Effectiveness of GlaxoSmithKline Biologicals S.A's Meningococcal Group B and Combined ABCWY Vaccines in Healthy Adolescents and Young Adults

Immune response was measured in terms of hSBA GMTs directed against serogroups A, C, W and Y. As pre-specified in the protocol, the data reported in this outcome measures data were presented for individual lots to demonstrate the consistency of the immune response of 3 lots (ABCWY- 1 Group, ABCWY-2 Group, and ABCWY-3 Group) of the ACWY component of the MenABCWY vaccine.

Time frame: At 1 month after the last vaccination of MenABCWY (Day 211)

Population: Analysis was performed on Per Protocol Set (PPS), which included participants who received at least 1 dose of the study treatment to which they were randomized and have post-vaccination data for the specified analysis at specified timepoints and did not have any protocol deviations that lead to exclusion from the PPS.

Assessed solicited local adverse events were injection or administration site = pain, erythema, swelling, induration. Any = occurrence of the adverse event regardless of intensity grade. Any erythema and swelling = adverse event reported with a surface diameter greater than 0 millimeters. No solicited AEs were collected after vaccination on Day 211 because these vaccines were administered as part of standard of care and to maintain blinding. As pre- specified in the protocol, data reported in this outcome measure were presented for MenB\_0\_2\_6 group, MenB\_0\_6 group, ACWY group, ABCWY pooled group.

Time frame: During 7 days after the first study intervention administration occurring at Day 1

Population: Analysis was performed on the Solicited Safety Set (SSS), which included participants who received at least 1 dose of the study treatment and had solicited safety data during the specified period.

Assessed solicited local adverse events were injection or administration site pain, erythema, swelling, induration. Any = occurrence of the adverse event regardless of intensity grade. Any erythema and swelling = adverse event reported with a surface diameter greater than 0 millimeters. No solicited AEs were collected after vaccination on Day 211 because these vaccines were administered as part of standard of care and to maintain blinding. As pre- specified in the protocol, data reported in this outcome measure were presented for MenB\_0\_2\_6 group, MenB\_0\_6 group, ACWY group, ABCWY pooled group.

Time frame: During 7 days after the second study intervention administration occurring at Day 61

Population: Analysis was performed on the Solicited Safety Set (SSS), which included participants who received at least 1 dose of the study treatment and had solicited safety data during the specified period.

Assessed solicited local adverse events were injection or administration site pain, erythema, swelling, induration. Any = occurrence of the adverse event regardless of intensity grade. Any erythema and swelling = adverse event reported with a surface diameter greater than 0 millimeters. No solicited AEs were collected after vaccination on Day 211 because these vaccines were administered as part of standard of care and to maintain blinding. As pre- specified in the protocol, data reported in this outcome measure were presented for MenB\_0\_2\_6 group, MenB\_0\_6 group, ACWY group, ABCWY pooled group.

Time frame: During 7 days after the third study intervention administration occurring at Day 181

Population: Analysis was performed on the Solicited Safety Set (SSS), which included participants who received at least 1 dose of the study treatment and had solicited safety data during the specified period.

Assessed solicited systemic AEs were fatigue, nausea, myalgia, arthralgia, headache and fever \[temperature \>= 38.0°C\]. Any = occurrence of the adverse event regardless of intensity grade or relation to study vaccination. No solicited AEs were collected after vaccination on Day 211 because these vaccines were administered as part of standard of care and to maintain blinding. As pre- specified in the protocol, data reported in this outcome measure were presented for MenB\_0\_2\_6 group, MenB\_0\_6 group, ACWY group, ABCWY pooled group.

Time frame: During 7 days after the first study intervention administration occurring at Day 1

Population: Analysis was performed on the Solicited Safety Set (SSS), which included participants who receive at least 1 dose of the study treatment and had solicited safety data during the specified period.

Assessed solicited systemic AEs were fatigue, nausea, myalgia, arthralgia, headache and fever \[temperature \>= 38.0°C\]. Any = occurrence of the adverse event regardless of intensity grade or relation to study vaccination. No solicited AEs were collected after vaccination on Day 211 because these vaccines were administered as part of standard of care and to maintain blinding. As pre- specified in the protocol, data reported in this outcome measure were presented for MenB\_0\_2\_6 group, MenB\_0\_6 group, ACWY group, ABCWY pooled group.

Time frame: During 7 days after the second study intervention administration occurring at Day 61

Population: Analysis was performed on the Solicited Safety Set (SSS), which included participants who receive at least 1 dose of the study treatment and had solicited safety data during the specified period.

Assessed solicited systemic AEs were fatigue, nausea, myalgia, arthralgia, headache and fever \[temperature \>= 38.0°C\]. Any = occurrence of the adverse event regardless of intensity grade or relation to study vaccination. No solicited AEs were collected after vaccination on Day 211 because these vaccines were administered as part of standard of care and to maintain blinding. As pre- specified in the protocol, data reported in this outcome measure were presented for MenB\_0\_2\_6 group, MenB\_0\_6 group, ACWY group, ABCWY pooled group.

Time frame: During 7 days after the third study intervention administration occurring at Day 181

Population: Analysis was performed on the Solicited Safety Set (SSS), which included participants who receive at least 1 dose of the study treatment and had solicited safety data during the specified period.

Unsolicited AEs are defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms were reported as an unsolicited AE. Any Unsolicited AEs (including Serious adverse events (SAEs), AEs leading to withdrawal, Adverse event of special interest (AESIs) and medically attended AEs were collected during 30 days after vaccination 1-3. For vaccination on Day 211 (Vaccination 4), conducted as part of standard of care and to maintain blinding, no eDiary data or all unsolicited AEs were collected for the 30 days following vaccination. However, SAEs, AEs leading to withdrawal, AESIs and medically attended AEs were collected throughout study duration. As pre-specified in the protocol, data reported in this outcome measure were presented for MenB\_0\_2\_6 group, MenB\_0\_6 group, ACWY group, ABCWY pooled group.

Time frame: During the 30 days after the first study intervention administration occurring at Day 1

Population: Analysis was performed on the Unsolicited Safety Set (USS), which included participants who received at least 1 dose of the study treatment and had Unsolicited safety data during the specified period.

Unsolicited AEs are defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms were reported as an unsolicited AE. Any Unsolicited AEs (including Serious adverse events (SAEs), AEs leading to withdrawal, Adverse event of special interest (AESIs) and medically attended AEs were collected during 30 days after vaccination 1-3. For vaccination on Day 211 (Vaccination 4), conducted as part of standard of care and to maintain blinding, no eDiary data or all unsolicited AEs were collected for the 30 days following vaccination. However, SAEs, AEs leading to withdrawal, AESIs and medically attended AEs were collected throughout study duration. As pre-specified in the protocol, data reported in this outcome measure were presented for MenB\_0\_2\_6 group, MenB\_0\_6 group, ACWY group, ABCWY pooled group.

Time frame: During the 30 days after the second study intervention administration occurring at Day 61

Population: Analysis was performed on the Unsolicited Safety Set (USS), which included participants who received at least 1 dose of the study treatment and had Unsolicited safety data during the specified period.

Unsolicited AEs are defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms were reported as an unsolicited AE. Any Unsolicited AEs (including Serious adverse events (SAEs), AEs leading to withdrawal, Adverse event of special interest (AESIs) and medically attended AEs were collected during 30 days after vaccination 1-3. For vaccination on Day 211 (Vaccination 4), conducted as part of standard of care and to maintain blinding, no eDiary data or all unsolicited AEs were collected for the 30 days following vaccination. However, SAEs, AEs leading to withdrawal, AESIs and medically attended AEs were collected throughout study duration. As pre-specified in the protocol, data reported in this outcome measure were presented for MenB\_0\_2\_6 group, MenB\_0\_6 group, ACWY group, ABCWY pooled group.

Time frame: During the 30 days after the third study intervention administration occurring at Day 181

Population: Analysis was performed on the Unsolicited Safety Set (USS), which included all participants who received at least 1 dose of the study treatment and had Unsolicited safety data during the specified period.

A SAEs is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity and is a congenital anomaly/birth defect in the offspring of a study subject. AESIs are predefined (serious or non-serious) AEs of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation to characterize and understand it. Medically attended AEs are symptoms or illnesses requiring hospitalization, or emergency room visit, or visit to/by a health care provider. As pre-specified in the protocol, data reported in this outcome measure were presented for MenB\_0\_2\_6 group, MenB\_0\_6 group, ACWY group, ABCWY pooled group.

Time frame: Throughout the study period (Day 1 to Day 361)

Population: Analysis was performed on the Unsolicited Safety Set (USS), which included participants who received at least 1 dose of the study treatment and report unsolicited AEs/report not having unsolicited AEs.

The effectiveness was measured in terms of percentage of samples with bactericidal activity using enc-hSBA, which provides a qualitative assessment (yes/no) of the presence of sufficient bactericidal antibodies in human sera to kill a meningococcal strain at a specific dilution of 1:4. As pre-specified in the protocol, data reported in this outcome measure were presented for MenB\_0\_2\_6 Group and ABCWY pooled group to evaluate the effectiveness of 2 doses of the MenABCWY vaccines against MenACWY vaccines, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.

Time frame: At 1 month after the vaccination schedule (i.e., Day 211 for the ABCWY_Pooled group and Day 91 for the MenB_0_2_6 Group [2-dose schedule])

Population: Analysis was performed on blood samples collected from PPS, which included participants who received at least 1 dose of the study treatment to which they were randomized and have post-vaccination data for the specified analysis at specified timepoints and did not have any protocol deviations that lead to exclusion from the PPS.

The effectiveness (test-based) of 2 doses of MenABCWY vaccine when compared to 1 dose of MenACWY vaccine, against a panel of N. meningitidis serogroup B strains was measured in terms of percentage of samples without bactericidal activity using enc-hSBA, which provides a qualitative assessment (yes/no) of the presence of sufficient bactericidal antibodies in human sera to kill a meningococcal strain at a specific dilution of 1:4. As pre-specified in the protocol, data reported in this outcome measure were presented for ACWY group and ABCWY pooled group to evaluate the effectiveness of 2 doses of the MenABCWY vaccines against MenACWY vaccines, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.

Time frame: At 1 month after the vaccination schedule (i.e., Day 211 for the ABCWY_Pooled group and Day 31 for the ACWY group)

Population: Analysis was performed on blood samples collected from Per Protocol Set (PPS), which included participants who received at least 1 dose of the study treatment to which they were randomized and have post-vaccination data for the specified analysis at specified timepoints and did not have any protocol deviations that lead to exclusion from the PPS.

The effectiveness (test-based) of rMenB+OMV vaccine at 1 month after the 2 doses in MenB\_0\_2\_6 group when compared to one dose of MenACWY vaccination in ACWY group, against a panel of N. meningitidis serogroup B strains was measured in terms of percentage of samples without bactericidal activity using endogenous complement human Serum Bactericidal Assay (enc-hSBA), which provides a qualitative assessment (yes/no) of the presence of sufficient bactericidal antibodies in human sera to kill a meningococcal strain at a specific dilution of 1:4. Participants were randomly selected for testing against each strain therefore only a subset of participants were tested for each of the strains.

Time frame: At 1 month after vaccination schedule (i.e., Day 91 for the MenB_0_2_6 group [2-dose schedule] and Day 31 for ACWY group)

Population: Analysis was performed on blood samples collected from Per Protocol Set (PPS) ,which included participants who received at least 1 dose of the study treatment to which they were randomized and have post-vaccination data for the specific analysis at specified timepoints and did not have any protocol deviations that lead to exclusion from the PPS.~Number of Participants analyzed = Total number of participants included in PPS.

The effectiveness (test-based) of rMenB+OMV vaccine at 1 month after the 3 doses in MenB\_0\_2\_6 group and 1 month after the 2 dose schedule in MenB\_0\_6 group when compared to one dose of MenACWY vaccination in ACWY group, against a panel of N. meningitidis serogroup B strains was measured in terms of percentage of samples without bactericidal activity using endogenous complement human Serum Bactericidal Assay (enc-hSBA), which provides a qualitative assessment (yes/no) of the presence of sufficient bactericidal antibodies in human sera to kill a meningococcal strain at a specific dilution of 1:4. Participants were randomly selected for testing against each strain therefore only a subset of participants were tested for each of the strains.

Time frame: At 1 month after vaccination schedule (i.e., Day 211 for MenB_0_2_6 group [3-dose schedule] and MenB_0_6 group, and Day 31 for ACWY group)

Population: Analysis was performed on blood samples collected from Per Protocol Set (PPS) ,which included participants who received at least 1 dose of the study treatment to which they were randomized and have post-vaccination data for the specified analysis at the specified timepoints and did not have any protocol deviations that lead to exclusion from the PPS.~Number of Participants analyzed = Total number of participants included in PPS.

The effectiveness (responder-based) of the rMenB+OMV NZ vaccine was measured in terms of percentage of participants whose sera kill \>=70% of the strains tested using enc-hSBA, calculated based on Clopper Pearson method. Effectiveness is demonstrated if Lower Limit (LL) of the two-sided 97.5% CI for the percentages of participants whose sera kill ≥70% of strains is above 65%.

Time frame: At 1 month after vaccination schedule (i.e., Day 91 for the MenB_0_2_6 group [2-dose schedule])

Population: Analysis was performed on the Full Analysis Set, which included participants who were randomized, received at least 1 dose of the study treatment and had post-vaccination effectiveness available for the specified analysis at the specified timepoint.

The effectiveness (responder-based) of the MenABCWY vaccine is measured in terms of percentage of participants whose sera kill \>=70% of the strains tested using enc-hSBA, being calculated based on Clopper Pearson method. Effectiveness is demonstrated Lower Limit (LL) of the two-sided 97.5% CI for the percentages of participants whose sera kill ≥70% of strains tested for MenABCWY is above 65%.

Time frame: At 1 month after the last vaccination of MenABCWY (Day 211)

Population: Analysis was performed on the FAS, which included all participants who were randomized, received at least 1 dose of the study treatment, and had post-vaccination effectiveness data available for the specified analysis at the specified time points.

The effectiveness (responder-based) of the rMenB+OMV NZ vaccine was measured in terms of percentage of participants whose sera kill \>=70% of the strains tested using enc-hSBA, calculated based on Clopper Pearson method. Effectiveness is demonstrated if Lower Limit (LL) of the two-sided 97.5% CI for the percentages of participants whose sera kill ≥70% of strains is above 65%.

Time frame: At 1 month after vaccination schedule (i.e., Day 211 for MenB_0_2_6 group [3-dose schedule] and MenB_0_6 group)

Population: Analysis was performed on the Full Analysis Set, which included participants who were randomized, received at least 1 dose of the study treatment and had post-vaccination effectiveness available for the specified analysis at the specified timepoint.

Four-fold rise is defined as: If the pre-vaccination hSBA titer is \< 4, then post-vaccination hSBA titer should be \>= 16 . If the pre-vaccination hSBA titer is \>= limit of detection (LOD) but \< LL of quantification (LLOQ), then post-vaccination hSBA titer should be \>= 4 times the LLOQ. If the pre-vaccination hSBA titer is \>= LLOQ, then post-vaccination hSBA titer should be \>= 4 times the pre-vaccination hSBA titer. As pre-specified in the protocol, data reported in this outcome measure were presented for ACWY group, ABCWY pooled group to evaluate the immunological non-inferiority of 2 doses of the MenABCWY vaccines against MenACWY vaccines, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.

Time frame: At 1 month after vaccination schedule (i.e., Day 211 for the ABCWY_Pooled group and Day 31 for the ACWY Group) compared to Day 1 (baseline)

Population: Analysis was performed on Per Protocol Set, which included participants who received at least 1 dose of the study treatment to which they were randomized and have post-vaccination data for the specified analysis at specified timepoints and did not have any protocol deviations that lead to exclusion from the PPS.

The immune responses to MenABCWY and MenACWY vaccines are evaluated by measuring bactericidal activity against N. meningitidis serogroups A, C, W and Y. For each N. meningitidis serogroups A, C, W and Y, the GMRs (after vaccination/baseline) are calculated, with their associated 2-sided 95% CIs. As pre-specified in the protocol, data reported in this outcome measure were presented for the ACWY group and ABCWY pooled group, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.

Time frame: 1 month after vaccination schedule (i.e, at Day 31 for ABCWY group [pooled lots -first dose] and for ACWY Group, and at Day 211 for ABCWY group [pooled lots - second dose]) compared to baseline (Day 1)

Population: Analysis was performed on the Full Analysis Set, which included participants who were randomized, received at least 1 dose of the study treatment, and had post-vaccination effectiveness data available for the specified analysis at the specified time points.

The immune response to rMenB+OMV NZ vaccine was evaluated by measuring bactericidal activity against N. meningitidis serogroup B test strains after vaccination compared to baseline (Day 1). For each N. meningitidis serogroup B test strain (M14459, M13520, 96217 and NZ98/254 for fHbp, NadA, NHBA and PorA P1.4 antigens, respectively), the GMRs (after vaccination/baseline) are calculated, with their associated 2-sided 95% CIs. As pre-specified in the protocol, data reported in this outcome measure were presented for the MenB\_0\_2\_6 group, MenB\_0\_6 group and ABCWY pooled group, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.

Time frame: At 1 month after the vaccination schedule (i.e., Day 211 for MenB_0_2_6 group (3 dose schedule), MenB_0_6 group and ABCWY_Pooled group) compared to Day 1 (baseline)

Population: Analysis was performed on the Full Analysis Set, which included participants who were randomized, received at least 1 dose of the study treatment, and had post-vaccination effectiveness data available for the specified analysis at the specified time points.

The immune response to rMenB+OMV NZ and MenABCWY vaccine was evaluated by measuring bactericidal activity against N. meningitidis serogroup B test strains in terms of GMTs after vaccination compared to baseline (Day 1). For each N. meningitidis serogroup B test strain (M14459, M13520, 96217 and NZ98/254 for fHbp, NadA, NHBA and PorA P1.4 antigens, respectively), The GMTs (After vaccination/baseline) are calculated, with their associated 2-sided 95% CIs. As pre-specified in the protocol, data reported in this outcome measure were presented for the MenB\_0\_2\_6 group, MenB\_0\_6 group and ABCWY pooled group, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.

Time frame: At Day 1 (pre-vaccination) and at 1 month after the vaccination schedule (i.e., Day 211 for MenB_0_2_6 group (3 dose schedule), MenB_0_6 group and ABCWY_Pooled group)

Population: Analysis was performed on the Full Analysis Set, which included participants who were randomized, received at least 1 dose of the study treatment, and had post-vaccination effectiveness data available for the specified analysis at the specified time points.

The immune response to rMenB+OMV NZ vaccine was evaluated by measuring bactericidal activity against N. meningitidis serogroup B test strains after vaccination compared to baseline (Day 1). For each N. meningitidis serogroup B test strain (M14459, M13520, 96217 and NZ98/254 for fHbp, NadA, NHBA and PorA P1.4 antigens, respectively), the GMRs (after vaccination/baseline) are calculated, with their associated 2-sided 95% CIs.

Time frame: At 1 month after the vaccination schedule (i.e., Day 91 for MenB_0_2_6 group [2-dose schedule]) compared to Day 1 (baseline)

Population: Analysis was performed on the Full Analysis Set, which included participants who were randomized, received at least 1 dose of the study treatment, and had post-vaccination effectiveness data available for the specified analysis at the specified time points.

The immune response to rMenB+OMV NZ and MenABCWY vaccine was evaluated by measuring bactericidal activity against N. meningitidis serogroup B test strains in terms of GMTs after vaccination compared to baseline (Day 1). For each N. meningitidis serogroup B test strain (M14459, M13520, 96217 and NZ98/254 for fHbp, NadA, NHBA and PorA P1.4 antigens, respectively), The GMTs (After vaccination/baseline) were calculated, with their associated 2-sided 95% CIs.

Time frame: At Day 1 (pre-vaccination) and at 1 month after the vaccination schedule (i.e., Day 91 for MenB_0_2_6 group[2-dose schedule])

Population: Analysis was performed on the Full Analysis Set, which included all participants who were randomized, received at least 1 dose of the study treatment, and had post-vaccination effectiveness data available for the specified analysis at the specified time points.

The immune responses to MenABCWY and MenACWY vaccines are evaluated by measuring bactericidal activity against N. meningitidis serogroups A, C, W and Y in terms of GMTs after vaccination compared to baseline (Day 1). For each N. meningitidis serogroups A, C, W and Y, the GMTs (after vaccination/baseline) are calculated, with their associated 2-sided 95% CIs. As pre-specified in the protocol, data reported in this outcome measure were presented for the ACWY group and ABCWY pooled group, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.

Time frame: At Day 1, and 1 month after vaccination schedule (i.e, at Day 31 for ABCWY group [pooled lots -first dose] and for ACWY Group, and at Day 211 for ABCWY group [pooled lots - second dose])

Population: Analysis was performed on the Full Analysis Set, which included participants who were randomized, received at least 1 dose of the study treatment, and had post-vaccination effectiveness data available for the specified analysis at the specified time points.

The effectiveness of the 3 dose (0,2,6-M) and 2 dose (0,6-M ) schedule of rMenB+OMV NZ vaccine and 2 doses of MenABCWY vaccine when compared to 1 month after the MenACWY vaccination (Day 31), against a panel of N. meningitidis serogroup B strains is measured in terms of percentage of samples without bactericidal activity using enc-hSBA, which provides a qualitative assessment (yes/no) of the presence of sufficient bactericidal antibodies in human sera to kill a meningococcal strain at a specific dilution of 1:4. As pre-specified in the protocol, data reported in this outcome measure were presented for the MenB\_0\_2\_6 group, MenB\_0\_6 group,ACWY group and ABCWY pooled group, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.

Time frame: At 1 month after the vaccination schedule (i.e., Day 211 for the MenB_0_2_6 group [3 dose schedule], MenB_0_6 group, ABCWY_Pooled group and Day 31 for the MenACWY group)

Population: Analysis was performed on blood samples collected from FAS, which included participants who were randomized, received at least one dose of the study treatment, and had post-vaccination effectiveness data available for the specified analysis at the specified time points. Participants were randomly selected for testing against each strain therefore only a subset of participants were tested for each of the strains.~Number of Participants analyzed = Total number of participants included in FAS.

The effectiveness of the 2 dose (0,2-M) schedule of rMenB+OMV NZ vaccine when compared to 1 month after the MenACWY vaccination (Day 31), against a panel of N. meningitidis serogroup B strains is measured in terms of percentage of samples without bactericidal activity using enc-hSBA, which provides a qualitative assessment (yes/no) of the presence of sufficient bactericidal antibodies in human sera to kill a meningococcal strain at a specific dilution of 1:4.

Time frame: At 1 month after the vaccination schedule (i.e., Day 91 for the MenB_0_2_6 group [2 dose schedule] and Day 31 for the MenACWY group)

Population: Analysis was performed on blood samples collected from FAS , which included all participants who were randomized, received at least 1 dose of the study treatment and had post-vaccination effectiveness data available for the specified analysis at the specified time points.~Participants were randomly selected for testing against each strain therefore only a subset of participants were tested for each of the strains.~Number of Participants analyzed = Total number of participants included in FAS.

The percentage of participants classified by percentage of N.meningitidis serogroup B invasive strains killed using enc-hSBA and the corresponding 2- sided 95% CI based on Clopper-Pearson method is calculated for each vaccine group. As pre-specified in the protocol, data reported in this outcome measure were presented for the MenB\_0\_2\_6 group, MenB\_0\_6 group and ABCWY pooled group, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.

Time frame: At 1 month after the vaccination schedule (Day 211 for MenB_0_2_6 group (3 dose schedule), MenB_0_6 group and ABCWY_Pooled group)

Population: Analysis was performed on the FAS, which included participants who were randomized, received at least 1 dose of the study treatment and had post-vaccination effectiveness data available for the specified analysis at the specified time points.

The percentage of participants classified by percentage of N.meningitidis serogroup B invasive strains killed using enc-hSBA and the corresponding 2- sided 95% CI based on Clopper-Pearson method is calculated for each vaccine group.

Time frame: At 1 month after the vaccination schedule (Day 91 for MenB_0_2_6 group [2 dose schedule])

Population: Analysis was performed on the FAS, which included participants who were randomized, received at least 1 dose of the study treatment, and had post-vaccination effectiveness data available for the specified analysis at the specified time points.

The immunogenicity is measured as percentage of participants achieving a 4-fold rise in hSBA titers against N. meningitidis serogroup B indicator strains (M14459, 96217, M13520 and NZ98/254 for fHbp, NadA, NHBA and PorA P1.4 antigens, respectively). 4-fold rise per each indicator strain was defined as a post-vaccination hSBA titre ≥16 for participants with a pre-vaccination hSBA titre \<4; a post-vaccination hSBA titre ≥4 times the LLOQ for participants with a pre-vaccination hSBA titre ≥LOD and \<LLOQ; a post-vaccination hSBA titre ≥4 times the pre-vaccination hSBA titre for participants with a pre-vaccination hSBA titre ≥ LLOQ. As pre-specified in the protocol, data reported in this outcome measure were presented for MenB\_0\_2\_6 Group and ABCWY pooled group to evaluate the effectiveness of 2 doses of the MenABCWY vaccines against MenACWY vaccines, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.

Time frame: At 1 month after the vaccination schedule (i.e., Day 211 for the ABCWY_Pooled group and Day 91 for the MenB_0_2_6 Group [2-dose schedule]) compared to Day 1 (Baseline)

Population: Analysis was performed on Per Protocol Set, which included participants who received at least 1 dose of the study treatment to which they were randomized and have post-vaccination data for the specified analysis at specified timepoints and did not have any protocol deviations that lead to exclusion from the PPS.

The immune response to MenABCWY vaccine compared to MenACWY vaccine was evaluated by measuring bactericidal activity against each of the N. meningitidis serogroups A, C, W and Y at Day 31 compared to baseline (Day 1). Four-fold rise is defined as: \- If the pre-vaccination hSBA titer is \< 4, then post-vaccination hSBA titer should be ≥ 16. - If the pre-vaccination hSBA titer is ≥ LOD but \< LLOQ, then post-vaccination hSBA titer should be ≥ 4 times the LLOQ. - If the pre-vaccination hSBA titer is ≥ LLOQ, then post-vaccination hSBA titer should be ≥ 4 times the pre-vaccination hSBA titer. The corresponding 2- sided 95% CI based on Clopper-Pearson method is calculated for each vaccine group. As pre-specified in the protocol, data reported in this outcome measure were presented for the ACWY group and ABCWY pooled group, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.

Time frame: At 1 month after vaccination schedule (i.e, at Day 31 for ABCWY group [pooled group] and for ACWY Group) relative to baseline (Day 1)

Population: Analysis was performed on the Full Analysis Set, which included participants who were randomized, received at least 1 dose of the study treatment, and had post-vaccination effectiveness available for the specified analysis at the specified time points.

The immune response to 3 dose (0,2,6-M), 2 dose (0,6-M) schedule of rMenB+OMV NZ and 2 doses of MenABCWY vaccine was evaluated by measuring bactericidal activity against each of the N. meningitidis serogroup B test strains- M14459, 96217, NZ98/254 and M13520 for fHbp, NadA, NHBA and PorA P1.4 antigens, respectively compared to baseline. Four-fold rise per each indicator strain was defined as a post-vaccination hSBA titre ≥16 for subjects with a pre-vaccination hSBA titre \<4 a post-vaccination hSBA titer ≥4 times the LLOQ for subjects with a pre-vaccination hSBA titre ≥LOD and \<LLOQ a post-vaccination hSBA titre ≥4 times the pre-vaccination hSBA titre for participants with a pre-vaccination hSBA titre ≥ LLOQ. As pre-specified in the protocol, data reported in this outcome measure were presented for the MenB\_0\_2\_6 group, MenB\_0\_6 group and ABCWY pooled group, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.

Time frame: At 1 month after the vaccination schedule (i.e., Day 211 for MenB_0_2_6 group [3 dose schedule], MenB_0_6 group and ABCWY_Pooled group) compared to Day 1 (baseline)

Population: Analysis was performed on the Full Analysis Set, which included participants who were randomized, received at least 1 dose of the study treatment, and had post-vaccination effectiveness data available for the specified analysis at the specified time points.

The immune response to 2 dose (0,2-M) is evaluated by measuring bactericidal activity against each of the N. meningitidis serogroup B test strains- M14459, 96217, NZ98/254 and M13520 for fHbp, NadA, NHBA and PorA P1.4 antigens, respectively compared to baseline. Four-fold rise per each indicator strain was defined as a post-vaccination hSBA titre ≥16 for participants with a pre-vaccination hSBA titre \<4 a post-vaccination hSBA titre ≥4 times the LLOQ for subjects with a pre-vaccination hSBA titre ≥LOD and \<LLOQ a post-vaccination hSBA titre ≥4 times the pre-vaccination hSBA titre for subjects with a pre-vaccination hSBA titre ≥ LLOQ.

Time frame: At 1 month after the vaccination schedule (i.e., Day 91 for MenB_0_2_6 [2-dose schedule]) compared to Day 1 (baseline)

Population: Analysis was performed on the Full Analysis Set, which included participants who were randomized, received at least 1 dose of the study treatment, and had post-vaccination effectiveness data available for the specified analysis at the specified time points.

The immune response to rMenB+OMV NZ and MenABCWY vaccine is evaluated by measuring bactericidal activity against each (individual response) and all (composite response) N. meningitidis serogroup B indicator strains(M14459, 96217, M13520 and NZ98/254 for fHbp, NadA, NHBA and PorA P1.4 antigens, respectively). As pre-specified in the protocol, data reported in this outcome measure were presented for the MenB\_0\_2\_6 group, MenB\_0\_6 group and ABCWY pooled group, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.

Time frame: At Day 1 (pre-vaccination) and1 month after the vaccination schedule (i.e., Day 211 for MenB_0_2_6 group [3 dose schedule], MenB_0_6 group and ABCWY_Pooled group)

Population: Analysis was performed on the Full Analysis Set, which included participants who were randomized, received at least 1 dose of the study treatment, and had post-vaccination effectiveness data available for the specified analysis at the specified time point.

The immune response to rMenB+OMV NZ is evaluated by measuring bactericidal activity against each (individual response) and all (composite response) N. meningitidis serogroup B indicator strains (M14459, 96217, M13520 and NZ98/254 for fHbp, NadA, NHBA and PorA P1.4 antigens, respectively).

Time frame: At Day 1 (pre-vaccination) and1 month after the vaccination schedule (i.e., Day 91 for MenB_0_2_6 group [2 dose schedule])

Population: Analysis was performed on the Full Analysis Set, which included participants who were randomized, received at least 1 dose of the study treatment, and had post-vaccination effectiveness data available for the specified analysis at the specified time points.

The immune responses to MenABCWY and MenACWY vaccines were evaluated by measuring bactericidal activity against N. meningitidis serogroups A, C, W and Y after vaccination compared to baseline (Day 1) and expressed as the percentage of participants with hSBA titers \>= LLOQ for serogroups A, C, W and Y at baseline and 1 month after vaccination schedule of MenABCWY and MenACWY vaccines. As pre-specified in the protocol, data reported in this outcome measure were presented for the ACWY group and ABCWY pooled group, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.

Time frame: At Day 1, and 1 month after vaccination schedule (i.e, at Day 31 for ABCWY group [pooled lots -first dose] and for ACWY Group, and at Day 211 for ABCWY group [pooled lots - second dose])

Population: Analysis was performed on the Full Analysis Set, which included participants who were randomized, received at least 1 dose of the study treatment, and had post-vaccination effectiveness data available for the specified analysis at the specified time points.

The immune responses to MenABCWY and MenACWY vaccines were evaluated by measuring the total IgG in terms of electrochemiluminescence-based multiplex (ECL) geometric mean concentrations (GMCs) which was an alternative assay to Enzyme-Linked Immunosorbent Assay (ELISA). ECL (validated assay) was used because ELISA is not validated. As pre- specified in the protocol, data reported in this outcome measure were presented for the ACWY group and ABCWY pooled group, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.

Time frame: At Day 1, and 1 month after vaccination schedule (i.e, at Day 31 for ABCWY group [pooled lots -first dose] and for ACWY Group, and at Day 211 for ABCWY group [pooled lots - second dose])

Population: Analysis was performed on the Full Analysis Set, which included participants who were randomized, received at least 1 dose of the study treatment, and had post-vaccination effectiveness data available for the specified analysis at the specified time points.