MenABCWY Noninferiority Study in Healthy Participants ≥10 to <26 Years of Age

4-fold increase was defined as: 1) for participants with baseline hSBA titer below limit of detection (LOD) (or hSBA titer less than [<] 1:4), 4-fold rise was defined as hSBA titer greater than or equal to (>=) 1:16; 2) baseline hSBA titer >=LOD and < lower limit of quantitation (LLOQ) (i.e. hSBA titer of 1:8), 4-fold rise was defined as hSBA titer >=4 times LLOQ; 3) baseline hSBA titer >=LLOQ, 4-fold rise was defined as hSBA titer >=4 times baseline titer. Exact 2-sided confidence interval (CI) using Clopper and Pearson method was presented. Analysis was performed on post-vaccination (PV) 1 evaluable immunogenicity population (EIP) for Group 2 and PV2 evaluable immunogenicity population for Group 1. Here, 'Overall Number of Participants Analyzed' represented as 'N' and 'Number Analyzed' represented as 'n'.

4-fold increase was defined as: 1) for participants with baseline hSBA titer below LOD (or hSBA titer <1:4), 4-fold rise was defined as hSBA titer >=1:16; 2) baseline hSBA titer >=LOD (i.e., hSBA titer of >=1:4) and < LLOQ (i.e., hSBA titer of 1:8), 4-fold rise was defined as hSBA titer >=4times LLOQ; 3) baseline hSBA titer >=LLOQ, 4-fold rise was defined as hSBA titer >=4 times baseline titer. Exact 2-sided CI using Clopper and Pearson method was presented. Here, 'Overall Number of Participants Analyzed' represented as 'N' and 'Number Analyzed' represented as 'n'.

Percentage of participants achieving hSBA titer >= LLOQ (1:16 for strain A22 and 1:8 for strains A56, B24, and B44) for all MenB test strains (A22, A56, B24 and B44) combined were reported in this outcome measure. Exact 2-sided CI using the Clopper and Pearson method was presented.

Percentage of participants achieving at least a 4-fold rise in hSBA titer for each primary MenB test strains (A22, A56, B24 and B44) were reported in this outcome measure. Exact 2-sided CI using the Clopper and Pearson method was presented.

Local reactions included pain at injection site, redness and swelling and were recorded by participants 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 were reported in this outcome measure. Exact 2-sided CI was based on the Clopper and Pearson method.

Local reactions included pain at injection site, redness and swelling and were recorded by participants in an e-diary. Redness and swelling were measured and recorded in caliper units. 1 caliper unit =0.5 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 were reported in this outcome measure. Exact 2-sided CI was based on the Clopper and Pearson method.

Systemic events were recorded by participants 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. Fatigue, headache, chills, muscle pain and joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24 hours(h), moderate: >2 times in 24h and severe: required intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h. Exact 2-sided CI was based on the Clopper and Pearson method.

Systemic events were recorded by participants 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. Fatigue, headache, chills, muscle pain and joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24h, moderate: >2 times in 24h and severe: required intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h. Exact 2-sided CI was based on the Clopper and Pearson method.

The use of antipyretic medication was recorded by participants in an e-diary for 7 days after vaccination. Exact 2-sided CI was based on the Clopper and Pearson method.

The use of antipyretic medication recorded by participants in an e-diary for 7 days after vaccination. Exact 2-sided CI was based on the Clopper and Pearson method.

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. Exact 2-sided CI was based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in 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. Exact 2-sided CI was based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in 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. Exact 2-sided CI was based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in 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. Exact 2-sided CI was based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.

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. Exact 2-sided CI was based on the Clopper and Pearson method.

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. Exact 2-sided CI was based on the Clopper and Pearson method.

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. Exact 2-sided CI was based on the Clopper and Pearson method.

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. Exact 2-sided CI was based on the Clopper and Pearson method.

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. Exact 2-sided CI was based on the Clopper and Pearson method.

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. Exact 2-sided CI was based on the Clopper and Pearson method.

MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. Exact 2-sided CI was based on the Clopper and Pearson method.

MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. Exact 2-sided CI was based on the Clopper and Pearson method.

MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. Exact 2-sided CI was based on the Clopper and Pearson method.

MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. Exact 2-sided CI was based on the Clopper and Pearson method.

MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. Exact 2-sided CI was based on the Clopper and Pearson method.

MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. Exact 2-sided CI was based on the Clopper and Pearson method.

An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or otherwise long-lasting in its effects. Exact 2-sided CI was based on the Clopper and Pearson method.

An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or otherwise long-lasting in its effects. Exact 2-sided CI was based on the Clopper and Pearson method.

An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or otherwise long-lasting in its effects. Exact 2-sided CI was based on the Clopper and Pearson method.

An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or otherwise long-lasting in its effects. Exact 2-sided CI was based on the Clopper and Pearson method.

An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or otherwise long-lasting in its effects. Exact 2-sided CI was based on the Clopper and Pearson method.

An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or otherwise long-lasting in its effects. Exact 2-sided CI was based on the Clopper and Pearson method.

Immediate AEs were defined as AEs occurring within the first 30 minutes after investigational product administration. Exact 2-sided CI was based on the Clopper and Pearson method.

Immediate AEs were defined as AEs occurring within the first 30 minutes after investigational product administration. Exact 2-sided CI was based on the Clopper and Pearson method.

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. Percentage of participants who missed days of school or work due to AEs during vaccination phase were reported in this outcome measure.

4-fold increase was defined as: 1) for participants with baseline hSBA titer below LOD (or hSBA titer <1:4), 4-fold rise was defined as hSBA titer >=1:16; 2) baseline hSBA titer >=LOD (i.e., hSBA titer of >=1:4) and < LLOQ (i.e. hSBA titer of 1:8), 4-fold rise was defined as hSBA titer >=4times LLOQ; 3) baseline hSBA titer >=LLOQ, 4-fold rise was defined as hSBA titer >=4 times baseline titer. Exact 2-sided CI using Clopper and Pearson method was presented.

4-fold increase was defined as: 1) for participants with baseline hSBA titer below LOD (or hSBA titer <1:4), 4-fold rise was defined as hSBA titer >=1:16; 2) baseline hSBA titer >=LOD (i.e., hSBA titer of >=1:4) and < LLOQ (i.e. hSBA titer of 1:8), 4-fold rise was defined as hSBA titer >=4 times LLOQ; 3) baseline hSBA titer > =LLOQ, 4-fold rise was defined as hSBA titer >=4 times baseline titer. Exact 2-sided CI using Clopper and Pearson method was presented.