A Clinical Trial to Assess the Safety, Tolerability and Immunogenicity of MenABCWY in Healthy Infants

Percentage of Participants Achieving hSBA Titer >= LLOQ for Each MenB Test Strain 1 Month After Booster Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined

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.

Time frame: 1 Month after booster vaccination

Percentage of Participants Achieving hSBA Titer >= LLOQ for Each MenB Test Strain 1 Month After Booster Vaccination: Groups 3, 4 and 5

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.

Time frame: 1 Month after booster vaccination

Percentage of Participants With Local Reactions Within 7 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined

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.

Time frame: Within 7 days after primary vaccination 1

Percentage of Participants With Local Reactions Within 7 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined

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.

Time frame: Within 7 Days after primary Vaccination 2

Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined

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

Time frame: Within 7 Days after primary Vaccination 1

Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined

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.

Time frame: Within 7 days after primary vaccination 2

Percentage of Participants With AEs, SAEs, MAEs and NDCMC Within 30 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined

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.

Time frame: Within 30 days after primary vaccination 1

Percentage of Participants With AEs, SAEs,MAEs and NDCMC Within 30 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined

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.

Time frame: Within 30 days after primary vaccination 2

Percentage of Participants With AEs, SAEs, MAEs and NDCMC Within 30 Days After Any Primary Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined

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.

Time frame: Within 30 days after any primary vaccination

Percentage of Participants With AEs, SAEs, MAEs and NDCMC During Primary Series Vaccination Phase: Group 7 and 11 Combined Versus Group 8 and 10 Combined

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.

Time frame: From day of primary vaccination 1 at Day 1 up to 1 month after primary vaccination 2

Percentage of Participants With SAEs, MAEs and NDCMC During Primary Series Follow-up Phase: Group 7 Versus Group 8 and 10 Combined

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.

Time frame: From 1 month after primary vaccination 2 up to booster vaccination

Percentage of Participants With AEs, SAEs, MAEs and NDCMC Throughout Primary Series Stage: Group 7 and 11 Combined Versus Group 8 and 10 Combined

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.

Time frame: From the date of primary vaccination 1 up to 8 months after primary vaccination 2 (maximum up to 9 months)

Percentage of Participants With Immediate AEs Within 30 Minutes After Primary Vaccination 1: Groups 7 and 11 Combined Versus Groups 8 and 10 Combined

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

Time frame: Within 30 minutes After primary vaccination 1

Percentage of Participants With Immediate AEs Within 30 Minutes After Primary Vaccination 2: Group 7 Versus Groups 8 and 10 Combined

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

Time frame: Within 30 minutes After primary vaccination 2

Percentage of Participants With Immediate AEs After Booster Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined

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

Time frame: Within 30 minutes after booster vaccination

Percentage of Participants With Local Reactions Within 7 Days After Booster Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined

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.

Time frame: Within 7 Days after booster vaccination

Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined

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.

Time frame: Within 7 days after booster vaccination

Percentage of Participants With AEs, SAEs, MAEs and NDCMC During Booster Vaccination Phase: Group 7 and 11 Combined Versus Group 8 and 10 Combined

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.

Time frame: From date of booster vaccination through 1 month after booster vaccination

Percentage of Participants With AEs, SAEs, MAEs and NDCMC During Booster Follow-up Phase: Group 7 and 11 Combined Versus Group 8 and 10 Combined

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.

Time frame: From 1 month after booster vaccination up to 6 months after booster vaccination (maximum up to 5 months)

Percentage of Participants With AEs, SAEs, MAEs and NDCMC Throughout Booster Stage: Group 7 and 11 Combined Versus Group 8 and 10 Combined

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.

Time frame: From 1 month after booster vaccination up to 6 months after booster vaccination (maximum up to 6 months)