Percentage of participants who achieved an hSBA titer >= LLOQ for all 4 primary MenB test strains combined (LLOQ was 1:16 for A22 and 1:8 for A56, B24, and B44) was reported in this outcome. Analysis for this outcome measure was planned for combined Group 2 and 4.

Stage 1 evaluable immunogenicity population(EIP)=all participants randomized to study group of interest,received all investigational products as randomized,had blood drawn for assay testing in required time frames at Months 0 and 7,had valid and determinate assay results,received no prohibited vaccines/treatment,had no major protocol violation determined by medical monitor.'Number of Participants Analyzed'=participants with valid and determinate hSBA results on all 4 strains at given time point.

The 4-fold increase: a) participants with baseline hSBA titer below limit of detection (LOD or an hSBA titer <1:4), response was defined as hSBA titer >=1:16 or LLOQ (whichever titer is higher); b) Participants with baseline hSBA titer >= LOD and < LLOQ, response was defined as hSBA titer >= 4 times the LLOQ; c) participants with baseline hSBA titer >= LLOQ, response was defined as hSBA titer >=4 times baseline titer. Four primary MenB test strains were PMB80 (A22), PMB2001 (A56), PMB2948 (B24) and PMB2707 (B44). Analysis for this outcome measure was planned for combined Group 2 and 4.

Stage 1 EIP analyzed. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row. "Number Analyzed": participants with valid and determinate hSBA titers for given strain at both specified time point and baseline.

Local reactions (redness, swelling, and pain) at the site of investigational product administration were recorded in e-diary. Redness and swelling were measured and recorded in caliper units. Each caliper unit represented 0.5 cm. Redness and swelling were 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 activity), moderate (interfered with activity), and severe (prevented daily activity).

Vaccination 1 safety population included participants who received the first dose of investigational product (MenABCWY+saline or bivalent rLP2086+MenACWY-CRM) at Visit 1 (Month 0), and for whom safety information from Visit 1 (Month 0) to prior to Visit 3 (Month 6) was available. Here, 'Overall Number of participants Analyzed' signifies number of participants with known values. Analysis was planned for combined Group 2 and 4.

Local reactions (redness, swelling, and pain) at the site of investigational product administration were recorded in e-diary. Redness and swelling were measured and recorded in caliper units. Each caliper unit represented 0.5 cm. Redness and swelling were 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 activity), moderate (interfered with activity), and severe (prevented daily activity).

Vaccination 2 safety population included participants who received the second dose of investigational product (MenABCWY or bivalent rLP2086) at Visit 3 (Month 6), and for whom safety information from Visit 3 (Month 6) up to and including Visit 4 (month 7) was available. Here, 'Overall Number of Participants Analyzed' signifies number of participants with known values. Analysis was planned for combined Group 2 and 4.

Systemic events fever, vomiting, diarrhea, headache, fatigue, chills, muscle pain other than muscle pain at the injection site, and joint pain were recorded by using an e-diary. Fever was defined as >=38.0 degree Celsius (C) and categorized to 38.0 to 38.4 degree C, 38.5 to 38.9 degree C, 39.0 to 40.0 degree C and >40.0 degree C. Headache, fatigue, chills, muscle pain and joint pain were graded as mild (did not interfere with activity), moderate (some interference with activity) and severe (prevented daily activity). Vomiting was graded as mild (1-2 times in 24 hours), moderate (>2 times in 24 hours) and severe (required IV hydration). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours) and severe (>=6 in 24 hours).

Vaccination 1 safety population included participants who received the first dose of investigational product (MenABCWY+saline or bivalent rLP2086+MenACWY-CRM) at Visit 1 (Month 0), and for whom safety information from Visit 1 (Month 0) to prior to Visit 3 (Month 6) was available. Here, "Overall Number of Participants Analyzed": number of participants with known values. Analysis was planned for combined Group 2 and 4.

Systemic events fever, vomiting, diarrhea, headache, fatigue, chills, muscle pain other than muscle pain at the injection site, and joint pain were recorded by using an e-diary. Fever was defined as >=38.0 degree C and categorized to 38.0 to 38.4 degree C, 38.5 to 38.9 degree C, 39.0 to 40.0 degree C and >40.0 degree C. Headache, fatigue, chills, muscle pain and joint pain were graded as mild (did not interfere with activity), moderate (some interference with activity) and severe (prevented daily activity). Vomiting was graded as mild (1-2 times in 24 hours), moderate (>2 times in 24 hours) and severe (required IV hydration). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours) and severe (>=6 in 24 hours).

Vaccination 2 safety population included participants who received the second dose of investigational product (MenABCWY or bivalent rLP2086) at Visit 3 (Month 6), and for whom safety information from Visit 3 (Month 6) up to and including Visit 4 (month 7) was available. Here, "Overall Number of Participants Analyzed": number of participants with known values. Analysis was planned for combined Group 2 and 4.

Vaccination 1 safety population included participants who received the first dose of investigational product (MenABCWY+saline or bivalent rLP2086+MenACWY-CRM) at Visit 1 (Month 0), and for whom safety information from Visit 1 (Month 0) to prior to Visit 3 (Month 6) was available. Here, "Overall Number of Participants Analyzed": number of participants with known values. Analysis was planned for combined Group 2 and 4.

Vaccination 2 safety population included participants who received the second dose of investigational product (MenABCWY or bivalent rLP2086) at Visit 3 (Month 6), and for whom safety information from Visit 3 (Month 6) up to and including Visit 4 (month 7) was available. Here, "Overall Number of participants Analyzed": number of participants with known values. Analysis was planned for combined Group 2 and 4.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Or that was considered to be an important medical event.

Vaccination 1 safety population included participants who received the first dose of investigational product (MenABCWY+saline or bivalent rLP2086+MenACWY-CRM) at Visit 1 (Month 0), and for whom safety information from Visit 1 (Month 0) to prior to Visit 3 (Month 6) was available. Analysis was planned for combined Group 2 and 4.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Or that was considered to be an important medical event.

Vaccination 2 safety population included participants who received the second dose of investigational product (MenABCWY or bivalent rLP2086) at Visit 3 (Month 6), and for whom safety information from Visit 3 (Month 6) up to and including Visit 4 (month 7) was available. Analysis was planned for combined Group 2 and 4.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Or that was considered to be an important medical event.

Stage 1 Safety population: participants who had received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Analysis was planned for combined Group 2 and 4.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Or that was considered to be an important medical event.

Stage 1 Safety population: participants who had received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Analysis was planned for combined Group 2 and 4.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Or that was considered to be an important medical event. There was one participant who did not meet criteria for Stage 1 follow-up safety population. The subject's SAE happened in the follow-up phase but was not included in the follow-up safety population for Stage 1 (but in the safety population for Stage 1). Therefore, the SAE was not included in the follow-up table but in the broadly defined throughout Stage 1 table.

Stage 1 Follow-up Safety population: participants who received at least 1 dose of investigational product and for whom safety information was available from after Visit 4 (Month 7) up to and including Visit 5 (Month 12). Analysis was planned for combined Group 2 and 4. Here overall number of participants analysed included those participants who met criteria for Stage 1 Follow-up safety population.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Or that was considered to be an important medical event. There was one participant who did not meet criteria for Stage 1 follow-up safety population. The subject's SAE happened in the follow-up phase but was not included in the follow-up safety population for Stage 1 (but in the safety population for Stage 1). Therefore, the SAE was not included in the follow-up table but in the broadly defined throughout Stage 1 table.

Stage 1 Safety population: participants who had received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Analysis was planned for combined Group 2 and 4. Here overall number of participants analysed included those participants who met criteria for Stage 1 safety population.

Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility.

Vaccination 1 safety population included participants who received the first dose of investigational product (MenABCWY+saline or bivalent rLP2086+MenACWY-CRM) at Visit 1 (Month 0), and for whom safety information from Visit 1 (Month 0) to prior to Visit 3 (Month 6) was available. Analysis was planned for combined Group 2 and 4.

Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility.

Vaccination 2 safety population included participants who received the second dose of investigational product (MenABCWY or bivalent rLP2086) at Visit 3 (Month 6), and for whom safety information from Visit 3 (Month 6) up to and including Visit 4 (month 7) was available. Analysis was planned for combined Group 2 and 4.

Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility.

Stage 1 Safety population: participants who had received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Analysis was planned for combined Group 2 and 4.

Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility.

Stage 1 Safety population: participants who had received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Analysis was planned for combined Group 2 and 4.

Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility.

Stage 1 Follow-up Safety population: participants who received at least 1 dose of investigational product and for whom safety information was available from after Visit 4 (Month 7) up to and including Visit 5 (Month 12). Analysis was planned for combined Group 2 and 4.

Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility.

Stage 1 Safety population: participants who had received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Analysis was planned for combined Group 2 and 4.

A 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.

Vaccination 1 safety population included participants who received the first dose of investigational product (MenABCWY+saline or bivalent rLP2086+MenACWY-CRM) at Visit 1 (Month 0), and for whom safety information from Visit 1 (Month 0) to prior to Visit 3 (Month 6) was available. Analysis was planned for combined Group 2 and 4.

A 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.

Vaccination 2 safety population included participants who received the second dose of investigational product (MenABCWY or bivalent rLP2086) at Visit 3 (Month 6), and for whom safety information from Visit 3 (Month 6) up to and including Visit 4 (month 7) was available. Analysis was planned for combined Group 2 and 4.

A 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 for Stage 1 included participants who had received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Analysis was planned for combined Group 2 and 4.

A 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 for Stage 1 included participants who had received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Analysis was planned for combined Group 2 and 4.

A 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.

Stage 1 Follow-up Safety population: participants who received at least 1 dose of investigational product and for whom safety information was available from after Visit 4 (Month 7) up to and including Visit 5 (Month 12). Analysis was planned for combined Group 2 and 4.

A 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 for Stage 1 included participants who had received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Analysis was planned for combined Group 2 and 4.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs did not include local reaction and systemic events collected by systematic approach.

Vaccination 1 safety population included participants who received the first dose of investigational product (MenABCWY+saline or bivalent rLP2086+MenACWY-CRM) at Visit 1 (Month 0), and for whom safety information from Visit 1 (Month 0) to prior to Visit 3 (Month 6) was available. Analysis was planned for combined Group 2 and 4.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs did not include local reaction and systemic events collected by systematic approach.

Vaccination 2 safety population included participants who received the second dose of investigational product (MenABCWY or bivalent rLP2086) at Visit 3 (Month 6), and for whom safety information from Visit 3 (Month 6) up to and including Visit 4 (month 7) was available. Analysis was planned for combined Group 2 and 4.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs did not include local reaction and systemic events collected by systematic approach.

Stage 1 Safety population: participants who had received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Analysis was planned for combined Group 2 and 4.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs did not include local reaction and systemic events collected by systematic approach.

Stage 1 Safety population: participants who had received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Analysis was planned for combined Group 2 and 4.

Immediate AE was defined as AE occurring within the first 30 minutes after investigational product administration.

Vaccination 1 safety population included participants who received the first dose of investigational product (MenABCWY+saline or bivalent rLP2086+MenACWY-CRM) at Visit 1 (Month 0), and for whom safety information from Visit 1 (Month 0) to prior to Visit 3 (Month 6) was available. Analysis was planned for combined Group 2 and 4.

Immediate AE was defined as AE occurring within the first 30 minutes after investigational product administration.

Vaccination 2 safety population included participants who received the second dose of investigational product (MenABCWY or bivalent rLP2086) at Visit 3 (Month 6), and for whom safety information from Visit 3 (Month 6) up to and including Visit 4 (Month 7) was available. Analysis was planned for combined Group 2 and 4.

Stage 1 Safety population: participants who had received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Analysis was planned for combined Group 2 and 4.

Local reactions (redness, swelling, and pain) at the site of investigational product administration were recorded in e-diary. Redness and swelling were measured and recorded in caliper units. Each caliper unit represented 0.5 cm. Redness and swelling were 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 activity), moderate (interfered with activity), and severe (prevented daily activity).

Booster vaccination safety population included participants who received the booster dose of investigational product (MenABCWY or bivalent rLP2086) at Visit 10 (Month 54), and for whom safety information from Visit 10 (Month 54) up to and including Visit 11 (Month 55) was available. Here, 'Overall Number of Participants Analyzed' signifies number of participants with known values.

Systemic events fever, vomiting, diarrhea, headache, fatigue, chills, muscle pain and joint pain were recorded in an e-diary. Fever was defined as >=38.0 degree Celsius (C) and categorized to 38.0 to 38.4 degree C, 38.5 to 38.9 degree C, 39.0 to 40.0 degree C and >40.0 degree C. Headache, fatigue, chills, muscle pain and joint pain were graded as mild (did not interfere with activity), moderate (some interference with activity) and severe (prevented daily activity). Vomiting was graded as mild (1-2 times in 24 hours), moderate (>2 times in 24 hours) and severe (required IV hydration). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours) and severe (>=6 in 24 hours).

Booster vaccination safety population included participants who received the booster dose of investigational product (MenABCWY or bivalent rLP2086) at Visit 10 (Month 54), and for whom safety information from Visit 10 (Month 54) up to and including Visit 11 (Month 55) was available. Here, 'Overall Number of Participants Analyzed' signifies number of participants with known values.

Booster vaccination safety population included participants who received the booster dose of investigational product (MenABCWY or bivalent rLP2086) at Visit 10 (Month 54), and for whom safety information from Visit 10 (Month 54) up to and including Visit 11 (Month 55) was available. Here, 'Overall Number of Participants Analyzed' signifies number of participants with known values.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Or that was considered to be an important medical event. SAE of "pregnancy" for one participant during the booster vaccination phase was recorded erroneously and hence it was included in results of Group 4.

Booster vaccination safety population included participants who received the booster dose of investigational product (MenABCWY or bivalent rLP2086) at Visit 10 (Month 54), and for whom safety information from Visit 10 (Month 54) up to and including Visit 11 (Month 55) was available.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Or that was considered to be an important medical event.

Booster Follow-up safety population for Stage 2 included participants who received the booster dose of investigational product and for whom safety information was available from after Visit 11 (Month 55) up to and including Visit 12 (Month 60).

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Or that was considered to be an important medical event. SAE of "pregnancy" for one participant during the booster vaccination phase was recorded erroneously and hence it was reported in result of outcome measure 37 for Group 4. Subsequently correction was made by the trial site and not included in subsequent phase/results. Hence, that 1 participant is not included in results of Group 4 here.

Booster safety population included participants who received the booster dose of investigational product (MenABCWY or bivalent rLP2086) at Visit 10 (Month 54), and for whom safety information from Visit 10 (Month 54) up to and including Visit 12 (Month 60) was available.

Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility.

Booster vaccination safety population included participants who received the booster dose of investigational product (MenABCWY or bivalent rLP2086) at Visit 10 (Month 54), and for whom safety information from Visit 10 (Month 54) up to and including Visit 11 (Month 55) was available.

Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility.

Booster Follow-up safety population for Stage 2 included participants who received the booster dose of investigational product and for whom safety information was available from after Visit 11 (Month 55) up to and including Visit 12 (Month 60).

Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility.

Booster safety population included participants who received the booster dose of investigational product (MenABCWY or bivalent rLP2086) at Visit 10 (Month 54), and for whom safety information from Visit 10 (Month 54) up to and including Visit 12 (Month 60) was available.

A 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 the booster dose of investigational product (MenABCWY or bivalent rLP2086) at Visit 10 (Month 54), and for whom safety information from Visit 10 (Month 54) up to and including Visit 11 (Month 55) was available.

A 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 Follow-up safety population for Stage 2 included participants who received the booster dose of investigational product and for whom safety information was available from after Visit 11 (Month 55) up to and including Visit 12 (Month 60).

A 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 safety population included participants who received the booster dose of investigational product (MenABCWY or bivalent rLP2086) at Visit 10 (Month 54), and for whom safety information from Visit 10 (Month 54) up to and including Visit 12 (Month 60) was available.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs did not include local reaction and systemic events collected by systematic approach.

Booster vaccination safety population included participants who received the booster dose of investigational product (MenABCWY or bivalent rLP2086) at Visit 10 (Month 54), and for whom safety information from Visit 10 (Month 54) up to and including Visit 11 (Month 55) was available.

Immediate AE was defined as AE occurring within the first 30 minutes after investigational product administration.

Booster vaccination safety population included participants who received the booster dose of investigational product (MenABCWY or bivalent rLP2086) at Visit 10 (Month 54), and for whom safety information from Visit 10 (Month 54) up to and including Visit 11 (Month 55) was available.

Booster vaccination safety population included participants who received the booster dose of investigational product (MenABCWY or bivalent rLP2086) at Visit 10 (Month 54), and for whom safety information from Visit 10 (Month 54) up to and including Visit 11 (Month 55) was available.

Percentage of participants who achieved an hSBA titer >= LLOQ for all 4 primary MenB test strains combined (LLOQ was 1:16 for A22 and 1:8 for A56, B24, and B44) was reported in this outcome measure. Four primary MenB test strains were PMB80 (A22), PMB2001 (A56), PMB2948 (B24) and PMB2707 (B44).

Stage 1 EIP analyzed. Here "Overall Number of Participants analyzed" included all participants who were measured and analyzed. Here, 'Number Analyzed' signifies number of participants with valid and determinate hSBA results on all 4 strains at given time point. Analysis was planned combined for Group 2 and 4.

Percentage of participants who achieved an hSBA titer >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for all 4 primary MenB test strains was reported in this outcome measure. Four primary MenB test strains were PMB80 (A22), PMB2001 (A56), PMB2948 (B24) and PMB2707 (B44).

Stage 1 EIP analyzed. Here "Overall Number of Participants analyzed" included all participants who were measured and analyzed. Here, 'Number Analyzed' signifies number of participants with valid and determinate hSBA results on all 4 strains at given time point. Analysis was planned for combined Group 2 and 4.

GMTs were calculated using all participants with valid and determinate hSBA titers at the given time point. LLOQ = 1:16 for A22; 1:8 for A56, B24, and B44. Titers below the LLOQ were set to 0.5 * LLOQ for analysis. Four primary MenB test strains were PMB80 (A22), PMB2001 (A56), PMB2948 (B24) and PMB2707 (B44).

Stage 1 EIP analyzed. Here "Overall Number of Participants analyzed" included all participants who were measured and analyzed. Here, 'Number Analyzed' signifies number of participants with valid and determinate hSBA results on all 4 strains at given time point. Analysis was planned for combined Group 2 and 4.

Percentage of participants who achieved an hSBA titer greater than or equal to LLOQ for 10 Secondary MenB test strains combined (LLOQ = 1:16 for A06, A12, and A19; 1:8 for A07, A15, A29, B03, B09, B15, and B16) was reported in this outcome measure.

Stage 1 EIP analyzed. Here "Overall Number of Participants analyzed" included all participants who were measured and analyzed. Here, 'Number Analyzed' signifies number of participants with valid and determinate hSBA results on all 10 strains at given time point. Analysis was planned for combined Group 2 and 4.

Percentage of participants who achieved an hSBA titer >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for each of the 10 secondary MenB test strains was reported in this outcome measure. 10 secondary MenB test strains were PMB3175 (A29), PMB3010 (A06), PMB824 (A12), PMB3040 (A07), PMB1672 (A15), PMB1989 (A19), PMB648 (B16), PMB866 (B09), PMB1256 (B03) and PMB431 (B15).

Stage 1 EIP analyzed. Here "Overall Number of Participants analyzed" included all participants who were measured and analyzed. Here, 'Number Analyzed' signifies number of participants with valid and determinate hSBA results on all 10 strains at given time point. Analysis was planned for combined Group 2 and 4.

GMTs were calculated using all participants with valid and determinate hSBA titers at the given time point. LLOQ = 1:16 for A06, A12, and A19; 1:8 for A07, A15, A29, B03, B09, B15, and B16. Titers below the LLOQ were set to 0.5*LLOQ for analysis.

Stage 1 EIP analyzed. Here "Overall Number of Participants analyzed" included all participants who were measured and analyzed. Here, 'Number Analyzed' signifies number of participants with valid and determinate hSBA results on all 10 strains at given time point. Analysis was planned for combined Group 2 and 4.

Percentage of participants who achieved an hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY titer >=LLOQ for ACWY test strains (LLOQ = 1:8 for all MenA, MenC, MenW, and MenY strains) was reported in this outcome measure.

Stage 1 modified intent-to-treat (mITT) population: all randomized participants who had received at least 1 study vaccination, who had at least 1 valid and determinate primary strain MenB or MenA/C/W/Y assay result available at any time point from Month 0 to 7. "Overall Number of Participants Analyzed": participants who were measured and analyzed for the outcome measure. 'Number Analyzed': participants with valid and determinate hSBA results for ACWY test strains at the given time point.

Percentage of participants who achieved an hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY titer >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for ACWY test strains was reported in this outcome measure.

Stage 1 mITT population included all randomized participants who had received at least 1 study vaccination and who had at least 1 valid and determinate primary strain MenB or MenA/C/W/Y assay result available at any time point from 0 to 7 months. "Overall Number of Participants Analyzed": participants who were measured and analyzed for the outcome measure and 'Number Analyzed' signifies number of participants with valid and determinate hSBA results for ACWY test strains at the given time point.

GMTs were calculated using all participants with valid and determinate hSBA titers at the given time point. LLOQ = 1:8 for all MenA, MenC, MenW, and MenY. Titers below the LLOQ were set to 0.5*LLOQ for analysis.

Stage 1 mITT population included all randomized participants who had received at least 1 study vaccination and who had at least 1 valid and determinate primary strain MenB or MenA/C/W/Y assay result available at any time point from 0 to 7 months. "Overall Number of Participants Analyzed": participants who were measured and analyzed for the outcome measure and 'Number Analyzed' signifies number of participants with valid and determinate hSBA results for ACWY test strains at the given time point.

Percentage of participants who achieved an hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY titer >= LLOQ for ACWY test strains (LLOQ = 1:8 for all MenA, MenC, MenW, and MenY strains) was reported in this outcome measure.

Stage 1 mITT population included all randomized participants who had received at least 1 study vaccination and who had at least 1 valid and determinate primary strain MenB or MenA/C/W/Y assay result available at any time point from 0 to 7 months. "Overall Number of Participants Analyzed": participants who were measured and analyzed for the outcome measure and 'Number Analyzed' signifies number of participants with valid and determinate hSBA results for ACWY test strains at the given time point.

Percentage of participants who achieved an hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY titer >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for ACWY test strains was reported in this outcome measure.

Stage 1 mITT population included all randomized participants who had received at least 1 study vaccination and who had at least 1 valid and determinate primary strain MenB or MenA/C/W/Y assay result available at any time point from 0 to 7 months. "Overall Number of Participants Analyzed": participants who were measured and analyzed for the outcome measure and 'Number Analyzed' signifies number of participants with valid and determinate hSBA results for ACWY test strains at the given time point.

GMTs were calculated using all participants with valid and determinate hSBA titers at the given time point. LLOQ = 1:8 for all MenA, MenC, MenW, and MenY. Titers below the LLOQ were set to 0.5*LLOQ for analysis.

Stage 1 mITT population included all randomized participants who had received at least 1 study vaccination and who had at least 1 valid and determinate primary strain MenB or MenA/C/W/Y assay result available at any time point from 0 to 7 months. "Overall Number of Participants Analyzed": participants who were measured and analyzed for the outcome measure and 'Number Analyzed' signifies number of participants with valid and determinate hSBA results for ACWY test strains at the given time point.

Percentage of participants who achieved an hSBA titer >=LLOQ for all 4 primary MenB test strains (LLOQ was 1:16 for A22 and 1:8 for A56, B24, and B44) was reported in this outcome measure.

Stage 1 EIP analyzed. Here, "Overall Number of Participants Analyzed" signifies number of participants measured and analyzed for this outcome measure. "Number Analyzed" signifies number of participants with valid and determinate hSBA results for each strains at given time point. Analysis was planned for combined Group 1 and 3 and combined Group 2 and 4.

Percentage of participants who achieved an hSBA titer greater than or equal to LLOQ for all 4 primary MenB test strains combined (LLOQ was 1:16 for A22 and 1:8 for A56, B24, and B44) was reported in this outcome measure.

Stage 1 EIP analyzed. Here, "Overall Number of Participants Analyzed" signifies number of participants measure and analyzed for this outcome measure. "Number Analyzed" signifies number of participants with valid and determinate hSBA results on all 4 strains at given time point. Analysis was planned for combined Group 1 and 3 and combined Group 2 and 4.

Percentage of participants who achieved an hSBA titer >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for all 4 primary MenB test strains was reported in this outcome measure.

Stage 1 EIP analyzed. Here, "Overall Number of Participants Analyzed" signifies number of participants measure and analyzed for this outcome measure. "Number Analyzed" signifies number of participants with valid and determinate hSBA results on all 4 strains at given time point. Analysis was planned for combined Group 1 and 3 and combined Group 2 and 4.

GMTs were calculated using all participants with valid and determinate hSBA titers at the given time point. LLOQ =1:16 for A22; 1:8 for A56, B24, and B44. Titers below the LLOQ were set to 0.5*LLOQ for analysis.

Stage 1 EIP analyzed. Here, "Overall Number of Participants Analyzed" signifies number of participants measure and analyzed for this outcome measure. "Number Analyzed" signifies number of participants with valid and determinate hSBA results on all 4 strains at given time point. Analysis was planned for combined Group 1 and 3 and combined Group 2 and 4.

Percentage of participants who achieved an hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY titer >=LLOQ for ACWY test strains (LLOQ = 1:8 for all MenA, MenC, MenW, and MenY strains) was reported in this outcome measure.

Stage 1 mITT population included all randomized participants who had received at least 1 study vaccination and who had at least 1 valid and determinate primary strain MenB or MenA/C/W/Y assay result available at any time point from 0 to 7 months. "Overall Number of Participants Analyzed": participants who were measured and analyzed for the outcome measure and 'Number Analyzed' signifies number of participants with valid and determinate hSBA results for ACWY test strains at the given time point.

Percentage of participants who achieved an hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY titer >=1:4, >= :8, >=1:16, >=1:32, >=1:64, >=1:128 for ACWY test strains was reported in this outcome measure.

Stage 1 mITT population included all randomized participants who had received at least 1 study vaccination and who had at least 1 valid and determinate primary strain MenB or MenA/C/W/Y assay result available at any time point from 0 to 7 months. "Overall Number of Participants Analyzed": participants who were measured and analyzed for the outcome measure and 'Number Analyzed' signifies number of participants with valid and determinate hSBA results for ACWY test strains at the given time point.

GMTs were calculated using all participants with valid and determinate hSBA titers at the given time point. LLOQ = 1:8 for all MenA, MenC, MenW, and MenY strains. Titers below the LLOQ were set to 0.5*LLOQ for analysis. Confidence intervals were back transformations of confidence levels based on the Student t distribution for the mean logarithm of the concentrations, or the mean of the ratio.

Stage 1 mITT population included all randomized participants who had received at least 1 study vaccination and who had at least 1 valid and determinate primary strain MenB or MenA/C/W/Y assay result available at any time point from 0 to 7 months. "Overall Number of Participants Analyzed": participants who were measured and analyzed for the outcome measure and 'Number Analyzed' signifies number of participants with valid and determinate hSBA results for ACWY test strains at the given time point.

Percentage of participants who achieved an hSBA titer >=LLOQ for all 4 primary MenB test strains (LLOQ was 1:16 for A22 and 1:8 for A56, B24, and B44) was reported in this outcome measure.

Stage 1 EIP analyzed. Here, "Overall Number of Participants Analyzed" signifies number of participants measured and analyzed for this outcome measure. "Number Analyzed" signifies number of participants with valid and determinate hSBA results for each strains at given time point. Analysis was planned for combined Group 1 and 3 and combined Group 2 and 4.

Percentage of participants who achieved an hSBA titer >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for each of the 4 primary MenB test strains was reported in this outcome measure.

Stage 1 EIP analyzed. Here, "Overall Number of Participants Analyzed" signifies number of participants measured and analyzed for this outcome measure. "Number Analyzed" signifies number of participants with valid and determinate hSBA results for each strain at given time point. Analysis was planned for combined Group 1 and 3 and combined Group 2 and 4.

GMTs were calculated using all participants with valid and determinate hSBA titers at the given time point. LLOQ =1:16 for A22; 1:8 for A56, B24, and B44. Titers below the LLOQ were set to 0.5*LLOQ for analysis. CIs were back transformations of confidence levels based on the Student t distribution for the mean logarithm of the hSBA titers.

Stage 1 EIP analyzed. Here, "Overall Number of Participants Analyzed" signifies number of participants measured and analyzed for this outcome measure. "Number Analyzed" signifies number of participants with valid and determinate hSBA results for each of the 4 strains at given time point. Analysis was planned for combined Group 1 and 3 and combined Group 2 and 4.

Percentage of participants who achieved an hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY titer >=LLOQ for ACWY Test Strains (LLOQ = 1:8 for all MenA, MenC, MenW, and MenY strains) was reported in this outcome measure.

Stage 2 mITT population included all participants who signed the ICD at Month 18 and who had at least 1 valid and determinate primary strain MenB or MenA/C/W/Y assay result available in Stage 2. "Overall Number of Participants Analyzed": participants who were measured and analyzed for the outcome measure and 'Number Analyzed' signifies number of participants with valid and determinate hSBA results for ACWY test strains at the given time point.

Percentage of participants who achieved an hSBA titer >=LLOQ for all 4 primary MenB test strains (LLOQ was 1:16 for A22 and 1:8 for A56, B24, and B44) was reported in this outcome measure.

Stage 2 mITT population analyzed. "Overall Number of Participants Analyzed": participants who were measured and analyzed for the outcome measure and 'Number Analyzed' signifies number of participants with valid and determinate hSBA results on all 4 strains at the given time point. Analysis planned for combined Group 1 and 3, and Group 1 and 4.

Percentage of participants who achieved an hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY titer >=LLOQ for ACWY test strains (LLOQ = 1:8 for all MenA, MenC, MenW, and MenY strains) was reported in this outcome measure. Analysis was planned for Group 1 and 3 separately.

Booster EIP=participants who were eligible(met Stage [S] 1 eligibility criteria, continually met S 2 eligibility criteria), received booster dose (BD) as intended (same vaccine as received in S 1), had blood drawn for assay testing in required time frame at Month 55, had valid and determinate (VAD) MenB or MenA/C/W/Y assay result after BD, no major protocol violations determined by medical monitor. 'Number Analyzed': participants with VAD hSBA results for ACWY test strains at given time point.

Percentage of participants who achieved an hSBA titer >=LLOQ for all 4 primary MenB test strains (LLOQ was 1:16 for A22 and 1:8 for A56, B24, and B44) was reported in this outcome measure.

Booster EIP analyzed. Here, "Overall Number of Participants analyzed" signifies number of participants who were measured and analyzed for this outcome measure. 'Number Analyzed'=number of participants with VAD hSBA results for ACWY test strains at given time point. Analysis was planned for combined Group 1 and 3 and combined Group 2 and 4.

Local reactions (redness, swelling, and pain) at the site of investigational product administration were recorded in e-diary. Redness and swelling were measured and recorded in caliper units. Each caliper unit represented 0.5 cm. Redness and swelling were 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 activity), moderate (interfered with activity), and severe (prevented daily activity).

Vaccination 1 safety population included participants who received the first dose of investigational product (MenABCWY+saline or bivalent rLP2086+MenACWY-CRM) at Visit 1 (Month 0), and for whom safety information from Visit 1 (Month 0) to prior to Visit 3 (Month 6) was available. Here, 'Number of Participants Analyzed' signifies number of participants measured and analyzed for this outcome measure. Analysis was planned for Group 1 and 3 separately.

Local reactions (redness, swelling, and pain) at the site of investigational product administration were recorded in e-diary. Redness and swelling were measured and recorded in caliper units. Each caliper unit represented 0.5 cm. Redness and swelling were 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 activity), moderate (interfered with activity), and severe (prevented daily activity).

Vaccination 2 safety population included participants who received the second dose of investigational product (MenABCWY or bivalent rLP2086) at Visit 3 (Month 6), and for whom safety information from Visit 3 (Month 6) up to and including Visit 4 (month 7) was available. Here, 'Number of Participants Analyzed' signifies number of participants measured and analyzed for this outcome measure. Analysis was planned for Group 1 and 3 separately.

Systemic events fever, vomiting, diarrhea, headache, fatigue, chills, muscle pain and joint pain were recorded in an e-diary. Fever was defined as >=38.0 degree C and categorized to 38.0 to 38.4 degree C, 38.5 to 38.9 degree C, 39.0 to 40.0 degree C and >40.0 degree C. Headache, fatigue, chills, muscle pain and joint pain were graded as mild (did not interfere with activity), moderate (some interference with activity) and severe (prevented daily activity). Vomiting was graded as mild (1-2 times in 24 hours), moderate (>2 times in 24 hours) and severe (required IV hydration). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours) and severe (>=6 in 24 hours).

Vaccination 1 safety population included participants who received the first dose of investigational product (MenABCWY+saline or bivalent rLP2086+MenACWY-CRM) at Visit 1 (Month 0), and for whom safety information from Visit 1 (Month 0) to prior to Visit 3 (Month 6) was available. Here, 'Number of Participants Analyzed' signifies number of participants measured and analyzed for this outcome measure. Analysis was planned for Group 1 and 3 separately.

Systemic events fever, vomiting, diarrhea, headache, fatigue, chills, muscle pain and joint pain were recorded in an e-diary. Fever was defined as >=38.0 degree C and categorized to 38.0 to 38.4 degree C, 38.5 to 38.9 degree C, 39.0 to 40.0 degree C and >40.0 degree C. Headache, fatigue, chills, muscle pain and joint pain were graded as mild (did not interfere with activity), moderate (some interference with activity) and severe (prevented daily activity). Vomiting was graded as mild (1-2 times in 24 hours), moderate (>2 times in 24 hours) and severe (required IV hydration). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours) and severe (>=6 in 24 hours).

Vaccination 2 safety population included participants who received the second dose of investigational product (MenABCWY or bivalent rLP2086) at Visit 3 (Month 6), and for whom safety information from Visit 3 (Month 6) up to and including Visit 4 (month 7) was available. Here, 'Number of Participants Analyzed' signifies number of participants measured and analyzed for this outcome measure. Analysis was planned for Group 1 and 3 separately.

Vaccination 1 safety population included participants who received the first dose of investigational product (MenABCWY+saline or bivalent rLP2086+MenACWY-CRM) at Visit 1 (Month 0), and for whom safety information from Visit 1 (Month 0) to prior to Visit 3 (Month 6) was available. Here, 'Number of Participants Analyzed' signifies number of participants measured and analyzed for this outcome measure. Analysis was planned for Group 1 and Group 3 separately.

Vaccination 2 safety population included participants who received the second dose of investigational product (MenABCWY or bivalent rLP2086) at Visit 3 (Month 6), and for whom safety information from Visit 3 (Month 6) up to and including Visit 4 (month 7) was available. Here, 'Number of Participants Analyzed' signifies number of participants measured and analyzed for this outcome measure. Analysis was planned for Group 1 and Group 3 separately.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Or that was considered to be an important medical event.

Vaccination 1 safety population included participants who received the first dose of investigational product (MenABCWY+saline or bivalent rLP2086+MenACWY-CRM) at Visit 1 (Month 0), and for whom safety information from Visit 1 (Month 0) to prior to Visit 3 (Month 6) was available. Analysis was planned for Group 1 and Group 3 separately.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Or that was considered to be an important medical event.

Vaccination 2 safety population included participants who received the second dose of investigational product (MenABCWY or bivalent rLP2086) at Visit 3 (Month 6), and for whom safety information from Visit 3 (Month 6) up to and including Visit 4 (month 7) was available. Analysis was planned for Group 1 and Group 3 separately.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Or that was considered to be an important medical event.

The safety population for Stage 1 included participants who had received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Analysis was planned for Group 1 and Group 3 separately.