Percentage of participants achieving hSBA titer greater than or equal to (>=) lower limit of quantitation (LLOQ) (i.e.,1:8) for each MenA, MenC, MenW and MenY test strains were reported in this outcome measure. Exact 2-sided confidence interval (CI) using the Clopper and Pearson method was presented. Analysis was performed on Post-primary vaccination 2 (post-PV2) evaluable immunogenicity population (EIP). No serum samples collected after vaccination 2 for participants in Group 11 as participants were not administered PV 2 due to study termination.

Post-PV 2 EIP: participants randomized,eligible through Visit(V)4;received vaccine at V1,V3;blood drawn for assay test within required timeframes at V4;had at least 1 valid, determinate MenA,C,W,Y,or B assay result at V4;received no prohibited vaccines/treatment,no protocol deviation through V4.''N''=participants evaluable for outcome measure; ''n''=participants evaluable for specific rows.

Percentage of participants achieving hSBA titer >= LLOQ (1:8) for each MenA, MenC, MenW and MenY test strains were reported in this outcome measure. Exact 2-sided CI using the Clopper and Pearson method was presented. No participants in Group 7 and Group 11 received booster vaccination due to study termination.

Post-booster vaccination EIP: randomized participants eligible through V6;received vaccine at V1, V3, V5;blood drawn for assay testing within required timeframes at V6; had at least 1 valid, determinate MenA, MenC, MenW, MenY, or MenB assay result at V6; received no prohibited vaccines/treatment and had no protocol deviations through V6. Here, ''N''=participants evaluable for the outcome measure and ''n''=participants evaluable for specific rows.

Percentage of participants achieving hSBA titer>= LLOQ for each MenB test strain (1:16 for strain A22 and 1:8 for strain B44) is reported in this outcome measure. Exact 2-sided CI using Clopper and Pearson method is presented. No serum samples collected after vaccination 2 for participants in Group 11 as participants were not administered PV 2 due to study termination.

Post-PV 2 EIP: participants randomized,eligible through Visit(V)4;received vaccine at V1,V3;blood drawn for assay test within required timeframes at V4;had at least 1 valid, determinate MenA,C,W,Y,or B assay result at V4;received no prohibited vaccines/treatment,no protocol deviation through V4.''N''=participants evaluable for outcome measure; ''n''=participants evaluable for specific rows.

Percentage of participants achieving hSBA titer>= LLOQ for each MenB test strain(1:16 for strain A22 and 1:8 for strain B44) is reported in this outcome measure. Exact 2-sided CI using Clopper and Pearson method is presented.

Post-PV 2 EIP: participants randomized,eligible through Visit(V)4;received vaccine at V1,V3;blood drawn for assay test within required timeframes at V4;had at least 1 valid, determinate MenA,C,W,Y,or B assay result at V4;received no prohibited vaccines/treatment,no protocol deviation through V4.''N''=participants evaluable for outcome measure; ''n''=participants evaluable for specific rows.

Percentage of participants achieving hSBA titer>= LLOQ for each MenB test strain (1:16 for strain A22 and 1:8 for strain B44) is reported in this outcome measure. Exact 2-sided CI using Clopper and Pearson method is presented. No participants in Group 7 and Group 11 received booster vaccination due to study termination.

Post booster vacc. evaluable immunogenicity population=randomised to study group of interest,eligible through V6. Received investigational products at V1,3,5 as randomised,blood drawn for assay testing at required time frames at V6(1 month after booster vacc[28-42 days]).At least 1 valid,determinate MenA, C, W, Y,or B assay result at V6, received no prohibited vaccines/treatment, no protocol deviations through V6.''N''=participants evaluable here; ''n''=participants evaluable for specific rows.

Percentage of participants achieving hSBA titer >= LLOQ for each MenB test strain (1:16 for strain A22 and 1:8 for strain B44) is reported in this outcome measure. Exact 2-sided CI using Clopper and Pearson method is presented. Groups 4 and 5 had no serum samples collected post-booster for serology testing due to study termination.

Post booster vacc. evaluable immunogenicity population=randomised to study group of interest,eligible through V6. Received investigational products at V1,3,5 as randomised,blood drawn for assay testing at required time frames at V6(1 month after booster vacc[28-42 days]).At least 1 valid,determinate MenA, C, W, Y,or B assay result at V6, received no prohibited vaccines/treatment, no protocol deviations through V6.''N''=participants evaluable here.

Local reactions included tenderness at injection site, redness and swelling and were recorded by participant's parents/legal guardians in an electronic diary (e-diary). Redness and swelling were measured and recorded in caliper units. 1 caliper unit =0.5 centimeter (cm) and graded as mild: 0.5 to 2.0 cm, moderate: >2.0 to 7.0 cm and severe: >7.0 cm. Tenderness at injection site was graded as mild: hurt if gently touched, moderate: hurt if gently touched with crying and severe: caused limitation of limb movement. Exact 2-sided CI was based on the Clopper and Pearson method.

Primary vaccination 1 safety population included all randomised participants who received the first dose of investigational product at Visit 1 and had safety follow-up between Visit 1 and prior to Visit 3. Here, ''N''=participants evaluable for this outcome measure.

Local reactions included tenderness at injection site, redness and swelling and were recorded by participant's parents/legal guardians in an e-diary. Redness and swelling were measured and recorded in caliper units. 1 caliper unit =0.5 cm and graded as mild: 0.5 to 2.0 cm, moderate: >2.0 to 7.0 cm and severe: >7.0 cm. Tenderness at injection site was graded as mild: hurt if gently touched, moderate: hurt if gently touched with crying and severe: caused limitation of limb movement. Exact 2-sided CI was based on the Clopper and Pearson method.

Primary vaccination 2 safety population included all participants who received the second dose of investigational product at Visit 3 and who had safety follow-up between Visit 3 and prior to Visit 4. Here, ''N''=participants evaluable for this outcome measure. Data was not collected from participants in Group 11 as no participants received primary vaccination 2 due to study termination.

Systemic events were recorded by participant's parents/legal guardians in e-diary. Fever was defined as temperature >=38.0 degrees (deg) Celsius(C) and was categorized as 38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Decreased appetite was categorized as Mild: decreased interest in eating, Moderate: decreased oral intake, Severe: refusal to feed. Drowsiness: Mild: Increased or prolonged sleeping bouts, Moderate: Slightly subdued interfering with daily activity, Severe; Disabling, not interested in usual daily activity. Irritability; Mild: Easily consolable, Moderate: required increased attention, Severe: Inconsolable; crying could not be comforted. Exact 2-sided CI was based on the Clopper and Pearson method

Primary vaccination 1 safety population included all randomized participants who received the first dose of investigational product at Visit 1 and had safety follow-up between Visit 1 and prior to Visit 3. Here, ''N''=participants evaluable for this outcome measure.

Systemic events were recorded by participant's parents/legal guardians in e-diary. Fever was defined as temperature >=38.0 deg C and was categorized as 38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Decreased appetite was categorized as Mild: decreased interest in eating, Moderate: decreased oral intake, Severe: refusal to feed. Drowsiness was graded as Mild: Increased or prolonged sleeping bouts, Moderate: Slightly subdued interfering with daily activity, Severe; Disabling, not interested in usual daily activity. Irritability; Mild: Easily consolable, Moderate: required increased attention, Severe: Inconsolable; crying could not be comforted. Exact 2-sided CI was based on the Clopper and Pearson method.

Primary vaccination 2 safety population included all participants who received the second dose of investigational product at Visit 3 and who had safety follow-up between Visit 3 and prior to Visit 4. Here, ''N''=participants evaluable for this outcome measure. Data was not collected from participants in Group 11 as no participants received primary vaccination 2 due to study termination.

An adverse event (AE) was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. A serious adverse event (SAE) was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. Medically attended adverse event (MAE) was defined as a nonserious AE that resulted in an evaluation at a medical facility. Newly diagnosed chronic medical condition (NDCMC) was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.

Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination. Here, ''N''=participants evaluable for this outcome measure.

An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. NDCMC was defined as a disease or medical condition, not previously identified, that wasis expected to be persistent or otherwise long-lasting in its effects.

Primary vaccination 2 safety population included all participants who received the second dose of investigational product at Visit 3 and who had safety follow-up between Visit 3 and prior to Visit 4. Here, ''N''=participants evaluable for this outcome measure. Data was not collected from participants in Group 11 as no participants received primary vaccination 2 due to study termination.

An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. NDCMC was defined as a disease or medical condition, not previously identified, that is was expected to be persistent or otherwise long-lasting in its effects.

Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination. Here, ''N''=participants evaluable for this outcome measure.

An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.

Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination. Here, ''N''=participants evaluable for this outcome measure.

An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.

Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination. Here, ''N''=participants evaluable for this outcome measure. Data was not collected from participants in Group 11 as no participants received primary vaccination 2 due to study termination.

Infant participants aged 2 months were administered single IM injection of 0.5mL of Bexsero into left thigh, 0.5mL of Nimenrix into right thigh at Day 1(primary vaccination 1), Month 2 (primary vaccination 2) and approximately 10 months after vaccination 1 (booster vaccination). Participants in Group 8 were administered PLP orally with 3 required doses, first dose starting 30 minutes before vaccination at Day1 and Month 2. All participants received single IM injection of Prevenar 13 and Vaxelis into right thigh at 2 and 4 months of age.

Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination. Here, ''N''=participants evaluable for this outcome measure.

Immediate AEs were defined as AEs occurring within the first 30 minutes after investigational product administration.

Primary vaccination 1 safety population included all participants who received the first dose of investigational product at Visit 1 and who had safety follow-up between Visit 1 and prior to Visit 3. Here, ''N''=participants evaluable for this outcome measure.

Immediate AEs were defined as AEs occurring within the first 30 minutes after investigational product administration.

Primary vaccination 2 safety population included all participants who received the second dose of investigational product at Visit 3 and who had safety follow-up between Visit 3 and prior to Visit 4. Here, ''N''=participants evaluable for this outcome measure.

Immediate AEs were defined as AEs occurring within the first 30 minutes after investigational product administration.

Booster vaccination safety population included participants who received booster dose of investigational product, had safety follow-up between Visit 5 and prior to Visit 6 (after booster vaccination). Here, 'N'=participants evaluable for this outcome measure. Data was not collected from participants in Groups 7 and 11 as no participants received booster vaccination due to study termination.

Local reactions included tenderness at injection site, redness and swelling and were recorded by participant's parents/legal guardians in an electronic diary (e-diary). Redness and swelling were measured and recorded in caliper units. 1 caliper unit =0.5 centimeter (cm) and graded as mild: 0.5 to 2.0 cm, moderate: >2.0 to 7.0 cm and severe: >7.0 cm. Tenderness at injection site was graded as mild: hurt if gently touched, moderate: hurt if gently touched with crying and severe: caused limitation of limb movement.

Booster vaccination safety population included participants who received booster dose of investigational product, had safety follow-up between Visit 5 and prior to Visit 6 (after booster vaccination). Here, 'N'=participants evaluable for this outcome measure. Data was not collected from participants in Groups 7 and 11 as no participants received booster vaccination due to study termination.

Systemic events were recorded by participant's parents/legal guardians in e-diary. Fever was defined as temperature >=38.0 deg C, categorized as 38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Decreased appetite was graded as Mild: decreased interest in eating, Moderate: decreased oral intake, Severe: refusal to feed. Drowsiness: Mild: Increased or prolonged sleeping bouts, Moderate: Slightly subdued interfering with daily activity, Severe; Disabling, not interested in usual daily activity. Irritability; Mild: Easily consolable, Moderate: required increased attention, Severe: Inconsolable; crying could not be comforted. Exact 2-sided CI was based on Clopper and Pearson method.

Booster vaccination safety population included participants who received booster dose of investigational product, had safety follow-up between Visit 5 and prior to Visit 6 (after booster vaccination). Here, 'N'=participants evaluable for this outcome measure. Data was not collected from participants in Groups 7 and 11 as no participants received booster vaccination due to study termination.

An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.

Booster vaccination safety population included participants who received booster dose of investigational product, had safety follow-up between Visit 5 and prior to Visit 6 (after booster vaccination). Here, 'N'=participants evaluable for this outcome measure. Data was not collected from participants in Groups 7 and 11 as no participants received booster vaccination due to study termination.

An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.

Booster vaccination follow-up safety population included participants who received the booster dose of investigational product and who had safety follow-up between Visit 6 and up to and including Visit 7 (after booster vaccination). Here, ''N''=participants evaluable for this outcome measure. Data was not collected from participants in Groups 7 and 11 as no participants received booster vaccination due to study termination.

An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.

Booster vaccination safety population included participants who received booster dose of investigational product, had safety follow-up between Visit 5 and prior to Visit 6 (after booster vaccination). Here, ''N''=participants evaluable for this outcome measure. Data was not collected from participants in Groups 7 and 11 as no participants received booster vaccination due to study termination.

GMTs were calculated by exponentiating mean logarithm of titers and CIs were calculated by exponentiating confidence limits based on the Student t distribution for the mean logarithm of the titers.

Post-primary vaccination 2 evaluable immunogenicity population: participants randomized to study group of interest; eligible through Visit(V)4; received vaccine at V1,V3;blood drawn for assay testing at required timeframes at V4; had at least 1 valid, determinate MenA, MenC, MenW, MenY, or MenB assay result at V4;received no prohibited vaccines/treatment,no protocol deviations through V4. Here,''N''= participants evaluable for the outcome measure;''n''= participants evaluable for specific rows.

GMTs were calculated by exponentiating the mean logarithm of the titers and CIs were calculated by exponentiating the confidence limits based on the Student t distribution for the mean logarithm of the titers. No serum samples were collected after booster dose for groups 4 and 5 due to study termination.

Post-primary vaccination 2 evaluable immunogenicity population:eligible participants randomized through Visit(V)4;received vaccine at V1,V3;blood drawn for assay testing within required timeframes at V4;had at least 1 valid, determinate MenA, C, W, Y, or B assay result at V4;received no prohibited vaccines/treatment;no protocol deviation through V4. Here,''N''=participants evaluable for this outcome measure.

Local reactions included pain at injection site, redness and swelling and were recorded by participant's in an electronic diary (e-diary). Redness and swelling were measured and recorded in caliper units. 1 caliper unit =0.5 centimeter (cm) and graded as mild: >2.0 to 5.0 cm, moderate: >5.0 to 10.0 cm and severe: >10.0 cm. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity and severe: prevented daily activity. Percentage of participants with local reactions at injection site on left arm were reported in this outcome measure.

Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination. Here, ''N''=participants evaluable for this outcome measure; ''n''= participants evaluable for specific rows.

Systemic events were recorded by participant's parents/legal guardians in e-diary. Fever was defined as temperature >=38.0 degrees (deg) Celsius(C) and was categorized as 38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Exact 2-sided CI was based on the Clopper and Pearson method. Decreased appetite was categorized as Grade 1:decreased interest in eating, Grade 2:decreased oral intake, Grade3: refusal to feed. Drowsiness: Grade 1 Increased or prolonged sleeping bouts,Grade2: Slightly subdued interfering with daily activity, Grade3; Disabling, not interested in usual daily activity. Irritability; Grade1: Easily consolable, Grade2: requiring increased attention, Grade 3: Inconsolable; crying could not be comforted.

Primary vaccination 1 safety population included all randomized participants who received the first dose of investigational product at Visit 1 and had safety follow-up between Visit 1 and prior to Visit 3. Here, ''N''=participants evaluable for this outcome measure; ''n''= participants evaluable for specific rows.

Infant participants aged 2 months were administered single IM injection of 0.5mL of Bexsero into left thigh, 0.5mL of Nimenrix into right thigh at Day 1(primary vaccination 1), Month 2 (primary vaccination 2) and approximately 10 months after vaccination 1 (booster vaccination). Participants in Group 8 were administered PLP orally with 3 required doses, first dose starting 30 minutes before vaccination at Day1 and Month 2. All participants received single IM injection of Prevenar 13 and Vaxelis into right thigh at 2 and 4 months of age.

Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination. Here, ''N''=participants evaluable for this outcome measure.