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

Number of Participants With Solicited Local AEs After the Vaccination With Placebo

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

Number of Participants With Solicited Local AEs After the Vaccination With Placebo

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

Number of Participants With Solicited Systemic AEs

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

Number of Participants With Solicited Systemic AEs

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

Number of Participants With Solicited Systemic AEs

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

Number of Participants With Any Unsolicited AEs (Including All Serious Adverse Events)

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

Number of Participants With Any Unsolicited AEs (Including All Serious Adverse Events)

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

Number of Participants With Any Unsolicited AEs (Including All Serious Adverse Events)

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

Number of Participants With Any AEs/SAEs Leading to Withdrawal

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

Number of Participants With Any AEs/SAEs Leading to Withdrawal

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

Number of Participants With Any AEs/SAEs Leading to Withdrawal

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

Number of Participants With Any Medically Attended AEs

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

Number of Participants With Any Medically Attended AEs

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

Number of Participants With Any Medically Attended AEs

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

Number of Participants With Any SAEs, AEs Leading to Withdrawal and Medically Attended AEs

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)

Number of Participants Who Received rMenB+OMV NZ With Adverse Events of Special Interest (AESI)

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)

Number of Participants With Any SAEs and AEs Leading to Withdrawal

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)

Number of Participants Who Received rMenB+OMV NZ With AESI

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)

Human Serum Bactericidal Assay (hSBA) Geometric Mean Titers (GMTs) Against Each of the N. Meningitidis Serogroup B Strains at 1 Month After the Second Vaccination With rMenB+OMV NZ (Groups MenB+MenACWY and MenB), and Between-group GMT Ratios

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)

hSBA GMTs Against Each of the N. Meningitidis Serogroups A, C, W and Y After Vaccination With MenACWY (Groups MenB+MenACWY and MenACWY), and Between-group GMT Ratios

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)