Trial Outcomes & Findings for 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 (NCT NCT04318548)

Last Updated: 2025-03-04

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

945 participants

Primary outcome timeframe

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

Results posted on

2025-03-04

Participant Flow

The study ended on Day 271 for participants who had not reached Day 271 when Protocol Amendment 7 took effect, and on Day 451 for those who had already passed Day 271. Safety follow-up period for each participant was from Day 1 up to Day 451 or Day 271 for participants who have not reached Day 271 at the time Protocol Amendment 7 took effect.

Out of 945 participants enrolled, only 940 were randomized into the three treatment groups. After randomization, two participants did not receive the vaccination, so only 938 participants were included in the Exposed Set and started the study.

Participant milestones

Participant milestones
Measure	MenB+MenACWY Group Participants received 1 dose of rMenB+OMV NZ vaccine administered concomitantly with 1 dose of MenACWY vaccine, as separate injections in each arm at Day 1, 1 dose of rMenB+OMV NZ vaccine at Day 61 and 1 dose of placebo at Day 91.	MenB Group Participants received 1 dose of rMenB+OMV NZ vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day 1, 1 dose of rMenB+OMV NZ vaccine at Day 61 and 1 dose of MenACWY at Day 91.	MenACWY Group Participants received 1 dose of MenACWY vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day1, 1 dose of rMenB+OMV NZ vaccine each administered at Day 61 and at Day 91.
Overall Study STARTED	310	308	320
Overall Study COMPLETED	297	284	298
Overall Study NOT COMPLETED	13	24	22

Reasons for withdrawal

Reasons for withdrawal
Measure	MenB+MenACWY Group Participants received 1 dose of rMenB+OMV NZ vaccine administered concomitantly with 1 dose of MenACWY vaccine, as separate injections in each arm at Day 1, 1 dose of rMenB+OMV NZ vaccine at Day 61 and 1 dose of placebo at Day 91.	MenB Group Participants received 1 dose of rMenB+OMV NZ vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day 1, 1 dose of rMenB+OMV NZ vaccine at Day 61 and 1 dose of MenACWY at Day 91.	MenACWY Group Participants received 1 dose of MenACWY vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day1, 1 dose of rMenB+OMV NZ vaccine each administered at Day 61 and at Day 91.
Overall Study Adverse Event	0	0	1
Overall Study Lost to Follow-up	6	13	9
Overall Study Protocol Violation	1	0	2
Overall Study Consent withdrawal, not due to a (S)AE	5	9	6
Overall Study Migrated / moved from the study area	0	0	1
Overall Study Other	1	2	3

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MenB+MenACWY Group n=310 Participants Participants received 1 dose of rMenB+OMV NZ vaccine administered concomitantly with 1 dose of MenACWY vaccine, as separate injections in each arm at Day 1, 1 dose of rMenB+OMV NZ vaccine at Day 61 and 1 dose of placebo at Day 91.	MenB Group n=308 Participants Participants received 1 dose of rMenB+OMV NZ vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day 1, 1 dose of rMenB+OMV NZ vaccine at Day 61 and 1 dose of MenACWY at Day 91.	MenACWY Group n=320 Participants Participants received 1 dose of MenACWY vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day1, 1 dose of rMenB+OMV NZ vaccine each administered at Day 61 and at Day 91.	Total n=938 Participants Total of all reporting groups
Age, Continuous	16.4 years STANDARD_DEVIATION 0.7 • n=5 Participants	16.4 years STANDARD_DEVIATION 0.7 • n=7 Participants	16.5 years STANDARD_DEVIATION 0.7 • n=5 Participants	16.4 years STANDARD_DEVIATION 0.7 • n=4 Participants
Sex: Female, Male Female	156 Participants n=5 Participants	138 Participants n=7 Participants	163 Participants n=5 Participants	457 Participants n=4 Participants
Sex: Female, Male Male	154 Participants n=5 Participants	170 Participants n=7 Participants	157 Participants n=5 Participants	481 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	46 Participants n=5 Participants	38 Participants n=7 Participants	37 Participants n=5 Participants	121 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	263 Participants n=5 Participants	270 Participants n=7 Participants	282 Participants n=5 Participants	815 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	MenB+MenACWY Group n=307 Participants Participants received 1 dose of rMenB+OMV NZ vaccine administered concomitantly with 1 dose of MenACWY vaccine, as separate injections in each arm at Day 1, 1 dose of rMenB+OMV NZ vaccine at Day 61 and 1 dose of placebo at Day 91.	MenB Group n=306 Participants Participants received 1 dose of rMenB+OMV NZ vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day 1, 1 dose of rMenB+OMV NZ vaccine at Day 61 and 1 dose of MenACWY at Day 91.	MenACWY Group Participants received 1 dose of MenACWY vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day1, 1 dose of rMenB+OMV NZ vaccine each administered at Day 61 and at Day 91.
Number of Participants With Solicited Local Adverse Events (AEs) After the Vaccination With rMenB+OMV NZ Induration	14 Participants	22 Participants	—
Number of Participants With Solicited Local Adverse Events (AEs) After the Vaccination With rMenB+OMV NZ Pain	246 Participants	247 Participants	—
Number of Participants With Solicited Local Adverse Events (AEs) After the Vaccination With rMenB+OMV NZ Swelling	15 Participants	18 Participants	—
Number of Participants With Solicited Local Adverse Events (AEs) After the Vaccination With rMenB+OMV NZ Erythema	12 Participants	12 Participants	—

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	MenB+MenACWY Group n=283 Participants Participants received 1 dose of rMenB+OMV NZ vaccine administered concomitantly with 1 dose of MenACWY vaccine, as separate injections in each arm at Day 1, 1 dose of rMenB+OMV NZ vaccine at Day 61 and 1 dose of placebo at Day 91.	MenB Group n=269 Participants Participants received 1 dose of rMenB+OMV NZ vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day 1, 1 dose of rMenB+OMV NZ vaccine at Day 61 and 1 dose of MenACWY at Day 91.	MenACWY Group n=287 Participants Participants received 1 dose of MenACWY vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day1, 1 dose of rMenB+OMV NZ vaccine each administered at Day 61 and at Day 91.
Number of Participants With Solicited Local Adverse Events (AEs) After the Vaccination With rMenB+OMV NZ Erythema	17 Participants	17 Participants	8 Participants
Number of Participants With Solicited Local Adverse Events (AEs) After the Vaccination With rMenB+OMV NZ Induration	18 Participants	19 Participants	6 Participants
Number of Participants With Solicited Local Adverse Events (AEs) After the Vaccination With rMenB+OMV NZ Pain	240 Participants	228 Participants	238 Participants
Number of Participants With Solicited Local Adverse Events (AEs) After the Vaccination With rMenB+OMV NZ Swelling	16 Participants	16 Participants	7 Participants

PRIMARY outcome

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

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

Outcome measures

Outcome measures
Measure	MenB+MenACWY Group Participants received 1 dose of rMenB+OMV NZ vaccine administered concomitantly with 1 dose of MenACWY vaccine, as separate injections in each arm at Day 1, 1 dose of rMenB+OMV NZ vaccine at Day 61 and 1 dose of placebo at Day 91.	MenB Group Participants received 1 dose of rMenB+OMV NZ vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day 1, 1 dose of rMenB+OMV NZ vaccine at Day 61 and 1 dose of MenACWY at Day 91.	MenACWY Group n=269 Participants Participants received 1 dose of MenACWY vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day1, 1 dose of rMenB+OMV NZ vaccine each administered at Day 61 and at Day 91.
Number of Participants With Solicited Local Adverse Events (AEs) After the Vaccination With rMenB+OMV NZ Erythema	—	—	14 Participants
Number of Participants With Solicited Local Adverse Events (AEs) After the Vaccination With rMenB+OMV NZ Induration	—	—	11 Participants
Number of Participants With Solicited Local Adverse Events (AEs) After the Vaccination With rMenB+OMV NZ Pain	—	—	205 Participants
Number of Participants With Solicited Local Adverse Events (AEs) After the Vaccination With rMenB+OMV NZ Swelling	—	—	13 Participants

PRIMARY outcome

Timeframe: During 7 days after the MenACWY vaccination at Day 1

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

Outcome measures

Outcome measures
Measure	MenB+MenACWY Group n=307 Participants Participants received 1 dose of rMenB+OMV NZ vaccine administered concomitantly with 1 dose of MenACWY vaccine, as separate injections in each arm at Day 1, 1 dose of rMenB+OMV NZ vaccine at Day 61 and 1 dose of placebo at Day 91.	MenB Group Participants received 1 dose of rMenB+OMV NZ vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day 1, 1 dose of rMenB+OMV NZ vaccine at Day 61 and 1 dose of MenACWY at Day 91.	MenACWY Group n=319 Participants Participants received 1 dose of MenACWY vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day1, 1 dose of rMenB+OMV NZ vaccine each administered at Day 61 and at Day 91.
Number of Participants With Solicited Local AEs After the Vaccination With MenACWY Pain	93 Participants	—	104 Participants
Number of Participants With Solicited Local AEs After the Vaccination With MenACWY Swelling	5 Participants	—	5 Participants
Number of Participants With Solicited Local AEs After the Vaccination With MenACWY Erythema	5 Participants	—	6 Participants
Number of Participants With Solicited Local AEs After the Vaccination With MenACWY Induration	7 Participants	—	7 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	MenB+MenACWY Group Participants received 1 dose of rMenB+OMV NZ vaccine administered concomitantly with 1 dose of MenACWY vaccine, as separate injections in each arm at Day 1, 1 dose of rMenB+OMV NZ vaccine at Day 61 and 1 dose of placebo at Day 91.	MenB Group n=1 Participants Participants received 1 dose of rMenB+OMV NZ vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day 1, 1 dose of rMenB+OMV NZ vaccine at Day 61 and 1 dose of MenACWY at Day 91.	MenACWY Group Participants received 1 dose of MenACWY vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day1, 1 dose of rMenB+OMV NZ vaccine each administered at Day 61 and at Day 91.
Number of Participants With Solicited Local AEs After the Vaccination With MenACWY Erythema	—	0 Participants	—
Number of Participants With Solicited Local AEs After the Vaccination With MenACWY Induration	—	0 Participants	—
Number of Participants With Solicited Local AEs After the Vaccination With MenACWY Pain	—	1 Participants	—
Number of Participants With Solicited Local AEs After the Vaccination With MenACWY Swelling	—	0 Participants	—

PRIMARY outcome

Timeframe: During 7 days after the MenACWY vaccination at Day 91

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

Outcome measures

Outcome measures
Measure	MenB+MenACWY Group Participants received 1 dose of rMenB+OMV NZ vaccine administered concomitantly with 1 dose of MenACWY vaccine, as separate injections in each arm at Day 1, 1 dose of rMenB+OMV NZ vaccine at Day 61 and 1 dose of placebo at Day 91.	MenB Group n=265 Participants Participants received 1 dose of rMenB+OMV NZ vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day 1, 1 dose of rMenB+OMV NZ vaccine at Day 61 and 1 dose of MenACWY at Day 91.	MenACWY Group Participants received 1 dose of MenACWY vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day1, 1 dose of rMenB+OMV NZ vaccine each administered at Day 61 and at Day 91.
Number of Participants With Solicited Local AEs After the Vaccination With MenACWY Erythema	—	4 Participants	—
Number of Participants With Solicited Local AEs After the Vaccination With MenACWY Induration	—	1 Participants	—
Number of Participants With Solicited Local AEs After the Vaccination With MenACWY Pain	—	38 Participants	—
Number of Participants With Solicited Local AEs After the Vaccination With MenACWY Swelling	—	5 Participants	—

PRIMARY outcome

Timeframe: During 7 days after the Placebo vaccination at Day 1

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

Outcome measures

Outcome measures
Measure	MenB+MenACWY Group Participants received 1 dose of rMenB+OMV NZ vaccine administered concomitantly with 1 dose of MenACWY vaccine, as separate injections in each arm at Day 1, 1 dose of rMenB+OMV NZ vaccine at Day 61 and 1 dose of placebo at Day 91.	MenB Group n=306 Participants Participants received 1 dose of rMenB+OMV NZ vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day 1, 1 dose of rMenB+OMV NZ vaccine at Day 61 and 1 dose of MenACWY at Day 91.	MenACWY Group n=320 Participants Participants received 1 dose of MenACWY vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day1, 1 dose of rMenB+OMV NZ vaccine each administered at Day 61 and at Day 91.
Number of Participants With Solicited Local AEs After the Vaccination With Placebo Erythema	—	2 Participants	2 Participants
Number of Participants With Solicited Local AEs After the Vaccination With Placebo Induration	—	5 Participants	0 Participants
Number of Participants With Solicited Local AEs After the Vaccination With Placebo Pain	—	78 Participants	77 Participants
Number of Participants With Solicited Local AEs After the Vaccination With Placebo Swelling	—	2 Participants	1 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	MenB+MenACWY Group n=282 Participants Participants received 1 dose of rMenB+OMV NZ vaccine administered concomitantly with 1 dose of MenACWY vaccine, as separate injections in each arm at Day 1, 1 dose of rMenB+OMV NZ vaccine at Day 61 and 1 dose of placebo at Day 91.	MenB Group Participants received 1 dose of rMenB+OMV NZ vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day 1, 1 dose of rMenB+OMV NZ vaccine at Day 61 and 1 dose of MenACWY at Day 91.	MenACWY Group n=1 Participants Participants received 1 dose of MenACWY vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day1, 1 dose of rMenB+OMV NZ vaccine each administered at Day 61 and at Day 91.
Number of Participants With Solicited Local AEs After the Vaccination With Placebo Induration	1 Participants	—	0 Participants
Number of Participants With Solicited Local AEs After the Vaccination With Placebo Pain	25 Participants	—	0 Participants
Number of Participants With Solicited Local AEs After the Vaccination With Placebo Swelling	0 Participants	—	0 Participants
Number of Participants With Solicited Local AEs After the Vaccination With Placebo Erythema	1 Participants	—	0 Participants

PRIMARY outcome

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

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

Outcome measures

Outcome measures
Measure	MenB+MenACWY Group n=307 Participants Participants received 1 dose of rMenB+OMV NZ vaccine administered concomitantly with 1 dose of MenACWY vaccine, as separate injections in each arm at Day 1, 1 dose of rMenB+OMV NZ vaccine at Day 61 and 1 dose of placebo at Day 91.	MenB Group n=306 Participants Participants received 1 dose of rMenB+OMV NZ vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day 1, 1 dose of rMenB+OMV NZ vaccine at Day 61 and 1 dose of MenACWY at Day 91.	MenACWY Group n=320 Participants Participants received 1 dose of MenACWY vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day1, 1 dose of rMenB+OMV NZ vaccine each administered at Day 61 and at Day 91.
Number of Participants With Solicited Systemic AEs Arthralgia	24 Participants	32 Participants	24 Participants
Number of Participants With Solicited Systemic AEs Nausea	46 Participants	57 Participants	51 Participants
Number of Participants With Solicited Systemic AEs Fever	7 Participants	10 Participants	2 Participants
Number of Participants With Solicited Systemic AEs Fatigue	114 Participants	118 Participants	108 Participants
Number of Participants With Solicited Systemic AEs Headache	128 Participants	135 Participants	134 Participants
Number of Participants With Solicited Systemic AEs Myalgia	36 Participants	49 Participants	31 Participants

PRIMARY outcome

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

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

Outcome measures

Outcome measures
Measure	MenB+MenACWY Group n=284 Participants Participants received 1 dose of rMenB+OMV NZ vaccine administered concomitantly with 1 dose of MenACWY vaccine, as separate injections in each arm at Day 1, 1 dose of rMenB+OMV NZ vaccine at Day 61 and 1 dose of placebo at Day 91.	MenB Group n=269 Participants Participants received 1 dose of rMenB+OMV NZ vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day 1, 1 dose of rMenB+OMV NZ vaccine at Day 61 and 1 dose of MenACWY at Day 91.	MenACWY Group n=287 Participants Participants received 1 dose of MenACWY vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day1, 1 dose of rMenB+OMV NZ vaccine each administered at Day 61 and at Day 91.
Number of Participants With Solicited Systemic AEs Arthralgia	28 Participants	24 Participants	27 Participants
Number of Participants With Solicited Systemic AEs Fatigue	96 Participants	101 Participants	88 Participants
Number of Participants With Solicited Systemic AEs Headache	112 Participants	103 Participants	93 Participants
Number of Participants With Solicited Systemic AEs Myalgia	41 Participants	42 Participants	43 Participants
Number of Participants With Solicited Systemic AEs Nausea	37 Participants	37 Participants	40 Participants
Number of Participants With Solicited Systemic AEs Fever	4 Participants	8 Participants	6 Participants

PRIMARY outcome

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

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

Outcome measures

Outcome measures
Measure	MenB+MenACWY Group n=282 Participants Participants received 1 dose of rMenB+OMV NZ vaccine administered concomitantly with 1 dose of MenACWY vaccine, as separate injections in each arm at Day 1, 1 dose of rMenB+OMV NZ vaccine at Day 61 and 1 dose of placebo at Day 91.	MenB Group n=263 Participants Participants received 1 dose of rMenB+OMV NZ vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day 1, 1 dose of rMenB+OMV NZ vaccine at Day 61 and 1 dose of MenACWY at Day 91.	MenACWY Group n=270 Participants Participants received 1 dose of MenACWY vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day1, 1 dose of rMenB+OMV NZ vaccine each administered at Day 61 and at Day 91.
Number of Participants With Solicited Systemic AEs Arthralgia	7 Participants	8 Participants	24 Participants
Number of Participants With Solicited Systemic AEs Fatigue	38 Participants	59 Participants	86 Participants
Number of Participants With Solicited Systemic AEs Nausea	20 Participants	18 Participants	31 Participants
Number of Participants With Solicited Systemic AEs Fever	2 Participants	2 Participants	6 Participants
Number of Participants With Solicited Systemic AEs Headache	56 Participants	53 Participants	84 Participants
Number of Participants With Solicited Systemic AEs Myalgia	7 Participants	16 Participants	39 Participants

PRIMARY outcome

Timeframe: 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 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.

Outcome measures

Outcome measures
Measure	MenB+MenACWY Group n=310 Participants Participants received 1 dose of rMenB+OMV NZ vaccine administered concomitantly with 1 dose of MenACWY vaccine, as separate injections in each arm at Day 1, 1 dose of rMenB+OMV NZ vaccine at Day 61 and 1 dose of placebo at Day 91.	MenB Group n=308 Participants Participants received 1 dose of rMenB+OMV NZ vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day 1, 1 dose of rMenB+OMV NZ vaccine at Day 61 and 1 dose of MenACWY at Day 91.	MenACWY Group n=320 Participants Participants received 1 dose of MenACWY vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day1, 1 dose of rMenB+OMV NZ vaccine each administered at Day 61 and at Day 91.
Number of Participants With Any Unsolicited AEs (Including All Serious Adverse Events)	49 Participants	54 Participants	55 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	MenB+MenACWY Group n=310 Participants Participants received 1 dose of rMenB+OMV NZ vaccine administered concomitantly with 1 dose of MenACWY vaccine, as separate injections in each arm at Day 1, 1 dose of rMenB+OMV NZ vaccine at Day 61 and 1 dose of placebo at Day 91.	MenB Group n=308 Participants Participants received 1 dose of rMenB+OMV NZ vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day 1, 1 dose of rMenB+OMV NZ vaccine at Day 61 and 1 dose of MenACWY at Day 91.	MenACWY Group n=320 Participants Participants received 1 dose of MenACWY vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day1, 1 dose of rMenB+OMV NZ vaccine each administered at Day 61 and at Day 91.
Number of Participants With Any Unsolicited AEs (Including All Serious Adverse Events)	51 Participants	47 Participants	44 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	MenB+MenACWY Group n=310 Participants Participants received 1 dose of rMenB+OMV NZ vaccine administered concomitantly with 1 dose of MenACWY vaccine, as separate injections in each arm at Day 1, 1 dose of rMenB+OMV NZ vaccine at Day 61 and 1 dose of placebo at Day 91.	MenB Group n=308 Participants Participants received 1 dose of rMenB+OMV NZ vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day 1, 1 dose of rMenB+OMV NZ vaccine at Day 61 and 1 dose of MenACWY at Day 91.	MenACWY Group n=320 Participants Participants received 1 dose of MenACWY vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day1, 1 dose of rMenB+OMV NZ vaccine each administered at Day 61 and at Day 91.
Number of Participants With Any Unsolicited AEs (Including All Serious Adverse Events)	37 Participants	37 Participants	38 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	MenB+MenACWY Group n=310 Participants Participants received 1 dose of rMenB+OMV NZ vaccine administered concomitantly with 1 dose of MenACWY vaccine, as separate injections in each arm at Day 1, 1 dose of rMenB+OMV NZ vaccine at Day 61 and 1 dose of placebo at Day 91.	MenB Group n=308 Participants Participants received 1 dose of rMenB+OMV NZ vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day 1, 1 dose of rMenB+OMV NZ vaccine at Day 61 and 1 dose of MenACWY at Day 91.	MenACWY Group n=320 Participants Participants received 1 dose of MenACWY vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day1, 1 dose of rMenB+OMV NZ vaccine each administered at Day 61 and at Day 91.
Number of Participants With Any AEs/SAEs Leading to Withdrawal	0 Participants	0 Participants	1 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	MenB+MenACWY Group n=310 Participants Participants received 1 dose of rMenB+OMV NZ vaccine administered concomitantly with 1 dose of MenACWY vaccine, as separate injections in each arm at Day 1, 1 dose of rMenB+OMV NZ vaccine at Day 61 and 1 dose of placebo at Day 91.	MenB Group n=308 Participants Participants received 1 dose of rMenB+OMV NZ vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day 1, 1 dose of rMenB+OMV NZ vaccine at Day 61 and 1 dose of MenACWY at Day 91.	MenACWY Group n=320 Participants Participants received 1 dose of MenACWY vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day1, 1 dose of rMenB+OMV NZ vaccine each administered at Day 61 and at Day 91.
Number of Participants With Any AEs/SAEs Leading to Withdrawal	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	MenB+MenACWY Group n=310 Participants Participants received 1 dose of rMenB+OMV NZ vaccine administered concomitantly with 1 dose of MenACWY vaccine, as separate injections in each arm at Day 1, 1 dose of rMenB+OMV NZ vaccine at Day 61 and 1 dose of placebo at Day 91.	MenB Group n=308 Participants Participants received 1 dose of rMenB+OMV NZ vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day 1, 1 dose of rMenB+OMV NZ vaccine at Day 61 and 1 dose of MenACWY at Day 91.	MenACWY Group n=320 Participants Participants received 1 dose of MenACWY vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day1, 1 dose of rMenB+OMV NZ vaccine each administered at Day 61 and at Day 91.
Number of Participants With Any AEs/SAEs Leading to Withdrawal	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	MenB+MenACWY Group n=310 Participants Participants received 1 dose of rMenB+OMV NZ vaccine administered concomitantly with 1 dose of MenACWY vaccine, as separate injections in each arm at Day 1, 1 dose of rMenB+OMV NZ vaccine at Day 61 and 1 dose of placebo at Day 91.	MenB Group n=308 Participants Participants received 1 dose of rMenB+OMV NZ vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day 1, 1 dose of rMenB+OMV NZ vaccine at Day 61 and 1 dose of MenACWY at Day 91.	MenACWY Group n=320 Participants Participants received 1 dose of MenACWY vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day1, 1 dose of rMenB+OMV NZ vaccine each administered at Day 61 and at Day 91.
Number of Participants With Any Medically Attended AEs	28 Participants	36 Participants	26 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	MenB+MenACWY Group n=310 Participants Participants received 1 dose of rMenB+OMV NZ vaccine administered concomitantly with 1 dose of MenACWY vaccine, as separate injections in each arm at Day 1, 1 dose of rMenB+OMV NZ vaccine at Day 61 and 1 dose of placebo at Day 91.	MenB Group n=308 Participants Participants received 1 dose of rMenB+OMV NZ vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day 1, 1 dose of rMenB+OMV NZ vaccine at Day 61 and 1 dose of MenACWY at Day 91.	MenACWY Group n=320 Participants Participants received 1 dose of MenACWY vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day1, 1 dose of rMenB+OMV NZ vaccine each administered at Day 61 and at Day 91.
Number of Participants With Any Medically Attended AEs	28 Participants	32 Participants	25 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	MenB+MenACWY Group n=310 Participants Participants received 1 dose of rMenB+OMV NZ vaccine administered concomitantly with 1 dose of MenACWY vaccine, as separate injections in each arm at Day 1, 1 dose of rMenB+OMV NZ vaccine at Day 61 and 1 dose of placebo at Day 91.	MenB Group n=308 Participants Participants received 1 dose of rMenB+OMV NZ vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day 1, 1 dose of rMenB+OMV NZ vaccine at Day 61 and 1 dose of MenACWY at Day 91.	MenACWY Group n=320 Participants Participants received 1 dose of MenACWY vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day1, 1 dose of rMenB+OMV NZ vaccine each administered at Day 61 and at Day 91.
Number of Participants With Any Medically Attended AEs	19 Participants	21 Participants	17 Participants

PRIMARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	MenB+MenACWY Group n=310 Participants Participants received 1 dose of rMenB+OMV NZ vaccine administered concomitantly with 1 dose of MenACWY vaccine, as separate injections in each arm at Day 1, 1 dose of rMenB+OMV NZ vaccine at Day 61 and 1 dose of placebo at Day 91.	MenB Group n=308 Participants Participants received 1 dose of rMenB+OMV NZ vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day 1, 1 dose of rMenB+OMV NZ vaccine at Day 61 and 1 dose of MenACWY at Day 91.	MenACWY Group n=320 Participants Participants received 1 dose of MenACWY vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day1, 1 dose of rMenB+OMV NZ vaccine each administered at Day 61 and at Day 91.
Number of Participants With Any SAEs, AEs Leading to Withdrawal and Medically Attended AEs SAEs	2 Participants	3 Participants	5 Participants
Number of Participants With Any SAEs, AEs Leading to Withdrawal and Medically Attended AEs AEs leading to withdrawal	0 Participants	0 Participants	1 Participants
Number of Participants With Any SAEs, AEs Leading to Withdrawal and Medically Attended AEs Medically attended AEs	93 Participants	103 Participants	96 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	MenB+MenACWY Group n=310 Participants Participants received 1 dose of rMenB+OMV NZ vaccine administered concomitantly with 1 dose of MenACWY vaccine, as separate injections in each arm at Day 1, 1 dose of rMenB+OMV NZ vaccine at Day 61 and 1 dose of placebo at Day 91.	MenB Group n=308 Participants Participants received 1 dose of rMenB+OMV NZ vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day 1, 1 dose of rMenB+OMV NZ vaccine at Day 61 and 1 dose of MenACWY at Day 91.	MenACWY Group n=320 Participants Participants received 1 dose of MenACWY vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day1, 1 dose of rMenB+OMV NZ vaccine each administered at Day 61 and at Day 91.
Number of Participants Who Received rMenB+OMV NZ With Adverse Events of Special Interest (AESI)	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	MenB+MenACWY Group n=88 Participants Participants received 1 dose of rMenB+OMV NZ vaccine administered concomitantly with 1 dose of MenACWY vaccine, as separate injections in each arm at Day 1, 1 dose of rMenB+OMV NZ vaccine at Day 61 and 1 dose of placebo at Day 91.	MenB Group n=90 Participants Participants received 1 dose of rMenB+OMV NZ vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day 1, 1 dose of rMenB+OMV NZ vaccine at Day 61 and 1 dose of MenACWY at Day 91.	MenACWY Group n=87 Participants Participants received 1 dose of MenACWY vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day1, 1 dose of rMenB+OMV NZ vaccine each administered at Day 61 and at Day 91.
Number of Participants With Any SAEs and AEs Leading to Withdrawal SAEs	0 Participants	1 Participants	2 Participants
Number of Participants With Any SAEs and AEs Leading to Withdrawal AEs leading to withdrawal	0 Participants	0 Participants	0 Participants

PRIMARY outcome

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

Outcome measures

Outcome measures
Measure	MenB+MenACWY Group n=88 Participants Participants received 1 dose of rMenB+OMV NZ vaccine administered concomitantly with 1 dose of MenACWY vaccine, as separate injections in each arm at Day 1, 1 dose of rMenB+OMV NZ vaccine at Day 61 and 1 dose of placebo at Day 91.	MenB Group n=90 Participants Participants received 1 dose of rMenB+OMV NZ vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day 1, 1 dose of rMenB+OMV NZ vaccine at Day 61 and 1 dose of MenACWY at Day 91.	MenACWY Group n=87 Participants Participants received 1 dose of MenACWY vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day1, 1 dose of rMenB+OMV NZ vaccine each administered at Day 61 and at Day 91.
Number of Participants Who Received rMenB+OMV NZ With AESI	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 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.

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 \[NHBA\]).

Outcome measures

Outcome measures
Measure	MenB+MenACWY Group n=274 Participants Participants received 1 dose of rMenB+OMV NZ vaccine administered concomitantly with 1 dose of MenACWY vaccine, as separate injections in each arm at Day 1, 1 dose of rMenB+OMV NZ vaccine at Day 61 and 1 dose of placebo at Day 91.	MenB Group n=267 Participants Participants received 1 dose of rMenB+OMV NZ vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day 1, 1 dose of rMenB+OMV NZ vaccine at Day 61 and 1 dose of MenACWY at Day 91.	MenACWY Group Participants received 1 dose of MenACWY vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day1, 1 dose of rMenB+OMV NZ vaccine each administered at Day 61 and at Day 91.
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 NadA (96217)	239.6 Titers Interval 202.9 to 283.0	272.4 Titers Interval 231.1 to 321.0	—
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 PorA (NZ98/254)	18.8 Titers Interval 15.6 to 22.6	21.3 Titers Interval 17.7 to 25.6	—
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 NHBA (M13520)	19.0 Titers Interval 15.6 to 23.1	20.5 Titers Interval 16.9 to 24.9	—
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 fHbp (M14459)	16.9 Titers Interval 14.4 to 19.8	18.7 Titers Interval 15.9 to 21.9	—

PRIMARY outcome

Timeframe: 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 GMTs against each of the 4 serogroups Men A, Men C, Men W and Men Y.

Outcome measures

Outcome measures
Measure	MenB+MenACWY Group n=295 Participants Participants received 1 dose of rMenB+OMV NZ vaccine administered concomitantly with 1 dose of MenACWY vaccine, as separate injections in each arm at Day 1, 1 dose of rMenB+OMV NZ vaccine at Day 61 and 1 dose of placebo at Day 91.	MenB Group n=303 Participants Participants received 1 dose of rMenB+OMV NZ vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day 1, 1 dose of rMenB+OMV NZ vaccine at Day 61 and 1 dose of MenACWY at Day 91.	MenACWY Group Participants received 1 dose of MenACWY vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day1, 1 dose of rMenB+OMV NZ vaccine each administered at Day 61 and at Day 91.
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 Men A	2388.8 Titers Interval 1977.2 to 2886.1	2536.1 Titers Interval 2095.7 to 3069.1	—
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 Men C	2075.9 Titers Interval 1602.5 to 2689.3	1867.6 Titers Interval 1438.7 to 2424.2	—
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 Men W	2299.3 Titers Interval 1902.5 to 2778.9	2305.7 Titers Interval 1905.3 to 2790.4	—
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 Men Y	2897.3 Titers Interval 2359.2 to 3558.3	2802.0 Titers Interval 2278.3 to 3446.2	—

SECONDARY outcome

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

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	MenB+MenACWY Group n=294 Participants Participants received 1 dose of rMenB+OMV NZ vaccine administered concomitantly with 1 dose of MenACWY vaccine, as separate injections in each arm at Day 1, 1 dose of rMenB+OMV NZ vaccine at Day 61 and 1 dose of placebo at Day 91.	MenB Group n=294 Participants Participants received 1 dose of rMenB+OMV NZ vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day 1, 1 dose of rMenB+OMV NZ vaccine at Day 61 and 1 dose of MenACWY at Day 91.	MenACWY Group Participants received 1 dose of MenACWY vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day1, 1 dose of rMenB+OMV NZ vaccine each administered at Day 61 and at Day 91.
hSBA GMTs Against Each of the Serogroup B Strains in Both MenB+MenACWY and MenB Groups After First rMenB+OMV NZ Vaccination and Between-group GMT Ratios NadA (96217)	45.2 Titers Interval 36.0 to 56.9	73.4 Titers Interval 58.5 to 91.9	—
hSBA GMTs Against Each of the Serogroup B Strains in Both MenB+MenACWY and MenB Groups After First rMenB+OMV NZ Vaccination and Between-group GMT Ratios PorA (NZ98/254)	4.2 Titers Interval 3.5 to 5.0	5.6 Titers Interval 4.7 to 6.6	—
hSBA GMTs Against Each of the Serogroup B Strains in Both MenB+MenACWY and MenB Groups After First rMenB+OMV NZ Vaccination and Between-group GMT Ratios NHBA (M13520)	6.4 Titers Interval 5.1 to 8.1	8.8 Titers Interval 7.0 to 11.1	—
hSBA GMTs Against Each of the Serogroup B Strains in Both MenB+MenACWY and MenB Groups After First rMenB+OMV NZ Vaccination and Between-group GMT Ratios fHbp (M14459)	4.3 Titers Interval 3.6 to 5.1	5.6 Titers Interval 4.7 to 6.7	—

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	MenB+MenACWY Group n=294 Participants Participants received 1 dose of rMenB+OMV NZ vaccine administered concomitantly with 1 dose of MenACWY vaccine, as separate injections in each arm at Day 1, 1 dose of rMenB+OMV NZ vaccine at Day 61 and 1 dose of placebo at Day 91.	MenB Group n=294 Participants Participants received 1 dose of rMenB+OMV NZ vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day 1, 1 dose of rMenB+OMV NZ vaccine at Day 61 and 1 dose of MenACWY at Day 91.	MenACWY Group Participants received 1 dose of MenACWY vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day1, 1 dose of rMenB+OMV NZ vaccine each administered at Day 61 and at Day 91.
Geometric Mean Ratios (GMRs) Against Each of the N. Meningitidis Serogroup B Strains in Both MenB+MenACWY and MenB Groups After the First rMenB+OMV NZ Vaccination PorA (NZ98/254)	1.4 Ratio Interval 1.2 to 1.6	1.8 Ratio Interval 1.5 to 2.1	—
Geometric Mean Ratios (GMRs) Against Each of the N. Meningitidis Serogroup B Strains in Both MenB+MenACWY and MenB Groups After the First rMenB+OMV NZ Vaccination NHBA (M13520)	1.8 Ratio Interval 1.5 to 2.2	2.3 Ratio Interval 1.9 to 2.8	—
Geometric Mean Ratios (GMRs) Against Each of the N. Meningitidis Serogroup B Strains in Both MenB+MenACWY and MenB Groups After the First rMenB+OMV NZ Vaccination fHbp (M14459)	1.6 Ratio Interval 1.4 to 1.9	2.0 Ratio Interval 1.7 to 2.4	—
Geometric Mean Ratios (GMRs) Against Each of the N. Meningitidis Serogroup B Strains in Both MenB+MenACWY and MenB Groups After the First rMenB+OMV NZ Vaccination NadA (96217)	5.9 Ratio Interval 4.7 to 7.4	9.3 Ratio Interval 7.5 to 11.6	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	MenB+MenACWY Group n=274 Participants Participants received 1 dose of rMenB+OMV NZ vaccine administered concomitantly with 1 dose of MenACWY vaccine, as separate injections in each arm at Day 1, 1 dose of rMenB+OMV NZ vaccine at Day 61 and 1 dose of placebo at Day 91.	MenB Group n=267 Participants Participants received 1 dose of rMenB+OMV NZ vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day 1, 1 dose of rMenB+OMV NZ vaccine at Day 61 and 1 dose of MenACWY at Day 91.	MenACWY Group Participants received 1 dose of MenACWY vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day1, 1 dose of rMenB+OMV NZ vaccine each administered at Day 61 and at Day 91.
GMRs Against Each of the N. Meningitidis Serogroup B Strains in Both MenB+MenACWY and MenB Groups After the Second rMenB+OMV NZ Vaccination fHbp (M14459)	6.4 Ratio Interval 5.5 to 7.5	7.0 Ratio Interval 5.9 to 8.1	—
GMRs Against Each of the N. Meningitidis Serogroup B Strains in Both MenB+MenACWY and MenB Groups After the Second rMenB+OMV NZ Vaccination NadA (96217)	30.7 Ratio Interval 25.8 to 36.6	35.1 Ratio Interval 29.5 to 41.7	—
GMRs Against Each of the N. Meningitidis Serogroup B Strains in Both MenB+MenACWY and MenB Groups After the Second rMenB+OMV NZ Vaccination PorA (NZ98/254)	6.0 Ratio Interval 5.0 to 7.2	6.9 Ratio Interval 5.8 to 8.3	—
GMRs Against Each of the N. Meningitidis Serogroup B Strains in Both MenB+MenACWY and MenB Groups After the Second rMenB+OMV NZ Vaccination NHBA (M13520)	5.2 Ratio Interval 4.4 to 6.2	5.6 Ratio Interval 4.7 to 6.6	—

SECONDARY outcome

Timeframe: 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.

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 \[NHBA\]).

Outcome measures

Outcome measures
Measure	MenB+MenACWY Group n=294 Participants Participants received 1 dose of rMenB+OMV NZ vaccine administered concomitantly with 1 dose of MenACWY vaccine, as separate injections in each arm at Day 1, 1 dose of rMenB+OMV NZ vaccine at Day 61 and 1 dose of placebo at Day 91.	MenB Group n=294 Participants Participants received 1 dose of rMenB+OMV NZ vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day 1, 1 dose of rMenB+OMV NZ vaccine at Day 61 and 1 dose of MenACWY at Day 91.	MenACWY Group Participants received 1 dose of MenACWY vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day1, 1 dose of rMenB+OMV NZ vaccine each administered at Day 61 and at Day 91.
Percentage of Participants With hSBA Titers >= Lower Limit of Quantitation (LLOQ) for Each and All Serogroup B Test Strains in Both MenB+MenACWY and MenB Groups After the First rMenB+OMV NZ Vaccination fHbp (M14459)	32.3 Percentage of participants Interval 27.0 to 38.0	44.9 Percentage of participants Interval 39.1 to 50.8	—
Percentage of Participants With hSBA Titers >= Lower Limit of Quantitation (LLOQ) for Each and All Serogroup B Test Strains in Both MenB+MenACWY and MenB Groups After the First rMenB+OMV NZ Vaccination NadA (96217)	77.9 Percentage of participants Interval 72.7 to 82.5	85.7 Percentage of participants Interval 81.2 to 89.5	—
Percentage of Participants With hSBA Titers >= Lower Limit of Quantitation (LLOQ) for Each and All Serogroup B Test Strains in Both MenB+MenACWY and MenB Groups After the First rMenB+OMV NZ Vaccination PorA ( NZ98/254)	21.1 Percentage of participants Interval 16.6 to 26.2	30.4 Percentage of participants Interval 25.2 to 36.0	—
Percentage of Participants With hSBA Titers >= Lower Limit of Quantitation (LLOQ) for Each and All Serogroup B Test Strains in Both MenB+MenACWY and MenB Groups After the First rMenB+OMV NZ Vaccination NHBA (M13520)	37.1 Percentage of participants Interval 31.5 to 42.9	44.4 Percentage of participants Interval 38.6 to 50.3	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	MenB+MenACWY Group n=274 Participants Participants received 1 dose of rMenB+OMV NZ vaccine administered concomitantly with 1 dose of MenACWY vaccine, as separate injections in each arm at Day 1, 1 dose of rMenB+OMV NZ vaccine at Day 61 and 1 dose of placebo at Day 91.	MenB Group n=267 Participants Participants received 1 dose of rMenB+OMV NZ vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day 1, 1 dose of rMenB+OMV NZ vaccine at Day 61 and 1 dose of MenACWY at Day 91.	MenACWY Group Participants received 1 dose of MenACWY vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day1, 1 dose of rMenB+OMV NZ vaccine each administered at Day 61 and at Day 91.
Percentage of Participants With hSBA Titers >= LLOQ for Each and All of the Serogroup B Test Strains in Both MenB+MenACWY and MenB Groups After the Second rMenB+OMV NZ Vaccination fHbp (M14459 )	92.3 Percentage of participants Interval 88.5 to 95.2	92.5 Percentage of participants Interval 88.6 to 95.3	—
Percentage of Participants With hSBA Titers >= LLOQ for Each and All of the Serogroup B Test Strains in Both MenB+MenACWY and MenB Groups After the Second rMenB+OMV NZ Vaccination NadA (96217)	99.6 Percentage of participants Interval 98.0 to 100.0	99.6 Percentage of participants Interval 97.9 to 100.0	—
Percentage of Participants With hSBA Titers >= LLOQ for Each and All of the Serogroup B Test Strains in Both MenB+MenACWY and MenB Groups After the Second rMenB+OMV NZ Vaccination PorA (NZ98/254)	83.2 Percentage of participants Interval 78.2 to 87.4	85.0 Percentage of participants Interval 80.1 to 89.0	—
Percentage of Participants With hSBA Titers >= LLOQ for Each and All of the Serogroup B Test Strains in Both MenB+MenACWY and MenB Groups After the Second rMenB+OMV NZ Vaccination NHBA (M13520)	84.2 Percentage of participants Interval 79.4 to 88.4	90.2 Percentage of participants Interval 86.0 to 93.5	—

SECONDARY outcome

Timeframe: 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 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.

Outcome measures

Outcome measures
Measure	MenB+MenACWY Group n=293 Participants Participants received 1 dose of rMenB+OMV NZ vaccine administered concomitantly with 1 dose of MenACWY vaccine, as separate injections in each arm at Day 1, 1 dose of rMenB+OMV NZ vaccine at Day 61 and 1 dose of placebo at Day 91.	MenB Group n=293 Participants Participants received 1 dose of rMenB+OMV NZ vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day 1, 1 dose of rMenB+OMV NZ vaccine at Day 61 and 1 dose of MenACWY at Day 91.	MenACWY Group Participants received 1 dose of MenACWY vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day1, 1 dose of rMenB+OMV NZ vaccine each administered at Day 61 and at Day 91.
Percentage of Participants With 4-fold Increase in hSBA Titers Relative to Baseline in Both MenB+MenACWY and MenB Groups After the First rMenB+OMV NZ Vaccination NadA (96217)	68.9 Percentage of participants Interval 63.3 to 74.2	78.4 Percentage of participants Interval 73.3 to 83.0	—
Percentage of Participants With 4-fold Increase in hSBA Titers Relative to Baseline in Both MenB+MenACWY and MenB Groups After the First rMenB+OMV NZ Vaccination PorA (NZ98/254)	8.9 Percentage of participants Interval 5.9 to 12.7	16.4 Percentage of participants Interval 12.4 to 21.2	—
Percentage of Participants With 4-fold Increase in hSBA Titers Relative to Baseline in Both MenB+MenACWY and MenB Groups After the First rMenB+OMV NZ Vaccination NHBA (M13520)	17.4 Percentage of participants Interval 13.2 to 22.2	25.3 Percentage of participants Interval 20.4 to 30.6	—
Percentage of Participants With 4-fold Increase in hSBA Titers Relative to Baseline in Both MenB+MenACWY and MenB Groups After the First rMenB+OMV NZ Vaccination fHbp (M14459)	14.7 Percentage of participants Interval 10.8 to 19.3	21.0 Percentage of participants Interval 16.4 to 26.1	—

SECONDARY outcome

Timeframe: 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 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.

Outcome measures

Outcome measures
Measure	MenB+MenACWY Group n=273 Participants Participants received 1 dose of rMenB+OMV NZ vaccine administered concomitantly with 1 dose of MenACWY vaccine, as separate injections in each arm at Day 1, 1 dose of rMenB+OMV NZ vaccine at Day 61 and 1 dose of placebo at Day 91.	MenB Group n=266 Participants Participants received 1 dose of rMenB+OMV NZ vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day 1, 1 dose of rMenB+OMV NZ vaccine at Day 61 and 1 dose of MenACWY at Day 91.	MenACWY Group Participants received 1 dose of MenACWY vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day1, 1 dose of rMenB+OMV NZ vaccine each administered at Day 61 and at Day 91.
Percentage of Participants With 4-fold Increase in hSBA Titers Relative to Baseline in Both MenB+MenACWY and MenB Groups After the Second rMenB+OMV NZ Vaccination fHbp (M14459)	57.1 Percentage of participants Interval 51.0 to 63.1	64.6 Percentage of participants Interval 58.5 to 70.4	—
Percentage of Participants With 4-fold Increase in hSBA Titers Relative to Baseline in Both MenB+MenACWY and MenB Groups After the Second rMenB+OMV NZ Vaccination NadA (96217)	96.0 Percentage of participants Interval 92.9 to 98.0	98.9 Percentage of participants Interval 96.7 to 99.8	—
Percentage of Participants With 4-fold Increase in hSBA Titers Relative to Baseline in Both MenB+MenACWY and MenB Groups After the Second rMenB+OMV NZ Vaccination PorA (NZ98/254)	51.5 Percentage of participants Interval 45.4 to 57.5	56.6 Percentage of participants Interval 50.4 to 62.7	—
Percentage of Participants With 4-fold Increase in hSBA Titers Relative to Baseline in Both MenB+MenACWY and MenB Groups After the Second rMenB+OMV NZ Vaccination NHBA (M13520)	55.1 Percentage of participants Interval 49.0 to 61.2	53.0 Percentage of participants Interval 46.8 to 59.1	—

SECONDARY outcome

Timeframe: 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 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.

Outcome measures

Outcome measures
Measure	MenB+MenACWY Group n=295 Participants Participants received 1 dose of rMenB+OMV NZ vaccine administered concomitantly with 1 dose of MenACWY vaccine, as separate injections in each arm at Day 1, 1 dose of rMenB+OMV NZ vaccine at Day 61 and 1 dose of placebo at Day 91.	MenB Group n=303 Participants Participants received 1 dose of rMenB+OMV NZ vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day 1, 1 dose of rMenB+OMV NZ vaccine at Day 61 and 1 dose of MenACWY at Day 91.	MenACWY Group Participants received 1 dose of MenACWY vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day1, 1 dose of rMenB+OMV NZ vaccine each administered at Day 61 and at Day 91.
Percentage of Participants With hSBA Titers >=LLOQ for Each of the Serogroup A, C, W and Y in Both MenB+MenACWY and MenACWY Groups After MenACWY Vaccination Men Y, Baseline (Day 1)	23.4 Percentage of participants Interval 18.6 to 28.7	23.0 Percentage of participants Interval 18.3 to 28.2	—
Percentage of Participants With hSBA Titers >=LLOQ for Each of the Serogroup A, C, W and Y in Both MenB+MenACWY and MenACWY Groups After MenACWY Vaccination Men Y, Day 31	99.7 Percentage of participants Interval 98.1 to 100.0	99.7 Percentage of participants Interval 98.2 to 100.0	—
Percentage of Participants With hSBA Titers >=LLOQ for Each of the Serogroup A, C, W and Y in Both MenB+MenACWY and MenACWY Groups After MenACWY Vaccination Men A, Baseline (Day 1)	28.1 Percentage of participants Interval 22.8 to 33.9	30.0 Percentage of participants Interval 24.7 to 35.9	—
Percentage of Participants With hSBA Titers >=LLOQ for Each of the Serogroup A, C, W and Y in Both MenB+MenACWY and MenACWY Groups After MenACWY Vaccination Men A, Day 31	99.7 Percentage of participants Interval 98.1 to 100.0	99.3 Percentage of participants Interval 97.5 to 99.9	—
Percentage of Participants With hSBA Titers >=LLOQ for Each of the Serogroup A, C, W and Y in Both MenB+MenACWY and MenACWY Groups After MenACWY Vaccination Men C, Baseline (Day 1)	46.3 Percentage of participants Interval 40.5 to 52.1	44.4 Percentage of participants Interval 38.7 to 50.3	—
Percentage of Participants With hSBA Titers >=LLOQ for Each of the Serogroup A, C, W and Y in Both MenB+MenACWY and MenACWY Groups After MenACWY Vaccination Men C, Day 31	99.0 Percentage of participants Interval 97.1 to 99.8	98.7 Percentage of participants Interval 96.6 to 99.6	—
Percentage of Participants With hSBA Titers >=LLOQ for Each of the Serogroup A, C, W and Y in Both MenB+MenACWY and MenACWY Groups After MenACWY Vaccination Men W, Baseline (Day 1)	27.4 Percentage of participants Interval 22.4 to 32.9	28.4 Percentage of participants Interval 23.3 to 34.0	—
Percentage of Participants With hSBA Titers >=LLOQ for Each of the Serogroup A, C, W and Y in Both MenB+MenACWY and MenACWY Groups After MenACWY Vaccination Men W, Day 31	100 Percentage of participants Interval 98.8 to 100.0	100 Percentage of participants Interval 98.8 to 100.0	—

SECONDARY outcome

Timeframe: 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 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.

Outcome measures

Outcome measures
Measure	MenB+MenACWY Group n=295 Participants Participants received 1 dose of rMenB+OMV NZ vaccine administered concomitantly with 1 dose of MenACWY vaccine, as separate injections in each arm at Day 1, 1 dose of rMenB+OMV NZ vaccine at Day 61 and 1 dose of placebo at Day 91.	MenB Group n=303 Participants Participants received 1 dose of rMenB+OMV NZ vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day 1, 1 dose of rMenB+OMV NZ vaccine at Day 61 and 1 dose of MenACWY at Day 91.	MenACWY Group Participants received 1 dose of MenACWY vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day1, 1 dose of rMenB+OMV NZ vaccine each administered at Day 61 and at Day 91.
GMRs Against Each of the N. Meningitidis Serogroup Men A, Men C, Men W and Men Y in Both MenB+MenACWY and MenACWY Groups After MenACWY Vaccination Men A	150.2 Ratio Interval 120.1 to 187.8	145.0 Ratio Interval 115.4 to 182.2	—
GMRs Against Each of the N. Meningitidis Serogroup Men A, Men C, Men W and Men Y in Both MenB+MenACWY and MenACWY Groups After MenACWY Vaccination Men C	130.0 Ratio Interval 97.7 to 173.1	131.9 Ratio Interval 98.8 to 176.1	—
GMRs Against Each of the N. Meningitidis Serogroup Men A, Men C, Men W and Men Y in Both MenB+MenACWY and MenACWY Groups After MenACWY Vaccination Men W	294.2 Ratio Interval 229.0 to 378.1	279.3 Ratio Interval 216.6 to 360.1	—
GMRs Against Each of the N. Meningitidis Serogroup Men A, Men C, Men W and Men Y in Both MenB+MenACWY and MenACWY Groups After MenACWY Vaccination Men Y	324.3 Ratio Interval 252.2 to 417.0	300.0 Ratio Interval 232.9 to 386.4	—

SECONDARY outcome

Timeframe: 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 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

Outcome measures

Outcome measures
Measure	MenB+MenACWY Group n=293 Participants Participants received 1 dose of rMenB+OMV NZ vaccine administered concomitantly with 1 dose of MenACWY vaccine, as separate injections in each arm at Day 1, 1 dose of rMenB+OMV NZ vaccine at Day 61 and 1 dose of placebo at Day 91.	MenB Group n=296 Participants Participants received 1 dose of rMenB+OMV NZ vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day 1, 1 dose of rMenB+OMV NZ vaccine at Day 61 and 1 dose of MenACWY at Day 91.	MenACWY Group Participants received 1 dose of MenACWY vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day1, 1 dose of rMenB+OMV NZ vaccine each administered at Day 61 and at Day 91.
Percentage of Participants With 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup Men A, Men C, Men W and Men Y Relative to Baseline in Both MenB+MenACWY and MenACWY Groups After MenACWY Vaccination Men A	98.5 Percentage of participants Interval 96.1 to 99.6	98.1 Percentage of participants Interval 95.6 to 99.4	—
Percentage of Participants With 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup Men A, Men C, Men W and Men Y Relative to Baseline in Both MenB+MenACWY and MenACWY Groups After MenACWY Vaccination Men C	95.2 Percentage of participants Interval 92.1 to 97.4	95.6 Percentage of participants Interval 92.6 to 97.6	—
Percentage of Participants With 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup Men A, Men C, Men W and Men Y Relative to Baseline in Both MenB+MenACWY and MenACWY Groups After MenACWY Vaccination Men W	98.6 Percentage of participants Interval 96.5 to 99.6	97.9 Percentage of participants Interval 95.6 to 99.2	—
Percentage of Participants With 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup Men A, Men C, Men W and Men Y Relative to Baseline in Both MenB+MenACWY and MenACWY Groups After MenACWY Vaccination Men Y	98.6 Percentage of participants Interval 96.5 to 99.6	98.3 Percentage of participants Interval 96.1 to 99.4	—

Adverse Events

MenB+MenACWY Group

Serious events: 2 serious events

Other events: 293 other events

Deaths: 0 deaths

MenB Group

Serious events: 4 serious events

Other events: 293 other events

Deaths: 0 deaths

MenACWY Group

Serious events: 7 serious events

Other events: 289 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	MenB+MenACWY Group n=310 participants at risk Participants received 1 dose of rMenB+OMV NZ vaccine administered concomitantly with 1 dose of MenACWY vaccine, as separate injections in each arm at Day 1, 1 dose of rMenB+OMV NZ vaccine at Day 61 and 1 dose of placebo at Day 91.	MenB Group n=308 participants at risk Participants received 1 dose of rMenB+OMV NZ vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day 1, 1 dose of rMenB+OMV NZ vaccine at Day 61 and 1 dose of MenACWY at Day 91.	MenACWY Group n=320 participants at risk Participants received 1 dose of MenACWY vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day1, 1 dose of rMenB+OMV NZ vaccine each administered at Day 61 and at Day 91.
Infections and infestations Appendicitis	0.00% 0/310 • Solicited AEs: collected during the 7-day follow-up after each vaccination Unsolicited AEs: collected during the 30-day follow-up after each vaccination All-cause mortality, SAEs, MAAEs, AEs leading to withdrawal, and AESIs: - For participants not reaching Day 271 by Protocol Amendment 7: from the first vaccination (Day 1) to Day 271 - For participants past Day 271 by the amendment: from the first vaccination (Day 1) to Day 451	0.32% 1/308 • Number of events 1 • Solicited AEs: collected during the 7-day follow-up after each vaccination Unsolicited AEs: collected during the 30-day follow-up after each vaccination All-cause mortality, SAEs, MAAEs, AEs leading to withdrawal, and AESIs: - For participants not reaching Day 271 by Protocol Amendment 7: from the first vaccination (Day 1) to Day 271 - For participants past Day 271 by the amendment: from the first vaccination (Day 1) to Day 451	0.00% 0/320 • Solicited AEs: collected during the 7-day follow-up after each vaccination Unsolicited AEs: collected during the 30-day follow-up after each vaccination All-cause mortality, SAEs, MAAEs, AEs leading to withdrawal, and AESIs: - For participants not reaching Day 271 by Protocol Amendment 7: from the first vaccination (Day 1) to Day 271 - For participants past Day 271 by the amendment: from the first vaccination (Day 1) to Day 451
Injury, poisoning and procedural complications Fibula fracture	0.00% 0/310 • Solicited AEs: collected during the 7-day follow-up after each vaccination Unsolicited AEs: collected during the 30-day follow-up after each vaccination All-cause mortality, SAEs, MAAEs, AEs leading to withdrawal, and AESIs: - For participants not reaching Day 271 by Protocol Amendment 7: from the first vaccination (Day 1) to Day 271 - For participants past Day 271 by the amendment: from the first vaccination (Day 1) to Day 451	0.00% 0/308 • Solicited AEs: collected during the 7-day follow-up after each vaccination Unsolicited AEs: collected during the 30-day follow-up after each vaccination All-cause mortality, SAEs, MAAEs, AEs leading to withdrawal, and AESIs: - For participants not reaching Day 271 by Protocol Amendment 7: from the first vaccination (Day 1) to Day 271 - For participants past Day 271 by the amendment: from the first vaccination (Day 1) to Day 451	0.31% 1/320 • Number of events 1 • Solicited AEs: collected during the 7-day follow-up after each vaccination Unsolicited AEs: collected during the 30-day follow-up after each vaccination All-cause mortality, SAEs, MAAEs, AEs leading to withdrawal, and AESIs: - For participants not reaching Day 271 by Protocol Amendment 7: from the first vaccination (Day 1) to Day 271 - For participants past Day 271 by the amendment: from the first vaccination (Day 1) to Day 451
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.32% 1/310 • Number of events 1 • Solicited AEs: collected during the 7-day follow-up after each vaccination Unsolicited AEs: collected during the 30-day follow-up after each vaccination All-cause mortality, SAEs, MAAEs, AEs leading to withdrawal, and AESIs: - For participants not reaching Day 271 by Protocol Amendment 7: from the first vaccination (Day 1) to Day 271 - For participants past Day 271 by the amendment: from the first vaccination (Day 1) to Day 451	0.00% 0/308 • Solicited AEs: collected during the 7-day follow-up after each vaccination Unsolicited AEs: collected during the 30-day follow-up after each vaccination All-cause mortality, SAEs, MAAEs, AEs leading to withdrawal, and AESIs: - For participants not reaching Day 271 by Protocol Amendment 7: from the first vaccination (Day 1) to Day 271 - For participants past Day 271 by the amendment: from the first vaccination (Day 1) to Day 451	0.00% 0/320 • Solicited AEs: collected during the 7-day follow-up after each vaccination Unsolicited AEs: collected during the 30-day follow-up after each vaccination All-cause mortality, SAEs, MAAEs, AEs leading to withdrawal, and AESIs: - For participants not reaching Day 271 by Protocol Amendment 7: from the first vaccination (Day 1) to Day 271 - For participants past Day 271 by the amendment: from the first vaccination (Day 1) to Day 451
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/310 • Solicited AEs: collected during the 7-day follow-up after each vaccination Unsolicited AEs: collected during the 30-day follow-up after each vaccination All-cause mortality, SAEs, MAAEs, AEs leading to withdrawal, and AESIs: - For participants not reaching Day 271 by Protocol Amendment 7: from the first vaccination (Day 1) to Day 271 - For participants past Day 271 by the amendment: from the first vaccination (Day 1) to Day 451	0.32% 1/308 • Number of events 1 • Solicited AEs: collected during the 7-day follow-up after each vaccination Unsolicited AEs: collected during the 30-day follow-up after each vaccination All-cause mortality, SAEs, MAAEs, AEs leading to withdrawal, and AESIs: - For participants not reaching Day 271 by Protocol Amendment 7: from the first vaccination (Day 1) to Day 271 - For participants past Day 271 by the amendment: from the first vaccination (Day 1) to Day 451	0.00% 0/320 • Solicited AEs: collected during the 7-day follow-up after each vaccination Unsolicited AEs: collected during the 30-day follow-up after each vaccination All-cause mortality, SAEs, MAAEs, AEs leading to withdrawal, and AESIs: - For participants not reaching Day 271 by Protocol Amendment 7: from the first vaccination (Day 1) to Day 271 - For participants past Day 271 by the amendment: from the first vaccination (Day 1) to Day 451
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/310 • Solicited AEs: collected during the 7-day follow-up after each vaccination Unsolicited AEs: collected during the 30-day follow-up after each vaccination All-cause mortality, SAEs, MAAEs, AEs leading to withdrawal, and AESIs: - For participants not reaching Day 271 by Protocol Amendment 7: from the first vaccination (Day 1) to Day 271 - For participants past Day 271 by the amendment: from the first vaccination (Day 1) to Day 451	0.00% 0/308 • Solicited AEs: collected during the 7-day follow-up after each vaccination Unsolicited AEs: collected during the 30-day follow-up after each vaccination All-cause mortality, SAEs, MAAEs, AEs leading to withdrawal, and AESIs: - For participants not reaching Day 271 by Protocol Amendment 7: from the first vaccination (Day 1) to Day 271 - For participants past Day 271 by the amendment: from the first vaccination (Day 1) to Day 451	0.31% 1/320 • Number of events 1 • Solicited AEs: collected during the 7-day follow-up after each vaccination Unsolicited AEs: collected during the 30-day follow-up after each vaccination All-cause mortality, SAEs, MAAEs, AEs leading to withdrawal, and AESIs: - For participants not reaching Day 271 by Protocol Amendment 7: from the first vaccination (Day 1) to Day 271 - For participants past Day 271 by the amendment: from the first vaccination (Day 1) to Day 451
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.00% 0/310 • Solicited AEs: collected during the 7-day follow-up after each vaccination Unsolicited AEs: collected during the 30-day follow-up after each vaccination All-cause mortality, SAEs, MAAEs, AEs leading to withdrawal, and AESIs: - For participants not reaching Day 271 by Protocol Amendment 7: from the first vaccination (Day 1) to Day 271 - For participants past Day 271 by the amendment: from the first vaccination (Day 1) to Day 451	0.00% 0/308 • Solicited AEs: collected during the 7-day follow-up after each vaccination Unsolicited AEs: collected during the 30-day follow-up after each vaccination All-cause mortality, SAEs, MAAEs, AEs leading to withdrawal, and AESIs: - For participants not reaching Day 271 by Protocol Amendment 7: from the first vaccination (Day 1) to Day 271 - For participants past Day 271 by the amendment: from the first vaccination (Day 1) to Day 451	0.31% 1/320 • Number of events 1 • Solicited AEs: collected during the 7-day follow-up after each vaccination Unsolicited AEs: collected during the 30-day follow-up after each vaccination All-cause mortality, SAEs, MAAEs, AEs leading to withdrawal, and AESIs: - For participants not reaching Day 271 by Protocol Amendment 7: from the first vaccination (Day 1) to Day 271 - For participants past Day 271 by the amendment: from the first vaccination (Day 1) to Day 451
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.00% 0/310 • Solicited AEs: collected during the 7-day follow-up after each vaccination Unsolicited AEs: collected during the 30-day follow-up after each vaccination All-cause mortality, SAEs, MAAEs, AEs leading to withdrawal, and AESIs: - For participants not reaching Day 271 by Protocol Amendment 7: from the first vaccination (Day 1) to Day 271 - For participants past Day 271 by the amendment: from the first vaccination (Day 1) to Day 451	0.00% 0/308 • Solicited AEs: collected during the 7-day follow-up after each vaccination Unsolicited AEs: collected during the 30-day follow-up after each vaccination All-cause mortality, SAEs, MAAEs, AEs leading to withdrawal, and AESIs: - For participants not reaching Day 271 by Protocol Amendment 7: from the first vaccination (Day 1) to Day 271 - For participants past Day 271 by the amendment: from the first vaccination (Day 1) to Day 451	0.31% 1/320 • Number of events 1 • Solicited AEs: collected during the 7-day follow-up after each vaccination Unsolicited AEs: collected during the 30-day follow-up after each vaccination All-cause mortality, SAEs, MAAEs, AEs leading to withdrawal, and AESIs: - For participants not reaching Day 271 by Protocol Amendment 7: from the first vaccination (Day 1) to Day 271 - For participants past Day 271 by the amendment: from the first vaccination (Day 1) to Day 451
Psychiatric disorders Adjustment disorder with depressed mood	0.00% 0/310 • Solicited AEs: collected during the 7-day follow-up after each vaccination Unsolicited AEs: collected during the 30-day follow-up after each vaccination All-cause mortality, SAEs, MAAEs, AEs leading to withdrawal, and AESIs: - For participants not reaching Day 271 by Protocol Amendment 7: from the first vaccination (Day 1) to Day 271 - For participants past Day 271 by the amendment: from the first vaccination (Day 1) to Day 451	0.00% 0/308 • Solicited AEs: collected during the 7-day follow-up after each vaccination Unsolicited AEs: collected during the 30-day follow-up after each vaccination All-cause mortality, SAEs, MAAEs, AEs leading to withdrawal, and AESIs: - For participants not reaching Day 271 by Protocol Amendment 7: from the first vaccination (Day 1) to Day 271 - For participants past Day 271 by the amendment: from the first vaccination (Day 1) to Day 451	0.31% 1/320 • Number of events 1 • Solicited AEs: collected during the 7-day follow-up after each vaccination Unsolicited AEs: collected during the 30-day follow-up after each vaccination All-cause mortality, SAEs, MAAEs, AEs leading to withdrawal, and AESIs: - For participants not reaching Day 271 by Protocol Amendment 7: from the first vaccination (Day 1) to Day 271 - For participants past Day 271 by the amendment: from the first vaccination (Day 1) to Day 451
Psychiatric disorders Depression	0.32% 1/310 • Number of events 1 • Solicited AEs: collected during the 7-day follow-up after each vaccination Unsolicited AEs: collected during the 30-day follow-up after each vaccination All-cause mortality, SAEs, MAAEs, AEs leading to withdrawal, and AESIs: - For participants not reaching Day 271 by Protocol Amendment 7: from the first vaccination (Day 1) to Day 271 - For participants past Day 271 by the amendment: from the first vaccination (Day 1) to Day 451	0.00% 0/308 • Solicited AEs: collected during the 7-day follow-up after each vaccination Unsolicited AEs: collected during the 30-day follow-up after each vaccination All-cause mortality, SAEs, MAAEs, AEs leading to withdrawal, and AESIs: - For participants not reaching Day 271 by Protocol Amendment 7: from the first vaccination (Day 1) to Day 271 - For participants past Day 271 by the amendment: from the first vaccination (Day 1) to Day 451	0.00% 0/320 • Solicited AEs: collected during the 7-day follow-up after each vaccination Unsolicited AEs: collected during the 30-day follow-up after each vaccination All-cause mortality, SAEs, MAAEs, AEs leading to withdrawal, and AESIs: - For participants not reaching Day 271 by Protocol Amendment 7: from the first vaccination (Day 1) to Day 271 - For participants past Day 271 by the amendment: from the first vaccination (Day 1) to Day 451
Psychiatric disorders Drug abuse	0.00% 0/310 • Solicited AEs: collected during the 7-day follow-up after each vaccination Unsolicited AEs: collected during the 30-day follow-up after each vaccination All-cause mortality, SAEs, MAAEs, AEs leading to withdrawal, and AESIs: - For participants not reaching Day 271 by Protocol Amendment 7: from the first vaccination (Day 1) to Day 271 - For participants past Day 271 by the amendment: from the first vaccination (Day 1) to Day 451	0.00% 0/308 • Solicited AEs: collected during the 7-day follow-up after each vaccination Unsolicited AEs: collected during the 30-day follow-up after each vaccination All-cause mortality, SAEs, MAAEs, AEs leading to withdrawal, and AESIs: - For participants not reaching Day 271 by Protocol Amendment 7: from the first vaccination (Day 1) to Day 271 - For participants past Day 271 by the amendment: from the first vaccination (Day 1) to Day 451	0.31% 1/320 • Number of events 1 • Solicited AEs: collected during the 7-day follow-up after each vaccination Unsolicited AEs: collected during the 30-day follow-up after each vaccination All-cause mortality, SAEs, MAAEs, AEs leading to withdrawal, and AESIs: - For participants not reaching Day 271 by Protocol Amendment 7: from the first vaccination (Day 1) to Day 271 - For participants past Day 271 by the amendment: from the first vaccination (Day 1) to Day 451
Psychiatric disorders Major depression	0.00% 0/310 • Solicited AEs: collected during the 7-day follow-up after each vaccination Unsolicited AEs: collected during the 30-day follow-up after each vaccination All-cause mortality, SAEs, MAAEs, AEs leading to withdrawal, and AESIs: - For participants not reaching Day 271 by Protocol Amendment 7: from the first vaccination (Day 1) to Day 271 - For participants past Day 271 by the amendment: from the first vaccination (Day 1) to Day 451	0.00% 0/308 • Solicited AEs: collected during the 7-day follow-up after each vaccination Unsolicited AEs: collected during the 30-day follow-up after each vaccination All-cause mortality, SAEs, MAAEs, AEs leading to withdrawal, and AESIs: - For participants not reaching Day 271 by Protocol Amendment 7: from the first vaccination (Day 1) to Day 271 - For participants past Day 271 by the amendment: from the first vaccination (Day 1) to Day 451	0.31% 1/320 • Number of events 1 • Solicited AEs: collected during the 7-day follow-up after each vaccination Unsolicited AEs: collected during the 30-day follow-up after each vaccination All-cause mortality, SAEs, MAAEs, AEs leading to withdrawal, and AESIs: - For participants not reaching Day 271 by Protocol Amendment 7: from the first vaccination (Day 1) to Day 271 - For participants past Day 271 by the amendment: from the first vaccination (Day 1) to Day 451
Psychiatric disorders Suicidal ideation	0.00% 0/310 • Solicited AEs: collected during the 7-day follow-up after each vaccination Unsolicited AEs: collected during the 30-day follow-up after each vaccination All-cause mortality, SAEs, MAAEs, AEs leading to withdrawal, and AESIs: - For participants not reaching Day 271 by Protocol Amendment 7: from the first vaccination (Day 1) to Day 271 - For participants past Day 271 by the amendment: from the first vaccination (Day 1) to Day 451	0.65% 2/308 • Number of events 2 • Solicited AEs: collected during the 7-day follow-up after each vaccination Unsolicited AEs: collected during the 30-day follow-up after each vaccination All-cause mortality, SAEs, MAAEs, AEs leading to withdrawal, and AESIs: - For participants not reaching Day 271 by Protocol Amendment 7: from the first vaccination (Day 1) to Day 271 - For participants past Day 271 by the amendment: from the first vaccination (Day 1) to Day 451	0.00% 0/320 • Solicited AEs: collected during the 7-day follow-up after each vaccination Unsolicited AEs: collected during the 30-day follow-up after each vaccination All-cause mortality, SAEs, MAAEs, AEs leading to withdrawal, and AESIs: - For participants not reaching Day 271 by Protocol Amendment 7: from the first vaccination (Day 1) to Day 271 - For participants past Day 271 by the amendment: from the first vaccination (Day 1) to Day 451

Other adverse events

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER