Trial Outcomes & Findings for Novartis Vaccine and Diagnostics Carriage Trial (NCT NCT01214850)

NCT ID: NCT01214850

Last Updated: 2016-04-21

Results Overview

Percentages of subjects with carriage of virulent sequence types (ST) of Neisseria meningitidis group B, one month after completion of rMenB+OMV NZ vaccination. The carriage rate of virulent sequence types (ST) of N. meningitidis group B (genogroupable) in subjects, one month after receiving two doses of rMenB+OMV NZ, as compared to the control group, was reported. Virulent ST types are defined as Clonal Complex multi locus sequence typing (MLST) or ST type being the same compared to history data (Clonal Complexes MLST or ST types found to be virulent and causing diseases) from the years 2006 to 2010.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 2968 participants
• Primary outcome timeframe: 61 days (31 days after receiving the second injection)
• Results posted on: 2016-04-21

Participant Flow

Subjects were enrolled from 10 sites in United Kingdom

Total 2968 subjects were enrolled of which 14 subjects were not randomized and were therefore removed from the study (2 subjects withdrew consent and 11 subjects were withdrawn due to inappropriate enrollment and 1 withdrawn due to protocol violation).

Participant milestones

Measure	rMenB+OMV Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart	MenACWY Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart	Control Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
Overall Study STARTED	979	988	987
Overall Study COMPLETED	796	844	826
Overall Study NOT COMPLETED	183	144	161

Reasons for withdrawal

Measure	rMenB+OMV Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart	MenACWY Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart	Control Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
Overall Study Withdrawal by Subject	38	31	28
Overall Study Lost to Follow-up	124	98	123
Overall Study Protocol Violation	5	5	6
Overall Study Adverse event or death	11	8	3
Overall Study Inappropriate enrollment	2	1	0
Overall Study Administrative reason	1	0	0
Overall Study Unable to classify	2	1	1

Baseline Characteristics

Novartis Vaccine and Diagnostics Carriage Trial

Baseline characteristics by cohort

Measure	rMenB+OMV n=979 Participants Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart	MenACWY n=988 Participants Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart	Control n=987 Participants Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart	Total n=2954 Participants Total of all reporting groups
Age, Continuous	19.9 years STANDARD_DEVIATION 1.6 • n=5 Participants	19.9 years STANDARD_DEVIATION 1.6 • n=7 Participants	19.8 years STANDARD_DEVIATION 1.6 • n=5 Participants	19.9 years STANDARD_DEVIATION 1.6 • n=4 Participants
Sex: Female, Male Female	516 Participants n=5 Participants	533 Participants n=7 Participants	547 Participants n=5 Participants	1596 Participants n=4 Participants
Sex: Female, Male Male	463 Participants n=5 Participants	455 Participants n=7 Participants	440 Participants n=5 Participants	1358 Participants n=4 Participants

PRIMARY outcome

Timeframe: 61 days (31 days after receiving the second injection)

Population: Analysis was done on the modified-intention to treat (MITT) dataset (Pharyngeal carriage), i.e subjects who actually received a study vaccination and provided at least one evaluable swab sample at baseline and after vaccination.

Percentages of subjects with carriage of virulent sequence types (ST) of Neisseria meningitidis group B, one month after completion of rMenB+OMV NZ vaccination. The carriage rate of virulent sequence types (ST) of N. meningitidis group B (genogroupable) in subjects, one month after receiving two doses of rMenB+OMV NZ, as compared to the control group, was reported.

Virulent ST types are defined as Clonal Complex multi locus sequence typing (MLST) or ST type being the same compared to history data (Clonal Complexes MLST or ST types found to be virulent and causing diseases) from the years 2006 to 2010.

Outcome measures

Measure	rMenB+OMV n=974 Participants Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart	Control n=984 Participants Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart	Control Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
Percentages of Subjects With Carriage of Virulent Sequence Types (ST) of Neisseria Meningitidis Group B, One Month After Completion of rMenB+OMV NZ Vaccination Baseline	8 Percentages of subjects Interval 6.0 to 10.0	7 Percentages of subjects Interval 6.0 to 9.0	—
Percentages of Subjects With Carriage of Virulent Sequence Types (ST) of Neisseria Meningitidis Group B, One Month After Completion of rMenB+OMV NZ Vaccination Month 2 (N= 916, 928)	9 Percentages of subjects Interval 8.0 to 12.0	8 Percentages of subjects Interval 6.0 to 10.0	—

PRIMARY outcome

Timeframe: 31 days after MenACWY-CRM injection

Population: Analysis was done on the MITT dataset (Pharyngeal carriage)

The percentage of subjects with combined carriage rate of N. meningitidis serogroups A, C, W and Y in subjects, one month after receiving a single dose of MenACWY-CRM conjugate vaccine as compared to the control group is reported.

Outcome measures

Measure	rMenB+OMV n=981 Participants Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart	Control n=984 Participants Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart	Control Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
Percentages of Subjects With Combined Carriage of N. Meningitidis Serogroups A, C, W and Y, One Month After MenACWY-CRM Vaccination Baseline	6 Percentages of subjects Interval 5.0 to 8.0	5 Percentages of subjects Interval 4.0 to 7.0	—
Percentages of Subjects With Combined Carriage of N. Meningitidis Serogroups A, C, W and Y, One Month After MenACWY-CRM Vaccination Month 1 (N=956, 947)	6 Percentages of subjects Interval 5.0 to 8.0	6 Percentages of subjects Interval 5.0 to 8.0	—

SECONDARY outcome

Timeframe: Up to 361 days after vaccination

Population: Analysis was done on the MITT dataset (Pharyngeal carriage)

The percentage of subjects with carriage of all (virulent + non-virulent) ST types of N. meningitidis B (genogroupable) in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ conjugate vaccine as compared to the control group is reported.

Outcome measures

Measure	rMenB+OMV n=974 Participants Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart	Control n=984 Participants Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart	Control Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
Percentages of Subjects With Carriage of All ST Types of N. Meningitidis B (Genogroupable) at Different Time Points Following rMenB+OMV NZ Vaccination Baseline	9 Percentages of subjects Interval 8.0 to 11.0	9 Percentages of subjects Interval 7.0 to 11.0	—
Percentages of Subjects With Carriage of All ST Types of N. Meningitidis B (Genogroupable) at Different Time Points Following rMenB+OMV NZ Vaccination 1 month post 1st vaccination (Day 31) N=931, 947	9 Percentages of subjects Interval 7.0 to 11.0	9 Percentages of subjects Interval 7.0 to 11.0	—
Percentages of Subjects With Carriage of All ST Types of N. Meningitidis B (Genogroupable) at Different Time Points Following rMenB+OMV NZ Vaccination 1 month post 2nd vaccination (Day 61) N=916, 928	11 Percentages of subjects Interval 9.0 to 13.0	10 Percentages of subjects Interval 8.0 to 12.0	—
Percentages of Subjects With Carriage of All ST Types of N. Meningitidis B (Genogroupable) at Different Time Points Following rMenB+OMV NZ Vaccination 3 months post 2nd vaccination (Day 121) N=860, 885	10 Percentages of subjects Interval 8.0 to 12.0	10 Percentages of subjects Interval 8.0 to 12.0	—
Percentages of Subjects With Carriage of All ST Types of N. Meningitidis B (Genogroupable) at Different Time Points Following rMenB+OMV NZ Vaccination 5 months post 2nd vaccination (Day 181) N=832, 864	9 Percentages of subjects Interval 8.0 to 12.0	10 Percentages of subjects Interval 8.0 to 12.0	—
Percentages of Subjects With Carriage of All ST Types of N. Meningitidis B (Genogroupable) at Different Time Points Following rMenB+OMV NZ Vaccination 11 months post 2nd vaccination (Day 361) N=797,827	8 Percentages of subjects Interval 6.0 to 10.0	10 Percentages of subjects Interval 8.0 to 12.0	—

SECONDARY outcome

Timeframe: Up to 361 days after vaccination

Population: Analysis was done on the MITT dataset (Pharyngeal carriage)

Percentage of subjects with carriage of virulent ST types of N. meningitidis group B (genogroupable) in subjects at different time points of the study point after administration of two doses of rMenB+OMV NZ conjugate vaccine as compared to the control group is reported.

Outcome measures

Measure	rMenB+OMV n=974 Participants Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart	Control n=984 Participants Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart	Control Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
Percentages of Subjects With Carriage of Virulent ST Types of N. Meningitidis Group B at Any Time Point After rMenB+OMV NZ Vaccination Baseline	8 Percentages of subjects Interval 6.0 to 10.0	7 Percentages of subjects Interval 6.0 to 9.0	—
Percentages of Subjects With Carriage of Virulent ST Types of N. Meningitidis Group B at Any Time Point After rMenB+OMV NZ Vaccination 1 month post 1st vaccination (Day 31) N=931,947	8 Percentages of subjects Interval 6.0 to 10.0	8 Percentages of subjects Interval 6.0 to 10.0	—
Percentages of Subjects With Carriage of Virulent ST Types of N. Meningitidis Group B at Any Time Point After rMenB+OMV NZ Vaccination 1 month post 2nd vaccination (Day 61) N=916, 928	9 Percentages of subjects Interval 8.0 to 12.0	8 Percentages of subjects Interval 6.0 to 10.0	—
Percentages of Subjects With Carriage of Virulent ST Types of N. Meningitidis Group B at Any Time Point After rMenB+OMV NZ Vaccination 3 months post 2nd vaccination (Day 121) N=860, 885	9 Percentages of subjects Interval 7.0 to 11.0	9 Percentages of subjects Interval 8.0 to 11.0	—
Percentages of Subjects With Carriage of Virulent ST Types of N. Meningitidis Group B at Any Time Point After rMenB+OMV NZ Vaccination 5 months post 2nd vaccination (Day 181) N=832,864	9 Percentages of subjects Interval 7.0 to 11.0	9 Percentages of subjects Interval 7.0 to 11.0	—
Percentages of Subjects With Carriage of Virulent ST Types of N. Meningitidis Group B at Any Time Point After rMenB+OMV NZ Vaccination 11 months post 2nd vaccination (Day 361) N=797,827	8 Percentages of subjects Interval 6.0 to 10.0	9 Percentages of subjects Interval 7.0 to 11.0	—

SECONDARY outcome

Timeframe: Up to 361 days after vaccination

Population: Analysis was done on the MITT dataset (Pharyngeal carriage)

Percentage of subjects with carriage of nonvirulent ST types of N. meningitidis group B (genogroupable) in subjects at different time points of the study point after administration of two doses of rMenB+OMV NZ conjugate vaccine as compared to the control group is reported.

Outcome measures

Measure	rMenB+OMV n=974 Participants Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart	Control n=984 Participants Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart	Control Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
Percentages of Subjects With Carriage of Nonvirulent ST Types of N. Meningitidis Group B at Any Time Point After rMenB+OMV NZ Vaccination Baseline	1 Percentages of subjects Interval 1.0 to 2.0	1 Percentages of subjects Interval 1.0 to 2.0	—
Percentages of Subjects With Carriage of Nonvirulent ST Types of N. Meningitidis Group B at Any Time Point After rMenB+OMV NZ Vaccination 1 month post 1st vaccination (N=931,947)	1 Percentages of subjects Interval 0.0 to 2.0	1 Percentages of subjects Interval 0.0 to 2.0	—
Percentages of Subjects With Carriage of Nonvirulent ST Types of N. Meningitidis Group B at Any Time Point After rMenB+OMV NZ Vaccination 1 month post 2nd vaccination (N=916,928)	1 Percentages of subjects Interval 1.0 to 2.0	2 Percentages of subjects Interval 1.0 to 3.0	—
Percentages of Subjects With Carriage of Nonvirulent ST Types of N. Meningitidis Group B at Any Time Point After rMenB+OMV NZ Vaccination 3 months post 2nd vaccination (N=860,885)	1 Percentages of subjects Interval 0.0 to 2.0	1 Percentages of subjects Interval 0.0 to 2.0	—
Percentages of Subjects With Carriage of Nonvirulent ST Types of N. Meningitidis Group B at Any Time Point After rMenB+OMV NZ Vaccination 5 months post 2nd vaccination (N=832,864)	1 Percentages of subjects Interval 0.0 to 2.0	1 Percentages of subjects Interval 0.0 to 2.0	—
Percentages of Subjects With Carriage of Nonvirulent ST Types of N. Meningitidis Group B at Any Time Point After rMenB+OMV NZ Vaccination 11 months post 2nd vaccination (N=797,827)	1 Percentages of subjects Interval 0.0 to 1.0	1 Percentages of subjects Interval 0.0 to 2.0	—

SECONDARY outcome

Timeframe: Up to 361 days after vaccination

Population: Analysis was done on the MITT dataset (Pharyngeal carriage)

Percentage of subjects with carriage of all N.meningitidis strains combined in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ vaccine as compared to the control group is reported.

Outcome measures

Measure	rMenB+OMV n=974 Participants Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart	Control n=984 Participants Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart	Control Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
Percentages of Subjects With Carriage of All N.Meningitidis Strain at Different Time Points After rMenB+OMV NZ Vaccination Baseline	33 Percentages of subjects Interval 31.0 to 37.0	31 Percentages of subjects Interval 28.0 to 34.0	—
Percentages of Subjects With Carriage of All N.Meningitidis Strain at Different Time Points After rMenB+OMV NZ Vaccination 1 month post 1st vaccination (N=931, 947)	34 Percentages of subjects Interval 31.0 to 37.0	32 Percentages of subjects Interval 29.0 to 35.0	—
Percentages of Subjects With Carriage of All N.Meningitidis Strain at Different Time Points After rMenB+OMV NZ Vaccination 1 month post 2nd vaccination (N=916, 928)	38 Percentages of subjects Interval 35.0 to 41.0	36 Percentages of subjects Interval 33.0 to 40.0	—
Percentages of Subjects With Carriage of All N.Meningitidis Strain at Different Time Points After rMenB+OMV NZ Vaccination 3 months post 2nd vaccination (N=860, 885)	35 Percentages of subjects Interval 32.0 to 39.0	36 Percentages of subjects Interval 33.0 to 39.0	—
Percentages of Subjects With Carriage of All N.Meningitidis Strain at Different Time Points After rMenB+OMV NZ Vaccination 5 months post 2nd vaccination (N=832, 864)	34 Percentages of subjects Interval 30.0 to 37.0	36 Percentages of subjects Interval 33.0 to 40.0	—
Percentages of Subjects With Carriage of All N.Meningitidis Strain at Different Time Points After rMenB+OMV NZ Vaccination 11 months post 2nd vaccination (N=797, 827)	27 Percentages of subjects Interval 24.0 to 30.0	30 Percentages of subjects Interval 27.0 to 34.0	—

SECONDARY outcome

Timeframe: Up to 361 days after vaccination

Population: Analysis was done on the MITT dataset (Pharyngeal carriage)

Percentages of subjects with carriage of N.meningitidis ABCWY genogroups in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ vaccine as compared to the control group is reported.

Outcome measures

Measure	rMenB+OMV n=974 Participants Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart	Control n=984 Participants Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart	Control Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
Percentages of Subjects With Carriage of N.Meningitidis ABCWY Genogroups at Different Time Points After rMenB+OMV NZ Vaccination Baseline	19 Percentages of subjects Interval 17.0 to 22.0	17 Percentages of subjects Interval 15.0 to 19.0	—
Percentages of Subjects With Carriage of N.Meningitidis ABCWY Genogroups at Different Time Points After rMenB+OMV NZ Vaccination 1 month post 1st vaccination (N=931, 947)	19 Percentages of subjects Interval 17.0 to 22.0	19 Percentages of subjects Interval 16.0 to 21.0	—
Percentages of Subjects With Carriage of N.Meningitidis ABCWY Genogroups at Different Time Points After rMenB+OMV NZ Vaccination 1 month post 2nd vaccination (N=916, 928)	22 Percentages of subjects Interval 19.0 to 25.0	22 Percentages of subjects Interval 19.0 to 24.0	—
Percentages of Subjects With Carriage of N.Meningitidis ABCWY Genogroups at Different Time Points After rMenB+OMV NZ Vaccination 3 months post 2nd vaccination (N=860, 885)	20 Percentages of subjects Interval 17.0 to 23.0	22 Percentages of subjects Interval 19.0 to 25.0	—
Percentages of Subjects With Carriage of N.Meningitidis ABCWY Genogroups at Different Time Points After rMenB+OMV NZ Vaccination 5 months post 2nd vaccination (N=832, 864)	19 Percentages of subjects Interval 17.0 to 22.0	23 Percentages of subjects Interval 20.0 to 26.0	—
Percentages of Subjects With Carriage of N.Meningitidis ABCWY Genogroups at Different Time Points After rMenB+OMV NZ Vaccination 11 months post 2nd vaccination (N=797, 827)	15 Percentages of subjects Interval 12.0 to 17.0	18 Percentages of subjects Interval 15.0 to 20.0	—

SECONDARY outcome

Timeframe: Up to 361 days after vaccination

Population: Analysis was done on the MITT dataset (Pharyngeal carriage)

Percentages of subjects with carriage of N.meningitidis ACWY genogroups in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ vaccine as compared to the control group is reported

Outcome measures

Measure	rMenB+OMV n=974 Participants Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart	Control n=984 Participants Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart	Control Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
Percentages of Subjects With Carriage of N.Meningitidis ACWY Genogroups at Different Time Points After rMenB+OMV NZ Vaccination Baseline	10 Percentages of subjects Interval 8.0 to 12.0	8 Percentages of subjects Interval 7.0 to 10.0	—
Percentages of Subjects With Carriage of N.Meningitidis ACWY Genogroups at Different Time Points After rMenB+OMV NZ Vaccination 1 month post 1st vaccination (N=931, 947)	11 Percentages of subjects Interval 9.0 to 13.0	10 Percentages of subjects Interval 8.0 to 12.0	—
Percentages of Subjects With Carriage of N.Meningitidis ACWY Genogroups at Different Time Points After rMenB+OMV NZ Vaccination 1 month post 2nd vaccination (N=916, 928)	11 Percentages of subjects Interval 9.0 to 13.0	12 Percentages of subjects Interval 10.0 to 14.0	—
Percentages of Subjects With Carriage of N.Meningitidis ACWY Genogroups at Different Time Points After rMenB+OMV NZ Vaccination 3 months post 2nd vaccination (N=860, 885)	10 Percentages of subjects Interval 8.0 to 12.0	12 Percentages of subjects Interval 10.0 to 14.0	—
Percentages of Subjects With Carriage of N.Meningitidis ACWY Genogroups at Different Time Points After rMenB+OMV NZ Vaccination 5 months post 2nd vaccination (N=832, 864)	10 Percentages of subjects Interval 8.0 to 12.0	13 Percentages of subjects Interval 11.0 to 15.0	—
Percentages of Subjects With Carriage of N.Meningitidis ACWY Genogroups at Different Time Points After rMenB+OMV NZ Vaccination 11 months post 2nd vaccination (N=797, 827)	7 Percentages of subjects Interval 5.0 to 8.0	8 Percentages of subjects Interval 6.0 to 10.0	—

SECONDARY outcome

Timeframe: Up to 361 days after vaccination

Population: Analysis was done on the MITT dataset (Pharyngeal carriage)

Percentages of subjects with carriage of N.meningitidis serogroups A,C,W or Y in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ vaccine as compared to the control group is reported.

Outcome measures

Measure	rMenB+OMV n=974 Participants Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart	Control n=984 Participants Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart	Control Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
Percentages of Subjects With Carriage of N.Meningitidis Serogroups A,C,W or Y at Different Time Points After rMenB+OMV NZ Vaccination Baseline	7 Percentages of subjects Interval 6.0 to 9.0	5 Percentages of subjects Interval 4.0 to 7.0	—
Percentages of Subjects With Carriage of N.Meningitidis Serogroups A,C,W or Y at Different Time Points After rMenB+OMV NZ Vaccination 1 month post 1st vaccination (N=931, 947)	7 Percentages of subjects Interval 5.0 to 9.0	6 Percentages of subjects Interval 5.0 to 8.0	—
Percentages of Subjects With Carriage of N.Meningitidis Serogroups A,C,W or Y at Different Time Points After rMenB+OMV NZ Vaccination 1 month post 2nd vaccination (N=916, 928)	7 Percentages of subjects Interval 5.0 to 9.0	8 Percentages of subjects Interval 6.0 to 10.0	—
Percentages of Subjects With Carriage of N.Meningitidis Serogroups A,C,W or Y at Different Time Points After rMenB+OMV NZ Vaccination 3 months post 2nd vaccination (N=860, 885)	6 Percentages of subjects Interval 5.0 to 8.0	8 Percentages of subjects Interval 6.0 to 10.0	—
Percentages of Subjects With Carriage of N.Meningitidis Serogroups A,C,W or Y at Different Time Points After rMenB+OMV NZ Vaccination 5 months post 2nd vaccination (N=832, 864)	6 Percentages of subjects Interval 5.0 to 8.0	9 Percentages of subjects Interval 7.0 to 11.0	—
Percentages of Subjects With Carriage of N.Meningitidis Serogroups A,C,W or Y at Different Time Points After rMenB+OMV NZ Vaccination 11 months post 2nd vaccination (N=797, 827)	5 Percentages of subjects Interval 4.0 to 7.0	5 Percentages of subjects Interval 3.0 to 7.0	—

SECONDARY outcome

Timeframe: Up to 361 days after vaccination

Population: Analysis was done on the MIIT dataset (Pharyngeal carriage)

Percentages of subjects with carriage of N.meningitidis genogroup Y in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ vaccine as compared to the control group is reported.

Outcome measures

Measure	rMenB+OMV n=974 Participants Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart	Control n=984 Participants Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart	Control Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
Percentages of Subjects With Carriage of N.Meningitidis Genogroup Y at Different Time Points After rMenB+OMV NZ Vaccination Baseline	7 Percentages of subjects Interval 6.0 to 9.0	7 Percentages of subjects Interval 5.0 to 9.0	—
Percentages of Subjects With Carriage of N.Meningitidis Genogroup Y at Different Time Points After rMenB+OMV NZ Vaccination 1 month post 1st vaccination (N=931, 947)	9 Percentages of subjects Interval 7.0 to 11.0	8 Percentages of subjects Interval 7.0 to 10.0	—
Percentages of Subjects With Carriage of N.Meningitidis Genogroup Y at Different Time Points After rMenB+OMV NZ Vaccination 1 month post 2nd vaccination (N=916, 928)	9 Percentages of subjects Interval 7.0 to 11.0	10 Percentages of subjects Interval 9.0 to 13.0	—
Percentages of Subjects With Carriage of N.Meningitidis Genogroup Y at Different Time Points After rMenB+OMV NZ Vaccination 3 months post 2nd vaccination (N=860, 885)	8 Percentages of subjects Interval 6.0 to 10.0	10 Percentages of subjects Interval 8.0 to 12.0	—
Percentages of Subjects With Carriage of N.Meningitidis Genogroup Y at Different Time Points After rMenB+OMV NZ Vaccination 5 months post 2nd vaccination (N=832, 864)	8 Percentages of subjects Interval 7.0 to 10.0	10 Percentages of subjects Interval 8.0 to 13.0	—
Percentages of Subjects With Carriage of N.Meningitidis Genogroup Y at Different Time Points After rMenB+OMV NZ Vaccination 11 months post 2nd vaccination (N=797, 827)	5 Percentages of subjects Interval 4.0 to 7.0	6 Percentages of subjects Interval 5.0 to 8.0	—

SECONDARY outcome

Timeframe: Up to 361 days after vaccination

Population: Analysis was done on the MITT dataset (Pharyngeal carriage)

Percentages of subjects with carriage of N.meningitidis serogroup Y in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ vaccine as compared to the control group is reported.

Outcome measures

Measure	rMenB+OMV n=974 Participants Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart	Control n=984 Participants Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart	Control Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
Percentages of Subjects With Carriage of N.Meningitidis Serogroup Y at Different Time Points After rMenB+OMV NZ Vaccination Baseline	6 Percentages of subjects Interval 4.0 to 7.0	5 Percentages of subjects Interval 3.0 to 6.0	—
Percentages of Subjects With Carriage of N.Meningitidis Serogroup Y at Different Time Points After rMenB+OMV NZ Vaccination 1 month post 1st vaccination (N=931, 947)	6 Percentages of subjects Interval 4.0 to 8.0	5 Percentages of subjects Interval 4.0 to 7.0	—
Percentages of Subjects With Carriage of N.Meningitidis Serogroup Y at Different Time Points After rMenB+OMV NZ Vaccination 1 month post 2nd vaccination (N=916, 928)	5 Percentages of subjects Interval 4.0 to 7.0	7 Percentages of subjects Interval 6.0 to 9.0	—
Percentages of Subjects With Carriage of N.Meningitidis Serogroup Y at Different Time Points After rMenB+OMV NZ Vaccination 3 months post 2nd vaccination (N=860, 885)	5 Percentages of subjects Interval 4.0 to 7.0	7 Percentages of subjects Interval 5.0 to 9.0	—
Percentages of Subjects With Carriage of N.Meningitidis Serogroup Y at Different Time Points After rMenB+OMV NZ Vaccination 5 months post 2nd vaccination (N=832, 864)	6 Percentages of subjects Interval 4.0 to 8.0	7 Percentages of subjects Interval 6.0 to 9.0	—
Percentages of Subjects With Carriage of N.Meningitidis Serogroup Y at Different Time Points After rMenB+OMV NZ Vaccination 11 months post 2nd vaccination (N=797, 827)	4 Percentages of subjects Interval 3.0 to 6.0	4 Percentages of subjects Interval 3.0 to 6.0	—

SECONDARY outcome

Timeframe: Up to 361 days after vaccination

Population: Analysis was done on the MITT dataset (Pharyngeal carriage)

Percentages of subject with carriage of N. meningitidis genogroups ACWY in subjects at different time points of the study after administration of a single dose of MenACWY-CRM conjugate vaccine as compared to the control group is reported.

Outcome measures

Measure	rMenB+OMV n=981 Participants Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart	Control n=984 Participants Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart	Control Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
Percentages of Subject With Carriage of N. Meningitidis Genogroups ACWY at Different Time Points After MenACWY-CRM Vaccination Baseline	9 Percentages of subjects Interval 7.0 to 11.0	8 Percentages of subjects Interval 7.0 to 10.0	—
Percentages of Subject With Carriage of N. Meningitidis Genogroups ACWY at Different Time Points After MenACWY-CRM Vaccination 1 month post 1 dose (N=956, 947)	10 Percentages of subjects Interval 8.0 to 12.0	10 Percentages of subjects Interval 8.0 to 12.0	—
Percentages of Subject With Carriage of N. Meningitidis Genogroups ACWY at Different Time Points After MenACWY-CRM Vaccination 2 months post 1 dose (N=929, 928)	9 Percentages of subjects Interval 8.0 to 12.0	12 Percentages of subjects Interval 10.0 to 14.0	—
Percentages of Subject With Carriage of N. Meningitidis Genogroups ACWY at Different Time Points After MenACWY-CRM Vaccination 4 months post 1 dose (N=884, 885)	10 Percentages of subjects Interval 8.0 to 12.0	12 Percentages of subjects Interval 10.0 to 14.0	—
Percentages of Subject With Carriage of N. Meningitidis Genogroups ACWY at Different Time Points After MenACWY-CRM Vaccination 6 months post 1 dose (N=867, 864)	11 Percentages of subjects Interval 9.0 to 13.0	13 Percentages of subjects Interval 11.0 to 15.0	—
Percentages of Subject With Carriage of N. Meningitidis Genogroups ACWY at Different Time Points After MenACWY-CRM Vaccination 12 months post 1 dose (N=845, 827)	8 Percentages of subjects Interval 6.0 to 10.0	8 Percentages of subjects Interval 6.0 to 10.0	—

SECONDARY outcome

Timeframe: Up to 361 days after vaccination

Population: Analysis was done on the MITT dataset (Pharyngeal carriage)

Percentages of subjects with carriage of N. meningitidis serogroups ACWY in subjects at different time points of the study after administration of a single dose of MenACWY-CRM conjugate vaccine as compared to the control group is reported.

Outcome measures

Measure	rMenB+OMV n=981 Participants Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart	Control n=984 Participants Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart	Control Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
Percentages of Subjects With Carriage of N. Meningitidis Serogroups ACWY at Different Time Points After MenACWY-CRM Vaccination Baseline (Day 1)	6 Percentages of subjects Interval 5.0 to 8.0	5 Percentages of subjects Interval 4.0 to 7.0	—
Percentages of Subjects With Carriage of N. Meningitidis Serogroups ACWY at Different Time Points After MenACWY-CRM Vaccination 1 month post 1 dose (N=956, 947)	6 Percentages of subjects Interval 5.0 to 8.0	6 Percentages of subjects Interval 5.0 to 8.0	—
Percentages of Subjects With Carriage of N. Meningitidis Serogroups ACWY at Different Time Points After MenACWY-CRM Vaccination 2 months post 1 dose (N=929, 928)	5 Percentages of subjects Interval 4.0 to 7.0	8 Percentages of subjects Interval 6.0 to 10.0	—
Percentages of Subjects With Carriage of N. Meningitidis Serogroups ACWY at Different Time Points After MenACWY-CRM Vaccination 4 months post 1 dose (N=884, 885)	6 Percentages of subjects Interval 5.0 to 8.0	8 Percentages of subjects Interval 6.0 to 10.0	—
Percentages of Subjects With Carriage of N. Meningitidis Serogroups ACWY at Different Time Points After MenACWY-CRM Vaccination 6 months post 1 dose (N=867, 864)	6 Percentages of subjects Interval 5.0 to 8.0	9 Percentages of subjects Interval 7.0 to 11.0	—
Percentages of Subjects With Carriage of N. Meningitidis Serogroups ACWY at Different Time Points After MenACWY-CRM Vaccination 12 months post 1 dose (N=845, 827)	4 Percentages of subjects Interval 3.0 to 6.0	5 Percentages of subjects Interval 3.0 to 7.0	—

SECONDARY outcome

Timeframe: Up to 361 days after vaccination

Population: Analysis was done on the MITT dataset (Pharyngeal carriage)

Percentages of subjects with carriage of N. meningitidis genogroup Y in subjects at different time points of the study after administration of a single dose of MenACWY-CRM conjugate vaccine as compared to the control group is reported.

Outcome measures

Measure	rMenB+OMV n=981 Participants Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart	Control n=984 Participants Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart	Control Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
Percentages of Subjects With Carriage of N. Meningitidis Genogroup Y at Different Time Points After MenACWY-CRM Vaccination Baseline	7 Percentages of subjects Interval 5.0 to 8.0	7 Percentages of subjects Interval 5.0 to 9.0	—
Percentages of Subjects With Carriage of N. Meningitidis Genogroup Y at Different Time Points After MenACWY-CRM Vaccination 1 month post 1 dose (N=956, 947)	7 Percentages of subjects Interval 6.0 to 9.0	8 Percentages of subjects Interval 7.0 to 10.0	—
Percentages of Subjects With Carriage of N. Meningitidis Genogroup Y at Different Time Points After MenACWY-CRM Vaccination 2 months post 1 dose (N=929, 928)	7 Percentages of subjects Interval 6.0 to 9.0	10 Percentages of subjects Interval 9.0 to 13.0	—
Percentages of Subjects With Carriage of N. Meningitidis Genogroup Y at Different Time Points After MenACWY-CRM Vaccination 4 months post 1 dose (N=884, 885)	8 Percentages of subjects Interval 6.0 to 10.0	10 Percentages of subjects Interval 8.0 to 12.0	—
Percentages of Subjects With Carriage of N. Meningitidis Genogroup Y at Different Time Points After MenACWY-CRM Vaccination 6 months post 1 dose (N=867, 864)	9 Percentages of subjects Interval 7.0 to 11.0	10 Percentages of subjects Interval 8.0 to 13.0	—
Percentages of Subjects With Carriage of N. Meningitidis Genogroup Y at Different Time Points After MenACWY-CRM Vaccination 12 months post 1 dose (N=845, 827)	6 Percentages of subjects Interval 5.0 to 8.0	6 Percentages of subjects Interval 5.0 to 8.0	—

SECONDARY outcome

Timeframe: Up to 361 days after vaccination

Population: Analysis was done on the MITT dataset (Pharyngeal carriage)

Percentages of subjects with carriage of N. meningitidis serogroup Y in subjects at different time points of the study after administration of a single dose of MenACWY-CRM conjugate vaccine as compared to the control group is reported.

Outcome measures

Measure	rMenB+OMV n=981 Participants Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart	Control n=984 Participants Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart	Control Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
Percentages of Subjects With Carriage of N. Meningitidis Serogroup Y at Different Time Points After MenACWY-CRM Vaccination 2 months post 1 dose (N=929, 928)	4 Percentages of subjects Interval 3.0 to 5.0	7 Percentages of subjects Interval 6.0 to 9.0	—
Percentages of Subjects With Carriage of N. Meningitidis Serogroup Y at Different Time Points After MenACWY-CRM Vaccination Baseline	4 Percentages of subjects Interval 3.0 to 6.0	5 Percentages of subjects Interval 3.0 to 6.0	—
Percentages of Subjects With Carriage of N. Meningitidis Serogroup Y at Different Time Points After MenACWY-CRM Vaccination 1 month post 1 dose (N=956, 947)	5 Percentages of subjects Interval 4.0 to 6.0	5 Percentages of subjects Interval 4.0 to 7.0	—
Percentages of Subjects With Carriage of N. Meningitidis Serogroup Y at Different Time Points After MenACWY-CRM Vaccination 4 months post 1 dose (N=884, 885)	5 Percentages of subjects Interval 4.0 to 7.0	7 Percentages of subjects Interval 5.0 to 9.0	—
Percentages of Subjects With Carriage of N. Meningitidis Serogroup Y at Different Time Points After MenACWY-CRM Vaccination 6 months post 1 dose (N=867, 864)	5 Percentages of subjects Interval 4.0 to 7.0	7 Percentages of subjects Interval 6.0 to 9.0	—
Percentages of Subjects With Carriage of N. Meningitidis Serogroup Y at Different Time Points After MenACWY-CRM Vaccination 12 months post 1 dose (N=845, 827)	4 Percentages of subjects Interval 3.0 to 5.0	4 Percentages of subjects Interval 3.0 to 6.0	—

SECONDARY outcome

Timeframe: Up to 361 days after vaccination

Population: Analysis was done on the MITT dataset (Pharyngeal carriage)

The percentages of subjects with newly acquired pharyngeal carriage of all ST types of N. meningitidis genogroup B in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ conjugate vaccine as compared to the control group is reported.

Outcome measures

Measure	rMenB+OMV n=748 Participants Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart	Control n=786 Participants Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart	Control Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
Percentages of Subjects With New Acquisition of Pharyngeal Carriage of All ST Types of N. Meningitidis Genogroup B at Different Time Points Following rMenB+OMV NZ Vaccination Baseline non-carrier	90 Percentages of subjects Interval 87.0 to 92.0	91 Percentages of subjects Interval 89.0 to 93.0	—
Percentages of Subjects With New Acquisition of Pharyngeal Carriage of All ST Types of N. Meningitidis Genogroup B at Different Time Points Following rMenB+OMV NZ Vaccination 1 month post 1st vaccination (N=671, 715)	3 Percentages of subjects Interval 2.0 to 5.0	4 Percentages of subjects Interval 2.0 to 5.0	—
Percentages of Subjects With New Acquisition of Pharyngeal Carriage of All ST Types of N. Meningitidis Genogroup B at Different Time Points Following rMenB+OMV NZ Vaccination 1 month post 2nd vaccination (N=650, 687)	3 Percentages of subjects Interval 2.0 to 5.0	2 Percentages of subjects Interval 1.0 to 3.0	—
Percentages of Subjects With New Acquisition of Pharyngeal Carriage of All ST Types of N. Meningitidis Genogroup B at Different Time Points Following rMenB+OMV NZ Vaccination 3 months post 2nd vaccination (N=628, 674)	1 Percentages of subjects Interval 0.0 to 2.0	3 Percentages of subjects Interval 1.0 to 4.0	—
Percentages of Subjects With New Acquisition of Pharyngeal Carriage of All ST Types of N. Meningitidis Genogroup B at Different Time Points Following rMenB+OMV NZ Vaccination 5 months post 2nd vaccination (N=623, 656)	1 Percentages of subjects Interval 1.0 to 3.0	2 Percentages of subjects Interval 1.0 to 4.0	—
Percentages of Subjects With New Acquisition of Pharyngeal Carriage of All ST Types of N. Meningitidis Genogroup B at Different Time Points Following rMenB+OMV NZ Vaccination 11 months post 2nd vaccination (N=614, 642)	3 Percentages of subjects Interval 2.0 to 5.0	3 Percentages of subjects Interval 2.0 to 5.0	—
Percentages of Subjects With New Acquisition of Pharyngeal Carriage of All ST Types of N. Meningitidis Genogroup B at Different Time Points Following rMenB+OMV NZ Vaccination At 3,5,11 months post 2nd vaccination (N=628,674)	5 Percentages of subjects Interval 4.0 to 7.0	7 Percentages of subjects Interval 6.0 to 10.0	—

SECONDARY outcome

Timeframe: Up to 361 days after vaccination

Population: Analysis was done on the MITT dataset (Pharyngeal carriage)

The percentages of subjects with newly acquired pharyngeal carriage of virulent ST types of N. meningitidis genogroup B in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ conjugate vaccine as compared to the control group is reported.

Outcome measures

Measure	rMenB+OMV n=748 Participants Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart	Control n=786 Participants Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart	Control Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
Percentages of Subjects With New Acquisition of Pharyngeal Carriage of Virulent ST Types of N. Meningitidis Genogroup B at Different Time Points Following rMenB+OMV NZ Vaccination Baseline non-carrier	91 Percentages of subjects Interval 89.0 to 93.0	92 Percentages of subjects Interval 90.0 to 94.0	—
Percentages of Subjects With New Acquisition of Pharyngeal Carriage of Virulent ST Types of N. Meningitidis Genogroup B at Different Time Points Following rMenB+OMV NZ Vaccination 1 month post 1st vaccination (N=682, 726)	3 Percentages of subjects Interval 2.0 to 5.0	3 Percentages of subjects Interval 2.0 to 5.0	—
Percentages of Subjects With New Acquisition of Pharyngeal Carriage of Virulent ST Types of N. Meningitidis Genogroup B at Different Time Points Following rMenB+OMV NZ Vaccination 1 month post 2nd vaccination (N=659, 699)	3 Percentages of subjects Interval 2.0 to 5.0	2 Percentages of subjects Interval 1.0 to 3.0	—
Percentages of Subjects With New Acquisition of Pharyngeal Carriage of Virulent ST Types of N. Meningitidis Genogroup B at Different Time Points Following rMenB+OMV NZ Vaccination 3 months post 2nd vaccination (N=638, 686)	1 Percentages of subjects Interval 0.0 to 2.0	2 Percentages of subjects Interval 1.0 to 4.0	—
Percentages of Subjects With New Acquisition of Pharyngeal Carriage of Virulent ST Types of N. Meningitidis Genogroup B at Different Time Points Following rMenB+OMV NZ Vaccination 5 months post 2nd vaccination (N=632, 670)	1 Percentages of subjects Interval 1.0 to 3.0	2 Percentages of subjects Interval 1.0 to 3.0	—
Percentages of Subjects With New Acquisition of Pharyngeal Carriage of Virulent ST Types of N. Meningitidis Genogroup B at Different Time Points Following rMenB+OMV NZ Vaccination 11 months post 2nd vaccination (N=623, 656)	3 Percentages of subjects Interval 2.0 to 5.0	2 Percentages of subjects Interval 1.0 to 4.0	—
Percentages of Subjects With New Acquisition of Pharyngeal Carriage of Virulent ST Types of N. Meningitidis Genogroup B at Different Time Points Following rMenB+OMV NZ Vaccination At 3,5, 11 months post 2nd vaccination (N=638,686)	5 Percentages of subjects Interval 4.0 to 7.0	6 Percentages of subjects Interval 5.0 to 9.0	—

SECONDARY outcome

Timeframe: Up to 361 days after vaccination

Population: Analysis was done on the MITT dataset (Pharyngeal carriage)

The percentages of subjects with newly acquired pharyngeal carriage of all N. meningitidis in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ conjugate vaccine as compared to the control group is reported.

Outcome measures

Measure	rMenB+OMV n=748 Participants Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart	Control n=786 Participants Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart	Control Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
Percentages of Subjects With New Acquisition of Pharyngeal Carriage of All N. Meningitidis at Different Time Points Following rMenB+OMV NZ Vaccination Baseline non-carrier	77 Percentages of subjects Interval 74.0 to 80.0	80 Percentages of subjects Interval 77.0 to 83.0	—
Percentages of Subjects With New Acquisition of Pharyngeal Carriage of All N. Meningitidis at Different Time Points Following rMenB+OMV NZ Vaccination 1 month post 1st vaccination (N=578, 627)	17 Percentages of subjects Interval 14.0 to 20.0	18 Percentages of subjects Interval 15.0 to 21.0	—
Percentages of Subjects With New Acquisition of Pharyngeal Carriage of All N. Meningitidis at Different Time Points Following rMenB+OMV NZ Vaccination 1 month post 2nd vaccination (N=479, 513)	14 Percentages of subjects Interval 11.0 to 18.0	12 Percentages of subjects Interval 9.0 to 15.0	—
Percentages of Subjects With New Acquisition of Pharyngeal Carriage of All N. Meningitidis at Different Time Points Following rMenB+OMV NZ Vaccination 3 months post 2nd vaccination (N=410, 452)	9 Percentages of subjects Interval 6.0 to 12.0	13 Percentages of subjects Interval 10.0 to 16.0	—
Percentages of Subjects With New Acquisition of Pharyngeal Carriage of All N. Meningitidis at Different Time Points Following rMenB+OMV NZ Vaccination 5 months post 2nd vaccination (N=374, 395)	8 Percentages of subjects Interval 5.0 to 11.0	9 Percentages of subjects Interval 6.0 to 12.0	—
Percentages of Subjects With New Acquisition of Pharyngeal Carriage of All N. Meningitidis at Different Time Points Following rMenB+OMV NZ Vaccination 11 months post 2nd vaccination (N=344, 361)	11 Percentages of subjects Interval 8.0 to 15.0	14 Percentages of subjects Interval 10.0 to 18.0	—
Percentages of Subjects With New Acquisition of Pharyngeal Carriage of All N. Meningitidis at Different Time Points Following rMenB+OMV NZ Vaccination At 3,5, 11 months post 2nd vaccination (N=410,452)	26 Percentages of subjects Interval 21.0 to 30.0	31 Percentages of subjects Interval 27.0 to 35.0	—

SECONDARY outcome

Timeframe: Up to 361 days after vaccination

Population: Analysis was done on the MITT dataset (Pharyngeal carriage)

The percentages of subjects with newly acquired pharyngeal carriage of N. meningitidis genogroups ABCWY in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ conjugate vaccine as compared to the control group is reported.

Outcome measures

Measure	rMenB+OMV n=748 Participants Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart	Control n=786 Participants Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart	Control Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
Percentages of Subjects With New Acquisition of Pharyngeal Carriage of N. Meningitidis Genogroups ABCWY at Different Time Points Following rMenB+OMV NZ Vaccination Baseline non-carrier	82 Percentages of subjects Interval 79.0 to 85.0	84 Percentages of subjects Interval 82.0 to 87.0	—
Percentages of Subjects With New Acquisition of Pharyngeal Carriage of N. Meningitidis Genogroups ABCWY at Different Time Points Following rMenB+OMV NZ Vaccination 1 month post 1st vaccination (N=611, 663)	9 Percentages of subjects Interval 7.0 to 12.0	10 Percentages of subjects Interval 8.0 to 13.0	—
Percentages of Subjects With New Acquisition of Pharyngeal Carriage of N. Meningitidis Genogroups ABCWY at Different Time Points Following rMenB+OMV NZ Vaccination 1 month post 2nd vaccination (N=553, 592)	6 Percentages of subjects Interval 4.0 to 8.0	7 Percentages of subjects Interval 5.0 to 9.0	—
Percentages of Subjects With New Acquisition of Pharyngeal Carriage of N. Meningitidis Genogroups ABCWY at Different Time Points Following rMenB+OMV NZ Vaccination 3 months post 2nd vaccination (N=519, 551)	4 Percentages of subjects Interval 3.0 to 6.0	7 Percentages of subjects Interval 5.0 to 9.0	—
Percentages of Subjects With New Acquisition of Pharyngeal Carriage of N. Meningitidis Genogroups ABCWY at Different Time Points Following rMenB+OMV NZ Vaccination 5 months post 2nd vaccination (N=497, 515)	5 Percentages of subjects Interval 3.0 to 7.0	5 Percentages of subjects Interval 3.0 to 7.0	—
Percentages of Subjects With New Acquisition of Pharyngeal Carriage of N. Meningitidis Genogroups ABCWY at Different Time Points Following rMenB+OMV NZ Vaccination 11 months post 2nd vaccination (N=472, 491)	6 Percentages of subjects Interval 4.0 to 8.0	6 Percentages of subjects Interval 4.0 to 9.0	—
Percentages of Subjects With New Acquisition of Pharyngeal Carriage of N. Meningitidis Genogroups ABCWY at Different Time Points Following rMenB+OMV NZ Vaccination At 3,5, 11 months post 2nd vaccination (N=519,551)	14 Percentages of subjects Interval 11.0 to 18.0	17 Percentages of subjects Interval 14.0 to 20.0	—

SECONDARY outcome

Timeframe: Up to 361 days after vaccination

Population: Analysis was done on the MITT dataset (Pharyngeal carriage)

The percentages of subjects with newly acquired pharyngeal carriage of N.meningitidis serogroups A,C, W or Y at different time-points in the study after MenACWY-CRM vaccination as compared to the control group is reported.

Outcome measures

Measure	rMenB+OMV n=794 Participants Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart	Control n=786 Participants Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart	Control Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
Percentages of Subjects With New Acquisition of Pharyngeal Carriage of N. Meningitidis Serogroups ACWY at Different Time-points After MenACWY-CRM Vaccination Baseline non-carrier	94 Percentages of subjects Interval 92.0 to 96.0	95 Percentages of subjects Interval 93.0 to 96.0	—
Percentages of Subjects With New Acquisition of Pharyngeal Carriage of N. Meningitidis Serogroups ACWY at Different Time-points After MenACWY-CRM Vaccination 1 month post 1st vaccination (N=746, 745)	4 Percentages of subjects Interval 3.0 to 6.0	5 Percentages of subjects Interval 3.0 to 6.0	—
Percentages of Subjects With New Acquisition of Pharyngeal Carriage of N. Meningitidis Serogroups ACWY at Different Time-points After MenACWY-CRM Vaccination 1 month post 2nd vaccination (N=712, 709)	2 Percentages of subjects Interval 1.0 to 3.0	4 Percentages of subjects Interval 3.0 to 6.0	—
Percentages of Subjects With New Acquisition of Pharyngeal Carriage of N. Meningitidis Serogroups ACWY at Different Time-points After MenACWY-CRM Vaccination 3 months post 2nd vaccination (N=701, 680)	2 Percentages of subjects Interval 1.0 to 4.0	3 Percentages of subjects Interval 2.0 to 5.0	—
Percentages of Subjects With New Acquisition of Pharyngeal Carriage of N. Meningitidis Serogroups ACWY at Different Time-points After MenACWY-CRM Vaccination 5 months post 2nd vaccination (N=685, 660)	3 Percentages of subjects Interval 2.0 to 4.0	2 Percentages of subjects Interval 1.0 to 3.0	—
Percentages of Subjects With New Acquisition of Pharyngeal Carriage of N. Meningitidis Serogroups ACWY at Different Time-points After MenACWY-CRM Vaccination 11 months post 2nd vaccination (N=666, 650)	2 Percentages of subjects Interval 1.0 to 3.0	1 Percentages of subjects Interval 1.0 to 3.0	—
Percentages of Subjects With New Acquisition of Pharyngeal Carriage of N. Meningitidis Serogroups ACWY at Different Time-points After MenACWY-CRM Vaccination 1,3,5, 11 months post 2nd vaccination (N=712, 709)	8 Percentages of subjects Interval 6.0 to 11.0	10 Percentages of subjects Interval 8.0 to 12.0	—

SECONDARY outcome

Timeframe: Up to 361 days after vaccination

Population: Analysis was done on the MITT dataset (Pharyngeal carriage)

The percentages of subjects with newly acquired pharyngeal carriage of N.meningitidis serogroup Y at different time-points in the study after MenACWY-CRM vaccination as compared to the control group is reported.

Outcome measures

Measure	rMenB+OMV n=794 Participants Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart	Control n=786 Participants Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart	Control Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
Percentages of Subjects With New Acquisition of Pharyngeal Carriage of N. Meningitidis Serogroup Y at Different Time-points After MenACWY-CRM Vaccination Baseline non-carrier	95 Percentages of subjects Interval 94.0 to 97.0	95 Percentages of subjects Interval 94.0 to 97.0	—
Percentages of Subjects With New Acquisition of Pharyngeal Carriage of N. Meningitidis Serogroup Y at Different Time-points After MenACWY-CRM Vaccination 1 month post 1st vaccination (N=758, 749)	4 Percentages of subjects Interval 2.0 to 5.0	4 Percentages of subjects Interval 3.0 to 6.0	—
Percentages of Subjects With New Acquisition of Pharyngeal Carriage of N. Meningitidis Serogroup Y at Different Time-points After MenACWY-CRM Vaccination 1 month post 2nd vaccination (N=730, 719)	1 Percentages of subjects Interval 1.0 to 2.0	4 Percentages of subjects Interval 2.0 to 5.0	—
Percentages of Subjects With New Acquisition of Pharyngeal Carriage of N. Meningitidis Serogroup Y at Different Time-points After MenACWY-CRM Vaccination 3 months post 2nd vaccination (N=719, 693)	1 Percentages of subjects Interval 1.0 to 3.0	2 Percentages of subjects Interval 1.0 to 4.0	—
Percentages of Subjects With New Acquisition of Pharyngeal Carriage of N. Meningitidis Serogroup Y at Different Time-points After MenACWY-CRM Vaccination 5 months post 2nd vaccination (N=709, 678)	2 Percentages of subjects Interval 1.0 to 3.0	1 Percentages of subjects Interval 1.0 to 3.0	—
Percentages of Subjects With New Acquisition of Pharyngeal Carriage of N. Meningitidis Serogroup Y at Different Time-points After MenACWY-CRM Vaccination 11 months post 2nd vaccination (N=694, 669)	2 Percentages of subjects Interval 1.0 to 3.0	1 Percentages of subjects Interval 1.0 to 3.0	—
Percentages of Subjects With New Acquisition of Pharyngeal Carriage of N. Meningitidis Serogroup Y at Different Time-points After MenACWY-CRM Vaccination 1,3,5, 11 months post 2nd vaccination (N=730, 719)	6 Percentages of subjects Interval 5.0 to 8.0	8 Percentages of subjects Interval 6.0 to 10.0	—

SECONDARY outcome

Timeframe: Any post vaccination timepoint (the date of first observation of the carriage and the date of the last observation of the carriage)

Population: Analysis was done on the MITT dataset (Pharyngeal carriage)

The duration of carriage of any N.meningitidis strains after receiving two doses of rMenB+OMV compared to that in the control group is reported.

Outcome measures

Measure	rMenB+OMV n=440 Participants Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart	Control n=470 Participants Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart	Control Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
The Duration of Any Carriage of N.Meningitidis Strains After Vaccination With rMenB+OMV Genogroup B All STs (N=152, 160)	127 Number of days Interval 92.0 to 162.0	146 Number of days Interval 112.0 to 180.0	—
The Duration of Any Carriage of N.Meningitidis Strains After Vaccination With rMenB+OMV Genogroup B virulent STs (N=142, 142)	122 Number of days Interval 87.0 to 157.0	147 Number of days Interval 113.0 to 182.0	—
The Duration of Any Carriage of N.Meningitidis Strains After Vaccination With rMenB+OMV All N meningitidis	193 Number of days Interval 176.0 to 210.0	202 Number of days Interval 185.0 to 219.0	—
The Duration of Any Carriage of N.Meningitidis Strains After Vaccination With rMenB+OMV Genogroups ABCWY (N=300, 323)	143 Number of days Interval 122.0 to 164.0	162 Number of days Interval 141.0 to 183.0	—
The Duration of Any Carriage of N.Meningitidis Strains After Vaccination With rMenB+OMV Serogroups ACWY (N=131, 142)	104 Number of days Interval 79.0 to 129.0	113 Number of days Interval 87.0 to 138.0	—
The Duration of Any Carriage of N.Meningitidis Strains After Vaccination With rMenB+OMV Serogroup Y (N=106, 123)	106 Number of days Interval 79.0 to 132.0	117 Number of days Interval 91.0 to 144.0	—

SECONDARY outcome

Timeframe: Any time post vaccination (the date of first observation of the carriage and the date of the last observation of the carriage)

Population: Analysis was done on the MITT dataset (Pharyngeal carriage)

The duration of carriage of any N meningitidis strain after receiving one dose MenACWY-CRM as compared to that in control group is reported.

Outcome measures

Measure	rMenB+OMV n=138 Participants Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart	Control n=142 Participants Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart	Control Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
The Duration of Carriage of Any N. Meningitidis Strain After Vaccination With MenACWY-CRM Serogroups ACWY	88 Number of days Interval 62.0 to 114.0	113 Number of days Interval 87.0 to 138.0	—
The Duration of Carriage of Any N. Meningitidis Strain After Vaccination With MenACWY-CRM Serogroup Y (N=110, 123)	86 Number of days Interval 59.0 to 114.0	117 Number of days Interval 91.0 to 144.0	—

SECONDARY outcome

Timeframe: Any post vaccination timepoint (the date of first observation of the carriage and the date of the last observation of the carriage)

Population: Analysis was done on the MITT dataset (Pharyngeal carriage)

The duration of carriage after new acquisition of N.meningitidis strains after receiving two doses of rMenB+OMV vaccine compared to that in the control group is reported.

Outcome measures

Measure	rMenB+OMV n=271 Participants Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart	Control n=312 Participants Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart	Control Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
The Duration of Carriage After New Acquisition N.Meningitidis Strains Following Vaccination With rMenB+OMV Vaccine Genogroup B All STs (N=76, 89)	82 Number of days Interval 44.0 to 120.0	107 Number of days Interval 71.0 to 142.0	—
The Duration of Carriage After New Acquisition N.Meningitidis Strains Following Vaccination With rMenB+OMV Vaccine Genogroup B virulent STs (N=77, 82)	80 Number of days Interval 42.0 to 117.0	107 Number of days Interval 70.0 to 143.0	—
The Duration of Carriage After New Acquisition N.Meningitidis Strains Following Vaccination With rMenB+OMV Vaccine All N meningitidis	158 Number of days Interval 135.0 to 181.0	165 Number of days Interval 142.0 to 188.0	—
The Duration of Carriage After New Acquisition N.Meningitidis Strains Following Vaccination With rMenB+OMV Vaccine Genogroups ABCWY (N=165, 201)	121 Number of days Interval 96.0 to 146.0	146 Number of days Interval 122.0 to 170.0	—
The Duration of Carriage After New Acquisition N.Meningitidis Strains Following Vaccination With rMenB+OMV Vaccine Serogroups ACWY (N=75, 102)	111 Number of days Interval 79.0 to 143.0	120 Number of days Interval 89.0 to 151.0	—
The Duration of Carriage After New Acquisition N.Meningitidis Strains Following Vaccination With rMenB+OMV Vaccine Serogroup Y (N=61, 87)	111 Number of days Interval 76.0 to 146.0	120 Number of days Interval 87.0 to 153.0	—

SECONDARY outcome

Timeframe: Any post vaccination timepoint (the date of first observation of the carriage and the date of the last observation of the carriage)

Population: Analysis was done on the MITT dataset (Pharyngeal carriage)

The duration of carriage after new acquisition of N.meningitidis strains after receiving one dose of MenACWY-CRM vaccine compared to that in the control group is reported.

Outcome measures

Measure	rMenB+OMV n=90 Participants Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart	Control n=102 Participants Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart	Control Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
The Duration of Carriage After New Acquisition N.Meningitidis Strains Following Vaccination With MenACWY Vaccine Serogroups ACWY	90 Number of days Interval 57.0 to 123.0	120 Number of days Interval 89.0 to 151.0	—
The Duration of Carriage After New Acquisition N.Meningitidis Strains Following Vaccination With MenACWY Vaccine Serogroup Y (N=74, 87)	87 Number of days Interval 52.0 to 122.0	120 Number of days Interval 87.0 to 153.0	—

SECONDARY outcome

Timeframe: Up to 361 days after vaccination

Population: Analysis was done on the MITT dataset (Pharyngeal carriage)

The percentages of subjects with N. meningitidis Virulent ST of serogroup B, at different time points of the study, in subjects stratified by pre-vaccination hSBA (<4 and ≥4) titers after administration of two doses of rMenB+OMV NZ vaccine as compared to the control group is reported.

The serum bactericidal antibodies directed against N.meningitides serogroups, are measured by Serum Bactericidal Assay using human complement (hSBA).

H44/76, 5/99 and NZ98/254 are strains in serogroup B.

Outcome measures

Measure	rMenB+OMV n=133 Participants Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart	Control n=31 Participants Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart	Control Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination Baseline hSBA < 4 (H44/76) (N=60,19)	0 Percentage Interval 0.0 to 6.0	0 Percentage Interval 0.0 to 18.0	—
Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination 1month post 1st dose; hSBA<4(H44/76) (N=60, 18)	3 Percentage Interval 0.0 to 12.0	0 Percentage Interval 0.0 to 19.0	—
Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination 1month post 2nd dose; hSBA<4(H44/76) (N=60, 18)	7 Percentage Interval 2.0 to 16.0	0 Percentage Interval 0.0 to 19.0	—
Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination 3months post 2nd dose; hSBA<4(H44/76) (N=56, 17)	4 Percentage Interval 0.0 to 12.0	0 Percentage Interval 0.0 to 20.0	—
Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination 5 months post 2nd dose; hSBA <4(H44/76) (N=56, 17)	7 Percentage Interval 2.0 to 17.0	0 Percentage Interval 0.0 to 20.0	—
Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination 11 months post 2nd dose;hSBA <4(H44/76) (N=56, 16)	11 Percentage Interval 4.0 to 22.0	0 Percentage Interval 0.0 to 21.0	—
Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination Baseline hSBA ≥4 (H44/76)	10 Percentage Interval 5.0 to 16.0	6 Percentage Interval 1.0 to 21.0	—
Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination 1month post 1st dose; hSBA ≥4 (H44/76) (N=130, 30)	5 Percentage Interval 2.0 to 11.0	10 Percentage Interval 2.0 to 27.0	—
Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination 1 month post 2nd dose;hSBA ≥4 (H44/76) (N=130, 30)	8 Percentage Interval 4.0 to 14.0	7 Percentage Interval 1.0 to 22.0	—
Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination 3 months post 2nd dose;hSBA ≥4 (H44/76) (N=120,29)	9 Percentage Interval 5.0 to 16.0	14 Percentage Interval 4.0 to 32.0	—
Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination 5 months post 2nd dose;hSBA ≥4 (H44/76) (N=115,28)	5 Percentage Interval 2.0 to 11.0	11 Percentage Interval 2.0 to 28.0	—
Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination 11 months post 2nd dose;hSBA ≥4 (H44/76)(N=123,30)	5 Percentage Interval 2.0 to 10.0	7 Percentage Interval 1.0 to 22.0	—
Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination Baseline hSBA < 4 (5/99) (N=77, 23)	5 Percentage Interval 1.0 to 13.0	9 Percentage Interval 1.0 to 28.0	—
Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination 1month post 1st dose; hSBA<4 (5/99) (N=77, 22)	4 Percentage Interval 1.0 to 11.0	9 Percentage Interval 1.0 to 29.0	—
Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination 1 month post 2nd dose;hSBA <4 (5/99) (N=77, 22)	6 Percentage Interval 2.0 to 15.0	0 Percentage Interval 0.0 to 15.0	—
Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination 3 months post 2nd dose;hSBA <4 (5/99) (N=71, 21)	4 Percentage Interval 1.0 to 12.0	10 Percentage Interval 1.0 to 30.0	—
Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination 5 months post 2nd dose;hSBA <4 (5/99) (N=68, 21)	3 Percentage Interval 0.0 to 10.0	10 Percentage Interval 1.0 to 30.0	—
Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination 11 months post 2nd dose;hSBA <4(5/99) (N=71, 20)	7 Percentage Interval 2.0 to 16.0	5 Percentage Interval 0.0 to 25.0	—
Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination Baseline hSBA ≥4 (5/99) (N=116, 27)	8 Percentage Interval 4.0 to 14.0	0 Percentage Interval 0.0 to 13.0	—
Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination 1month post 1st dose; hSBA ≥4 (5/99) (N=113, 26)	5 Percentage Interval 2.0 to 11.0	4 Percentage Interval 0.097 to 20.0	—
Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination 1 month post 2nd dose;hSBA ≥4 (5/99) (N=113, 26)	8 Percentage Interval 4.0 to 15.0	8 Percentage Interval 1.0 to 25.0	—
Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination 3 months post 2nd dose;hSBA ≥4 (5/99) (N=105, 25)	10 Percentage Interval 5.0 to 17.0	8 Percentage Interval 1.0 to 26.0	—
Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination 5 months post 2nd dose;hSBA ≥4 (5/99) (N=103, 24)	8 Percentage Interval 3.0 to 15.0	4 Percentage Interval 0.0 to 21.0	—
Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination 11 months post 2nd dose;hSBA ≥4(5/99) (N=108, 26)	6 Percentage Interval 3.0 to 13.0	4 Percentage Interval 0.097 to 20.0	—
Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination Baseline hSBA < 4 (NZ98/254) (N=83, 31)	2 Percentage Interval 0.0 to 8.0	6 Percentage Interval 1.0 to 21.0	—
Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination 1month post 1st dose; hSBA<4(NZ98/254) (N=81, 30)	4 Percentage Interval 1.0 to 10.0	7 Percentage Interval 1.0 to 22.0	—
Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination 1month post 2nd dose; hSBA<4 (NZ98/254) (N=81, 30)	4 Percentage Interval 1.0 to 10.0	0 Percentage Interval 0.0 to 12.0	—
Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination 3 months post 2nd dose;hSBA <4 (NZ98/254)(N=75,29)	3 Percentage Interval 0.0 to 9.0	3 Percentage Interval 0.087 to 18.0	—
Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination 5 months post 2nd dose;hSBA <4 (NZ98/254)(N=70,29)	3 Percentage Interval 0.0 to 10.0	3 Percentage Interval 0.087 to 18.0	—
Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination 11 months post 2nd dose;hSBA <4(NZ98/254)(N=75,28)	11 Percentage Interval 5.0 to 20.0	4 Percentage Interval 0.09 to 18.0	—
Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination Baseline hSBA ≥4 (NZ98/254) (N=110, 19)	10 Percentage Interval 5.0 to 17.0	0 Percentage Interval 0.0 to 18.0	—
Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination 1month post 1st dose; hSBA ≥4 (NZ98/254)(N=109,18)	6 Percentage Interval 2.0 to 12.0	6 Percentage Interval 0.0 to 27.0	—
Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination 1 month post 2nd dose;hSBA ≥4 (NZ98/254)(N=109,18)	10 Percentage Interval 5.0 to 17.0	11 Percentage Interval 1.0 to 35.0	—
Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination 3 months post 2nd dose;hSBA ≥4(NZ98/254)(N=101,17)	11 Percentage Interval 6.0 to 19.0	18 Percentage Interval 4.0 to 43.0	—
Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination 5 months post 2nd dose;hSBA ≥4(NZ98/254)(N=101,16)	8 Percentage Interval 3.0 to 15.0	13 Percentage Interval 2.0 to 38.0	—
Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination 11 months post 2nd dose;hSBA≥4(NZ98/254)(N=104,18)	4 Percentage Interval 1.0 to 10.0	6 Percentage Interval 0.0 to 27.0	—

SECONDARY outcome

Timeframe: Up to 12 months after vaccination

Population: Analysis was done on the MITT dataset (Pharyngeal carriage)

The prevalence of carriage of N. meningitidis serogroup Y, at different time points of the study, in subjects stratified by pre-vaccination hSBA (<8 and ≥8) titers, after administration of one dose of MenACWY-CRM vaccine as compared to the control group is reported.

Outcome measures

Measure	rMenB+OMV n=152 Participants Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart	Control n=154 Participants Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart	Control Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
Percentages of Subjects With N. Meningitidis Carriage of Serogroup Y After MenACWY-CRM Vaccination, Stratified by Pre-vaccination hSBA Titers Baseline hSBA <8 (MenY) (N=42, 44)	0 Percentages of subjects Interval 0.0 to 8.0	0 Percentages of subjects Interval 0.0 to 8.0	—
Percentages of Subjects With N. Meningitidis Carriage of Serogroup Y After MenACWY-CRM Vaccination, Stratified by Pre-vaccination hSBA Titers 1month post 1st dose; hSBA <8 (MenY) (N=39, 40)	0 Percentages of subjects Interval 0.0 to 9.0	3 Percentages of subjects Interval 0.063 to 13.0	—
Percentages of Subjects With N. Meningitidis Carriage of Serogroup Y After MenACWY-CRM Vaccination, Stratified by Pre-vaccination hSBA Titers 1 month post 2nd dose;hSBA <8 (MenY) (N=39, 40)	0 Percentages of subjects Interval 0.0 to 9.0	0 Percentages of subjects Interval 0.0 to 9.0	—
Percentages of Subjects With N. Meningitidis Carriage of Serogroup Y After MenACWY-CRM Vaccination, Stratified by Pre-vaccination hSBA Titers 3 months post 2nd dose;hSBA <8 (MenY) (N=36, 37)	0 Percentages of subjects Interval 0.0 to 10.0	3 Percentages of subjects Interval 0.068 to 14.0	—
Percentages of Subjects With N. Meningitidis Carriage of Serogroup Y After MenACWY-CRM Vaccination, Stratified by Pre-vaccination hSBA Titers 5 months post 2nd dose;hSBA <8 (MenY) (N=36, 36)	0 Percentages of subjects Interval 0.0 to 10.0	6 Percentages of subjects Interval 1.0 to 19.0	—
Percentages of Subjects With N. Meningitidis Carriage of Serogroup Y After MenACWY-CRM Vaccination, Stratified by Pre-vaccination hSBA Titers 11 months post 2nd dose;hSBA <8 (MenY) (N=34, 35)	3 Percentages of subjects Interval 0.074 to 15.0	6 Percentages of subjects Interval 1.0 to 19.0	—
Percentages of Subjects With N. Meningitidis Carriage of Serogroup Y After MenACWY-CRM Vaccination, Stratified by Pre-vaccination hSBA Titers Baseline hSBA ≥8 (MenY)	6 Percentages of subjects Interval 3.0 to 11.0	6 Percentages of subjects Interval 3.0 to 11.0	—
Percentages of Subjects With N. Meningitidis Carriage of Serogroup Y After MenACWY-CRM Vaccination, Stratified by Pre-vaccination hSBA Titers 1month post 1st dose; hSBA ≥8 (MenY) (N=146,151)	6 Percentages of subjects Interval 3.0 to 11.0	5 Percentages of subjects Interval 2.0 to 10.0	—
Percentages of Subjects With N. Meningitidis Carriage of Serogroup Y After MenACWY-CRM Vaccination, Stratified by Pre-vaccination hSBA Titers 1 month post 2nd dose;hSBA ≥8 (MenY) (N=143, 149)	5 Percentages of subjects Interval 2.0 to 10.0	5 Percentages of subjects Interval 2.0 to 10.0	—
Percentages of Subjects With N. Meningitidis Carriage of Serogroup Y After MenACWY-CRM Vaccination, Stratified by Pre-vaccination hSBA Titers 3 months post 2nd dose;hSBA ≥8 (MenY) (N=131, 139)	8 Percentages of subjects Interval 4.0 to 14.0	7 Percentages of subjects Interval 4.0 to 13.0	—
Percentages of Subjects With N. Meningitidis Carriage of Serogroup Y After MenACWY-CRM Vaccination, Stratified by Pre-vaccination hSBA Titers 5 months post 2nd dose;hSBA ≥8 (MenY) (N=130, 134)	9 Percentages of subjects Interval 5.0 to 16.0	5 Percentages of subjects Interval 2.0 to 10.0	—
Percentages of Subjects With N. Meningitidis Carriage of Serogroup Y After MenACWY-CRM Vaccination, Stratified by Pre-vaccination hSBA Titers 11 months post 2nd dose;hSBA ≥8 (MenY) (N=129,135)	4 Percentages of subjects Interval 1.0 to 9.0	3 Percentages of subjects Interval 1.0 to 7.0	—

SECONDARY outcome

Timeframe: Up to 361 days after vaccination

Population: Analysis was done on the MITT dataset (Immunogenicity subset) i.e all enrolled subjects who actually received a study vaccination, provided at least one evaluable serum sample after vaccination and whose assay result was available for at least one serogroup.

The percentages of subjects with hSBA titers ≥1:4 against the three strains of N. meningitidis B, after rMenB+OMV NZ or MenACWY-CRM vaccination at different time points of the study as compared to the control group are reported.

Outcome measures

Measure	rMenB+OMV n=193 Participants Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart	Control n=49 Participants Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart	Control n=50 Participants Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
Percentages of Subjects With hSBA Titers ≥1:4 Against N. Meningitidis Serogroup B After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group Baseline H44/76	69 Percentages of subjects Interval 62.0 to 75.0	71 Percentages of subjects Interval 57.0 to 83.0	62 Percentages of subjects Interval 47.0 to 75.0
Percentages of Subjects With hSBA Titers ≥1:4 Against N. Meningitidis Serogroup B After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group 1 month post 2nd dose (H44/76) (N=189, 45, 48)	100 Percentages of subjects Interval 98.0 to 100.0	76 Percentages of subjects Interval 60.0 to 87.0	63 Percentages of subjects Interval 47.0 to 76.0
Percentages of Subjects With hSBA Titers ≥1:4 Against N. Meningitidis Serogroup B After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group 3 months post 2nd dose (H44/76) (N=173, 40, 46)	99 Percentages of subjects Interval 97.0 to 100.0	73 Percentages of subjects Interval 56.0 to 85.0	65 Percentages of subjects Interval 50.0 to 79.0
Percentages of Subjects With hSBA Titers ≥1:4 Against N. Meningitidis Serogroup B After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group 5 months post 2nd dose (H44/76) (N=169, 43, 45)	100 Percentages of subjects Interval 98.0 to 100.0	74 Percentages of subjects Interval 59.0 to 86.0	67 Percentages of subjects Interval 51.0 to 80.0
Percentages of Subjects With hSBA Titers ≥1:4 Against N. Meningitidis Serogroup B After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group 11 months post 2nd dose (H44/76) (N=177, 41, 46)	95 Percentages of subjects Interval 91.0 to 98.0	76 Percentages of subjects Interval 60.0 to 88.0	70 Percentages of subjects Interval 54.0 to 82.0
Percentages of Subjects With hSBA Titers ≥1:4 Against N. Meningitidis Serogroup B After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group Baseline 5/99	60 Percentages of subjects Interval 53.0 to 67.0	45 Percentages of subjects Interval 31.0 to 60.0	54 Percentages of subjects Interval 39.0 to 68.0
Percentages of Subjects With hSBA Titers ≥1:4 Against N. Meningitidis Serogroup B After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group 1 month post 2nd dose (5/99) (N=189, 45, 48)	100 Percentages of subjects Interval 98.0 to 100.0	40 Percentages of subjects Interval 26.0 to 56.0	58 Percentages of subjects Interval 43.0 to 72.0
Percentages of Subjects With hSBA Titers ≥1:4 Against N. Meningitidis Serogroup B After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group 3 months post 2nd dose (5/99) (N=173, 40, 46)	99 Percentages of subjects Interval 97.0 to 100.0	49 Percentages of subjects Interval 33.0 to 65.0	53 Percentages of subjects Interval 38.0 to 68.0
Percentages of Subjects With hSBA Titers ≥1:4 Against N. Meningitidis Serogroup B After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group 5 months post 2nd dose (5/99) (N=169, 43, 45)	99 Percentages of subjects Interval 97.0 to 100.0	49 Percentages of subjects Interval 33.0 to 65.0	53 Percentages of subjects Interval 38.0 to 68.0
Percentages of Subjects With hSBA Titers ≥1:4 Against N. Meningitidis Serogroup B After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group 11 months post 2nd dose (5/99) (N=177, 41, 46)	97 Percentages of subjects Interval 94.0 to 99.0	51 Percentages of subjects Interval 35.0 to 67.0	63 Percentages of subjects Interval 48.0 to 77.0
Percentages of Subjects With hSBA Titers ≥1:4 Against N. Meningitidis Serogroup B After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group Baseline NZ98/254	57 Percentages of subjects Interval 50.0 to 64.0	53 Percentages of subjects Interval 38.0 to 67.0	38 Percentages of subjects Interval 25.0 to 53.0
Percentages of Subjects With hSBA Titers ≥1:4 Against N. Meningitidis Serogroup B After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group 1 month post 2nd dose (NZ98/254) (N=189, 45, 48)	99 Percentages of subjects Interval 97.0 to 100.0	53 Percentages of subjects Interval 38.0 to 68.0	44 Percentages of subjects Interval 29.0 to 59.0
Percentages of Subjects With hSBA Titers ≥1:4 Against N. Meningitidis Serogroup B After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group 3 months post 2nd dose (NZ98/254) (N=173, 40, 46)	93 Percentages of subjects Interval 88.0 to 96.0	48 Percentages of subjects Interval 32.0 to 64.0	48 Percentages of subjects Interval 33.0 to 63.0
Percentages of Subjects With hSBA Titers ≥1:4 Against N. Meningitidis Serogroup B After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group 5 months post 2nd dose (NZ98/254) (N=169, 43, 45)	91 Percentages of subjects Interval 85.0 to 94.0	58 Percentages of subjects Interval 42.0 to 73.0	42 Percentages of subjects Interval 28.0 to 58.0
Percentages of Subjects With hSBA Titers ≥1:4 Against N. Meningitidis Serogroup B After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group 11 months post 2nd dose (NZ98/254) (N=177, 41, 46)	85 Percentages of subjects Interval 79.0 to 90.0	66 Percentages of subjects Interval 49.0 to 80.0	43 Percentages of subjects Interval 29.0 to 59.0

SECONDARY outcome

Timeframe: Up to 361 days after vaccination

Population: Analysis was done on the MITT dataset (Immunogenicity subset)

The hSBA Geometric Mean Titers (GMTs) against the three strains of N. meningitidis serogroup B, after rMenB+OMV NZ or MenACWY-CRM vaccination at different time points of the study as compared to the control group are reported.

Outcome measures

Measure	rMenB+OMV n=193 Participants Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart	Control n=49 Participants Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart	Control n=50 Participants Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup B, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. Baseline H44/76	11 Titers Interval 8.74 to 14.0	11 Titers Interval 6.59 to 18.0	9.42 Titers Interval 5.73 to 15.0
The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup B, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. 1 month post 2nd dose (H44/76) (N=189, 45, 48)	229 Titers Interval 192.0 to 274.0	11 Titers Interval 7.92 to 16.0	10 Titers Interval 7.18 to 15.0
The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup B, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. 3 months post 2nd dose (H44/76) (N=173, 40, 46)	144 Titers Interval 116.0 to 178.0	9.07 Titers Interval 5.79 to 14.0	11 Titers Interval 7.07 to 16.0
The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup B, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. 5 months post 2nd dose (H44/76) (N=169, 43, 45)	111 Titers Interval 89.0 to 138.0	12 Titers Interval 7.57 to 18.0	12 Titers Interval 7.62 to 18.0
The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup B, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. 11 months post 2nd dose (H44/76) (N=177, 40, 46)	68 Titers Interval 54.0 to 84.0	14 Titers Interval 8.84 to 22.0	14 Titers Interval 8.97 to 21.0
The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup B, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. Baseline 5/99	6.44 Titers Interval 5.1 to 8.13	3.12 Titers Interval 1.97 to 4.95	5.49 Titers Interval 3.47 to 8.67
The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup B, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. 1 month post 2nd dose (5/99) (N=189, 45, 48)	424 Titers Interval 355.0 to 507.0	2.63 Titers Interval 1.83 to 3.79	5.62 Titers Interval 3.95 to 8.01
The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup B, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. 3 months post 2nd dose (5/99) (N=173, 40, 46)	169 Titers Interval 139.0 to 207.0	2.95 Titers Interval 1.94 to 4.47	5.6 Titers Interval 3.8 to 8.26
The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup B, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. 5 months post 2nd dose (5/99) (N=169, 43, 45)	105 Titers Interval 87.0 to 128.0	3.36 Titers Interval 2.27 to 4.97	5.32 Titers Interval 3.63 to 7.79
The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup B, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. 11 months post 2nd dose (5/99) (N=177, 41, 46)	55 Titers Interval 45.0 to 67.0	3.58 Titers Interval 2.37 to 5.4	5.98 Titers Interval 4.05 to 8.82
The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup B, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. Baseline NZ98/254	6.15 Titers Interval 4.82 to 7.84	4.32 Titers Interval 2.66 to 7.0	4.16 Titers Interval 2.58 to 6.72
The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup B, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. 1 month post 2nd dose (NZ98/254) (N=188, 45, 48)	99 Titers Interval 80.0 to 122.0	4.82 Titers Interval 3.11 to 7.47	3.88 Titers Interval 2.54 to 5.93
The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup B, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. 3 months post 2nd dose (NZ98/254) (N=172, 40, 46)	56 Titers Interval 44.0 to 73.0	4.93 Titers Interval 2.89 to 8.4	4.72 Titers Interval 2.87 to 7.76
The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup B, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. 5 months post 2nd dose (NZ98/254) (N=169, 43, 45)	50 Titers Interval 38.0 to 66.0	6.5 Titers Interval 3.73 to 11.0	4.67 Titers Interval 2.72 to 8.03
The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup B, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. 11 months post 2nd dose (NZ98/254) (N=176, 41, 44)	34 Titers Interval 26.0 to 45.0	7.77 Titers Interval 4.38 to 14.0	6.93 Titers Interval 3.99 to 12.0

SECONDARY outcome

Timeframe: Up to 361 days after vaccination

Population: Analysis was done on the MITT dataset (Immunogenicity subset)

The percentages of subjects with hSBA titers ≥1:8 against N. meningitidis serogroups C and Y, after rMenB+OMV NZ or MenACWY-CRM vaccination at different time points of the study as compared to the control group are reported.

As serogroup A and W strains were not detected in substantial proportion of subjects during pharyngeal carriage analysis, these serogroups were not tested.

Outcome measures

Measure	rMenB+OMV n=193 Participants Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart	Control n=194 Participants Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart	Control n=198 Participants Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
Percentages of Subjects With hSBA Titers ≥1:8 Against N. Meningitidis Serogroup C and Y, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. Baseline Men C (N= 49, 194,50)	90 Percentages of subjects Interval 78.0 to 97.0	87 Percentages of subjects Interval 81.0 to 91.0	80 Percentages of subjects Interval 66.0 to 90.0
Percentages of Subjects With hSBA Titers ≥1:8 Against N. Meningitidis Serogroup C and Y, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. 1 month post 2nd dose (Men C) (N=48, 182, 48)	98 Percentages of subjects Interval 89.0 to 100.0	99 Percentages of subjects Interval 96.0 to 100.0	88 Percentages of subjects Interval 75.0 to 95.0
Percentages of Subjects With hSBA Titers ≥1:8 Against N. Meningitidis Serogroup C and Y, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. 11 months post 2nd dose (Men C) (N=48, 158, 41)	94 Percentages of subjects Interval 83.0 to 99.0	97 Percentages of subjects Interval 93.0 to 99.0	88 Percentages of subjects Interval 74.0 to 96.0
Percentages of Subjects With hSBA Titers ≥1:8 Against N. Meningitidis Serogroup C and Y, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. Baseline Men Y	72 Percentages of subjects Interval 65.0 to 78.0	78 Percentages of subjects Interval 72.0 to 84.0	78 Percentages of subjects Interval 71.0 to 83.0
Percentages of Subjects With hSBA Titers ≥1:8 Against N. Meningitidis Serogroup C and Y, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. 1 month post 2nd dose (Men Y) (N=187, 182, 188)	81 Percentages of subjects Interval 74.0 to 86.0	95 Percentages of subjects Interval 90.0 to 97.0	82 Percentages of subjects Interval 76.0 to 88.0
Percentages of Subjects With hSBA Titers ≥1:8 Against N. Meningitidis Serogroup C and Y, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. 3 months post 2nd dose (Men Y) (N=173,164,175)	79 Percentages of subjects Interval 72.0 to 85.0	95 Percentages of subjects Interval 90.0 to 97.0	82 Percentages of subjects Interval 75.0 to 87.0
Percentages of Subjects With hSBA Titers ≥1:8 Against N. Meningitidis Serogroup C and Y, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. 5 months post 2nd dose (Men Y) (N=170, 165, 170)	78 Percentages of subjects Interval 71.0 to 84.0	92 Percentages of subjects Interval 87.0 to 96.0	84 Percentages of subjects Interval 77.0 to 89.0
Percentages of Subjects With hSBA Titers ≥1:8 Against N. Meningitidis Serogroup C and Y, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. 11 months post 2nd dose (Men Y) (N=177, 158, 165)	77 Percentages of subjects Interval 71.0 to 83.0	91 Percentages of subjects Interval 86.0 to 95.0	81 Percentages of subjects Interval 74.0 to 87.0

SECONDARY outcome

Timeframe: Up to 361 days after vaccination

Population: Analysis was done on the MITT dataset (Immunogenicity subset)

The hSBA antibody titers against N. meningitidis serogroups C and Y after rMenB+OMV NZ or MenACWY-CRM vaccination at different time points of the study as compared to the control group, are reported as GMTs.

Serogroups A and W were not analysed.

Outcome measures

Measure	rMenB+OMV n=193 Participants Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart	Control n=194 Participants Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart	Control n=198 Participants Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup C and Y, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. Baseline Men C (N=49, 194, 50)	43 Titers Interval 26.0 to 70.0	50 Titers Interval 39.0 to 65.0	32 Titers Interval 20.0 to 53.0
The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup C and Y, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. 1 month post 2nd dose (Men C) (N=48, 182, 48)	83 Titers Interval 55.0 to 126.0	1302 Titers Interval 1050.0 to 1615.0	37 Titers Interval 24.0 to 56.0
The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup C and Y, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. 11 months post 2nd dose (MenC) (N=48, 158, 41)	59 Titers Interval 38.0 to 91.0	438 Titers Interval 343.0 to 560.0	41 Titers Interval 25.0 to 66.0
The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup C and Y, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. Baseline Men Y	18 Titers Interval 14.0 to 22.0	19 Titers Interval 15.0 to 23.0	19 Titers Interval 15.0 to 23.0
The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup C and Y, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. 1 month post 2nd dose (Men Y) (N=187, 182, 188)	26 Titers Interval 21.0 to 32.0	83 Titers Interval 67.0 to 103.0	23 Titers Interval 18.0 to 28.0
The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup C and Y, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. 3 months post 2nd dose (Men Y) (N=173, 164, 175)	24 Titers Interval 19.0 to 30.0	69 Titers Interval 56.0 to 86.0	22 Titers Interval 17.0 to 27.0
The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup C and Y, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. 5 months post 2nd dose (Men Y (N=170, 165, 170)	23 Titers Interval 19.0 to 29.0	63 Titers Interval 51.0 to 78.0	22 Titers Interval 18.0 to 28.0
The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup C and Y, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. 11 months post 2nd dose (Men Y) (N=177, 158, 165)	21 Titers Interval 17.0 to 26.0	49 Titers Interval 39.0 to 61.0	22 Titers Interval 17.0 to 27.0

SECONDARY outcome

Timeframe: 61 days

Population: Analysis was done on the MITT dataset (Immunogenicity subset)

The percentages of subjects with hSBA seroresponse against N. meningitidis serogroups C and Y, after rMenB+OMV NZ or MenACWY-CRM vaccination as compared to the control group are reported.

Seroresponse to N. meningitidis serogroups Cand Y is defined as :(1)for subjects with a pre-vaccination hSBA titer < 1:4 to a post-vaccination hSBA titer ≥ 1:8 or (2) for subjects with a pre-vaccination hSBA titer ≥ 1:4, an increase in hSBA titer of at least four times the pre-vaccination titer.

Analysis was not done for serogroups A and W.

Outcome measures

Measure	rMenB+OMV n=187 Participants Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart	Control n=181 Participants Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart	Control n=188 Participants Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups C and Y After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group. 1 month post 2nd dose from day 1(Men C)N=48,181,48	8 Percentages of subjects Interval 2.0 to 20.0	81 Percentages of subjects Interval 75.0 to 87.0	4 Percentages of subjects Interval 1.0 to 14.0
Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups C and Y After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group. 1 month post 2nd dose from day 1(Men Y)	12 Percentages of subjects Interval 8.0 to 17.0	44 Percentages of subjects Interval 37.0 to 52.0	7 Percentages of subjects Interval 4.0 to 12.0

SECONDARY outcome

Timeframe: Up to 361 days after vaccination

Population: Analysis was done on the MITT dataset (Immunogenicity subset)

The hSBA geometric mean titers against the N. meningitidis serogroups C and Y in subjects (who have received a prior dose of MenC vaccine) after MenACWY-CRM vaccination at different time points of the study as compared to the control group are reported.

Analysis was not done for serogroups A and W.

Outcome measures

Measure	rMenB+OMV n=46 Participants Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart	Control n=26 Participants Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart	Control Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
The hSBA Geometric Mean Titers Against N. Meningitidis Serogroups C and Y in Subjects (Who Have Received a Prior Dose of MenC Vaccine) After Vaccination With MenACWY-CRM in This Study Compared to Control Group 3 months post 2nd vaccination (Men Y) (N=42, 25)	67 Titers Interval 41.0 to 110.0	20 Titers Interval 11.0 to 38.0	—
The hSBA Geometric Mean Titers Against N. Meningitidis Serogroups C and Y in Subjects (Who Have Received a Prior Dose of MenC Vaccine) After Vaccination With MenACWY-CRM in This Study Compared to Control Group 5 months post 2nd vaccination (Men Y) (N=45, 26)	65 Titers Interval 41.0 to 103.0	20 Titers Interval 11.0 to 37.0	—
The hSBA Geometric Mean Titers Against N. Meningitidis Serogroups C and Y in Subjects (Who Have Received a Prior Dose of MenC Vaccine) After Vaccination With MenACWY-CRM in This Study Compared to Control Group 11 months post 2nd vaccination (Men Y) (N=45, 26)	48 Titers Interval 31.0 to 76.0	22 Titers Interval 12.0 to 39.0	—
The hSBA Geometric Mean Titers Against N. Meningitidis Serogroups C and Y in Subjects (Who Have Received a Prior Dose of MenC Vaccine) After Vaccination With MenACWY-CRM in This Study Compared to Control Group Baseline (Men Y)	21 Titers Interval 13.0 to 32.0	23 Titers Interval 13.0 to 41.0	—
The hSBA Geometric Mean Titers Against N. Meningitidis Serogroups C and Y in Subjects (Who Have Received a Prior Dose of MenC Vaccine) After Vaccination With MenACWY-CRM in This Study Compared to Control Group 1 month post 2nd vaccination (Men Y) (N=45, 26)	89 Titers Interval 55.0 to 142.0	19 Titers Interval 10.0 to 36.0	—
The hSBA Geometric Mean Titers Against N. Meningitidis Serogroups C and Y in Subjects (Who Have Received a Prior Dose of MenC Vaccine) After Vaccination With MenACWY-CRM in This Study Compared to Control Group Baseline (Men C) (N=46, 6)	91 Titers Interval 51.0 to 160.0	157 Titers Interval 33.0 to 756.0	—
The hSBA Geometric Mean Titers Against N. Meningitidis Serogroups C and Y in Subjects (Who Have Received a Prior Dose of MenC Vaccine) After Vaccination With MenACWY-CRM in This Study Compared to Control Group 1 month post 2nd vaccination (Men C) (N=45, 6)	1905 Titers Interval 1305.0 to 2779.0	154 Titers Interval 55.0 to 434.0	—
The hSBA Geometric Mean Titers Against N. Meningitidis Serogroups C and Y in Subjects (Who Have Received a Prior Dose of MenC Vaccine) After Vaccination With MenACWY-CRM in This Study Compared to Control Group 11 months post 2nd vaccination (Men C) (N=45, 6)	691 Titers Interval 464.0 to 1028.0	125 Titers Interval 42.0 to 371.0	—

SECONDARY outcome

Timeframe: Up to 361 days after vaccination

Population: Analysis was done on the MITT dataset (Immunogenicity subset)

The percentages of subjects (who have received a prior dose of MenC vaccine) with hSBA titers ≥1:8 against N. meningitidis serogroups C and Y after receiving MenACWY-CRM vaccination in this study as compared to the control group are reported.

Analysis was not done for serogroups A and W.

Outcome measures

Measure	rMenB+OMV n=46 Participants Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart	Control n=26 Participants Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart	Control Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
Percentages of Subjects (Who Have Received a Prior Dose of MenC Vaccine) With hSBA Titers ≥1:8 Against N. Meningitidis Serogroups C and Y After Vaccination With MenACWY-CRM in This Study Compared to Control Group. Baseline (Men C) (N=46,6)	93 Percentages of subjects Interval 82.0 to 99.0	100 Percentages of subjects Interval 54.0 to 100.0	—
Percentages of Subjects (Who Have Received a Prior Dose of MenC Vaccine) With hSBA Titers ≥1:8 Against N. Meningitidis Serogroups C and Y After Vaccination With MenACWY-CRM in This Study Compared to Control Group. Baseline (Men Y)	80 Percentages of subjects Interval 66.0 to 91.0	81 Percentages of subjects Interval 61.0 to 93.0	—
Percentages of Subjects (Who Have Received a Prior Dose of MenC Vaccine) With hSBA Titers ≥1:8 Against N. Meningitidis Serogroups C and Y After Vaccination With MenACWY-CRM in This Study Compared to Control Group. 1 month post 2nd vaccination (Men C) (N=45, 6)	100 Percentages of subjects Interval 92.0 to 100.0	100 Percentages of subjects Interval 54.0 to 100.0	—
Percentages of Subjects (Who Have Received a Prior Dose of MenC Vaccine) With hSBA Titers ≥1:8 Against N. Meningitidis Serogroups C and Y After Vaccination With MenACWY-CRM in This Study Compared to Control Group. 11 months post 2nd vaccination (Men C) (N=45, 6)	100 Percentages of subjects Interval 92.0 to 100.0	100 Percentages of subjects Interval 54.0 to 100.0	—
Percentages of Subjects (Who Have Received a Prior Dose of MenC Vaccine) With hSBA Titers ≥1:8 Against N. Meningitidis Serogroups C and Y After Vaccination With MenACWY-CRM in This Study Compared to Control Group. 1 month post 2nd vaccination (Men Y) (N=45, 26)	96 Percentages of subjects Interval 85.0 to 99.0	77 Percentages of subjects Interval 56.0 to 91.0	—
Percentages of Subjects (Who Have Received a Prior Dose of MenC Vaccine) With hSBA Titers ≥1:8 Against N. Meningitidis Serogroups C and Y After Vaccination With MenACWY-CRM in This Study Compared to Control Group. 3 months post 2nd vaccination (Men Y) (N=42, 25)	95 Percentages of subjects Interval 84.0 to 99.0	80 Percentages of subjects Interval 59.0 to 93.0	—
Percentages of Subjects (Who Have Received a Prior Dose of MenC Vaccine) With hSBA Titers ≥1:8 Against N. Meningitidis Serogroups C and Y After Vaccination With MenACWY-CRM in This Study Compared to Control Group. 5 months post 2nd vaccination (Men Y) (N=45, 26)	96 Percentages of subjects Interval 85.0 to 99.0	77 Percentages of subjects Interval 56.0 to 91.0	—
Percentages of Subjects (Who Have Received a Prior Dose of MenC Vaccine) With hSBA Titers ≥1:8 Against N. Meningitidis Serogroups C and Y After Vaccination With MenACWY-CRM in This Study Compared to Control Group. 11 months post 2nd vaccination (Men Y) (N=45, 26)	91 Percentages of subjects Interval 79.0 to 98.0	77 Percentages of subjects Interval 56.0 to 91.0	—

SECONDARY outcome

Timeframe: Day 1 through day 7 after any vaccination

Population: Analysis was done on the Immunogenicity Subset, Safety Population i.e. all subjects in the exposed population who provided postvaccination safety data.

The safety and tolerability of two doses of rMenB+OMV NZ vaccine (Group rMenB+OMV) and one dose of MenACWY-CRM vaccine (Group MenACWY) was assessed in terms of number of subjects with solicited local and systemic adverse events and other adverse events, following vaccination and compared to that of the control group.

Outcome measures

Measure	rMenB+OMV n=190 Participants Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart	Control n=187 Participants Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart	Control n=191 Participants Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group Any local	184 number of subjects	158 number of subjects	139 number of subjects
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group Injection site pain (N=190, 186,191)	181 number of subjects	143 number of subjects	117 number of subjects
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group Injection site erythema (N=190, 186, 191)	100 number of subjects	71 number of subjects	61 number of subjects
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group Injection site induration (N=190, 186, 191)	68 number of subjects	41 number of subjects	21 number of subjects
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group Injection site swelling (N=190, 186, 191)	68 number of subjects	31 number of subjects	23 number of subjects
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group Any systemic	169 number of subjects	133 number of subjects	140 number of subjects
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group Arthralgia (N=190, 186, 191)	38 number of subjects	27 number of subjects	29 number of subjects
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group Nausea (N=190, 186, 191)	36 number of subjects	23 number of subjects	24 number of subjects
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group Malaise (N=190, 186, 191)	57 number of subjects	41 number of subjects	46 number of subjects
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group Myalgia (N=190, 186, 191)	155 number of subjects	117 number of subjects	112 number of subjects
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group Headache (N=190, 186, 191)	71 number of subjects	56 number of subjects	75 number of subjects
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group Rash (N=190, 186, 191)	9 number of subjects	9 number of subjects	12 number of subjects
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group Fever (≥38°C) (N= 190, 186,191)	7 number of subjects	5 number of subjects	7 number of subjects
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group Any Other	64 number of subjects	22 number of subjects	25 number of subjects
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group Temperature (≥40°C) (N= 190, 186, 191)	0 number of subjects	0 number of subjects	0 number of subjects
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group Antipyretic preventive med. used (N=190, 186, 191)	20 number of subjects	7 number of subjects	3 number of subjects
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group Antipyretic treatment med. used (N=190, 186, 191)	55 number of subjects	17 number of subjects	22 number of subjects

Adverse Events

rMenB+OMV

Serious events: 31 serious events

Other events: 200 other events

Deaths: 0 deaths

MenACWY

Serious events: 26 serious events

Other events: 186 other events

Deaths: 0 deaths

Control

Serious events: 20 serious events

Other events: 172 other events

Deaths: 0 deaths

Serious adverse events

Measure	rMenB+OMV n=974 participants at risk Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart	MenACWY n=984 participants at risk Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart	Control n=985 participants at risk Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
Cardiac disorders Palpitations	0.00% 0/974 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.10% 1/984 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/985 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.
Endocrine disorders Thyroiditis acute	0.10% 1/974 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/984 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/985 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.
Gastrointestinal disorders Abdominal pain	0.10% 1/974 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.30% 3/984 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/985 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.
General disorders Edema peripheral	0.10% 1/974 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/984 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/985 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.
General disorders Pyrexia	0.00% 0/974 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.10% 1/984 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/985 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.
Immune system disorders Anaphylactic reaction	0.10% 1/974 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.10% 1/984 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/985 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.
Infections and infestations Acute tonsillitis	0.00% 0/974 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.10% 1/984 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/985 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.
Infections and infestations Appendiceal abscess	0.10% 1/974 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/984 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/985 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.
Infections and infestations Appendicitis	0.10% 1/974 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.30% 3/984 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.10% 1/985 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.
Infections and infestations Cellulitis	0.10% 1/974 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/984 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/985 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.
Infections and infestations Diarrhea infectious	0.00% 0/974 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/984 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.10% 1/985 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.
Infections and infestations Gastroenteritis	0.00% 0/974 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/984 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.10% 1/985 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.
Infections and infestations Gastroenteritis viral	0.10% 1/974 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/984 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/985 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.
Infections and infestations Genital abscess	0.00% 0/974 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.10% 1/984 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/985 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.
Infections and infestations Infectious mononucleosis	0.00% 0/974 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/984 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.10% 1/985 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.
Infections and infestations Influenza	0.00% 0/974 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/984 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.10% 1/985 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.
Infections and infestations Kidney infection	0.00% 0/974 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.10% 1/984 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/985 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.
Infections and infestations Leptospirosis	0.00% 0/974 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/984 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.10% 1/985 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.
Infections and infestations Pelvic inflammatory disease	0.10% 1/974 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/984 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/985 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.
Infections and infestations Peritonitis	0.10% 1/974 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/984 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/985 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.
Infections and infestations Peritonsillar abscess	0.10% 1/974 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/984 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.10% 1/985 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.
Infections and infestations Pilonidal cyst	0.00% 0/974 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.20% 2/984 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/985 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.
Infections and infestations Pyelonephritis	0.31% 3/974 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/984 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/985 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.
Infections and infestations Tonsillitis	0.21% 2/974 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/984 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/985 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.
Infections and infestations Tracheitis	0.00% 0/974 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/984 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.10% 1/985 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.
Infections and infestations Upper respiratory tract infection	0.00% 0/974 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.10% 1/984 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/985 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.
Infections and infestations Urinary tract infection	0.21% 2/974 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/984 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/985 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.
Infections and infestations Varicella	0.00% 0/974 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/984 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.10% 1/985 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.
Infections and infestations Viral infection	0.00% 0/974 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/984 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.10% 1/985 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.
Infections and infestations Viral pharyngitis	0.10% 1/974 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/984 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/985 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.
Infections and infestations Viral rash	0.10% 1/974 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/984 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/985 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/974 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/984 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.10% 1/985 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.
Injury, poisoning and procedural complications Burns third degree	0.00% 0/974 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.10% 1/984 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/985 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.
Injury, poisoning and procedural complications Cartilage injury	0.10% 1/974 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/984 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/985 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.
Injury, poisoning and procedural complications Clavicle fracture	0.00% 0/974 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.10% 1/984 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/985 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.
Injury, poisoning and procedural complications Contusion	0.00% 0/974 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.10% 1/984 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/985 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.
Injury, poisoning and procedural complications Facial bones fracture	0.00% 0/974 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/984 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.10% 1/985 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.
Injury, poisoning and procedural complications Fall	0.00% 0/974 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.10% 1/984 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/985 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.
Injury, poisoning and procedural complications Fibula fracture	0.00% 0/974 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.10% 1/984 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/985 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.
Injury, poisoning and procedural complications Foot fracture	0.10% 1/974 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/984 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/985 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.
Injury, poisoning and procedural complications Forearm fracture	0.00% 0/974 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/984 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.10% 1/985 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.
Injury, poisoning and procedural complications Head injury	0.00% 0/974 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.10% 1/984 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/985 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.
Injury, poisoning and procedural complications Jaw fracture	0.00% 0/974 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.10% 1/984 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/985 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.
Injury, poisoning and procedural complications Joint dislocation	0.00% 0/974 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.10% 1/984 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/985 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.
Injury, poisoning and procedural complications Joint injury	0.00% 0/974 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.10% 1/984 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.10% 1/985 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.
Injury, poisoning and procedural complications Laceration	0.10% 1/974 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/984 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/985 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.
Injury, poisoning and procedural complications Ligament rupture	0.00% 0/974 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.10% 1/984 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.10% 1/985 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.
Injury, poisoning and procedural complications Lower limb fracture	0.00% 0/974 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/984 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.10% 1/985 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.00% 0/974 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/984 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.10% 1/985 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.
Injury, poisoning and procedural complications Meniscus lesion	0.00% 0/974 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.10% 1/984 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/985 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.
Injury, poisoning and procedural complications Multiple drug overdose	0.10% 1/974 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/984 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/985 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.
Injury, poisoning and procedural complications Overdose	0.00% 0/974 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/984 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.10% 1/985 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.
Injury, poisoning and procedural complications Patella fracture	0.00% 0/974 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/984 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.10% 1/985 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.
Injury, poisoning and procedural complications Pelvic fracture	0.00% 0/974 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.10% 1/984 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.10% 1/985 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/974 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/984 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.10% 1/985 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.
Injury, poisoning and procedural complications Spinal fracture	0.10% 1/974 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/984 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/985 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.
Injury, poisoning and procedural complications Tendon rupture	0.00% 0/974 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/984 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.10% 1/985 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.
Injury, poisoning and procedural complications Tibia fracture	0.10% 1/974 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/984 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/985 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.
Injury, poisoning and procedural complications Traumatic fracture	0.00% 0/974 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.10% 1/984 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/985 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.
Injury, poisoning and procedural complications Traumatic liver injury	0.00% 0/974 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/984 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.10% 1/985 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.
Injury, poisoning and procedural complications Ulna fracture	0.00% 0/974 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/984 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.10% 1/985 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.
Metabolism and nutrition disorders Hypoglycaemia	0.10% 1/974 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/984 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/985 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/974 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.10% 1/984 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/985 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.
Musculoskeletal and connective tissue disorders Muscloskeletal chest pain	0.00% 0/974 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.10% 1/984 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.10% 1/985 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Carcinoid tumor pulmonary	0.10% 1/974 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/984 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/985 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian germ cell cancer stage IV	0.10% 1/974 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/984 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/985 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.
Nervous system disorders Convulsion	0.10% 1/974 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.10% 1/984 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/985 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.
Nervous system disorders Migraine	0.00% 0/974 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.10% 1/984 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/985 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.
Nervous system disorders Tremor	0.10% 1/974 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/984 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/985 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.
Pregnancy, puerperium and perinatal conditions Ectopic pregnancy	0.10% 1/974 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/984 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/985 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.
Psychiatric disorders Suicidal ideation	0.10% 1/974 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/984 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/985 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.
Renal and urinary disorders IGA Nephropathy	0.00% 0/974 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.10% 1/984 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/985 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.
Renal and urinary disorders Pelvic-ureteric obstruction	0.00% 0/974 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.10% 1/984 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/985 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.
Reproductive system and breast disorders Cervical dysplasia	0.10% 1/974 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/984 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/985 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.
Reproductive system and breast disorders Vulval disorder	0.10% 1/974 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/984 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/985 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/974 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.20% 2/984 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/985 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.10% 1/974 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/984 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/985 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/974 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/984 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.10% 1/985 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/974 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.10% 1/984 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/985 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.
Surgical and medical procedures Appendicectomy	0.00% 0/974 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.10% 1/984 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.10% 1/985 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.
Surgical and medical procedures Ligament operation	0.10% 1/974 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/984 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	0.00% 0/985 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.

Other adverse events

Measure	rMenB+OMV n=974 participants at risk Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart	MenACWY n=984 participants at risk Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart	Control n=985 participants at risk Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
General disorders Injection site erythema	10.5% 102/974 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	7.2% 71/984 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	6.2% 61/985 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.
General disorders Injection site induration	7.0% 68/974 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	4.3% 42/984 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	2.1% 21/985 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.
General disorders Injection site pain	18.7% 182/974 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	14.7% 145/984 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	11.9% 117/985 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.
General disorders Injection site swelling	7.0% 68/974 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	3.3% 32/984 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	2.3% 23/985 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.
General disorders Malaise	6.0% 58/974 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	4.4% 43/984 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	4.8% 47/985 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.
Musculoskeletal and connective tissue disorders Myalgia	15.9% 155/974 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	12.1% 119/984 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	11.4% 112/985 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.
Nervous system disorders Headache	8.4% 82/974 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	6.8% 67/984 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.	8.6% 85/985 • Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361) The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.

Additional Information

Posting Director

Novartis Vaccines and Diagnostics

Email: RegistryContactVaccinesUS@novartis.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60