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.

Analysis was performed on Per-Protocol Analysis Set 3 (PPAS3) defined for accessing ACYW immune response data for participants who received at least 1 dose of study vaccine and had valid post-vaccination serology results of 2nd year of life, with no relevant protocol deviation. Here, 'number analyzed' = participants with available data for each specified category.

GMTs of antibody against meningococcal serogroups A, C, Y, and W were measured by hSBA. Titers were expressed in terms of 1/dilution.

Analysis was performed on PPAS3. Here, 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Group 3.

GMTs of antibody against meningococcal serogroups A, C, Y, and W were measured by hSBA. 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.

Analysis was performed on per-protocol analysis set 1 (PPAS1) defined for accessing ACYW immune response data for participants who received at least 1 dose of study vaccine and had valid post-vaccination serology result of infancy (up to 4 months age) vaccination stage, with no relevant protocol deviations. Here, 'number analyzed' = participants with available data for each specified category.

GMTs of antibody against meningococcal serogroups A, C, Y, and W were measured by hSBA. Infancy was defined as up to 4 months of age. Titers were expressed in terms of 1/dilution. Data for this outcome measure was not planned to be collected and analyzed for Group 3.

Analysis was performed PPAS1. Here, 'number analyzed' = participants with available data for each specified category.

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.

Analysis was performed on PPAS3. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Group 3.

GMTs of antibodies against meningococcal serogroups A, C, Y, and W were measured by hSBA. Titers were expressed in terms of 1/dilution.

Analysis was performed on PPAS3. Here, 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Group 3.

GMTs of antibodies against meningococcal serogroups A, C, Y, and W were measured by 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.

Analysis was performed on PPAS1. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Group 3.

GMTs of antibodies against meningococcal serogroups A, C, Y, and W were measured by rSBA. Infancy was defined as up to 4 months of age. Titers were expressed in terms of 1/dilution.

Analysis was performed on PPAS1. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Group 3.

GMTs of antibody against meningococcal serogroups A, C, Y, and W were measured by rSBA. Titers were expressed in terms of 1/dilution.

Analysis was performed on PPAS3. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Group 3.

GMTs of antibody against meningococcal serogroups A, C, Y, and W were measured by rSBA. Titers were expressed in terms of 1/dilution.

Analysis was performed on PPAS3. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Group 3.

Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by hSBA assay. Infancy was defined as up to 4 months of age. Percentage of participants with antibody titers >=1.4 and >=1:8 for meningococcal serogroups A, C, Y, and W were reported in this outcome measure.

Analysis was performed on PPAS1. Here, 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Group 3.

Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by hSBA assay. Infancy was defined as up to 4 months of age. Percentage of participants with antibody titers >=1.4 and >=1:8 for meningococcal serogroups A, C, Y, and W were reported in this outcome measure.

Analysis was performed on PPAS1. Here, 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Group 3.

Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by hSBA assay. Infancy was defined as up to 4 months of age. Percentage of participants with antibody titers >=1.4 and >=1:8 for meningococcal serogroups A, C, Y, and W were reported in this outcome measure.

Analysis was performed on PPAS3. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Group 3.

Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by hSBA assay. 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.

Analysis was performed on PPAS3. Here, 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Group 3.

Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by 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.

Analysis was performed on PPAS1. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Group 3.

Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by rSBA assay. Infancy was defined as up to 4 months of age. Percentage of participants with antibody titers >=1.8 and >=1:128 for meningococcal serogroups A, C, Y, and W were reported in this outcome measure.

Analysis was performed on PPAS1. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Group 3.

Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by rSBA assay. Infancy was defined as up to 4 months of age. Percentage of participants with antibody titers >=1.8 and >=1:128 for meningococcal serogroups A, C, Y, and W were reported in this outcome measure.

Analysis was performed on PPAS3. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Group 3.

Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by rSBA assay. Percentage of participants with antibody titers >=1.8 and >=1:128 for meningococcal serogroups A, C, Y, and W were reported in this outcome measure.

Analysis was performed on PPAS3. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Group 3.

Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by hSBA assay. Fold-rise was calculated as ratio of post-vaccination titer (i.e., 30 days post-vaccination at the age of 3 months) to pre-dose titer at the age of 3 months. Infancy was defined as up to 4 months of age.

Analysis was performed on PPAS1. Here, 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Group 3.

Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by hSBA assay. Fold-rise was calculated as ratio of post-vaccination titer (i.e., 30 days post-vaccination at the age of 12 to 13 months) to pre-dose titer before vaccination at the age of 3 months.

Analysis was performed on PPAS3. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Group 3.

Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by hSBA assay. Fold-rise was calculated as ratio of post-vaccination titer (i.e., 30 days post-vaccination at the age of 12 to 13 months) to pre-dose titer before vaccination at the age of 12 to 13 months.

Analysis was performed on PPAS3. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Group 3.

Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by rSBA assay. Fold-rise was calculated as ratio of post-vaccination titer (i.e., 30 days post-vaccination at the age of 3 months) to pre-dose titer at the age of 3 months. Infancy was defined as up to 4 months of age.

Analysis was performed on PPAS1. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Group 3.

Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by rSBA assay. Fold-rise was calculated as ratio of post-vaccination titer (i.e., 30 days post-vaccination at the age of 12 to 13 months) to pre-dose titer before vaccination at the age of 3 months.

Analysis was performed on PPAS3. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Group 3.

Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by rSBA assay. Fold-rise was calculated as ratio of post-vaccination titer (i.e., 30 days post-vaccination at the age of 12 to 13 months) to pre-dose titer before vaccination at the age of 12 to 13 months.

Analysis was performed on PPAS3. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Group 3.

The hSBA vaccine seroresponse against serogroups A, C, Y, and W was defined as post-vaccination hSBA titer >=1:16 for participants with pre-vaccination hSBA titer <1:8 or at least a 4-fold increase in hSBA titers from pre to post-vaccination for participants with pre-vaccination hSBA titers >=1:8. Infancy was defined as up to 4 months of age.

Analysis was performed on PPAS1. Here, 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Group 3.

The hSBA vaccine seroresponse against serogroups A, C, Y, and W was defined as post-vaccination hSBA titer >=1:16 for participants with pre-vaccination hSBA titer <1:8 or at least a 4-fold increase in hSBA titers from pre to post-vaccination for participants with pre-vaccination hSBA titers >=1:8.

Analysis was performed on PPAS3. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Group 3.

The hSBA vaccine seroresponse against serogroups A, C, Y, and W was defined as post-vaccination hSBA titer >=1:16 for participants with pre-vaccination hSBA titer <1:8 or at least a 4-fold increase in hSBA titers from pre to post-vaccination for participants with pre-vaccination hSBA titers >=1:8.

Analysis was performed on PPAS3. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Group 3.

The rSBA vaccine seroresponse against serogroups A, C, Y, and W was defined as post-vaccination rSBA titer >=1:32 for participants with pre-vaccination rSBA titer <1:8 or at least a 4-fold increase in hSBA titers from pre to post-vaccination for participants with pre-vaccination hSBA titers >=1:8. Infancy was defined as up to 4 months of age.

Analysis was performed on PPAS1. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Group 3.

The rSBA vaccine seroresponse against serogroups A, C, Y, and W was defined as post-vaccination rSBA titer >=1:32 for participants with pre-vaccination rSBA titer <1:8 or at least a 4-fold increase in hSBA titers from pre to post-vaccination for participants with pre-vaccination hSBA titers >=1:8.

Analysis was performed on PPAS3. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Group 3.

The rSBA vaccine seroresponse against serogroups A, C, Y, and W was defined as post-vaccination rSBA titer >=1:32 for participants with pre-vaccination rSBA titer <1:8 or at least a 4-fold increase in hSBA titers from pre to post-vaccination for participants with pre-vaccination hSBA titers >=1:8.

Analysis was performed on PPAS3. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Group 3.

Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by hSBA assay. 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.

Analysis was performed on PPAS1. Here, 'number analyzed' = participants with available data for each specified category and '0' in the number analyzed field denotes that no participant had available data for the specified titer category.

Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by hSBA assay. Infancy was defined as up to 4 months of age. Percentage of participants with hSBA antibody titers distribution <1:4, >=1:4, >=1:8, >=1:16; >=1:32; >=1:64, >=1:128, >=1:256; >=1:512; >=1:1024 for meningococcal serogroups A, C, Y, and W were reported in this outcome measure.

Analysis was performed on PPAS1. Here, 'number analyzed' = participants with available data for each specified category and '0' in the number analyzed field denotes that no participant had available data for the specified titer category.

Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by hSBA assay. Infancy was defined as up to 4 months of age. Percentage of participants with hSBA antibody titers distribution <1:4, >=1:4, >=1:8, >=1:16; >=1:32; >=1:64, >=1:128, >=1:256; >=1:512; >=1:1024; >=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.

Analysis was performed on PPAS3. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified category. Here, '0' in the number analyzed field denotes that no participant had available data for the specified titer category.

Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by hSBA assay. 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.

Analysis was performed on PPAS3. Here, 'number analyzed' = participants with available data for each specified category and '0' in the number analyzed field denotes that no participant had available data for the specified titer category.

Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by 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.

Analysis was performed on PPAS1. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified category. Here, '0' in the number analyzed field denotes that no participant had available data for the specified titer category.

Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by rSBA assay. Infancy was defined as up to 4 months of age. Percentage of participants with rSBA antibody titers distribution <1:4, >=1:4, >=1:8, >=1:16; >=1:32; >=1:64, >=1:128, >=1:256; >=1:512; >=1:1024; >=1:2048; >=1:4096; >=1:8192 for meningococcal serogroups A, C, Y, and W were reported in this outcome measure.

Analysis was performed on PPAS1. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified category. Here, '0' in the number analyzed field denotes that no participant had available data for the specified titer category.

Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by rSBA assay. Infancy was defined as up to 4 months of age. Percentage of participants with rSBA antibody titers distribution <1:4, >=1:4, >=1:8, >=1:16; >=1:32; >=1:64, >=1:128, >=1:256; >=1:512; >=1:1024; >=1:2048; >=1:4096; >=1:8192; >=1:16384; >=1:32768 for meningococcal serogroups A, C, Y, and W were reported in this outcome measure.

Analysis was performed on PPAS3. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified category. Here, '0' in the number analyzed field denotes that no participant had available data for the specified titer category.

Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by rSBA assay. Percentage of participants with rSBA antibody titers distribution <1:4, >=1:4, >=1:8, >=1:16; >=1:32; >=1:64, >=1:128, >=1:256; >=1:512; >=1:1024; >=1:2048; >=1:4096; >=1:8192; >=1:16384; >=1:32768 for meningococcal serogroups A, C, Y, and W were reported in this outcome measure.

Analysis was performed on PPAS3. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified category. Here, '0' in the number analyzed field denotes that no participant had available data for the specified titer category.

GMTs of antibody against meningococcal serogroups A, C, Y, and W were measured by hSBA. Titers were expressed in terms of 1/dilution.

Analysis was performed on per-protocol analysis set 2 (PPAS2) defined for accessing ACYW immune response data for participants who received at least 1 dose of study vaccine in infancy and had valid post-vaccination serology results at 12 to13 months of age, with no relevant protocol violations. Here, 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Group 3.

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.

Analysis was performed on PPAS2. Here, 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Group 3.

GMTs of antibody against meningococcal serogroups A, C, Y, and W were measured by rSBA. Titers were expressed in terms of 1/dilution.

Analysis was performed on PPAS2. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Group 3.

Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by rSBA assay. Percentage of participants with rSBA antibody titers >=1:8 and >=1:128 for meningococcal serogroups A, C, Y, and W were reported in this outcome measure.

Analysis was performed on PPAS2. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Group 3.

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.

Analysis was performed on safety analysis set. Here, 'number analyzed' = participants with available data for each specified category.

A SR was an expected AR (sign or symptom) observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the CRB and considered as related to the product administered. Solicited systemic reactions included fever, vomiting, crying abnormal, drowsiness, appetite lost, and irritability. Reported AEs for each arm were presented as pre-specified in the study protocol.

Analysis was performed on safety analysis set. Here, 'number analyzed' = participants with available data for each specified category.