Trial Outcomes & Findings for Safety and Immunogenicity of a Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers in the Russian Federation and Mexico (NCT NCT03630705)
NCT ID: NCT03630705
Last Updated: 2023-10-19
Results Overview
Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by serum bactericidal assay using human complement (hSBA) assay. Group 3 data were presented separately.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
525 participants
Primary outcome timeframe
30 days after the last vaccination at the age of 12 months (i.e., at the age of 13 months)
Results posted on
2023-10-19
Participant Flow
Study was conducted from 17 October 2018 to 18 February 2022 at 11 active sites in Mexico and the Russian Federation.
A total of 525 participants were enrolled and randomized in the study.
Participant milestones
| Measure |
Group 1: MenACYW Conjugate Vaccine (Mexico)
Participants aged 2 months (at the time of enrollment) received Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus toxoid (MenACYW) Conjugate vaccine at the age of Months 2, 6, and 12 along with Prevnar 13®, Hexacima®, vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6 and measles, mumps, rubella (MMR®II) vaccine at the age of Month 12.
|
Group 2: Menveo® Vaccine (Mexico)
Participants aged 2 months (at the time of enrollment) received Menveo® vaccine at the age of Months 2, 4, 6, and 12 along with Prevnar 13®, Hexacima® vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6, and MMR®II vaccine at the age of Month 12.
|
Group 3: MenACYW Conjugate Vaccine (Russian Federation)
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 3, 6, and 12 along with Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
|
Group 4: Routine Pediatric Vaccines (Russian Federation)
Participants aged 2 months (at the time of enrollment) received Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
200
|
100
|
150
|
75
|
|
Overall Study
Vaccinated at the Age of 2 Months
|
200
|
100
|
150
|
75
|
|
Overall Study
Vaccinated at the Age of 3 Months
|
0
|
0
|
149
|
75
|
|
Overall Study
Vaccinated at the Age of 4 Months
|
195
|
96
|
0
|
0
|
|
Overall Study
Vaccinated at the Age of 4.5 Months
|
0
|
0
|
149
|
75
|
|
Overall Study
Vaccinated at the Age of 6 Months
|
194
|
95
|
149
|
75
|
|
Overall Study
Vaccinated at the Age of 12 Months
|
192
|
92
|
148
|
75
|
|
Overall Study
Safety Analysis Set
|
201
|
99
|
150
|
75
|
|
Overall Study
COMPLETED
|
190
|
92
|
148
|
75
|
|
Overall Study
NOT COMPLETED
|
10
|
8
|
2
|
0
|
Reasons for withdrawal
| Measure |
Group 1: MenACYW Conjugate Vaccine (Mexico)
Participants aged 2 months (at the time of enrollment) received Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus toxoid (MenACYW) Conjugate vaccine at the age of Months 2, 6, and 12 along with Prevnar 13®, Hexacima®, vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6 and measles, mumps, rubella (MMR®II) vaccine at the age of Month 12.
|
Group 2: Menveo® Vaccine (Mexico)
Participants aged 2 months (at the time of enrollment) received Menveo® vaccine at the age of Months 2, 4, 6, and 12 along with Prevnar 13®, Hexacima® vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6, and MMR®II vaccine at the age of Month 12.
|
Group 3: MenACYW Conjugate Vaccine (Russian Federation)
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 3, 6, and 12 along with Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
|
Group 4: Routine Pediatric Vaccines (Russian Federation)
Participants aged 2 months (at the time of enrollment) received Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Parent/Guardian
|
9
|
6
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
0
|
0
|
Baseline Characteristics
Safety and Immunogenicity of a Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers in the Russian Federation and Mexico
Baseline characteristics by cohort
| Measure |
Group 1: MenACYW Conjugate Vaccine (Mexico)
n=200 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 6, and 12 along with Prevnar 13®, Hexacima®, vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6 and MMR®II vaccine at the age of Month 12.
|
Group 2: Menveo® Vaccine (Mexico)
n=100 Participants
Participants aged 2 months (at the time of enrollment) received Menveo® vaccine at the age of Months 2, 4, 6, and 12 along with Prevnar 13®, Hexacima® vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6, and MMR®II vaccine at the age of Month 12.
|
Group 3: MenACYW Conjugate Vaccine (Russian Federation)
n=150 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 3, 6, and 12 along with Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
|
Group 4: Routine Pediatric Vaccines (Russian Federation)
n=75 Participants
Participants aged 2 months (at the time of enrollment) received Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
|
Total
n=525 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
2.2 months
STANDARD_DEVIATION 0.24 • n=5 Participants
|
2.3 months
STANDARD_DEVIATION 0.25 • n=7 Participants
|
2.4 months
STANDARD_DEVIATION 0.28 • n=5 Participants
|
2.4 months
STANDARD_DEVIATION 0.29 • n=4 Participants
|
2.3 months
STANDARD_DEVIATION 0.28 • n=21 Participants
|
|
Sex: Female, Male
Female
|
100 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
271 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
100 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
254 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
166 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
244 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
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
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
150 Participants
n=5 Participants
|
75 Participants
n=4 Participants
|
225 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
34 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
56 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 30 days after the last vaccination at the age of 12 months (i.e., at the age of 13 months)Population: 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 and had valid post-vaccination serology result of 2nd year of life, with no major 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 4.
Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by serum bactericidal assay using human complement (hSBA) assay. Group 3 data were presented separately.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine (Mexico)
n=126 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 6, and 12 along with Prevnar 13®, Hexacima®, vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6 and MMR®II vaccine at the age of Month 12.
|
Group 2: Menveo® Vaccine (Mexico)
n=60 Participants
Participants aged 2 months (at the time of enrollment) received Menveo® vaccine at the age of Months 2, 4, 6, and 12 along with Prevnar 13®, Hexacima® vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6, and MMR®II vaccine at the age of Month 12.
|
Group 3: MenACYW Conjugate Vaccine (Russian Federation)
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 3, 6, and 12 along with Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
|
Group 4: Routine Pediatric Vaccines (Russian Federation)
Participants aged 2 months (at the time of enrollment) received Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
|
|---|---|---|---|---|
|
Percentage of Participants With Antibody Titers Greater Than or Equal to (>=) 1:8 Against Meningococcal Serogroups A, C, Y, and W Following Last Vaccination With MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2
Serogroup A
|
97.6 percentage of participants
Interval 93.2 to 99.5
|
95.0 percentage of participants
Interval 86.1 to 99.0
|
—
|
—
|
|
Percentage of Participants With Antibody Titers Greater Than or Equal to (>=) 1:8 Against Meningococcal Serogroups A, C, Y, and W Following Last Vaccination With MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2
Serogroup C
|
99.2 percentage of participants
Interval 95.7 to 100.0
|
93.3 percentage of participants
Interval 83.8 to 98.2
|
—
|
—
|
|
Percentage of Participants With Antibody Titers Greater Than or Equal to (>=) 1:8 Against Meningococcal Serogroups A, C, Y, and W Following Last Vaccination With MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2
Serogroup Y
|
100 percentage of participants
Interval 97.1 to 100.0
|
100 percentage of participants
Interval 94.0 to 100.0
|
—
|
—
|
|
Percentage of Participants With Antibody Titers Greater Than or Equal to (>=) 1:8 Against Meningococcal Serogroups A, C, Y, and W Following Last Vaccination With MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2
Serogroup W
|
100 percentage of participants
Interval 97.1 to 100.0
|
100 percentage of participants
Interval 94.0 to 100.0
|
—
|
—
|
PRIMARY outcome
Timeframe: 30 days after the last vaccination at the age of 12 months (i.e., at the age of 13 months)Population: Analysis was performed on PPAS2. Data for this outcome measure was not planned to be collected and analyzed for Group 4.
Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by hSBA assay.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine (Mexico)
n=96 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 6, and 12 along with Prevnar 13®, Hexacima®, vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6 and MMR®II vaccine at the age of Month 12.
|
Group 2: Menveo® Vaccine (Mexico)
Participants aged 2 months (at the time of enrollment) received Menveo® vaccine at the age of Months 2, 4, 6, and 12 along with Prevnar 13®, Hexacima® vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6, and MMR®II vaccine at the age of Month 12.
|
Group 3: MenACYW Conjugate Vaccine (Russian Federation)
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 3, 6, and 12 along with Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
|
Group 4: Routine Pediatric Vaccines (Russian Federation)
Participants aged 2 months (at the time of enrollment) received Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
|
|---|---|---|---|---|
|
Percentage of Participants With Antibody Titers >=1:8 Against Meningococcal Serogroups A, C, Y, and W Following Last Vaccination With MenACYW Conjugate Vaccine: Group 3
Serogroup A
|
89.6 percentage of participants
Interval 81.7 to 94.9
|
—
|
—
|
—
|
|
Percentage of Participants With Antibody Titers >=1:8 Against Meningococcal Serogroups A, C, Y, and W Following Last Vaccination With MenACYW Conjugate Vaccine: Group 3
Serogroup C
|
82.3 percentage of participants
Interval 73.2 to 89.3
|
—
|
—
|
—
|
|
Percentage of Participants With Antibody Titers >=1:8 Against Meningococcal Serogroups A, C, Y, and W Following Last Vaccination With MenACYW Conjugate Vaccine: Group 3
Serogroup Y
|
80.2 percentage of participants
Interval 70.8 to 87.6
|
—
|
—
|
—
|
|
Percentage of Participants With Antibody Titers >=1:8 Against Meningococcal Serogroups A, C, Y, and W Following Last Vaccination With MenACYW Conjugate Vaccine: Group 3
Serogroup W
|
80.2 percentage of participants
Interval 70.8 to 87.6
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 30 days after the last vaccination at the age of 6 months of the infant series (i.e., at the age of 7 months)Population: 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 (6 months of age) vaccination stage, with no major protocol deviations. Data for this outcome measure was not planned to be collected and analyzed for Group 4.
The hSBA vaccine seroresponse against serogroups A, C, Y, and W was defined as post-vaccination hSBA titers greater than or equal to (\>=) 1:16 for participants with pre-vaccination hSBA titers less than (\<) 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. Group 3 data were presented separately. Infant series here denotes the vaccines administered at the age of 6 months of participants.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine (Mexico)
n=176 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 6, and 12 along with Prevnar 13®, Hexacima®, vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6 and MMR®II vaccine at the age of Month 12.
|
Group 2: Menveo® Vaccine (Mexico)
n=81 Participants
Participants aged 2 months (at the time of enrollment) received Menveo® vaccine at the age of Months 2, 4, 6, and 12 along with Prevnar 13®, Hexacima® vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6, and MMR®II vaccine at the age of Month 12.
|
Group 3: MenACYW Conjugate Vaccine (Russian Federation)
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 3, 6, and 12 along with Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
|
Group 4: Routine Pediatric Vaccines (Russian Federation)
Participants aged 2 months (at the time of enrollment) received Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W Following Last Vaccination With MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2 (up to the Infant Age of 6 Months)
Serogroup W
|
98.3 percentage of participants
Interval 95.1 to 99.6
|
97.5 percentage of participants
Interval 91.4 to 99.7
|
—
|
—
|
|
Percentage of Participants Achieving Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W Following Last Vaccination With MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2 (up to the Infant Age of 6 Months)
Serogroup A
|
84.7 percentage of participants
Interval 78.5 to 89.6
|
58.0 percentage of participants
Interval 46.5 to 68.9
|
—
|
—
|
|
Percentage of Participants Achieving Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W Following Last Vaccination With MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2 (up to the Infant Age of 6 Months)
Serogroup C
|
100 percentage of participants
Interval 97.9 to 100.0
|
86.4 percentage of participants
Interval 77.0 to 93.0
|
—
|
—
|
|
Percentage of Participants Achieving Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W Following Last Vaccination With MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2 (up to the Infant Age of 6 Months)
Serogroup Y
|
99.4 percentage of participants
Interval 96.9 to 100.0
|
92.6 percentage of participants
Interval 84.6 to 97.2
|
—
|
—
|
SECONDARY outcome
Timeframe: 30 days after the last vaccination at the age of 6 months of the infant series (i.e., at the age of 7 months)Population: Analysis was performed on PPAS1. Data for this outcome measure was not planned to be collected and analyzed for Group 4.
Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. The hSBA vaccine seroresponse against serogroups A, C, Y, and W was defined as post-vaccination hSBA titers \>=1:16 for participants with pre-vaccination hSBA titers \<1:8 or at least a 4-fold increase in hSBA titers from pre- to post-vaccination for participants with pre-vaccination hSBA titers \>=1:8. Infant series here denotes the vaccines administered at the age of 6 months of participants.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine (Mexico)
n=97 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 6, and 12 along with Prevnar 13®, Hexacima®, vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6 and MMR®II vaccine at the age of Month 12.
|
Group 2: Menveo® Vaccine (Mexico)
Participants aged 2 months (at the time of enrollment) received Menveo® vaccine at the age of Months 2, 4, 6, and 12 along with Prevnar 13®, Hexacima® vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6, and MMR®II vaccine at the age of Month 12.
|
Group 3: MenACYW Conjugate Vaccine (Russian Federation)
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 3, 6, and 12 along with Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
|
Group 4: Routine Pediatric Vaccines (Russian Federation)
Participants aged 2 months (at the time of enrollment) received Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W Following Last Vaccination With MenACYW Conjugate Vaccine: Group 3 (up to the Infant Age of 6 Months)
Serogroup Y
|
87.6 percentage of participants
Interval 79.4 to 93.4
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W Following Last Vaccination With MenACYW Conjugate Vaccine: Group 3 (up to the Infant Age of 6 Months)
Serogroup A
|
70.1 percentage of participants
Interval 60.0 to 79.0
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W Following Last Vaccination With MenACYW Conjugate Vaccine: Group 3 (up to the Infant Age of 6 Months)
Serogroup C
|
94.8 percentage of participants
Interval 88.4 to 98.3
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W Following Last Vaccination With MenACYW Conjugate Vaccine: Group 3 (up to the Infant Age of 6 Months)
Serogroup W
|
93.8 percentage of participants
Interval 87.0 to 97.7
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 0 (before the first vaccination with Hexacima® vaccine) of the infant series (i.e., at the age of 2 months)Population: Analysis was performed on PPAS2. Data for this outcome measure was not planned to be collected and analyzed for Groups 3 and 4.
Geometric mean concentration (GMCs) for PT and FHA were measured by electrochemiluminescent (ECL) assay. Concentration was expressed in terms of titers (1/dilution). Infant series here denotes the vaccines administered at the age of 6 months of participants.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine (Mexico)
n=126 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 6, and 12 along with Prevnar 13®, Hexacima®, vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6 and MMR®II vaccine at the age of Month 12.
|
Group 2: Menveo® Vaccine (Mexico)
n=60 Participants
Participants aged 2 months (at the time of enrollment) received Menveo® vaccine at the age of Months 2, 4, 6, and 12 along with Prevnar 13®, Hexacima® vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6, and MMR®II vaccine at the age of Month 12.
|
Group 3: MenACYW Conjugate Vaccine (Russian Federation)
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 3, 6, and 12 along with Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
|
Group 4: Routine Pediatric Vaccines (Russian Federation)
Participants aged 2 months (at the time of enrollment) received Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
|
|---|---|---|---|---|
|
Geometric Mean Concentration of Pertussis Toxoid (PT) and Filamentous Hemagglutinin (FHA) Antibodies Before Vaccination With Hexacima® Vaccine Administered Along With MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2 (up to the Infant Age of 6 Months)
PT
|
5.36 titers
Interval 4.27 to 6.73
|
8.34 titers
Interval 6.13 to 11.4
|
—
|
—
|
|
Geometric Mean Concentration of Pertussis Toxoid (PT) and Filamentous Hemagglutinin (FHA) Antibodies Before Vaccination With Hexacima® Vaccine Administered Along With MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2 (up to the Infant Age of 6 Months)
FHA
|
22.0 titers
Interval 17.2 to 28.1
|
39.9 titers
Interval 27.8 to 57.2
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 0 (before the first vaccination with RotaTeq® vaccine at the age of 2 months) and 30 days after the vaccination with RotaTeq® vaccine at the age of 6 months of the infant series (i.e., at the age of 7 months)Population: Analysis was performed on PPAS1. Data for this outcome measure was not planned to be collected and analyzed for Groups 3 and 4.
GMCs of Anti-rotavirus serum IgA antibodies were assessed using enzyme-linked immunosorbent assay (ELISA). Concentrations were measured in terms of units/milliliter (U/mL). Infant series here denotes the vaccines administered at the age of 6 months of participants.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine (Mexico)
n=176 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 6, and 12 along with Prevnar 13®, Hexacima®, vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6 and MMR®II vaccine at the age of Month 12.
|
Group 2: Menveo® Vaccine (Mexico)
n=81 Participants
Participants aged 2 months (at the time of enrollment) received Menveo® vaccine at the age of Months 2, 4, 6, and 12 along with Prevnar 13®, Hexacima® vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6, and MMR®II vaccine at the age of Month 12.
|
Group 3: MenACYW Conjugate Vaccine (Russian Federation)
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 3, 6, and 12 along with Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
|
Group 4: Routine Pediatric Vaccines (Russian Federation)
Participants aged 2 months (at the time of enrollment) received Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
|
|---|---|---|---|---|
|
Geometric Mean Concentrations of Anti-rotavirus Serum Immunoglobulin A (IgA) Antibodies Before and After RotaTeq® Vaccine Administered Alone or Along With the MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2 (up to the Infant Age of 6 Months)
At the age of 7 months
|
621 U/mL
Interval 496.0 to 776.0
|
572 U/mL
Interval 402.0 to 815.0
|
—
|
—
|
|
Geometric Mean Concentrations of Anti-rotavirus Serum Immunoglobulin A (IgA) Antibodies Before and After RotaTeq® Vaccine Administered Alone or Along With the MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2 (up to the Infant Age of 6 Months)
Day 0 (at the age of 2 months)
|
4.24 U/mL
Interval 3.84 to 4.67
|
4.91 U/mL
Interval 4.0 to 6.01
|
—
|
—
|
SECONDARY outcome
Timeframe: 30 days after the vaccination with Prevnar 13® vaccine at the age of 6 months of the infant series (i.e., at the age of 7 months)Population: Analysis was performed on PPAS1. Here, 'Number analyzed'=participants with available data for the specified categories. Data for this outcome measure was not planned to be collected and analyzed for Groups 3 and 4.
GMCs of anti-pneumococcal antibodies was assessed by electrochemiluminscent (ECL) assay. GMCs of Prevnar 13 serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F were reported. Concentration was expressed in terms of titers (1/dilution). Infant series here denotes the vaccines administered at the age of 6 months of participants.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine (Mexico)
n=176 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 6, and 12 along with Prevnar 13®, Hexacima®, vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6 and MMR®II vaccine at the age of Month 12.
|
Group 2: Menveo® Vaccine (Mexico)
n=81 Participants
Participants aged 2 months (at the time of enrollment) received Menveo® vaccine at the age of Months 2, 4, 6, and 12 along with Prevnar 13®, Hexacima® vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6, and MMR®II vaccine at the age of Month 12.
|
Group 3: MenACYW Conjugate Vaccine (Russian Federation)
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 3, 6, and 12 along with Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
|
Group 4: Routine Pediatric Vaccines (Russian Federation)
Participants aged 2 months (at the time of enrollment) received Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
|
|---|---|---|---|---|
|
Geometric Mean Concentration of Anti-pneumococcal Antibodies After Prevnar 13® Vaccine Administered Alone or Along With the MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2 (up to the Infant Age of 6 Months)
Serotype 1
|
3.28 titers
Interval 2.95 to 3.64
|
2.75 titers
Interval 2.34 to 3.24
|
—
|
—
|
|
Geometric Mean Concentration of Anti-pneumococcal Antibodies After Prevnar 13® Vaccine Administered Alone or Along With the MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2 (up to the Infant Age of 6 Months)
Serotype 3
|
0.607 titers
Interval 0.553 to 0.665
|
0.498 titers
Interval 0.436 to 0.569
|
—
|
—
|
|
Geometric Mean Concentration of Anti-pneumococcal Antibodies After Prevnar 13® Vaccine Administered Alone or Along With the MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2 (up to the Infant Age of 6 Months)
Serotype 4
|
1.90 titers
Interval 1.73 to 2.08
|
1.63 titers
Interval 1.42 to 1.86
|
—
|
—
|
|
Geometric Mean Concentration of Anti-pneumococcal Antibodies After Prevnar 13® Vaccine Administered Alone or Along With the MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2 (up to the Infant Age of 6 Months)
Serotype 5
|
2.26 titers
Interval 2.04 to 2.52
|
1.91 titers
Interval 1.65 to 2.21
|
—
|
—
|
|
Geometric Mean Concentration of Anti-pneumococcal Antibodies After Prevnar 13® Vaccine Administered Alone or Along With the MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2 (up to the Infant Age of 6 Months)
Serotype 6A
|
4.57 titers
Interval 4.13 to 5.05
|
3.76 titers
Interval 3.3 to 4.29
|
—
|
—
|
|
Geometric Mean Concentration of Anti-pneumococcal Antibodies After Prevnar 13® Vaccine Administered Alone or Along With the MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2 (up to the Infant Age of 6 Months)
Serotype 6B
|
2.64 titers
Interval 2.3 to 3.03
|
1.96 titers
Interval 1.63 to 2.34
|
—
|
—
|
|
Geometric Mean Concentration of Anti-pneumococcal Antibodies After Prevnar 13® Vaccine Administered Alone or Along With the MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2 (up to the Infant Age of 6 Months)
Serotype 7F
|
3.97 titers
Interval 3.64 to 4.33
|
3.62 titers
Interval 3.21 to 4.08
|
—
|
—
|
|
Geometric Mean Concentration of Anti-pneumococcal Antibodies After Prevnar 13® Vaccine Administered Alone or Along With the MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2 (up to the Infant Age of 6 Months)
Serotype 9V
|
2.33 titers
Interval 2.11 to 2.57
|
1.99 titers
Interval 1.72 to 2.31
|
—
|
—
|
|
Geometric Mean Concentration of Anti-pneumococcal Antibodies After Prevnar 13® Vaccine Administered Alone or Along With the MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2 (up to the Infant Age of 6 Months)
Serotype 14
|
9.36 titers
Interval 8.47 to 10.3
|
9.72 titers
Interval 8.18 to 11.5
|
—
|
—
|
|
Geometric Mean Concentration of Anti-pneumococcal Antibodies After Prevnar 13® Vaccine Administered Alone or Along With the MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2 (up to the Infant Age of 6 Months)
Serotype 18C
|
2.24 titers
Interval 2.06 to 2.45
|
1.71 titers
Interval 1.49 to 1.97
|
—
|
—
|
|
Geometric Mean Concentration of Anti-pneumococcal Antibodies After Prevnar 13® Vaccine Administered Alone or Along With the MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2 (up to the Infant Age of 6 Months)
Serotype 19A
|
2.45 titers
Interval 2.19 to 2.74
|
1.95 titers
Interval 1.72 to 2.21
|
—
|
—
|
|
Geometric Mean Concentration of Anti-pneumococcal Antibodies After Prevnar 13® Vaccine Administered Alone or Along With the MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2 (up to the Infant Age of 6 Months)
Serotype 19F
|
3.55 titers
Interval 3.2 to 3.94
|
2.83 titers
Interval 2.42 to 3.32
|
—
|
—
|
|
Geometric Mean Concentration of Anti-pneumococcal Antibodies After Prevnar 13® Vaccine Administered Alone or Along With the MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2 (up to the Infant Age of 6 Months)
Serotype 23F
|
2.05 titers
Interval 1.79 to 2.34
|
1.61 titers
Interval 1.38 to 1.88
|
—
|
—
|
SECONDARY outcome
Timeframe: 30 days after the vaccination with Prevnar 13® vaccine at the age of 6 months of the infant series (i.e., at the age of 7 months)Population: Analysis was performed on PPAS1. Here, 'Number analyzed'=participants with available data for specified categories. Data for this outcome measure was not planned to be collected and analyzed for Groups 3 and 4.
Percentage of participants with anti-pneumococcal antibody concentrations \>=0.35 micrograms per milliliter (mcg/mL) and \>=1.0 mcg/mL for Prevnar 13 serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F was reported in this outcome measure. Infant series here denotes the vaccines administered at the age of 6 months of participants.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine (Mexico)
n=176 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 6, and 12 along with Prevnar 13®, Hexacima®, vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6 and MMR®II vaccine at the age of Month 12.
|
Group 2: Menveo® Vaccine (Mexico)
n=81 Participants
Participants aged 2 months (at the time of enrollment) received Menveo® vaccine at the age of Months 2, 4, 6, and 12 along with Prevnar 13®, Hexacima® vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6, and MMR®II vaccine at the age of Month 12.
|
Group 3: MenACYW Conjugate Vaccine (Russian Federation)
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 3, 6, and 12 along with Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
|
Group 4: Routine Pediatric Vaccines (Russian Federation)
Participants aged 2 months (at the time of enrollment) received Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
|
|---|---|---|---|---|
|
Percentage of Participants With Anti-pneumococcal Antibody Concentrations (>=0.35 mcg/mL and >=1.0 mcg/mL) After Prevnar 13® Vaccine Administered Alone or Along With MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2 (up to the Infant Age of 6 Months)
Serotype 6B: >=0.35 mcg/mL
|
97.7 percentage of participants
Interval 94.3 to 99.4
|
98.8 percentage of participants
Interval 93.3 to 100.0
|
—
|
—
|
|
Percentage of Participants With Anti-pneumococcal Antibody Concentrations (>=0.35 mcg/mL and >=1.0 mcg/mL) After Prevnar 13® Vaccine Administered Alone or Along With MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2 (up to the Infant Age of 6 Months)
Serotype 7F: >=0.35 mcg/mL
|
100 percentage of participants
Interval 97.9 to 100.0
|
100 percentage of participants
Interval 95.5 to 100.0
|
—
|
—
|
|
Percentage of Participants With Anti-pneumococcal Antibody Concentrations (>=0.35 mcg/mL and >=1.0 mcg/mL) After Prevnar 13® Vaccine Administered Alone or Along With MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2 (up to the Infant Age of 6 Months)
Serotype 9V: >=0.35 mcg/mL
|
100 percentage of participants
Interval 97.9 to 100.0
|
100 percentage of participants
Interval 95.5 to 100.0
|
—
|
—
|
|
Percentage of Participants With Anti-pneumococcal Antibody Concentrations (>=0.35 mcg/mL and >=1.0 mcg/mL) After Prevnar 13® Vaccine Administered Alone or Along With MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2 (up to the Infant Age of 6 Months)
Serotype 23F: >=0.35 mcg/mL
|
96.0 percentage of participants
Interval 91.9 to 98.4
|
96.3 percentage of participants
Interval 89.6 to 99.2
|
—
|
—
|
|
Percentage of Participants With Anti-pneumococcal Antibody Concentrations (>=0.35 mcg/mL and >=1.0 mcg/mL) After Prevnar 13® Vaccine Administered Alone or Along With MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2 (up to the Infant Age of 6 Months)
Serotype 1: >=1.0 mcg/mL
|
95.4 percentage of participants
Interval 91.2 to 98.0
|
95.1 percentage of participants
Interval 87.8 to 98.6
|
—
|
—
|
|
Percentage of Participants With Anti-pneumococcal Antibody Concentrations (>=0.35 mcg/mL and >=1.0 mcg/mL) After Prevnar 13® Vaccine Administered Alone or Along With MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2 (up to the Infant Age of 6 Months)
Serotype 14: >=1.0 mcg/mL
|
98.9 percentage of participants
Interval 95.9 to 99.9
|
100 percentage of participants
Interval 95.5 to 100.0
|
—
|
—
|
|
Percentage of Participants With Anti-pneumococcal Antibody Concentrations (>=0.35 mcg/mL and >=1.0 mcg/mL) After Prevnar 13® Vaccine Administered Alone or Along With MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2 (up to the Infant Age of 6 Months)
Serotype 19F: >=1.0 mcg/mL
|
97.7 percentage of participants
Interval 94.3 to 99.4
|
98.8 percentage of participants
Interval 93.3 to 100.0
|
—
|
—
|
|
Percentage of Participants With Anti-pneumococcal Antibody Concentrations (>=0.35 mcg/mL and >=1.0 mcg/mL) After Prevnar 13® Vaccine Administered Alone or Along With MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2 (up to the Infant Age of 6 Months)
Serotype 1: >=0.35 mcg/mL
|
100 percentage of participants
Interval 97.9 to 100.0
|
100 percentage of participants
Interval 95.5 to 100.0
|
—
|
—
|
|
Percentage of Participants With Anti-pneumococcal Antibody Concentrations (>=0.35 mcg/mL and >=1.0 mcg/mL) After Prevnar 13® Vaccine Administered Alone or Along With MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2 (up to the Infant Age of 6 Months)
Serotype 3: >=0.35 mcg/mL
|
81.7 percentage of participants
Interval 75.2 to 87.1
|
74.1 percentage of participants
Interval 63.1 to 83.2
|
—
|
—
|
|
Percentage of Participants With Anti-pneumococcal Antibody Concentrations (>=0.35 mcg/mL and >=1.0 mcg/mL) After Prevnar 13® Vaccine Administered Alone or Along With MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2 (up to the Infant Age of 6 Months)
Serotype 4: >=0.35 mcg/mL
|
99.4 percentage of participants
Interval 96.9 to 100.0
|
98.8 percentage of participants
Interval 93.3 to 100.0
|
—
|
—
|
|
Percentage of Participants With Anti-pneumococcal Antibody Concentrations (>=0.35 mcg/mL and >=1.0 mcg/mL) After Prevnar 13® Vaccine Administered Alone or Along With MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2 (up to the Infant Age of 6 Months)
Serotype 5: >=0.35 mcg/mL
|
99.4 percentage of participants
Interval 96.9 to 100.0
|
100 percentage of participants
Interval 95.5 to 100.0
|
—
|
—
|
|
Percentage of Participants With Anti-pneumococcal Antibody Concentrations (>=0.35 mcg/mL and >=1.0 mcg/mL) After Prevnar 13® Vaccine Administered Alone or Along With MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2 (up to the Infant Age of 6 Months)
Serotype 6A: >=0.35 mcg/mL
|
100 percentage of participants
Interval 97.9 to 100.0
|
100 percentage of participants
Interval 95.5 to 100.0
|
—
|
—
|
|
Percentage of Participants With Anti-pneumococcal Antibody Concentrations (>=0.35 mcg/mL and >=1.0 mcg/mL) After Prevnar 13® Vaccine Administered Alone or Along With MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2 (up to the Infant Age of 6 Months)
Serotype 14: >=0.35 mcg/mL
|
100 percentage of participants
Interval 97.9 to 100.0
|
100 percentage of participants
Interval 95.5 to 100.0
|
—
|
—
|
|
Percentage of Participants With Anti-pneumococcal Antibody Concentrations (>=0.35 mcg/mL and >=1.0 mcg/mL) After Prevnar 13® Vaccine Administered Alone or Along With MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2 (up to the Infant Age of 6 Months)
Serotype 18C: >=0.35 mcg/mL
|
100 percentage of participants
Interval 97.9 to 100.0
|
97.5 percentage of participants
Interval 91.4 to 99.7
|
—
|
—
|
|
Percentage of Participants With Anti-pneumococcal Antibody Concentrations (>=0.35 mcg/mL and >=1.0 mcg/mL) After Prevnar 13® Vaccine Administered Alone or Along With MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2 (up to the Infant Age of 6 Months)
Serotype 19A: >=0.35 mcg/mL
|
99.4 percentage of participants
Interval 96.9 to 100.0
|
100 percentage of participants
Interval 95.5 to 100.0
|
—
|
—
|
|
Percentage of Participants With Anti-pneumococcal Antibody Concentrations (>=0.35 mcg/mL and >=1.0 mcg/mL) After Prevnar 13® Vaccine Administered Alone or Along With MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2 (up to the Infant Age of 6 Months)
Serotype 19F: >=0.35 mcg/mL
|
99.4 percentage of participants
Interval 96.9 to 100.0
|
98.8 percentage of participants
Interval 93.3 to 100.0
|
—
|
—
|
|
Percentage of Participants With Anti-pneumococcal Antibody Concentrations (>=0.35 mcg/mL and >=1.0 mcg/mL) After Prevnar 13® Vaccine Administered Alone or Along With MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2 (up to the Infant Age of 6 Months)
Serotype 3: >=1.0 mcg/mL
|
20.0 percentage of participants
Interval 14.3 to 26.7
|
14.8 percentage of participants
Interval 7.9 to 24.4
|
—
|
—
|
|
Percentage of Participants With Anti-pneumococcal Antibody Concentrations (>=0.35 mcg/mL and >=1.0 mcg/mL) After Prevnar 13® Vaccine Administered Alone or Along With MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2 (up to the Infant Age of 6 Months)
Serotype 4: >=1.0 mcg/mL
|
84.0 percentage of participants
Interval 77.7 to 89.1
|
79.0 percentage of participants
Interval 68.5 to 87.3
|
—
|
—
|
|
Percentage of Participants With Anti-pneumococcal Antibody Concentrations (>=0.35 mcg/mL and >=1.0 mcg/mL) After Prevnar 13® Vaccine Administered Alone or Along With MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2 (up to the Infant Age of 6 Months)
Serotype 5: >=1.0 mcg/mL
|
88.6 percentage of participants
Interval 82.9 to 92.9
|
81.5 percentage of participants
Interval 71.3 to 89.2
|
—
|
—
|
|
Percentage of Participants With Anti-pneumococcal Antibody Concentrations (>=0.35 mcg/mL and >=1.0 mcg/mL) After Prevnar 13® Vaccine Administered Alone or Along With MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2 (up to the Infant Age of 6 Months)
Serotype 6A: >=1.0 mcg/mL
|
96.6 percentage of participants
Interval 92.7 to 98.7
|
96.3 percentage of participants
Interval 89.6 to 99.2
|
—
|
—
|
|
Percentage of Participants With Anti-pneumococcal Antibody Concentrations (>=0.35 mcg/mL and >=1.0 mcg/mL) After Prevnar 13® Vaccine Administered Alone or Along With MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2 (up to the Infant Age of 6 Months)
Serotype 6B: >=1.0 mcg/mL
|
88.6 percentage of participants
Interval 82.9 to 92.9
|
81.5 percentage of participants
Interval 71.3 to 89.2
|
—
|
—
|
|
Percentage of Participants With Anti-pneumococcal Antibody Concentrations (>=0.35 mcg/mL and >=1.0 mcg/mL) After Prevnar 13® Vaccine Administered Alone or Along With MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2 (up to the Infant Age of 6 Months)
Serotype 7F: >=1.0 mcg/mL
|
99.4 percentage of participants
Interval 96.9 to 100.0
|
100 percentage of participants
Interval 95.5 to 100.0
|
—
|
—
|
|
Percentage of Participants With Anti-pneumococcal Antibody Concentrations (>=0.35 mcg/mL and >=1.0 mcg/mL) After Prevnar 13® Vaccine Administered Alone or Along With MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2 (up to the Infant Age of 6 Months)
Serotype 9V: >=1.0 mcg/mL
|
86.9 percentage of participants
Interval 80.9 to 91.5
|
85.2 percentage of participants
Interval 75.6 to 92.1
|
—
|
—
|
|
Percentage of Participants With Anti-pneumococcal Antibody Concentrations (>=0.35 mcg/mL and >=1.0 mcg/mL) After Prevnar 13® Vaccine Administered Alone or Along With MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2 (up to the Infant Age of 6 Months)
Serotype 18C: >=1.0 mcg/mL
|
90.9 percentage of participants
Interval 85.6 to 94.7
|
81.5 percentage of participants
Interval 71.3 to 89.2
|
—
|
—
|
|
Percentage of Participants With Anti-pneumococcal Antibody Concentrations (>=0.35 mcg/mL and >=1.0 mcg/mL) After Prevnar 13® Vaccine Administered Alone or Along With MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2 (up to the Infant Age of 6 Months)
Serotype 19A: >=1.0 mcg/mL
|
86.9 percentage of participants
Interval 80.9 to 91.5
|
84.0 percentage of participants
Interval 74.1 to 91.2
|
—
|
—
|
|
Percentage of Participants With Anti-pneumococcal Antibody Concentrations (>=0.35 mcg/mL and >=1.0 mcg/mL) After Prevnar 13® Vaccine Administered Alone or Along With MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2 (up to the Infant Age of 6 Months)
Serotype 23F: >=1.0 mcg/mL
|
81.1 percentage of participants
Interval 74.5 to 86.6
|
79.0 percentage of participants
Interval 68.5 to 87.3
|
—
|
—
|
SECONDARY outcome
Timeframe: From Day 0 (before the first vaccination with RotaTeq® vaccine at the age of 2 months), 30 days after the vaccination with RotaTeq® vaccine at the age of 6 months of the infant series (i.e., at the age of 7 months)Population: Analysis was performed on PPAS1. Data for this outcome measure was not planned to be collected and analyzed for Groups 3 and 4.
Anti-rotavirus IgA antibodies in human serum was measured by ELISA. Fold-rise was calculated as ratio of post-vaccination titer (i.e., 30 days after 6-months vaccination) to pre-dose titer at age of 2 months (i.e., Day 0). Infant series here denotes the vaccines administered at the age of 6 months of participants.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine (Mexico)
n=176 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 6, and 12 along with Prevnar 13®, Hexacima®, vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6 and MMR®II vaccine at the age of Month 12.
|
Group 2: Menveo® Vaccine (Mexico)
n=81 Participants
Participants aged 2 months (at the time of enrollment) received Menveo® vaccine at the age of Months 2, 4, 6, and 12 along with Prevnar 13®, Hexacima® vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6, and MMR®II vaccine at the age of Month 12.
|
Group 3: MenACYW Conjugate Vaccine (Russian Federation)
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 3, 6, and 12 along with Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
|
Group 4: Routine Pediatric Vaccines (Russian Federation)
Participants aged 2 months (at the time of enrollment) received Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
|
|---|---|---|---|---|
|
Percentage of Participants With >=3-fold and >=4-fold Rise in Anti-rotavirus Serum IgA Antibody Concentrations After RotaTeq® Vaccine Administered Alone or Along With MenACYW Conjugate or Menveo® Vaccine: Groups 1 & 2 (up to the Infant Age of 6 Months)
>=3-fold rise
|
93.8 percentage of participants
Interval 89.1 to 96.8
|
91.4 percentage of participants
Interval 83.0 to 96.5
|
—
|
—
|
|
Percentage of Participants With >=3-fold and >=4-fold Rise in Anti-rotavirus Serum IgA Antibody Concentrations After RotaTeq® Vaccine Administered Alone or Along With MenACYW Conjugate or Menveo® Vaccine: Groups 1 & 2 (up to the Infant Age of 6 Months)
>=4-fold rise
|
93.8 percentage of participants
Interval 89.1 to 96.8
|
88.9 percentage of participants
Interval 80.0 to 94.8
|
—
|
—
|
SECONDARY outcome
Timeframe: 30 days after the vaccination with M-M-R®II vaccine at the age of 12 months (i.e., at the age of 13 months)Population: Analysis was performed on PPAS2. Here, "overall number of participants analyzed" signifies participants with available data for this outcome measure and 'Number analyzed'=participants with available data for each specified category.
GMTs against anti-measles and anti-rubella antibodies were measured by Bulk Measles immunoglobulin G (IgG) Enzyme Immunoassay (EIA) and anti-mumps antibodies were assessed by ELISA. Titers were expressed in terms of 1/dilution.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine (Mexico)
n=125 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 6, and 12 along with Prevnar 13®, Hexacima®, vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6 and MMR®II vaccine at the age of Month 12.
|
Group 2: Menveo® Vaccine (Mexico)
n=60 Participants
Participants aged 2 months (at the time of enrollment) received Menveo® vaccine at the age of Months 2, 4, 6, and 12 along with Prevnar 13®, Hexacima® vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6, and MMR®II vaccine at the age of Month 12.
|
Group 3: MenACYW Conjugate Vaccine (Russian Federation)
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 3, 6, and 12 along with Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
|
Group 4: Routine Pediatric Vaccines (Russian Federation)
Participants aged 2 months (at the time of enrollment) received Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
|
|---|---|---|---|---|
|
Geometric Mean Titers (GMTs) of MMR Antibodies Following Vaccination With M-M-R®II Vaccine Administered Alone or Along With the MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2
Anti-Mumps
|
130 titers
Interval 114.0 to 149.0
|
109 titers
Interval 83.7 to 142.0
|
—
|
—
|
|
Geometric Mean Titers (GMTs) of MMR Antibodies Following Vaccination With M-M-R®II Vaccine Administered Alone or Along With the MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2
Anti-Rubella
|
117 titers
Interval 104.0 to 132.0
|
117 titers
Interval 100.0 to 136.0
|
—
|
—
|
|
Geometric Mean Titers (GMTs) of MMR Antibodies Following Vaccination With M-M-R®II Vaccine Administered Alone or Along With the MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2
Anti-Measles
|
5256 titers
Interval 4718.0 to 5855.0
|
5679 titers
Interval 5120.0 to 6299.0
|
—
|
—
|
SECONDARY outcome
Timeframe: 30 days after the vaccination with Prevnar13® vaccine at the age of 12 months (i.e., at the age of 13 months)Population: Analysis was performed on PPAS2. Here, "overall number of participants analyzed" signifies participants with available data for this outcome measure. Data for this outcome measure was not planned to be collected and analyzed for Groups 3 and 4.
GMCs against Streptococcus pneumoniae polysaccharide (PS) serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F were measured by ECL assay. Concentration was expressed in terms of titers (1/dilution).
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine (Mexico)
n=125 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 6, and 12 along with Prevnar 13®, Hexacima®, vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6 and MMR®II vaccine at the age of Month 12.
|
Group 2: Menveo® Vaccine (Mexico)
n=60 Participants
Participants aged 2 months (at the time of enrollment) received Menveo® vaccine at the age of Months 2, 4, 6, and 12 along with Prevnar 13®, Hexacima® vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6, and MMR®II vaccine at the age of Month 12.
|
Group 3: MenACYW Conjugate Vaccine (Russian Federation)
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 3, 6, and 12 along with Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
|
Group 4: Routine Pediatric Vaccines (Russian Federation)
Participants aged 2 months (at the time of enrollment) received Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
|
|---|---|---|---|---|
|
Geometric Mean Concentration of Anti-pneumococcal Antibodies Following Vaccination With Prevnar 13® Vaccine Administered Alone or Along With the MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2
Serotype 5
|
2.48 titers
Interval 2.09 to 2.95
|
2.18 titers
Interval 1.73 to 2.74
|
—
|
—
|
|
Geometric Mean Concentration of Anti-pneumococcal Antibodies Following Vaccination With Prevnar 13® Vaccine Administered Alone or Along With the MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2
Serotype 7F
|
3.79 titers
Interval 3.21 to 4.48
|
3.91 titers
Interval 3.12 to 4.91
|
—
|
—
|
|
Geometric Mean Concentration of Anti-pneumococcal Antibodies Following Vaccination With Prevnar 13® Vaccine Administered Alone or Along With the MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2
Serotype 18C
|
2.35 titers
Interval 1.97 to 2.82
|
1.79 titers
Interval 1.35 to 2.39
|
—
|
—
|
|
Geometric Mean Concentration of Anti-pneumococcal Antibodies Following Vaccination With Prevnar 13® Vaccine Administered Alone or Along With the MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2
Serotype 19A
|
4.13 titers
Interval 3.35 to 5.09
|
4.18 titers
Interval 3.16 to 5.53
|
—
|
—
|
|
Geometric Mean Concentration of Anti-pneumococcal Antibodies Following Vaccination With Prevnar 13® Vaccine Administered Alone or Along With the MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2
Serotype 19F
|
4.15 titers
Interval 3.41 to 5.05
|
3.84 titers
Interval 2.8 to 5.25
|
—
|
—
|
|
Geometric Mean Concentration of Anti-pneumococcal Antibodies Following Vaccination With Prevnar 13® Vaccine Administered Alone or Along With the MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2
Serotype 23F
|
3.13 titers
Interval 2.52 to 3.9
|
2.53 titers
Interval 1.8 to 3.56
|
—
|
—
|
|
Geometric Mean Concentration of Anti-pneumococcal Antibodies Following Vaccination With Prevnar 13® Vaccine Administered Alone or Along With the MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2
Serotype 1
|
2.96 titers
Interval 2.49 to 3.52
|
2.74 titers
Interval 2.1 to 3.57
|
—
|
—
|
|
Geometric Mean Concentration of Anti-pneumococcal Antibodies Following Vaccination With Prevnar 13® Vaccine Administered Alone or Along With the MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2
Serotype 3
|
0.504 titers
Interval 0.431 to 0.59
|
0.518 titers
Interval 0.398 to 0.674
|
—
|
—
|
|
Geometric Mean Concentration of Anti-pneumococcal Antibodies Following Vaccination With Prevnar 13® Vaccine Administered Alone or Along With the MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2
Serotype 4
|
1.59 titers
Interval 1.32 to 1.93
|
1.36 titers
Interval 1.04 to 1.79
|
—
|
—
|
|
Geometric Mean Concentration of Anti-pneumococcal Antibodies Following Vaccination With Prevnar 13® Vaccine Administered Alone or Along With the MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2
Serotype 6A
|
7.22 titers
Interval 5.92 to 8.8
|
5.85 titers
Interval 4.33 to 7.91
|
—
|
—
|
|
Geometric Mean Concentration of Anti-pneumococcal Antibodies Following Vaccination With Prevnar 13® Vaccine Administered Alone or Along With the MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2
Serotype 6B
|
4.89 titers
Interval 3.96 to 6.03
|
4.06 titers
Interval 3.03 to 5.46
|
—
|
—
|
|
Geometric Mean Concentration of Anti-pneumococcal Antibodies Following Vaccination With Prevnar 13® Vaccine Administered Alone or Along With the MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2
Serotype 9V
|
2.59 titers
Interval 2.14 to 3.14
|
2.31 titers
Interval 1.76 to 3.03
|
—
|
—
|
|
Geometric Mean Concentration of Anti-pneumococcal Antibodies Following Vaccination With Prevnar 13® Vaccine Administered Alone or Along With the MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2
Serotype 14
|
7.55 titers
Interval 6.18 to 9.22
|
7.47 titers
Interval 5.72 to 9.74
|
—
|
—
|
SECONDARY outcome
Timeframe: 30 days after the vaccination with Prevnar 13® vaccine at the age of 12 months (i.e., at the age of 13 months)Population: Analysis was performed on PPAS2. Here, "overall number of participants analyzed" = participants with available data for this outcome measure. Data for this outcome measure was not planned to be collected and analyzed for Groups 3 and 4.
Percentage of participants with anti-pneumococcal antibody concentrations \>=0.35 mcg/mL and \>=1.0 mcg/mL for Prevnar 13 serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F was reported in this outcome measure.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine (Mexico)
n=125 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 6, and 12 along with Prevnar 13®, Hexacima®, vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6 and MMR®II vaccine at the age of Month 12.
|
Group 2: Menveo® Vaccine (Mexico)
n=60 Participants
Participants aged 2 months (at the time of enrollment) received Menveo® vaccine at the age of Months 2, 4, 6, and 12 along with Prevnar 13®, Hexacima® vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6, and MMR®II vaccine at the age of Month 12.
|
Group 3: MenACYW Conjugate Vaccine (Russian Federation)
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 3, 6, and 12 along with Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
|
Group 4: Routine Pediatric Vaccines (Russian Federation)
Participants aged 2 months (at the time of enrollment) received Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
|
|---|---|---|---|---|
|
Percentage of Participants With Anti-pneumococcal Antibody Concentrations (>=0.35 mcg/mL and >=1.0 mcg/mL) Following Vaccination With Prevnar13® Vaccine Administered Alone or Along With the MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2
Serotype 1: >=0.35 mcg/mL
|
97.6 percentage of participants
Interval 93.1 to 99.5
|
98.3 percentage of participants
Interval 91.1 to 100.0
|
—
|
—
|
|
Percentage of Participants With Anti-pneumococcal Antibody Concentrations (>=0.35 mcg/mL and >=1.0 mcg/mL) Following Vaccination With Prevnar13® Vaccine Administered Alone or Along With the MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2
Serotype 4: >=0.35 mcg/mL
|
90.4 percentage of participants
Interval 83.8 to 94.9
|
86.7 percentage of participants
Interval 75.4 to 94.1
|
—
|
—
|
|
Percentage of Participants With Anti-pneumococcal Antibody Concentrations (>=0.35 mcg/mL and >=1.0 mcg/mL) Following Vaccination With Prevnar13® Vaccine Administered Alone or Along With the MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2
Serotype 1: >=1.0 mcg/mL
|
84.0 percentage of participants
Interval 76.4 to 89.9
|
80.0 percentage of participants
Interval 67.7 to 89.2
|
—
|
—
|
|
Percentage of Participants With Anti-pneumococcal Antibody Concentrations (>=0.35 mcg/mL and >=1.0 mcg/mL) Following Vaccination With Prevnar13® Vaccine Administered Alone or Along With the MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2
Serotype 3: >=1.0 mcg/mL
|
20.0 percentage of participants
Interval 13.4 to 28.1
|
25.0 percentage of participants
Interval 14.7 to 37.9
|
—
|
—
|
|
Percentage of Participants With Anti-pneumococcal Antibody Concentrations (>=0.35 mcg/mL and >=1.0 mcg/mL) Following Vaccination With Prevnar13® Vaccine Administered Alone or Along With the MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2
Serotype 4: >=1.0 mcg/mL
|
72.0 percentage of participants
Interval 63.3 to 79.7
|
65.0 percentage of participants
Interval 51.6 to 76.9
|
—
|
—
|
|
Percentage of Participants With Anti-pneumococcal Antibody Concentrations (>=0.35 mcg/mL and >=1.0 mcg/mL) Following Vaccination With Prevnar13® Vaccine Administered Alone or Along With the MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2
Serotype 3: >=0.35 mcg/mL
|
68.8 percentage of participants
Interval 59.9 to 76.8
|
66.7 percentage of participants
Interval 53.3 to 78.3
|
—
|
—
|
|
Percentage of Participants With Anti-pneumococcal Antibody Concentrations (>=0.35 mcg/mL and >=1.0 mcg/mL) Following Vaccination With Prevnar13® Vaccine Administered Alone or Along With the MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2
Serotype 5: >=0.35 mcg/mL
|
95.2 percentage of participants
Interval 89.8 to 98.2
|
96.7 percentage of participants
Interval 88.5 to 99.6
|
—
|
—
|
|
Percentage of Participants With Anti-pneumococcal Antibody Concentrations (>=0.35 mcg/mL and >=1.0 mcg/mL) Following Vaccination With Prevnar13® Vaccine Administered Alone or Along With the MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2
Serotype 6A: >=0.35 mcg/mL
|
98.4 percentage of participants
Interval 94.3 to 99.8
|
100 percentage of participants
Interval 94.0 to 100.0
|
—
|
—
|
|
Percentage of Participants With Anti-pneumococcal Antibody Concentrations (>=0.35 mcg/mL and >=1.0 mcg/mL) Following Vaccination With Prevnar13® Vaccine Administered Alone or Along With the MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2
Serotype 6B: >=0.35 mcg/mL
|
95.2 percentage of participants
Interval 89.8 to 98.2
|
93.3 percentage of participants
Interval 83.8 to 98.2
|
—
|
—
|
|
Percentage of Participants With Anti-pneumococcal Antibody Concentrations (>=0.35 mcg/mL and >=1.0 mcg/mL) Following Vaccination With Prevnar13® Vaccine Administered Alone or Along With the MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2
Serotype 7F: >=0.35 mcg/mL
|
99.2 percentage of participants
Interval 95.6 to 100.0
|
100 percentage of participants
Interval 94.0 to 100.0
|
—
|
—
|
|
Percentage of Participants With Anti-pneumococcal Antibody Concentrations (>=0.35 mcg/mL and >=1.0 mcg/mL) Following Vaccination With Prevnar13® Vaccine Administered Alone or Along With the MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2
Serotype 9V: >=0.35 mcg/mL
|
93.6 percentage of participants
Interval 87.8 to 97.2
|
90.0 percentage of participants
Interval 79.5 to 96.2
|
—
|
—
|
|
Percentage of Participants With Anti-pneumococcal Antibody Concentrations (>=0.35 mcg/mL and >=1.0 mcg/mL) Following Vaccination With Prevnar13® Vaccine Administered Alone or Along With the MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2
Serotype 14: >=0.35 mcg/mL
|
99.2 percentage of participants
Interval 95.6 to 100.0
|
98.3 percentage of participants
Interval 91.1 to 100.0
|
—
|
—
|
|
Percentage of Participants With Anti-pneumococcal Antibody Concentrations (>=0.35 mcg/mL and >=1.0 mcg/mL) Following Vaccination With Prevnar13® Vaccine Administered Alone or Along With the MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2
Serotype 18C: >=0.35 mcg/mL
|
93.6 percentage of participants
Interval 87.8 to 97.2
|
85.0 percentage of participants
Interval 73.4 to 92.9
|
—
|
—
|
|
Percentage of Participants With Anti-pneumococcal Antibody Concentrations (>=0.35 mcg/mL and >=1.0 mcg/mL) Following Vaccination With Prevnar13® Vaccine Administered Alone or Along With the MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2
Serotype 19A: >=0.35 mcg/mL
|
96.0 percentage of participants
Interval 90.9 to 98.7
|
100 percentage of participants
Interval 94.0 to 100.0
|
—
|
—
|
|
Percentage of Participants With Anti-pneumococcal Antibody Concentrations (>=0.35 mcg/mL and >=1.0 mcg/mL) Following Vaccination With Prevnar13® Vaccine Administered Alone or Along With the MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2
Serotype 19F: >=0.35 mcg/mL
|
97.6 percentage of participants
Interval 93.1 to 99.5
|
91.7 percentage of participants
Interval 81.6 to 97.2
|
—
|
—
|
|
Percentage of Participants With Anti-pneumococcal Antibody Concentrations (>=0.35 mcg/mL and >=1.0 mcg/mL) Following Vaccination With Prevnar13® Vaccine Administered Alone or Along With the MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2
Serotype 23F: >=0.35 mcg/mL
|
93.6 percentage of participants
Interval 87.8 to 97.2
|
90.0 percentage of participants
Interval 79.5 to 96.2
|
—
|
—
|
|
Percentage of Participants With Anti-pneumococcal Antibody Concentrations (>=0.35 mcg/mL and >=1.0 mcg/mL) Following Vaccination With Prevnar13® Vaccine Administered Alone or Along With the MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2
Serotype 5: >=1.0 mcg/mL
|
84.8 percentage of participants
Interval 77.3 to 90.6
|
81.7 percentage of participants
Interval 69.6 to 90.5
|
—
|
—
|
|
Percentage of Participants With Anti-pneumococcal Antibody Concentrations (>=0.35 mcg/mL and >=1.0 mcg/mL) Following Vaccination With Prevnar13® Vaccine Administered Alone or Along With the MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2
Serotype 6A: >=1.0 mcg/mL
|
90.4 percentage of participants
Interval 83.8 to 94.9
|
86.7 percentage of participants
Interval 75.4 to 94.1
|
—
|
—
|
|
Percentage of Participants With Anti-pneumococcal Antibody Concentrations (>=0.35 mcg/mL and >=1.0 mcg/mL) Following Vaccination With Prevnar13® Vaccine Administered Alone or Along With the MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2
Serotype 6B: >=1.0 mcg/mL
|
88.8 percentage of participants
Interval 81.9 to 93.7
|
86.7 percentage of participants
Interval 75.4 to 94.1
|
—
|
—
|
|
Percentage of Participants With Anti-pneumococcal Antibody Concentrations (>=0.35 mcg/mL and >=1.0 mcg/mL) Following Vaccination With Prevnar13® Vaccine Administered Alone or Along With the MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2
Serotype 7F: >=1.0 mcg/mL
|
90.4 percentage of participants
Interval 83.8 to 94.9
|
90.0 percentage of participants
Interval 79.5 to 96.2
|
—
|
—
|
|
Percentage of Participants With Anti-pneumococcal Antibody Concentrations (>=0.35 mcg/mL and >=1.0 mcg/mL) Following Vaccination With Prevnar13® Vaccine Administered Alone or Along With the MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2
Serotype 9V: >=1.0 mcg/mL
|
80.8 percentage of participants
Interval 72.8 to 87.3
|
80.0 percentage of participants
Interval 67.7 to 89.2
|
—
|
—
|
|
Percentage of Participants With Anti-pneumococcal Antibody Concentrations (>=0.35 mcg/mL and >=1.0 mcg/mL) Following Vaccination With Prevnar13® Vaccine Administered Alone or Along With the MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2
Serotype 14: >=1.0 mcg/mL
|
94.4 percentage of participants
Interval 88.8 to 97.7
|
96.7 percentage of participants
Interval 88.5 to 99.6
|
—
|
—
|
|
Percentage of Participants With Anti-pneumococcal Antibody Concentrations (>=0.35 mcg/mL and >=1.0 mcg/mL) Following Vaccination With Prevnar13® Vaccine Administered Alone or Along With the MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2
Serotype 18C: >=1.0 mcg/mL
|
82.4 percentage of participants
Interval 74.6 to 88.6
|
78.3 percentage of participants
Interval 65.8 to 87.9
|
—
|
—
|
|
Percentage of Participants With Anti-pneumococcal Antibody Concentrations (>=0.35 mcg/mL and >=1.0 mcg/mL) Following Vaccination With Prevnar13® Vaccine Administered Alone or Along With the MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2
Serotype 19A: >=1.0 mcg/mL
|
84.0 percentage of participants
Interval 76.4 to 89.9
|
85.0 percentage of participants
Interval 73.4 to 92.9
|
—
|
—
|
|
Percentage of Participants With Anti-pneumococcal Antibody Concentrations (>=0.35 mcg/mL and >=1.0 mcg/mL) Following Vaccination With Prevnar13® Vaccine Administered Alone or Along With the MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2
Serotype 19F: >=1.0 mcg/mL
|
84.8 percentage of participants
Interval 77.3 to 90.6
|
83.3 percentage of participants
Interval 71.5 to 91.7
|
—
|
—
|
|
Percentage of Participants With Anti-pneumococcal Antibody Concentrations (>=0.35 mcg/mL and >=1.0 mcg/mL) Following Vaccination With Prevnar13® Vaccine Administered Alone or Along With the MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2
Serotype 23F: >=1.0 mcg/mL
|
82.4 percentage of participants
Interval 74.6 to 88.6
|
80.0 percentage of participants
Interval 67.7 to 89.2
|
—
|
—
|
SECONDARY outcome
Timeframe: 30 days after the vaccination with M-M-R®II vaccine at the age of 12 months (i.e., at the age of 13 months)Population: 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.
Percentage of participants with anti-measles Ab concentrations \>=255 milli-international unit per milliliter (mIU/mL), anti-mumps Ab concentrations: \>=10 Ab units/mL, and anti-rubella Ab concentrations \>=10 international unit per milliliter (IU/mL) was reported in this outcome measure.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine (Mexico)
n=125 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 6, and 12 along with Prevnar 13®, Hexacima®, vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6 and MMR®II vaccine at the age of Month 12.
|
Group 2: Menveo® Vaccine (Mexico)
n=60 Participants
Participants aged 2 months (at the time of enrollment) received Menveo® vaccine at the age of Months 2, 4, 6, and 12 along with Prevnar 13®, Hexacima® vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6, and MMR®II vaccine at the age of Month 12.
|
Group 3: MenACYW Conjugate Vaccine (Russian Federation)
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 3, 6, and 12 along with Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
|
Group 4: Routine Pediatric Vaccines (Russian Federation)
Participants aged 2 months (at the time of enrollment) received Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
|
|---|---|---|---|---|
|
Percentage of Participants With Anti-MMR Antibodies (Ab) Concentrations Following Vaccination With MMR Vaccine Administered Alone or Along With the MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2
Anti-Rubella
|
100 percentage of participants
Interval 97.1 to 100.0
|
100 percentage of participants
Interval 94.0 to 100.0
|
—
|
—
|
|
Percentage of Participants With Anti-MMR Antibodies (Ab) Concentrations Following Vaccination With MMR Vaccine Administered Alone or Along With the MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2
Anti-Measles
|
99.2 percentage of participants
Interval 95.6 to 100.0
|
100 percentage of participants
Interval 94.0 to 100.0
|
—
|
—
|
|
Percentage of Participants With Anti-MMR Antibodies (Ab) Concentrations Following Vaccination With MMR Vaccine Administered Alone or Along With the MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2
Anti-Mumps
|
100 percentage of participants
Interval 97.1 to 100.0
|
96.6 percentage of participants
Interval 88.3 to 99.6
|
—
|
—
|
SECONDARY outcome
Timeframe: 30 days after the vaccination with Hexacima® vaccine at the age of 12 months (i.e., at the age of 13 months)Population: Analysis was performed on PPAS2. Data for this outcome measure was not planned to be collected and analyzed for Groups 3 and 4. Here, "overall number of participants analyzed" signifies participants with available data for this outcome measure.
Percentage of participants with anti-diphtheria Ab concentrations: \>= 0.1 and 1 IU/mL, and anti-tetanus Ab concentrations: \>= 0.1 and 1 IU/mL, anti-poliovirus types 1, 2, and 3 Ab titers \>= 8 (1/dilution), anti-hepatitis B surface (HBs) antigen Ab concentrations: \>= 10 and \>= 100 mIU/mL and anti-polyribosyl-ribitol phosphate (anti-PRP) Ab concentrations: \>= 0.15 and 1.0 microgram per milliliter (mcg/mL) was reported in this outcome measure.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine (Mexico)
n=125 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 6, and 12 along with Prevnar 13®, Hexacima®, vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6 and MMR®II vaccine at the age of Month 12.
|
Group 2: Menveo® Vaccine (Mexico)
n=60 Participants
Participants aged 2 months (at the time of enrollment) received Menveo® vaccine at the age of Months 2, 4, 6, and 12 along with Prevnar 13®, Hexacima® vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6, and MMR®II vaccine at the age of Month 12.
|
Group 3: MenACYW Conjugate Vaccine (Russian Federation)
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 3, 6, and 12 along with Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
|
Group 4: Routine Pediatric Vaccines (Russian Federation)
Participants aged 2 months (at the time of enrollment) received Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
|
|---|---|---|---|---|
|
Percentage of Participants With Antibodies Concentrations Following Vaccination With Hexacima® (DTaP-IPV-HB-Hib) Vaccine Administered Alone or Along With the MenACYW Conjugate Vaccine: Groups 1 and 2
Anti-Diphtheria: >=0.1
|
100 percentage of participants
Interval 97.1 to 100.0
|
100 percentage of participants
Interval 94.0 to 100.0
|
—
|
—
|
|
Percentage of Participants With Antibodies Concentrations Following Vaccination With Hexacima® (DTaP-IPV-HB-Hib) Vaccine Administered Alone or Along With the MenACYW Conjugate Vaccine: Groups 1 and 2
Anti-Diphtheria: >=1
|
98.4 percentage of participants
Interval 94.3 to 99.8
|
93.3 percentage of participants
Interval 83.8 to 98.2
|
—
|
—
|
|
Percentage of Participants With Antibodies Concentrations Following Vaccination With Hexacima® (DTaP-IPV-HB-Hib) Vaccine Administered Alone or Along With the MenACYW Conjugate Vaccine: Groups 1 and 2
Anti-Tetanus: >=0.1
|
100 percentage of participants
Interval 97.1 to 100.0
|
100 percentage of participants
Interval 94.0 to 100.0
|
—
|
—
|
|
Percentage of Participants With Antibodies Concentrations Following Vaccination With Hexacima® (DTaP-IPV-HB-Hib) Vaccine Administered Alone or Along With the MenACYW Conjugate Vaccine: Groups 1 and 2
Anti-Tetanus: >=1
|
100 percentage of participants
Interval 97.1 to 100.0
|
98.3 percentage of participants
Interval 91.1 to 100.0
|
—
|
—
|
|
Percentage of Participants With Antibodies Concentrations Following Vaccination With Hexacima® (DTaP-IPV-HB-Hib) Vaccine Administered Alone or Along With the MenACYW Conjugate Vaccine: Groups 1 and 2
Anti-Polio 1: >=8
|
100 percentage of participants
Interval 97.1 to 100.0
|
100 percentage of participants
Interval 94.0 to 100.0
|
—
|
—
|
|
Percentage of Participants With Antibodies Concentrations Following Vaccination With Hexacima® (DTaP-IPV-HB-Hib) Vaccine Administered Alone or Along With the MenACYW Conjugate Vaccine: Groups 1 and 2
Anti-Polio 2: >=8
|
100 percentage of participants
Interval 97.1 to 100.0
|
100 percentage of participants
Interval 94.0 to 100.0
|
—
|
—
|
|
Percentage of Participants With Antibodies Concentrations Following Vaccination With Hexacima® (DTaP-IPV-HB-Hib) Vaccine Administered Alone or Along With the MenACYW Conjugate Vaccine: Groups 1 and 2
Anti-Polio 3: >=8
|
100 percentage of participants
Interval 97.1 to 100.0
|
100 percentage of participants
Interval 94.0 to 100.0
|
—
|
—
|
|
Percentage of Participants With Antibodies Concentrations Following Vaccination With Hexacima® (DTaP-IPV-HB-Hib) Vaccine Administered Alone or Along With the MenACYW Conjugate Vaccine: Groups 1 and 2
Anti-Hepatitis B: >=10
|
100 percentage of participants
Interval 97.1 to 100.0
|
100 percentage of participants
Interval 94.0 to 100.0
|
—
|
—
|
|
Percentage of Participants With Antibodies Concentrations Following Vaccination With Hexacima® (DTaP-IPV-HB-Hib) Vaccine Administered Alone or Along With the MenACYW Conjugate Vaccine: Groups 1 and 2
Anti-Hepatitis B: >=100
|
100 percentage of participants
Interval 97.1 to 100.0
|
100 percentage of participants
Interval 94.0 to 100.0
|
—
|
—
|
|
Percentage of Participants With Antibodies Concentrations Following Vaccination With Hexacima® (DTaP-IPV-HB-Hib) Vaccine Administered Alone or Along With the MenACYW Conjugate Vaccine: Groups 1 and 2
Anti-PRP: >=0.15
|
100 percentage of participants
Interval 97.1 to 100.0
|
98.3 percentage of participants
Interval 91.1 to 100.0
|
—
|
—
|
|
Percentage of Participants With Antibodies Concentrations Following Vaccination With Hexacima® (DTaP-IPV-HB-Hib) Vaccine Administered Alone or Along With the MenACYW Conjugate Vaccine: Groups 1 and 2
Anti-PRP: >=1.0
|
100 percentage of participants
Interval 97.1 to 100.0
|
98.3 percentage of participants
Interval 91.1 to 100.0
|
—
|
—
|
SECONDARY outcome
Timeframe: 30 days after the vaccination with Hexacima® vaccine at the age of 12 months (i.e., at the age of 13 months)Population: Analysis was performed on PPAS2. Here, "overall number of participants analyzed" = participants with available data for this outcome measure.
Pertussis and FHA vaccine response was defined as: if the pre-vaccination concentration was \>=4\*lower limit of quantification (LLOQ), then the post-vaccination concentration was \>=pre-vaccination concentration and if the pre-vaccination concentration was \<4\*LLOQ, then the post-booster vaccination concentration was \>= 4\*LLOQ. The LLOQ was equal to 2.00 Endotoxin units per milliliter (EU/mL).
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine (Mexico)
n=125 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 6, and 12 along with Prevnar 13®, Hexacima®, vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6 and MMR®II vaccine at the age of Month 12.
|
Group 2: Menveo® Vaccine (Mexico)
n=60 Participants
Participants aged 2 months (at the time of enrollment) received Menveo® vaccine at the age of Months 2, 4, 6, and 12 along with Prevnar 13®, Hexacima® vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6, and MMR®II vaccine at the age of Month 12.
|
Group 3: MenACYW Conjugate Vaccine (Russian Federation)
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 3, 6, and 12 along with Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
|
Group 4: Routine Pediatric Vaccines (Russian Federation)
Participants aged 2 months (at the time of enrollment) received Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
|
|---|---|---|---|---|
|
Percentage of Participants With Vaccine Response for Pertussis (PT) and FHA Antibodies Following Vaccination With Hexacima® (DTaP-IPV-HB-Hib) Vaccine Administered Alone or Along With the MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2
PT
|
92.8 percentage of participants
Interval 86.8 to 96.7
|
95.0 percentage of participants
Interval 86.1 to 99.0
|
—
|
—
|
|
Percentage of Participants With Vaccine Response for Pertussis (PT) and FHA Antibodies Following Vaccination With Hexacima® (DTaP-IPV-HB-Hib) Vaccine Administered Alone or Along With the MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2
FHA
|
91.2 percentage of participants
Interval 84.8 to 95.5
|
83.3 percentage of participants
Interval 71.5 to 91.7
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 0 (before first vaccination with Pentaxim® vaccine) of the infant series (i.e., at the age of 2 months)Population: Analysis was performed on PPAS1. Here, "overall number of participants analyzed" = participants with available data for this outcome measure. Data for this outcome measure was not planned to be collected and analyzed for Groups 1 and 2.
GMCs for PT and FHA were measured by ECL assay. Concentration was expressed in terms of titers (1/dilution). Infant series here denotes the vaccines administered at the age of 6 months of participants.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine (Mexico)
n=96 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 6, and 12 along with Prevnar 13®, Hexacima®, vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6 and MMR®II vaccine at the age of Month 12.
|
Group 2: Menveo® Vaccine (Mexico)
n=53 Participants
Participants aged 2 months (at the time of enrollment) received Menveo® vaccine at the age of Months 2, 4, 6, and 12 along with Prevnar 13®, Hexacima® vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6, and MMR®II vaccine at the age of Month 12.
|
Group 3: MenACYW Conjugate Vaccine (Russian Federation)
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 3, 6, and 12 along with Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
|
Group 4: Routine Pediatric Vaccines (Russian Federation)
Participants aged 2 months (at the time of enrollment) received Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
|
|---|---|---|---|---|
|
Geometric Mean Concentration of PT and FHA Antibodies Before Vaccination With Pentaxim® (DTaP-Hib-IPV) Vaccine Administered Alone or Along With the MenACYW Conjugate Vaccine: Groups 3 and 4 (up to the Infant Age of 6 Months)
FHA
|
6.99 titers
Interval 5.53 to 8.84
|
6.23 titers
Interval 4.36 to 8.88
|
—
|
—
|
|
Geometric Mean Concentration of PT and FHA Antibodies Before Vaccination With Pentaxim® (DTaP-Hib-IPV) Vaccine Administered Alone or Along With the MenACYW Conjugate Vaccine: Groups 3 and 4 (up to the Infant Age of 6 Months)
PT
|
2.03 titers
Interval 1.64 to 2.51
|
1.75 titers
Interval 1.35 to 2.25
|
—
|
—
|
SECONDARY outcome
Timeframe: 30 days after the vaccination with Pentaxim® vaccine at the age of 6 months of the infant series (i.e., at the age of Month 7)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 Groups 1 and 2.
Percentage of participants with anti-diphtheria Ab concentrations: \>= 0.1 and 1 IU/mL, anti-tetanus Ab concentrations: \>= 0.1 and 1 IU/mL, anti-poliovirus types 1, 2, and 3 Ab titers \>= 8 (1/dilution), and anti-PRP Ab concentrations: \>= 0.15 and 1.0 mcg/mL were reported in this outcome measure. Infant series here denotes the vaccines administered at the age of 6 months of participants.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine (Mexico)
n=97 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 6, and 12 along with Prevnar 13®, Hexacima®, vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6 and MMR®II vaccine at the age of Month 12.
|
Group 2: Menveo® Vaccine (Mexico)
n=53 Participants
Participants aged 2 months (at the time of enrollment) received Menveo® vaccine at the age of Months 2, 4, 6, and 12 along with Prevnar 13®, Hexacima® vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6, and MMR®II vaccine at the age of Month 12.
|
Group 3: MenACYW Conjugate Vaccine (Russian Federation)
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 3, 6, and 12 along with Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
|
Group 4: Routine Pediatric Vaccines (Russian Federation)
Participants aged 2 months (at the time of enrollment) received Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
|
|---|---|---|---|---|
|
Percentage of Participants With Antibodies Concentrations Following Vaccination With Pentaxim® (DTaP-Hib-IPV) Vaccine Administered Alone or Along With the MenACYW Conjugate Vaccine: Groups 3 and 4 (up to the Infant Age of 6 Months)
Anti-Diphtheria: >=0.1
|
98.9 percentage of participants
Interval 94.3 to 100.0
|
92.5 percentage of participants
Interval 81.8 to 97.9
|
—
|
—
|
|
Percentage of Participants With Antibodies Concentrations Following Vaccination With Pentaxim® (DTaP-Hib-IPV) Vaccine Administered Alone or Along With the MenACYW Conjugate Vaccine: Groups 3 and 4 (up to the Infant Age of 6 Months)
Anti-Diphtheria: >=1
|
80.0 percentage of participants
Interval 70.5 to 87.5
|
71.7 percentage of participants
Interval 57.7 to 83.2
|
—
|
—
|
|
Percentage of Participants With Antibodies Concentrations Following Vaccination With Pentaxim® (DTaP-Hib-IPV) Vaccine Administered Alone or Along With the MenACYW Conjugate Vaccine: Groups 3 and 4 (up to the Infant Age of 6 Months)
Anti-Tetanus: >=0.1
|
100 percentage of participants
Interval 96.2 to 100.0
|
98.1 percentage of participants
Interval 89.9 to 100.0
|
—
|
—
|
|
Percentage of Participants With Antibodies Concentrations Following Vaccination With Pentaxim® (DTaP-Hib-IPV) Vaccine Administered Alone or Along With the MenACYW Conjugate Vaccine: Groups 3 and 4 (up to the Infant Age of 6 Months)
Anti-Tetanus: >=1
|
74.7 percentage of participants
Interval 64.8 to 83.1
|
54.7 percentage of participants
Interval 40.4 to 68.4
|
—
|
—
|
|
Percentage of Participants With Antibodies Concentrations Following Vaccination With Pentaxim® (DTaP-Hib-IPV) Vaccine Administered Alone or Along With the MenACYW Conjugate Vaccine: Groups 3 and 4 (up to the Infant Age of 6 Months)
Anti-Polio 1: >=8
|
100 percentage of participants
Interval 95.9 to 100.0
|
100 percentage of participants
Interval 92.5 to 100.0
|
—
|
—
|
|
Percentage of Participants With Antibodies Concentrations Following Vaccination With Pentaxim® (DTaP-Hib-IPV) Vaccine Administered Alone or Along With the MenACYW Conjugate Vaccine: Groups 3 and 4 (up to the Infant Age of 6 Months)
Anti-Polio 2: >=8
|
100 percentage of participants
Interval 95.9 to 100.0
|
100 percentage of participants
Interval 92.5 to 100.0
|
—
|
—
|
|
Percentage of Participants With Antibodies Concentrations Following Vaccination With Pentaxim® (DTaP-Hib-IPV) Vaccine Administered Alone or Along With the MenACYW Conjugate Vaccine: Groups 3 and 4 (up to the Infant Age of 6 Months)
Anti-Polio 3: >=8
|
100 percentage of participants
Interval 95.9 to 100.0
|
100 percentage of participants
Interval 92.5 to 100.0
|
—
|
—
|
|
Percentage of Participants With Antibodies Concentrations Following Vaccination With Pentaxim® (DTaP-Hib-IPV) Vaccine Administered Alone or Along With the MenACYW Conjugate Vaccine: Groups 3 and 4 (up to the Infant Age of 6 Months)
Anti-PRP: >=0.15
|
94.4 percentage of participants
Interval 87.5 to 98.2
|
90.4 percentage of participants
Interval 79.0 to 96.8
|
—
|
—
|
|
Percentage of Participants With Antibodies Concentrations Following Vaccination With Pentaxim® (DTaP-Hib-IPV) Vaccine Administered Alone or Along With the MenACYW Conjugate Vaccine: Groups 3 and 4 (up to the Infant Age of 6 Months)
Anti-PRP: >=1.0
|
72.2 percentage of participants
Interval 61.8 to 81.1
|
57.7 percentage of participants
Interval 43.2 to 71.3
|
—
|
—
|
SECONDARY outcome
Timeframe: 30 days after the vaccination with Pentaxim® vaccine at the age of 6 months of the infant series (i.e., at the age of 7 months)Population: Analysis was performed on PPAS1. Here, "overall number of participants analyzed" = participants with available data for this outcome measure.
Pertussis and FHA vaccine response was defined as: if the pre-vaccination concentration was \>=4\*LLOQ, then the post-vaccination concentration was \>= pre-vaccination concentration and if the pre-vaccination concentration was \<4\*LLOQ, then the post-booster vaccination concentration was \>= 4\*LLOQ. The LLOQ was equal to 2.00 EU/mL. Infant series here denotes the vaccines administered at the age of 6 months of participants.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine (Mexico)
n=94 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 6, and 12 along with Prevnar 13®, Hexacima®, vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6 and MMR®II vaccine at the age of Month 12.
|
Group 2: Menveo® Vaccine (Mexico)
n=53 Participants
Participants aged 2 months (at the time of enrollment) received Menveo® vaccine at the age of Months 2, 4, 6, and 12 along with Prevnar 13®, Hexacima® vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6, and MMR®II vaccine at the age of Month 12.
|
Group 3: MenACYW Conjugate Vaccine (Russian Federation)
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 3, 6, and 12 along with Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
|
Group 4: Routine Pediatric Vaccines (Russian Federation)
Participants aged 2 months (at the time of enrollment) received Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
|
|---|---|---|---|---|
|
Percentage of Participants With Vaccine Response for PT and FHA Antibodies Following Vaccination With Pentaxim® (DTaP-Hib-IPV) Vaccine Administered Alone or Along With the MenACYW Conjugate Vaccine: Groups 3 and 4 (up to the Infant Age of 6 Months)
PT
|
97.9 percentage of participants
Interval 92.5 to 99.7
|
90.6 percentage of participants
Interval 79.3 to 96.9
|
—
|
—
|
|
Percentage of Participants With Vaccine Response for PT and FHA Antibodies Following Vaccination With Pentaxim® (DTaP-Hib-IPV) Vaccine Administered Alone or Along With the MenACYW Conjugate Vaccine: Groups 3 and 4 (up to the Infant Age of 6 Months)
FHA
|
97.9 percentage of participants
Interval 92.5 to 99.7
|
94.3 percentage of participants
Interval 84.3 to 98.8
|
—
|
—
|
SECONDARY outcome
Timeframe: 30 days after the vaccination with ENGERIX-B® vaccine at the age of 6 months of the infant series (i.e., at the age of 7 months)Population: Analysis was performed on PPAS1. Here, "overall number of participants analyzed" = participants with available data for this outcome measure.
Percentage of participants with anti-hepatitis B surface (HBs) antigen Ab concentrations: \>=10 and \>=100 mIU/mL was presented in this outcome measure. Infant series here denotes the vaccines administered at the age of 6 months of participants.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine (Mexico)
n=87 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 6, and 12 along with Prevnar 13®, Hexacima®, vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6 and MMR®II vaccine at the age of Month 12.
|
Group 2: Menveo® Vaccine (Mexico)
n=50 Participants
Participants aged 2 months (at the time of enrollment) received Menveo® vaccine at the age of Months 2, 4, 6, and 12 along with Prevnar 13®, Hexacima® vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6, and MMR®II vaccine at the age of Month 12.
|
Group 3: MenACYW Conjugate Vaccine (Russian Federation)
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 3, 6, and 12 along with Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
|
Group 4: Routine Pediatric Vaccines (Russian Federation)
Participants aged 2 months (at the time of enrollment) received Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
|
|---|---|---|---|---|
|
Percentage of Participants With Anti-Hepatitis (HBs) Concentrations Following Vaccination With ENGERIX-B® (Hepatitis B) Vaccine Administered Alone or Along With the MenACYW Conjugate Vaccine: Groups 3 and 4 (up to the Infant Age of 6 Months)
Anti-HBs: >=10
|
97.7 percentage of participants
Interval 91.9 to 99.7
|
98.0 percentage of participants
Interval 89.4 to 99.9
|
—
|
—
|
|
Percentage of Participants With Anti-Hepatitis (HBs) Concentrations Following Vaccination With ENGERIX-B® (Hepatitis B) Vaccine Administered Alone or Along With the MenACYW Conjugate Vaccine: Groups 3 and 4 (up to the Infant Age of 6 Months)
Anti-HBs: >=100
|
93.1 percentage of participants
Interval 85.6 to 97.4
|
80.0 percentage of participants
Interval 66.3 to 90.0
|
—
|
—
|
SECONDARY outcome
Timeframe: 30 days after the vaccination with MMR vaccine at the age of 12 months (i.e., at the age of 13 months)Population: Analysis was performed on PPAS2.
GMCs against anti-measles and anti-rubella antibodies were measured by Bulk Measles IgG EIA, and anti-mumps antibodies were assessed by ELISA. Concentrations were expressed in terms of titers (1/dilution).
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine (Mexico)
n=96 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 6, and 12 along with Prevnar 13®, Hexacima®, vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6 and MMR®II vaccine at the age of Month 12.
|
Group 2: Menveo® Vaccine (Mexico)
n=50 Participants
Participants aged 2 months (at the time of enrollment) received Menveo® vaccine at the age of Months 2, 4, 6, and 12 along with Prevnar 13®, Hexacima® vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6, and MMR®II vaccine at the age of Month 12.
|
Group 3: MenACYW Conjugate Vaccine (Russian Federation)
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 3, 6, and 12 along with Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
|
Group 4: Routine Pediatric Vaccines (Russian Federation)
Participants aged 2 months (at the time of enrollment) received Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
|
|---|---|---|---|---|
|
Geometric Mean Concentrations of MMR Antibodies Following Vaccination With MMR Vaccine Administered Alone or Along With the MenACYW Conjugate Vaccine: Groups 3 and 4
Anti-Measles
|
1461 titers
Interval 1128.0 to 1893.0
|
1233 titers
Interval 800.0 to 1901.0
|
—
|
—
|
|
Geometric Mean Concentrations of MMR Antibodies Following Vaccination With MMR Vaccine Administered Alone or Along With the MenACYW Conjugate Vaccine: Groups 3 and 4
Anti-Mumps
|
50.5 titers
Interval 40.4 to 63.1
|
53.5 titers
Interval 40.8 to 70.2
|
—
|
—
|
|
Geometric Mean Concentrations of MMR Antibodies Following Vaccination With MMR Vaccine Administered Alone or Along With the MenACYW Conjugate Vaccine: Groups 3 and 4
Anti-Rubella
|
47.6 titers
Interval 39.5 to 57.2
|
55.2 titers
Interval 42.3 to 72.1
|
—
|
—
|
SECONDARY outcome
Timeframe: 30 days after the vaccination with MMR vaccine at the age of 12 months (i.e., at the age of 13 months)Population: Analysis was performed on PPAS2.
Percentage of participants with anti-measles Ab concentrations \>=255 mIU/mL, anti-mumps Ab concentrations: \>=10 Ab units/mL, and anti-rubella Ab concentrations \>=10 IU/mL was reported in this outcome measure.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine (Mexico)
n=96 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 6, and 12 along with Prevnar 13®, Hexacima®, vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6 and MMR®II vaccine at the age of Month 12.
|
Group 2: Menveo® Vaccine (Mexico)
n=50 Participants
Participants aged 2 months (at the time of enrollment) received Menveo® vaccine at the age of Months 2, 4, 6, and 12 along with Prevnar 13®, Hexacima® vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6, and MMR®II vaccine at the age of Month 12.
|
Group 3: MenACYW Conjugate Vaccine (Russian Federation)
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 3, 6, and 12 along with Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
|
Group 4: Routine Pediatric Vaccines (Russian Federation)
Participants aged 2 months (at the time of enrollment) received Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
|
|---|---|---|---|---|
|
Percentage of Participants With Anti-MMR Concentrations Following Vaccination With MMR Vaccine Administered Alone or Along With the MenACYW Vaccine or Routine Pediatric Vaccines: Groups 3 and 4
Anti-Measles
|
93.8 percentage of participants
Interval 86.9 to 97.7
|
88.0 percentage of participants
Interval 75.7 to 95.5
|
—
|
—
|
|
Percentage of Participants With Anti-MMR Concentrations Following Vaccination With MMR Vaccine Administered Alone or Along With the MenACYW Vaccine or Routine Pediatric Vaccines: Groups 3 and 4
Anti-Mumps
|
89.6 percentage of participants
Interval 81.7 to 94.9
|
90.0 percentage of participants
Interval 78.2 to 96.7
|
—
|
—
|
|
Percentage of Participants With Anti-MMR Concentrations Following Vaccination With MMR Vaccine Administered Alone or Along With the MenACYW Vaccine or Routine Pediatric Vaccines: Groups 3 and 4
Anti-Rubella
|
95.8 percentage of participants
Interval 89.7 to 98.9
|
94.0 percentage of participants
Interval 83.5 to 98.7
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 0 (before the first vaccination with MenACYW Conjugate or Menveo® Vaccine) of the infant series (i.e., at the age of 2 months)Population: Analysis was performed on PPAS1. Data for this outcome measure was not planned to be collected and analyzed for Group 4.
GMTs of antibody against meningococcal serogroups A, C, Y, and W were measured by hSBA. Titers were expressed in terms of 1/dilution. Infant series here denotes the vaccines administered at the age of 6 months of participants.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine (Mexico)
n=176 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 6, and 12 along with Prevnar 13®, Hexacima®, vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6 and MMR®II vaccine at the age of Month 12.
|
Group 2: Menveo® Vaccine (Mexico)
n=81 Participants
Participants aged 2 months (at the time of enrollment) received Menveo® vaccine at the age of Months 2, 4, 6, and 12 along with Prevnar 13®, Hexacima® vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6, and MMR®II vaccine at the age of Month 12.
|
Group 3: MenACYW Conjugate Vaccine (Russian Federation)
n=97 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 3, 6, and 12 along with Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
|
Group 4: Routine Pediatric Vaccines (Russian Federation)
Participants aged 2 months (at the time of enrollment) received Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
|
|---|---|---|---|---|
|
Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA Before Vaccination With MenACYW Conjugate or Menveo® Vaccine: Groups 1, 2 and 3 (up to the Infant Age of 6 Months)
Serogroup A
|
2.65 titers
Interval 2.39 to 2.93
|
2.24 titers
Interval 2.1 to 2.38
|
2.88 titers
Interval 2.64 to 3.14
|
—
|
|
Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA Before Vaccination With MenACYW Conjugate or Menveo® Vaccine: Groups 1, 2 and 3 (up to the Infant Age of 6 Months)
Serogroup C
|
2.16 titers
Interval 2.08 to 2.23
|
2.29 titers
Interval 2.13 to 2.47
|
2.16 titers
Interval 2.04 to 2.3
|
—
|
|
Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA Before Vaccination With MenACYW Conjugate or Menveo® Vaccine: Groups 1, 2 and 3 (up to the Infant Age of 6 Months)
Serogroup Y
|
2.62 titers
Interval 2.45 to 2.81
|
2.89 titers
Interval 2.51 to 3.33
|
2.37 titers
Interval 2.07 to 2.72
|
—
|
|
Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA Before Vaccination With MenACYW Conjugate or Menveo® Vaccine: Groups 1, 2 and 3 (up to the Infant Age of 6 Months)
Serogroup W
|
3.57 titers
Interval 3.21 to 3.97
|
3.15 titers
Interval 2.79 to 3.55
|
2.18 titers
Interval 2.04 to 2.32
|
—
|
SECONDARY outcome
Timeframe: 30 days after the vaccination with MenACYW Conjugate vaccine at the age of 6 months of the infant series (i.e., at the age of 7 months)Population: Analysis was performed on PPAS1. Data for this outcome measure was not planned to be collected and analyzed for Group 4.
GMTs of antibody against meningococcal serogroups A, C, Y, and W were measured by hSBA. Titers were expressed in terms of 1/dilution. Group 2 data were presented separately. Infant series here denotes the vaccines administered at the age of 6 months of participants.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine (Mexico)
n=176 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 6, and 12 along with Prevnar 13®, Hexacima®, vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6 and MMR®II vaccine at the age of Month 12.
|
Group 2: Menveo® Vaccine (Mexico)
n=97 Participants
Participants aged 2 months (at the time of enrollment) received Menveo® vaccine at the age of Months 2, 4, 6, and 12 along with Prevnar 13®, Hexacima® vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6, and MMR®II vaccine at the age of Month 12.
|
Group 3: MenACYW Conjugate Vaccine (Russian Federation)
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 3, 6, and 12 along with Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
|
Group 4: Routine Pediatric Vaccines (Russian Federation)
Participants aged 2 months (at the time of enrollment) received Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
|
|---|---|---|---|---|
|
Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA Following MenACYW Conjugate Vaccine: Groups 1 and 3 (up to the Infant Age of 6 Months)
Serogroup A
|
71.7 titers
Interval 56.8 to 90.7
|
31.5 titers
Interval 22.2 to 44.9
|
—
|
—
|
|
Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA Following MenACYW Conjugate Vaccine: Groups 1 and 3 (up to the Infant Age of 6 Months)
Serogroup C
|
626 titers
Interval 549.0 to 714.0
|
267 titers
Interval 196.0 to 365.0
|
—
|
—
|
|
Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA Following MenACYW Conjugate Vaccine: Groups 1 and 3 (up to the Infant Age of 6 Months)
Serogroup Y
|
246 titers
Interval 216.0 to 281.0
|
78.2 titers
Interval 60.3 to 101.0
|
—
|
—
|
|
Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA Following MenACYW Conjugate Vaccine: Groups 1 and 3 (up to the Infant Age of 6 Months)
Serogroup W
|
340 titers
Interval 294.0 to 393.0
|
78.7 titers
Interval 61.9 to 100.0
|
—
|
—
|
SECONDARY outcome
Timeframe: 30 days after the vaccination with MenACYW Conjugate vaccine at the age of 6 months of the infant series (i.e., at the age of Month 7)Population: Analysis was performed on PPAS1. Data for this outcome measure was not planned to be collected and analyzed for Group 4.
Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by hSBA assay. Group 2 data were presented separately. Infant series here denotes the vaccines administered at the age of 6 months of participants.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine (Mexico)
n=176 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 6, and 12 along with Prevnar 13®, Hexacima®, vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6 and MMR®II vaccine at the age of Month 12.
|
Group 2: Menveo® Vaccine (Mexico)
n=97 Participants
Participants aged 2 months (at the time of enrollment) received Menveo® vaccine at the age of Months 2, 4, 6, and 12 along with Prevnar 13®, Hexacima® vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6, and MMR®II vaccine at the age of Month 12.
|
Group 3: MenACYW Conjugate Vaccine (Russian Federation)
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 3, 6, and 12 along with Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
|
Group 4: Routine Pediatric Vaccines (Russian Federation)
Participants aged 2 months (at the time of enrollment) received Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
|
|---|---|---|---|---|
|
Percentage of Participants With Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccines: Groups 1 and 3 (up to the Infant Age of 6 Months)
Serogroup Y: >=1:8
|
99.4 percentage of participants
Interval 96.9 to 100.0
|
92.8 percentage of participants
Interval 85.7 to 97.0
|
—
|
—
|
|
Percentage of Participants With Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccines: Groups 1 and 3 (up to the Infant Age of 6 Months)
Serogroup A: >=1:4
|
96.0 percentage of participants
Interval 92.0 to 98.4
|
93.8 percentage of participants
Interval 87.0 to 97.7
|
—
|
—
|
|
Percentage of Participants With Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccines: Groups 1 and 3 (up to the Infant Age of 6 Months)
Serogroup A: >=1:8
|
90.9 percentage of participants
Interval 85.7 to 94.7
|
78.4 percentage of participants
Interval 68.8 to 86.1
|
—
|
—
|
|
Percentage of Participants With Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccines: Groups 1 and 3 (up to the Infant Age of 6 Months)
Serogroup C: >=1:4
|
100 percentage of participants
Interval 97.9 to 100.0
|
94.8 percentage of participants
Interval 88.4 to 98.3
|
—
|
—
|
|
Percentage of Participants With Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccines: Groups 1 and 3 (up to the Infant Age of 6 Months)
Serogroup C: >=1:8
|
100 percentage of participants
Interval 97.9 to 100.0
|
94.8 percentage of participants
Interval 88.4 to 98.3
|
—
|
—
|
|
Percentage of Participants With Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccines: Groups 1 and 3 (up to the Infant Age of 6 Months)
Serogroup Y: >=1:4
|
99.4 percentage of participants
Interval 96.9 to 100.0
|
94.8 percentage of participants
Interval 88.4 to 98.3
|
—
|
—
|
|
Percentage of Participants With Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccines: Groups 1 and 3 (up to the Infant Age of 6 Months)
Serogroup W: >=1:4
|
99.4 percentage of participants
Interval 96.9 to 100.0
|
94.8 percentage of participants
Interval 88.4 to 98.3
|
—
|
—
|
|
Percentage of Participants With Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccines: Groups 1 and 3 (up to the Infant Age of 6 Months)
Serogroup W: >=1:8
|
99.4 percentage of participants
Interval 96.9 to 100.0
|
94.8 percentage of participants
Interval 88.4 to 98.3
|
—
|
—
|
SECONDARY outcome
Timeframe: From Day 0 (before the first vaccination, at the age of 2 months), 30 days after vaccination with MenACYW Conjugate vaccine at the age of 6 months of infant series (i.e., at the age of 7 months)Population: Analysis was performed on PPAS1. Data for this outcome measure was not planned to be collected and analyzed for Group 4.
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 after the 6-months vaccination) to pre-dose titer at 2 months of age (i.e., Day 0). Group 2 data were presented separately. Infant series here denotes the vaccines administered at the age of 6 months of participants.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine (Mexico)
n=176 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 6, and 12 along with Prevnar 13®, Hexacima®, vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6 and MMR®II vaccine at the age of Month 12.
|
Group 2: Menveo® Vaccine (Mexico)
n=97 Participants
Participants aged 2 months (at the time of enrollment) received Menveo® vaccine at the age of Months 2, 4, 6, and 12 along with Prevnar 13®, Hexacima® vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6, and MMR®II vaccine at the age of Month 12.
|
Group 3: MenACYW Conjugate Vaccine (Russian Federation)
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 3, 6, and 12 along with Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
|
Group 4: Routine Pediatric Vaccines (Russian Federation)
Participants aged 2 months (at the time of enrollment) received Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
|
|---|---|---|---|---|
|
Percentage of Participants With >=4-Fold Rise in Antibody Titers Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine: Groups 1 and 3 (up to the Infant Age of 6 Months)
Serogroup A
|
84.7 percentage of participants
Interval 78.5 to 89.6
|
70.1 percentage of participants
Interval 60.0 to 79.0
|
—
|
—
|
|
Percentage of Participants With >=4-Fold Rise in Antibody Titers Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine: Groups 1 and 3 (up to the Infant Age of 6 Months)
Serogroup C
|
100 percentage of participants
Interval 97.9 to 100.0
|
94.8 percentage of participants
Interval 88.4 to 98.3
|
—
|
—
|
|
Percentage of Participants With >=4-Fold Rise in Antibody Titers Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine: Groups 1 and 3 (up to the Infant Age of 6 Months)
Serogroup Y
|
99.4 percentage of participants
Interval 96.9 to 100.0
|
87.6 percentage of participants
Interval 79.4 to 93.4
|
—
|
—
|
|
Percentage of Participants With >=4-Fold Rise in Antibody Titers Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine: Groups 1 and 3 (up to the Infant Age of 6 Months)
Serogroup W
|
98.3 percentage of participants
Interval 95.1 to 99.6
|
93.8 percentage of participants
Interval 87.0 to 97.7
|
—
|
—
|
SECONDARY outcome
Timeframe: 30 days after the vaccination with Menveo® vaccine at the age of 6 months of the infant series (i.e., at the age of 7 months)Population: Analysis was performed on PPAS1. Data for this outcome measure was not planned to be collected and analyzed for Group 4.
GMTs of antibody against meningococcal serogroups A, C, Y, and W were measured by hSBA. Titers were expressed in terms of 1/dilution. Infant series here denotes the vaccines administered at the age of 6 months of participants.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine (Mexico)
n=81 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 6, and 12 along with Prevnar 13®, Hexacima®, vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6 and MMR®II vaccine at the age of Month 12.
|
Group 2: Menveo® Vaccine (Mexico)
Participants aged 2 months (at the time of enrollment) received Menveo® vaccine at the age of Months 2, 4, 6, and 12 along with Prevnar 13®, Hexacima® vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6, and MMR®II vaccine at the age of Month 12.
|
Group 3: MenACYW Conjugate Vaccine (Russian Federation)
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 3, 6, and 12 along with Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
|
Group 4: Routine Pediatric Vaccines (Russian Federation)
Participants aged 2 months (at the time of enrollment) received Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
|
|---|---|---|---|---|
|
Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA Following Vaccination With Menveo® Vaccine: Group 2 (up to the Infant Age of 6 Months)
Serogroup A
|
16.7 titers
Interval 12.0 to 23.3
|
—
|
—
|
—
|
|
Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA Following Vaccination With Menveo® Vaccine: Group 2 (up to the Infant Age of 6 Months)
Serogroup C
|
62.4 titers
Interval 47.2 to 82.4
|
—
|
—
|
—
|
|
Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA Following Vaccination With Menveo® Vaccine: Group 2 (up to the Infant Age of 6 Months)
Serogroup Y
|
59.8 titers
Interval 46.9 to 76.1
|
—
|
—
|
—
|
|
Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA Following Vaccination With Menveo® Vaccine: Group 2 (up to the Infant Age of 6 Months)
Serogroup W
|
95.7 titers
Interval 78.4 to 117.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 30 days after the vaccination with Menveo® vaccine at the age of 6 months of the infant series (i.e., at the age of 7 months)Population: Analysis was performed on PPAS1. Data for this outcome measure was not planned to be collected and analyzed for Group 4.
Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by hSBA assay. Infant series here denotes the vaccines administered at the age of 6 months of participants.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine (Mexico)
n=81 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 6, and 12 along with Prevnar 13®, Hexacima®, vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6 and MMR®II vaccine at the age of Month 12.
|
Group 2: Menveo® Vaccine (Mexico)
Participants aged 2 months (at the time of enrollment) received Menveo® vaccine at the age of Months 2, 4, 6, and 12 along with Prevnar 13®, Hexacima® vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6, and MMR®II vaccine at the age of Month 12.
|
Group 3: MenACYW Conjugate Vaccine (Russian Federation)
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 3, 6, and 12 along with Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
|
Group 4: Routine Pediatric Vaccines (Russian Federation)
Participants aged 2 months (at the time of enrollment) received Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
|
|---|---|---|---|---|
|
Percentage of Participants With Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With Menveo® Vaccine: Group 2 (up to the Infant Age of 6 Months)
Serogroup A: >=1:4
|
85.2 percentage of participants
Interval 75.6 to 92.1
|
—
|
—
|
—
|
|
Percentage of Participants With Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With Menveo® Vaccine: Group 2 (up to the Infant Age of 6 Months)
Serogroup W: >=1:4
|
100 percentage of participants
Interval 95.5 to 100.0
|
—
|
—
|
—
|
|
Percentage of Participants With Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With Menveo® Vaccine: Group 2 (up to the Infant Age of 6 Months)
Serogroup A: >=1:8
|
69.1 percentage of participants
Interval 57.9 to 78.9
|
—
|
—
|
—
|
|
Percentage of Participants With Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With Menveo® Vaccine: Group 2 (up to the Infant Age of 6 Months)
Serogroup C: >=1:4
|
98.8 percentage of participants
Interval 93.3 to 100.0
|
—
|
—
|
—
|
|
Percentage of Participants With Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With Menveo® Vaccine: Group 2 (up to the Infant Age of 6 Months)
Serogroup C: >=1:8
|
97.5 percentage of participants
Interval 91.4 to 99.7
|
—
|
—
|
—
|
|
Percentage of Participants With Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With Menveo® Vaccine: Group 2 (up to the Infant Age of 6 Months)
Serogroup Y: >=1:4
|
98.8 percentage of participants
Interval 93.3 to 100.0
|
—
|
—
|
—
|
|
Percentage of Participants With Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With Menveo® Vaccine: Group 2 (up to the Infant Age of 6 Months)
Serogroup Y: >=1:8
|
97.5 percentage of participants
Interval 91.4 to 99.7
|
—
|
—
|
—
|
|
Percentage of Participants With Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With Menveo® Vaccine: Group 2 (up to the Infant Age of 6 Months)
Serogroup W: >=1:8
|
100 percentage of participants
Interval 95.5 to 100.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 0 (before the first vaccination, at the age of 2 months), 30 days after vaccination with Menveo® vaccines at the age of 6 months of the infant series (i.e., at the age of 7 months)Population: Analysis was performed on PPAS1. Data for this outcome measure was not planned to be collected and analyzed for Group 4.
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 after the vaccination at the age of 6 months) to pre-dose titer at Day 0 (i.e., before the first vaccination, at 2 months of age). Infant series here denotes the vaccines administered at the age of 6 months of participants.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine (Mexico)
n=81 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 6, and 12 along with Prevnar 13®, Hexacima®, vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6 and MMR®II vaccine at the age of Month 12.
|
Group 2: Menveo® Vaccine (Mexico)
Participants aged 2 months (at the time of enrollment) received Menveo® vaccine at the age of Months 2, 4, 6, and 12 along with Prevnar 13®, Hexacima® vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6, and MMR®II vaccine at the age of Month 12.
|
Group 3: MenACYW Conjugate Vaccine (Russian Federation)
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 3, 6, and 12 along with Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
|
Group 4: Routine Pediatric Vaccines (Russian Federation)
Participants aged 2 months (at the time of enrollment) received Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
|
|---|---|---|---|---|
|
Percentage of Participants With >=4-Fold Rise in Antibody Titers Against Meningococcal Serogroups A, C, Y, and W Following Vaccinations With Menveo® Vaccine: Group 2 (up to the Infant Age of 6 Months)
Serogroup A
|
58.0 percentage of participants
Interval 46.5 to 68.9
|
—
|
—
|
—
|
|
Percentage of Participants With >=4-Fold Rise in Antibody Titers Against Meningococcal Serogroups A, C, Y, and W Following Vaccinations With Menveo® Vaccine: Group 2 (up to the Infant Age of 6 Months)
Serogroup C
|
86.4 percentage of participants
Interval 77.0 to 93.0
|
—
|
—
|
—
|
|
Percentage of Participants With >=4-Fold Rise in Antibody Titers Against Meningococcal Serogroups A, C, Y, and W Following Vaccinations With Menveo® Vaccine: Group 2 (up to the Infant Age of 6 Months)
Serogroup Y
|
92.6 percentage of participants
Interval 84.6 to 97.2
|
—
|
—
|
—
|
|
Percentage of Participants With >=4-Fold Rise in Antibody Titers Against Meningococcal Serogroups A, C, Y, and W Following Vaccinations With Menveo® Vaccine: Group 2 (up to the Infant Age of 6 Months)
Serogroup W
|
97.5 percentage of participants
Interval 91.4 to 99.7
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 30 days after the vaccination with MenACYW Conjugate vaccine at the age of 12 months (i.e., at the age of 13 months)Population: Analysis was performed on PPAS2. Data for this outcome measure was not planned to be collected and analyzed for Group 4. Here, 'Number analyzed'=participants with available data for the specified categories.
GMTs of antibody against meningococcal serogroups A, C, Y, and W were measured by hSBA. Titers were expressed in terms of 1/dilution. Group 2 data were presented separately.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine (Mexico)
n=126 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 6, and 12 along with Prevnar 13®, Hexacima®, vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6 and MMR®II vaccine at the age of Month 12.
|
Group 2: Menveo® Vaccine (Mexico)
n=96 Participants
Participants aged 2 months (at the time of enrollment) received Menveo® vaccine at the age of Months 2, 4, 6, and 12 along with Prevnar 13®, Hexacima® vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6, and MMR®II vaccine at the age of Month 12.
|
Group 3: MenACYW Conjugate Vaccine (Russian Federation)
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 3, 6, and 12 along with Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
|
Group 4: Routine Pediatric Vaccines (Russian Federation)
Participants aged 2 months (at the time of enrollment) received Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
|
|---|---|---|---|---|
|
Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA Antibodies Following Last Vaccination With MenACYW Conjugate Vaccine: Groups 1 and 3
Serogroup A
|
145 titers
Interval 114.0 to 185.0
|
85.4 titers
Interval 54.0 to 135.0
|
—
|
—
|
|
Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA Antibodies Following Last Vaccination With MenACYW Conjugate Vaccine: Groups 1 and 3
Serogroup C
|
897 titers
Interval 742.0 to 1086.0
|
214 titers
Interval 130.0 to 353.0
|
—
|
—
|
|
Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA Antibodies Following Last Vaccination With MenACYW Conjugate Vaccine: Groups 1 and 3
Serogroup Y
|
401 titers
Interval 343.0 to 469.0
|
97.3 titers
Interval 63.4 to 149.0
|
—
|
—
|
|
Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA Antibodies Following Last Vaccination With MenACYW Conjugate Vaccine: Groups 1 and 3
Serogroup W
|
639 titers
Interval 542.0 to 754.0
|
123 titers
Interval 77.1 to 195.0
|
—
|
—
|
SECONDARY outcome
Timeframe: 30 days after the vaccination with MenACYW Conjugate vaccine at the age of 12 months (i.e., at the age of 13 months)Population: Analysis was performed on PPAS2. Data for this outcome measure was not planned to be collected and analyzed for Group 4. Here, 'Number analyzed' = participants with available data for each specified category.
Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by hSBA assay. Group 2 data were presented separately.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine (Mexico)
n=126 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 6, and 12 along with Prevnar 13®, Hexacima®, vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6 and MMR®II vaccine at the age of Month 12.
|
Group 2: Menveo® Vaccine (Mexico)
n=96 Participants
Participants aged 2 months (at the time of enrollment) received Menveo® vaccine at the age of Months 2, 4, 6, and 12 along with Prevnar 13®, Hexacima® vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6, and MMR®II vaccine at the age of Month 12.
|
Group 3: MenACYW Conjugate Vaccine (Russian Federation)
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 3, 6, and 12 along with Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
|
Group 4: Routine Pediatric Vaccines (Russian Federation)
Participants aged 2 months (at the time of enrollment) received Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
|
|---|---|---|---|---|
|
Percentage of Participants With Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine: Groups 1 and 3
Serogroup C: >=1:8
|
99.2 percentage of participants
Interval 95.7 to 100.0
|
82.3 percentage of participants
Interval 73.2 to 89.3
|
—
|
—
|
|
Percentage of Participants With Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine: Groups 1 and 3
Serogroup W: >=1:8
|
100 percentage of participants
Interval 97.1 to 100.0
|
80.2 percentage of participants
Interval 70.8 to 87.6
|
—
|
—
|
|
Percentage of Participants With Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine: Groups 1 and 3
Serogroup A: >=1:4
|
98.4 percentage of participants
Interval 94.4 to 99.8
|
97.9 percentage of participants
Interval 92.7 to 99.7
|
—
|
—
|
|
Percentage of Participants With Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine: Groups 1 and 3
Serogroup A: >=1:8
|
97.6 percentage of participants
Interval 93.2 to 99.5
|
89.6 percentage of participants
Interval 81.7 to 94.9
|
—
|
—
|
|
Percentage of Participants With Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine: Groups 1 and 3
Serogroup C: >=1:4
|
100 percentage of participants
Interval 97.1 to 100.0
|
91.7 percentage of participants
Interval 84.2 to 96.3
|
—
|
—
|
|
Percentage of Participants With Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine: Groups 1 and 3
Serogroup Y: >=1:4
|
100 percentage of participants
Interval 97.1 to 100.0
|
83.3 percentage of participants
Interval 74.4 to 90.2
|
—
|
—
|
|
Percentage of Participants With Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine: Groups 1 and 3
Serogroup Y: >=1:8
|
100 percentage of participants
Interval 97.1 to 100.0
|
80.2 percentage of participants
Interval 70.8 to 87.6
|
—
|
—
|
|
Percentage of Participants With Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine: Groups 1 and 3
Serogroup W: >=1:4
|
100 percentage of participants
Interval 97.1 to 100.0
|
85.4 percentage of participants
Interval 76.7 to 91.8
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 0 (before the first vaccination, at the age of 2 months), 30 days after the vaccination with MenACYW Conjugate vaccine at the age of 12 months (i.e., at the age of 13 months)Population: 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 4.
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 after the vaccination at the age of 6 months) to pre-dose titer at Day 0 (i.e., before the first vaccination, at the age of 2 months). Group 2 data were presented separately.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine (Mexico)
n=126 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 6, and 12 along with Prevnar 13®, Hexacima®, vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6 and MMR®II vaccine at the age of Month 12.
|
Group 2: Menveo® Vaccine (Mexico)
n=96 Participants
Participants aged 2 months (at the time of enrollment) received Menveo® vaccine at the age of Months 2, 4, 6, and 12 along with Prevnar 13®, Hexacima® vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6, and MMR®II vaccine at the age of Month 12.
|
Group 3: MenACYW Conjugate Vaccine (Russian Federation)
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 3, 6, and 12 along with Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
|
Group 4: Routine Pediatric Vaccines (Russian Federation)
Participants aged 2 months (at the time of enrollment) received Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
|
|---|---|---|---|---|
|
Percentage of Participants With >=4-Fold Rise in Antibody Titers Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine: Groups 1 and 3
Serogroup A
|
96.8 percentage of participants
Interval 92.1 to 99.1
|
74.0 percentage of participants
Interval 64.0 to 82.4
|
—
|
—
|
|
Percentage of Participants With >=4-Fold Rise in Antibody Titers Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine: Groups 1 and 3
Serogroup C
|
99.2 percentage of participants
Interval 95.7 to 100.0
|
81.3 percentage of participants
Interval 72.0 to 88.5
|
—
|
—
|
|
Percentage of Participants With >=4-Fold Rise in Antibody Titers Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine: Groups 1 and 3
Serogroup Y
|
100 percentage of participants
Interval 97.1 to 100.0
|
80.2 percentage of participants
Interval 70.8 to 87.6
|
—
|
—
|
|
Percentage of Participants With >=4-Fold Rise in Antibody Titers Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine: Groups 1 and 3
Serogroup W
|
99.2 percentage of participants
Interval 95.6 to 100.0
|
79.2 percentage of participants
Interval 69.7 to 86.8
|
—
|
—
|
SECONDARY outcome
Timeframe: 30 days after the vaccination with MenACYW Conjugate vaccine at the age of 12 months (i.e., at the age of 13 months)Population: Analysis was performed on PPAS2. Here, 'Number analyzed'=participants with available data for specified categories. Data for this outcome measure was not planned to be collected and analyzed for Group 4.
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. Group 2 data were presented separately.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine (Mexico)
n=126 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 6, and 12 along with Prevnar 13®, Hexacima®, vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6 and MMR®II vaccine at the age of Month 12.
|
Group 2: Menveo® Vaccine (Mexico)
n=96 Participants
Participants aged 2 months (at the time of enrollment) received Menveo® vaccine at the age of Months 2, 4, 6, and 12 along with Prevnar 13®, Hexacima® vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6, and MMR®II vaccine at the age of Month 12.
|
Group 3: MenACYW Conjugate Vaccine (Russian Federation)
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 3, 6, and 12 along with Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
|
Group 4: Routine Pediatric Vaccines (Russian Federation)
Participants aged 2 months (at the time of enrollment) received Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W Following Last Vaccination With MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 3
Serogroup A
|
96.8 percentage of participants
Interval 92.1 to 99.1
|
74.0 percentage of participants
Interval 64.0 to 82.4
|
—
|
—
|
|
Percentage of Participants Achieving Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W Following Last Vaccination With MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 3
Serogroup C
|
99.2 percentage of participants
Interval 95.7 to 100.0
|
81.3 percentage of participants
Interval 72.0 to 88.5
|
—
|
—
|
|
Percentage of Participants Achieving Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W Following Last Vaccination With MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 3
Serogroup Y
|
100 percentage of participants
Interval 97.1 to 100.0
|
80.2 percentage of participants
Interval 70.8 to 87.6
|
—
|
—
|
|
Percentage of Participants Achieving Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W Following Last Vaccination With MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 3
Serogroup W
|
99.2 percentage of participants
Interval 95.6 to 100.0
|
79.2 percentage of participants
Interval 69.7 to 86.8
|
—
|
—
|
SECONDARY outcome
Timeframe: 30 days after the vaccination with Menveo® vaccine at the age of 12 months (i.e., at the age of 13 months)Population: Analysis was performed on PPAS2. Data for this outcome measure was not planned to be collected and analyzed for Group 4.
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 (Mexico)
n=60 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 6, and 12 along with Prevnar 13®, Hexacima®, vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6 and MMR®II vaccine at the age of Month 12.
|
Group 2: Menveo® Vaccine (Mexico)
Participants aged 2 months (at the time of enrollment) received Menveo® vaccine at the age of Months 2, 4, 6, and 12 along with Prevnar 13®, Hexacima® vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6, and MMR®II vaccine at the age of Month 12.
|
Group 3: MenACYW Conjugate Vaccine (Russian Federation)
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 3, 6, and 12 along with Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
|
Group 4: Routine Pediatric Vaccines (Russian Federation)
Participants aged 2 months (at the time of enrollment) received Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
|
|---|---|---|---|---|
|
Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA Antibodies Following Last Vaccination With Menveo® Vaccine: Group 2
Serogroup A
|
65.5 titers
Interval 44.5 to 96.3
|
—
|
—
|
—
|
|
Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA Antibodies Following Last Vaccination With Menveo® Vaccine: Group 2
Serogroup C
|
77.0 titers
Interval 52.5 to 113.0
|
—
|
—
|
—
|
|
Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA Antibodies Following Last Vaccination With Menveo® Vaccine: Group 2
Serogroup Y
|
228 titers
Interval 173.0 to 301.0
|
—
|
—
|
—
|
|
Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA Antibodies Following Last Vaccination With Menveo® Vaccine: Group 2
Serogroup W
|
242 titers
Interval 184.0 to 318.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 30 days after the vaccination with Menveo® vaccine at the age of 12 months (i.e., at the age of 13 months)Population: Analysis was performed on PPAS2. Data for this outcome measure was not planned to be collected and analyzed for Group 4.
Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by hSBA assay.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine (Mexico)
n=60 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 6, and 12 along with Prevnar 13®, Hexacima®, vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6 and MMR®II vaccine at the age of Month 12.
|
Group 2: Menveo® Vaccine (Mexico)
Participants aged 2 months (at the time of enrollment) received Menveo® vaccine at the age of Months 2, 4, 6, and 12 along with Prevnar 13®, Hexacima® vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6, and MMR®II vaccine at the age of Month 12.
|
Group 3: MenACYW Conjugate Vaccine (Russian Federation)
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 3, 6, and 12 along with Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
|
Group 4: Routine Pediatric Vaccines (Russian Federation)
Participants aged 2 months (at the time of enrollment) received Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
|
|---|---|---|---|---|
|
Percentage of Participants With Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With Menveo® Vaccine: Group 2
Serogroup C: >=1:4
|
96.7 percentage of participants
Interval 88.5 to 99.6
|
—
|
—
|
—
|
|
Percentage of Participants With Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With Menveo® Vaccine: Group 2
Serogroup A: >=1:4
|
96.7 percentage of participants
Interval 88.5 to 99.6
|
—
|
—
|
—
|
|
Percentage of Participants With Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With Menveo® Vaccine: Group 2
Serogroup A: >=1:8
|
95.0 percentage of participants
Interval 86.1 to 99.0
|
—
|
—
|
—
|
|
Percentage of Participants With Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With Menveo® Vaccine: Group 2
Serogroup C: >=1:8
|
93.3 percentage of participants
Interval 83.8 to 98.2
|
—
|
—
|
—
|
|
Percentage of Participants With Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With Menveo® Vaccine: Group 2
Serogroup Y: >=1:4
|
100 percentage of participants
Interval 94.0 to 100.0
|
—
|
—
|
—
|
|
Percentage of Participants With Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With Menveo® Vaccine: Group 2
Serogroup Y: >=1:8
|
100 percentage of participants
Interval 94.0 to 100.0
|
—
|
—
|
—
|
|
Percentage of Participants With Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With Menveo® Vaccine: Group 2
Serogroup W: >=1:4
|
100 percentage of participants
Interval 94.0 to 100.0
|
—
|
—
|
—
|
|
Percentage of Participants With Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With Menveo® Vaccine: Group 2
Serogroup W: >=1:8
|
100 percentage of participants
Interval 94.0 to 100.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 0 (before the first vaccination, at the age of Month 2), 30 days after the vaccination with Menveo® vaccine at the age of 12 months (i.e., at the age of 13 months)Population: Analysis was performed on PPAS2. Data for this outcome measure was not planned to be collected and analyzed for Group 4.
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 after the vaccination at the age of 12 months) to pre-dose titer at Day 0 (i.e., before first vaccination, at the age of 2 months).
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine (Mexico)
n=60 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 6, and 12 along with Prevnar 13®, Hexacima®, vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6 and MMR®II vaccine at the age of Month 12.
|
Group 2: Menveo® Vaccine (Mexico)
Participants aged 2 months (at the time of enrollment) received Menveo® vaccine at the age of Months 2, 4, 6, and 12 along with Prevnar 13®, Hexacima® vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6, and MMR®II vaccine at the age of Month 12.
|
Group 3: MenACYW Conjugate Vaccine (Russian Federation)
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 3, 6, and 12 along with Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
|
Group 4: Routine Pediatric Vaccines (Russian Federation)
Participants aged 2 months (at the time of enrollment) received Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
|
|---|---|---|---|---|
|
Percentage of Participants With >=4-Fold Rise in Antibody Titers Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With Menveo® Vaccine: Group 2
Serogroup A
|
85.0 percentage of participants
Interval 73.4 to 92.9
|
—
|
—
|
—
|
|
Percentage of Participants With >=4-Fold Rise in Antibody Titers Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With Menveo® Vaccine: Group 2
Serogroup C
|
88.3 percentage of participants
Interval 77.4 to 95.2
|
—
|
—
|
—
|
|
Percentage of Participants With >=4-Fold Rise in Antibody Titers Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With Menveo® Vaccine: Group 2
Serogroup Y
|
96.7 percentage of participants
Interval 88.5 to 99.6
|
—
|
—
|
—
|
|
Percentage of Participants With >=4-Fold Rise in Antibody Titers Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With Menveo® Vaccine: Group 2
Serogroup W
|
100 percentage of participants
Interval 94.0 to 100.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 30 days after the vaccination with Menveo® vaccine at the age of 12 months (i.e., at the age of 13 months)Population: Analysis was performed on PPAS2. Data for this outcome measure was not planned to be collected and analyzed for Group 4.
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 (Mexico)
n=60 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 6, and 12 along with Prevnar 13®, Hexacima®, vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6 and MMR®II vaccine at the age of Month 12.
|
Group 2: Menveo® Vaccine (Mexico)
Participants aged 2 months (at the time of enrollment) received Menveo® vaccine at the age of Months 2, 4, 6, and 12 along with Prevnar 13®, Hexacima® vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6, and MMR®II vaccine at the age of Month 12.
|
Group 3: MenACYW Conjugate Vaccine (Russian Federation)
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 3, 6, and 12 along with Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
|
Group 4: Routine Pediatric Vaccines (Russian Federation)
Participants aged 2 months (at the time of enrollment) received Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W Following Last Vaccination With Menveo® Vaccine: Group 2
Serogroup A
|
85.0 percentage of participants
Interval 73.4 to 92.9
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W Following Last Vaccination With Menveo® Vaccine: Group 2
Serogroup C
|
88.3 percentage of participants
Interval 77.4 to 95.2
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W Following Last Vaccination With Menveo® Vaccine: Group 2
Serogroup Y
|
96.7 percentage of participants
Interval 88.5 to 99.6
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W Following Last Vaccination With Menveo® Vaccine: Group 2
Serogroup W
|
100 percentage of participants
Interval 94.0 to 100.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 0 (before the first vaccination, at the age of 2 months), 30 days after the vaccination with MenACYW Conjugate vaccine at the age of 6 months (i.e., at the age of 7 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 4.
GMTs of antibody against meningococcal serogroups A, C, Y, and W were measured by serum bactericidal assay using rabbit complement (rSBA). Titers were expressed in terms of 1/dilution. Group 3 data were presented separately. Infant series here denotes the vaccines administered at the age of 6 months of participants.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine (Mexico)
n=90 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 6, and 12 along with Prevnar 13®, Hexacima®, vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6 and MMR®II vaccine at the age of Month 12.
|
Group 2: Menveo® Vaccine (Mexico)
n=40 Participants
Participants aged 2 months (at the time of enrollment) received Menveo® vaccine at the age of Months 2, 4, 6, and 12 along with Prevnar 13®, Hexacima® vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6, and MMR®II vaccine at the age of Month 12.
|
Group 3: MenACYW Conjugate Vaccine (Russian Federation)
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 3, 6, and 12 along with Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
|
Group 4: Routine Pediatric Vaccines (Russian Federation)
Participants aged 2 months (at the time of enrollment) received Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
|
|---|---|---|---|---|
|
Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by Serum Bactericidal Assay Using Baby Rabbit Complement Following MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2 (up to the Infant Age of 6 Months)
Serogroup A: Day 0
|
2.09 titers
Interval 1.96 to 2.23
|
2.03 titers
Interval 1.96 to 2.11
|
—
|
—
|
|
Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by Serum Bactericidal Assay Using Baby Rabbit Complement Following MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2 (up to the Infant Age of 6 Months)
Serogroup A: 30 days post-vaccination
|
387 titers
Interval 293.0 to 510.0
|
1328 titers
Interval 708.0 to 2489.0
|
—
|
—
|
|
Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by Serum Bactericidal Assay Using Baby Rabbit Complement Following MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2 (up to the Infant Age of 6 Months)
Serogroup C: Day 0
|
2.05 titers
Interval 1.95 to 2.14
|
2.38 titers
Interval 1.85 to 3.05
|
—
|
—
|
|
Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by Serum Bactericidal Assay Using Baby Rabbit Complement Following MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2 (up to the Infant Age of 6 Months)
Serogroup C: 30 days post-vaccination
|
1366 titers
Interval 1138.0 to 1640.0
|
235 titers
Interval 173.0 to 319.0
|
—
|
—
|
|
Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by Serum Bactericidal Assay Using Baby Rabbit Complement Following MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2 (up to the Infant Age of 6 Months)
Serogroup Y: Day 0
|
2.28 titers
Interval 1.93 to 2.69
|
2.93 titers
Interval 1.89 to 4.54
|
—
|
—
|
|
Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by Serum Bactericidal Assay Using Baby Rabbit Complement Following MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2 (up to the Infant Age of 6 Months)
Serogroup Y: 30 days post-vaccination
|
1056 titers
Interval 872.0 to 1280.0
|
549 titers
Interval 336.0 to 897.0
|
—
|
—
|
|
Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by Serum Bactericidal Assay Using Baby Rabbit Complement Following MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2 (up to the Infant Age of 6 Months)
Serogroup W: Day 0
|
2.00 titers
The 95% confidence interval was not computed as the standard deviation of the sample was 0, since all participants had the same value.
|
2.00 titers
The 95% confidence interval was not computed as the standard deviation of the sample was 0, since all participants had the same value.
|
—
|
—
|
|
Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by Serum Bactericidal Assay Using Baby Rabbit Complement Following MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2 (up to the Infant Age of 6 Months)
Serogroup W: 30 days post-vaccination
|
2587 titers
Interval 2071.0 to 3231.0
|
763 titers
Interval 509.0 to 1143.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 0 (before the first vaccination, at the age of Month 2), 30 days after the vaccination of MenACYW Conjugate vaccine at the age of 6 months (i.e., at the age of 7 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 4.
GMTs of antibody against meningococcal serogroups A, C, Y, and W were measured by serum bactericidal assay using rabbit complement (rSBA). Titers were expressed in terms of 1/dilution. Infant series here denotes the vaccines administered at the age of 6 months of participants.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine (Mexico)
n=56 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 6, and 12 along with Prevnar 13®, Hexacima®, vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6 and MMR®II vaccine at the age of Month 12.
|
Group 2: Menveo® Vaccine (Mexico)
Participants aged 2 months (at the time of enrollment) received Menveo® vaccine at the age of Months 2, 4, 6, and 12 along with Prevnar 13®, Hexacima® vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6, and MMR®II vaccine at the age of Month 12.
|
Group 3: MenACYW Conjugate Vaccine (Russian Federation)
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 3, 6, and 12 along with Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
|
Group 4: Routine Pediatric Vaccines (Russian Federation)
Participants aged 2 months (at the time of enrollment) received Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
|
|---|---|---|---|---|
|
Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by rSBA Following MenACYW Conjugate Vaccine: Group 3 (up to the Infant Age of 6 Months)
Serogroup A: Day 0
|
2.18 titers
Interval 1.83 to 2.61
|
—
|
—
|
—
|
|
Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by rSBA Following MenACYW Conjugate Vaccine: Group 3 (up to the Infant Age of 6 Months)
Serogroup A: 30 days post-vaccination
|
213 titers
Interval 126.0 to 358.0
|
—
|
—
|
—
|
|
Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by rSBA Following MenACYW Conjugate Vaccine: Group 3 (up to the Infant Age of 6 Months)
Serogroup C: Day 0
|
2.02 titers
Interval 1.98 to 2.08
|
—
|
—
|
—
|
|
Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by rSBA Following MenACYW Conjugate Vaccine: Group 3 (up to the Infant Age of 6 Months)
Serogroup C: 30 days post-vaccination
|
460 titers
Interval 286.0 to 738.0
|
—
|
—
|
—
|
|
Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by rSBA Following MenACYW Conjugate Vaccine: Group 3 (up to the Infant Age of 6 Months)
Serogroup Y: Day 0
|
2.15 titers
Interval 1.86 to 2.5
|
—
|
—
|
—
|
|
Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by rSBA Following MenACYW Conjugate Vaccine: Group 3 (up to the Infant Age of 6 Months)
Serogroup Y: 30 days post-vaccination
|
817 titers
Interval 587.0 to 1138.0
|
—
|
—
|
—
|
|
Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by rSBA Following MenACYW Conjugate Vaccine: Group 3 (up to the Infant Age of 6 Months)
Serogroup W: Day 0
|
2.15 titers
Interval 1.93 to 2.4
|
—
|
—
|
—
|
|
Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by rSBA Following MenACYW Conjugate Vaccine: Group 3 (up to the Infant Age of 6 Months)
Serogroup W: 30 days post-vaccination
|
961 titers
Interval 593.0 to 1558.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 30 days after the vaccination with MenACYW Conjugate or Menveo® vaccine at the age of 12 months (i.e., at the age of 13 months)Population: 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 4.
GMTs of antibody against meningococcal serogroups A, C, Y, and W were measured by rSBA. Titers were expressed in terms of 1/dilution. Group 3 data were presented separately.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine (Mexico)
n=57 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 6, and 12 along with Prevnar 13®, Hexacima®, vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6 and MMR®II vaccine at the age of Month 12.
|
Group 2: Menveo® Vaccine (Mexico)
n=25 Participants
Participants aged 2 months (at the time of enrollment) received Menveo® vaccine at the age of Months 2, 4, 6, and 12 along with Prevnar 13®, Hexacima® vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6, and MMR®II vaccine at the age of Month 12.
|
Group 3: MenACYW Conjugate Vaccine (Russian Federation)
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 3, 6, and 12 along with Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
|
Group 4: Routine Pediatric Vaccines (Russian Federation)
Participants aged 2 months (at the time of enrollment) received Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
|
|---|---|---|---|---|
|
Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by rSBA Following Last Vaccination With MenACYW Conjugate Vaccine or Menveo® Vaccine: Groups 1 and 2
Serogroup A
|
1102 titers
Interval 808.0 to 1502.0
|
5113 titers
Interval 2999.0 to 8717.0
|
—
|
—
|
|
Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by rSBA Following Last Vaccination With MenACYW Conjugate Vaccine or Menveo® Vaccine: Groups 1 and 2
Serogroup C
|
2023 titers
Interval 1551.0 to 2639.0
|
572 titers
Interval 338.0 to 969.0
|
—
|
—
|
|
Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by rSBA Following Last Vaccination With MenACYW Conjugate Vaccine or Menveo® Vaccine: Groups 1 and 2
Serogroup Y
|
1156 titers
Interval 913.0 to 1464.0
|
2288 titers
Interval 1343.0 to 3900.0
|
—
|
—
|
|
Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by rSBA Following Last Vaccination With MenACYW Conjugate Vaccine or Menveo® Vaccine: Groups 1 and 2
Serogroup W
|
3135 titers
Interval 2196.0 to 4474.0
|
1938 titers
Interval 1075.0 to 3493.0
|
—
|
—
|
SECONDARY outcome
Timeframe: 30 days after the vaccination with MenACYW Conjugate vaccine at the age of 12 months (i.e., at the age of 13 months)Population: 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 4.
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 (Mexico)
n=67 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 6, and 12 along with Prevnar 13®, Hexacima®, vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6 and MMR®II vaccine at the age of Month 12.
|
Group 2: Menveo® Vaccine (Mexico)
Participants aged 2 months (at the time of enrollment) received Menveo® vaccine at the age of Months 2, 4, 6, and 12 along with Prevnar 13®, Hexacima® vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6, and MMR®II vaccine at the age of Month 12.
|
Group 3: MenACYW Conjugate Vaccine (Russian Federation)
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 3, 6, and 12 along with Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
|
Group 4: Routine Pediatric Vaccines (Russian Federation)
Participants aged 2 months (at the time of enrollment) received Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
|
|---|---|---|---|---|
|
Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by rSBA Following Last Vaccination With MenACYW Conjugate Vaccine or Menveo® Vaccine: Group 3
Serogroup Y
|
586 titers
Interval 394.0 to 871.0
|
—
|
—
|
—
|
|
Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by rSBA Following Last Vaccination With MenACYW Conjugate Vaccine or Menveo® Vaccine: Group 3
Serogroup A
|
1234 titers
Interval 864.0 to 1762.0
|
—
|
—
|
—
|
|
Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by rSBA Following Last Vaccination With MenACYW Conjugate Vaccine or Menveo® Vaccine: Group 3
Serogroup C
|
236 titers
Interval 114.0 to 485.0
|
—
|
—
|
—
|
|
Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by rSBA Following Last Vaccination With MenACYW Conjugate Vaccine or Menveo® Vaccine: Group 3
Serogroup W
|
816 titers
Interval 464.0 to 1433.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 7 days after any vaccination and each vaccination (i.e., at the age 2 months, 3 months, 4 months, 4.5 months, 6 months and 12 months)Population: Safety analysis set. 'Number analyzed'=participants with available data for each specified category \& '0' in number analyzed field of specified age of vaccination (2, 3, 4, 4.5, 6 \& 12 months) signifies that no participants received specified category vaccine \& thus were not available for analysis. Reported AEs for each arm were presented as pre-specified in protocol \& were not planned to be collected for Rotavirus vaccine because it was given orally \& no injection site reactions were expected.
SR: expected AR (sign/symptom) observed \& reported under conditions (nature \& onset) prelisted (i.e., solicited) in protocol \& CRF. Injection site reactions were tenderness, erythema \& swelling. Assessment of injection site reactions after MenACYW Conjugate vaccine, Menveo, Prevnar 13, Hexacima, MMR, Pentaxim \& ENGERIX-B allowed local reactogenicity assessment \& helped to identify injection site reaction per vaccine received. Here, for Groups (Gps) 2 \& 4: "0" in number analyzed for MenACYW vaccine (Vac.) categories signifies that no participant were evaluable; for Gps 1, 3 \& 4: "0" in number analyzed for Menveo Vac. categories signifies that no participant were evaluable; for Gps 3 and 4: '0' in number analyzed field of Hexacima Vac. categories signifies that no participant were evaluable; for Gps 1 and 2: '0' in number analyzed field of Pentaxim and ENGERIX-B Vac. categories signifies that no participant were evaluable, as specified vaccines were not administered in specified groups.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine (Mexico)
n=201 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 6, and 12 along with Prevnar 13®, Hexacima®, vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6 and MMR®II vaccine at the age of Month 12.
|
Group 2: Menveo® Vaccine (Mexico)
n=99 Participants
Participants aged 2 months (at the time of enrollment) received Menveo® vaccine at the age of Months 2, 4, 6, and 12 along with Prevnar 13®, Hexacima® vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6, and MMR®II vaccine at the age of Month 12.
|
Group 3: MenACYW Conjugate Vaccine (Russian Federation)
n=150 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 3, 6, and 12 along with Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
|
Group 4: Routine Pediatric Vaccines (Russian Federation)
n=75 Participants
Participants aged 2 months (at the time of enrollment) received Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
|
|---|---|---|---|---|
|
Number of Participants With Solicited Injection Site Reactions After Any and Each Vaccination
MMR: Erythema: Post any vaccination
|
66 Participants
|
27 Participants
|
5 Participants
|
3 Participants
|
|
Number of Participants With Solicited Injection Site Reactions After Any and Each Vaccination
ENGERIX-B: Erythema: Post any vaccination
|
—
|
—
|
8 Participants
|
4 Participants
|
|
Number of Participants With Solicited Injection Site Reactions After Any and Each Vaccination
Prevnar 13: Erythema: Post vaccination at the age of 2 months
|
16 Participants
|
6 Participants
|
5 Participants
|
2 Participants
|
|
Number of Participants With Solicited Injection Site Reactions After Any and Each Vaccination
MenACYW conjugate vaccine: Swelling: Post vaccination at the age of 3 months
|
—
|
—
|
3 Participants
|
—
|
|
Number of Participants With Solicited Injection Site Reactions After Any and Each Vaccination
Pentaxim: Erythema: Post vaccination at the age of 4.5 months
|
—
|
—
|
7 Participants
|
2 Participants
|
|
Number of Participants With Solicited Injection Site Reactions After Any and Each Vaccination
Pentaxim: Swelling: Post vaccination at the age of 4.5 months
|
—
|
—
|
4 Participants
|
1 Participants
|
|
Number of Participants With Solicited Injection Site Reactions After Any and Each Vaccination
Hexacima: Tenderness: Post vaccination at the age of 6 months
|
73 Participants
|
30 Participants
|
—
|
—
|
|
Number of Participants With Solicited Injection Site Reactions After Any and Each Vaccination
MenACYW conjugate vaccine: Tenderness: Post any vaccination
|
121 Participants
|
—
|
9 Participants
|
—
|
|
Number of Participants With Solicited Injection Site Reactions After Any and Each Vaccination
MenACYW conjugate vaccine: Erythema: Post any vaccination
|
52 Participants
|
—
|
11 Participants
|
—
|
|
Number of Participants With Solicited Injection Site Reactions After Any and Each Vaccination
MenACYW conjugate vaccine: Swelling: Post any vaccination
|
24 Participants
|
—
|
6 Participants
|
—
|
|
Number of Participants With Solicited Injection Site Reactions After Any and Each Vaccination
Menveo: Tenderness: Post any vaccination
|
—
|
60 Participants
|
—
|
—
|
|
Number of Participants With Solicited Injection Site Reactions After Any and Each Vaccination
Menveo: Erythema: Post any vaccination
|
—
|
13 Participants
|
—
|
—
|
|
Number of Participants With Solicited Injection Site Reactions After Any and Each Vaccination
Menveo: Swelling: Post any vaccination
|
—
|
9 Participants
|
—
|
—
|
|
Number of Participants With Solicited Injection Site Reactions After Any and Each Vaccination
Prevnar 13: Tenderness: Post any vaccination
|
125 Participants
|
57 Participants
|
8 Participants
|
7 Participants
|
|
Number of Participants With Solicited Injection Site Reactions After Any and Each Vaccination
Prevnar 13: Erythema: Post any vaccination
|
48 Participants
|
20 Participants
|
9 Participants
|
4 Participants
|
|
Number of Participants With Solicited Injection Site Reactions After Any and Each Vaccination
Prevnar 13: Swelling: Post any vaccination
|
21 Participants
|
4 Participants
|
5 Participants
|
4 Participants
|
|
Number of Participants With Solicited Injection Site Reactions After Any and Each Vaccination
Hexacima: Tenderness: Post any vaccination
|
132 Participants
|
56 Participants
|
—
|
—
|
|
Number of Participants With Solicited Injection Site Reactions After Any and Each Vaccination
Hexacima: Erythema: Post any vaccination
|
73 Participants
|
20 Participants
|
—
|
—
|
|
Number of Participants With Solicited Injection Site Reactions After Any and Each Vaccination
Hexacima: Swelling: Post any vaccination
|
32 Participants
|
7 Participants
|
—
|
—
|
|
Number of Participants With Solicited Injection Site Reactions After Any and Each Vaccination
MMR: Tenderness: Post any vaccination
|
69 Participants
|
24 Participants
|
3 Participants
|
3 Participants
|
|
Number of Participants With Solicited Injection Site Reactions After Any and Each Vaccination
MMR: Swelling: Post any vaccination
|
14 Participants
|
6 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Solicited Injection Site Reactions After Any and Each Vaccination
Pentaxim: Tenderness: Post any vaccination
|
—
|
—
|
7 Participants
|
6 Participants
|
|
Number of Participants With Solicited Injection Site Reactions After Any and Each Vaccination
Pentaxim: Erythema: Post any vaccination
|
—
|
—
|
18 Participants
|
4 Participants
|
|
Number of Participants With Solicited Injection Site Reactions After Any and Each Vaccination
Pentaxim: Swelling: Post any vaccination
|
—
|
—
|
11 Participants
|
3 Participants
|
|
Number of Participants With Solicited Injection Site Reactions After Any and Each Vaccination
ENGERIX-B: Tenderness: Post any vaccination
|
—
|
—
|
5 Participants
|
3 Participants
|
|
Number of Participants With Solicited Injection Site Reactions After Any and Each Vaccination
ENGERIX-B: Swelling: Post any vaccination
|
—
|
—
|
5 Participants
|
1 Participants
|
|
Number of Participants With Solicited Injection Site Reactions After Any and Each Vaccination
MenACYW conjugate vaccine: Tenderness: Post vaccination at the age of 2 months
|
87 Participants
|
—
|
—
|
—
|
|
Number of Participants With Solicited Injection Site Reactions After Any and Each Vaccination
MenACYW conjugate vaccine: Erythema: Post vaccination at the age of 2 months
|
19 Participants
|
—
|
—
|
—
|
|
Number of Participants With Solicited Injection Site Reactions After Any and Each Vaccination
MenACYW conjugate vaccine: Swelling: Post vaccination at the age of 2 months
|
9 Participants
|
—
|
—
|
—
|
|
Number of Participants With Solicited Injection Site Reactions After Any and Each Vaccination
Menveo: Tenderness: Post vaccination at the age of 2 months
|
—
|
38 Participants
|
—
|
—
|
|
Number of Participants With Solicited Injection Site Reactions After Any and Each Vaccination
Menveo: Erythema: Post vaccination at the age of 2 months
|
—
|
6 Participants
|
—
|
—
|
|
Number of Participants With Solicited Injection Site Reactions After Any and Each Vaccination
Menveo: Swelling: Post vaccination at the age of 2 months
|
—
|
3 Participants
|
—
|
—
|
|
Number of Participants With Solicited Injection Site Reactions After Any and Each Vaccination
Prevnar 13: Tenderness: Post vaccination at the age of 2 months
|
81 Participants
|
35 Participants
|
5 Participants
|
5 Participants
|
|
Number of Participants With Solicited Injection Site Reactions After Any and Each Vaccination
Prevnar 13: Swelling: Post vaccination at the age of 2 months
|
6 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Solicited Injection Site Reactions After Any and Each Vaccination
Hexacima: Tenderness: Post vaccination at the age of 2 months
|
82 Participants
|
32 Participants
|
—
|
—
|
|
Number of Participants With Solicited Injection Site Reactions After Any and Each Vaccination
Hexacima: Erythema: Post vaccination at the age of 2 months
|
21 Participants
|
5 Participants
|
—
|
—
|
|
Number of Participants With Solicited Injection Site Reactions After Any and Each Vaccination
Hexacima: Swelling: Post vaccination at the age of 2 months
|
9 Participants
|
3 Participants
|
—
|
—
|
|
Number of Participants With Solicited Injection Site Reactions After Any and Each Vaccination
MenACYW conjugate vaccine: Tenderness: Post vaccination at the age of 3 months
|
—
|
—
|
4 Participants
|
—
|
|
Number of Participants With Solicited Injection Site Reactions After Any and Each Vaccination
MenACYW conjugate vaccine: Erythema: Post vaccination at the age of 3 months
|
—
|
—
|
6 Participants
|
—
|
|
Number of Participants With Solicited Injection Site Reactions After Any and Each Vaccination
Pentaxim: Tenderness: Post vaccination at the age of 3 months
|
—
|
—
|
3 Participants
|
2 Participants
|
|
Number of Participants With Solicited Injection Site Reactions After Any and Each Vaccination
Pentaxim: Erythema: Post vaccination at the age of 3 months
|
—
|
—
|
7 Participants
|
2 Participants
|
|
Number of Participants With Solicited Injection Site Reactions After Any and Each Vaccination
Pentaxim: Swelling: Post vaccination at the age of 3 months
|
—
|
—
|
4 Participants
|
2 Participants
|
|
Number of Participants With Solicited Injection Site Reactions After Any and Each Vaccination
Menveo: Tenderness: Post vaccination at the age of 4 months
|
—
|
36 Participants
|
—
|
—
|
|
Number of Participants With Solicited Injection Site Reactions After Any and Each Vaccination
Menveo: Erythema: Post vaccination at the age of 4 months
|
—
|
3 Participants
|
—
|
—
|
|
Number of Participants With Solicited Injection Site Reactions After Any and Each Vaccination
Menveo: Swelling: Post vaccination at the age of 4 months
|
—
|
3 Participants
|
—
|
—
|
|
Number of Participants With Solicited Injection Site Reactions After Any and Each Vaccination
Prevnar 13: Tenderness: Post vaccination at the age of 4 months
|
71 Participants
|
32 Participants
|
—
|
—
|
|
Number of Participants With Solicited Injection Site Reactions After Any and Each Vaccination
Prevnar 13: Erythema: Post vaccination at the age of 4 months
|
21 Participants
|
4 Participants
|
—
|
—
|
|
Number of Participants With Solicited Injection Site Reactions After Any and Each Vaccination
Prevnar 13: Swelling: Post vaccination at the age of 4 months
|
8 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants With Solicited Injection Site Reactions After Any and Each Vaccination
Hexacima: Tenderness: Post vaccination at the age of 4 months
|
77 Participants
|
33 Participants
|
—
|
—
|
|
Number of Participants With Solicited Injection Site Reactions After Any and Each Vaccination
Hexacima: Erythema: Post vaccination at the age of 4 months
|
26 Participants
|
4 Participants
|
—
|
—
|
|
Number of Participants With Solicited Injection Site Reactions After Any and Each Vaccination
Hexacima: Swelling: Post vaccination at the age of 4 months
|
15 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants With Solicited Injection Site Reactions After Any and Each Vaccination
Prevnar 13: Tenderness: Post vaccination at the age of 4.5 months
|
—
|
—
|
5 Participants
|
4 Participants
|
|
Number of Participants With Solicited Injection Site Reactions After Any and Each Vaccination
Prevnar 13: Erythema: Post vaccination at the age of 4.5 months
|
—
|
—
|
5 Participants
|
2 Participants
|
|
Number of Participants With Solicited Injection Site Reactions After Any and Each Vaccination
Prevnar 13: Swelling: Post vaccination at the age of 4.5 months
|
—
|
—
|
3 Participants
|
2 Participants
|
|
Number of Participants With Solicited Injection Site Reactions After Any and Each Vaccination
Pentaxim: Tenderness: Post vaccination at the age of 4.5 months
|
—
|
—
|
3 Participants
|
4 Participants
|
|
Number of Participants With Solicited Injection Site Reactions After Any and Each Vaccination
MenACYW conjugate vaccine: Tenderness: Post vaccination at the age of 6 months
|
75 Participants
|
—
|
6 Participants
|
—
|
|
Number of Participants With Solicited Injection Site Reactions After Any and Each Vaccination
MenACYW conjugate vaccine: Erythema: Post vaccination at the age of 6 months
|
20 Participants
|
—
|
7 Participants
|
—
|
|
Number of Participants With Solicited Injection Site Reactions After Any and Each Vaccination
MenACYW conjugate vaccine: Swelling: Post vaccination at the age of 6 months
|
7 Participants
|
—
|
2 Participants
|
—
|
|
Number of Participants With Solicited Injection Site Reactions After Any and Each Vaccination
Menveo: Tenderness: Post vaccination at the age of 6 months
|
—
|
31 Participants
|
—
|
—
|
|
Number of Participants With Solicited Injection Site Reactions After Any and Each Vaccination
Menveo: Erythema: Post vaccination at the age of 6 months
|
—
|
4 Participants
|
—
|
—
|
|
Number of Participants With Solicited Injection Site Reactions After Any and Each Vaccination
Menveo: Swelling: Post vaccination at the age of 6 months
|
—
|
1 Participants
|
—
|
—
|
|
Number of Participants With Solicited Injection Site Reactions After Any and Each Vaccination
Prevnar 13: Tenderness: Post vaccination at the age of 6 months
|
75 Participants
|
30 Participants
|
—
|
—
|
|
Number of Participants With Solicited Injection Site Reactions After Any and Each Vaccination
Prevnar 13: Erythema: Post vaccination at the age of 6 months
|
21 Participants
|
10 Participants
|
—
|
—
|
|
Number of Participants With Solicited Injection Site Reactions After Any and Each Vaccination
Prevnar 13: Swelling: Post vaccination at the age of 6 months
|
8 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Solicited Injection Site Reactions After Any and Each Vaccination
Hexacima: Erythema: Post vaccination at the age of 6 months
|
32 Participants
|
11 Participants
|
—
|
—
|
|
Number of Participants With Solicited Injection Site Reactions After Any and Each Vaccination
Hexacima: Swelling: Post vaccination at the age of 6 months
|
11 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants With Solicited Injection Site Reactions After Any and Each Vaccination
Pentaxim: Tenderness: Post vaccination at the age of 6 months
|
—
|
—
|
5 Participants
|
3 Participants
|
|
Number of Participants With Solicited Injection Site Reactions After Any and Each Vaccination
Pentaxim: Erythema: Post vaccination at the age of 6 months
|
—
|
—
|
11 Participants
|
3 Participants
|
|
Number of Participants With Solicited Injection Site Reactions After Any and Each Vaccination
Pentaxim: Swelling: Post vaccination at the age of 6 months
|
—
|
—
|
5 Participants
|
2 Participants
|
|
Number of Participants With Solicited Injection Site Reactions After Any and Each Vaccination
ENGERIX-B: Tenderness: Post vaccination at the age of 6 months
|
—
|
—
|
5 Participants
|
3 Participants
|
|
Number of Participants With Solicited Injection Site Reactions After Any and Each Vaccination
ENGERIX-B: Erythema: Post vaccination at the age of 6 months
|
—
|
—
|
8 Participants
|
4 Participants
|
|
Number of Participants With Solicited Injection Site Reactions After Any and Each Vaccination
ENGERIX-B: Swelling: Post vaccination at the age of 6 months
|
—
|
—
|
5 Participants
|
1 Participants
|
|
Number of Participants With Solicited Injection Site Reactions After Any and Each Vaccination
MenACYW conjugate vaccine: Tenderness: Post vaccination at the age of 12 months
|
77 Participants
|
—
|
4 Participants
|
—
|
|
Number of Participants With Solicited Injection Site Reactions After Any and Each Vaccination
MenACYW conjugate vaccine: Erythema: Post vaccination at the age of 12 months
|
27 Participants
|
—
|
3 Participants
|
—
|
|
Number of Participants With Solicited Injection Site Reactions After Any and Each Vaccination
MenACYW conjugate vaccine: Swelling: Post vaccination at the age of 12 months
|
11 Participants
|
—
|
2 Participants
|
—
|
|
Number of Participants With Solicited Injection Site Reactions After Any and Each Vaccination
Menveo: Tenderness: Post vaccination at the age of 12 months
|
—
|
30 Participants
|
—
|
—
|
|
Number of Participants With Solicited Injection Site Reactions After Any and Each Vaccination
Menveo: Erythema: Post vaccination at the age of 12 months
|
—
|
9 Participants
|
—
|
—
|
|
Number of Participants With Solicited Injection Site Reactions After Any and Each Vaccination
Menveo: Swelling: Post vaccination at the age of 12 months
|
—
|
3 Participants
|
—
|
—
|
|
Number of Participants With Solicited Injection Site Reactions After Any and Each Vaccination
Prevnar 13: Tenderness: Post vaccination at the age of 12 months
|
50 Participants
|
21 Participants
|
—
|
—
|
|
Number of Participants With Solicited Injection Site Reactions After Any and Each Vaccination
Prevnar 13: Erythema: Post vaccination at the age of 12 months
|
15 Participants
|
10 Participants
|
—
|
—
|
|
Number of Participants With Solicited Injection Site Reactions After Any and Each Vaccination
Prevnar 13: Swelling: Post vaccination at the age of 12 months
|
10 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants With Solicited Injection Site Reactions After Any and Each Vaccination
Hexacima: Tenderness: Post vaccination at the age of 12 months
|
79 Participants
|
29 Participants
|
—
|
—
|
|
Number of Participants With Solicited Injection Site Reactions After Any and Each Vaccination
Hexacima: Erythema: Post vaccination at the age of 12 months
|
37 Participants
|
16 Participants
|
—
|
—
|
|
Number of Participants With Solicited Injection Site Reactions After Any and Each Vaccination
Hexacima: Swelling: Post vaccination at the age of 12 months
|
16 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants With Solicited Injection Site Reactions After Any and Each Vaccination
MMR: Tenderness: Post vaccination at the age of 12 months
|
69 Participants
|
24 Participants
|
3 Participants
|
3 Participants
|
|
Number of Participants With Solicited Injection Site Reactions After Any and Each Vaccination
MMR: Erythema: Post vaccination at the age of 12 months
|
66 Participants
|
27 Participants
|
5 Participants
|
3 Participants
|
|
Number of Participants With Solicited Injection Site Reactions After Any and Each Vaccination
MMR: Swelling: Post vaccination at the age of 12 months
|
14 Participants
|
6 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Within 7 days after any vaccination and each vaccination (i.e., at the age of 2 months, 3 months, 4 months, 4.5 months, 6 months and 12 months)Population: Analysis was performed on safety analysis set. Here, 'Number analyzed'=participants with available data for each specified category and '0' in the number analyzed field signifies that none of the participants received the specified category vaccination and thus were not available for analysis.
A solicited reaction (SR) was an expected adverse reaction (AR) (sign or symptom) observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the case report form (CRF) 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 (Mexico)
n=201 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 6, and 12 along with Prevnar 13®, Hexacima®, vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6 and MMR®II vaccine at the age of Month 12.
|
Group 2: Menveo® Vaccine (Mexico)
n=99 Participants
Participants aged 2 months (at the time of enrollment) received Menveo® vaccine at the age of Months 2, 4, 6, and 12 along with Prevnar 13®, Hexacima® vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6, and MMR®II vaccine at the age of Month 12.
|
Group 3: MenACYW Conjugate Vaccine (Russian Federation)
n=150 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 3, 6, and 12 along with Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
|
Group 4: Routine Pediatric Vaccines (Russian Federation)
n=75 Participants
Participants aged 2 months (at the time of enrollment) received Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
|
|---|---|---|---|---|
|
Number of Participants With Solicited Systemic Reactions After Any and Each Vaccination
Fever: Post-any vaccination
|
84 Participants
|
33 Participants
|
11 Participants
|
6 Participants
|
|
Number of Participants With Solicited Systemic Reactions After Any and Each Vaccination
Vomiting: Post-any vaccination
|
39 Participants
|
11 Participants
|
6 Participants
|
0 Participants
|
|
Number of Participants With Solicited Systemic Reactions After Any and Each Vaccination
Crying abnormal: Post-any vaccination
|
117 Participants
|
50 Participants
|
18 Participants
|
6 Participants
|
|
Number of Participants With Solicited Systemic Reactions After Any and Each Vaccination
Drowsiness: Post-any vaccination
|
80 Participants
|
36 Participants
|
33 Participants
|
17 Participants
|
|
Number of Participants With Solicited Systemic Reactions After Any and Each Vaccination
Appetite lost: Post-any vaccination
|
72 Participants
|
33 Participants
|
26 Participants
|
11 Participants
|
|
Number of Participants With Solicited Systemic Reactions After Any and Each Vaccination
Irritability: Post-any vaccination
|
134 Participants
|
58 Participants
|
32 Participants
|
20 Participants
|
|
Number of Participants With Solicited Systemic Reactions After Any and Each Vaccination
Fever: Post vaccination at the age of 2 months
|
29 Participants
|
11 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Systemic Reactions After Any and Each Vaccination
Vomiting: Post vaccination at the age of 2 months
|
18 Participants
|
6 Participants
|
4 Participants
|
0 Participants
|
|
Number of Participants With Solicited Systemic Reactions After Any and Each Vaccination
Crying abnormal: Post vaccination at the age of 2 months
|
72 Participants
|
29 Participants
|
9 Participants
|
2 Participants
|
|
Number of Participants With Solicited Systemic Reactions After Any and Each Vaccination
Drowsiness: Post vaccination at the age of 2 months
|
51 Participants
|
19 Participants
|
15 Participants
|
7 Participants
|
|
Number of Participants With Solicited Systemic Reactions After Any and Each Vaccination
Appetite lost: Post vaccination at the age of 2 months
|
34 Participants
|
13 Participants
|
7 Participants
|
2 Participants
|
|
Number of Participants With Solicited Systemic Reactions After Any and Each Vaccination
Irritability: Post vaccination at the age of 2 months
|
92 Participants
|
44 Participants
|
13 Participants
|
6 Participants
|
|
Number of Participants With Solicited Systemic Reactions After Any and Each Vaccination
Fever: Post vaccination at the age of 3 months
|
—
|
—
|
0 Participants
|
1 Participants
|
|
Number of Participants With Solicited Systemic Reactions After Any and Each Vaccination
Vomiting: Post vaccination at the age of 3 months
|
—
|
—
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Systemic Reactions After Any and Each Vaccination
Crying abnormal: Post vaccination at the age of 3 months
|
—
|
—
|
6 Participants
|
0 Participants
|
|
Number of Participants With Solicited Systemic Reactions After Any and Each Vaccination
Drowsiness: Post vaccination at the age of 3 months
|
—
|
—
|
9 Participants
|
4 Participants
|
|
Number of Participants With Solicited Systemic Reactions After Any and Each Vaccination
Appetite lost: Post vaccination at the age of 3 months
|
—
|
—
|
5 Participants
|
1 Participants
|
|
Number of Participants With Solicited Systemic Reactions After Any and Each Vaccination
Irritability: Post vaccination at the age of 3 months
|
—
|
—
|
5 Participants
|
6 Participants
|
|
Number of Participants With Solicited Systemic Reactions After Any and Each Vaccination
Fever: Post vaccination at the age of 4 months
|
28 Participants
|
17 Participants
|
—
|
—
|
|
Number of Participants With Solicited Systemic Reactions After Any and Each Vaccination
Vomiting: Post vaccination at the age of 4 months
|
12 Participants
|
5 Participants
|
—
|
—
|
|
Number of Participants With Solicited Systemic Reactions After Any and Each Vaccination
Crying abnormal: Post vaccination at the age of 4 months
|
61 Participants
|
30 Participants
|
—
|
—
|
|
Number of Participants With Solicited Systemic Reactions After Any and Each Vaccination
Drowsiness: Post vaccination at the age of 4 months
|
36 Participants
|
21 Participants
|
—
|
—
|
|
Number of Participants With Solicited Systemic Reactions After Any and Each Vaccination
Appetite lost: Post vaccination at the age of 4 months
|
30 Participants
|
12 Participants
|
—
|
—
|
|
Number of Participants With Solicited Systemic Reactions After Any and Each Vaccination
Irritability: Post vaccination at the age of 4 months
|
74 Participants
|
38 Participants
|
—
|
—
|
|
Number of Participants With Solicited Systemic Reactions After Any and Each Vaccination
Fever: Post vaccination at the age of 4.5 months
|
—
|
—
|
9 Participants
|
5 Participants
|
|
Number of Participants With Solicited Systemic Reactions After Any and Each Vaccination
Vomiting: Post vaccination at the age of 4.5 months
|
—
|
—
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Systemic Reactions After Any and Each Vaccination
Crying abnormal: Post vaccination at the age of 4.5 months
|
—
|
—
|
8 Participants
|
3 Participants
|
|
Number of Participants With Solicited Systemic Reactions After Any and Each Vaccination
Drowsiness: Post vaccination at the age of 4.5 months
|
—
|
—
|
13 Participants
|
6 Participants
|
|
Number of Participants With Solicited Systemic Reactions After Any and Each Vaccination
Appetite lost: Post vaccination at the age of 4.5 months
|
—
|
—
|
12 Participants
|
4 Participants
|
|
Number of Participants With Solicited Systemic Reactions After Any and Each Vaccination
Irritability: Post vaccination at the age of 4.5 months
|
—
|
—
|
17 Participants
|
10 Participants
|
|
Number of Participants With Solicited Systemic Reactions After Any and Each Vaccination
Fever: Post vaccination at the age of 6 months
|
26 Participants
|
7 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Solicited Systemic Reactions After Any and Each Vaccination
Vomiting: Post vaccination at the age of 6 months
|
13 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Solicited Systemic Reactions After Any and Each Vaccination
Crying abnormal: Post vaccination at the age of 6 months
|
60 Participants
|
20 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Solicited Systemic Reactions After Any and Each Vaccination
Drowsiness: Post vaccination at the age of 6 months
|
38 Participants
|
12 Participants
|
12 Participants
|
6 Participants
|
|
Number of Participants With Solicited Systemic Reactions After Any and Each Vaccination
Appetite lost: Post vaccination at the age of 6 months
|
20 Participants
|
10 Participants
|
10 Participants
|
6 Participants
|
|
Number of Participants With Solicited Systemic Reactions After Any and Each Vaccination
Irritability: Post vaccination at the age of 6 months
|
77 Participants
|
26 Participants
|
10 Participants
|
10 Participants
|
|
Number of Participants With Solicited Systemic Reactions After Any and Each Vaccination
Fever: Post vaccination at the age of 12 months
|
39 Participants
|
9 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Solicited Systemic Reactions After Any and Each Vaccination
Vomiting: Post vaccination at the age of 12 months
|
10 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Solicited Systemic Reactions After Any and Each Vaccination
Crying abnormal: Post vaccination at the age of 12 months
|
60 Participants
|
21 Participants
|
4 Participants
|
2 Participants
|
|
Number of Participants With Solicited Systemic Reactions After Any and Each Vaccination
Drowsiness: Post vaccination at the age of 12 months
|
33 Participants
|
14 Participants
|
6 Participants
|
7 Participants
|
|
Number of Participants With Solicited Systemic Reactions After Any and Each Vaccination
Appetite lost: Post vaccination at the age of 12 months
|
43 Participants
|
16 Participants
|
11 Participants
|
3 Participants
|
|
Number of Participants With Solicited Systemic Reactions After Any and Each Vaccination
Irritability: Post vaccination at the age of 12 months
|
75 Participants
|
26 Participants
|
13 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Within 30 days after any vaccination and each vaccination (i.e., at the age 2 months, 3 months, 4 months, 4.5 months, 6 months and 12 months)Population: Analysis was performed on safety analysis set. Here, 'Number analyzed'=participants with available data for each specified category and '0' in the number analyzed field signifies that none of the participants received the specified category vaccination and thus were not available for analysis.
An AE was any untoward medical occurrence in a participant or in a clinical investigation participant administered a medicinal product and which did not had any casual relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination. Reported AEs for each arm were presented as pre-specified in the study protocol.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine (Mexico)
n=201 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 6, and 12 along with Prevnar 13®, Hexacima®, vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6 and MMR®II vaccine at the age of Month 12.
|
Group 2: Menveo® Vaccine (Mexico)
n=99 Participants
Participants aged 2 months (at the time of enrollment) received Menveo® vaccine at the age of Months 2, 4, 6, and 12 along with Prevnar 13®, Hexacima® vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6, and MMR®II vaccine at the age of Month 12.
|
Group 3: MenACYW Conjugate Vaccine (Russian Federation)
n=150 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 3, 6, and 12 along with Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
|
Group 4: Routine Pediatric Vaccines (Russian Federation)
n=75 Participants
Participants aged 2 months (at the time of enrollment) received Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
|
|---|---|---|---|---|
|
Number of Participants With Unsolicited Adverse Events After Any and Each Vaccination
Post-any vaccination
|
100 Participants
|
47 Participants
|
15 Participants
|
6 Participants
|
|
Number of Participants With Unsolicited Adverse Events After Any and Each Vaccination
Post vaccination at the age of 2 months
|
33 Participants
|
15 Participants
|
5 Participants
|
3 Participants
|
|
Number of Participants With Unsolicited Adverse Events After Any and Each Vaccination
Post vaccination at the age of 3 months
|
—
|
—
|
4 Participants
|
1 Participants
|
|
Number of Participants With Unsolicited Adverse Events After Any and Each Vaccination
Post vaccination at the age of 4 months
|
25 Participants
|
15 Participants
|
—
|
—
|
|
Number of Participants With Unsolicited Adverse Events After Any and Each Vaccination
Post vaccination at the age of 4.5 months
|
—
|
—
|
5 Participants
|
0 Participants
|
|
Number of Participants With Unsolicited Adverse Events After Any and Each Vaccination
Post vaccination at the age of 6 months
|
45 Participants
|
23 Participants
|
4 Participants
|
3 Participants
|
|
Number of Participants With Unsolicited Adverse Events After Any and Each Vaccination
Post vaccination at the age of 12 months
|
43 Participants
|
17 Participants
|
5 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each Group (i.e., up to the age of 13 months)Population: Analysis was performed on safety analysis set.
A SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. An AESI was an event for which ongoing monitoring and rapid communication by the Investigator to the Sponsor must be done. Such an event might warrant further investigation in order to characterize and understand it. Depending on the nature of the event, rapid communication by the study Sponsor to other parties (e.g, regulators) might also be warranted. Reported AEs for each arm were presented as pre-specified in the study protocol.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine (Mexico)
n=201 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 6, and 12 along with Prevnar 13®, Hexacima®, vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6 and MMR®II vaccine at the age of Month 12.
|
Group 2: Menveo® Vaccine (Mexico)
n=99 Participants
Participants aged 2 months (at the time of enrollment) received Menveo® vaccine at the age of Months 2, 4, 6, and 12 along with Prevnar 13®, Hexacima® vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6, and MMR®II vaccine at the age of Month 12.
|
Group 3: MenACYW Conjugate Vaccine (Russian Federation)
n=150 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 3, 6, and 12 along with Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
|
Group 4: Routine Pediatric Vaccines (Russian Federation)
n=75 Participants
Participants aged 2 months (at the time of enrollment) received Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
|
|---|---|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs) and Adverse Events of Special Interests (AESIs)
SAE
|
4 Participants
|
3 Participants
|
4 Participants
|
2 Participants
|
|
Number of Participants With Serious Adverse Events (SAEs) and Adverse Events of Special Interests (AESIs)
AESI
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 30 days after the vaccination at the age of 6 months of the infant series (i.e., at the age of 7 months)Population: Analysis was performed on PPAS1. Data for this outcome measure was not planned to be collected and analyzed for Group 4.
Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by hSBA assay. Percentage of participants with hSBA Titers distribution \< 1:4, 1:4 and 1:8 is reported in this outcome measure. Infant series here denotes the vaccines administered at the age of 6 months of participants.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine (Mexico)
n=176 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 6, and 12 along with Prevnar 13®, Hexacima®, vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6 and MMR®II vaccine at the age of Month 12.
|
Group 2: Menveo® Vaccine (Mexico)
n=81 Participants
Participants aged 2 months (at the time of enrollment) received Menveo® vaccine at the age of Months 2, 4, 6, and 12 along with Prevnar 13®, Hexacima® vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6, and MMR®II vaccine at the age of Month 12.
|
Group 3: MenACYW Conjugate Vaccine (Russian Federation)
n=97 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 3, 6, and 12 along with Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
|
Group 4: Routine Pediatric Vaccines (Russian Federation)
Participants aged 2 months (at the time of enrollment) received Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
|
|---|---|---|---|---|
|
Percentage of Participants With hSBA Titers Distribution Less Than (<) 1:4, 1:4 and 1:8 Against Meningococcal Serogroups A, C, Y and W Following Last Vaccination With MenACYW Conjugate or Menveo® Vaccine: Groups 1, 2 and 3 (up to Infant Age of 6 Months)
Serogroup A: <1:4
|
4.0 percentage of participants
|
14.8 percentage of participants
|
6.2 percentage of participants
|
—
|
|
Percentage of Participants With hSBA Titers Distribution Less Than (<) 1:4, 1:4 and 1:8 Against Meningococcal Serogroups A, C, Y and W Following Last Vaccination With MenACYW Conjugate or Menveo® Vaccine: Groups 1, 2 and 3 (up to Infant Age of 6 Months)
Serogroup A: 1:4
|
5.1 percentage of participants
|
16.0 percentage of participants
|
15.5 percentage of participants
|
—
|
|
Percentage of Participants With hSBA Titers Distribution Less Than (<) 1:4, 1:4 and 1:8 Against Meningococcal Serogroups A, C, Y and W Following Last Vaccination With MenACYW Conjugate or Menveo® Vaccine: Groups 1, 2 and 3 (up to Infant Age of 6 Months)
Serogroup A: 1:8
|
4.5 percentage of participants
|
11.1 percentage of participants
|
8.2 percentage of participants
|
—
|
|
Percentage of Participants With hSBA Titers Distribution Less Than (<) 1:4, 1:4 and 1:8 Against Meningococcal Serogroups A, C, Y and W Following Last Vaccination With MenACYW Conjugate or Menveo® Vaccine: Groups 1, 2 and 3 (up to Infant Age of 6 Months)
Serogroup C: <1:4
|
0 percentage of participants
|
1.2 percentage of participants
|
5.2 percentage of participants
|
—
|
|
Percentage of Participants With hSBA Titers Distribution Less Than (<) 1:4, 1:4 and 1:8 Against Meningococcal Serogroups A, C, Y and W Following Last Vaccination With MenACYW Conjugate or Menveo® Vaccine: Groups 1, 2 and 3 (up to Infant Age of 6 Months)
Serogroup C: 1:4
|
0 percentage of participants
|
1.2 percentage of participants
|
0 percentage of participants
|
—
|
|
Percentage of Participants With hSBA Titers Distribution Less Than (<) 1:4, 1:4 and 1:8 Against Meningococcal Serogroups A, C, Y and W Following Last Vaccination With MenACYW Conjugate or Menveo® Vaccine: Groups 1, 2 and 3 (up to Infant Age of 6 Months)
Serogroup C: 1:8
|
0 percentage of participants
|
9.9 percentage of participants
|
0 percentage of participants
|
—
|
|
Percentage of Participants With hSBA Titers Distribution Less Than (<) 1:4, 1:4 and 1:8 Against Meningococcal Serogroups A, C, Y and W Following Last Vaccination With MenACYW Conjugate or Menveo® Vaccine: Groups 1, 2 and 3 (up to Infant Age of 6 Months)
Serogroup Y: <1:4
|
0.6 percentage of participants
|
1.2 percentage of participants
|
5.2 percentage of participants
|
—
|
|
Percentage of Participants With hSBA Titers Distribution Less Than (<) 1:4, 1:4 and 1:8 Against Meningococcal Serogroups A, C, Y and W Following Last Vaccination With MenACYW Conjugate or Menveo® Vaccine: Groups 1, 2 and 3 (up to Infant Age of 6 Months)
Serogroup Y: 1:4
|
0 percentage of participants
|
1.2 percentage of participants
|
2.1 percentage of participants
|
—
|
|
Percentage of Participants With hSBA Titers Distribution Less Than (<) 1:4, 1:4 and 1:8 Against Meningococcal Serogroups A, C, Y and W Following Last Vaccination With MenACYW Conjugate or Menveo® Vaccine: Groups 1, 2 and 3 (up to Infant Age of 6 Months)
Serogroup Y: 1:8
|
0 percentage of participants
|
1.2 percentage of participants
|
3.1 percentage of participants
|
—
|
|
Percentage of Participants With hSBA Titers Distribution Less Than (<) 1:4, 1:4 and 1:8 Against Meningococcal Serogroups A, C, Y and W Following Last Vaccination With MenACYW Conjugate or Menveo® Vaccine: Groups 1, 2 and 3 (up to Infant Age of 6 Months)
Serogroup W: <1:4
|
0.6 percentage of participants
|
0 percentage of participants
|
5.2 percentage of participants
|
—
|
|
Percentage of Participants With hSBA Titers Distribution Less Than (<) 1:4, 1:4 and 1:8 Against Meningococcal Serogroups A, C, Y and W Following Last Vaccination With MenACYW Conjugate or Menveo® Vaccine: Groups 1, 2 and 3 (up to Infant Age of 6 Months)
Serogroup W: 1:4
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
|
Percentage of Participants With hSBA Titers Distribution Less Than (<) 1:4, 1:4 and 1:8 Against Meningococcal Serogroups A, C, Y and W Following Last Vaccination With MenACYW Conjugate or Menveo® Vaccine: Groups 1, 2 and 3 (up to Infant Age of 6 Months)
Serogroup W: 1:8
|
0 percentage of participants
|
1.2 percentage of participants
|
1.0 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: 30 days after the vaccination at the age of 12 months (i.e., at the age of 13 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 4.
Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by hSBA assay. Percentage of participants with hSBA Titers distribution \< 1:4, 1:4 and 1:8 is reported in this outcome measure.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine (Mexico)
n=126 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 6, and 12 along with Prevnar 13®, Hexacima®, vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6 and MMR®II vaccine at the age of Month 12.
|
Group 2: Menveo® Vaccine (Mexico)
n=60 Participants
Participants aged 2 months (at the time of enrollment) received Menveo® vaccine at the age of Months 2, 4, 6, and 12 along with Prevnar 13®, Hexacima® vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6, and MMR®II vaccine at the age of Month 12.
|
Group 3: MenACYW Conjugate Vaccine (Russian Federation)
n=96 Participants
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 3, 6, and 12 along with Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
|
Group 4: Routine Pediatric Vaccines (Russian Federation)
Participants aged 2 months (at the time of enrollment) received Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
|
|---|---|---|---|---|
|
Percentage of Participants With hSBA Titers Distribution <1:4, 1:4 and 1:8 Against Meningococcal Serogroups A, C, Y, and W Following Last Vaccination With MenACYW Conjugate or Menveo® Vaccine: Groups 1, 2 and 3
Serogroup A: <1:4
|
1.6 percentage of participants
|
3.3 percentage of participants
|
2.1 percentage of participants
|
—
|
|
Percentage of Participants With hSBA Titers Distribution <1:4, 1:4 and 1:8 Against Meningococcal Serogroups A, C, Y, and W Following Last Vaccination With MenACYW Conjugate or Menveo® Vaccine: Groups 1, 2 and 3
Serogroup A: 1:4
|
0.8 percentage of participants
|
1.7 percentage of participants
|
8.3 percentage of participants
|
—
|
|
Percentage of Participants With hSBA Titers Distribution <1:4, 1:4 and 1:8 Against Meningococcal Serogroups A, C, Y, and W Following Last Vaccination With MenACYW Conjugate or Menveo® Vaccine: Groups 1, 2 and 3
Serogroup A: 1:8
|
0.8 percentage of participants
|
10.0 percentage of participants
|
15.6 percentage of participants
|
—
|
|
Percentage of Participants With hSBA Titers Distribution <1:4, 1:4 and 1:8 Against Meningococcal Serogroups A, C, Y, and W Following Last Vaccination With MenACYW Conjugate or Menveo® Vaccine: Groups 1, 2 and 3
Serogroup C: <1:4
|
0 percentage of participants
|
3.3 percentage of participants
|
8.3 percentage of participants
|
—
|
|
Percentage of Participants With hSBA Titers Distribution <1:4, 1:4 and 1:8 Against Meningococcal Serogroups A, C, Y, and W Following Last Vaccination With MenACYW Conjugate or Menveo® Vaccine: Groups 1, 2 and 3
Serogroup C: 1:4
|
0.8 percentage of participants
|
3.3 percentage of participants
|
9.4 percentage of participants
|
—
|
|
Percentage of Participants With hSBA Titers Distribution <1:4, 1:4 and 1:8 Against Meningococcal Serogroups A, C, Y, and W Following Last Vaccination With MenACYW Conjugate or Menveo® Vaccine: Groups 1, 2 and 3
Serogroup C: 1:8
|
0 percentage of participants
|
5.0 percentage of participants
|
1.0 percentage of participants
|
—
|
|
Percentage of Participants With hSBA Titers Distribution <1:4, 1:4 and 1:8 Against Meningococcal Serogroups A, C, Y, and W Following Last Vaccination With MenACYW Conjugate or Menveo® Vaccine: Groups 1, 2 and 3
Serogroup Y: <1:4
|
0 percentage of participants
|
0 percentage of participants
|
16.7 percentage of participants
|
—
|
|
Percentage of Participants With hSBA Titers Distribution <1:4, 1:4 and 1:8 Against Meningococcal Serogroups A, C, Y, and W Following Last Vaccination With MenACYW Conjugate or Menveo® Vaccine: Groups 1, 2 and 3
Serogroup Y: 1:4
|
0 percentage of participants
|
0 percentage of participants
|
3.1 percentage of participants
|
—
|
|
Percentage of Participants With hSBA Titers Distribution <1:4, 1:4 and 1:8 Against Meningococcal Serogroups A, C, Y, and W Following Last Vaccination With MenACYW Conjugate or Menveo® Vaccine: Groups 1, 2 and 3
Serogroup Y: 1:8
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
|
Percentage of Participants With hSBA Titers Distribution <1:4, 1:4 and 1:8 Against Meningococcal Serogroups A, C, Y, and W Following Last Vaccination With MenACYW Conjugate or Menveo® Vaccine: Groups 1, 2 and 3
Serogroup W: <1:4
|
0 percentage of participants
|
0 percentage of participants
|
14.6 percentage of participants
|
—
|
|
Percentage of Participants With hSBA Titers Distribution <1:4, 1:4 and 1:8 Against Meningococcal Serogroups A, C, Y, and W Following Last Vaccination With MenACYW Conjugate or Menveo® Vaccine: Groups 1, 2 and 3
Serogroup W: 1:4
|
0 percentage of participants
|
0 percentage of participants
|
5.2 percentage of participants
|
—
|
|
Percentage of Participants With hSBA Titers Distribution <1:4, 1:4 and 1:8 Against Meningococcal Serogroups A, C, Y, and W Following Last Vaccination With MenACYW Conjugate or Menveo® Vaccine: Groups 1, 2 and 3
Serogroup W: 1:8
|
0 percentage of participants
|
0 percentage of participants
|
1.0 percentage of participants
|
—
|
Adverse Events
Group 1: MenACYW Conjugate Vaccine (Mexico)
Serious events: 4 serious events
Other events: 181 other events
Deaths: 0 deaths
Group 2: Menveo® Vaccine (Mexico)
Serious events: 3 serious events
Other events: 78 other events
Deaths: 0 deaths
Group 3: MenACYW Conjugate Vaccine (Russian Federation)
Serious events: 4 serious events
Other events: 64 other events
Deaths: 0 deaths
Group 4: Routine Pediatric Vaccines (Russian Federation)
Serious events: 2 serious events
Other events: 34 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1: MenACYW Conjugate Vaccine (Mexico)
n=201 participants at risk
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 6, and 12 along with Prevnar 13®, Hexacima®, vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6 and MMR®II vaccine at the age of Month 12.
|
Group 2: Menveo® Vaccine (Mexico)
n=99 participants at risk
Participants aged 2 months (at the time of enrollment) received Menveo® vaccine at the age of Months 2, 4, 6, and 12 along with Prevnar 13®, Hexacima®, vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6 and MMR®II vaccine at the age of Month 12.
|
Group 3: MenACYW Conjugate Vaccine (Russian Federation)
n=150 participants at risk
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 3, 6, and 12 along with Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
|
Group 4: Routine Pediatric Vaccines (Russian Federation)
n=75 participants at risk
Participants aged 2 months (at the time of enrollment) received Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/201 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
0.00%
0/99 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
0.67%
1/150 • Number of events 1 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
0.00%
0/75 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/201 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
2.0%
2/99 • Number of events 2 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
0.00%
0/150 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
0.00%
0/75 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
|
Infections and infestations
Covid-19
|
0.00%
0/201 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
0.00%
0/99 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
0.67%
1/150 • Number of events 1 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
0.00%
0/75 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
|
Infections and infestations
Enterocolitis Viral
|
0.00%
0/201 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
0.00%
0/99 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
0.67%
1/150 • Number of events 1 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
0.00%
0/75 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/201 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
0.00%
0/99 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
0.67%
1/150 • Number of events 1 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
0.00%
0/75 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
|
Infections and infestations
Pneumonia
|
1.00%
2/201 • Number of events 2 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
0.00%
0/99 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
0.00%
0/150 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
1.3%
1/75 • Number of events 1 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
|
Injury, poisoning and procedural complications
Head Injury
|
0.50%
1/201 • Number of events 1 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
0.00%
0/99 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
0.00%
0/150 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
0.00%
0/75 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
|
Injury, poisoning and procedural complications
Skull Fracture
|
0.00%
0/201 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
0.00%
0/99 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
0.00%
0/150 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
1.3%
1/75 • Number of events 1 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
|
Nervous system disorders
Atonic Seizures
|
0.00%
0/201 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
0.00%
0/99 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
0.67%
1/150 • Number of events 1 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
0.00%
0/75 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
|
Nervous system disorders
Febrile Convulsion
|
0.00%
0/201 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
1.0%
1/99 • Number of events 1 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
0.00%
0/150 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
0.00%
0/75 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
|
Nervous system disorders
Seizure
|
0.50%
1/201 • Number of events 1 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
0.00%
0/99 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
0.00%
0/150 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
0.00%
0/75 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
|
Respiratory, thoracic and mediastinal disorders
Neuroendocrine Cell Hyperplasia Of Infancy
|
0.00%
0/201 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
0.00%
0/99 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
0.00%
0/150 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
1.3%
1/75 • Number of events 1 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
Other adverse events
| Measure |
Group 1: MenACYW Conjugate Vaccine (Mexico)
n=201 participants at risk
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 6, and 12 along with Prevnar 13®, Hexacima®, vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6 and MMR®II vaccine at the age of Month 12.
|
Group 2: Menveo® Vaccine (Mexico)
n=99 participants at risk
Participants aged 2 months (at the time of enrollment) received Menveo® vaccine at the age of Months 2, 4, 6, and 12 along with Prevnar 13®, Hexacima®, vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6 and MMR®II vaccine at the age of Month 12.
|
Group 3: MenACYW Conjugate Vaccine (Russian Federation)
n=150 participants at risk
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 3, 6, and 12 along with Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
|
Group 4: Routine Pediatric Vaccines (Russian Federation)
n=75 participants at risk
Participants aged 2 months (at the time of enrollment) received Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
3.5%
7/201 • Number of events 7 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
6.1%
6/99 • Number of events 7 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
0.00%
0/150 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
0.00%
0/75 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
|
Gastrointestinal disorders
Vomiting
|
20.4%
41/201 • Number of events 55 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
14.1%
14/99 • Number of events 20 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
4.0%
6/150 • Number of events 6 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
0.00%
0/75 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
|
General disorders
Crying
|
58.2%
117/201 • Number of events 253 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
50.5%
50/99 • Number of events 100 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
12.0%
18/150 • Number of events 29 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
8.0%
6/75 • Number of events 9 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
|
General disorders
Injection Site Erythema
|
52.7%
106/201 • Number of events 321 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
38.4%
38/99 • Number of events 115 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
17.3%
26/150 • Number of events 64 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
10.7%
8/75 • Number of events 18 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
|
General disorders
Injection Site Haematoma
|
2.5%
5/201 • Number of events 5 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
5.1%
5/99 • Number of events 6 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
0.00%
0/150 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
0.00%
0/75 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
|
General disorders
Injection Site Pain
|
70.6%
142/201 • Number of events 896 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
62.6%
62/99 • Number of events 401 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
10.0%
15/150 • Number of events 43 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
13.3%
10/75 • Number of events 24 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
|
General disorders
Injection Site Swelling
|
18.9%
38/201 • Number of events 124 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
16.2%
16/99 • Number of events 31 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
9.3%
14/150 • Number of events 31 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
5.3%
4/75 • Number of events 11 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
|
General disorders
Pyrexia
|
42.3%
85/201 • Number of events 126 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
38.4%
38/99 • Number of events 56 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
8.0%
12/150 • Number of events 12 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
9.3%
7/75 • Number of events 7 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
|
Infections and infestations
Influenza
|
7.0%
14/201 • Number of events 16 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
3.0%
3/99 • Number of events 3 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
0.00%
0/150 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
0.00%
0/75 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
|
Infections and infestations
Nasopharyngitis
|
15.4%
31/201 • Number of events 43 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
19.2%
19/99 • Number of events 26 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
0.00%
0/150 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
0.00%
0/75 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
|
Infections and infestations
Pharyngitis
|
14.4%
29/201 • Number of events 31 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
10.1%
10/99 • Number of events 10 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
0.00%
0/150 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
0.00%
0/75 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
35.8%
72/201 • Number of events 127 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
33.3%
33/99 • Number of events 51 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
17.3%
26/150 • Number of events 45 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
14.7%
11/75 • Number of events 16 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
|
Nervous system disorders
Somnolence
|
39.8%
80/201 • Number of events 158 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
36.4%
36/99 • Number of events 66 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
22.0%
33/150 • Number of events 55 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
22.7%
17/75 • Number of events 30 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
|
Psychiatric disorders
Irritability
|
66.7%
134/201 • Number of events 318 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
58.6%
58/99 • Number of events 134 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
21.3%
32/150 • Number of events 58 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
|
26.7%
20/75 • Number of events 35 • Unsolicited AEs: from Day 0 (before first vaccination, at the age of 2 months) up to 30 days post any vaccination. SRs: within 7 days post any vaccination. SAE: from Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each group (i.e., up to the age of 13 months)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Safety population. In AE section, SR: fever, crying abnormal, and appetite lost are reported under pyrexia, crying, and decreased appetite, respectively.
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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.
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Restriction type: OTHER