Trial Outcomes & Findings for A Study to Evaluate 4-year Antibody Persistence and Booster Response Following MenABCWY Vaccination in Healthy Adolescents and Young Adults Who Previously Participated in Studies V102_02 (NCT01210885) and V102_02E1 (NCT01367158) (NCT NCT02451514)

Last Updated: 2020-07-09

Results Overview

The HT-hSBA assay format was changed in 2015 in response to CBER comments and no new LLQ values were defined as the validation of this format was not relevant. The LLQ cut off values for the old assay format correspond to 8 for serogroups A,C,W and Y and 5 for serogroup B strains and these results are presented in outcome measures 2 and 3 and are considered final in Company's judgement.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

129 participants

Primary outcome timeframe

At Day 1 (4 years persistence)

Results posted on

2020-07-09

Participant Flow

Subjects were recruited from 5 sites in Panama, 3 sites in Colombia and 1 site in Chile.

Healthy adolescents and young adults, who received 2 doses of MenABCWY+OMV vaccine or 1 dose of MenACWY in the parent study V102\_02 (NCT01210885) and only Tdap vaccination in study V102\_02E1 (NCT01367158) were included in the present study along with Naive subjects of similar age.

Participant milestones

Participant milestones
Measure	Naive Group Subjects similar in age to subjects in the MenABCWY+OMV and MenACWY groups, who had not previously received any meningococcal vaccine and who received 2 doses of MenABCWY+OMV vaccine, 1 month apart (Day 1 and Day 31), in the current study.	MenABCWY+OMV Group Subjects who received 2 doses of MenABCWY+OMV vaccine in the parent study V102\_02 (NCT01210885) and received no subsequent meningococcal vaccines, received a booster dose of MenABCWY+OMV vaccine in the current study at Day 1.	MenACWY Group Subjects who received MenACWY vaccine in the parent study V102\_02 (NCT01210885) and received no subsequent meningococcal vaccines, received 2 doses of MenABCWY+OMV vaccine, one month apart (Day 1 and Day 31), in the current study.
Overall Study STARTED	50	33	46
Overall Study COMPLETED	50	33	46
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to Evaluate 4-year Antibody Persistence and Booster Response Following MenABCWY Vaccination in Healthy Adolescents and Young Adults Who Previously Participated in Studies V102_02 (NCT01210885) and V102_02E1 (NCT01367158)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MenABCWY+OMV Group n=33 Participants Subjects who received 2 doses of MenABCWY+OMV vaccine in the parent study V102\_02 (NCT01210885) and received no subsequent meningococcal vaccines, received a booster dose of MenABCWY+OMV vaccine in the current study at Day 1.	MenACWY Group n=46 Participants Subjects who received MenACWY vaccine in the parent study V102\_02 (NCT01210885) and received no subsequent meningococcal vaccines, received 2 doses of MenABCWY+OMV vaccine, one month apart (Day 1 and Day 31), in the current study.	Naive Group n=50 Participants Subjects similar in age to subjects in the MenABCWY+OMV and MenACWY groups, who had not previously received any meningococcal vaccine and who received 2 doses of MenABCWY+OMV vaccine, 1 month apart (Day 1 and Day 31), in the current study.	Total n=129 Participants Total of all reporting groups
Age, Continuous	18.61 Years STANDARD_DEVIATION 2.207 • n=5 Participants	18.72 Years STANDARD_DEVIATION 1.87 • n=7 Participants	17.96 Years STANDARD_DEVIATION 2.04 • n=5 Participants	18.4 Years STANDARD_DEVIATION 2.04 • n=4 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	27 Participants n=7 Participants	25 Participants n=5 Participants	74 Participants n=4 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	19 Participants n=7 Participants	25 Participants n=5 Participants	55 Participants n=4 Participants
Race/Ethnicity, Customized Race · American Indian or Alaska Native	2 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	9 Participants n=4 Participants
Race/Ethnicity, Customized Race · Black or African American	4 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	10 Participants n=4 Participants
Race/Ethnicity, Customized Race · White	7 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants	19 Participants n=4 Participants
Race/Ethnicity, Customized Race · Other	20 Participants n=5 Participants	34 Participants n=7 Participants	37 Participants n=5 Participants	91 Participants n=4 Participants

PRIMARY outcome

Timeframe: At Day 1 (4 years persistence)

Population: Data was not collected for this outcome measure as validation procedure of the hSBA assay was not relevant to the study.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: At Day 1 (4 years persistence)

Population: Analysis was performed on Full Analysis Set immunogenicity persistence population set- all subjects in the enrolled population who provided at least one evaluable serum sample at baseline (visit 1 in this study) and whose assay result was available for at least one strain.

Antibody levels against N. meningitidis serogroups A, C, W and Y in subjects who previously received MenABCWY+OMV or MenACWY approximately 4 years earlier, and in Naïve subjects as measured by the percentages of subjects with hSBA ≥ 8.

Outcome measures

Outcome measures
Measure	MenABCWY+OMV Group n=33 Participants Subjects who received 2 doses of MenABCWY+OMV vaccine in the parent study V102\_02 (NCT01210885) and received no subsequent meningococcal vaccines, received a booster dose of MenABCWY+OMV vaccine in the current study at Day 1.	MenACWY Group n=46 Participants Subjects who received MenACWY vaccine in the parent study V102\_02 (NCT01210885) and received no subsequent meningococcal vaccines, received 2 doses of MenABCWY+OMV vaccine, one month apart (Day 1 and Day 31), in the current study.	Naive Group n=50 Participants Subjects similar in age to subjects in the MenABCWY+OMV and MenACWY groups, who had not previously received any meningococcal vaccine and who received 2 doses of MenABCWY+OMV vaccine, 1 month apart (Day 1 and Day 31), in the current study.	Naive Group (C1) Subjects similar in age to subjects in the MenABCWY+OMV and MenACWY groups, who had not previously received any meningococcal vaccine and who received 2 doses of MenABCWY+OMV vaccine, 1 month apart (Day 1 and Day 31), in the current study. Blood samples will be collected from subjects at Day 1 (before vaccination), Day 31 (before vaccination), Day 34 and Day 61.	Naive Group (C2) Subjects similar in age to subjects in the MenABCWY+OMV and MenACWY groups, who had not previously received any meningococcal vaccine and who received 2 doses of MenABCWY+OMV vaccine, 1 month apart (Day 1 and Day 31), in the current study. Blood samples will be collected from subjects at Day 1 (before vaccination), Day 31 (before vaccination), Day 38 and Day 61.
Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. Serogroup A	27 Percentages of subjects Interval 13.3 to 45.5	41 Percentages of subjects Interval 27.0 to 56.8	2 Percentages of subjects Interval 0.05 to 10.6	—	—
Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. Serogroup C	69 Percentages of subjects Interval 50.0 to 83.9	43 Percentages of subjects Interval 28.9 to 58.9	45 Percentages of subjects Interval 30.7 to 59.8	—	—
Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. Serogroup W	75 Percentages of subjects Interval 56.6 to 88.5	78 Percentages of subjects Interval 63.6 to 89.1	53 Percentages of subjects Interval 38.1 to 67.9	—	—
Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. Serogroup Y	38 Percentages of subjects Interval 21.1 to 56.3	59 Percentages of subjects Interval 43.2 to 73.7	19 Percentages of subjects Interval 9.1 to 33.3	—	—

PRIMARY outcome

Timeframe: At Day 1 (4 years persistence)

Antibody levels against N. meningitidis serogroup B test strains in subjects who previously received MenABCWY+OMV or MenACWY approximately 4 years earlier, and in Naïve subjects as measured by the percentages of Subjects with hSBA ≥ 5. The Meningococcal B Strains were M14459, M01-0240364, NZ98/254, M10713, H44/76 and 5/99.

Outcome measures

Outcome measures
Measure	MenABCWY+OMV Group n=33 Participants Subjects who received 2 doses of MenABCWY+OMV vaccine in the parent study V102\_02 (NCT01210885) and received no subsequent meningococcal vaccines, received a booster dose of MenABCWY+OMV vaccine in the current study at Day 1.	MenACWY Group n=46 Participants Subjects who received MenACWY vaccine in the parent study V102\_02 (NCT01210885) and received no subsequent meningococcal vaccines, received 2 doses of MenABCWY+OMV vaccine, one month apart (Day 1 and Day 31), in the current study.	Naive Group n=50 Participants Subjects similar in age to subjects in the MenABCWY+OMV and MenACWY groups, who had not previously received any meningococcal vaccine and who received 2 doses of MenABCWY+OMV vaccine, 1 month apart (Day 1 and Day 31), in the current study.	Naive Group (C1) Subjects similar in age to subjects in the MenABCWY+OMV and MenACWY groups, who had not previously received any meningococcal vaccine and who received 2 doses of MenABCWY+OMV vaccine, 1 month apart (Day 1 and Day 31), in the current study. Blood samples will be collected from subjects at Day 1 (before vaccination), Day 31 (before vaccination), Day 34 and Day 61.	Naive Group (C2) Subjects similar in age to subjects in the MenABCWY+OMV and MenACWY groups, who had not previously received any meningococcal vaccine and who received 2 doses of MenABCWY+OMV vaccine, 1 month apart (Day 1 and Day 31), in the current study. Blood samples will be collected from subjects at Day 1 (before vaccination), Day 31 (before vaccination), Day 38 and Day 61.
Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. Serogroup B, M14459	18 Percentages of subjects Interval 7.0 to 35.5	4 Percentages of subjects Interval 0.5 to 14.8	8 Percentages of subjects Interval 2.2 to 19.2	—	—
Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. Serogroup B, M01-0240364	13 Percentages of subjects Interval 3.6 to 29.8	5 Percentages of subjects Interval 0.6 to 15.5	4 Percentages of subjects Interval 0.49 to 13.7	—	—
Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. Serogroup B, NZ98/254	15 Percentages of subjects Interval 5.1 to 31.9	2 Percentages of subjects Interval 0.06 to 11.5	6 Percentages of subjects Interval 1.3 to 16.5	—	—
Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. Serogroup B, M10713	48 Percentages of subjects Interval 30.8 to 66.5	33 Percentages of subjects Interval 19.5 to 48.0	38 Percentages of subjects Interval 24.7 to 52.8	—	—
Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. Serogroup B, H44/76	27 Percentages of subjects Interval 13.3 to 45.5	4 Percentages of subjects Interval 0.5 to 14.8	10 Percentages of subjects Interval 3.3 to 21.8	—	—
Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. Serogroup B, 5/99	70 Percentages of subjects Interval 51.3 to 84.4	17 Percentages of subjects Interval 7.8 to 31.4	16 Percentages of subjects Interval 7.2 to 29.1	—	—

PRIMARY outcome

Timeframe: At Day 1

GMTs against N. meningitidis serogroups A, C, W and Y and serogroup B test strains in subjects who previously received MenABCWY+OMV or MenACWY approximately 4 years earlier, and in Naïve subjects. The Meningococcal B Strains were M14459, M01-0240364, NZ98/254, M10713, H44/76 and 5/99.

Outcome measures

Outcome measures
Measure	MenABCWY+OMV Group n=33 Participants Subjects who received 2 doses of MenABCWY+OMV vaccine in the parent study V102\_02 (NCT01210885) and received no subsequent meningococcal vaccines, received a booster dose of MenABCWY+OMV vaccine in the current study at Day 1.	MenACWY Group n=46 Participants Subjects who received MenACWY vaccine in the parent study V102\_02 (NCT01210885) and received no subsequent meningococcal vaccines, received 2 doses of MenABCWY+OMV vaccine, one month apart (Day 1 and Day 31), in the current study.	Naive Group n=50 Participants Subjects similar in age to subjects in the MenABCWY+OMV and MenACWY groups, who had not previously received any meningococcal vaccine and who received 2 doses of MenABCWY+OMV vaccine, 1 month apart (Day 1 and Day 31), in the current study.	Naive Group (C1) Subjects similar in age to subjects in the MenABCWY+OMV and MenACWY groups, who had not previously received any meningococcal vaccine and who received 2 doses of MenABCWY+OMV vaccine, 1 month apart (Day 1 and Day 31), in the current study. Blood samples will be collected from subjects at Day 1 (before vaccination), Day 31 (before vaccination), Day 34 and Day 61.	Naive Group (C2) Subjects similar in age to subjects in the MenABCWY+OMV and MenACWY groups, who had not previously received any meningococcal vaccine and who received 2 doses of MenABCWY+OMV vaccine, 1 month apart (Day 1 and Day 31), in the current study. Blood samples will be collected from subjects at Day 1 (before vaccination), Day 31 (before vaccination), Day 38 and Day 61.
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup W	28 Titers Interval 15.0 to 53.0	25 Titers Interval 15.0 to 40.0	8.37 Titers Interval 4.78 to 15.0	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, M14459	2.04 Titers Interval 1.46 to 2.83	1.37 Titers Interval 1.12 to 1.69	1.48 Titers Interval 1.18 to 1.85	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, M01-0240364	2.26 Titers Interval 1.26 to 4.08	1.14 Titers Interval 0.97 to 1.35	1.23 Titers Interval 1.02 to 1.47	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, NZ98/254	1.81 Titers Interval 1.3 to 2.51	1.35 Titers Interval 1.15 to 1.59	1.45 Titers Interval 1.18 to 1.77	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, M10713	3.66 Titers Interval 2.38 to 5.62	2.56 Titers Interval 1.74 to 3.75	3.10 Titers Interval 2.16 to 4.45	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, H44/76	2.33 Titers Interval 1.57 to 3.45	1.21 Titers Interval 1.03 to 1.42	1.44 Titers Interval 1.14 to 1.8	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, 5/99	13 Titers Interval 7.29 to 22.0	1.78 Titers Interval 1.36 to 2.34	1.90 Titers Interval 1.42 to 2.53	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup A	4.06 Titers Interval 2.22 to 7.44	6.64 Titers Interval 3.56 to 12.0	1.20 Titers Interval 1.05 to 1.37	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup C	17 Titers Interval 7.8 to 37.0	6.62 Titers Interval 4.1 to 11.0	5.11 Titers Interval 3.49 to 7.48	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup Y	6.17 Titers Interval 3.0 to 13.0	12 Titers Interval 6.29 to 22.0	2.00 Titers Interval 1.4 to 2.85	—	—

PRIMARY outcome

Timeframe: At Day 31

Population: Data was not collected for this outcome measure as validation procedure of the hSBA assay was not relevant to the study.

The HT-hSBA assay format was changed in 2015 in response to CBER comments and no new LLQ values were defined as the validation of this format was not relevant. The LLQ cut off values for the old assay format correspond to 8 for serogroups A,C,W and Y and 5 for serogroup B strains and these results are presented in outcome measures 6 and 7 and are considered final in Company's judgement.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: At Day 31

Population: Analysis was performed on Full Analysis Set immunogenicity persistence population set Day 31- all subjects in the enrolled population who received a study vaccination, provided at least one evaluable serum sample at 1 month post vaccination and whose assay result was available for at least one strain.

Immune response against N. meningitidis serogroups A, C, W and Y 30 days after a single dose of MenABCWY+OMV in subjects who previously vaccinated subjects, and in Naïve subjects of similar age, as measured by the percentages of subjects with hSBA ≥ 8.

Outcome measures

Outcome measures
Measure	MenABCWY+OMV Group n=33 Participants Subjects who received 2 doses of MenABCWY+OMV vaccine in the parent study V102\_02 (NCT01210885) and received no subsequent meningococcal vaccines, received a booster dose of MenABCWY+OMV vaccine in the current study at Day 1.	MenACWY Group n=46 Participants Subjects who received MenACWY vaccine in the parent study V102\_02 (NCT01210885) and received no subsequent meningococcal vaccines, received 2 doses of MenABCWY+OMV vaccine, one month apart (Day 1 and Day 31), in the current study.	Naive Group n=50 Participants Subjects similar in age to subjects in the MenABCWY+OMV and MenACWY groups, who had not previously received any meningococcal vaccine and who received 2 doses of MenABCWY+OMV vaccine, 1 month apart (Day 1 and Day 31), in the current study.	Naive Group (C1) Subjects similar in age to subjects in the MenABCWY+OMV and MenACWY groups, who had not previously received any meningococcal vaccine and who received 2 doses of MenABCWY+OMV vaccine, 1 month apart (Day 1 and Day 31), in the current study. Blood samples will be collected from subjects at Day 1 (before vaccination), Day 31 (before vaccination), Day 34 and Day 61.	Naive Group (C2) Subjects similar in age to subjects in the MenABCWY+OMV and MenACWY groups, who had not previously received any meningococcal vaccine and who received 2 doses of MenABCWY+OMV vaccine, 1 month apart (Day 1 and Day 31), in the current study. Blood samples will be collected from subjects at Day 1 (before vaccination), Day 31 (before vaccination), Day 38 and Day 61.
Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. Serogroup A	100 Percentage of Subjects Interval 89.4 to 100.0	100 Percentage of Subjects Interval 92.3 to 100.0	76 Percentage of Subjects Interval 61.8 to 86.9	—	—
Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. Serogroup C	100 Percentage of Subjects Interval 88.4 to 100.0	100 Percentage of Subjects Interval 90.7 to 100.0	94 Percentage of Subjects Interval 82.8 to 98.7	—	—
Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. Serogroup Y	100 Percentage of Subjects Interval 85.2 to 100.0	100 Percentage of Subjects Interval 85.2 to 100.0	85 Percentage of Subjects Interval 71.1 to 93.7	—	—
Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. Serogroup W	100 Percentage of Subjects Interval 87.7 to 100.0	100 Percentage of Subjects Interval 90.7 to 100.0	96 Percentage of Subjects Interval 85.2 to 99.5	—	—

PRIMARY outcome

Timeframe: At Day 31

Immune response against N. meningitidis serogroup B test strains 30 days after a single dose of MenABCWY+OMV in previously vaccinated subjects, and in Naïve subjects of similar age, as measured by the percentages of Subjects with hSBA ≥ 5. The Meningococcal B Strains were M14459, M01-0240364, NZ98/254, M10713, H44/76 and 5/99.

Outcome measures

Outcome measures
Measure	MenABCWY+OMV Group n=33 Participants Subjects who received 2 doses of MenABCWY+OMV vaccine in the parent study V102\_02 (NCT01210885) and received no subsequent meningococcal vaccines, received a booster dose of MenABCWY+OMV vaccine in the current study at Day 1.	MenACWY Group n=46 Participants Subjects who received MenACWY vaccine in the parent study V102\_02 (NCT01210885) and received no subsequent meningococcal vaccines, received 2 doses of MenABCWY+OMV vaccine, one month apart (Day 1 and Day 31), in the current study.	Naive Group n=50 Participants Subjects similar in age to subjects in the MenABCWY+OMV and MenACWY groups, who had not previously received any meningococcal vaccine and who received 2 doses of MenABCWY+OMV vaccine, 1 month apart (Day 1 and Day 31), in the current study.	Naive Group (C1) Subjects similar in age to subjects in the MenABCWY+OMV and MenACWY groups, who had not previously received any meningococcal vaccine and who received 2 doses of MenABCWY+OMV vaccine, 1 month apart (Day 1 and Day 31), in the current study. Blood samples will be collected from subjects at Day 1 (before vaccination), Day 31 (before vaccination), Day 34 and Day 61.	Naive Group (C2) Subjects similar in age to subjects in the MenABCWY+OMV and MenACWY groups, who had not previously received any meningococcal vaccine and who received 2 doses of MenABCWY+OMV vaccine, 1 month apart (Day 1 and Day 31), in the current study. Blood samples will be collected from subjects at Day 1 (before vaccination), Day 31 (before vaccination), Day 38 and Day 61.
Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. Serogroup B, NZ98/254	82 Percentages of Subjects Interval 64.5 to 93.0	37 Percentages of Subjects Interval 23.2 to 52.5	52 Percentages of Subjects Interval 37.4 to 66.3	—	—
Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. Serogroup B, H44/76	97 Percentages of Subjects Interval 84.2 to 99.92	52 Percentages of Subjects Interval 36.9 to 67.1	60 Percentages of Subjects Interval 45.2 to 73.6	—	—
Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. Serogroup B, 5/99	100 Percentages of Subjects Interval 89.4 to 100.0	78 Percentages of Subjects Interval 63.6 to 89.1	82 Percentages of Subjects Interval 68.6 to 91.4	—	—
Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. Serogroup B, M14459	85 Percentages of Subjects Interval 68.1 to 94.9	31 Percentages of Subjects Interval 18.2 to 46.6	40 Percentages of Subjects Interval 26.4 to 54.8	—	—
Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. Serogroup B, M01-0240364	97 Percentages of Subjects Interval 82.8 to 99.92	25 Percentages of Subjects Interval 13.2 to 40.3	29 Percentages of Subjects Interval 16.4 to 44.3	—	—
Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. Serogroup B, M10713	85 Percentages of Subjects Interval 68.1 to 94.9	52 Percentages of Subjects Interval 36.9 to 67.1	58 Percentages of Subjects Interval 43.2 to 71.8	—	—

PRIMARY outcome

Timeframe: At Day 31

GMTs against N. meningitidis serogroups A, C, W and Y and serogroup B test strains 30 days after a single dose of MenABCWY+OMV in previously vaccinated subjects, and in Naïve subjects of similar age. The Meningococcal B Strains were M14459, M01-0240364, NZ98/254, M10713, H44/76 and 5/99.

Outcome measures

Outcome measures
Measure	MenABCWY+OMV Group n=33 Participants Subjects who received 2 doses of MenABCWY+OMV vaccine in the parent study V102\_02 (NCT01210885) and received no subsequent meningococcal vaccines, received a booster dose of MenABCWY+OMV vaccine in the current study at Day 1.	MenACWY Group n=46 Participants Subjects who received MenACWY vaccine in the parent study V102\_02 (NCT01210885) and received no subsequent meningococcal vaccines, received 2 doses of MenABCWY+OMV vaccine, one month apart (Day 1 and Day 31), in the current study.	Naive Group n=50 Participants Subjects similar in age to subjects in the MenABCWY+OMV and MenACWY groups, who had not previously received any meningococcal vaccine and who received 2 doses of MenABCWY+OMV vaccine, 1 month apart (Day 1 and Day 31), in the current study.	Naive Group (C1) Subjects similar in age to subjects in the MenABCWY+OMV and MenACWY groups, who had not previously received any meningococcal vaccine and who received 2 doses of MenABCWY+OMV vaccine, 1 month apart (Day 1 and Day 31), in the current study. Blood samples will be collected from subjects at Day 1 (before vaccination), Day 31 (before vaccination), Day 34 and Day 61.	Naive Group (C2) Subjects similar in age to subjects in the MenABCWY+OMV and MenACWY groups, who had not previously received any meningococcal vaccine and who received 2 doses of MenABCWY+OMV vaccine, 1 month apart (Day 1 and Day 31), in the current study. Blood samples will be collected from subjects at Day 1 (before vaccination), Day 31 (before vaccination), Day 38 and Day 61.
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, M14459	24 Titers Interval 14.0 to 42.0	2.83 Titers Interval 1.88 to 4.24	4.02 Titers Interval 2.67 to 6.06	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, NZ98/254	13 Titers Interval 8.5 to 18.0	3.57 Titers Interval 2.37 to 5.38	5.75 Titers Interval 3.95 to 8.37	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, M10713	20 Titers Interval 13.0 to 31.0	5.51 Titers Interval 3.45 to 8.79	7.70 Titers Interval 5.04 to 12.0	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, H44/76	98 Titers Interval 57.0 to 170.0	5.78 Titers Interval 3.59 to 9.31	7.27 Titers Interval 4.53 to 12.0	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, 5/99	1426 Titers Interval 940.0 to 2164.0	19 Titers Interval 11.0 to 34.0	25 Titers Interval 15.0 to 42.0	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, M01-0240364	601 Titers Interval 339.0 to 1064.0	3.05 Titers Interval 1.77 to 5.26	3.11 Titers Interval 1.76 to 5.51	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup A	396 Titers Interval 288.0 to 545.0	149 Titers Interval 106.0 to 210.0	22 Titers Interval 14.0 to 35.0	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup C	1676 Titers Interval 1164.0 to 2414.0	1199 Titers Interval 849.0 to 1692.0	58 Titers Interval 35.0 to 96.0	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup W	1823 Titers Interval 1163.0 to 2856.0	2259 Titers Interval 1678.0 to 3041.0	117 Titers Interval 83.0 to 166.0	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup Y	779 Titers Interval 430.0 to 1413.0	1692 Titers Interval 1206.0 to 2373.0	85 Titers Interval 45.0 to 163.0	—	—

PRIMARY outcome

Timeframe: Day 31 versus Day 1

GMRs as measure of the immune response against N. meningitidis serogroups A, C, W and Y and serogroup B test strains in previously vaccinated subjects, and in Naïve subjects of similar age. The Meningococcal B Strains were M14459, M01-0240364, NZ98/254, M10713, H44/76 and 5/99.

Outcome measures

Outcome measures
Measure	MenABCWY+OMV Group n=33 Participants Subjects who received 2 doses of MenABCWY+OMV vaccine in the parent study V102\_02 (NCT01210885) and received no subsequent meningococcal vaccines, received a booster dose of MenABCWY+OMV vaccine in the current study at Day 1.	MenACWY Group n=46 Participants Subjects who received MenACWY vaccine in the parent study V102\_02 (NCT01210885) and received no subsequent meningococcal vaccines, received 2 doses of MenABCWY+OMV vaccine, one month apart (Day 1 and Day 31), in the current study.	Naive Group n=50 Participants Subjects similar in age to subjects in the MenABCWY+OMV and MenACWY groups, who had not previously received any meningococcal vaccine and who received 2 doses of MenABCWY+OMV vaccine, 1 month apart (Day 1 and Day 31), in the current study.	Naive Group (C1) Subjects similar in age to subjects in the MenABCWY+OMV and MenACWY groups, who had not previously received any meningococcal vaccine and who received 2 doses of MenABCWY+OMV vaccine, 1 month apart (Day 1 and Day 31), in the current study. Blood samples will be collected from subjects at Day 1 (before vaccination), Day 31 (before vaccination), Day 34 and Day 61.	Naive Group (C2) Subjects similar in age to subjects in the MenABCWY+OMV and MenACWY groups, who had not previously received any meningococcal vaccine and who received 2 doses of MenABCWY+OMV vaccine, 1 month apart (Day 1 and Day 31), in the current study. Blood samples will be collected from subjects at Day 1 (before vaccination), Day 31 (before vaccination), Day 38 and Day 61.
Geometric Mean hSBA Ratio (GMRs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, M14459	12 Ratios Interval 6.88 to 20.0	2.11 Ratios Interval 1.45 to 3.07	2.72 Ratios Interval 1.91 to 3.87	—	—
Geometric Mean hSBA Ratio (GMRs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, M01-0240364	229 Ratios Interval 108.0 to 485.0	2.80 Ratios Interval 1.59 to 4.96	2.48 Ratios Interval 1.51 to 4.07	—	—
Geometric Mean hSBA Ratio (GMRs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, M10713	5.38 Ratios Interval 3.54 to 8.17	2.15 Ratios Interval 1.46 to 3.17	2.48 Ratios Interval 1.78 to 3.45	—	—
Geometric Mean hSBA Ratio (GMRs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, H44/76	42 Ratios Interval 25.0 to 72.0	4.78 Ratios Interval 2.9 to 7.89	5.06 Ratios Interval 3.21 to 7.97	—	—
Geometric Mean hSBA Ratio (GMRs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, 5/99	112 Ratios Interval 68.0 to 185.0	11 Ratios Interval 6.09 to 19.0	13 Ratios Interval 8.14 to 22.0	—	—
Geometric Mean hSBA Ratio (GMRs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup A	98 Ratios Interval 54.0 to 177.0	22 Ratios Interval 13.0 to 38.0	18 Ratios Interval 12.0 to 29.0	—	—
Geometric Mean hSBA Ratio (GMRs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup C	105 Ratios Interval 49.0 to 222.0	238 Ratios Interval 145.0 to 392.0	12 Ratios Interval 6.88 to 19.0	—	—
Geometric Mean hSBA Ratio (GMRs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup W	67 Ratios Interval 34.0 to 132.0	112 Ratios Interval 65.0 to 191.0	16 Ratios Interval 8.35 to 30.0	—	—
Geometric Mean hSBA Ratio (GMRs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup Y	162 Ratios Interval 70.0 to 375.0	216 Ratios Interval 80.0 to 580.0	46 Ratios Interval 23.0 to 92.0	—	—
Geometric Mean hSBA Ratio (GMRs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, NZ98/254	6.92 Ratios Interval 4.61 to 10.0	2.64 Ratios Interval 1.73 to 4.02	3.98 Ratios Interval 2.73 to 5.79	—	—

SECONDARY outcome

Timeframe: At Days 1, 4, 8 and 31

Population: Data was not collected for this outcome measure as validation procedure of the hSBA assay was not relevant to the study.

The HT-hSBA assay format was changed in 2015 in response to CBER comments and no new LLQ values were defined as the validation of this format was not relevant. The LLQ cut off values for the old assay format correspond to 8 for serogroups A,C,W and Y and 5 for serogroup B strains and these results are presented in outcome measures 12 and 13 and are considered final in Company's judgement.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At Days 1, 31, 34, 38 and 61

Population: Data was not collected for this outcome measure as validation procedure of the hSBA assay was not relevant to the study.

The HT-hSBA assay format was changed in 2015 in response to CBER comments and no new LLQ values were defined as the validation of this format was not relevant. The LLQ cut off values for the old assay format correspond to 8 for serogroups A,C,W and Y and 5 for serogroup B strains and these results are presented in outcome measures 12 and 13 and are considered final in Company's judgement.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At Days 1, 4, 8, 31, 34, 38 and 61

Population: Analysis was performed on Full Analysis Set immunogenicity kinetics population set- all subjects in the enrolled population who received a study vaccination, provided at least one evaluable serum sample post vaccination and whose assay result was available for at least one strain.

Kinetics of immune response following 1 dose of MenABCWY+OMV in subjects who previously received 2 doses of MenABCWY+OMV or 1 dose of MenACWY, at Days 1, 4, 8, 31, 34, 38 and 61, as measured by the percentages of subjects with hSBA ≥ 8.

Outcome measures

Outcome measures
Measure	MenABCWY+OMV Group n=33 Participants Subjects who received 2 doses of MenABCWY+OMV vaccine in the parent study V102\_02 (NCT01210885) and received no subsequent meningococcal vaccines, received a booster dose of MenABCWY+OMV vaccine in the current study at Day 1.	MenACWY Group n=23 Participants Subjects who received MenACWY vaccine in the parent study V102\_02 (NCT01210885) and received no subsequent meningococcal vaccines, received 2 doses of MenABCWY+OMV vaccine, one month apart (Day 1 and Day 31), in the current study.	Naive Group n=23 Participants Subjects similar in age to subjects in the MenABCWY+OMV and MenACWY groups, who had not previously received any meningococcal vaccine and who received 2 doses of MenABCWY+OMV vaccine, 1 month apart (Day 1 and Day 31), in the current study.	Naive Group (C1) n=26 Participants Subjects similar in age to subjects in the MenABCWY+OMV and MenACWY groups, who had not previously received any meningococcal vaccine and who received 2 doses of MenABCWY+OMV vaccine, 1 month apart (Day 1 and Day 31), in the current study. Blood samples will be collected from subjects at Day 1 (before vaccination), Day 31 (before vaccination), Day 34 and Day 61.	Naive Group (C2) n=24 Participants Subjects similar in age to subjects in the MenABCWY+OMV and MenACWY groups, who had not previously received any meningococcal vaccine and who received 2 doses of MenABCWY+OMV vaccine, 1 month apart (Day 1 and Day 31), in the current study. Blood samples will be collected from subjects at Day 1 (before vaccination), Day 31 (before vaccination), Day 38 and Day 61.
Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. Serogroup A; Day 1	27 Percentages of subjects Interval 13.3 to 45.5	52 Percentages of subjects Interval 30.6 to 73.2	30 Percentages of subjects Interval 13.2 to 52.9	0 Percentages of subjects Interval 0.0 to 13.2	4 Percentages of subjects Interval 0.11 to 21.1
Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. Serogroup A; Day 4	24 Percentages of subjects Interval 11.1 to 42.3	52 Percentages of subjects Interval 30.6 to 73.2	—	—	—
Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. Serogroup A; Day 8	100 Percentages of subjects Interval 89.4 to 100.0	—	82 Percentages of subjects Interval 59.7 to 94.8	—	—
Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. Serogroup A; Day 34	—	—	—	77 Percentages of subjects Interval 56.4 to 91.0	—
Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. Serogroup C; Day 4	73 Percentages of subjects Interval 54.1 to 87.7	64 Percentages of subjects Interval 40.7 to 82.8	—	—	—
Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. Serogroup C; Day 8	100 Percentages of subjects Interval 88.1 to 100.0	—	100 Percentages of subjects Interval 82.4 to 100.0	—	—
Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. Serogroup C; Day 31	100 Percentages of subjects Interval 88.4 to 100.0	100 Percentages of subjects Interval 80.5 to 100.0	100 Percentages of subjects Interval 83.9 to 100.0	100 Percentages of subjects Interval 86.3 to 100.0	87 Percentages of subjects Interval 66.4 to 97.2
Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. Serogroup C; Day 61	—	100 Percentages of subjects Interval 78.2 to 100.0	100 Percentages of subjects Interval 82.4 to 100.0	100 Percentages of subjects Interval 85.8 to 100.0	100 Percentages of subjects Interval 85.2 to 100.0
Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. Serogroup W; Day 1	75 Percentages of subjects Interval 56.6 to 88.5	70 Percentages of subjects Interval 47.1 to 86.8	87 Percentages of subjects Interval 66.4 to 97.2	44 Percentages of subjects Interval 24.4 to 65.1	64 Percentages of subjects Interval 40.7 to 82.8
Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. Serogroup W; Day 31	100 Percentages of subjects Interval 87.7 to 100.0	100 Percentages of subjects Interval 80.5 to 100.0	100 Percentages of subjects Interval 83.9 to 100.0	100 Percentages of subjects Interval 84.6 to 100.0	92 Percentages of subjects Interval 73.0 to 99.0
Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. Serogroup W; Day 38	—	—	—	—	100 Percentages of subjects Interval 83.2 to 100.0
Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. Serogroup W; Day 61	—	100 Percentages of subjects Interval 78.2 to 100.0	100 Percentages of subjects Interval 80.5 to 100.0	100 Percentages of subjects Interval 83.2 to 100.0	100 Percentages of subjects Interval 83.9 to 100.0
Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. Serogroup Y; Day 1	38 Percentages of subjects Interval 21.1 to 56.3	64 Percentages of subjects Interval 40.7 to 82.8	55 Percentages of subjects Interval 32.2 to 75.6	17 Percentages of subjects Interval 5.0 to 38.8	21 Percentages of subjects Interval 7.1 to 42.2
Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. Serogroup Y; Day 4	42 Percentages of subjects Interval 24.5 to 60.9	50 Percentages of subjects Interval 28.2 to 71.8	—	—	—
Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. Serogroup Y; Day 8	100 Percentages of subjects Interval 85.2 to 100.0	—	100 Percentages of subjects Interval 75.3 to 100.0	—	—
Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. Serogroup Y; Day 31	100 Percentages of subjects Interval 85.2 to 100.0	100 Percentages of subjects Interval 73.5 to 100.0	100 Percentages of subjects Interval 71.5 to 100.0	91 Percentages of subjects Interval 72.0 to 98.9	78 Percentages of subjects Interval 56.3 to 92.5
Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. Serogroup Y; Day 34	—	—	—	96 Percentages of subjects Interval 78.1 to 99.89	—
Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. Serogroup Y; Day 61	—	100 Percentages of subjects Interval 73.5 to 100.0	100 Percentages of subjects Interval 78.2 to 100.0	100 Percentages of subjects Interval 85.2 to 100.0	95 Percentages of subjects Interval 75.1 to 99.87
Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. Serogroup A; Day 31	100 Percentages of subjects Interval 89.4 to 100.0	100 Percentages of subjects Interval 85.2 to 100.0	100 Percentages of subjects Interval 85.2 to 100.0	73 Percentages of subjects Interval 52.2 to 88.4	79 Percentages of subjects Interval 57.8 to 92.9
Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. Serogroup A; Day 38	—	—	—	—	96 Percentages of subjects Interval 78.9 to 99.89
Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. Serogroup A; Day 61	—	100 Percentages of subjects Interval 85.2 to 100.0	100 Percentages of subjects Interval 85.2 to 100.0	100 Percentages of subjects Interval 85.2 to 100.0	88 Percentages of subjects Interval 67.6 to 97.3
Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. Serogroup C; Day 1	69 Percentages of subjects Interval 50.0 to 83.9	61 Percentages of subjects Interval 38.5 to 80.3	26 Percentages of subjects Interval 10.2 to 48.4	40 Percentages of subjects Interval 21.1 to 61.3	50 Percentages of subjects Interval 29.1 to 70.9
Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. Serogroup C; Day 34	—	—	—	100 Percentages of subjects Interval 83.2 to 100.0	—
Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. Serogroup C; Day 38	—	—	—	—	100 Percentages of subjects Interval 84.6 to 100.0
Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. Serogroup W; Day 4	76 Percentages of subjects Interval 54.9 to 90.6	73 Percentages of subjects Interval 49.8 to 89.3	—	—	—
Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. Serogroup W; Day 8	100 Percentages of subjects Interval 86.3 to 100.0	—	100 Percentages of subjects Interval 79.4 to 100.0	—	—
Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. Serogroup W; Day 34	—	—	—	100 Percentages of subjects Interval 82.4 to 100.0	—
Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. Serogroup Y; Day 38	—	—	—	—	100 Percentages of subjects Interval 83.2 to 100.0

SECONDARY outcome

Timeframe: At Days 1, 4, 8, 31, 34, 38 and 61

Population: Kinetics of immune response against N. meningitidis serogroup B test strains in previously vaccinated subjects, at Day 1, 4, 8, 31, as measured by the percentages of Subjects with hSBA ≥ 5. The data were reported based on the FAS immunogenicity kinetics population set.

Kinetics of immune response against N. meningitidis serogroup B test strains in previously vaccinated subjects, at Days 1, 4, 8, 31, 34, 38 and 61, as measured by the percentages of Subjects with hSBA ≥ 5. The Meningococcal B Strains were M14459, M01-0240364, NZ98/254, M10713, H44/76 and 5/99.

Outcome measures

Outcome measures
Measure	MenABCWY+OMV Group n=33 Participants Subjects who received 2 doses of MenABCWY+OMV vaccine in the parent study V102\_02 (NCT01210885) and received no subsequent meningococcal vaccines, received a booster dose of MenABCWY+OMV vaccine in the current study at Day 1.	MenACWY Group n=23 Participants Subjects who received MenACWY vaccine in the parent study V102\_02 (NCT01210885) and received no subsequent meningococcal vaccines, received 2 doses of MenABCWY+OMV vaccine, one month apart (Day 1 and Day 31), in the current study.	Naive Group n=23 Participants Subjects similar in age to subjects in the MenABCWY+OMV and MenACWY groups, who had not previously received any meningococcal vaccine and who received 2 doses of MenABCWY+OMV vaccine, 1 month apart (Day 1 and Day 31), in the current study.	Naive Group (C1) n=26 Participants Subjects similar in age to subjects in the MenABCWY+OMV and MenACWY groups, who had not previously received any meningococcal vaccine and who received 2 doses of MenABCWY+OMV vaccine, 1 month apart (Day 1 and Day 31), in the current study. Blood samples will be collected from subjects at Day 1 (before vaccination), Day 31 (before vaccination), Day 34 and Day 61.	Naive Group (C2) n=24 Participants Subjects similar in age to subjects in the MenABCWY+OMV and MenACWY groups, who had not previously received any meningococcal vaccine and who received 2 doses of MenABCWY+OMV vaccine, 1 month apart (Day 1 and Day 31), in the current study. Blood samples will be collected from subjects at Day 1 (before vaccination), Day 31 (before vaccination), Day 38 and Day 61.
Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. Serogroup B, H44/76; Day 61	—	78 Percentages of subjects Interval 56.3 to 92.5	91 Percentages of subjects Interval 72.0 to 98.9	96 Percentages of subjects Interval 79.6 to 99.9	79 Percentages of subjects Interval 57.8 to 92.9
Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. Serogroup B, M14459; Day 31	85 Percentages of subjects Interval 68.1 to 94.9	35 Percentages of subjects Interval 16.4 to 57.3	27 Percentages of subjects Interval 10.7 to 50.2	46 Percentages of subjects Interval 26.6 to 66.6	33 Percentages of subjects Interval 15.6 to 55.3
Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. Serogroup B, M14459; Day 1	18 Percentages of subjects Interval 7.0 to 35.5	9 Percentages of subjects Interval 1.1 to 28.0	0 Percentages of subjects Interval 0.0 to 14.8	8 Percentages of subjects Interval 0.9 to 25.1	8 Percentages of subjects Interval 1.0 to 27.0
Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. Serogroup B, M14459; Day 4	21 Percentages of subjects Interval 9.0 to 38.9	4 Percentages of subjects Interval 0.11 to 21.9	—	—	—
Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. Serogroup B, M14459; Day 34	—	—	—	42 Percentages of subjects Interval 23.4 to 63.1	—
Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. Serogroup B, M14459; Day 38	—	—	—	—	71 Percentages of subjects Interval 48.9 to 87.4
Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. Serogroup B, M14459; Day 61	—	43 Percentages of subjects Interval 23.2 to 65.5	48 Percentages of subjects Interval 26.8 to 69.4	80 Percentages of subjects Interval 59.3 to 93.2	54 Percentages of subjects Interval 32.8 to 74.4
Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. Serogroup B, M01-0240364; Day 1	13 Percentages of subjects Interval 3.6 to 29.8	9 Percentages of subjects Interval 1.1 to 29.2	0 Percentages of subjects Interval 0.0 to 15.4	4 Percentages of subjects Interval 0.1 to 19.6	4 Percentages of subjects Interval 0.11 to 21.1
Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. Serogroup B, M01-0240364; Day 4	17 Percentages of subjects Interval 5.6 to 34.7	4 Percentages of subjects Interval 0.11 to 21.9	—	—	—
Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. Serogroup B, M01-0240364; Day 8	93 Percentages of subjects Interval 77.2 to 99.2	—	10 Percentages of subjects Interval 1.2 to 30.4	—	—
Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. Serogroup B, M01-0240364; Day 31	97 Percentages of subjects Interval 82.8 to 99.92	29 Percentages of subjects Interval 11.3 to 52.2	22 Percentages of subjects Interval 7.5 to 43.7	33 Percentages of subjects Interval 15.6 to 55.3	24 Percentages of subjects Interval 8.2 to 47.2
Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. Serogroup B, NZ98/254; Day 1	15 Percentages of subjects Interval 5.1 to 31.9	4 Percentages of subjects Interval 0.11 to 21.9	0 Percentages of subjects Interval 0.0 to 14.8	8 Percentages of subjects Interval 0.9 to 25.1	4 Percentages of subjects Interval 0.11 to 21.1
Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. Serogroup B, NZ98/254; Day 31	82 Percentages of subjects Interval 64.5 to 93.0	48 Percentages of subjects Interval 26.8 to 69.4	26 Percentages of subjects Interval 10.2 to 48.4	58 Percentages of subjects Interval 36.9 to 76.6	46 Percentages of subjects Interval 25.6 to 67.2
Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. Serogroup B, NZ98/254; Day 34	—	—	—	50 Percentages of subjects Interval 29.9 to 70.1	—
Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. Serogroup B, NZ98/254; Day 61	—	52 Percentages of subjects Interval 30.6 to 73.2	39 Percentages of subjects Interval 19.7 to 61.5	72 Percentages of subjects Interval 50.6 to 87.9	50 Percentages of subjects Interval 29.1 to 70.9
Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. Serogroup B, M10713; Day 1	48 Percentages of subjects Interval 30.8 to 66.5	48 Percentages of subjects Interval 26.8 to 69.4	17 Percentages of subjects Interval 5.0 to 38.8	38 Percentages of subjects Interval 20.2 to 59.4	38 Percentages of subjects Interval 18.8 to 59.4
Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. Serogroup B, M10713; Day 4	56 Percentages of subjects Interval 37.7 to 73.6	39 Percentages of subjects Interval 19.7 to 61.5	—	—	—
Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. Serogroup B, M10713; Day 8	79 Percentages of subjects Interval 61.1 to 91.0	—	32 Percentages of subjects Interval 13.9 to 54.9	—	—
Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. Serogroup B, M10713; Day 31	85 Percentages of subjects Interval 68.1 to 94.9	70 Percentages of subjects Interval 47.1 to 86.8	35 Percentages of subjects Interval 16.4 to 57.3	62 Percentages of subjects Interval 40.6 to 79.8	54 Percentages of subjects Interval 32.8 to 74.4
Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. Serogroup B, M10713; Day 61	—	65 Percentages of subjects Interval 42.7 to 83.6	43 Percentages of subjects Interval 23.2 to 65.5	68 Percentages of subjects Interval 46.5 to 85.1	63 Percentages of subjects Interval 40.6 to 81.2
Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. Serogroup B, H44/76; Day 1	27 Percentages of subjects Interval 13.3 to 45.5	9 Percentages of subjects Interval 1.1 to 28.0	0 Percentages of subjects Interval 0.0 to 14.8	12 Percentages of subjects Interval 2.4 to 30.2	8 Percentages of subjects Interval 1.0 to 27.0
Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. Serogroup B, H44/76; Day 31	97 Percentages of subjects Interval 84.2 to 99.92	52 Percentages of subjects Interval 30.6 to 73.2	52 Percentages of subjects Interval 30.6 to 73.2	73 Percentages of subjects Interval 52.2 to 88.4	46 Percentages of subjects Interval 25.6 to 67.2
Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. Serogroup B, H44/76; Day 34	—	—	—	69 Percentages of subjects Interval 48.2 to 85.7	—
Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. Serogroup B, H44/76; Day 38	—	—	—	—	96 Percentages of subjects Interval 78.9 to 99.89
Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. Serogroup B, 5/99; Day 8	100 Percentages of subjects Interval 89.4 to 100.0	—	9 Percentages of subjects Interval 1.1 to 29.2	—	—
Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. Serogroup B, 5/99; Day 31	100 Percentages of subjects Interval 89.4 to 100.0	78 Percentages of subjects Interval 56.3 to 92.5	78 Percentages of subjects Interval 56.3 to 92.5	85 Percentages of subjects Interval 65.1 to 95.6	79 Percentages of subjects Interval 57.8 to 92.9
Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. Serogroup B, 5/99; Day 34	—	—	—	85 Percentages of subjects Interval 65.1 to 95.6	—
Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. Serogroup B, 5/99; Day 38	—	—	—	—	100 Percentages of subjects Interval 85.8 to 100.0
Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. Serogroup B, 5/99; Day 61	—	100 Percentages of subjects Interval 85.2 to 100.0	100 Percentages of subjects Interval 85.2 to 100.0	100 Percentages of subjects Interval 86.3 to 100.0	100 Percentages of subjects Interval 85.8 to 100.0
Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. Serogroup B, M14459; Day 8	79 Percentages of subjects Interval 61.1 to 91.0	—	14 Percentages of subjects Interval 2.9 to 34.9	—	—
Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. Serogroup B, M01-0240364; Day 34	—	—	—	40 Percentages of subjects Interval 21.1 to 61.3	—
Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. Serogroup B, M01-0240364; Day 38	—	—	—	—	82 Percentages of subjects Interval 59.7 to 94.8
Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. Serogroup B, M01-0240364; Day 61	—	65 Percentages of subjects Interval 42.7 to 83.6	65 Percentages of subjects Interval 42.7 to 83.6	70 Percentages of subjects Interval 47.1 to 86.8	71 Percentages of subjects Interval 48.9 to 87.4
Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. Serogroup B, NZ98/254; Day 4	12 Percentages of subjects Interval 3.4 to 28.2	13 Percentages of subjects Interval 2.8 to 33.6	—	—	—
Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. Serogroup B, NZ98/254; Day 8	67 Percentages of subjects Interval 48.2 to 82.0	—	9 Percentages of subjects Interval 1.1 to 29.2	—	—
Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. Serogroup B, NZ98/254; Day 38	—	—	—	—	75 Percentages of subjects Interval 53.3 to 90.2
Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. Serogroup B, M10713; Day 34	—	—	—	57 Percentages of subjects Interval 34.5 to 76.8	—
Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. Serogroup B, M10713; Day 38	—	—	—	—	67 Percentages of subjects Interval 44.7 to 84.4
Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. Serogroup B, H44/76; Day 4	21 Percentages of subjects Interval 9.0 to 38.9	4 Percentages of subjects Interval 0.11 to 21.9	—	—	—
Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. Serogroup B, H44/76; Day 8	94 Percentages of subjects Interval 79.8 to 99.3	—	14 Percentages of subjects Interval 2.9 to 34.9	—	—
Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. Serogroup B, 5/99; Day 1	70 Percentages of subjects Interval 51.3 to 84.4	22 Percentages of subjects Interval 7.5 to 43.7	13 Percentages of subjects Interval 2.8 to 33.6	19 Percentages of subjects Interval 6.6 to 39.4	13 Percentages of subjects Interval 2.7 to 32.4
Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. Serogroup B, 5/99; Day 4	79 Percentages of subjects Interval 61.1 to 91.0	9 Percentages of subjects Interval 1.1 to 28.0	—	—	—

SECONDARY outcome

Timeframe: At Days 1, 4, 8 and 31.

GMTs at Day 1, 4, 8, 31 as measure of the kinetics of the immune response following a dose of MenABCWY+OMV, in subjects who previously received 2 doses of MenABCWY+OMV or 1 dose of MenACWY. This outcome measure reports data only for the MenABCWY+OMV and MenACWY Groups as per protocol. The Meningococcal B Strains were M14459, M01-0240364, NZ98/254, M10713, H44/76 and 5/99.

Outcome measures

Outcome measures
Measure	MenABCWY+OMV Group n=33 Participants Subjects who received 2 doses of MenABCWY+OMV vaccine in the parent study V102\_02 (NCT01210885) and received no subsequent meningococcal vaccines, received a booster dose of MenABCWY+OMV vaccine in the current study at Day 1.	MenACWY Group n=46 Participants Subjects who received MenACWY vaccine in the parent study V102\_02 (NCT01210885) and received no subsequent meningococcal vaccines, received 2 doses of MenABCWY+OMV vaccine, one month apart (Day 1 and Day 31), in the current study.	Naive Group Subjects similar in age to subjects in the MenABCWY+OMV and MenACWY groups, who had not previously received any meningococcal vaccine and who received 2 doses of MenABCWY+OMV vaccine, 1 month apart (Day 1 and Day 31), in the current study.	Naive Group (C1) Subjects similar in age to subjects in the MenABCWY+OMV and MenACWY groups, who had not previously received any meningococcal vaccine and who received 2 doses of MenABCWY+OMV vaccine, 1 month apart (Day 1 and Day 31), in the current study. Blood samples will be collected from subjects at Day 1 (before vaccination), Day 31 (before vaccination), Day 34 and Day 61.	Naive Group (C2) Subjects similar in age to subjects in the MenABCWY+OMV and MenACWY groups, who had not previously received any meningococcal vaccine and who received 2 doses of MenABCWY+OMV vaccine, 1 month apart (Day 1 and Day 31), in the current study. Blood samples will be collected from subjects at Day 1 (before vaccination), Day 31 (before vaccination), Day 38 and Day 61.
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, M14459; Day 31	24 Titers Interval 14.0 to 42.0	2.83 Titers Interval 1.88 to 4.24	—	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, M01-0240364; Day 1	2.26 Titers Interval 1.26 to 4.08	1.14 Titers Interval 0.97 to 1.35	—	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, M01-0240364; Day 31	601 Titers Interval 339.0 to 1064.0	3.05 Titers Interval 1.77 to 5.26	—	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, M10713; Day 1	3.66 Titers Interval 2.38 to 5.62	2.56 Titers Interval 1.74 to 3.75	—	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, M10713; Day 4	4.16 Titers Interval 2.7 to 6.41	3.73 Titers Interval 2.1 to 6.65	—	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, M10713; Day 8	15 Titers Interval 9.26 to 23.0	2.03 Titers Interval 1.3 to 3.17	—	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, M10713; Day 31	20 Titers Interval 13.0 to 31.0	5.51 Titers Interval 3.45 to 8.79	—	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, H44/76; Day 31	98 Titers Interval 57.0 to 170.0	5.78 Titers Interval 3.59 to 9.31	—	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, 5/99; Day 8	1768 Titers Interval 1204.0 to 2596.0	1.97 Titers Interval 0.88 to 4.42	—	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup A; Day 1	4.06 Titers Interval 2.22 to 7.44	6.64 Titers Interval 3.56 to 12.0	—	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup A; Day 8	474 Titers Interval 321.0 to 701.0	61 Titers Interval 25.0 to 146.0	—	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup C; Day 1	17 Titers Interval 7.8 to 37.0	6.62 Titers Interval 4.1 to 11.0	—	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup C; Day 4	21 Titers Interval 9.93 to 43.0	12 Titers Interval 5.13 to 29.0	—	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup Y; Day 1	6.17 Titers Interval 3.0 to 13.0	12 Titers Interval 6.29 to 22.0	—	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, M14459; Day 1	2.04 Titers Interval 1.46 to 2.83	1.37 Titers Interval 1.12 to 1.69	—	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, M14459; Day 4	1.99 Titers Interval 1.44 to 2.75	1.22 Titers Interval 0.96 to 1.54	—	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, M14459; Day 8	17 Titers Interval 9.31 to 30.0	1.52 Titers Interval 1.05 to 2.2	—	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, M01-0240364; Day 4	2.50 Titers Interval 1.25 to 5.02	1.36 Titers Interval 1.02 to 1.82	—	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, M01-0240364; Day 8	525 Titers Interval 257.0 to 1074.0	1.65 Titers Interval 0.79 to 3.43	—	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, NZ98/254; Day 1	1.81 Titers Interval 1.3 to 2.51	1.35 Titers Interval 1.15 to 1.59	—	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, NZ98/254; Day 4	1.90 Titers Interval 1.41 to 2.57	1.89 Titers Interval 1.38 to 2.59	—	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, NZ98/254; Day 8	8.19 Titers Interval 5.45 to 12.0	1.52 Titers Interval 1.12 to 2.06	—	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, NZ98/254; Day 31	13 Titers Interval 8.5 to 18.0	3.57 Titers Interval 2.37 to 5.38	—	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, H44/76; Day 1	2.33 Titers Interval 1.57 to 3.45	1.21 Titers Interval 1.03 to 1.42	—	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, H44/76; Day 4	2.58 Titers Interval 1.78 to 3.75	1.38 Titers Interval 1.05 to 1.81	—	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, H44/76; Day 8	64 Titers Interval 38.0 to 109.0	1.84 Titers Interval 1.18 to 2.89	—	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, 5/99; Day 1	13 Titers Interval 7.29 to 22.0	1.78 Titers Interval 1.36 to 2.34	—	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, 5/99; Day 4	17 Titers Interval 9.56 to 31.0	1.99 Titers Interval 1.36 to 2.92	—	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, 5/99; Day 31	1426 Titers Interval 940.0 to 2164.0	19 Titers Interval 11.0 to 34.0	—	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup A; Day 4	3.85 Titers Interval 2.0 to 7.42	9.69 Titers Interval 3.9 to 24.0	—	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup A; Day 31	396 Titers Interval 288.0 to 545.0	149 Titers Interval 106.0 to 210.0	—	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup C; Day 8	2664 Titers Interval 1840.0 to 3855.0	1710 Titers Interval 979.0 to 2985.0	—	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup C; Day 31	1676 Titers Interval 1164.0 to 2414.0	1199 Titers Interval 849.0 to 1692.0	—	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup W; Day 1	28 Titers Interval 15.0 to 53.0	25 Titers Interval 15.0 to 40.0	—	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup W; Day 4	19 Titers Interval 8.77 to 41.0	20 Titers Interval 8.11 to 51.0	—	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup W; Day 8	1285 Titers Interval 900.0 to 1833.0	1693 Titers Interval 924.0 to 3103.0	—	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup W; Day 31	1823 Titers Interval 1163.0 to 2856.0	2259 Titers Interval 1678.0 to 3041.0	—	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup Y; Day 4	6.53 Titers Interval 3.05 to 14.0	9.60 Titers Interval 3.56 to 26.0	—	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup Y; Day 8	722 Titers Interval 429.0 to 1216.0	1133 Titers Interval 710.0 to 1809.0	—	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup Y; Day 31	779 Titers Interval 430.0 to 1413.0	1692 Titers Interval 1206.0 to 2373.0	—	—	—

SECONDARY outcome

Timeframe: At Days 1, 31, 34, 38 and 61

GMTs at Day 1, 31, 34, 38, 61 as measure of the kinetics of the immune response following a dose of MenABCWY+OMV, in subjects who were not primed with any meningococcal vaccine (i.e., Naïve Group). This outcome measure reports data for only the Naïve Group as per protocol. The Meningococcal B Strains were M14459, M01-0240364, NZ98/254, M10713, H44/76 and 5/99.

Outcome measures

Outcome measures
Measure	MenABCWY+OMV Group n=50 Participants Subjects who received 2 doses of MenABCWY+OMV vaccine in the parent study V102\_02 (NCT01210885) and received no subsequent meningococcal vaccines, received a booster dose of MenABCWY+OMV vaccine in the current study at Day 1.	MenACWY Group Subjects who received MenACWY vaccine in the parent study V102\_02 (NCT01210885) and received no subsequent meningococcal vaccines, received 2 doses of MenABCWY+OMV vaccine, one month apart (Day 1 and Day 31), in the current study.	Naive Group Subjects similar in age to subjects in the MenABCWY+OMV and MenACWY groups, who had not previously received any meningococcal vaccine and who received 2 doses of MenABCWY+OMV vaccine, 1 month apart (Day 1 and Day 31), in the current study.	Naive Group (C1) Subjects similar in age to subjects in the MenABCWY+OMV and MenACWY groups, who had not previously received any meningococcal vaccine and who received 2 doses of MenABCWY+OMV vaccine, 1 month apart (Day 1 and Day 31), in the current study. Blood samples will be collected from subjects at Day 1 (before vaccination), Day 31 (before vaccination), Day 34 and Day 61.	Naive Group (C2) Subjects similar in age to subjects in the MenABCWY+OMV and MenACWY groups, who had not previously received any meningococcal vaccine and who received 2 doses of MenABCWY+OMV vaccine, 1 month apart (Day 1 and Day 31), in the current study. Blood samples will be collected from subjects at Day 1 (before vaccination), Day 31 (before vaccination), Day 38 and Day 61.
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, M14459; Day 34	5.06 Titers Interval 2.96 to 8.66	—	—	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, M14459; Day 38	9.16 Titers Interval 5.35 to 16.0	—	—	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, M14459; Day 61	9.78 Titers Interval 6.42 to 15.0	—	—	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, M01-0240364; Day 1	1.23 Titers Interval 1.02 to 1.47	—	—	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, M01-0240364; Day 31	3.11 Titers Interval 1.76 to 5.51	—	—	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, M01-0240364; Day 34	5.13 Titers Interval 2.171 to 12.0	—	—	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, M01-0240364; Day 61	21 Titers Interval 11.0 to 38.0	—	—	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, NZ98/254; Day 1	1.45 Titers Interval 1.18 to 1.77	—	—	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, M10713; Day 38	8.94 Titers Interval 4.91 to 16.0	—	—	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, M10713; Day 61	8.73 Titers Interval 5.8 to 13.0	—	—	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, H44/76; Day 38	35 Titers Interval 20.0 to 60.0	—	—	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, 5/99; Day 1	1.90 Titers Interval 1.42 to 2.53	—	—	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, 5/99; Day 31	25 Titers Interval 15.0 to 42.0	—	—	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, 5/99; Day 38	432 Titers Interval 273.0 to 683.0	—	—	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup W; Day 34	180 Titers Interval 107.0 to 305.0	—	—	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup W; Day 61	168 Titers Interval 129.0 to 218.0	—	—	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup Y; Day 1	2.00 Titers Interval 1.4 to 2.85	—	—	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, M14459; Day 1	1.48 Titers Interval 1.18 to 1.85	—	—	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, M14459; Day 31	4.02 Titers Interval 2.67 to 6.06	—	—	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, M01-0240364; Day 38	75 Titers Interval 29.0 to 199.0	—	—	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, NZ98/254; Day 31	5.75 Titers Interval 3.95 to 8.37	—	—	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, NZ98/254; Day 34	6.93 Titers Interval 4.02 to 12.0	—	—	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, NZ98/254; Day 38	7.92 Titers Interval 5.03 to 12.0	—	—	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, NZ98/254; Day 61	7.50 Titers Interval 5.12 to 11.0	—	—	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, M10713; Day 1	3.10 Titers Interval 2.16 to 4.45	—	—	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, M10713; Day 31	7.70 Titers Interval 5.04 to 12.0	—	—	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, M10713; Day 34	6.70 Titers Interval 3.37 to 13.0	—	—	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, H44/76; Day 1	1.44 Titers Interval 1.14 to 1.8	—	—	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, H44/76; Day 31	7.27 Titers Interval 4.53 to 12.0	—	—	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, H44/76; Day 34	8.91 Titers Interval 4.62 to 17.0	—	—	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, H44/76; Day 61	32 Titers Interval 21.0 to 49.0	—	—	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, 5/99; Day 34	40 Titers Interval 18.0 to 90.0	—	—	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, 5/99; Day 61	256 Titers Interval 194.0 to 338.0	—	—	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup A; Day 1	1.20 Titers Interval 1.05 to 1.37	—	—	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup A; Day 31	22 Titers Interval 14.0 to 35.0	—	—	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup A; Day 34	31 Titers Interval 15.0 to 67.0	—	—	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup A; Day 38	107 Titers Interval 64.0 to 179.0	—	—	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup A; Day 61	74 Titers Interval 51.0 to 108.0	—	—	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup C; Day 1	5.11 Titers Interval 3.49 to 7.48	—	—	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup C; Day 31	58 Titers Interval 35.0 to 96.0	—	—	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup C; Day 34	94 Titers Interval 54.0 to 162.0	—	—	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup C; Day 38	259 Titers Interval 149.0 to 449.0	—	—	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup C; Day 61	188 Titers Interval 132.0 to 266.0	—	—	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup W; Day 1	8.37 Titers Interval 4.78 to 15.0	—	—	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup W; Day 31	117 Titers Interval 83.0 to 166.0	—	—	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup W; Day 38	188 Titers Interval 129.0 to 272.0	—	—	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup Y; Day 31	85 Titers Interval 45.0 to 163.0	—	—	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup Y; Day 34	109 Titers Interval 55.0 to 215.0	—	—	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup Y; Day 38	299 Titers Interval 180.0 to 495.0	—	—	—	—
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup Y; Day 61	224 Titers Interval 147.0 to 343.0	—	—	—	—

SECONDARY outcome

Timeframe: At Days 4, 8 and 31 versus Day 1.

GMRs as measure of the kinetics of the immune response following a dose of MenABCWY+OMV, in subjects who previously received 2 doses of MenABCWY+OMV or 1 dose of MenACWY. The Meningococcal B Strains were M14459, M01-0240364, NZ98/254, M10713, H44/76 and 5/99.

Outcome measures

Outcome measures
Measure	MenABCWY+OMV Group n=33 Participants Subjects who received 2 doses of MenABCWY+OMV vaccine in the parent study V102\_02 (NCT01210885) and received no subsequent meningococcal vaccines, received a booster dose of MenABCWY+OMV vaccine in the current study at Day 1.	MenACWY Group n=46 Participants Subjects who received MenACWY vaccine in the parent study V102\_02 (NCT01210885) and received no subsequent meningococcal vaccines, received 2 doses of MenABCWY+OMV vaccine, one month apart (Day 1 and Day 31), in the current study.	Naive Group Subjects similar in age to subjects in the MenABCWY+OMV and MenACWY groups, who had not previously received any meningococcal vaccine and who received 2 doses of MenABCWY+OMV vaccine, 1 month apart (Day 1 and Day 31), in the current study.	Naive Group (C1) Subjects similar in age to subjects in the MenABCWY+OMV and MenACWY groups, who had not previously received any meningococcal vaccine and who received 2 doses of MenABCWY+OMV vaccine, 1 month apart (Day 1 and Day 31), in the current study. Blood samples will be collected from subjects at Day 1 (before vaccination), Day 31 (before vaccination), Day 34 and Day 61.	Naive Group (C2) Subjects similar in age to subjects in the MenABCWY+OMV and MenACWY groups, who had not previously received any meningococcal vaccine and who received 2 doses of MenABCWY+OMV vaccine, 1 month apart (Day 1 and Day 31), in the current study. Blood samples will be collected from subjects at Day 1 (before vaccination), Day 31 (before vaccination), Day 38 and Day 61.
GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, 5/99; Day 8/Day 1	139 Ratios Interval 77.0 to 248.0	1.30 Ratios Interval 0.66 to 2.57	—	—	—
GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, 5/99; Day 31/Day 1	112 Ratios Interval 68.0 to 185.0	11 Ratios Interval 6.09 to 19.0	—	—	—
GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup C; Day 31/Day 1	105 Ratios Interval 49.0 to 222.0	238 Ratios Interval 145.0 to 392.0	—	—	—
GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, M14459; Dy 4/Day 1	0.98 Ratios Interval 0.88 to 1.09	0.80 Ratios Interval 0.6 to 1.05	—	—	—
GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, M14459; Day 8/Day 1	8.19 Ratios Interval 4.58 to 15.0	1.21 Ratios Interval 0.8 to 1.83	—	—	—
GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, M14459; Day 31/Day 1	12 Ratios Interval 6.88 to 20.0	2.11 Ratios Interval 1.45 to 3.07	—	—	—
GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, M01-0240364; Day 4/Day 1	1.08 Ratios Interval 0.68 to 1.71	1.06 Ratios Interval 0.9 to 1.25	—	—	—
GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, M01-0240364; Day 8/Day 1	210 Ratios Interval 85.0 to 517.0	1.69 Ratios Interval 0.78 to 3.66	—	—	—
GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, M01-0240364; Day 31/Day 1	229 Ratios Interval 108.0 to 485.0	2.80 Ratios Interval 1.59 to 4.96	—	—	—
GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, NZ98/254; Day 4/Day 1	1.05 Ratios Interval 0.84 to 1.31	1.19 Ratios Interval 0.9 to 1.58	—	—	—
GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, NZ98/254; Day 8/Day 1	4.53 Ratios Interval 2.93 to 7.02	1.31 Ratios Interval 0.9 to 1.9	—	—	—
GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, NZ98/254; Day 31/Day 1	6.92 Ratios Interval 4.61 to 10.0	2.64 Ratios Interval 1.73 to 4.02	—	—	—
GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, M10713; Day 4/Day 1	1.09 Ratios Interval 0.93 to 1.28	0.93 Ratios Interval 0.76 to 1.14	—	—	—
GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, M10713; Day 8/Day 1	4.02 Ratios Interval 2.74 to 5.88	1.22 Ratios Interval 0.89 to 1.67	—	—	—
GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, M10713; Day 31/Day 1	5.38 Ratios Interval 3.54 to 8.17	2.15 Ratios Interval 1.46 to 3.17	—	—	—
GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, H44/76; Day 4/Day 1	1.11 Ratios Interval 0.88 to 1.4128	1.00 Ratios Interval 0.79 to 1.27	—	—	—
GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, H44/76; Day 8/Day 1	28 Ratios Interval 15.0 to 50.0	1.73 Ratios Interval 1.06 to 2.81	—	—	—
GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, H44/76; Day 31/Day 1	42 Ratios Interval 25.0 to 72.0	4.78 Ratios Interval 2.9 to 7.89	—	—	—
GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, 5/99; Day 4/Day 1	1.35 Ratios Interval 0.9 to 2.04	0.93 Ratios Interval 0.68 to 1.26	—	—	—
GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup A; Day 4/Day 1	0.95 Ratios Interval 0.72 to 1.24	0.87 Ratios Interval 0.61 to 1.24	—	—	—
GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup A; Day 8/Day 1	117 Ratios Interval 59.0 to 232.0	17 Ratios Interval 7.78 to 37.0	—	—	—
GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup A; Day 31/Day 1	98 Ratios Interval 54.0 to 177.0	22 Ratios Interval 13.0 to 38.0	—	—	—
GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup C; Day 4/Day 1	1.30 Ratios Interval 0.98 to 1.73	1.20 Ratios Interval 0.92 to 1.56	—	—	—
GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup C; Day 8/Day 1	164 Ratios Interval 65.0 to 411.0	491 Ratios Interval 211.0 to 1141.0	—	—	—
GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup W; Day 4/Day 1	0.90 Ratios Interval 0.56 to 1.442	0.97 Ratios Interval 0.68 to 1.37	—	—	—
GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup W; Day 8/Day 1	61 Ratios Interval 29.0 to 131.0	67 Ratios Interval 27.0 to 168.0	—	—	—
GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup W; Day 31/Day 1	67 Ratios Interval 34.0 to 132.0	112 Ratios Interval 65.0 to 191.0	—	—	—
GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup Y; Day 4/Day 1	1.06 Ratios Interval 0.79 to 1.41	0.73 Ratios Interval 0.49 to 1.09	—	—	—
GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup Y; Day 8/Day 1	156 Ratios Interval 62.0 to 390.0	132 Ratios Interval 33.0 to 535.0	—	—	—
GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup Y; Day 31/Day 1	162 Ratios Interval 70.0 to 375.0	216 Ratios Interval 80.0 to 580.0	—	—	—

SECONDARY outcome

Timeframe: At Days 31, 34, 38 and 61 versus Day 1.

GMRs as measure of the kinetics of the immune response following a dose of MenABCWY+OMV, in Naïve subjects. The Meningococcal B Strains were M14459, M01-0240364, NZ98/254, M10713, H44/76 and 5/99.

Outcome measures

Outcome measures
Measure	MenABCWY+OMV Group n=50 Participants Subjects who received 2 doses of MenABCWY+OMV vaccine in the parent study V102\_02 (NCT01210885) and received no subsequent meningococcal vaccines, received a booster dose of MenABCWY+OMV vaccine in the current study at Day 1.	MenACWY Group Subjects who received MenACWY vaccine in the parent study V102\_02 (NCT01210885) and received no subsequent meningococcal vaccines, received 2 doses of MenABCWY+OMV vaccine, one month apart (Day 1 and Day 31), in the current study.	Naive Group Subjects similar in age to subjects in the MenABCWY+OMV and MenACWY groups, who had not previously received any meningococcal vaccine and who received 2 doses of MenABCWY+OMV vaccine, 1 month apart (Day 1 and Day 31), in the current study.	Naive Group (C1) Subjects similar in age to subjects in the MenABCWY+OMV and MenACWY groups, who had not previously received any meningococcal vaccine and who received 2 doses of MenABCWY+OMV vaccine, 1 month apart (Day 1 and Day 31), in the current study. Blood samples will be collected from subjects at Day 1 (before vaccination), Day 31 (before vaccination), Day 34 and Day 61.	Naive Group (C2) Subjects similar in age to subjects in the MenABCWY+OMV and MenACWY groups, who had not previously received any meningococcal vaccine and who received 2 doses of MenABCWY+OMV vaccine, 1 month apart (Day 1 and Day 31), in the current study. Blood samples will be collected from subjects at Day 1 (before vaccination), Day 31 (before vaccination), Day 38 and Day 61.
GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, M01-0240364; Day 38/Day 1	64 Ratios Interval 24.0 to 167.0	—	—	—	—
GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, NZ98/254; Day 38/Day 1	5.84 Ratios Interval 3.34 to 10.0	—	—	—	—
GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, NZ98/254; Day 61/Day 1	5.28 Ratios Interval 3.61 to 7.74	—	—	—	—
GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, H44/76; Day 38/Day 1	24 Ratios Interval 14.0 to 42.0	—	—	—	—
GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, H44/76; Day 61/Day 1	23 Ratios Interval 15.0 to 35.0	—	—	—	—
GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, 5/99; Day 31/Day 1	13 Ratios Interval 8.14 to 22.0	—	—	—	—
GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, M14459; Day 31/Day 1	2.72 Ratios Interval 1.91 to 3.87	—	—	—	—
GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, M14459; Day 34/Day 1	3.45 Ratios Interval 2.09 to 5.72	—	—	—	—
GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, M14459; Day 38/Day 1	6.15 Ratios Interval 3.65 to 10.0	—	—	—	—
GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, M14459; Day 61/Day 1	6.78 Ratios Interval 4.51 to 10.0	—	—	—	—
GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, M01-0240364; Day 31/Day 1	2.48 Ratios Interval 1.51 to 4.07	—	—	—	—
GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, M01-0240364; Day 34/Day 1	3.97 Ratios Interval 1.79 to 8.8	—	—	—	—
GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, M01-0240364; Day 61/Day 1	18 Ratios Interval 9.9 to 33.0	—	—	—	—
GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, NZ98/254; Day 31/Day 1	3.98 Ratios Interval 2.73 to 5.79	—	—	—	—
GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, NZ98/254; Day 34/Day 1	4.52 Ratios Interval 2.6 to 7.84	—	—	—	—
GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, M10713; Day 31/Day 1	2.48 Ratios Interval 1.78 to 3.45	—	—	—	—
GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, M10713; Day 34/Day 1	2.54 Ratios Interval 1.67 to 3.86	—	—	—	—
GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, M10713; Day 38/Day 1	2.83 Ratios Interval 1.64 to 4.87	—	—	—	—
GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, M10713; Day 61/Day 1	2.85 Ratios Interval 1.98 to 4.11	—	—	—	—
GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, H44/76; Day 31/Day 1	5.06 Ratios Interval 3.21 to 7.97	—	—	—	—
GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, H44/76; Day 34/Day 1	6.17 Ratios Interval 3.33 to 11.0	—	—	—	—
GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, 5/99; Day 34/Day 1	20 Ratios Interval 8.58 to 49.0	—	—	—	—
GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, 5/99; Day 38/Day 1	233 Ratios Interval 141.0 to 385.0	—	—	—	—
GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, 5/99; Day 61/Day 1	141 Ratios Interval 106.0 to 189.0	—	—	—	—
GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup A; Day 31/Day 1	18 Ratios Interval 12.0 to 29.0	—	—	—	—
GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup A; Day 34/Day 1	28 Ratios Interval 13.0 to 61.0	—	—	—	—
GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup A; Day 38/Day 1	82 Ratios Interval 48.0 to 140.0	—	—	—	—
GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup A; Day 61/Day 1	61 Ratios Interval 41.0 to 90.0	—	—	—	—
GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup C; Day 31/Day 1	12 Ratios Interval 6.88 to 19.0	—	—	—	—
GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup C; Day 34/Day 1	18 Ratios Interval 8.98 to 36.0	—	—	—	—
GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup C; Day 38/Day 1	64 Ratios Interval 32.0 to 128.0	—	—	—	—
GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup C; Day 61/Day 1	39 Ratios Interval 25.0 to 61.0	—	—	—	—
GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup W; Day 31/Day 1	16 Ratios Interval 8.35 to 30.0	—	—	—	—
GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup W; Day 34/Day 1	42 Ratios Interval 15.0 to 116.0	—	—	—	—
GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup W; Day 38/Day 1	16 Ratios Interval 6.68 to 40.0	—	—	—	—
GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup W; Day 61/Day 1	22 Ratios Interval 11.0 to 42.0	—	—	—	—
GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup Y; Day 31/Day 1	46 Ratios Interval 23.0 to 92.0	—	—	—	—
GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup Y; Day 34/Day 1	69 Ratios Interval 30.0 to 1601.0	—	—	—	—
GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup Y; Day 38/Day 1	134 Ratios Interval 68.0 to 264.0	—	—	—	—
GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup Y; Day 61/Day 1	106 Ratios Interval 62.0 to 182.0	—	—	—	—

SECONDARY outcome

Timeframe: At Day 61

Population: Data was not collected for this outcome measure as validation procedure of the hSBA assay was not relevant to the study.

The HT-hSBA assay format was changed in 2015 in response to CBER comments and no new LLQ values were defined as the validation of this format was not relevant. The LLQ cut off values for the old assay format correspond to 8 for serogroups A,C,W and Y and 5 for serogroup B strains and these results are presented in outcome measures 19 and 20 and are considered final in Company's judgement.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At Day 61

Population: Analysis was performed on Full Analysis Set immunogenicity persistence population set Day 61- all subjects in the enrolled population who received a study vaccination, provided at least one evaluable serum sample at 1 month post second vaccination and whose assay result was available for at least one serogroup/ test strain

Immunogenicity against N. meningitidis serogroup A, C, W and Y following 2 doses of MenABCWY+OMV in subjects who previously received 1 dose of MenACWY and Naïve subjects, at Day 61, as measured by percentages of subjects with hSBA ≥ 8.

Outcome measures

Outcome measures
Measure	MenABCWY+OMV Group n=46 Participants Subjects who received 2 doses of MenABCWY+OMV vaccine in the parent study V102\_02 (NCT01210885) and received no subsequent meningococcal vaccines, received a booster dose of MenABCWY+OMV vaccine in the current study at Day 1.	MenACWY Group n=47 Participants Subjects who received MenACWY vaccine in the parent study V102\_02 (NCT01210885) and received no subsequent meningococcal vaccines, received 2 doses of MenABCWY+OMV vaccine, one month apart (Day 1 and Day 31), in the current study.	Naive Group Subjects similar in age to subjects in the MenABCWY+OMV and MenACWY groups, who had not previously received any meningococcal vaccine and who received 2 doses of MenABCWY+OMV vaccine, 1 month apart (Day 1 and Day 31), in the current study.	Naive Group (C1) Subjects similar in age to subjects in the MenABCWY+OMV and MenACWY groups, who had not previously received any meningococcal vaccine and who received 2 doses of MenABCWY+OMV vaccine, 1 month apart (Day 1 and Day 31), in the current study. Blood samples will be collected from subjects at Day 1 (before vaccination), Day 31 (before vaccination), Day 34 and Day 61.	Naive Group (C2) Subjects similar in age to subjects in the MenABCWY+OMV and MenACWY groups, who had not previously received any meningococcal vaccine and who received 2 doses of MenABCWY+OMV vaccine, 1 month apart (Day 1 and Day 31), in the current study. Blood samples will be collected from subjects at Day 1 (before vaccination), Day 31 (before vaccination), Day 38 and Day 61.
Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. Serogroup C	100 Percentages of subjects Interval 89.7 to 100.0	100 Percentages of subjects Interval 92.5 to 100.0	—	—	—
Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. Serogroup W	100 Percentages of subjects Interval 89.1 to 100.0	100 Percentages of subjects Interval 91.4 to 100.0	—	—	—
Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. Serogroup Y	100 Percentages of subjects Interval 87.2 to 100.0	98 Percentages of subjects Interval 87.7 to 99.94	—	—	—
Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. Serogroup A	100 Percentages of subjects Interval 92.3 to 100.0	94 Percentages of subjects Interval 82.5 to 98.7	—	—	—

SECONDARY outcome

Timeframe: At Day 61

Immunogenicity against N. meningitidis serogroup B test strains following 2 doses of MenABCWY+OMV in subjects who previously received 1 dose of MenACWY and Naïve subjects, at Day 61, as measured by percentages of subjects with hSBA ≥ 5. The Meningococcal B Strains were M14459, M01-0240364, NZ98/254, M10713, H44/76 and 5/99.

Outcome measures

Outcome measures
Measure	MenABCWY+OMV Group n=46 Participants Subjects who received 2 doses of MenABCWY+OMV vaccine in the parent study V102\_02 (NCT01210885) and received no subsequent meningococcal vaccines, received a booster dose of MenABCWY+OMV vaccine in the current study at Day 1.	MenACWY Group n=49 Participants Subjects who received MenACWY vaccine in the parent study V102\_02 (NCT01210885) and received no subsequent meningococcal vaccines, received 2 doses of MenABCWY+OMV vaccine, one month apart (Day 1 and Day 31), in the current study.	Naive Group Subjects similar in age to subjects in the MenABCWY+OMV and MenACWY groups, who had not previously received any meningococcal vaccine and who received 2 doses of MenABCWY+OMV vaccine, 1 month apart (Day 1 and Day 31), in the current study.	Naive Group (C1) Subjects similar in age to subjects in the MenABCWY+OMV and MenACWY groups, who had not previously received any meningococcal vaccine and who received 2 doses of MenABCWY+OMV vaccine, 1 month apart (Day 1 and Day 31), in the current study. Blood samples will be collected from subjects at Day 1 (before vaccination), Day 31 (before vaccination), Day 34 and Day 61.	Naive Group (C2) Subjects similar in age to subjects in the MenABCWY+OMV and MenACWY groups, who had not previously received any meningococcal vaccine and who received 2 doses of MenABCWY+OMV vaccine, 1 month apart (Day 1 and Day 31), in the current study. Blood samples will be collected from subjects at Day 1 (before vaccination), Day 31 (before vaccination), Day 38 and Day 61.
Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. Serogroup B, NZ98/254	46 Percentages of subjects Interval 30.9 to 61.0	61 Percentages of subjects Interval 46.2 to 74.8	—	—	—
Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. Serogroup B, M10713	54 Percentages of subjects Interval 39.0 to 69.1	65 Percentages of subjects Interval 50.4 to 78.3	—	—	—
Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. Serogroup B, H44/76	85 Percentages of subjects Interval 71.1 to 93.7	88 Percentages of subjects Interval 75.2 to 95.4	—	—	—
Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. Serogroup B, 5/99	100 Percentages of subjects Interval 92.3 to 100.0	100 Percentages of subjects Interval 92.7 to 100.0	—	—	—
Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. Serogroup B, M14459	46 Percentages of subjects Interval 30.9 to 61.0	67 Percentages of subjects Interval 52.5 to 80.1	—	—	—
Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. Serogroup B, M01-0240364	65 Percentages of subjects Interval 49.8 to 78.6	70 Percentages of subjects Interval 55.1 to 82.7	—	—	—

SECONDARY outcome

Timeframe: At Day 61

GMTs as measure of the immunogenicity of 2 doses of MenABCWY+OMV in subjects who previously received 1 dose of MenACWY and Naïve subjects, at Day 61. The Meningococcal B Strains were M14459, M01-0240364, NZ98/254, M10713, H44/76 and 5/99.

Outcome measures

Outcome measures
Measure	MenABCWY+OMV Group n=46 Participants Subjects who received 2 doses of MenABCWY+OMV vaccine in the parent study V102\_02 (NCT01210885) and received no subsequent meningococcal vaccines, received a booster dose of MenABCWY+OMV vaccine in the current study at Day 1.	MenACWY Group n=49 Participants Subjects who received MenACWY vaccine in the parent study V102\_02 (NCT01210885) and received no subsequent meningococcal vaccines, received 2 doses of MenABCWY+OMV vaccine, one month apart (Day 1 and Day 31), in the current study.	Naive Group Subjects similar in age to subjects in the MenABCWY+OMV and MenACWY groups, who had not previously received any meningococcal vaccine and who received 2 doses of MenABCWY+OMV vaccine, 1 month apart (Day 1 and Day 31), in the current study.	Naive Group (C1) Subjects similar in age to subjects in the MenABCWY+OMV and MenACWY groups, who had not previously received any meningococcal vaccine and who received 2 doses of MenABCWY+OMV vaccine, 1 month apart (Day 1 and Day 31), in the current study. Blood samples will be collected from subjects at Day 1 (before vaccination), Day 31 (before vaccination), Day 34 and Day 61.	Naive Group (C2) Subjects similar in age to subjects in the MenABCWY+OMV and MenACWY groups, who had not previously received any meningococcal vaccine and who received 2 doses of MenABCWY+OMV vaccine, 1 month apart (Day 1 and Day 31), in the current study. Blood samples will be collected from subjects at Day 1 (before vaccination), Day 31 (before vaccination), Day 38 and Day 61.
GMTs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, NZ98/254	6.24 Titers Interval 4.47 to 8.7	7.50 Titers Interval 5.12 to 11.0	—	—	—
GMTs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, M10713	6.91 Titers Interval 4.43 to 11.0	8.73 Titers Interval 5.8 to 13.0	—	—	—
GMTs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup W	1440 Titers Interval 1078.0 to 1924.0	168 Titers Interval 129.0 to 218.0	—	—	—
GMTs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup Y	1576 Titers Interval 1190.0 to 2087.0	224 Titers Interval 147.0 to 343.0	—	—	—
GMTs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, M14459	4.82 Titers Interval 3.26 to 7.12	9.78 Titers Interval 6.42 to 15.0	—	—	—
GMTs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, M01-0240364	19 Titers Interval 10.0 to 34.0	21 Titers Interval 11.0 to 38.0	—	—	—
GMTs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, H44/76	19 Titers Interval 13.0 to 28.0	32 Titers Interval 21.0 to 49.0	—	—	—
GMTs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, 5/99	196 Titers Interval 149.0 to 257.0	256 Titers Interval 194.0 to 338.0	—	—	—
GMTs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup A	222 Titers Interval 170.0 to 290.0	74 Titers Interval 51.0 to 108.0	—	—	—
GMTs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup C	879 Titers Interval 712.0 to 1085.0	188 Titers Interval 132.0 to 266.0	—	—	—

SECONDARY outcome

Timeframe: Day 61 versus Day 1 (baseline)

GMRs as measure of the immunogenicity of 2 doses of MenABCWY+OMV in subjects who previously received 1 dose of MenACWY and Naïve subjects. The Meningococcal B Strains were M14459, M01-0240364, NZ98/254, M10713, H44/76 and 5/99.

Outcome measures

Outcome measures
Measure	MenABCWY+OMV Group n=46 Participants Subjects who received 2 doses of MenABCWY+OMV vaccine in the parent study V102\_02 (NCT01210885) and received no subsequent meningococcal vaccines, received a booster dose of MenABCWY+OMV vaccine in the current study at Day 1.	MenACWY Group n=49 Participants Subjects who received MenACWY vaccine in the parent study V102\_02 (NCT01210885) and received no subsequent meningococcal vaccines, received 2 doses of MenABCWY+OMV vaccine, one month apart (Day 1 and Day 31), in the current study.	Naive Group Subjects similar in age to subjects in the MenABCWY+OMV and MenACWY groups, who had not previously received any meningococcal vaccine and who received 2 doses of MenABCWY+OMV vaccine, 1 month apart (Day 1 and Day 31), in the current study.	Naive Group (C1) Subjects similar in age to subjects in the MenABCWY+OMV and MenACWY groups, who had not previously received any meningococcal vaccine and who received 2 doses of MenABCWY+OMV vaccine, 1 month apart (Day 1 and Day 31), in the current study. Blood samples will be collected from subjects at Day 1 (before vaccination), Day 31 (before vaccination), Day 34 and Day 61.	Naive Group (C2) Subjects similar in age to subjects in the MenABCWY+OMV and MenACWY groups, who had not previously received any meningococcal vaccine and who received 2 doses of MenABCWY+OMV vaccine, 1 month apart (Day 1 and Day 31), in the current study. Blood samples will be collected from subjects at Day 1 (before vaccination), Day 31 (before vaccination), Day 38 and Day 61.
GMRs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, 5/99	110 Ratios Interval 76.0 to 159.0	141 Ratios Interval 106.0 to 189.0	—	—	—
GMRs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, M14459	3.50 Ratios Interval 2.33 to 5.26	6.78 Ratios Interval 4.51 to 10.0	—	—	—
GMRs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, M01-0240364	16 Ratios Interval 8.77 to 31.0	18 Ratios Interval 9.9 to 33.0	—	—	—
GMRs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, NZ98/254	4.61 Ratios Interval 3.22 to 6.6	5.28 Ratios Interval 3.61 to 7.74	—	—	—
GMRs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, M10713	2.70 Ratios Interval 1.94 to 3.77	2.85 Ratios Interval 1.98 to 4.11	—	—	—
GMRs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup B, H44/76	16 Ratios Interval 10.0 to 24.0	23 Ratios Interval 15.0 to 35.0	—	—	—
GMRs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup A	33 Ratios Interval 20.0 to 56.0	61 Ratios Interval 41.0 to 90.0	—	—	—
GMRs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup C	181 Ratios Interval 108.0 to 303.0	39 Ratios Interval 25.0 to 61.0	—	—	—
GMRs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup W	85 Ratios Interval 46.0 to 155.0	22 Ratios Interval 11.0 to 42.0	—	—	—
GMRs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. Serogroup Y	264 Ratios Interval 117.0 to 598.0	106 Ratios Interval 62.0 to 182.0	—	—	—

SECONDARY outcome

Timeframe: Within 30 min after each vaccination

Population: Analysis was performed on Solicited safety Set- included all subjects in the Full Analysis Set Immunogenicity population who provided post-vaccination safety data.

Any solicited and unsolicited AEs reported within 30 minutes after each vaccination. Assessed solicited local symptoms were: Erythema and Induration. Any = occurrence of the symptom spreading beyond 25 millimeters (mm) of injection site. Assessed solicited general symptoms were: Arthralgia, Chills, Fatigue, Headache, Loss of Appetite, Myalgia, Nausea and Fever (body temperature ≥ 38°C). Other solicited data included: Prevention of Pain and/or Fever and Treatment of Pain and/or Fever. Any = occurrence of the symptom regardless of intensity grade. Note: There were no unsolicited AEs reported within 30 minutes after vaccination.

Outcome measures

Outcome measures
Measure	MenABCWY+OMV Group n=33 Participants Subjects who received 2 doses of MenABCWY+OMV vaccine in the parent study V102\_02 (NCT01210885) and received no subsequent meningococcal vaccines, received a booster dose of MenABCWY+OMV vaccine in the current study at Day 1.	MenACWY Group n=46 Participants Subjects who received MenACWY vaccine in the parent study V102\_02 (NCT01210885) and received no subsequent meningococcal vaccines, received 2 doses of MenABCWY+OMV vaccine, one month apart (Day 1 and Day 31), in the current study.	Naive Group n=50 Participants Subjects similar in age to subjects in the MenABCWY+OMV and MenACWY groups, who had not previously received any meningococcal vaccine and who received 2 doses of MenABCWY+OMV vaccine, 1 month apart (Day 1 and Day 31), in the current study.	Naive Group (C1) Subjects similar in age to subjects in the MenABCWY+OMV and MenACWY groups, who had not previously received any meningococcal vaccine and who received 2 doses of MenABCWY+OMV vaccine, 1 month apart (Day 1 and Day 31), in the current study. Blood samples will be collected from subjects at Day 1 (before vaccination), Day 31 (before vaccination), Day 34 and Day 61.	Naive Group (C2) Subjects similar in age to subjects in the MenABCWY+OMV and MenACWY groups, who had not previously received any meningococcal vaccine and who received 2 doses of MenABCWY+OMV vaccine, 1 month apart (Day 1 and Day 31), in the current study. Blood samples will be collected from subjects at Day 1 (before vaccination), Day 31 (before vaccination), Day 38 and Day 61.
Number of Subjects Reporting Any Unsolicited and Solicited Adverse Events (AEs) Within 30 Min After Each Vaccination Erythema (2nd vaccination)	—	1 Subjects	0 Subjects	—	—
Number of Subjects Reporting Any Unsolicited and Solicited Adverse Events (AEs) Within 30 Min After Each Vaccination Induration (1st vaccination)	0 Subjects	0 Subjects	0 Subjects	—	—
Number of Subjects Reporting Any Unsolicited and Solicited Adverse Events (AEs) Within 30 Min After Each Vaccination Arthralgia (2nd vaccination)	—	0 Subjects	0 Subjects	—	—
Number of Subjects Reporting Any Unsolicited and Solicited Adverse Events (AEs) Within 30 Min After Each Vaccination Headache (1st vaccination)	1 Subjects	0 Subjects	0 Subjects	—	—
Number of Subjects Reporting Any Unsolicited and Solicited Adverse Events (AEs) Within 30 Min After Each Vaccination Loss of Appetite (1st vaccination)	0 Subjects	0 Subjects	0 Subjects	—	—
Number of Subjects Reporting Any Unsolicited and Solicited Adverse Events (AEs) Within 30 Min After Each Vaccination Myalgia (1st vaccination)	0 Subjects	0 Subjects	0 Subjects	—	—
Number of Subjects Reporting Any Unsolicited and Solicited Adverse Events (AEs) Within 30 Min After Each Vaccination Fever (1st vaccination)	0 Subjects	0 Subjects	0 Subjects	—	—
Number of Subjects Reporting Any Unsolicited and Solicited Adverse Events (AEs) Within 30 Min After Each Vaccination Treatment of Pain/Fever (1st vaccination)	0 Subjects	0 Subjects	0 Subjects	—	—
Number of Subjects Reporting Any Unsolicited and Solicited Adverse Events (AEs) Within 30 Min After Each Vaccination Treatment of Pain/Fever (2nd vaccination)	—	0 Subjects	2 Subjects	—	—
Number of Subjects Reporting Any Unsolicited and Solicited Adverse Events (AEs) Within 30 Min After Each Vaccination Erythema (1st vaccination)	0 Subjects	1 Subjects	0 Subjects	—	—
Number of Subjects Reporting Any Unsolicited and Solicited Adverse Events (AEs) Within 30 Min After Each Vaccination Induration (2nd vaccination)	—	0 Subjects	0 Subjects	—	—
Number of Subjects Reporting Any Unsolicited and Solicited Adverse Events (AEs) Within 30 Min After Each Vaccination Pain (1st vaccination)	4 Subjects	8 Subjects	6 Subjects	—	—
Number of Subjects Reporting Any Unsolicited and Solicited Adverse Events (AEs) Within 30 Min After Each Vaccination Pain (2nd vaccination)	—	3 Subjects	4 Subjects	—	—
Number of Subjects Reporting Any Unsolicited and Solicited Adverse Events (AEs) Within 30 Min After Each Vaccination Arthralgia (1st vaccination)	0 Subjects	0 Subjects	0 Subjects	—	—
Number of Subjects Reporting Any Unsolicited and Solicited Adverse Events (AEs) Within 30 Min After Each Vaccination Chills (1st vaccination)	0 Subjects	0 Subjects	0 Subjects	—	—
Number of Subjects Reporting Any Unsolicited and Solicited Adverse Events (AEs) Within 30 Min After Each Vaccination Chills (2nd vaccination)	—	0 Subjects	0 Subjects	—	—
Number of Subjects Reporting Any Unsolicited and Solicited Adverse Events (AEs) Within 30 Min After Each Vaccination Fatigue (1st vaccination)	0 Subjects	0 Subjects	0 Subjects	—	—
Number of Subjects Reporting Any Unsolicited and Solicited Adverse Events (AEs) Within 30 Min After Each Vaccination Fatigue (2nd vaccination)	—	0 Subjects	1 Subjects	—	—
Number of Subjects Reporting Any Unsolicited and Solicited Adverse Events (AEs) Within 30 Min After Each Vaccination Headache (2nd vaccination)	—	0 Subjects	1 Subjects	—	—
Number of Subjects Reporting Any Unsolicited and Solicited Adverse Events (AEs) Within 30 Min After Each Vaccination Loss of Appetite (2nd vaccination)	—	0 Subjects	0 Subjects	—	—
Number of Subjects Reporting Any Unsolicited and Solicited Adverse Events (AEs) Within 30 Min After Each Vaccination Myalgia (2nd vaccination)	—	0 Subjects	0 Subjects	—	—
Number of Subjects Reporting Any Unsolicited and Solicited Adverse Events (AEs) Within 30 Min After Each Vaccination Nausea (1st vaccination)	0 Subjects	0 Subjects	0 Subjects	—	—
Number of Subjects Reporting Any Unsolicited and Solicited Adverse Events (AEs) Within 30 Min After Each Vaccination Nausea (2nd vaccination)	—	0 Subjects	0 Subjects	—	—
Number of Subjects Reporting Any Unsolicited and Solicited Adverse Events (AEs) Within 30 Min After Each Vaccination Fever (2nd vaccination)	—	0 Subjects	0 Subjects	—	—
Number of Subjects Reporting Any Unsolicited and Solicited Adverse Events (AEs) Within 30 Min After Each Vaccination Prevention of Pain/Fever (1st vaccination)	0 Subjects	0 Subjects	0 Subjects	—	—
Number of Subjects Reporting Any Unsolicited and Solicited Adverse Events (AEs) Within 30 Min After Each Vaccination Prevention of Pain/Fever (2nd vaccination)	—	0 Subjects	1 Subjects	—	—

SECONDARY outcome

Timeframe: From Day 1 (6 hours) to Day 7 after each vaccination

Population: Analysis was performed on Solicited safety Set- included all subjects in the Full Analysis Set Immunogenicity population who provided post-vaccination safety data.

Assessed solicited local symptoms were Erythema, Induration and Pain. Any = occurrence of the symptom spreading beyond 25 millimeters (mm) of injection site.

Outcome measures

Outcome measures
Measure	MenABCWY+OMV Group n=33 Participants Subjects who received 2 doses of MenABCWY+OMV vaccine in the parent study V102\_02 (NCT01210885) and received no subsequent meningococcal vaccines, received a booster dose of MenABCWY+OMV vaccine in the current study at Day 1.	MenACWY Group n=46 Participants Subjects who received MenACWY vaccine in the parent study V102\_02 (NCT01210885) and received no subsequent meningococcal vaccines, received 2 doses of MenABCWY+OMV vaccine, one month apart (Day 1 and Day 31), in the current study.	Naive Group n=50 Participants Subjects similar in age to subjects in the MenABCWY+OMV and MenACWY groups, who had not previously received any meningococcal vaccine and who received 2 doses of MenABCWY+OMV vaccine, 1 month apart (Day 1 and Day 31), in the current study.	Naive Group (C1) Subjects similar in age to subjects in the MenABCWY+OMV and MenACWY groups, who had not previously received any meningococcal vaccine and who received 2 doses of MenABCWY+OMV vaccine, 1 month apart (Day 1 and Day 31), in the current study. Blood samples will be collected from subjects at Day 1 (before vaccination), Day 31 (before vaccination), Day 34 and Day 61.	Naive Group (C2) Subjects similar in age to subjects in the MenABCWY+OMV and MenACWY groups, who had not previously received any meningococcal vaccine and who received 2 doses of MenABCWY+OMV vaccine, 1 month apart (Day 1 and Day 31), in the current study. Blood samples will be collected from subjects at Day 1 (before vaccination), Day 31 (before vaccination), Day 38 and Day 61.
Number of Subjects With Any Solicited Local Symptoms Any local AEs (1st vaccination)	31 Subjects	41 Subjects	47 Subjects	—	—
Number of Subjects With Any Solicited Local Symptoms Pain (1st vaccination)	31 Subjects	41 Subjects	47 Subjects	—	—
Number of Subjects With Any Solicited Local Symptoms Erythema (1st vaccination)	8 Subjects	7 Subjects	8 Subjects	—	—
Number of Subjects With Any Solicited Local Symptoms Induration (1st vaccination)	12 Subjects	7 Subjects	13 Subjects	—	—
Number of Subjects With Any Solicited Local Symptoms Any local AEs (2nd vaccination)	—	35 Subjects	41 Subjects	—	—
Number of Subjects With Any Solicited Local Symptoms Erythema (2nd vaccination)	—	6 Subjects	7 Subjects	—	—
Number of Subjects With Any Solicited Local Symptoms Induration (2nd vaccination)	—	9 Subjects	8 Subjects	—	—
Number of Subjects With Any Solicited Local Symptoms Pain (2nd vaccination)	—	34 Subjects	41 Subjects	—	—

SECONDARY outcome

Timeframe: From Day 1 (6 hours) to Day 7 after each vaccination

Population: Analysis was performed on Solicited safety Set- included all subjects in the Full Analysis Set Immunogenicity population who provided post-vaccination safety data.

Assessed solicited systemic symptoms were Arthralgia, Chills, Fatigue, Headache, Loss of Appetite, Myalgia, Nausea and Fever (body temperature ≥ 38°C). Other solicited data included: Prevention of pain and/or fever and Treatment of pain and/or fever. Any = occurrence of the symptom regardless of intensity grade.

Outcome measures

Outcome measures
Measure	MenABCWY+OMV Group n=33 Participants Subjects who received 2 doses of MenABCWY+OMV vaccine in the parent study V102\_02 (NCT01210885) and received no subsequent meningococcal vaccines, received a booster dose of MenABCWY+OMV vaccine in the current study at Day 1.	MenACWY Group n=46 Participants Subjects who received MenACWY vaccine in the parent study V102\_02 (NCT01210885) and received no subsequent meningococcal vaccines, received 2 doses of MenABCWY+OMV vaccine, one month apart (Day 1 and Day 31), in the current study.	Naive Group n=50 Participants Subjects similar in age to subjects in the MenABCWY+OMV and MenACWY groups, who had not previously received any meningococcal vaccine and who received 2 doses of MenABCWY+OMV vaccine, 1 month apart (Day 1 and Day 31), in the current study.	Naive Group (C1) Subjects similar in age to subjects in the MenABCWY+OMV and MenACWY groups, who had not previously received any meningococcal vaccine and who received 2 doses of MenABCWY+OMV vaccine, 1 month apart (Day 1 and Day 31), in the current study. Blood samples will be collected from subjects at Day 1 (before vaccination), Day 31 (before vaccination), Day 34 and Day 61.	Naive Group (C2) Subjects similar in age to subjects in the MenABCWY+OMV and MenACWY groups, who had not previously received any meningococcal vaccine and who received 2 doses of MenABCWY+OMV vaccine, 1 month apart (Day 1 and Day 31), in the current study. Blood samples will be collected from subjects at Day 1 (before vaccination), Day 31 (before vaccination), Day 38 and Day 61.
Number of Subjects With Solicited Systemic Symptoms and Other Solicited Data Headache (1st vaccination)	19 Subjects	20 Subjects	23 Subjects	—	—
Number of Subjects With Solicited Systemic Symptoms and Other Solicited Data Loss of Appetite (1st vaccination)	5 Subjects	9 Subjects	9 Subjects	—	—
Number of Subjects With Solicited Systemic Symptoms and Other Solicited Data Myalgia (1st vaccination)	18 Subjects	22 Subjects	23 Subjects	—	—
Number of Subjects With Solicited Systemic Symptoms and Other Solicited Data Nausea (1st vaccination)	4 Subjects	10 Subjects	13 Subjects	—	—
Number of Subjects With Solicited Systemic Symptoms and Other Solicited Data Any systemic AEs (2nd vaccination)	—	22 Subjects	28 Subjects	—	—
Number of Subjects With Solicited Systemic Symptoms and Other Solicited Data Headache (2nd vaccination)	—	11 Subjects	18 Subjects	—	—
Number of Subjects With Solicited Systemic Symptoms and Other Solicited Data Loss of Appetite (2nd vaccination)	—	3 Subjects	5 Subjects	—	—
Number of Subjects With Solicited Systemic Symptoms and Other Solicited Data Any systemic AEs (1st vaccination)	24 Subjects	35 Subjects	37 Subjects	—	—
Number of Subjects With Solicited Systemic Symptoms and Other Solicited Data Arthralgia (1st vaccination)	8 Subjects	8 Subjects	15 Subjects	—	—
Number of Subjects With Solicited Systemic Symptoms and Other Solicited Data Chills (1st vaccination)	5 Subjects	11 Subjects	11 Subjects	—	—
Number of Subjects With Solicited Systemic Symptoms and Other Solicited Data Fatigue (1st vaccination)	14 Subjects	19 Subjects	24 Subjects	—	—
Number of Subjects With Solicited Systemic Symptoms and Other Solicited Data Fever (1st vaccination)	0 Subjects	4 Subjects	8 Subjects	—	—
Number of Subjects With Solicited Systemic Symptoms and Other Solicited Data Prevention of Pain/Fever (1st vaccination)	0 Subjects	1 Subjects	1 Subjects	—	—
Number of Subjects With Solicited Systemic Symptoms and Other Solicited Data Treatment of Pain/Fever (1st vaccination)	8 Subjects	7 Subjects	11 Subjects	—	—
Number of Subjects With Solicited Systemic Symptoms and Other Solicited Data Arthralgia (2nd vaccination)	—	4 Subjects	7 Subjects	—	—
Number of Subjects With Solicited Systemic Symptoms and Other Solicited Data Chills (2nd vaccination)	—	5 Subjects	9 Subjects	—	—
Number of Subjects With Solicited Systemic Symptoms and Other Solicited Data Fatigue (2nd vaccination)	—	10 Subjects	12 Subjects	—	—
Number of Subjects With Solicited Systemic Symptoms and Other Solicited Data Myalgia (2nd vaccination)	—	12 Subjects	14 Subjects	—	—
Number of Subjects With Solicited Systemic Symptoms and Other Solicited Data Nausea (2nd vaccination)	—	4 Subjects	4 Subjects	—	—
Number of Subjects With Solicited Systemic Symptoms and Other Solicited Data Fever (2nd vaccination)	—	4 Subjects	2 Subjects	—	—
Number of Subjects With Solicited Systemic Symptoms and Other Solicited Data Prevention of Pain/Fever (2nd vaccination)	—	1 Subjects	3 Subjects	—	—
Number of Subjects With Solicited Systemic Symptoms and Other Solicited Data Treatment of Pain/Fever (2nd vaccination)	—	2 Subjects	6 Subjects	—	—

SECONDARY outcome

Timeframe: From Day 1 to Day 31 after each vaccination (Day 1 to Day 31 for MenABCWY+OMV Group and Day 1 to Day 61 for MenACWY and Naive Groups)

Population: Analysis was performed on Unsolicited Safety Set- included all subjects in the Exposed Set who had post-vaccination unsolicited adverse event records.

An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Possibly or Probably related = AE assessed by the investigator as related to the vaccination.

Outcome measures

Outcome measures
Measure	MenABCWY+OMV Group n=33 Participants Subjects who received 2 doses of MenABCWY+OMV vaccine in the parent study V102\_02 (NCT01210885) and received no subsequent meningococcal vaccines, received a booster dose of MenABCWY+OMV vaccine in the current study at Day 1.	MenACWY Group n=46 Participants Subjects who received MenACWY vaccine in the parent study V102\_02 (NCT01210885) and received no subsequent meningococcal vaccines, received 2 doses of MenABCWY+OMV vaccine, one month apart (Day 1 and Day 31), in the current study.	Naive Group n=50 Participants Subjects similar in age to subjects in the MenABCWY+OMV and MenACWY groups, who had not previously received any meningococcal vaccine and who received 2 doses of MenABCWY+OMV vaccine, 1 month apart (Day 1 and Day 31), in the current study.	Naive Group (C1) Subjects similar in age to subjects in the MenABCWY+OMV and MenACWY groups, who had not previously received any meningococcal vaccine and who received 2 doses of MenABCWY+OMV vaccine, 1 month apart (Day 1 and Day 31), in the current study. Blood samples will be collected from subjects at Day 1 (before vaccination), Day 31 (before vaccination), Day 34 and Day 61.	Naive Group (C2) Subjects similar in age to subjects in the MenABCWY+OMV and MenACWY groups, who had not previously received any meningococcal vaccine and who received 2 doses of MenABCWY+OMV vaccine, 1 month apart (Day 1 and Day 31), in the current study. Blood samples will be collected from subjects at Day 1 (before vaccination), Day 31 (before vaccination), Day 38 and Day 61.
Number of Subjects With Unsolicited Adverse Events (AEs). Any AEs	11 Subjects	21 Subjects	20 Subjects	—	—
Number of Subjects With Unsolicited Adverse Events (AEs). Possibly or Probably Related AEs	3 Subjects	11 Subjects	8 Subjects	—	—

SECONDARY outcome

Timeframe: During the entire study period (Day 1 to Day 31 for MenABCWY+OMV Group and Day 1 to Day 61 for MenACWY and Naive Groups)

Population: Analysis was performed on Unsolicited Safety Set- included all subjects in the Exposed Set who had post-vaccination unsolicited adverse event records.

Medically attended AEs = were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any medically attended AE(s) = Occurrence of any medically attended AE(s) regardless of intensity grade or relation to vaccination.

Outcome measures

Outcome measures
Measure	MenABCWY+OMV Group n=33 Participants Subjects who received 2 doses of MenABCWY+OMV vaccine in the parent study V102\_02 (NCT01210885) and received no subsequent meningococcal vaccines, received a booster dose of MenABCWY+OMV vaccine in the current study at Day 1.	MenACWY Group n=46 Participants Subjects who received MenACWY vaccine in the parent study V102\_02 (NCT01210885) and received no subsequent meningococcal vaccines, received 2 doses of MenABCWY+OMV vaccine, one month apart (Day 1 and Day 31), in the current study.	Naive Group n=50 Participants Subjects similar in age to subjects in the MenABCWY+OMV and MenACWY groups, who had not previously received any meningococcal vaccine and who received 2 doses of MenABCWY+OMV vaccine, 1 month apart (Day 1 and Day 31), in the current study.	Naive Group (C1) Subjects similar in age to subjects in the MenABCWY+OMV and MenACWY groups, who had not previously received any meningococcal vaccine and who received 2 doses of MenABCWY+OMV vaccine, 1 month apart (Day 1 and Day 31), in the current study. Blood samples will be collected from subjects at Day 1 (before vaccination), Day 31 (before vaccination), Day 34 and Day 61.	Naive Group (C2) Subjects similar in age to subjects in the MenABCWY+OMV and MenACWY groups, who had not previously received any meningococcal vaccine and who received 2 doses of MenABCWY+OMV vaccine, 1 month apart (Day 1 and Day 31), in the current study. Blood samples will be collected from subjects at Day 1 (before vaccination), Day 31 (before vaccination), Day 38 and Day 61.
Number of Subjects With Medically Attended AEs Reported During the Entire Study Period.	2 Subjects	6 Subjects	5 Subjects	—	—

SECONDARY outcome

Timeframe: From Day 1 to Day 31 (MenABCWY+OMV Group) and from Day 1 to Day 61 (MenACWY and Naive Groups)

Population: Analysis was performed on Unsolicited Safety Set- included all subjects in the Exposed Set who had post-vaccination unsolicited adverse event records.

The number of subjects who reported unsolicited AEs leading to premature withdrawal from study after any vaccination.

Outcome measures

Outcome measures
Measure	MenABCWY+OMV Group n=33 Participants Subjects who received 2 doses of MenABCWY+OMV vaccine in the parent study V102\_02 (NCT01210885) and received no subsequent meningococcal vaccines, received a booster dose of MenABCWY+OMV vaccine in the current study at Day 1.	MenACWY Group n=46 Participants Subjects who received MenACWY vaccine in the parent study V102\_02 (NCT01210885) and received no subsequent meningococcal vaccines, received 2 doses of MenABCWY+OMV vaccine, one month apart (Day 1 and Day 31), in the current study.	Naive Group n=50 Participants Subjects similar in age to subjects in the MenABCWY+OMV and MenACWY groups, who had not previously received any meningococcal vaccine and who received 2 doses of MenABCWY+OMV vaccine, 1 month apart (Day 1 and Day 31), in the current study.	Naive Group (C1) Subjects similar in age to subjects in the MenABCWY+OMV and MenACWY groups, who had not previously received any meningococcal vaccine and who received 2 doses of MenABCWY+OMV vaccine, 1 month apart (Day 1 and Day 31), in the current study. Blood samples will be collected from subjects at Day 1 (before vaccination), Day 31 (before vaccination), Day 34 and Day 61.	Naive Group (C2) Subjects similar in age to subjects in the MenABCWY+OMV and MenACWY groups, who had not previously received any meningococcal vaccine and who received 2 doses of MenABCWY+OMV vaccine, 1 month apart (Day 1 and Day 31), in the current study. Blood samples will be collected from subjects at Day 1 (before vaccination), Day 31 (before vaccination), Day 38 and Day 61.
Number of Subjects With Unsolicited AEs Leading to Premature Withdrawal From Study Reported During the Entire Study Period.	0 Subjects	1 Subjects	0 Subjects	—	—

SECONDARY outcome

Timeframe: During the entire study period (Day 1 to Day 31 for MenABCWY+OMV Group and Day 1 to Day 61 for MenACWY and Naive Groups)

Population: Analysis was performed on Unsolicited Safety Set- included all subjects in the Exposed Set who had post-vaccination unsolicited adverse event records.

Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Any SAE(s) = Occurrence of any SAE(s) regardless of intensity grade or relation to vaccination. Possibly or probably related SAE(s) = SAE(s) assessed by the investigator as related to the vaccination.

Outcome measures

Outcome measures
Measure	MenABCWY+OMV Group n=33 Participants Subjects who received 2 doses of MenABCWY+OMV vaccine in the parent study V102\_02 (NCT01210885) and received no subsequent meningococcal vaccines, received a booster dose of MenABCWY+OMV vaccine in the current study at Day 1.	MenACWY Group n=46 Participants Subjects who received MenACWY vaccine in the parent study V102\_02 (NCT01210885) and received no subsequent meningococcal vaccines, received 2 doses of MenABCWY+OMV vaccine, one month apart (Day 1 and Day 31), in the current study.	Naive Group n=50 Participants Subjects similar in age to subjects in the MenABCWY+OMV and MenACWY groups, who had not previously received any meningococcal vaccine and who received 2 doses of MenABCWY+OMV vaccine, 1 month apart (Day 1 and Day 31), in the current study.	Naive Group (C1) Subjects similar in age to subjects in the MenABCWY+OMV and MenACWY groups, who had not previously received any meningococcal vaccine and who received 2 doses of MenABCWY+OMV vaccine, 1 month apart (Day 1 and Day 31), in the current study. Blood samples will be collected from subjects at Day 1 (before vaccination), Day 31 (before vaccination), Day 34 and Day 61.	Naive Group (C2) Subjects similar in age to subjects in the MenABCWY+OMV and MenACWY groups, who had not previously received any meningococcal vaccine and who received 2 doses of MenABCWY+OMV vaccine, 1 month apart (Day 1 and Day 31), in the current study. Blood samples will be collected from subjects at Day 1 (before vaccination), Day 31 (before vaccination), Day 38 and Day 61.
Number of Subjects With Serious Adverse Events (SAEs) Reported During the Entire Study Period. Any SAEs	0 Subjects	0 Subjects	0 Subjects	—	—
Number of Subjects With Serious Adverse Events (SAEs) Reported During the Entire Study Period. Possibly or probably related SAEs	0 Subjects	0 Subjects	0 Subjects	—	—
Number of Subjects With Serious Adverse Events (SAEs) Reported During the Entire Study Period. AEs leading to death	0 Subjects	0 Subjects	0 Subjects	—	—

Adverse Events

MenABCWY+OMV Group

Serious events: 0 serious events

Other events: 33 other events

Deaths: 0 deaths

MenACWY Group

Serious events: 0 serious events

Other events: 44 other events

Deaths: 0 deaths

Naive Group

Serious events: 0 serious events

Other events: 48 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	MenABCWY+OMV Group n=33 participants at risk Subjects who received 2 doses of MenABCWY+OMV vaccine in the parent study V102\_02 (NCT01210885) and received no subsequent meningococcal vaccines, received a booster dose of MenABCWY+OMV vaccine in the current study at Day 1.	MenACWY Group n=46 participants at risk Subjects who received MenACWY vaccine in the parent study V102\_02 (NCT01210885) and received no subsequent meningococcal vaccines, received 2 doses of MenABCWY+OMV vaccine, one month apart (Day 1 and Day 31), in the current study.	Naive Group n=50 participants at risk Subjects similar in age to subjects in the MenABCWY+OMV and MenACWY groups, who had not previously received any meningococcal vaccine and who received 2 doses of MenABCWY+OMV vaccine, 1 month apart (Day 1 and Day 31), in the current study.
Nervous system disorders Headache	57.6% 19/33 • Number of events 43 • Solicited local and systemic symptoms: from Day 1 (6 hours) to Day 7 after each study vaccination; Unsolicited AEs: from Day 1 to Day 31 after each study vaccination; SAEs: during the entire study period (from Day 1 to Day 61).	50.0% 23/46 • Number of events 84 • Solicited local and systemic symptoms: from Day 1 (6 hours) to Day 7 after each study vaccination; Unsolicited AEs: from Day 1 to Day 31 after each study vaccination; SAEs: during the entire study period (from Day 1 to Day 61).	56.0% 28/50 • Number of events 120 • Solicited local and systemic symptoms: from Day 1 (6 hours) to Day 7 after each study vaccination; Unsolicited AEs: from Day 1 to Day 31 after each study vaccination; SAEs: during the entire study period (from Day 1 to Day 61).
General disorders Chills	15.2% 5/33 • Number of events 10 • Solicited local and systemic symptoms: from Day 1 (6 hours) to Day 7 after each study vaccination; Unsolicited AEs: from Day 1 to Day 31 after each study vaccination; SAEs: during the entire study period (from Day 1 to Day 61).	30.4% 14/46 • Number of events 25 • Solicited local and systemic symptoms: from Day 1 (6 hours) to Day 7 after each study vaccination; Unsolicited AEs: from Day 1 to Day 31 after each study vaccination; SAEs: during the entire study period (from Day 1 to Day 61).	32.0% 16/50 • Number of events 31 • Solicited local and systemic symptoms: from Day 1 (6 hours) to Day 7 after each study vaccination; Unsolicited AEs: from Day 1 to Day 31 after each study vaccination; SAEs: during the entire study period (from Day 1 to Day 61).
General disorders Fatigue	42.4% 14/33 • Number of events 29 • Solicited local and systemic symptoms: from Day 1 (6 hours) to Day 7 after each study vaccination; Unsolicited AEs: from Day 1 to Day 31 after each study vaccination; SAEs: during the entire study period (from Day 1 to Day 61).	43.5% 20/46 • Number of events 75 • Solicited local and systemic symptoms: from Day 1 (6 hours) to Day 7 after each study vaccination; Unsolicited AEs: from Day 1 to Day 31 after each study vaccination; SAEs: during the entire study period (from Day 1 to Day 61).	54.0% 27/50 • Number of events 82 • Solicited local and systemic symptoms: from Day 1 (6 hours) to Day 7 after each study vaccination; Unsolicited AEs: from Day 1 to Day 31 after each study vaccination; SAEs: during the entire study period (from Day 1 to Day 61).
General disorders Injection site erythema	33.3% 11/33 • Number of events 45 • Solicited local and systemic symptoms: from Day 1 (6 hours) to Day 7 after each study vaccination; Unsolicited AEs: from Day 1 to Day 31 after each study vaccination; SAEs: during the entire study period (from Day 1 to Day 61).	56.5% 26/46 • Number of events 135 • Solicited local and systemic symptoms: from Day 1 (6 hours) to Day 7 after each study vaccination; Unsolicited AEs: from Day 1 to Day 31 after each study vaccination; SAEs: during the entire study period (from Day 1 to Day 61).	60.0% 30/50 • Number of events 123 • Solicited local and systemic symptoms: from Day 1 (6 hours) to Day 7 after each study vaccination; Unsolicited AEs: from Day 1 to Day 31 after each study vaccination; SAEs: during the entire study period (from Day 1 to Day 61).
General disorders Injection site induration	54.5% 18/33 • Number of events 75 • Solicited local and systemic symptoms: from Day 1 (6 hours) to Day 7 after each study vaccination; Unsolicited AEs: from Day 1 to Day 31 after each study vaccination; SAEs: during the entire study period (from Day 1 to Day 61).	58.7% 27/46 • Number of events 173 • Solicited local and systemic symptoms: from Day 1 (6 hours) to Day 7 after each study vaccination; Unsolicited AEs: from Day 1 to Day 31 after each study vaccination; SAEs: during the entire study period (from Day 1 to Day 61).	60.0% 30/50 • Number of events 169 • Solicited local and systemic symptoms: from Day 1 (6 hours) to Day 7 after each study vaccination; Unsolicited AEs: from Day 1 to Day 31 after each study vaccination; SAEs: during the entire study period (from Day 1 to Day 61).
General disorders Injection site pain	93.9% 31/33 • Number of events 114 • Solicited local and systemic symptoms: from Day 1 (6 hours) to Day 7 after each study vaccination; Unsolicited AEs: from Day 1 to Day 31 after each study vaccination; SAEs: during the entire study period (from Day 1 to Day 61).	91.3% 42/46 • Number of events 295 • Solicited local and systemic symptoms: from Day 1 (6 hours) to Day 7 after each study vaccination; Unsolicited AEs: from Day 1 to Day 31 after each study vaccination; SAEs: during the entire study period (from Day 1 to Day 61).	96.0% 48/50 • Number of events 333 • Solicited local and systemic symptoms: from Day 1 (6 hours) to Day 7 after each study vaccination; Unsolicited AEs: from Day 1 to Day 31 after each study vaccination; SAEs: during the entire study period (from Day 1 to Day 61).
General disorders Pyrexia	0.00% 0/33 • Solicited local and systemic symptoms: from Day 1 (6 hours) to Day 7 after each study vaccination; Unsolicited AEs: from Day 1 to Day 31 after each study vaccination; SAEs: during the entire study period (from Day 1 to Day 61).	17.4% 8/46 • Number of events 12 • Solicited local and systemic symptoms: from Day 1 (6 hours) to Day 7 after each study vaccination; Unsolicited AEs: from Day 1 to Day 31 after each study vaccination; SAEs: during the entire study period (from Day 1 to Day 61).	20.0% 10/50 • Number of events 13 • Solicited local and systemic symptoms: from Day 1 (6 hours) to Day 7 after each study vaccination; Unsolicited AEs: from Day 1 to Day 31 after each study vaccination; SAEs: during the entire study period (from Day 1 to Day 61).
Gastrointestinal disorders Nausea	12.1% 4/33 • Number of events 11 • Solicited local and systemic symptoms: from Day 1 (6 hours) to Day 7 after each study vaccination; Unsolicited AEs: from Day 1 to Day 31 after each study vaccination; SAEs: during the entire study period (from Day 1 to Day 61).	21.7% 10/46 • Number of events 30 • Solicited local and systemic symptoms: from Day 1 (6 hours) to Day 7 after each study vaccination; Unsolicited AEs: from Day 1 to Day 31 after each study vaccination; SAEs: during the entire study period (from Day 1 to Day 61).	30.0% 15/50 • Number of events 25 • Solicited local and systemic symptoms: from Day 1 (6 hours) to Day 7 after each study vaccination; Unsolicited AEs: from Day 1 to Day 31 after each study vaccination; SAEs: during the entire study period (from Day 1 to Day 61).
Musculoskeletal and connective tissue disorders Arthralgia	24.2% 8/33 • Number of events 14 • Solicited local and systemic symptoms: from Day 1 (6 hours) to Day 7 after each study vaccination; Unsolicited AEs: from Day 1 to Day 31 after each study vaccination; SAEs: during the entire study period (from Day 1 to Day 61).	23.9% 11/46 • Number of events 35 • Solicited local and systemic symptoms: from Day 1 (6 hours) to Day 7 after each study vaccination; Unsolicited AEs: from Day 1 to Day 31 after each study vaccination; SAEs: during the entire study period (from Day 1 to Day 61).	38.0% 19/50 • Number of events 51 • Solicited local and systemic symptoms: from Day 1 (6 hours) to Day 7 after each study vaccination; Unsolicited AEs: from Day 1 to Day 31 after each study vaccination; SAEs: during the entire study period (from Day 1 to Day 61).
Musculoskeletal and connective tissue disorders Myalgia	54.5% 18/33 • Number of events 42 • Solicited local and systemic symptoms: from Day 1 (6 hours) to Day 7 after each study vaccination; Unsolicited AEs: from Day 1 to Day 31 after each study vaccination; SAEs: during the entire study period (from Day 1 to Day 61).	54.3% 25/46 • Number of events 85 • Solicited local and systemic symptoms: from Day 1 (6 hours) to Day 7 after each study vaccination; Unsolicited AEs: from Day 1 to Day 31 after each study vaccination; SAEs: during the entire study period (from Day 1 to Day 61).	52.0% 26/50 • Number of events 96 • Solicited local and systemic symptoms: from Day 1 (6 hours) to Day 7 after each study vaccination; Unsolicited AEs: from Day 1 to Day 31 after each study vaccination; SAEs: during the entire study period (from Day 1 to Day 61).
Metabolism and nutrition disorders Decreased appetite	15.2% 5/33 • Number of events 11 • Solicited local and systemic symptoms: from Day 1 (6 hours) to Day 7 after each study vaccination; Unsolicited AEs: from Day 1 to Day 31 after each study vaccination; SAEs: during the entire study period (from Day 1 to Day 61).	23.9% 11/46 • Number of events 25 • Solicited local and systemic symptoms: from Day 1 (6 hours) to Day 7 after each study vaccination; Unsolicited AEs: from Day 1 to Day 31 after each study vaccination; SAEs: during the entire study period (from Day 1 to Day 61).	26.0% 13/50 • Number of events 30 • Solicited local and systemic symptoms: from Day 1 (6 hours) to Day 7 after each study vaccination; Unsolicited AEs: from Day 1 to Day 31 after each study vaccination; SAEs: during the entire study period (from Day 1 to Day 61).
Infections and infestations Nasopharyngitis	3.0% 1/33 • Number of events 1 • Solicited local and systemic symptoms: from Day 1 (6 hours) to Day 7 after each study vaccination; Unsolicited AEs: from Day 1 to Day 31 after each study vaccination; SAEs: during the entire study period (from Day 1 to Day 61).	13.0% 6/46 • Number of events 6 • Solicited local and systemic symptoms: from Day 1 (6 hours) to Day 7 after each study vaccination; Unsolicited AEs: from Day 1 to Day 31 after each study vaccination; SAEs: during the entire study period (from Day 1 to Day 61).	2.0% 1/50 • Number of events 1 • Solicited local and systemic symptoms: from Day 1 (6 hours) to Day 7 after each study vaccination; Unsolicited AEs: from Day 1 to Day 31 after each study vaccination; SAEs: during the entire study period (from Day 1 to Day 61).

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

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

Restriction type: OTHER