The primary objective of the study was to demonstrate the non-inferiority of the antibody responses to meningococcal serogroups A, C, W, and Y (MenACYW) in terms of serum bactericidal assay using human complement (hSBA) vaccine seroprotection (antibody titer greater than or equal to \[\>=\] 1:8) when MenACYW Conjugate vaccine was administered concomitantly with Bexsero® in the second year of life compared to when MenACYW Conjugate vaccine was given alone. The secondary objectives were to compare the hSBA antibody response in terms of geometric mean titers (GMTs) against meningococcal serogroups A, C, W, and Y when MenACYW Conjugate vaccine was administered concomitantly with Bexsero® or when MenACYW Conjugate vaccine was given alone in the second year of life; to describe the hSBA and serum bactericidal assay using baby rabbit complement (rSBA) antibody responses against meningococcal serogroups A, C, W, and Y before and after the 1st dose of MenACYW Conjugate vaccine administered at 3 months of age, before and after the 2nd dose of MenACYW Conjugate vaccine administered at 12 to 13 months of age for Group 1 and Group 2; to describe the hSBA and rSBA antibody persistence against meningococcal serogroups A, C, W, and Y after the 1st dose of MenACYW Conjugate vaccine administered at 3 months of age for Group 1 and Group 2.
Study duration per participant was approximately 11 to 12 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
788
Pharmaceutical form: solution for injection; route of administration: intramuscular, 0.5 mL
Pharmaceutical form: suspension for injection; route of administration: deep intramuscular, 0.5 mL
Pharmaceutical form: powder and suspension for suspension injection; route of administration: deep intramuscular, 0.5 mL
Pharmaceutical form: oral suspension; route of administration: oral, 1.5 mL
Pharmaceutical form: suspension for injection; route of administration: intramuscular, 0.5 mL
Investigational Site Number :8260024
Newquay, Cornwall, United Kingdom
Investigational Site Number :8260009
Penzance, Cornwall, United Kingdom
Investigational Site Number :8260013
Torpoint, Cornwall, United Kingdom
Investigational Site Number :8260010
Exeter, Devon, United Kingdom
Investigational Site Number :8260017
Poole, Dorset, United Kingdom
Investigational Site Number :8260018
Gloucester, Gloucestershire, United Kingdom
Investigational Site Number :8260001
Bristol, United Kingdom
Investigational Site Number :8260011
Ivybridge, United Kingdom
Investigational Site Number :8260002
London, United Kingdom
Investigational Site Number :8260004
Manchester, United Kingdom
...and 3 more locations
Percentage of Participants With Antibody Titers Greater Than or Equal to (>=) 1:8 Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA After Vaccination: Groups 1 and 2 - PPAS3
Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by serum bactericidal assay using human complement (hSBA) assay. Percentage of participants with antibody titers \>=1:8 for meningococcal serogroups A, C, Y, and W were reported in this outcome measure. Data for this outcome measure was not planned to be collected and analyzed for Group 3.
Time frame: 30 days post-vaccination at the age of 12 to 13 months (i.e., at the age of 13 to 14 months)
Geometric Mean Titers (GMTs) of Antibodies Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS3
GMTs of antibody against meningococcal serogroups A, C, Y, and W were measured by hSBA. Titers were expressed in terms of 1/dilution.
Time frame: 30 days post-vaccination at the age of 12 to 13 months (i.e., at the age of 13 to 14 months)
Geometric Mean Titers of Antibodies Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W Before Vaccination: Group 1 and 2 - PPAS1
GMTs of antibody against meningococcal serogroups A, C, Y, and W were measured by hSBA. Infancy was defined as up to 4 months of age. Titers were expressed in terms of 1/dilution. Data for this outcome measure was not planned to be collected and analyzed for Group 3.
Time frame: Before vaccination at the age of 3 months
Geometric Mean Titers of Antibodies Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS1
GMTs of antibody against meningococcal serogroups A, C, Y, and W were measured by hSBA. Infancy was defined as up to 4 months of age. Titers were expressed in terms of 1/dilution. Data for this outcome measure was not planned to be collected and analyzed for Group 3.
Time frame: 30 days post-vaccination at the age of 3 months (i.e., at the age of 4 months)
Geometric Mean Titers of Antibodies Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W Before Vaccination: Group 1 and 2 - PPAS3
GMTs of antibodies against meningococcal serogroups A, C, Y, and W were measured by hSBA. Infancy was defined as up to 4 months of age. Titers were expressed in terms of 1/dilution.
Time frame: Before vaccination at the age of 12 to 13 months
Geometric Mean Titers of Antibodies Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS3
GMTs of antibodies against meningococcal serogroups A, C, Y, and W were measured by hSBA. Titers were expressed in terms of 1/dilution.
Time frame: 30 days post-vaccination at the age of 12 to 13 months (i.e., at the age of 13 to 14 months)
Geometric Mean Titers of Antibodies Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W Before Vaccination: Group 1 and 2 - PPAS1
GMTs of antibodies against meningococcal serogroups A, C, Y, and W were measured by serum bactericidal assay using baby rabbit complement (rSBA). Infancy was defined as up to 4 months of age. Titers were expressed in terms of 1/dilution.
Time frame: Before vaccination at the age of 3 months
Geometric Mean Titers of Antibodies Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS1
GMTs of antibodies against meningococcal serogroups A, C, Y, and W were measured by rSBA. Infancy was defined as up to 4 months of age. Titers were expressed in terms of 1/dilution.
Time frame: 30 days post-vaccination at the age of 3 months (i.e., at the age of 4 months)
Geometric Mean Titers of Antibodies Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W Before Vaccination: Group 1 and 2 - PPAS3
GMTs of antibody against meningococcal serogroups A, C, Y, and W were measured by rSBA. Titers were expressed in terms of 1/dilution.
Time frame: Before vaccination at the age of 12 to 13 months
Geometric Mean Titers of Antibodies Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS3
GMTs of antibody against meningococcal serogroups A, C, Y, and W were measured by rSBA. Titers were expressed in terms of 1/dilution.
Time frame: 30 days post-vaccination at the age of 12 to 13 months (i.e., at the age of 13 to 14 months)
Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W Before Vaccination: Group 1 and 2 - PPAS1
Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by hSBA assay. Infancy was defined as up to 4 months of age. Percentage of participants with antibody titers \>=1.4 and \>=1:8 for meningococcal serogroups A, C, Y, and W were reported in this outcome measure.
Time frame: Before vaccination at the age of 3 months
Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS1
Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by hSBA assay. Infancy was defined as up to 4 months of age. Percentage of participants with antibody titers \>=1.4 and \>=1:8 for meningococcal serogroups A, C, Y, and W were reported in this outcome measure.
Time frame: 30 days post-vaccination at the age of 3 months (i.e., at the age of 4 months)
Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W Before Vaccination: Group 1 and 2 - PPAS3
Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by hSBA assay. Infancy was defined as up to 4 months of age. Percentage of participants with antibody titers \>=1.4 and \>=1:8 for meningococcal serogroups A, C, Y, and W were reported in this outcome measure.
Time frame: Before vaccination at the age of 12 to 13 months
Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS3
Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by hSBA assay. Percentage of participants with antibody titers \>=1.4 and \>=1:8 for meningococcal serogroups A, C, Y, and W were reported in this outcome measure.
Time frame: 30 days post-vaccination at the age of 12 to 13 months (i.e., at the age of 13 to 14 months)
Percentage of Participants With rSBA Antibody Titers >=1:8 and >=1:128 Against Meningococcal Serogroups A, C, Y, and W Before Vaccination: Group 1 and 2 - PPAS1
Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by rSBA assay. Infancy was defined as up to 4 months of age. Percentage of participants with antibody titers \>=1.8 and \>=1:128 for meningococcal serogroups A, C, Y, and W were reported in this outcome measure.
Time frame: Before vaccination at the age of 3 months
Percentage of Participants With rSBA Antibody Titers >=1:8 and >=1:128 Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS1
Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by rSBA assay. Infancy was defined as up to 4 months of age. Percentage of participants with antibody titers \>=1.8 and \>=1:128 for meningococcal serogroups A, C, Y, and W were reported in this outcome measure.
Time frame: 30 days post-vaccination at the age of 3 months (i.e., at the age of 4 months)
Percentage of Participants With rSBA Antibody Titers >=1:8 and >=1:128 Against Meningococcal Serogroups A, C, Y, and W Before Vaccination: Group 1 and 2 - PPAS3
Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by rSBA assay. Infancy was defined as up to 4 months of age. Percentage of participants with antibody titers \>=1.8 and \>=1:128 for meningococcal serogroups A, C, Y, and W were reported in this outcome measure.
Time frame: Before vaccination at the age of 12 to 13 months
Percentage of Participants With rSBA Antibody Titers >=1:8 and >=1:128 Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS3
Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by rSBA assay. Percentage of participants with antibody titers \>=1.8 and \>=1:128 for meningococcal serogroups A, C, Y, and W were reported in this outcome measure.
Time frame: 30 days post-vaccination at the age of 12 to 13 months (i.e., at the age of 13 to 14 months)
Percentage of Participants With >= 4-Fold Rise in hSBA Antibody Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS1
Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by hSBA assay. Fold-rise was calculated as ratio of post-vaccination titer (i.e., 30 days post-vaccination at the age of 3 months) to pre-dose titer at the age of 3 months. Infancy was defined as up to 4 months of age.
Time frame: Before vaccination at the age of 3 months, 30 days post-vaccination at the age of 3 months (i.e., at the age of 4 months)
Percentage of Participants With >= 4-Fold Rise in hSBA Antibody Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS3
Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by hSBA assay. Fold-rise was calculated as ratio of post-vaccination titer (i.e., 30 days post-vaccination at the age of 12 to 13 months) to pre-dose titer before vaccination at the age of 3 months.
Time frame: Before vaccination at the age of 3 months, 30 days post-vaccination at the age of 12 to 13 months (i.e., at the age of 13 to 14 months)
Percentage of Participants With >= 4-Fold Rise in hSBA Antibody Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS3
Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by hSBA assay. Fold-rise was calculated as ratio of post-vaccination titer (i.e., 30 days post-vaccination at the age of 12 to 13 months) to pre-dose titer before vaccination at the age of 12 to 13 months.
Time frame: Before vaccination at the age of 12 to 13 months, 30 days post-vaccination at the age of 12 to 13 months (i.e., at the age of 13 to 14 months)
Percentage of Participants With >= 4-Fold Rise in rSBA Antibody Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS1
Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by rSBA assay. Fold-rise was calculated as ratio of post-vaccination titer (i.e., 30 days post-vaccination at the age of 3 months) to pre-dose titer at the age of 3 months. Infancy was defined as up to 4 months of age.
Time frame: Before vaccination at the age of 3 months, 30 days post-vaccination at the age of 3 months (i.e., at the age of 4 months)
Percentage of Participants With >= 4-Fold Rise in rSBA Antibody Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS3
Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by rSBA assay. Fold-rise was calculated as ratio of post-vaccination titer (i.e., 30 days post-vaccination at the age of 12 to 13 months) to pre-dose titer before vaccination at the age of 3 months.
Time frame: Before vaccination at the age of 3 months, 30 days post-vaccination at the age of 12 to 13 months (i.e., at the age of 13 to 14 months)
Percentage of Participants With >= 4-Fold Rise in rSBA Antibody Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS3
Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by rSBA assay. Fold-rise was calculated as ratio of post-vaccination titer (i.e., 30 days post-vaccination at the age of 12 to 13 months) to pre-dose titer before vaccination at the age of 12 to 13 months.
Time frame: Before vaccination at the age of 12 to 13 months, 30 days post-vaccination at the age of 12 to 13 months (i.e., at the age of 13 to 14 months)
Percentage of Participants With Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS1
The hSBA vaccine seroresponse against serogroups A, C, Y, and W was defined as post-vaccination hSBA titer \>=1:16 for participants with pre-vaccination hSBA titer \<1:8 or at least a 4-fold increase in hSBA titers from pre to post-vaccination for participants with pre-vaccination hSBA titers \>=1:8. Infancy was defined as up to 4 months of age.
Time frame: Before vaccination at the age of 3 months up to 30 days post-vaccination at the age of 3 months (i.e., at the age of 4 months)
Percentage of Participants With Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS3
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.
Time frame: Before vaccination at the age of 3 months up to 30 days post-vaccination at the age of 12 to 13 months (i.e., at the age of 13 to 14 months)
Percentage of Participants With Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS3
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.
Time frame: Before vaccination at the age of 12 to 13 months up to 30 days post-vaccination at the age of 12 to 13 months (i.e., at the age of 13 to 14 months)
Percentage of Participants With Vaccine Seroresponse Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS1
The rSBA vaccine seroresponse against serogroups A, C, Y, and W was defined as post-vaccination rSBA titer \>=1:32 for participants with pre-vaccination rSBA titer \<1:8 or at least a 4-fold increase in hSBA titers from pre to post-vaccination for participants with pre-vaccination hSBA titers \>=1:8. Infancy was defined as up to 4 months of age.
Time frame: Before vaccination at the age of 3 months up to 30 days post-vaccination at the age of 3 months (i.e., at the age of 4 months)
Percentage of Participants With Vaccine Seroresponse Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS3
The rSBA vaccine seroresponse against serogroups A, C, Y, and W was defined as post-vaccination rSBA titer \>=1:32 for participants with pre-vaccination rSBA titer \<1:8 or at least a 4-fold increase in hSBA titers from pre to post-vaccination for participants with pre-vaccination hSBA titers \>=1:8.
Time frame: Before vaccination at the age of 3 months up to 30 days post-vaccination at the age of 12 to 13 months (i.e., at the age of 13 to 14 months)
Percentage of Participants With Vaccine Seroresponse Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS3
The rSBA vaccine seroresponse against serogroups A, C, Y, and W was defined as post-vaccination rSBA titer \>=1:32 for participants with pre-vaccination rSBA titer \<1:8 or at least a 4-fold increase in hSBA titers from pre to post-vaccination for participants with pre-vaccination hSBA titers \>=1:8.
Time frame: Before vaccination at the age of 12 to 13 months up to 30 days post-vaccination at the age of 12 to 13 months (i.e., at the age of 13 to 14 months)
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS1
Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by hSBA assay. Percentage of participants with hSBA antibody titers distribution \<1:4, \>=1:4, \>=1:8, \>=1:16; \>=1:32; \>=1:64, \>=1:128, \>=1:256; \>=1:512; \>=1:1024 for meningococcal serogroups A, C, Y, and W were reported in this outcome measure.
Time frame: Before vaccination at the age of 3 months
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS1
Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by hSBA assay. Infancy was defined as up to 4 months of age. Percentage of participants with hSBA antibody titers distribution \<1:4, \>=1:4, \>=1:8, \>=1:16; \>=1:32; \>=1:64, \>=1:128, \>=1:256; \>=1:512; \>=1:1024 for meningococcal serogroups A, C, Y, and W were reported in this outcome measure.
Time frame: 30 days post-vaccination at the age of 3 months (i.e., at the age of 4 months)
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by hSBA assay. Infancy was defined as up to 4 months of age. Percentage of participants with hSBA antibody titers distribution \<1:4, \>=1:4, \>=1:8, \>=1:16; \>=1:32; \>=1:64, \>=1:128, \>=1:256; \>=1:512; \>=1:1024; \>=1:2048; \>=1:4096; \>=1:8192; \>=1:16384; \>=1:32768; \>=1:65536 for meningococcal serogroups A, C, Y, and W were reported in this outcome measure.
Time frame: Before vaccination at the age of 12 to 13 months
Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by hSBA assay. Percentage of participants with hSBA antibody titers distribution \<1:4, \>=1:4, \>=1:8, \>=1:16; \>=1:32; \>=1:64, \>=1:128, \>=1:256; \>=1:512; \>=1:1024; \>=1:2048; \>=1:4096; \>=1:8192; \>=1:16384; \>=1:32768; \>=1:65536 for meningococcal serogroups A, C, Y, and W were reported in this outcome measure.
Time frame: 30 days post-vaccination at the age of 12 to 13 months (i.e., at the age of 13 to 14 months)
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS1
Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by rSBA assay. Infancy was defined as up to 4 months of age. Percentage of participants with rSBA antibody titers distribution \<1:4, \>=1:4, \>=1:8, \>=1:16; \>=1:32; \>=1:64, \>=1:128, \>=1:256; \>=1:512; \>=1:1024; \>=1:2048; \>=1:4096; \>=1:8192 for meningococcal serogroups A, C, Y, and W were reported in this outcome measure.
Time frame: Before vaccination at the age of 3 months
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS1
Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by rSBA assay. Infancy was defined as up to 4 months of age. Percentage of participants with rSBA antibody titers distribution \<1:4, \>=1:4, \>=1:8, \>=1:16; \>=1:32; \>=1:64, \>=1:128, \>=1:256; \>=1:512; \>=1:1024; \>=1:2048; \>=1:4096; \>=1:8192 for meningococcal serogroups A, C, Y, and W were reported in this outcome measure.
Time frame: 30 days post-vaccination at the age of 3 months (i.e., at the age of 4 months)
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3
Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by rSBA assay. Infancy was defined as up to 4 months of age. Percentage of participants with rSBA antibody titers distribution \<1:4, \>=1:4, \>=1:8, \>=1:16; \>=1:32; \>=1:64, \>=1:128, \>=1:256; \>=1:512; \>=1:1024; \>=1:2048; \>=1:4096; \>=1:8192; \>=1:16384; \>=1:32768 for meningococcal serogroups A, C, Y, and W were reported in this outcome measure.
Time frame: Before vaccination at the age of 12 to 13 months
Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3
Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by rSBA assay. Percentage of participants with rSBA antibody titers distribution \<1:4, \>=1:4, \>=1:8, \>=1:16; \>=1:32; \>=1:64, \>=1:128, \>=1:256; \>=1:512; \>=1:1024; \>=1:2048; \>=1:4096; \>=1:8192; \>=1:16384; \>=1:32768 for meningococcal serogroups A, C, Y, and W were reported in this outcome measure.
Time frame: 30 days post-vaccination at the age of 12 to 13 months (i.e., at the age of 13 to 14 months)
Geometric Mean Titers of Antibodies Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W: Group 1 and 2 - PPAS2
GMTs of antibody against meningococcal serogroups A, C, Y, and W were measured by hSBA. Titers were expressed in terms of 1/dilution.
Time frame: 30 days post-vaccination at the age of 3 months (i.e., at the age of 4 months) and before vaccination at the age of 12-13 months
Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W - PPAS2
Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by hSBA assay. Percentage of participants with hSBA antibody titers \>=1.4 and \>=1:8 for meningococcal serogroups A, C, Y, and W were reported in this outcome measure.
Time frame: 30 days post-vaccination at the age of 3 months (i.e., at the age of 4 months) and before vaccination at the age of 12-13 months
Geometric Mean Titers of Antibodies Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W: Group 1 and 2 - PPAS2
GMTs of antibody against meningococcal serogroups A, C, Y, and W were measured by rSBA. Titers were expressed in terms of 1/dilution.
Time frame: 30 days post-vaccination at the age of 3 months (i.e., at the age of 4 months) and before vaccination at the age of 12-13 months
Percentage of Participants With rSBA Antibody Titers >=1:8 and >=1:128 Against Meningococcal Serogroups A, C, Y, and W - PPAS2
Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by rSBA assay. Percentage of participants with rSBA antibody titers \>=1:8 and \>=1:128 for meningococcal serogroups A, C, Y, and W were reported in this outcome measure.
Time frame: 30 days post-vaccination at the age of 3 months (i.e., at the age of 4 months) and before vaccination at the age of 12-13 months
Number of Participants With Solicited Injection Site Reactions After Any Vaccination
A solicited reaction (SR) was defined as an "expected" adverse reaction (AR) (sign or symptom) observed and reported under the conditions (nature and onset) pre-listed (i.e., solicited) in the protocol and case report form (CRF) and considered as related to vaccination. Solicited injection site reactions included injection site tenderness, injection site erythema, and injection site swelling and were planned to be collected and reported for each vaccine separately; and not planned to be collected for Rotavirus vaccine as the vaccine was administered orally, and no injection site reactions were expected to occur. Reported AEs for each arm were presented as pre-specified in the study protocol. Here, '0' in number analyzed field for MenACYW categories signifies that no participant was evaluable because in Group 3 MenACYW vaccine was not administered.
Time frame: Within 7 days post any vaccination
Number of Participants With Solicited Systemic Reactions After Any Vaccination
A SR was an expected AR (sign or symptom) observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the CRB and considered as related to the product administered. Solicited systemic reactions included fever, vomiting, crying abnormal, drowsiness, appetite lost, and irritability. Reported AEs for each arm were presented as pre-specified in the study protocol.
Time frame: Within 7 days after any vaccination
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