Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
|---|---|---|---|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup W: >=1:32
|
100 percentage of participants
|
100 percentage of participants
|
16.7 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup W: >=1:64
|
100 percentage of participants
|
100 percentage of participants
|
16.7 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup A: <1:4
|
0 percentage of participants
|
0 percentage of participants
|
14.6 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup A: >=1:4
|
100 percentage of participants
|
100 percentage of participants
|
85.4 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup A: >=1:8
|
100 percentage of participants
|
100 percentage of participants
|
85.4 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup A: >=1:16
|
100 percentage of participants
|
100 percentage of participants
|
85.4 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup A: >=1:32
|
100 percentage of participants
|
100 percentage of participants
|
85.4 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup A: >=1:64
|
100 percentage of participants
|
100 percentage of participants
|
85.4 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup A: >=1:128
|
100 percentage of participants
|
97.7 percentage of participants
|
85.4 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup A: >=1:256
|
100 percentage of participants
|
97.7 percentage of participants
|
75.6 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup A: >=1:512
|
97.9 percentage of participants
|
88.4 percentage of participants
|
68.3 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup A: >=1:1024
|
87.2 percentage of participants
|
79.1 percentage of participants
|
51.2 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup A: >=1:2048
|
53.2 percentage of participants
|
51.2 percentage of participants
|
36.6 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup A: >=1:4096
|
29.8 percentage of participants
|
32.6 percentage of participants
|
17.1 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup A: >=1:8192
|
6.4 percentage of participants
|
9.3 percentage of participants
|
—
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup A: >=1:16384
|
2.1 percentage of participants
|
0 percentage of participants
|
—
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup A: >=1:32768
|
0 percentage of participants
|
0 percentage of participants
|
—
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup C: <1:4
|
0 percentage of participants
|
0 percentage of participants
|
88.6 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup C: >=1:4
|
100 percentage of participants
|
100 percentage of participants
|
11.4 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup C: >=1:8
|
100 percentage of participants
|
100 percentage of participants
|
11.4 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup C: >=1:16
|
100 percentage of participants
|
100 percentage of participants
|
11.4 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup C: >=1:32
|
100 percentage of participants
|
100 percentage of participants
|
11.4 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup C: >=1:64
|
100 percentage of participants
|
100 percentage of participants
|
11.4 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup C: >=1:128
|
100 percentage of participants
|
100 percentage of participants
|
9.1 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup C: >=1:256
|
100 percentage of participants
|
95.3 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup C: >=1:512
|
89.4 percentage of participants
|
88.4 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup C: >=1:1024
|
74.5 percentage of participants
|
72.1 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup C: >=1:2048
|
51.1 percentage of participants
|
53.5 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup C: >=1:4096
|
21.3 percentage of participants
|
34.9 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup C: >=1:8192
|
8.5 percentage of participants
|
9.3 percentage of participants
|
—
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup C: >=1:16384
|
0 percentage of participants
|
4.7 percentage of participants
|
—
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup C: >=1:32768
|
0 percentage of participants
|
0 percentage of participants
|
—
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup Y: <1:4
|
0 percentage of participants
|
0 percentage of participants
|
7.0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup Y: >=1:4
|
100 percentage of participants
|
100 percentage of participants
|
93.0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup Y: >=1:8
|
100 percentage of participants
|
100 percentage of participants
|
93.0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup Y: >=1:16
|
100 percentage of participants
|
100 percentage of participants
|
93.0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup Y: >=1:32
|
100 percentage of participants
|
97.7 percentage of participants
|
93.0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup Y: >=1:64
|
100 percentage of participants
|
97.7 percentage of participants
|
93.0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup Y: >=1:128
|
100 percentage of participants
|
97.7 percentage of participants
|
93.0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup Y: >=1:256
|
100 percentage of participants
|
95.3 percentage of participants
|
90.7 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup Y: >=1:512
|
97.8 percentage of participants
|
95.3 percentage of participants
|
79.1 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup Y: >=1:1024
|
93.3 percentage of participants
|
79.1 percentage of participants
|
67.4 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup Y: >=1:2048
|
77.8 percentage of participants
|
53.5 percentage of participants
|
46.5 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup Y: >=1:4096
|
44.4 percentage of participants
|
20.9 percentage of participants
|
11.6 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup Y: >=1:8192
|
17.8 percentage of participants
|
9.3 percentage of participants
|
—
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup Y: >=1:16384
|
2.2 percentage of participants
|
0 percentage of participants
|
—
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup Y: >=1:32768
|
2.2 percentage of participants
|
0 percentage of participants
|
—
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup W: <1:4
|
0 percentage of participants
|
0 percentage of participants
|
81.0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup W: >=1:4
|
100 percentage of participants
|
100 percentage of participants
|
19.0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup W: >=1:8
|
100 percentage of participants
|
100 percentage of participants
|
16.7 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup W: >=1:16
|
100 percentage of participants
|
100 percentage of participants
|
16.7 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup W: >=1:128
|
100 percentage of participants
|
97.7 percentage of participants
|
11.9 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup W: >=1:256
|
100 percentage of participants
|
97.7 percentage of participants
|
4.8 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup W: >=1:512
|
97.8 percentage of participants
|
95.3 percentage of participants
|
2.4 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup W: >=1:1024
|
87.0 percentage of participants
|
86.0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup W: >=1:2048
|
73.9 percentage of participants
|
74.4 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup W: >=1:4096
|
39.1 percentage of participants
|
46.5 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup W: >=1:8192
|
28.3 percentage of participants
|
25.6 percentage of participants
|
—
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup W: >=1:16384
|
2.2 percentage of participants
|
9.3 percentage of participants
|
—
|
|
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Serogroup W: >=1:32768
|
0 percentage of participants
|
0 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: 30 days post-vaccination at the age of 3 months (i.e., at the age of 4 months) and before vaccination at the age of 12-13 monthsPopulation: Analysis was performed on per-protocol analysis set 2 (PPAS2) defined for accessing ACYW immune response data for participants who received at least 1 dose of study vaccine in infancy and had valid post-vaccination serology results at 12 to13 months of age, with no relevant protocol violations. Here, 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Group 3.
GMTs of antibody against meningococcal serogroups A, C, Y, and W were measured by hSBA. Titers were expressed in terms of 1/dilution.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine + Bexsero® (2, 4, and 12 to 13 Months)
n=41 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
Group 2: MenACYW Conjugate Vaccine + Bexsero® (2 and 4 Months)
n=36 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2 and 4 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
Group 3: Bexsero® (2, 4, and 12 to 13 Months)
Participants aged 2 months (at the time of enrollment) received Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
|---|---|---|---|
|
Geometric Mean Titers of Antibodies Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W: Group 1 and 2 - PPAS2
Serogroup A: 30 days after 3-month vaccination
|
12.7 titers
Interval 8.68 to 18.6
|
9.28 titers
Interval 6.29 to 13.7
|
—
|
|
Geometric Mean Titers of Antibodies Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W: Group 1 and 2 - PPAS2
Serogroup A: Before 12-13 months vaccination
|
46.1 titers
Interval 28.9 to 73.6
|
31.4 titers
Interval 18.9 to 52.1
|
—
|
|
Geometric Mean Titers of Antibodies Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W: Group 1 and 2 - PPAS2
Serogroup C: 30 days after 3-month vaccination
|
95.1 titers
Interval 54.1 to 167.0
|
59.4 titers
Interval 31.6 to 112.0
|
—
|
|
Geometric Mean Titers of Antibodies Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W: Group 1 and 2 - PPAS2
Serogroup C: Before 12-13 months vaccination
|
24.4 titers
Interval 15.5 to 38.5
|
16.6 titers
Interval 9.71 to 28.5
|
—
|
|
Geometric Mean Titers of Antibodies Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W: Group 1 and 2 - PPAS2
Serogroup Y: 30 days after 3-month vaccination
|
9.69 titers
Interval 5.69 to 16.5
|
4.95 titers
Interval 3.39 to 7.22
|
—
|
|
Geometric Mean Titers of Antibodies Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W: Group 1 and 2 - PPAS2
Serogroup Y: Before 12-13 months vaccination
|
21.4 titers
Interval 14.6 to 31.5
|
12.4 titers
Interval 8.36 to 18.5
|
—
|
|
Geometric Mean Titers of Antibodies Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W: Group 1 and 2 - PPAS2
Serogroup W: 30 days after 3-month vaccination
|
4.32 titers
Interval 2.99 to 6.24
|
3.62 titers
Interval 2.6 to 5.05
|
—
|
|
Geometric Mean Titers of Antibodies Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W: Group 1 and 2 - PPAS2
Serogroup W: Before 12-13 months vaccination
|
29.4 titers
Interval 18.7 to 46.3
|
11.2 titers
Interval 7.59 to 16.5
|
—
|
SECONDARY outcome
Timeframe: 30 days post-vaccination at the age of 3 months (i.e., at the age of 4 months) and before vaccination at the age of 12-13 monthsPopulation: Analysis was performed on PPAS2. Here, 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Group 3.
Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by hSBA assay. Percentage of participants with hSBA antibody titers \>=1.4 and \>=1:8 for meningococcal serogroups A, C, Y, and W were reported in this outcome measure.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine + Bexsero® (2, 4, and 12 to 13 Months)
n=41 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
Group 2: MenACYW Conjugate Vaccine + Bexsero® (2 and 4 Months)
n=36 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2 and 4 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
Group 3: Bexsero® (2, 4, and 12 to 13 Months)
Participants aged 2 months (at the time of enrollment) received Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
|---|---|---|---|
|
Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W - PPAS2
Serogroup A: Before 12-13 months vaccination: >= 1:8
|
91.7 percentage of participants
Interval 77.5 to 98.2
|
83.3 percentage of participants
Interval 67.2 to 93.6
|
—
|
|
Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W - PPAS2
Serogroup C: 30 days after 3-month vaccination: >= 1:4
|
100 percentage of participants
Interval 87.7 to 100.0
|
96.4 percentage of participants
Interval 81.7 to 99.9
|
—
|
|
Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W - PPAS2
Serogroup C: 30 days after 3-month vaccination: >= 1:8
|
92.9 percentage of participants
Interval 76.5 to 99.1
|
92.9 percentage of participants
Interval 76.5 to 99.1
|
—
|
|
Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W - PPAS2
Serogroup C: Before 12-13 months vaccination: >= 1:4
|
87.8 percentage of participants
Interval 73.8 to 95.9
|
80.6 percentage of participants
Interval 64.0 to 91.8
|
—
|
|
Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W - PPAS2
Serogroup C: Before 12-13 months vaccination: >= 1:8
|
80.5 percentage of participants
Interval 65.1 to 91.2
|
69.4 percentage of participants
Interval 51.9 to 83.7
|
—
|
|
Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W - PPAS2
Serogroup Y: 30 days after 3-month vaccination: >= 1:4
|
75.9 percentage of participants
Interval 56.5 to 89.7
|
57.7 percentage of participants
Interval 36.9 to 76.6
|
—
|
|
Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W - PPAS2
Serogroup Y: 30 days after 3-month vaccination: >= 1:8
|
65.5 percentage of participants
Interval 45.7 to 82.1
|
46.2 percentage of participants
Interval 26.6 to 66.6
|
—
|
|
Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W - PPAS2
Serogroup Y: Before 12-13 months vaccination: >= 1:4
|
94.7 percentage of participants
Interval 82.3 to 99.4
|
90.9 percentage of participants
Interval 75.7 to 98.1
|
—
|
|
Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W - PPAS2
Serogroup Y: Before 12-13 months vaccination: >= 1:8
|
89.5 percentage of participants
Interval 75.2 to 97.1
|
78.8 percentage of participants
Interval 61.1 to 91.0
|
—
|
|
Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W - PPAS2
Serogroup W: 30 days after 3-month vaccination: >= 1:4
|
51.9 percentage of participants
Interval 31.9 to 71.3
|
39.3 percentage of participants
Interval 21.5 to 59.4
|
—
|
|
Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W - PPAS2
Serogroup W: 30 days after 3-month vaccination: >= 1:8
|
37.0 percentage of participants
Interval 19.4 to 57.6
|
28.6 percentage of participants
Interval 13.2 to 48.7
|
—
|
|
Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W - PPAS2
Serogroup W: Before 12-13 months vaccination: >= 1:4
|
92.7 percentage of participants
Interval 80.1 to 98.5
|
88.6 percentage of participants
Interval 73.3 to 96.8
|
—
|
|
Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W - PPAS2
Serogroup W: Before 12-13 months vaccination: >= 1:8
|
85.4 percentage of participants
Interval 70.8 to 94.4
|
68.6 percentage of participants
Interval 50.7 to 83.1
|
—
|
|
Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W - PPAS2
Serogroup A: 30 days after 3-month vaccination: >= 1:4
|
88.9 percentage of participants
Interval 70.8 to 97.6
|
89.3 percentage of participants
Interval 71.8 to 97.7
|
—
|
|
Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W - PPAS2
Serogroup A: 30 days after 3-month vaccination: >= 1:8
|
81.5 percentage of participants
Interval 61.9 to 93.7
|
64.3 percentage of participants
Interval 44.1 to 81.4
|
—
|
|
Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W - PPAS2
Serogroup A: Before 12-13 months vaccination: >= 1:4
|
97.2 percentage of participants
Interval 85.5 to 99.9
|
97.2 percentage of participants
Interval 85.5 to 99.9
|
—
|
SECONDARY outcome
Timeframe: 30 days post-vaccination at the age of 3 months (i.e., at the age of 4 months) and before vaccination at the age of 12-13 monthsPopulation: Analysis was performed on PPAS2. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Group 3.
GMTs of antibody against meningococcal serogroups A, C, Y, and W were measured by rSBA. Titers were expressed in terms of 1/dilution.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine + Bexsero® (2, 4, and 12 to 13 Months)
n=11 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
Group 2: MenACYW Conjugate Vaccine + Bexsero® (2 and 4 Months)
n=10 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2 and 4 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
Group 3: Bexsero® (2, 4, and 12 to 13 Months)
Participants aged 2 months (at the time of enrollment) received Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
|---|---|---|---|
|
Geometric Mean Titers of Antibodies Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W: Group 1 and 2 - PPAS2
Serogroup W: Before 12-13 months vaccination
|
16.0 titers
Interval 1.4 to 183.0
|
4.67 titers
Interval 1.8 to 12.1
|
—
|
|
Geometric Mean Titers of Antibodies Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W: Group 1 and 2 - PPAS2
Serogroup A: 30 days after 3-month vaccination
|
80.6 titers
95% CI was not computable as the sample size was too small to compute valid data.
|
18.0 titers
Interval 3.33 to 96.9
|
—
|
|
Geometric Mean Titers of Antibodies Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W: Group 1 and 2 - PPAS2
Serogroup A: Before 12-13 months vaccination
|
21.5 titers
Interval 1.29 to 360.0
|
27.4 titers
Interval 2.92 to 258.0
|
—
|
|
Geometric Mean Titers of Antibodies Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W: Group 1 and 2 - PPAS2
Serogroup C: 30 days after 3-month vaccination
|
431 titers
95% CI was not computable as the sample size was too small to compute valid data.
|
144 titers
Interval 44.8 to 461.0
|
—
|
|
Geometric Mean Titers of Antibodies Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W: Group 1 and 2 - PPAS2
Serogroup C: Before 12-13 months vaccination
|
38.1 titers
Interval 9.61 to 151.0
|
11.8 titers
Interval 1.96 to 70.4
|
—
|
|
Geometric Mean Titers of Antibodies Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W: Group 1 and 2 - PPAS2
Serogroup Y: 30 days after 3-month vaccination
|
323 titers
95% CI was not computable as the sample size was too small to compute valid data.
|
102 titers
Interval 22.6 to 456.0
|
—
|
|
Geometric Mean Titers of Antibodies Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W: Group 1 and 2 - PPAS2
Serogroup Y: Before 12-13 months vaccination
|
69.8 titers
Interval 11.0 to 441.0
|
20.7 titers
Interval 3.81 to 113.0
|
—
|
|
Geometric Mean Titers of Antibodies Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W: Group 1 and 2 - PPAS2
Serogroup W: 30 days after 3-month vaccination
|
256 titers
95% CI was not computable as the sample size was too small to compute valid data.
|
90.5 titers
Interval 5.16 to 1587.0
|
—
|
SECONDARY outcome
Timeframe: 30 days post-vaccination at the age of 3 months (i.e., at the age of 4 months) and before vaccination at the age of 12-13 monthsPopulation: Analysis was performed on PPAS2. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Group 3.
Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by rSBA assay. Percentage of participants with rSBA antibody titers \>=1:8 and \>=1:128 for meningococcal serogroups A, C, Y, and W were reported in this outcome measure.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine + Bexsero® (2, 4, and 12 to 13 Months)
n=11 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
Group 2: MenACYW Conjugate Vaccine + Bexsero® (2 and 4 Months)
n=10 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2 and 4 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
Group 3: Bexsero® (2, 4, and 12 to 13 Months)
Participants aged 2 months (at the time of enrollment) received Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
|---|---|---|---|
|
Percentage of Participants With rSBA Antibody Titers >=1:8 and >=1:128 Against Meningococcal Serogroups A, C, Y, and W - PPAS2
Serogroup A: 30 days after 3-month vaccination: >= 1:8
|
66.7 percentage of participants
Interval 9.4 to 99.2
|
66.7 percentage of participants
Interval 22.3 to 95.7
|
—
|
|
Percentage of Participants With rSBA Antibody Titers >=1:8 and >=1:128 Against Meningococcal Serogroups A, C, Y, and W - PPAS2
Serogroup A: 30 days after 3-month vaccination: >= 1:128
|
66.7 percentage of participants
Interval 9.4 to 99.2
|
16.7 percentage of participants
Interval 0.4 to 64.1
|
—
|
|
Percentage of Participants With rSBA Antibody Titers >=1:8 and >=1:128 Against Meningococcal Serogroups A, C, Y, and W - PPAS2
Serogroup A: Before 12-13 months vaccination: >= 1:8
|
42.9 percentage of participants
Interval 9.9 to 81.6
|
55.6 percentage of participants
Interval 21.2 to 86.3
|
—
|
|
Percentage of Participants With rSBA Antibody Titers >=1:8 and >=1:128 Against Meningococcal Serogroups A, C, Y, and W - PPAS2
Serogroup A: Before 12-13 months vaccination: >= 1:128
|
42.9 percentage of participants
Interval 9.9 to 81.6
|
44.4 percentage of participants
Interval 13.7 to 78.8
|
—
|
|
Percentage of Participants With rSBA Antibody Titers >=1:8 and >=1:128 Against Meningococcal Serogroups A, C, Y, and W - PPAS2
Serogroup C: 30 days after 3-month vaccination: >= 1:8
|
100 percentage of participants
Interval 39.8 to 100.0
|
100 percentage of participants
Interval 54.1 to 100.0
|
—
|
|
Percentage of Participants With rSBA Antibody Titers >=1:8 and >=1:128 Against Meningococcal Serogroups A, C, Y, and W - PPAS2
Serogroup C: 30 days after 3-month vaccination: >= 1:128
|
100 percentage of participants
Interval 39.8 to 100.0
|
83.3 percentage of participants
Interval 35.9 to 99.6
|
—
|
|
Percentage of Participants With rSBA Antibody Titers >=1:8 and >=1:128 Against Meningococcal Serogroups A, C, Y, and W - PPAS2
Serogroup C: Before 12-13 months vaccination: >= 1:8
|
87.5 percentage of participants
Interval 47.3 to 99.7
|
55.6 percentage of participants
Interval 21.2 to 86.3
|
—
|
|
Percentage of Participants With rSBA Antibody Titers >=1:8 and >=1:128 Against Meningococcal Serogroups A, C, Y, and W - PPAS2
Serogroup C: Before 12-13 months vaccination: >= 1:128
|
37.5 percentage of participants
Interval 8.5 to 75.5
|
11.1 percentage of participants
Interval 0.3 to 48.2
|
—
|
|
Percentage of Participants With rSBA Antibody Titers >=1:8 and >=1:128 Against Meningococcal Serogroups A, C, Y, and W - PPAS2
Serogroup Y: 30 days after 3-month vaccination: >= 1:8
|
100 percentage of participants
Interval 29.2 to 100.0
|
100 percentage of participants
Interval 54.1 to 100.0
|
—
|
|
Percentage of Participants With rSBA Antibody Titers >=1:8 and >=1:128 Against Meningococcal Serogroups A, C, Y, and W - PPAS2
Serogroup Y: 30 days after 3-month vaccination: >= 1:128
|
100 percentage of participants
Interval 29.2 to 100.0
|
50.0 percentage of participants
Interval 11.8 to 88.2
|
—
|
|
Percentage of Participants With rSBA Antibody Titers >=1:8 and >=1:128 Against Meningococcal Serogroups A, C, Y, and W - PPAS2
Serogroup Y: Before 12-13 months vaccination: >= 1:8
|
87.5 percentage of participants
Interval 47.3 to 99.7
|
62.5 percentage of participants
Interval 24.5 to 91.5
|
—
|
|
Percentage of Participants With rSBA Antibody Titers >=1:8 and >=1:128 Against Meningococcal Serogroups A, C, Y, and W - PPAS2
Serogroup Y: Before 12-13 months vaccination: >= 1:128
|
37.5 percentage of participants
Interval 8.5 to 75.5
|
25.0 percentage of participants
Interval 3.2 to 65.1
|
—
|
|
Percentage of Participants With rSBA Antibody Titers >=1:8 and >=1:128 Against Meningococcal Serogroups A, C, Y, and W - PPAS2
Serogroup W: 30 days after 3-month vaccination: >= 1:8
|
100 percentage of participants
Interval 39.8 to 100.0
|
66.7 percentage of participants
Interval 22.3 to 95.7
|
—
|
|
Percentage of Participants With rSBA Antibody Titers >=1:8 and >=1:128 Against Meningococcal Serogroups A, C, Y, and W - PPAS2
Serogroup W: 30 days after 3-month vaccination: >= 1:128
|
100 percentage of participants
Interval 39.8 to 100.0
|
66.7 percentage of participants
Interval 22.3 to 95.7
|
—
|
|
Percentage of Participants With rSBA Antibody Titers >=1:8 and >=1:128 Against Meningococcal Serogroups A, C, Y, and W - PPAS2
Serogroup W: Before 12-13 months vaccination: >= 1:8
|
50.0 percentage of participants
Interval 11.8 to 88.2
|
33.3 percentage of participants
Interval 7.5 to 70.1
|
—
|
|
Percentage of Participants With rSBA Antibody Titers >=1:8 and >=1:128 Against Meningococcal Serogroups A, C, Y, and W - PPAS2
Serogroup W: Before 12-13 months vaccination: >= 1:128
|
33.3 percentage of participants
Interval 4.3 to 77.7
|
0 percentage of participants
Interval 0.0 to 33.6
|
—
|
SECONDARY outcome
Timeframe: Within 7 days post any vaccinationPopulation: Analysis was performed on safety analysis set. Here, 'number analyzed' = participants with available data for each specified category.
A solicited reaction (SR) was defined as an "expected" adverse reaction (AR) (sign or symptom) observed and reported under the conditions (nature and onset) pre-listed (i.e., solicited) in the protocol and case report form (CRF) and considered as related to vaccination. Solicited injection site reactions included injection site tenderness, injection site erythema, and injection site swelling and were planned to be collected and reported for each vaccine separately; and not planned to be collected for Rotavirus vaccine as the vaccine was administered orally, and no injection site reactions were expected to occur. Reported AEs for each arm were presented as pre-specified in the study protocol. Here, '0' in number analyzed field for MenACYW categories signifies that no participant was evaluable because in Group 3 MenACYW vaccine was not administered.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine + Bexsero® (2, 4, and 12 to 13 Months)
n=314 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
Group 2: MenACYW Conjugate Vaccine + Bexsero® (2 and 4 Months)
n=314 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2 and 4 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
Group 3: Bexsero® (2, 4, and 12 to 13 Months)
n=157 Participants
Participants aged 2 months (at the time of enrollment) received Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
|---|---|---|---|
|
Number of Participants With Solicited Injection Site Reactions After Any Vaccination
MenACYW conjugate vaccine: Tenderness
|
198 Participants
|
161 Participants
|
—
|
|
Number of Participants With Solicited Injection Site Reactions After Any Vaccination
MenACYW conjugate vaccine: Erythema
|
220 Participants
|
205 Participants
|
—
|
|
Number of Participants With Solicited Injection Site Reactions After Any Vaccination
MenACYW conjugate vaccine: Swelling
|
139 Participants
|
111 Participants
|
—
|
|
Number of Participants With Solicited Injection Site Reactions After Any Vaccination
Bexsero: Tenderness
|
266 Participants
|
230 Participants
|
138 Participants
|
|
Number of Participants With Solicited Injection Site Reactions After Any Vaccination
Bexsero: Erythema
|
271 Participants
|
246 Participants
|
136 Participants
|
|
Number of Participants With Solicited Injection Site Reactions After Any Vaccination
Bexsero: Swelling
|
234 Participants
|
192 Participants
|
118 Participants
|
|
Number of Participants With Solicited Injection Site Reactions After Any Vaccination
Infanrix hexa: Tenderness
|
220 Participants
|
216 Participants
|
119 Participants
|
|
Number of Participants With Solicited Injection Site Reactions After Any Vaccination
Infanrix hexa: Erythema
|
254 Participants
|
231 Participants
|
117 Participants
|
|
Number of Participants With Solicited Injection Site Reactions After Any Vaccination
Infanrix hexa: Swelling
|
188 Participants
|
189 Participants
|
86 Participants
|
|
Number of Participants With Solicited Injection Site Reactions After Any Vaccination
Prevnar 13: Tenderness
|
195 Participants
|
196 Participants
|
118 Participants
|
|
Number of Participants With Solicited Injection Site Reactions After Any Vaccination
Prevnar 13: Erythema
|
214 Participants
|
202 Participants
|
104 Participants
|
|
Number of Participants With Solicited Injection Site Reactions After Any Vaccination
Prevnar 13: Swelling
|
140 Participants
|
137 Participants
|
69 Participants
|
SECONDARY outcome
Timeframe: Within 7 days after any vaccinationPopulation: Analysis was performed on safety analysis set. Here, 'number analyzed' = participants with available data for each specified category.
A SR was an expected AR (sign or symptom) observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the CRB and considered as related to the product administered. Solicited systemic reactions included fever, vomiting, crying abnormal, drowsiness, appetite lost, and irritability. Reported AEs for each arm were presented as pre-specified in the study protocol.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine + Bexsero® (2, 4, and 12 to 13 Months)
n=314 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
Group 2: MenACYW Conjugate Vaccine + Bexsero® (2 and 4 Months)
n=314 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2 and 4 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
Group 3: Bexsero® (2, 4, and 12 to 13 Months)
n=157 Participants
Participants aged 2 months (at the time of enrollment) received Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
|---|---|---|---|
|
Number of Participants With Solicited Systemic Reactions After Any Vaccination
Fever
|
100 Participants
|
86 Participants
|
50 Participants
|
|
Number of Participants With Solicited Systemic Reactions After Any Vaccination
Vomiting
|
173 Participants
|
172 Participants
|
71 Participants
|
|
Number of Participants With Solicited Systemic Reactions After Any Vaccination
Crying abnormal
|
293 Participants
|
273 Participants
|
141 Participants
|
|
Number of Participants With Solicited Systemic Reactions After Any Vaccination
Drowsiness
|
275 Participants
|
275 Participants
|
137 Participants
|
|
Number of Participants With Solicited Systemic Reactions After Any Vaccination
Appetite lost
|
230 Participants
|
230 Participants
|
121 Participants
|
|
Number of Participants With Solicited Systemic Reactions After Any Vaccination
Irritability
|
306 Participants
|
299 Participants
|
147 Participants
|
Adverse Events
Group 1: MenACYW Conjugate Vaccine + Bexsero® (2, 4, and 12 to 13 Months)
Serious events: 18 serious events
Other events: 310 other events
Deaths: 0 deaths
Group 2: MenACYW Conjugate Vaccine + Bexsero® (2 and 4 Months)
Serious events: 34 serious events
Other events: 310 other events
Deaths: 0 deaths
Group 3: Bexsero® (2, 4, and 12 to 13 Months)
Serious events: 7 serious events
Other events: 155 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1: MenACYW Conjugate Vaccine + Bexsero® (2, 4, and 12 to 13 Months)
n=314 participants at risk
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
Group 2: MenACYW Conjugate Vaccine + Bexsero® (2 and 4 Months)
n=314 participants at risk
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2 and 4 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
Group 3: Bexsero® (2, 4, and 12 to 13 Months)
n=157 participants at risk
Participants aged 2 months (at the time of enrollment) received Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
|---|---|---|---|
|
Cardiac disorders
Tachycardia
|
0.00%
0/314 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
0.32%
1/314 • Number of events 1 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
0.00%
0/157 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
|
Congenital, familial and genetic disorders
Cystic Lymphangioma
|
0.32%
1/314 • Number of events 1 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
0.00%
0/314 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
0.00%
0/157 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
|
Gastrointestinal disorders
Constipation
|
0.32%
1/314 • Number of events 1 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
0.00%
0/314 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
0.00%
0/157 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.32%
1/314 • Number of events 1 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
0.00%
0/314 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
0.00%
0/157 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.00%
0/314 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
0.32%
1/314 • Number of events 1 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
0.00%
0/157 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/314 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
0.32%
1/314 • Number of events 1 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
0.00%
0/157 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
|
General disorders
Pyrexia
|
0.32%
1/314 • Number of events 1 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
0.64%
2/314 • Number of events 2 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
0.00%
0/157 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
|
Immune system disorders
Anaphylactic Reaction
|
0.00%
0/314 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
0.64%
2/314 • Number of events 2 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
0.00%
0/157 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
|
Infections and infestations
Bronchiolitis
|
0.96%
3/314 • Number of events 3 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
1.3%
4/314 • Number of events 5 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
1.9%
3/157 • Number of events 3 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
|
Infections and infestations
Covid-19
|
0.32%
1/314 • Number of events 1 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
0.00%
0/314 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
0.00%
0/157 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
|
Infections and infestations
Conjunctivitis
|
0.32%
1/314 • Number of events 1 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
0.00%
0/314 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
0.00%
0/157 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
|
Infections and infestations
Gastroenteritis
|
0.64%
2/314 • Number of events 2 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
0.32%
1/314 • Number of events 1 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
0.00%
0/157 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
|
Infections and infestations
Gastroenteritis Viral
|
0.00%
0/314 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
0.32%
1/314 • Number of events 2 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
0.00%
0/157 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
|
Infections and infestations
Herpes Virus Infection
|
0.00%
0/314 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
0.32%
1/314 • Number of events 1 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
0.00%
0/157 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
0.32%
1/314 • Number of events 1 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
0.96%
3/314 • Number of events 3 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
0.64%
1/157 • Number of events 1 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
|
Infections and infestations
Lymph Node Abscess
|
0.00%
0/314 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
0.32%
1/314 • Number of events 1 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
0.00%
0/157 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
|
Infections and infestations
Mastoiditis
|
0.00%
0/314 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
0.32%
1/314 • Number of events 1 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
0.00%
0/157 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
|
Infections and infestations
Pneumonia Viral
|
0.32%
1/314 • Number of events 1 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
0.32%
1/314 • Number of events 1 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
0.00%
0/157 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
|
Infections and infestations
Respiratory Syncytial Virus Bronchiolitis
|
0.00%
0/314 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
0.64%
2/314 • Number of events 2 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
0.00%
0/157 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
|
Infections and infestations
Respiratory Tract Infection Viral
|
0.32%
1/314 • Number of events 1 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
0.00%
0/314 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
0.00%
0/157 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
|
Infections and infestations
Sepsis
|
0.64%
2/314 • Number of events 2 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
0.32%
1/314 • Number of events 1 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
0.00%
0/157 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/314 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
0.32%
1/314 • Number of events 1 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
0.00%
0/157 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
|
Infections and infestations
Varicella
|
0.00%
0/314 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
0.32%
1/314 • Number of events 1 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
0.00%
0/157 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
|
Infections and infestations
Viral Rash
|
0.00%
0/314 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
0.32%
1/314 • Number of events 1 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
0.00%
0/157 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
|
Infections and infestations
Viral Upper Respiratory Tract Infection
|
0.00%
0/314 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
0.32%
1/314 • Number of events 1 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
0.00%
0/157 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
|
Injury, poisoning and procedural complications
Head Injury
|
0.00%
0/314 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
0.64%
2/314 • Number of events 2 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
0.64%
1/157 • Number of events 1 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/314 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
0.32%
1/314 • Number of events 1 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
0.00%
0/157 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
|
Metabolism and nutrition disorders
Failure To Thrive
|
0.00%
0/314 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
0.64%
2/314 • Number of events 2 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
0.00%
0/157 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.32%
1/314 • Number of events 1 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
0.32%
1/314 • Number of events 1 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
0.00%
0/157 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
|
Metabolism and nutrition disorders
Weight Gain Poor
|
0.00%
0/314 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
0.32%
1/314 • Number of events 1 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
0.00%
0/157 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
|
Nervous system disorders
Embolic Stroke
|
0.32%
1/314 • Number of events 1 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
0.00%
0/314 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
0.00%
0/157 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
|
Nervous system disorders
Febrile Convulsion
|
0.00%
0/314 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
0.64%
2/314 • Number of events 2 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
0.00%
0/157 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
|
Nervous system disorders
Head Titubation
|
0.00%
0/314 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
0.00%
0/314 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
0.64%
1/157 • Number of events 1 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
|
Nervous system disorders
Seizure
|
0.64%
2/314 • Number of events 2 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
0.00%
0/314 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
0.64%
1/157 • Number of events 1 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/314 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
0.64%
2/314 • Number of events 2 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
0.00%
0/157 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/314 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
0.32%
1/314 • Number of events 1 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
0.00%
0/157 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
|
Skin and subcutaneous tissue disorders
Rash Erythematous
|
0.00%
0/314 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
0.32%
1/314 • Number of events 1 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
0.00%
0/157 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
|
Vascular disorders
Cyanosis
|
0.32%
1/314 • Number of events 1 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
0.00%
0/314 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
0.00%
0/157 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
Other adverse events
| Measure |
Group 1: MenACYW Conjugate Vaccine + Bexsero® (2, 4, and 12 to 13 Months)
n=314 participants at risk
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
Group 2: MenACYW Conjugate Vaccine + Bexsero® (2 and 4 Months)
n=314 participants at risk
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2 and 4 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
Group 3: Bexsero® (2, 4, and 12 to 13 Months)
n=157 participants at risk
Participants aged 2 months (at the time of enrollment) received Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age.
|
|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
3.8%
12/314 • Number of events 13 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
5.1%
16/314 • Number of events 16 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
5.1%
8/157 • Number of events 8 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
|
Gastrointestinal disorders
Diarrhoea
|
13.4%
42/314 • Number of events 46 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
10.2%
32/314 • Number of events 42 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
14.6%
23/157 • Number of events 26 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
5.7%
18/314 • Number of events 19 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
4.5%
14/314 • Number of events 16 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
4.5%
7/157 • Number of events 8 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
|
Gastrointestinal disorders
Teething
|
35.7%
112/314 • Number of events 195 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
36.6%
115/314 • Number of events 184 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
39.5%
62/157 • Number of events 98 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
|
Gastrointestinal disorders
Vomiting
|
56.4%
177/314 • Number of events 323 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
55.4%
174/314 • Number of events 291 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
45.9%
72/157 • Number of events 144 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
|
General disorders
Crying
|
93.6%
294/314 • Number of events 820 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
87.3%
274/314 • Number of events 709 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
89.8%
141/157 • Number of events 418 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
|
General disorders
Injection Site Bruising
|
29.3%
92/314 • Number of events 154 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
28.3%
89/314 • Number of events 137 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
22.3%
35/157 • Number of events 64 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
|
General disorders
Injection Site Erythema
|
93.6%
294/314 • Number of events 1806 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
89.5%
281/314 • Number of events 1455 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
91.7%
144/157 • Number of events 685 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
|
General disorders
Injection Site Mass
|
8.3%
26/314 • Number of events 46 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
7.0%
22/314 • Number of events 40 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
8.9%
14/157 • Number of events 24 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
|
General disorders
Injection Site Pain
|
88.2%
277/314 • Number of events 1521 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
83.8%
263/314 • Number of events 1295 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
89.8%
141/157 • Number of events 745 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
|
General disorders
Injection Site Swelling
|
83.4%
262/314 • Number of events 1161 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
79.0%
248/314 • Number of events 909 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
80.9%
127/157 • Number of events 466 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
|
General disorders
Pyrexia
|
36.6%
115/314 • Number of events 157 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
33.4%
105/314 • Number of events 137 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
36.9%
58/157 • Number of events 77 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
|
Infections and infestations
Conjunctivitis
|
5.1%
16/314 • Number of events 16 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
3.5%
11/314 • Number of events 11 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
1.3%
2/157 • Number of events 2 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
|
Infections and infestations
Nasopharyngitis
|
21.0%
66/314 • Number of events 98 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
17.8%
56/314 • Number of events 75 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
18.5%
29/157 • Number of events 39 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
11.1%
35/314 • Number of events 40 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
11.8%
37/314 • Number of events 51 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
7.0%
11/157 • Number of events 15 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
|
Infections and infestations
Viral Upper Respiratory Tract Infection
|
5.7%
18/314 • Number of events 20 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
6.1%
19/314 • Number of events 22 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
2.5%
4/157 • Number of events 5 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
73.2%
230/314 • Number of events 443 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
73.2%
230/314 • Number of events 425 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
77.1%
121/157 • Number of events 239 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
|
Nervous system disorders
Somnolence
|
87.6%
275/314 • Number of events 688 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
87.6%
275/314 • Number of events 636 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
87.3%
137/157 • Number of events 320 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
|
Psychiatric disorders
Irritability
|
97.5%
306/314 • Number of events 999 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
95.2%
299/314 • Number of events 905 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
93.6%
147/157 • Number of events 472 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.6%
30/314 • Number of events 35 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
11.8%
37/314 • Number of events 43 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
5.7%
9/157 • Number of events 11 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
3.2%
10/314 • Number of events 10 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
3.8%
12/314 • Number of events 14 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
5.7%
9/157 • Number of events 9 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.4%
20/314 • Number of events 23 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
9.6%
30/314 • Number of events 33 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
5.7%
9/157 • Number of events 9 • Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)
SR was an "expected" AR (sign or symptom) observed \& reported under conditions (nature \& onset) pre-listed in the protocol and CRF. Unsolicited AE: observed AE that does not fulfill the conditions prelisted in the CRF. Safety analysis set. Reported AEs for each arm were presented as pre-specified in protocol. In AE section, solicited reactions Fever, Crying abnormal, Drowsiness, and Appetite lost are reported under Pyrexia, Crying, Somnolence, and decreased appetite, respectively.
|
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