Study to Assess the Safety and Immunogenicity of GSK Meningococcal Group B Vaccine When Administered Concomitantly With GSK Meningococcal MenACWY Conjugate Vaccine in Healthy Subjects of 16-18 Years of Age

hSBA titers were measured by serum bactericidal assay and expressed as GMTs against each of the 4 serogroups Men A, Men C, Men W and Men Y.

Time frame: At Day 31 (1 month after the vaccination with MenACWY in MenACWY and MenB+MenACWY groups)

Population: Analysis was performed on the Per Protocol Set (PPS). Only those participants with data available at specified timepoint were included in analysis.

hSBA titers were measured by serum bactericidal assay and expressed as Geometric Mean Titers (GMTs) against N. meningitidis serogroup B indicator strains (M14459 \[fHbp\], 96217 \[NadA\], NZ98/254 \[PorA\] and M13520 \[NHBA\]).

Time frame: At Day 91 (1 month after the second vaccination with rMenB+OMV NZ in MenB+MenACWY and MenB groups)

Population: Analysis was performed on the Per Protocol Set (PPS), which included participants who received at least 1 dose of the study intervention to which they were randomized and had post-vaccination data available at the specified timepoint minus participants with protocol deviations that led to exclusion from the PPS.

AESIs are predefined (serious or non-serious) adverse events 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 in order to characterize and understand it.

Time frame: Throughout the study period (Day 1 to Day 271)

Population: Analysis was performed on the Exposed set (ES). Only participants with data available at specified timepoints were included in the analysis.

AESIs are predefined (serious or non-serious) adverse events 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 in order to characterize and understand it.

Time frame: During safety follow-up (Day 271 to Day 451)

Population: Analysis was performed on the Exposed set (ES). Only participants with data available at specified timepoints (during safety follow-up period from Day 271 to Day 451) were included in the analysis.

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 are reported as an unsolicited adverse event. Any solicited AE that has not resolved within 30 days post vaccination and is reported during clinic visits or safety follow-up calls is entered into the subject's electronic Case Report Form (eCRF) as an unsolicited AE. SAEs are any untoward medical occurrence that result in death, are life-threatening, require hospitalization or prolongation of existing hospitalization, result in disability/incapacity and is a congenital anomaly/birth defect in the offspring of a study subject. A participant was considered a 'withdrawal' from the study when no study procedure has occurred, no follow-up has been performed and no further information has been collected for this participant from the date of withdrawal/last contact.

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

Population: Analysis was performed on the Exposed set (ES). Only participants with data available at specified timepoints were included in the analysis.

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 are reported as an unsolicited adverse event. Any solicited AE that has not resolved within 30 days post vaccination and is reported during clinic visits or safety follow-up calls is entered into the subject's electronic Case Report Form (eCRF) as an unsolicited AE. SAEs are any untoward medical occurrence that result in death, are life-threatening, require hospitalization or prolongation of existing hospitalization, result in disability/incapacity and is a congenital anomaly/birth defect in the offspring of a study subject. A participant was considered a 'withdrawal' from the study when no study procedure has occurred, no follow-up has been performed and no further information has been collected for this participant from the date of withdrawal/last contact.

Time frame: During 30 days after the third study intervention administration occurring at Day 91

Population: Analysis was performed on the Exposed set (ES). Only participants with data available at specified timepoints were included in the analysis.

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 are reported as an unsolicited adverse event. Any solicited AE that has not resolved within 30 days post vaccination and is reported during clinic visits or safety follow-up calls is entered into the subject's electronic Case Report Form (eCRF) as an unsolicited AE. SAEs are any untoward medical occurrence that result in death, are life-threatening, require hospitalization or prolongation of existing hospitalization, result in disability/incapacity and is a congenital anomaly/birth defect in the offspring of a study subject. A participant was considered a 'withdrawal' from the study when no study procedure has occurred, no follow-up has been performed and no further information has been collected for this participant from the date of withdrawal/last contact.

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

Population: Analysis was performed on the Exposed set (ES). Only participants with data available at specified timepoints were included in the analysis.

Medically attended AEs are symptoms or illnesses requiring hospitalization, or emergency room visit, or visit to/by a health care provider.

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

Population: Analysis was performed on the Exposed set (ES). Only participants with data available at specified timepoints were included in the analysis.

Medically attended AEs are symptoms or illnesses requiring hospitalization, or emergency room visit, or visit to/by a health care provider.

Time frame: During 30 days after the third study intervention administration occurring at Day 91

Population: Analysis was performed on the Exposed set (ES). Only participants with data available at specified timepoints were included in the analysis.

Medically attended AEs are symptoms or illnesses requiring hospitalization, or emergency room visit, or visit to/by a health care provider.

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

Population: Analysis was performed on the Exposed set (ES). Only participants with data available at specified timepoints were included in the analysis.

SAEs, AEs leading to withdrawal and medically attended AEs were assessed throughout the study period are reported in this outcome measure.

Time frame: Throughout the study period (Day 1 to Day 271)

Population: Analysis was performed on the Exposed set (ES), which included all participants who received at least one dose of the study treatment.

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 are reported as an unsolicited adverse event. Any solicited AE that has not resolved within 30 days post vaccination and is reported during clinic visits or safety follow-up calls is entered into the subject's electronic Case Report Form (eCRF) as an unsolicited AE. SAEs are any untoward medical occurrence that result in death, are life-threatening, require hospitalization or prolongation of existing hospitalization, result in disability/incapacity and is a congenital anomaly/birth defect in the offspring of a study subject. A participant was considered a 'withdrawal' from the study when no study procedure has occurred, no follow-up has been performed and no further information has been collected for this participant from the date of withdrawal/last contact.

Time frame: During safety follow-up (Day 271 to Day 451)

Population: Analysis was performed on the Exposed set (ES). Only participants with data available at specified timepoints (during safety follow-up period from Day 271 to Day 451) were included in the analysis.

Unsolicited adverse events 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 are reported as an unsolicited adverse event. Any solicited AE that has not resolved within 30 days post vaccination and is reported during clinic visits or safety follow-up calls is entered into the subject's electronic Case Report Form (eCRF) as an unsolicited AE. Serious Adverse Events (SAEs) are any untoward medical occurrence that result in death, are life-threatening, require hospitalization or prolongation of existing hospitalization, result in disability/incapacity and is a congenital anomaly/birth defect in the offspring of a study subject.

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

Population: Analysis was performed on the Exposed set (ES). Only participants with data available at specified timepoints were included in the analysis.

Unsolicited adverse events 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 are reported as an unsolicited adverse event. Any solicited AE that has not resolved within 30 days post vaccination and is reported during clinic visits or safety follow-up calls is entered into the subject's electronic Case Report Form (eCRF) as an unsolicited AE. Serious Adverse Events (SAEs) are any untoward medical occurrence that result in death, are life-threatening, require hospitalization or prolongation of existing hospitalization, result in disability/incapacity and is a congenital anomaly/birth defect in the offspring of a study subject.

Time frame: During 30 days after the third study intervention administration occurring at Day 91

Population: Analysis was performed on the Exposed set (ES). Only participants with data available at specified timepoints were included in the analysis.

Unsolicited adverse events 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 are reported as an unsolicited adverse event. Any solicited AE that has not resolved within 30 days post vaccination and is reported during clinic visits or safety follow-up calls is entered into the subject's electronic Case Report Form (eCRF) as an unsolicited AE. Serious Adverse Events (SAEs) are any untoward medical occurrence that result in death, are life-threatening, require hospitalization or prolongation of existing hospitalization, result in disability/incapacity and is a congenital anomaly/birth defect in the offspring of a study subject.

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

Population: Analysis was performed on the Exposed set (ES). Only participants with data available at specified timepoints were included in the analysis.

Solicited local adverse events assessed are injection site pain, erythema, swelling, induration. Any solicited local AEs = occurrence of the symptom regardless of intensity grade.

Time frame: During 7 days after the rMenB+OMV NZ vaccination at Day 1

Population: Analysis was performed on the Exposed set (ES), which included all participants who received at least one dose of the study treatment and had the electronic diary (eDiary) for solicited events completed after the administration of study treatment and for whom data were available during the specified period. Allocation per group is based on the treatment administered. Only participants with data available at specified timepoints were included in the analysis.

Solicited local adverse events assessed are injection site pain, erythema, swelling, induration. Any solicited local AEs = occurrence of the symptom regardless of intensity grade.

Time frame: During 7 days after the rMenB+OMV NZ vaccination at Day 61

Population: Analysis was performed on the Exposed set (ES), which included all participants who received at least one dose of the study treatment and had the eDiary for solicited events completed after the administration of study treatment and for whom data were available during the specified period. Allocation per group is based on the treatment administered.

Solicited local adverse events assessed are injection site pain, erythema, swelling, induration. Any solicited local AEs = occurrence of the symptom regardless of intensity grade.

Time frame: During 7 days after the rMenB+OMV NZ vaccination at Day 91

Population: Analysis was performed on the Exposed set (ES), which included all participants who received at least one dose of the study treatment and had the eDiary for solicited events completed after the administration of study treatment and for whom data were available during the specified period. Allocation per group is based on the treatment administered.

Solicited local adverse events assessed are injection site pain, erythema, swelling, induration. Any solicited local AEs= occurrence of the symptom regardless of intensity grade.

Time frame: During 7 days after the MenACWY vaccination at Day 91

Population: Analysis was performed on the Exposed set (ES), which included all participants who received at least one dose of the study treatment and had the eDiary for solicited events completed after the administration of study treatment and for whom data were available during the specified period. Allocation per group is based on the treatment administered.

Solicited local adverse events assessed are injection site pain, erythema, swelling, induration. Any solicited local AEs= occurrence of the symptom regardless of intensity grade.

Time frame: During 7 days after the MenACWY vaccination at Day 61

Population: Analysis was performed on the ES, which included all participants who received at least one dose of the study treatment and had the eDiary for solicited events completed after the administration of study treatment and for whom data were available during the specified period. Allocation per group is based on the treatment administered. 1 participant in MenB Group received wrong study treatment at Day 61 (MenACWY vaccine instead of rMenB+OMV NZ), hence was considered in the analysis population.

Solicited local adverse events assessed are injection site pain, erythema, swelling, induration. Any solicited local AEs= occurrence of the symptom regardless of intensity grade.

Time frame: During 7 days after the MenACWY vaccination at Day 1

Population: Analysis was performed on the Exposed set (ES), which included all participants who received at least one dose of the study treatment and had the eDiary for solicited events completed after the administration of study treatment and for whom data were available during the specified period. Allocation per group is based on the treatment administered.

Solicited local adverse events assessed are injection site pain, erythema, swelling, induration. Any solicited local AEs = occurrence of the symptom regardless of intensity grade.

Time frame: During 7 days after the Placebo vaccination at Day 91

Population: Analysis was performed on the ES, which included all participants who received at least one dose of the study treatment and had the eDiary for solicited events completed after the administration of study treatment and for whom data were available during the specified period. Allocation per group is based on the treatment administered. 1 participant in MenACWY Group received wrong study treatment at Day 91 (placebo instead of rMenB+OMV NZ), hence was considered in the analysis population.

Solicited local adverse events assessed are injection site pain, erythema, swelling, induration. Any solicited local AEs = occurrence of the symptom regardless of intensity grade.

Time frame: During 7 days after the Placebo vaccination at Day 1

Population: Analysis was performed on the Exposed set (ES), which included all participants who received at least one dose of the study treatment and had the eDiary for solicited events completed after the administration of study treatment and for whom data were available during the specified period. Allocation per group is based on the treatment administered.

Solicited systemic adverse events assessed are fever \[temperature \>= 38.0°C\], nausea, fatigue, myalgia, arthralgia, and headache.

Time frame: During 7 days after the third study intervention administration occurring at Day 91

Population: Analysis was performed on the Exposed set (ES), which included all participants who received at least one dose of the study treatment and had the eDiary for solicited events completed after the administration of study treatment and for whom data were available during the specified period.

Solicited systemic adverse events assessed are fever \[temperature \>= 38.0°C\], nausea, fatigue, myalgia, arthralgia, and headache.

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

Population: Analysis was performed on the Exposed set (ES), which included all participants who received at least one dose of the study treatment and had the eDiary for solicited events completed after the administration of study treatment and for whom data were available during the specified period.

Solicited systemic adverse events assessed are fever \[temperature \>= 38.0°C\], nausea, fatigue, myalgia, arthralgia, and headache.

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

Population: Analysis was performed on the Exposed set (ES), which included all participants who received at least one dose of the study treatment and had the eDiary for solicited events completed after the administration of study treatment and for whom data were available during the specified period.

The immune response to rMenB+OMV NZ was measured by bactericidal activity against N. meningitidis serogroup B indicator strains (M14459 \[fHbp\], 96217 \[NadA\], NZ98/254 \[PorA\] and M13520 \[NHBA\]) in terms of GMRs (after vaccination/baseline).

Time frame: At Dya 31 (1 month after first rMenB+OMV NZ vaccination) compared to the baseline (Day 1)

Population: Analysis was performed on the Per Protocol Set (PPS). Only those participants with data available at specified timepoint were included in analysis.

The immune response to rMenB+OMV NZ was measured by bactericidal activity against N. meningitidis serogroup B indicator strains (M14459 \[fHbp\], 96217 \[NadA\], NZ98/254 \[PorA\] and M13520 \[NHBA\]) in terms of GMRs (after vaccination/baseline).

Time frame: At Day 91 (1 month after the second rMenB+OMV NZ vaccination) compared to the baseline (Day 1)

Population: Analysis was performed on the Per Protocol Set (PPS). Only those participants with data available at specified timepoint were included in analysis.

Immune response to MenACWY given with or without rMenB+OMV NZ was measured by bactericidal activity against the four serogroups Men A, Men C, Men W and Men Y in terms of GMRs at one month after MenACWY vaccination compared to the baseline at Day 1/Month 0. GMR was measured within-group.

Time frame: At 1 month after MenACWY vaccination (i.e.at Day 31) compared to the baseline (Day 1)

Population: Analysis was performed on the Per Protocol Set (PPS). Only those participants with data available at specified timepoint were included in analysis.

Immune response to MenACWY given with or without rMenB+OMV NZ, as measured by ectrochemiluminescence-based multiplex (ECL) GMCs against each of the serogroups A, C, W and Y. ECL (validated assay) was used because ELISA is not validated.

Time frame: At Day 31 (1 month after the vaccination of MenACWY in MenACWY and MenB+MenACWY groups)

hSBA titers were measured by bactericidal activity against N. meningitidis serogroup B indicator strains (M14459 \[fHbp\], 96217 \[NadA\], NZ98/254 \[PorA\] and M13520 \[NHBA\]) and expressed in GMTs.

Time frame: At Day 31 (1 month after first vaccination with rMenB+OMV NZ)

Population: Analysis was performed on the Per Protocol Set (PPS). Only those participants with data available at specified timepoint were included in analysis.

The immune response to MenACWY vaccine is evaluated by measuring percentage of participants with 4-fold increase for the four serogroups Men A, Men C, Men W and Men Y. The Four-fold increase defined as: - For a pre-vaccination titer \<LOD, a post-vaccination titer of \>= 4-fold the LOD or \>= LLOQ, whichever is greater, - For a pre-vaccination titer \>=LOD but \<LLOQ, a post vaccination titer of at least 4-fold the LLOQ, - For a pre-vaccination titer \>= LLOQ, a post vaccination titer of at least 4-fold the pre-vaccination titer

Time frame: At 1 month after MenACWY vaccination (i.e at Day 31) relative to baseline (i.e. Day 1)

Population: Analysis was performed on the Per Protocol Set (PPS). Only those participants with data available at specified timepoint were included in analysis.

The immune response to rMenB+OMV NZ vaccine is evaluated by measuring bactericidal activity against each of N. meningitidis serogroup B test strains (M14459 \[fHbp\], 96217 \[NadA\], NZ98/254 \[PorA\] and M13520 \[NHBA\]) in terms of the Four-fold increase defined as: - For a pre-vaccination titer \< limit of detection (LOD), a post-vaccination titer of \>= 4-fold the LOD or \>= LLOQ, whichever is greater, - For a pre-vaccination titer \>= LOD but \<LLOQ, a post vaccination titer of at least 4-fold the LLOQ, - For a pre-vaccination titer \>= LLOQ, a post vaccination titer of at least 4-fold the pre-vaccination titer.

Time frame: At 1 month after the first rMenB+OMV NZ vaccination (i.e at Day 31) relative to baseline (i.e. Day 1)

Population: Analysis was performed on the Per Protocol Set (PPS). Only those participants with data available at specified timepoint were included in analysis.

The immune response to rMenB+OMV NZ vaccine is evaluated by measuring bactericidal activity against each of the N. meningitidis serogroup B test strains (M14459 \[fHbp\], 96217 \[NadA\], NZ98/254 \[PorA\] and M13520 \[NHBA\]) in terms of the Four-fold increase defined as: - For a pre-vaccination titer \<LOD, a post-vaccination titer of \>= 4-fold the LOD or \>= LLOQ, whichever is greater, - For a pre-vaccination titer \>=LOD but \<LLOQ, a post vaccination titer of at least 4-fold the LLOQ, - For a pre-vaccination titer \>=LLOQ, a post vaccination titer of at least 4-fold the pre-vaccination titer.

Time frame: At 1 month after the second rMenB+OMV vaccination (i.e at Day 91) relative to baseline (i.e. Day 1)

Population: Analysis was performed on the Per Protocol Set (PPS). Only those participants with data available at specified timepoint were included in analysis.

The immune response to rMenB+OMV NZ vaccine is evaluated by measuring bactericidal activity in terms of participants with hSBA titers \>= LLOQ against N. meningitidis serogroup B test strains (M14459 \[fHbp\], 96217 \[NadA\], NZ98/254 \[PorA\] and M13520 \[NHBA\]).

Time frame: At Day 91 (1 month after the second rMenB+OMV NZ vaccination)

Population: Analysis was performed on the Per Protocol Set (PPS). Only those participants with data available at specified timepoint were included in analysis.

The immune response to MenACWY vaccines is expressed in terms of percentage of participants with hSBA titers \>=LLOQ for each of the serogroup Men A, Men C, Men W and Men Y.

Time frame: At baseline (Day 1) and at one month after the MenACWY vaccination (i.e. Day 31)

Population: Analysis was performed on the Per Protocol Set (PPS). Only those participants with data available at specified timepoint were included in analysis.

The immune response to rMenB+OMV NZ vaccine is evaluated by measuring bactericidal activity in terms of participants with hSBA titers \>= LLOQ against N. meningitidis serogroup B test strains (M14459 \[fHbp\], 96217 \[NadA\], NZ98/254 \[PorA\] and M13520 \[NHBA\]).

Time frame: At Day 31 (one month after the first rMenB+OMV NZ vaccination)

Population: Analysis was performed on the Per Protocol Set (PPS). Only those participants with data available at specified timepoint were included in analysis.