Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine in Infants and Toddlers When Administered Concomitantly With Routine Pediatric Vaccines in the United Kingdom

Study duration per participant was approximately 11 to 12 months.

• Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid Conjugate vaccine (Biological), also known as MenACYW Conjugate vaccine: Pharmaceutical form: solution for injection; route of administration: intramuscular, 0.5 mL
• Meningococcal group B vaccine (Biological), also known as Bexsero®: Pharmaceutical form: suspension for injection; route of administration: deep intramuscular, 0.5 mL
• Diphtheria, tetanus, pertussis (acellular component), hepatitis B, poliomyelitis (inactivated) vaccine (Biological), also known as Infanrix hexa®: Pharmaceutical form: powder and suspension for suspension injection; route of administration: deep intramuscular, 0.5 mL
• Human rotavirus RIX4414 strain vaccine (Biological), also known as Rotarix®: Pharmaceutical form: oral suspension; route of administration: oral, 1.5 mL
• Pneumococcal 13-valent polysaccharide conjugate vaccine (Biological), also known as Prevenar 13®: Pharmaceutical form: suspension for injection; route of administration: intramuscular, 0.5 mL

Primary outcomes

• 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 [30 days post-vaccination at the age of 12 to 13 months (i.e., at the age of 13 to 14 months)]: 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.

Secondary outcomes

• Geometric Mean Titers (GMTs) of Antibodies Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS3 [30 days post-vaccination at the age of 12 to 13 months (i.e., at the age of 13 to 14 months)]: GMTs of antibody against meningococcal serogroups A, C, Y, and W were measured by hSBA. Titers were expressed in terms of 1/dilution.
• Geometric Mean Titers of Antibodies Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W Before Vaccination: Group 1 and 2 - PPAS1 [Before vaccination at the age of 3 months]: 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.
• Geometric Mean Titers of Antibodies Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS1 [30 days post-vaccination at the age of 3 months (i.e., at the age of 4 months)]: 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.
• Geometric Mean Titers of Antibodies Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W Before Vaccination: Group 1 and 2 - PPAS3 [Before vaccination at the age of 12 to 13 months]: 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.
• Geometric Mean Titers of Antibodies Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS3 [30 days post-vaccination at the age of 12 to 13 months (i.e., at the age of 13 to 14 months)]: GMTs of antibodies against meningococcal serogroups A, C, Y, and W were measured by hSBA. Titers were expressed in terms of 1/dilution.
• Geometric Mean Titers of Antibodies Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W Before Vaccination: Group 1 and 2 - PPAS1 [Before vaccination at the age of 3 months]: 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.
• Geometric Mean Titers of Antibodies Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS1 [30 days post-vaccination at the age of 3 months (i.e., at the age of 4 months)]: 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.
• Geometric Mean Titers of Antibodies Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W Before Vaccination: Group 1 and 2 - PPAS3 [Before vaccination at the age of 12 to 13 months]: GMTs of antibody against meningococcal serogroups A, C, Y, and W were measured by rSBA. Titers were expressed in terms of 1/dilution.
• Geometric Mean Titers of Antibodies Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS3 [30 days post-vaccination at the age of 12 to 13 months (i.e., at the age of 13 to 14 months)]: GMTs of antibody against meningococcal serogroups A, C, Y, and W were measured by rSBA. Titers were expressed in terms of 1/dilution.
• 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 [Before vaccination at the age of 3 months]: 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.
• 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 [30 days post-vaccination at the age of 3 months (i.e., at the age of 4 months)]: 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.
• 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 [Before vaccination at the age of 12 to 13 months]: 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.
• 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 [30 days post-vaccination at the age of 12 to 13 months (i.e., at the age of 13 to 14 months)]: 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.
• 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 [Before vaccination at the age of 3 months]: 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.
• 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 [30 days post-vaccination at the age of 3 months (i.e., at the age of 4 months)]: 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.
• 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 [Before vaccination at the age of 12 to 13 months]: 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.
• 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 [30 days post-vaccination at the age of 12 to 13 months (i.e., at the age of 13 to 14 months)]: 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.
• 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 [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)]: 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.
• 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 [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)]: 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.
• 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 [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)]: 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.
• 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 [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)]: 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.
• 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 [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)]: 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.
• 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 [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)]: 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.
• Percentage of Participants With Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS1 [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)]: 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.
• Percentage of Participants With Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS3 [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)]: 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.
• Percentage of Participants With Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS3 [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)]: 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.
• Percentage of Participants With Vaccine Seroresponse Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS1 [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)]: 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.
• Percentage of Participants With Vaccine Seroresponse Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS3 [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)]: 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.
• Percentage of Participants With Vaccine Seroresponse Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS3 [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)]: 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.
• Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS1 [Before vaccination at the age of 3 months]: 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.
• Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS1 [30 days post-vaccination at the age of 3 months (i.e., at the age of 4 months)]: 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.
• Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3 [Before vaccination at the age of 12 to 13 months]: 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.
• Percentage of Participants With Distribution of hSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3 [30 days post-vaccination at the age of 12 to 13 months (i.e., at the age of 13 to 14 months)]: 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.
• Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS1 [Before vaccination at the age of 3 months]: 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.
• Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS1 [30 days post-vaccination at the age of 3 months (i.e., at the age of 4 months)]: 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.
• Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W Before Vaccination - PPAS3 [Before vaccination at the age of 12 to 13 months]: 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.
• Percentage of Participants With Distribution of rSBA Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination - PPAS3 [30 days post-vaccination at the age of 12 to 13 months (i.e., at the age of 13 to 14 months)]: 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.
• Geometric Mean Titers of Antibodies Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W: Group 1 and 2 - PPAS2 [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]: GMTs of antibody against meningococcal serogroups A, C, Y, and W were measured by hSBA. Titers were expressed in terms of 1/dilution.
• Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W - PPAS2 [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]: 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.
• Geometric Mean Titers of Antibodies Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W: Group 1 and 2 - PPAS2 [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]: GMTs of antibody against meningococcal serogroups A, C, Y, and W were measured by rSBA. Titers were expressed in terms of 1/dilution.
• Percentage of Participants With rSBA Antibody Titers >=1:8 and >=1:128 Against Meningococcal Serogroups A, C, Y, and W - PPAS2 [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]: 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.
• Number of Participants With Solicited Injection Site Reactions After Any Vaccination [Within 7 days post 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.
• Number of Participants With Solicited Systemic Reactions After Any Vaccination [Within 7 days 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.

Sex: All, ages: 56 Days to 89 Days, accepts healthy volunteers

Inclusion Criteria:

* Aged >= 56 to less than or equal to (<=) 89 days on the day of the first study visit.
* Born at full term of pregnancy (>= 37 weeks) and with a birth weight >= 2.5 kilogram (kg) (or 5 lb and 8 oz).
* Informed consent form had been signed and dated by the parent(s) or other legally acceptable representative (and by an independent witness if required by local regulations).
* Participant and parent/legally acceptable representative were able to attend all scheduled visits and to comply with all trial procedures.

Exclusion Criteria:

\-- Participation at the time of study enrollment (or in the 4 weeks preceding the first trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure.

* Receipt of any vaccine in the 4 weeks preceding the first trial vaccination (at Visit 1) or planned receipt of any vaccine in the 4 weeks before and/or following any trial vaccination except for influenza vaccination, which may be received at a gap of at least 2 weeks before or 2 weeks after any study vaccines. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines.
* Previous vaccination against meningococcal disease with either the trial vaccine or another vaccine (i.e., mono- or polyvalent, polysaccharide, or conjugate meningococcal vaccine containing serogroups A, C, W, or Y; or meningococcal B serogroup-containing vaccine).
* Previous vaccination (before Visit 1) with any pneumococcal, diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b (Hib), poliovirus, and/or rotavirus vaccines. Receipt of BCG vaccine at birth was acceptable.
* Receipt of immune globulins, blood or blood-derived since birth.
* Known or suspected congenital or acquired immunodeficiency, including Severe Combined Immunodeficiency disorder (SCID); or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks) since birth.
* History of any neurologic disorders, including any seizures and progressive neurologic disorders or encephalopathy.
* History of Neisseria meningitidis infection, confirmed either clinically, serologically, or microbiologically.
* History of diphtheria, tetanus, pertussis, poliomyelitis, Hib, hepatitis B, Streptococcus pneumoniae, and/or rotavirus infection or disease.
* At high risk for meningococcal infection during the trial (specifically, but not limited to, participants with persistent complement deficiency, with anatomic or functional asplenia, or participants travelling to countries with high endemic or epidemic disease).
* History of Guillain-Barré syndrome.
* Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances including neomycin, kanamycin, polymyxin, formaldehyde, and latex.
* Hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency.
* History of intussusception or uncorrected congenital malformation of the gastrointestinal tract that would predispose to intussusception.
* Verbal report of thrombocytopenia, contraindicating intramuscular vaccination in the investigator's opinion.
* Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination.
* Chronic illness that, in the opinion of the investigator, was at a stage where it might interfere with trial conduct or completion.
* Any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives, including planning to leave the area of the study site before the end of the study.
* Moderate or severe acute illness/infection (according to investigator judgment), or febrile illness (temperature >= 38.0°C), or diarrhea or vomiting on the day of vaccination. A prospective participant should not be included in the study until the condition had resolved or the febrile event has subsided.
* Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study.

Participant flow

Outcome results

• 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 (Primary), Number, percentage of participants: Group 1: MenACYW Conjugate Vaccine + Bexsero® (2, 4, and 12 to 13 Months) 100 (97.7 to 100); Group 2: MenACYW Conjugate Vaccine + Bexsero® (2 and 4 Months) 99.4 (96.5 to 100)
• Geometric Mean Titers (GMTs) of Antibodies Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS3 (Secondary), Geometric mean, titers: Group 1: MenACYW Conjugate Vaccine + Bexsero® (2, 4, and 12 to 13 Months) 1214 (993 to 1484); Group 2: MenACYW Conjugate Vaccine + Bexsero® (2 and 4 Months) 205 (168 to 250)
• Geometric Mean Titers of Antibodies Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W Before Vaccination: Group 1 and 2 - PPAS1 (Secondary), Geometric mean, titers: Group 1: MenACYW Conjugate Vaccine + Bexsero® (2, 4, and 12 to 13 Months) 8.52 (5.16 to 14.1); Group 2: MenACYW Conjugate Vaccine + Bexsero® (2 and 4 Months) 7.22 (4.39 to 11.9)
• Geometric Mean Titers of Antibodies Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS1 (Secondary), Geometric mean, titers: Group 1: MenACYW Conjugate Vaccine + Bexsero® (2, 4, and 12 to 13 Months) 10.8 (8.40 to 14.0); Group 2: MenACYW Conjugate Vaccine + Bexsero® (2 and 4 Months) 9.63 (7.46 to 12.4)
• Geometric Mean Titers of Antibodies Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W Before Vaccination: Group 1 and 2 - PPAS3 (Secondary), Geometric mean, titers: Group 1: MenACYW Conjugate Vaccine + Bexsero® (2, 4, and 12 to 13 Months) 45.8 (28.4 to 73.8); Group 2: MenACYW Conjugate Vaccine + Bexsero® (2 and 4 Months) 22.6 (13.5 to 37.9)
• Geometric Mean Titers of Antibodies Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS3 (Secondary), Geometric mean, titers: Group 1: MenACYW Conjugate Vaccine + Bexsero® (2, 4, and 12 to 13 Months) 1214 (993 to 1484); Group 2: MenACYW Conjugate Vaccine + Bexsero® (2 and 4 Months) 205 (168 to 250)
• Geometric Mean Titers of Antibodies Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W Before Vaccination: Group 1 and 2 - PPAS1 (Secondary), Geometric mean, titers: Group 1: MenACYW Conjugate Vaccine + Bexsero® (2, 4, and 12 to 13 Months) 2.00 (NA to NA); Group 2: MenACYW Conjugate Vaccine + Bexsero® (2 and 4 Months) 2.00 (NA to NA)
• Geometric Mean Titers of Antibodies Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS1 (Secondary), Geometric mean, titers: Group 1: MenACYW Conjugate Vaccine + Bexsero® (2, 4, and 12 to 13 Months) 13.7 (6.89 to 27.3); Group 2: MenACYW Conjugate Vaccine + Bexsero® (2 and 4 Months) 20.7 (9.96 to 43.2)
• Geometric Mean Titers of Antibodies Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W Before Vaccination: Group 1 and 2 - PPAS3 (Secondary), Geometric mean, titers: Group 1: MenACYW Conjugate Vaccine + Bexsero® (2, 4, and 12 to 13 Months) 32.0 (1.20 to 855); Group 2: MenACYW Conjugate Vaccine + Bexsero® (2 and 4 Months) 169 (NA to NA)
• Geometric Mean Titers of Antibodies Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS3 (Secondary), Geometric mean, titers: Group 1: MenACYW Conjugate Vaccine + Bexsero® (2, 4, and 12 to 13 Months) 1741 (1354 to 2240); Group 2: MenACYW Conjugate Vaccine + Bexsero® (2 and 4 Months) 1508 (1073 to 2118)
• 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 (Secondary), Number, percentage of participants: Group 1: MenACYW Conjugate Vaccine + Bexsero® (2, 4, and 12 to 13 Months) 81.8 (59.7 to 94.8); Group 2: MenACYW Conjugate Vaccine + Bexsero® (2 and 4 Months) 74.1 (53.7 to 88.9)
• Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS1 (Secondary), Number, percentage of participants: Group 1: MenACYW Conjugate Vaccine + Bexsero® (2, 4, and 12 to 13 Months) 87.5 (76.8 to 94.4); Group 2: MenACYW Conjugate Vaccine + Bexsero® (2 and 4 Months) 85.9 (75.6 to 93.0)
• Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W Before Vaccination: Group 1 and 2 - PPAS3 (Secondary), Number, percentage of participants: Group 1: MenACYW Conjugate Vaccine + Bexsero® (2, 4, and 12 to 13 Months) 100 (88.8 to 100); Group 2: MenACYW Conjugate Vaccine + Bexsero® (2 and 4 Months) 96.2 (80.4 to 99.9)
• Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS3 (Secondary), Number, percentage of participants: Group 1: MenACYW Conjugate Vaccine + Bexsero® (2, 4, and 12 to 13 Months) 100 (97.7 to 100); Group 2: MenACYW Conjugate Vaccine + Bexsero® (2 and 4 Months) 100 (97.7 to 100)
• 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 (Secondary), Number, percentage of participants: Group 1: MenACYW Conjugate Vaccine + Bexsero® (2, 4, and 12 to 13 Months) 0 (0 to 20.6); Group 2: MenACYW Conjugate Vaccine + Bexsero® (2 and 4 Months) 0 (0 to 15.4)
• Percentage of Participants With rSBA Antibody Titers >=1:8 and >=1:128 Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS1 (Secondary), Number, percentage of participants: Group 1: MenACYW Conjugate Vaccine + Bexsero® (2, 4, and 12 to 13 Months) 52.8 (35.5 to 69.6); Group 2: MenACYW Conjugate Vaccine + Bexsero® (2 and 4 Months) 65.6 (46.8 to 81.4)
• Percentage of Participants With rSBA Antibody Titers >=1:8 and >=1:128 Against Meningococcal Serogroups A, C, Y, and W Before Vaccination: Group 1 and 2 - PPAS3 (Secondary), Number, percentage of participants: Group 1: MenACYW Conjugate Vaccine + Bexsero® (2, 4, and 12 to 13 Months) 50.0 (11.8 to 88.2); Group 2: MenACYW Conjugate Vaccine + Bexsero® (2 and 4 Months) 80.0 (28.4 to 99.5)
• Percentage of Participants With rSBA Antibody Titers >=1:8 and >=1:128 Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS3 (Secondary), Number, percentage of participants: Group 1: MenACYW Conjugate Vaccine + Bexsero® (2, 4, and 12 to 13 Months) 100 (92.5 to 100); Group 2: MenACYW Conjugate Vaccine + Bexsero® (2 and 4 Months) 100 (91.8 to 100)
• 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 (Secondary), Number, percentage of participants: Group 1: MenACYW Conjugate Vaccine + Bexsero® (2, 4, and 12 to 13 Months) 5.9 (0.1 to 28.7); Group 2: MenACYW Conjugate Vaccine + Bexsero® (2 and 4 Months) 25.0 (9.8 to 46.7)
• Percentage of Participants With >= 4-Fold Rise in hSBA Antibody Titers Against Meningococcal Serogroups A, C, Y, and W After Vaccination: Group 1 and 2 - PPAS3 (Secondary), Number, percentage of participants: Group 1: MenACYW Conjugate Vaccine + Bexsero® (2, 4, and 12 to 13 Months) 100 (84.6 to 100); Group 2: MenACYW Conjugate Vaccine + Bexsero® (2 and 4 Months) 91.7 (73.0 to 99.0)
• 24 more outcome measures not shown.

Adverse events

Time frame: Unsolicited AEs: before first vaccination at the age of 3 months up to 30 days post any vaccination. SRs: within 7 days post any vaccination. Serious AEs: before first vaccination at the age of 3 months up to 30 days post last vaccination in each group (i.e., up to the age of 13 to 14 months)

Serious adverse events by term

Other adverse events by term

• Study Protocol (PDF, 2021-05-03)
• Statistical Analysis Plan (PDF, 2023-03-08)

• Clinical Sciences & Operations, Study director, Sanofi

NIH grants: 2017