Trial Outcomes & Findings for Combined Study - Phase 3b MenB Long Term Persistence in Adolescents (NCT NCT02446743)

NCT ID: NCT02446743

Last Updated: 2018-11-08

Results Overview

Bactericidal activity was measured against the N. meningitidis group B indicator strains 5/99 and NZ98/254. This outcome measure was assessed only for strains 5/99 and NZ98/254.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 531 participants
• Primary outcome timeframe: Group 3B: Day 1 (prior to booster dose); Group B_0_1: Day 1 (prior to first dose).
• Results posted on: 2018-11-08

Participant Flow

Subjects were recruited from 4 sites in Australia,6 sites in Canada & 2 sites in Chile.Analysis were performed on the study population (Groups 3B and B_0_1), but also repeated & stratified by parent study (i.e., V72_41 subjects using naïve subjects in Australia and Canada as controls, and V72P10 subjects using naïve subjects in Chile as controls)

All enrolled subjects were included in the study. Only groups 3B & B_0_1 were accounted for enrollment number as subjects from parent studies are included in the group 3B.

Participant milestones

Measure	Group 3B Subjects who received two doses of rMenB+OMV NZ administered at 0, 1 or 0,2 or 0,6 month schedule in study V72P10 and at 0,1 month schedule in study V72\_41, and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during parent studies, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.	Group B_0_1 Naive subjects from Australia,Canada and Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.
Overall Study STARTED	276	255
Overall Study COMPLETED	271	250
Overall Study NOT COMPLETED	5	5

Reasons for withdrawal

Measure	Group 3B Subjects who received two doses of rMenB+OMV NZ administered at 0, 1 or 0,2 or 0,6 month schedule in study V72P10 and at 0,1 month schedule in study V72\_41, and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during parent studies, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.	Group B_0_1 Naive subjects from Australia,Canada and Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.
Overall Study Withdrawal by Subject	1	1
Overall Study Lost to Follow-up	1	0
Overall Study Adverse Event	1	1
Overall Study Other	2	3

Baseline Characteristics

Combined Study - Phase 3b MenB Long Term Persistence in Adolescents

Baseline characteristics by cohort

Measure	Group 3B n=276 Participants Subjects who received two doses of rMenB+OMV NZ administered at 0, 1 or 0,2 or 0,6 month schedule in study V72P10 and at 0,1 month schedule in study V72\_41, and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during parent studies, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.	Group B_0_1 n=255 Participants Naive subjects from Australia,Canada and Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.	Total n=531 Participants Total of all reporting groups
Age, Continuous	19.5 years STANDARD_DEVIATION 2.42 • n=5 Participants	20.0 years STANDARD_DEVIATION 2.69 • n=7 Participants	19.7 years STANDARD_DEVIATION 2.56 • n=5 Participants
Sex: Female, Male Female	133 Participants n=5 Participants	128 Participants n=7 Participants	261 Participants n=5 Participants
Sex: Female, Male Male	143 Participants n=5 Participants	127 Participants n=7 Participants	270 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethinicity · American Indian or Alaska Native	11 Participants n=5 Participants	1 Participants n=7 Participants	12 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethinicity · Asian	22 Participants n=5 Participants	18 Participants n=7 Participants	40 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethinicity · Black or African American	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethinicity · Native Hawaiian or other Pacific Islander	3 Participants n=5 Participants	8 Participants n=7 Participants	11 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethinicity · White	98 Participants n=5 Participants	74 Participants n=7 Participants	172 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethinicity · Other	139 Participants n=5 Participants	152 Participants n=7 Participants	291 Participants n=5 Participants

PRIMARY outcome

Timeframe: Group 3B: Day 1 (prior to booster dose); Group B_0_1: Day 1 (prior to first dose).

Population: Analysis was performed on the Full analysis set (FAS) persistence. The FAS included all follow-on subjects (Group 3B) in the All Enrolled Set,\& all naïve subjects (group B\_0\_1) in the All Enrolled Set who provided evaluable immunogenicity result at day 1,for at least one indicator strain.

Bactericidal activity was measured against the N. meningitidis group B indicator strains 5/99 and NZ98/254. This outcome measure was assessed only for strains 5/99 and NZ98/254.

Outcome measures

Measure	Group 3B (V72_41) n=144 Participants Subjects who received two doses of rMenB+OMV NZ administered at 0,1-month schedule in study V72\_41 (NCT0142384) and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during study V72\_41, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.	Group 3B (V72P10) n=129 Participants Subjects who received two doses of rMenB+OMV NZ administered at 0,1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during study V72P10, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.	Group 3B n=273 Participants Subjects who received two doses of rMenB+OMV NZ administered at 0, 1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and at 0,1 month schedule in study V72\_41(NCT0142384), and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during parent studies, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.	Group B_0_1 (V72_41) n=105 Participants Naive subjects from Australia and Canada, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.	Group B_0_1 (V72P10) n=148 Participants Naive subjects from Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.	Group B_0_1 n=253 Participants Naive subjects from Australia,Canada and Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose
Percentage of Subjects With Human Serum Bactericidal Activity (hSBA)≥1:4 5/99	84 Percentage of subjects Interval 77.0 to 90.0	84 Percentage of subjects Interval 76.4 to 90.2	84 Percentage of subjects Interval 79.2 to 88.5	7 Percentage of subjects Interval 2.9 to 13.9	24 Percentage of subjects Interval 16.9 to 31.7	17 Percentage of subjects Interval 12.2 to 22.1
Percentage of Subjects With Human Serum Bactericidal Activity (hSBA)≥1:4 NZ98/254	9 Percentage of subjects Interval 4.9 to 14.9	29 Percentage of subjects Interval 21.1 to 37.3	18 Percentage of subjects Interval 13.9 to 23.4	0 Percentage of subjects Interval 0.0 to 3.5	14 Percentage of subjects Interval 9.0 to 20.9	8 Percentage of subjects Interval 5.2 to 12.4

PRIMARY outcome

Timeframe: Group 3B: Day 1 (prior to booster dose); Group B_0_1: Day 1 (prior to first dose).

Population: Analysis was performed on the Full analysis set (FAS) persistence.The FAS included all follow-on subjects (Group 3B) in the All Enrolled Set, and all naïve subjects (group B\_0\_1) in the All Enrolled Set who provided evaluable immunogenicity result at day 1, for at least one indicator strain.

Bactericidal activity was measured against the N. meningitidis group B indicator strains H44/76 and M10713. This outcome measure was assessed only for strains H44/76 and M10713.

Outcome measures

Measure	Group 3B (V72_41) n=144 Participants Subjects who received two doses of rMenB+OMV NZ administered at 0,1-month schedule in study V72\_41 (NCT0142384) and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during study V72\_41, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.	Group 3B (V72P10) n=131 Participants Subjects who received two doses of rMenB+OMV NZ administered at 0,1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during study V72P10, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.	Group 3B n=275 Participants Subjects who received two doses of rMenB+OMV NZ administered at 0, 1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and at 0,1 month schedule in study V72\_41(NCT0142384), and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during parent studies, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.	Group B_0_1 (V72_41) n=105 Participants Naive subjects from Australia and Canada, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.	Group B_0_1 (V72P10) n=150 Participants Naive subjects from Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.	Group B_0_1 n=255 Participants Naive subjects from Australia,Canada and Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose
Percentage of Subjects With hSBA≥1:5 H44/76	26 Percentage of subjects Interval 19.4 to 34.4	41 Percentage of subjects Interval 32.7 to 50.2	33 Percentage of subjects Interval 27.9 to 39.4	5 Percentage of subjects Interval 1.6 to 10.8	11 Percentage of subjects Interval 6.7 to 17.5	9 Percentage of subjects Interval 5.5 to 12.8
Percentage of Subjects With hSBA≥1:5 M10713	71 Percentage of subjects Interval 63.2 to 78.6	78 Percentage of subjects Interval 69.8 to 84.6	74 Percentage of subjects Interval 68.9 to 79.5	59 Percentage of subjects Interval 49.0 to 68.5	78 Percentage of subjects Interval 70.5 to 84.3	70 Percentage of subjects Interval 64.2 to 75.7

PRIMARY outcome

Timeframe: At one month after last vaccination in parent studies- V72P10 (Month 7) and V72_41 (Month 2)

Population: Analysis was performed on the Full analysis set (FAS) persistence. The FAS included all follow-on subjects (Group 3B) in the All Enrolled Set, and all naïve subjects (group B\_0\_1) in the All Enrolled Set who provided evaluable immunogenicity result at day 1, for at least one indicator strain.

Bactericidal activity was measured against the N. meningitidis group B indicator strains H44/76 and M10713

Outcome measures

Measure	Group 3B (V72_41) n=144 Participants Subjects who received two doses of rMenB+OMV NZ administered at 0,1-month schedule in study V72\_41 (NCT0142384) and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during study V72\_41, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.	Group 3B (V72P10) n=131 Participants Subjects who received two doses of rMenB+OMV NZ administered at 0,1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during study V72P10, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.	Group 3B Subjects who received two doses of rMenB+OMV NZ administered at 0, 1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and at 0,1 month schedule in study V72\_41(NCT0142384), and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during parent studies, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.	Group B_0_1 (V72_41) Naive subjects from Australia and Canada, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.	Group B_0_1 (V72P10) Naive subjects from Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.	Group B_0_1 Naive subjects from Australia,Canada and Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose
Percentage of Subjects With hSBA Titers≥1:5 in Parent Studies-V72P10 and V72_41 H44/76- Baseline in Parent study	1 Percentage of subjects Interval 0.17 to 4.9	23 Percentage of subjects Interval 16.0 to 31.1	—	—	—	—
Percentage of Subjects With hSBA Titers≥1:5 in Parent Studies-V72P10 and V72_41 H44/76- 1 month after last vacc in Parent study	99 Percentage of subjects Interval 95.1 to 99.83	100 Percentage of subjects Interval 97.2 to 100.0	—	—	—	—
Percentage of Subjects With hSBA Titers≥1:5 in Parent Studies-V72P10 and V72_41 M10713- Baseline in Parent study	34 Percentage of subjects Interval 25.9 to 41.9	73 Percentage of subjects Interval 64.0 to 80.0	—	—	—	—
Percentage of Subjects With hSBA Titers≥1:5 in Parent Studies-V72P10 and V72_41 M10713- 1 month after last vacc in Parent study	68 Percentage of subjects Interval 59.4 to 75.5	98 Percentage of subjects Interval 94.6 to 99.81	—	—	—	—

PRIMARY outcome

Timeframe: Group 3B: Day 1 (prior to booster dose); Group B_0_1: Day 1 (prior to first dose).

Population: Analysis was performed on the Full analysis set (FAS) persistence. The FAS included all follow-on subjects (Group 3B) in the All Enrolled Set, and all naïve subjects (group B\_0\_1) in the All Enrolled Set who provided evaluable immunogenicity result at day 1, for at least one indicator strain.

Bactericidal activity was measured against each of the N. meningitidis group B indicator strains H44/76,5/99,NZ98/254 and M10713

Outcome measures

Measure	Group 3B (V72_41) n=144 Participants Subjects who received two doses of rMenB+OMV NZ administered at 0,1-month schedule in study V72\_41 (NCT0142384) and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during study V72\_41, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.	Group 3B (V72P10) n=131 Participants Subjects who received two doses of rMenB+OMV NZ administered at 0,1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during study V72P10, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.	Group 3B n=275 Participants Subjects who received two doses of rMenB+OMV NZ administered at 0, 1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and at 0,1 month schedule in study V72\_41(NCT0142384), and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during parent studies, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.	Group B_0_1 (V72_41) n=105 Participants Naive subjects from Australia and Canada, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.	Group B_0_1 (V72P10) n=150 Participants Naive subjects from Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.	Group B_0_1 n=255 Participants Naive subjects from Australia,Canada and Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose
Percentage of Subjects With hSBA≥1:8 H44/76	22 Percentage of subjects Interval 15.7 to 29.9	35 Percentage of subjects Interval 27.0 to 43.9	28 Percentage of subjects Interval 23.1 to 34.1	1 Percentage of subjects Interval 0.02 to 5.2	9 Percentage of subjects Interval 5.2 to 15.2	6 Percentage of subjects Interval 3.3 to 9.5
Percentage of Subjects With hSBA≥1:8 5/99	78 Percentage of subjects Interval 70.4 to 85.0	83 Percentage of subjects Interval 75.4 to 89.5	81 Percentage of subjects Interval 75.3 to 85.4	4 Percentage of subjects Interval 1.1 to 9.9	19 Percentage of subjects Interval 13.2 to 27.0	13 Percentage of subjects Interval 9.0 to 17.9
Percentage of Subjects With hSBA≥1:8 NZ98/254	7 Percentage of subjects Interval 3.4 to 12.4	22 Percentage of subjects Interval 15.6 to 30.7	14 Percentage of subjects Interval 10.4 to 19.0	0 Percentage of subjects Interval 0.0 to 3.5	9 Percentage of subjects Interval 5.3 to 15.4	6 Percentage of subjects Interval 3.1 to 9.1
Percentage of Subjects With hSBA≥1:8 M10713	62 Percentage of subjects Interval 53.0 to 69.5	75 Percentage of subjects Interval 66.5 to 82.0	68 Percentage of subjects Interval 62.0 to 73.4	52 Percentage of subjects Interval 42.4 to 62.2	71 Percentage of subjects Interval 62.7 to 77.8	63 Percentage of subjects Interval 56.9 to 69.1

PRIMARY outcome

Timeframe: Group 3B: Day 1 (prior to booster dose); Group B_0_1: Day 1 (prior to first dose).

Population: Analysis was performed on the Full analysis set (FAS) persistence. The FAS included all follow-on subjects (Group 3B) in the All Enrolled Set, and all naïve subjects in the All Enrolled Set who provided evaluable immunogenicity result at day 1, for at least one indicator strain.

Bactericidal activity was measured against each of the N. meningitidis group B Indicator strains H44/76,5/99,NZ98/254 and M10713

Outcome measures

Measure	Group 3B (V72_41) n=144 Participants Subjects who received two doses of rMenB+OMV NZ administered at 0,1-month schedule in study V72\_41 (NCT0142384) and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during study V72\_41, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.	Group 3B (V72P10) n=131 Participants Subjects who received two doses of rMenB+OMV NZ administered at 0,1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during study V72P10, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.	Group 3B n=275 Participants Subjects who received two doses of rMenB+OMV NZ administered at 0, 1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and at 0,1 month schedule in study V72\_41(NCT0142384), and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during parent studies, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.	Group B_0_1 (V72_41) n=105 Participants Naive subjects from Australia and Canada, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.	Group B_0_1 (V72P10) n=150 Participants Naive subjects from Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.	Group B_0_1 n=255 Participants Naive subjects from Australia,Canada and Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose
Percentage of Subjects With hSBA≥1:16 H44/76	12 Percentage of subjects Interval 7.0 to 18.2	28 Percentage of subjects Interval 20.7 to 36.8	20 Percentage of subjects Interval 15.1 to 24.8	0 Percentage of subjects Interval 0.0 to 3.5	7 Percentage of subjects Interval 3.7 to 12.7	4 Percentage of subjects Interval 2.2 to 7.6
Percentage of Subjects With hSBA≥1:16 5/99	72 Percentage of subjects Interval 63.2 to 79.1	78 Percentage of subjects Interval 69.9 to 85.3	75 Percentage of subjects Interval 69.0 to 80.0	2 Percentage of subjects Interval 0.24 to 7.0	13 Percentage of subjects Interval 7.9 to 19.7	8 Percentage of subjects Interval 5.2 to 12.6
Percentage of Subjects With hSBA≥1:16 NZ98/254	5 Percentage of subjects Interval 2.0 to 9.8	19 Percentage of subjects Interval 12.3 to 26.4	11 Percentage of subjects Interval 7.8 to 15.7	0 Percentage of subjects Interval 0.0 to 3.5	4 Percentage of subjects Interval 1.5 to 8.6	2 Percentage of subjects Interval 0.9 to 5.1
Percentage of Subjects With hSBA≥1:16 M10713	50 Percentage of subjects Interval 41.9 to 58.8	65 Percentage of subjects Interval 56.1 to 73.0	57 Percentage of subjects Interval 51.2 to 63.2	48 Percentage of subjects Interval 37.8 to 57.6	61 Percentage of subjects Interval 53.0 to 69.2	56 Percentage of subjects Interval 49.4 to 61.9

PRIMARY outcome

Timeframe: Group 3B: 1 month after the last rMenB+OMV NZ vaccination in parent study and Day 1(prior to booster dose); Group B_0_1: Day 1(prior to first dose)

Population: Analysis was performed on the Full analysis set (FAS) persistence. The FAS included all follow-on subjects (Group 3B) in the All Enrolled Set, and all naïve subjects (group B\_0\_1) in the All Enrolled Set who provided evaluable immunogenicity result at day 1, for at least one indicator strain.

Bactericidal activity was measured against each of the N. meningitidis group B indicator strains H44/76,5/99, NZ98/254 a nd M10713.

Outcome measures

Measure	Group 3B (V72_41) n=144 Participants Subjects who received two doses of rMenB+OMV NZ administered at 0,1-month schedule in study V72\_41 (NCT0142384) and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during study V72\_41, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.	Group 3B (V72P10) n=131 Participants Subjects who received two doses of rMenB+OMV NZ administered at 0,1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during study V72P10, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.	Group 3B n=275 Participants Subjects who received two doses of rMenB+OMV NZ administered at 0, 1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and at 0,1 month schedule in study V72\_41(NCT0142384), and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during parent studies, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.	Group B_0_1 (V72_41) n=105 Participants Naive subjects from Australia and Canada, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.	Group B_0_1 (V72P10) n=150 Participants Naive subjects from Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.	Group B_0_1 n=255 Participants Naive subjects from Australia,Canada and Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose
hSBA Geometric Mean Titers (GMTs) After the Last Dose of rMenB+OMV NZ Vaccination in the Parent Study. H44/76(1 month post last vacc in parent study)	99 Titers Interval 82.0 to 119.0	197 Titers Interval 165.0 to 235.0	124 Titers Interval 108.0 to 143.0	—	—	—
hSBA Geometric Mean Titers (GMTs) After the Last Dose of rMenB+OMV NZ Vaccination in the Parent Study. H44/76( Day 1)	2.43 Titers Interval 2.04 to 2.89	4.51 Titers Interval 3.57 to 5.69	3.05 Titers Interval 2.61 to 3.56	1.14 Titers Interval 0.93 to 1.4	1.52 Titers Interval 1.23 to 1.9	1.20 Titers Interval 1.02 to 1.42
hSBA Geometric Mean Titers (GMTs) After the Last Dose of rMenB+OMV NZ Vaccination in the Parent Study. 5/99(1 month post last vacc in parent study)	180 Titers Interval 153.0 to 211.0	606 Titers Interval 492.0 to 746.0	270 Titers Interval 234.0 to 311.0	—	—	—
hSBA Geometric Mean Titers (GMTs) After the Last Dose of rMenB+OMV NZ Vaccination in the Parent Study. 5/99 (Day 1)	24 Titers Interval 19.0 to 30.0	31 Titers Interval 23.0 to 42.0	26 Titers Interval 21.0 to 31.0	1.20 Titers Interval 0.91 to 1.58	2.30 Titers Interval 1.75 to 3.04	1.57 Titers Interval 1.26 to 1.95
hSBA Geometric Mean Titers (GMTs) After the Last Dose of rMenB+OMV NZ Vaccination in the Parent Study. NZ98/254(1 month post last vacc in parent study)	11 Titers Interval 8.67 to 14.0	93 Titers Interval 75.0 to 117.0	22 Titers Interval 19.0 to 27.0	—	—	—
hSBA Geometric Mean Titers (GMTs) After the Last Dose of rMenB+OMV NZ Vaccination in the Parent Study. NZ98/254( Day 1)	1.31 Titers Interval 1.17 to 1.45	2.56 Titers Interval 2.07 to 3.17	1.66 Titers Interval 1.46 to 1.89	1.01 Titers Interval 0.89 to 1.14	1.50 Titers Interval 1.23 to 1.84	1.11 Titers Interval 0.97 to 1.27
hSBA Geometric Mean Titers (GMTs) After the Last Dose of rMenB+OMV NZ Vaccination in the Parent Study. M10713(1 month post last vacc in parent study)	10 Titers Interval 7.65 to 14.0	66 Titers Interval 53.0 to 81.0	19 Titers Interval 16.0 to 24.0	—	—	—
hSBA Geometric Mean Titers (GMTs) After the Last Dose of rMenB+OMV NZ Vaccination in the Parent Study. M10713(Day 1)	13 Titers Interval 9.86 to 18.0	22 Titers Interval 16.0 to 29.0	16 Titers Interval 13.0 to 20.0	10 Titers Interval 7.13 to 15.0	18 Titers Interval 14.0 to 24.0	12 Titers Interval 9.86 to 16.0

PRIMARY outcome

Timeframe: Group 3B: 1 month after the last vaccination in parent study and Day 1 (prior to booster dose)

Population: Analysis was performed on the Full analysis set (FAS) persistence. The FAS included all follow-on subjects (Group 3B) in the All Enrolled Set, and all naïve subjects (B\_0\_1) in the All Enrolled Set who provided evaluable immunogenicity result at day 1, for at least one indicator strain.

The GMRs of GMTs at Day 1 versus one month after the last dose of rMenB+OMV NZ vaccination in the parent study were calculated. Bactericidal activity was measured against each of the N. meningitidis group B indicator strains H44/76, 5/99,NZ98/254 and M10713.

Outcome measures

Measure	Group 3B (V72_41) n=144 Participants Subjects who received two doses of rMenB+OMV NZ administered at 0,1-month schedule in study V72\_41 (NCT0142384) and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during study V72\_41, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.	Group 3B (V72P10) n=131 Participants Subjects who received two doses of rMenB+OMV NZ administered at 0,1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during study V72P10, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.	Group 3B n=275 Participants Subjects who received two doses of rMenB+OMV NZ administered at 0, 1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and at 0,1 month schedule in study V72\_41(NCT0142384), and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during parent studies, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.	Group B_0_1 (V72_41) Naive subjects from Australia and Canada, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.	Group B_0_1 (V72P10) Naive subjects from Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.	Group B_0_1 Naive subjects from Australia,Canada and Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose
Geometric Mean Ratios (GMRs) of GMTs After the Last Dose of rMenB+OMV NZ Vaccination in the Parent Study Versus Day 1. H44/76	0.026 Ratio Interval 0.02 to 0.033	0.023 Ratio Interval 0.018 to 0.029	0.025 Ratio Interval 0.02 to 0.03	—	—	—
Geometric Mean Ratios (GMRs) of GMTs After the Last Dose of rMenB+OMV NZ Vaccination in the Parent Study Versus Day 1. 5/99	0.13 Ratio Interval 0.1 to 0.18	0.052 Ratio Interval 0.039 to 0.068	0.098 Ratio Interval 0.079 to 0.12	—	—	—
Geometric Mean Ratios (GMRs) of GMTs After the Last Dose of rMenB+OMV NZ Vaccination in the Parent Study Versus Day 1. NZ98/254	0.12 Ratio Interval 0.092 to 0.15	0.027 Ratio Interval 0.021 to 0.036	0.073 Ratio Interval 0.059 to 0.089	—	—	—
Geometric Mean Ratios (GMRs) of GMTs After the Last Dose of rMenB+OMV NZ Vaccination in the Parent Study Versus Day 1. M10713	1.26 Ratio Interval 0.92 to 1.73	0.33 Ratio Interval 0.25 to 0.43	0.81 Ratio Interval 0.65 to 1.01	—	—	—

PRIMARY outcome

Timeframe: 7 days (including the day of vaccination) after each vaccination

Population: The analysis was done on the Solicited Safety Set. The solicited safety set included all subjects in the exposed set with any solicited adverse event data and/indicators of solicited adverse events.

Solicited adverse events are signs and symptoms derived from organized data collection systems, such as Subject Diaries or interview. The percentage and frequencies of subjects reporting solicited local and systemic AEs were tabulated. Threshold for any Erythema, Swelling and Induration: >= 25 mm Note:Vaccination 2 was performed only on group B_0_1 subjects. Threshold for any Erythema, Swelling and Induration: >= 25 mm

Outcome measures

Measure	Group 3B (V72_41) n=266 Participants Subjects who received two doses of rMenB+OMV NZ administered at 0,1-month schedule in study V72\_41 (NCT0142384) and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during study V72\_41, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.	Group 3B (V72P10) n=254 Participants Subjects who received two doses of rMenB+OMV NZ administered at 0,1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during study V72P10, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.	Group 3B Subjects who received two doses of rMenB+OMV NZ administered at 0, 1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and at 0,1 month schedule in study V72\_41(NCT0142384), and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during parent studies, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.	Group B_0_1 (V72_41) Naive subjects from Australia and Canada, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.	Group B_0_1 (V72P10) Naive subjects from Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.	Group B_0_1 Naive subjects from Australia,Canada and Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose
Number of Subjects With Solicited Local and Systemic AEs. Any	263 Subjects	251 Subjects	—	—	—	—
Number of Subjects With Solicited Local and Systemic AEs. Any Local (vaccination 1)	258 Subjects	247 Subjects	—	—	—	—
Number of Subjects With Solicited Local and Systemic AEs. Injection site pain (vaccination 1)	258 Subjects	247 Subjects	—	—	—	—
Number of Subjects With Solicited Local and Systemic AEs. Erythema (vaccination 1)	54 Subjects	18 Subjects	—	—	—	—
Number of Subjects With Solicited Local and Systemic AEs. Swelling (vaccination 1)	60 Subjects	34 Subjects	—	—	—	—
Number of Subjects With Solicited Local and Systemic AEs. Induration (vaccination 1)	54 Subjects	26 Subjects	—	—	—	—
Number of Subjects With Solicited Local and Systemic AEs. Any systemic (vaccination 1)	203 Subjects	163 Subjects	—	—	—	—
Number of Subjects With Solicited Local and Systemic AEs. Fever (≥ 38.0°C) (vaccination 1)	16 Subjects	4 Subjects	—	—	—	—
Number of Subjects With Solicited Local and Systemic AEs. High fever (≥ 39.5°C) (vaccination 1)	0 Subjects	0 Subjects	—	—	—	—
Number of Subjects With Solicited Local and Systemic AEs. Nausea (vaccination 1)	56 Subjects	30 Subjects	—	—	—	—
Number of Subjects With Solicited Local and Systemic AEs. Fatigue (vaccination 1)	155 Subjects	110 Subjects	—	—	—	—
Number of Subjects With Solicited Local and Systemic AEs. Myalgia (vaccination 1)	120 Subjects	71 Subjects	—	—	—	—
Number of Subjects With Solicited Local and Systemic AEs. Arthralgia (vaccination 1)	84 Subjects	47 Subjects	—	—	—	—
Number of Subjects With Solicited Local and Systemic AEs. Headache (vaccination 1)	146 Subjects	94 Subjects	—	—	—	—
Number of Subjects With Solicited Local and Systemic AEs. Any Local (vaccination 2)	—	226 Subjects	—	—	—	—
Number of Subjects With Solicited Local and Systemic AEs. Injection site pain (vaccination 2)	—	226 Subjects	—	—	—	—
Number of Subjects With Solicited Local and Systemic AEs. Erythema (vaccination 2)	—	21 Subjects	—	—	—	—
Number of Subjects With Solicited Local and Systemic AEs. Swelling (vaccination 2)	—	32 Subjects	—	—	—	—
Number of Subjects With Solicited Local and Systemic AEs. Induration (vaccination 2)	—	31 Subjects	—	—	—	—
Number of Subjects With Solicited Local and Systemic AEs. Any systemic (vaccination 2)	—	140 Subjects	—	—	—	—
Number of Subjects With Solicited Local and Systemic AEs. Fever (≥ 38.0°C) (vaccination 2)	—	5 Subjects	—	—	—	—
Number of Subjects With Solicited Local and Systemic AEs. High fever (≥ 39.5°C) (vaccination 2)	—	0 Subjects	—	—	—	—
Number of Subjects With Solicited Local and Systemic AEs. Nausea (vaccination 2)	—	33 Subjects	—	—	—	—
Number of Subjects With Solicited Local and Systemic AEs. Fatigue (vaccination 2)	—	92 Subjects	—	—	—	—
Number of Subjects With Solicited Local and Systemic AEs. Myalgia (vaccination 2)	—	64 Subjects	—	—	—	—
Number of Subjects With Solicited Local and Systemic AEs. Arthralgia (vaccination 2)	—	36 Subjects	—	—	—	—
Number of Subjects With Solicited Local and Systemic AEs. Headache (vaccination 2)	—	84 Subjects	—	—	—	—

PRIMARY outcome

Timeframe: 30 days (including the day of vaccination) after each vaccination.

Population: Analysis was performed on the unsolicited safety set. The unsolicited safety set included all subjects who received a study vaccination with unsolicited adverse event data.

An unsolicited adverse event is an adverse event that was not solicited using a subject Diary and that was spontaneously communicated by a subject and/or parent(s)/legal guardian(s) who has signed the informed consent. Note : Vaccination 2 was performed only on group B_0_1 subjects.

Outcome measures

Measure	Group 3B (V72_41) n=275 Participants Subjects who received two doses of rMenB+OMV NZ administered at 0,1-month schedule in study V72\_41 (NCT0142384) and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during study V72\_41, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.	Group 3B (V72P10) n=255 Participants Subjects who received two doses of rMenB+OMV NZ administered at 0,1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during study V72P10, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.	Group 3B Subjects who received two doses of rMenB+OMV NZ administered at 0, 1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and at 0,1 month schedule in study V72\_41(NCT0142384), and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during parent studies, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.	Group B_0_1 (V72_41) Naive subjects from Australia and Canada, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.	Group B_0_1 (V72P10) Naive subjects from Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.	Group B_0_1 Naive subjects from Australia,Canada and Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose
Number of Subjects With Any Unsolicited Adverse Events (AEs). Any	87 Subjects	131 Subjects	—	—	—	—
Number of Subjects With Any Unsolicited Adverse Events (AEs). Any unsolicited AEs ( vaccination 1)	87 Subjects	96 Subjects	—	—	—	—
Number of Subjects With Any Unsolicited Adverse Events (AEs). Any unsolicited AEs (vaccination 2)	—	73 Subjects	—	—	—	—

PRIMARY outcome

Timeframe: Group 3B: from Day 1 to Day 31 (study termination visit) and Group B_0_1: from Day 1 to Day 61 (study termination visit)

Population: Analysis was performed on the Overall safety set. The overall safety set included all screened subjects in the solicited and unsolicited safety set who provided informed consent and provided demographic and/or baseline screening assessments, regardless of the subject's randomization and treatment status in the study and received a Subject ID.

A serious adverse event is any untoward medical occurrence that at any dose results in death or is life threatening or requires prolonged hospitalization, leads to Persistent or significant disability/incapacity.

Outcome measures

Measure	Group 3B (V72_41) n=275 Participants Subjects who received two doses of rMenB+OMV NZ administered at 0,1-month schedule in study V72\_41 (NCT0142384) and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during study V72\_41, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.	Group 3B (V72P10) n=255 Participants Subjects who received two doses of rMenB+OMV NZ administered at 0,1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during study V72P10, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.	Group 3B Subjects who received two doses of rMenB+OMV NZ administered at 0, 1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and at 0,1 month schedule in study V72\_41(NCT0142384), and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during parent studies, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.	Group B_0_1 (V72_41) Naive subjects from Australia and Canada, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.	Group B_0_1 (V72P10) Naive subjects from Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.	Group B_0_1 Naive subjects from Australia,Canada and Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose
Number of Subjects With Any SAEs, AEs Leading to Withdrawal and Medically Attended AEs. Any SAEs	0 Subjects	1 Subjects	—	—	—	—
Number of Subjects With Any SAEs, AEs Leading to Withdrawal and Medically Attended AEs. Any Medically Attended AEs	17 Subjects	34 Subjects	—	—	—	—
Number of Subjects With Any SAEs, AEs Leading to Withdrawal and Medically Attended AEs. Any AEs leading to premature withdrawal	0 Subjects	1 Subjects	—	—	—	—

SECONDARY outcome

Timeframe: Group 3B: 30 days after booster dose, Group B_0_1 : 30 days after first vaccination.

Population: Analysis was performed on the Full Analysis set( FAS) booster. The FAS booster included all follow on subjects and all naive subjects in the All enrolled set who received vaccination at day 1 and provided evaluable immunogenicity result at day 31 for at least one indicator strain.

Bactericidal activity was measured against the N. meningitidis group B indicator strains 5/99 and NZ98/254. This outcome measure was assessed only for strains 5/99 and NZ98/254.

Outcome measures

Measure	Group 3B (V72_41) n=142 Participants Subjects who received two doses of rMenB+OMV NZ administered at 0,1-month schedule in study V72\_41 (NCT0142384) and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during study V72\_41, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.	Group 3B (V72P10) n=120 Participants Subjects who received two doses of rMenB+OMV NZ administered at 0,1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during study V72P10, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.	Group 3B n=262 Participants Subjects who received two doses of rMenB+OMV NZ administered at 0, 1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and at 0,1 month schedule in study V72\_41(NCT0142384), and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during parent studies, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.	Group B_0_1 (V72_41) n=103 Participants Naive subjects from Australia and Canada, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.	Group B_0_1 (V72P10) n=148 Participants Naive subjects from Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.	Group B_0_1 n=251 Participants Naive subjects from Australia,Canada and Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose
Percentage of Subjects With hSBA ≥1:4 After Booster Dose/First Vaccination of rMenB+OMV NZ. 5/99	100 Percentage of subjects Interval 97.1 to 100.0	100 Percentage of subjects Interval 96.4 to 100.0	100 Percentage of subjects Interval 98.4 to 100.0	87 Percentage of subjects Interval 78.2 to 92.7	84 Percentage of subjects Interval 76.7 to 89.7	85 Percentage of subjects Interval 79.8 to 89.4
Percentage of Subjects With hSBA ≥1:4 After Booster Dose/First Vaccination of rMenB+OMV NZ. NZ98/254	94 Percentage of subjects Interval 89.2 to 97.5	93 Percentage of subjects Interval 87.3 to 97.1	94 Percentage of subjects Interval 90.3 to 96.5	41 Percentage of subjects Interval 31.2 to 50.9	62 Percentage of subjects Interval 53.8 to 70.0	53 Percentage of subjects Interval 47.0 to 59.7

SECONDARY outcome

Timeframe: Group 3B: 30 days after booster dose, Group B_0_1 : 30 days after first vaccination.

Population: Analysis was performed on the Full Analysis set( FAS) booster. The FAS booster included all follow on subjects and all naive subjects in the All enrolled set who received vaccination at day 1 and provided evaluable immunogenicity result at day 31 for at least one indicator strain.

Bactericidal activity was measured against the N. meningitidis group B indicator strains H44/76 and M10713. This outcome measure was assessed only for strains H44/76 and M10713.

Outcome measures

Measure	Group 3B (V72_41) n=141 Participants Subjects who received two doses of rMenB+OMV NZ administered at 0,1-month schedule in study V72\_41 (NCT0142384) and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during study V72\_41, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.	Group 3B (V72P10) n=127 Participants Subjects who received two doses of rMenB+OMV NZ administered at 0,1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during study V72P10, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.	Group 3B n=268 Participants Subjects who received two doses of rMenB+OMV NZ administered at 0, 1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and at 0,1 month schedule in study V72\_41(NCT0142384), and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during parent studies, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.	Group B_0_1 (V72_41) n=104 Participants Naive subjects from Australia and Canada, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.	Group B_0_1 (V72P10) n=149 Participants Naive subjects from Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.	Group B_0_1 n=253 Participants Naive subjects from Australia,Canada and Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose
Percentage of Subjects With hSBA ≥1:5 After Booster Dose/First Vaccination of rMenB+OMV NZ. H44/76	98 Percentage of subjects Interval 93.9 to 99.56	100 Percentage of subjects Interval 97.1 to 100.0	99 Percentage of subjects Interval 96.8 to 99.77	80 Percentage of subjects Interval 70.8 to 87.0	79 Percentage of subjects Interval 71.1 to 84.8	79 Percentage of subjects Interval 73.5 to 83.9
Percentage of Subjects With hSBA ≥1:5 After Booster Dose/First Vaccination of rMenB+OMV NZ. M10713	99 Percentage of subjects Interval 96.1 to 99.98	98 Percentage of subjects Interval 94.4 to 99.81	99 Percentage of subjects Interval 96.8 to 99.77	80 Percentage of subjects Interval 70.5 to 86.9	92 Percentage of subjects Interval 86.4 to 95.8	87 Percentage of subjects Interval 82.1 to 90.8

SECONDARY outcome

Timeframe: Group 3B : 30 days after booster dose, Group B_0_1 : 30 days after first vaccination.

Population: Analysis was performed on the Full Analysis set( FAS) booster. The FAS booster included all follow on subjects and all naive subjects in the All enrolled set who received vaccination at day 1 and provided evaluable immunogenicity result at day 31 for at least one indicator strain.

Bactericidal activity was measured against each of the four N. meningitidis group B indicator strains H44/76,5/99,NZ98/254 and M10713.

Outcome measures

Measure	Group 3B (V72_41) n=142 Participants Subjects who received two doses of rMenB+OMV NZ administered at 0,1-month schedule in study V72\_41 (NCT0142384) and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during study V72\_41, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.	Group 3B (V72P10) n=127 Participants Subjects who received two doses of rMenB+OMV NZ administered at 0,1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during study V72P10, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.	Group 3B n=268 Participants Subjects who received two doses of rMenB+OMV NZ administered at 0, 1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and at 0,1 month schedule in study V72\_41(NCT0142384), and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during parent studies, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.	Group B_0_1 (V72_41) n=104 Participants Naive subjects from Australia and Canada, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.	Group B_0_1 (V72P10) n=149 Participants Naive subjects from Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.	Group B_0_1 n=253 Participants Naive subjects from Australia,Canada and Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose
Percentage of Subjects With hSBA ≥1:8 After Booster Dose/First Vaccination of rMenB+OMV NZ H44/76	98 Percentage of subjects Interval 93.9 to 99.56	100 Percentage of subjects Interval 97.1 to 100.0	99 Percentage of subjects Interval 96.8 to 99.77	67 Percentage of subjects Interval 57.4 to 76.2	74 Percentage of subjects Interval 66.7 to 81.3	72 Percentage of subjects Interval 65.6 to 77.0
Percentage of Subjects With hSBA ≥1:8 After Booster Dose/First Vaccination of rMenB+OMV NZ 5/99	100 Percentage of subjects Interval 97.1 to 100.0	100 Percentage of subjects Interval 96.4 to 100.0	100 Percentage of subjects Interval 98.4 to 100.0	81 Percentage of subjects Interval 72.3 to 88.6	81 Percentage of subjects Interval 73.4 to 87.2	81 Percentage of subjects Interval 75.6 to 86.0
Percentage of Subjects With hSBA ≥1:8 After Booster Dose/First Vaccination of rMenB+OMV NZ NZ98/254	86 Percentage of subjects Interval 79.1 to 91.2	89 Percentage of subjects Interval 82.2 to 94.1	87 Percentage of subjects Interval 82.8 to 91.2	28 Percentage of subjects Interval 19.7 to 37.9	56 Percentage of subjects Interval 47.7 to 64.2	45 Percentage of subjects Interval 38.4 to 51.0
Percentage of Subjects With hSBA ≥1:8 After Booster Dose/First Vaccination of rMenB+OMV NZ M10713	99 Percentage of subjects Interval 95.0 to 99.83	98 Percentage of subjects Interval 93.3 to 99.51	98 Percentage of subjects Interval 95.7 to 99.4	79 Percentage of subjects Interval 69.5 to 86.1	89 Percentage of subjects Interval 83.1 to 93.7	85 Percentage of subjects Interval 79.9 to 89.1

SECONDARY outcome

Timeframe: Group 3B: 30 days after booster dose, Group B_0_1 : 30 days after first vaccination.

Population: Analysis was performed on the Full Analysis set( FAS) booster. The FAS booster included all follow on subjects and all naive subjects in the All enrolled set who received vaccination at day 1 and provided evaluable immunogenicity result at day 31 for at least one indicator strain.

Bactericidal activity was measured against each of the four N. meningitidis group B indicator strains H44/76, 5/99, NZ98/254 & M10713.

Outcome measures

Measure	Group 3B (V72_41) n=142 Participants Subjects who received two doses of rMenB+OMV NZ administered at 0,1-month schedule in study V72\_41 (NCT0142384) and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during study V72\_41, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.	Group 3B (V72P10) n=127 Participants Subjects who received two doses of rMenB+OMV NZ administered at 0,1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during study V72P10, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.	Group 3B n=268 Participants Subjects who received two doses of rMenB+OMV NZ administered at 0, 1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and at 0,1 month schedule in study V72\_41(NCT0142384), and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during parent studies, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.	Group B_0_1 (V72_41) n=104 Participants Naive subjects from Australia and Canada, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.	Group B_0_1 (V72P10) n=149 Participants Naive subjects from Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.	Group B_0_1 n=253 Participants Naive subjects from Australia,Canada and Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose
Percentage of Subjects With hSBA ≥1:16 After Booster Dose/First Vaccination of rMenB+OMV NZ H44/76	98 Percentage of subjects Interval 93.9 to 99.56	99 Percentage of subjects Interval 95.7 to 99.98	99 Percentage of subjects Interval 96.2 to 99.59	49 Percentage of subjects Interval 39.1 to 59.0	65 Percentage of subjects Interval 56.9 to 72.7	58 Percentage of subjects Interval 52.2 to 64.6
Percentage of Subjects With hSBA ≥1:16 After Booster Dose/First Vaccination of rMenB+OMV NZ 5/99	100 Percentage of subjects Interval 97.1 to 100.0	100 Percentage of subjects Interval 96.4 to 100.0	100 Percentage of subjects Interval 98.4 to 100.0	77 Percentage of subjects Interval 67.7 to 85.2	70 Percentage of subjects Interval 61.7 to 77.6	73 Percentage of subjects Interval 66.9 to 78.6
Percentage of Subjects With hSBA ≥1:16 After Booster Dose/First Vaccination of rMenB+OMV NZ NZ98/254	73 Percentage of subjects Interval 65.2 to 80.3	86 Percentage of subjects Interval 78.3 to 91.5	79 Percentage of subjects Interval 73.6 to 83.8	22 Percentage of subjects Interval 14.7 to 31.6	45 Percentage of subjects Interval 37.1 to 53.7	36 Percentage of subjects Interval 29.9 to 42.1
Percentage of Subjects With hSBA ≥1:16 After Booster Dose/First Vaccination of rMenB+OMV NZ M10713	94 Percentage of subjects Interval 88.2 to 97.0	97 Percentage of subjects Interval 92.1 to 99.1	95 Percentage of subjects Interval 91.8 to 97.4	66 Percentage of subjects Interval 56.0 to 75.1	84 Percentage of subjects Interval 77.0 to 89.4	77 Percentage of subjects Interval 70.9 to 81.7

SECONDARY outcome

Timeframe: Group 3B subjects: Day 1(pre-booster dose) and 30 days post-booster dose. Group B_0_1: Day 1 (pre-first dose) and 30 days post-first dose.

Population: Analysis was performed on the Full Analysis set( FAS) booster. The FAS booster included all follow on subjects and all naive subjects in the All enrolled set who received vaccination at day 1 and provided evaluable immunogenicity result at day 31 for at least one indicator strain.

Bactericidal activity was measured against each of the four N. meningitidis group B indicator strains H44/76, 5/99,NZ98/254 and M10713.

Outcome measures

Measure	Group 3B (V72_41) n=142 Participants Subjects who received two doses of rMenB+OMV NZ administered at 0,1-month schedule in study V72\_41 (NCT0142384) and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during study V72\_41, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.	Group 3B (V72P10) n=127 Participants Subjects who received two doses of rMenB+OMV NZ administered at 0,1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during study V72P10, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.	Group 3B n=268 Participants Subjects who received two doses of rMenB+OMV NZ administered at 0, 1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and at 0,1 month schedule in study V72\_41(NCT0142384), and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during parent studies, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.	Group B_0_1 (V72_41) n=104 Participants Naive subjects from Australia and Canada, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.	Group B_0_1 (V72P10) n=149 Participants Naive subjects from Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.	Group B_0_1 n=253 Participants Naive subjects from Australia,Canada and Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose
hSBA Geometric Mean Titers Prior to Booster/First Dose of Vaccination & Post Booster/First Dose of Vaccination. M10713-1 month post booster/first dose	65 Titers Interval 52.0 to 81.0	113 Titers Interval 90.0 to 142.0	78 Titers Interval 66.0 to 92.0	23 Titers Interval 18.0 to 30.0	46 Titers Interval 37.0 to 57.0	30 Titers Interval 25.0 to 36.0
hSBA Geometric Mean Titers Prior to Booster/First Dose of Vaccination & Post Booster/First Dose of Vaccination. H44/76- pre booster/ pre first dose	2.45 Titers Interval 2.06 to 2.92	4.65 Titers Interval 3.66 to 5.89	3.10 Titers Interval 2.65 to 3.62	1.13 Titers Interval 0.92 to 1.38	1.53 Titers Interval 1.23 to 1.9	1.19 Titers Interval 1.01 to 1.41
hSBA Geometric Mean Titers Prior to Booster/First Dose of Vaccination & Post Booster/First Dose of Vaccination. H44/76-1 month post booster/first dose	158 Titers Interval 123.0 to 204.0	269 Titers Interval 206.0 to 351.0	188 Titers Interval 155.0 to 228.0	13 Titers Interval 10.0 to 18.0	24 Titers Interval 19.0 to 31.0	16 Titers Interval 13.0 to 20.0
hSBA Geometric Mean Titers Prior to Booster/First Dose of Vaccination & Post Booster/First Dose of Vaccination. 5/99- pre booster/ pre first dose	22 Titers Interval 17.0 to 28.0	31 Titers Interval 22.0 to 43.0	24 Titers Interval 19.0 to 30.0	1.19 Titers Interval 0.89 to 1.59	2.19 Titers Interval 1.65 to 2.92	1.51 Titers Interval 1.21 to 1.88
hSBA Geometric Mean Titers Prior to Booster/First Dose of Vaccination & Post Booster/First Dose of Vaccination. 5/99-1 month post booster/first dose	2191 Titers Interval 1681.0 to 2856.0	1951 Titers Interval 1425.0 to 2671.0	2089 Titers Interval 1690.0 to 2582.0	30 Titers Interval 22.0 to 40.0	31 Titers Interval 24.0 to 41.0	31 Titers Interval 25.0 to 38.0
hSBA Geometric Mean Titers Prior to Booster/First Dose of Vaccination & Post Booster/First Dose of Vaccination. NZ98/254-pre booster/ pre first dose	1.31 Titers Interval 1.18 to 1.46	2.48 Titers Interval 1.99 to 3.09	1.64 Titers Interval 1.44 to 1.86	1.00 Titers Interval 0.88 to 1.13	1.51 Titers Interval 1.24 to 1.84	1.11 Titers Interval 0.97 to 1.28
hSBA Geometric Mean Titers Prior to Booster/First Dose of Vaccination & Post Booster/First Dose of Vaccination. NZ98/254-1 month post booster/first dose	30 Titers Interval 23.0 to 38.0	41 Titers Interval 30.0 to 56.0	32 Titers Interval 26.0 to 39.0	3.58 Titers Interval 2.7 to 4.76	9.43 Titers Interval 7.15 to 12.0	5.39 Titers Interval 4.33 to 6.72
hSBA Geometric Mean Titers Prior to Booster/First Dose of Vaccination & Post Booster/First Dose of Vaccination. M10713-pre booster/ pre first dose	14 Titers Interval 10.0 to 19.0	22 Titers Interval 16.0 to 29.0	16 Titers Interval 13.0 to 20.0	9.82 Titers Interval 6.87 to 14.0	18 Titers Interval 14.0 to 23.0	12 Titers Interval 9.62 to 15.0

SECONDARY outcome

Timeframe: At Day 31 (30 days post booster dose/first dose of vaccination) versus Day 1 (prior to booster dose/first dose of vaccination).

Population: Analysis was performed on the Full Analysis set( FAS) booster. The FAS booster included all follow on subjects and all naive subjects in the All enrolled set who received vaccination at day 1 and provided evaluable immunogenicity result at day 31 for at least one indicator strain.

Bactericidal activity was measured against each of the fout N. meningitidis group B indicator strains H44/76,5/99,NZ98/254 and M10713 by calculating the GMRs of GMTs one month post-vaccination of a booster dose versus pre-booster dose (follow-on subjects) or first dose of rMenB+OMV NZ versus prefirst dose (naïve subjects) to each N. meningitidis group B indicator strain.

Outcome measures

Measure	Group 3B (V72_41) n=142 Participants Subjects who received two doses of rMenB+OMV NZ administered at 0,1-month schedule in study V72\_41 (NCT0142384) and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during study V72\_41, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.	Group 3B (V72P10) n=127 Participants Subjects who received two doses of rMenB+OMV NZ administered at 0,1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during study V72P10, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.	Group 3B n=268 Participants Subjects who received two doses of rMenB+OMV NZ administered at 0, 1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and at 0,1 month schedule in study V72\_41(NCT0142384), and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during parent studies, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.	Group B_0_1 (V72_41) n=104 Participants Naive subjects from Australia and Canada, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.	Group B_0_1 (V72P10) n=149 Participants Naive subjects from Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.	Group B_0_1 n=253 Participants Naive subjects from Australia,Canada and Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose
Geometric Mean Ratio (GMRs) of GMTs After Booster Dose/First rMenB+OMV NZ Vaccination Versus Day 1. H44/76	65 Ratio Interval 49.0 to 85.0	58 Ratio Interval 44.0 to 76.0	61 Ratio Interval 50.0 to 74.0	12 Ratio Interval 8.69 to 16.0	16 Ratio Interval 12.0 to 20.0	14 Ratio Interval 11.0 to 17.0
Geometric Mean Ratio (GMRs) of GMTs After Booster Dose/First rMenB+OMV NZ Vaccination Versus Day 1. 5/99	100 Ratio Interval 72.0 to 139.0	64 Ratio Interval 44.0 to 93.0	87 Ratio Interval 67.0 to 112.0	25 Ratio Interval 18.0 to 36.0	14 Ratio Interval 9.9 to 19.0	20 Ratio Interval 16.0 to 26.0
Geometric Mean Ratio (GMRs) of GMTs After Booster Dose/First rMenB+OMV NZ Vaccination Versus Day 1. NZ98/254	23 Ratio Interval 18.0 to 29.0	16 Ratio Interval 12.0 to 22.0	19 Ratio Interval 16.0 to 24.0	3.60 Ratio Interval 2.69 to 4.81	6.43 Ratio Interval 4.95 to 8.34	4.92 Ratio Interval 3.97 to 6.1
Geometric Mean Ratio (GMRs) of GMTs After Booster Dose/First rMenB+OMV NZ Vaccination Versus Day 1. M10713	4.69 Ratio Interval 3.72 to 5.92	5.16 Ratio Interval 4.14 to 6.42	4.85 Ratio Interval 4.1 to 5.72	2.37 Ratio Interval 1.81 to 3.1	2.58 Ratio Interval 2.11 to 3.16	2.44 Ratio Interval 2.04 to 2.91

SECONDARY outcome

Timeframe: Group 3B: 1 month after booster dose; Group B_0_1: 1 month after first vaccination

Population: Analysis was performed on the Full Analysis set (FAS) booster. The FAS booster included all follow on subjects and all naive subjects in the All enrolled set who received vaccination at day 1 and provided evaluable immunogenicity result at day 31 for atleast one indicator strain.

The percentage of subjects with 4-fold rise at one month post-vaccination with a booster dose (follow-on subjects) /first dose (naive subjects) of rMenB+OMV NZ with respect to day 1 (follow-on subjects) / pre-first dose of rMenB+OMV NZ (naïve subjects). Percentage of subjects with four-fold rise in hSBA titers relative to baseline were defined as: • for a pre-vaccination titer < 4, a post-vaccination titer of at least 16; • for a pre-vaccination titer ≥ 4 but <LLOQ, a post vaccination titer of at least fourfold the LLOQ; • for a pre-vaccination titer ≥LLOQ, a post vaccination titer of at least fourfold the pre-vaccination titer

Outcome measures

Measure	Group 3B (V72_41) n=142 Participants Subjects who received two doses of rMenB+OMV NZ administered at 0,1-month schedule in study V72\_41 (NCT0142384) and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during study V72\_41, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.	Group 3B (V72P10) n=127 Participants Subjects who received two doses of rMenB+OMV NZ administered at 0,1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during study V72P10, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.	Group 3B n=268 Participants Subjects who received two doses of rMenB+OMV NZ administered at 0, 1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and at 0,1 month schedule in study V72\_41(NCT0142384), and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during parent studies, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.	Group B_0_1 (V72_41) n=104 Participants Naive subjects from Australia and Canada, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.	Group B_0_1 (V72P10) n=149 Participants Naive subjects from Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.	Group B_0_1 n=253 Participants Naive subjects from Australia,Canada and Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose
Percentages of Subjects With at Least 4-fold Increase in hSBA Titers Pre Vaccination Compared to One Month Post-booster/First rMenB+OMV NZ Vaccination H44/76	95 Percentage of subjects Interval 90.0 to 98.0	98 Percentage of subjects Interval 93.3 to 99.51	96 Percentage of subjects Interval 93.2 to 98.2	66 Percentage of subjects Interval 56.4 to 75.3	72 Percentage of subjects Interval 63.9 to 78.9	70 Percentage of subjects Interval 63.5 to 75.2
Percentages of Subjects With at Least 4-fold Increase in hSBA Titers Pre Vaccination Compared to One Month Post-booster/First rMenB+OMV NZ Vaccination 5/99	98 Percentage of subjects Interval 94.0 to 99.79	97 Percentage of subjects Interval 90.9 to 99.3	98 Percentage of subjects Interval 94.6 to 99.2	79 Percentage of subjects Interval 69.7 to 86.8	74 Percentage of subjects Interval 65.2 to 81.0	76 Percentage of subjects Interval 69.9 to 81.4
Percentages of Subjects With at Least 4-fold Increase in hSBA Titers Pre Vaccination Compared to One Month Post-booster/First rMenB+OMV NZ Vaccination NZ98/254	83 Percentage of subjects Interval 75.9 to 88.9	77 Percentage of subjects Interval 68.5 to 84.3	80 Percentage of subjects Interval 75.0 to 85.0	28 Percentage of subjects Interval 19.7 to 37.9	53 Percentage of subjects Interval 44.3 to 61.1	43 Percentage of subjects Interval 36.3 to 49.0
Percentages of Subjects With at Least 4-fold Increase in hSBA Titers Pre Vaccination Compared to One Month Post-booster/First rMenB+OMV NZ Vaccination M10713	49 Percentage of subjects Interval 40.0 to 57.2	49 Percentage of subjects Interval 39.9 to 57.8	49 Percentage of subjects Interval 42.6 to 54.9	24 Percentage of subjects Interval 16.4 to 33.7	27 Percentage of subjects Interval 19.9 to 34.7	26 Percentage of subjects Interval 20.5 to 31.7

SECONDARY outcome

Timeframe: Group 3B: 3, 7 and 30 days after third dose booster; Group B_0_1: At 3 (group B_0_1_1 only), 7 (sub-group B_0_1_2 only) and 30 days post-second dose.

Population: Analysis was performed on PPS kinetics which included all subjects who correctly received the vaccination at day 1/ day 1 \& day 31 (naive subjects) \& provided evaluable immunogenicity result at all of days 4, 8 \& 31 (for follow-on subjects) or at all of days 34,38 and 61 (naive subjects).

Bactericidal activity was measured against the N. meningitidis group B indicator strains 5/99 and NZ98/254. On day 1, subjects in the Group B_0_1 were to be randomized into 2 different blood draw schedules according to a 1:1 ratio : 2 blood samples at different time points:

Group B_0_1_1: blood draws at 3 and 30 days after the second dose. Group B_0_1_2: blood draws at 7 and 30 days after the second dose.

This outcome measure was assessed only for strains 5/99 and NZ98/254.

Outcome measures

Measure	Group 3B (V72_41) n=130 Participants Subjects who received two doses of rMenB+OMV NZ administered at 0,1-month schedule in study V72\_41 (NCT0142384) and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during study V72\_41, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.	Group 3B (V72P10) n=103 Participants Subjects who received two doses of rMenB+OMV NZ administered at 0,1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during study V72P10, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.	Group 3B n=233 Participants Subjects who received two doses of rMenB+OMV NZ administered at 0, 1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and at 0,1 month schedule in study V72\_41(NCT0142384), and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during parent studies, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.	Group B_0_1 (V72_41) n=94 Participants Naive subjects from Australia and Canada, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.	Group B_0_1 (V72P10) n=109 Participants Naive subjects from Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.	Group B_0_1 n=203 Participants Naive subjects from Australia,Canada and Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose
Percentage of Subjects With hSBA ≥1:4 After Booster Dose/Second Vaccination of rMenB+OMV NZ 5/99- 3 days post vaccination	78 Percentage of subjects Interval 68.4 to 85.3	80 Percentage of subjects Interval 70.3 to 88.4	79 Percentage of subjects Interval 72.3 to 84.6	82 Percentage of subjects Interval 67.3 to 91.8	88 Percentage of subjects Interval 74.4 to 96.0	85 Percentage of subjects Interval 75.5 to 91.7
Percentage of Subjects With hSBA ≥1:4 After Booster Dose/Second Vaccination of rMenB+OMV NZ 5/99- 7 days post vaccination	100 Percentage of subjects Interval 96.5 to 100.0	100 Percentage of subjects Interval 95.6 to 100.0	100 Percentage of subjects Interval 98.0 to 100.0	100 Percentage of subjects Interval 91.2 to 100.0	98 Percentage of subjects Interval 88.9 to 99.95	99 Percentage of subjects Interval 93.8 to 99.97
Percentage of Subjects With hSBA ≥1:4 After Booster Dose/Second Vaccination of rMenB+OMV NZ 5/99- 1 month post vaccination	100 Percentage of subjects Interval 96.5 to 100.0	100 Percentage of subjects Interval 95.6 to 100.0	100 Percentage of subjects Interval 98.0 to 100.0	100 Percentage of subjects Interval 95.7 to 100.0	98 Percentage of subjects Interval 92.2 to 99.73	99 Percentage of subjects Interval 95.9 to 99.86
Percentage of Subjects With hSBA ≥1:4 After Booster Dose/Second Vaccination of rMenB+OMV NZ NZ98/254- 3 days post vaccination	12 Percentage of subjects Interval 6.6 to 18.3	28 Percentage of subjects Interval 19.7 to 37.9	19 Percentage of subjects Interval 14.1 to 24.5	32 Percentage of subjects Interval 19.5 to 46.7	60 Percentage of subjects Interval 45.9 to 73.0	47 Percentage of subjects Interval 36.9 to 56.7
Percentage of Subjects With hSBA ≥1:4 After Booster Dose/Second Vaccination of rMenB+OMV NZ NZ98/254- 7 days post vaccination	73 Percentage of subjects Interval 64.6 to 80.5	80 Percentage of subjects Interval 70.5 to 86.9	76 Percentage of subjects Interval 70.0 to 81.3	80 Percentage of subjects Interval 64.7 to 90.2	81 Percentage of subjects Interval 68.6 to 90.7	81 Percentage of subjects Interval 71.4 to 87.9
Percentage of Subjects With hSBA ≥1:4 After Booster Dose/Second Vaccination of rMenB+OMV NZ NZ98/254- 1 month post vaccination	94 Percentage of subjects Interval 88.2 to 97.3	94 Percentage of subjects Interval 87.8 to 97.8	94 Percentage of subjects Interval 90.1 to 96.7	82 Percentage of subjects Interval 72.6 to 89.1	79 Percentage of subjects Interval 70.0 to 86.1	80 Percentage of subjects Interval 74.1 to 85.5

SECONDARY outcome

Timeframe: Group 3B: 3, 7 and 30 days after third dose booster; Group B_0_1: At 3 (group B_0_1_1 only), 7 (sub-group B_0_1_2 only) and 30 days post-second dose."

Population: Analysis was performed on the PPS kinetics which included all subjects who correctly received the vaccination at day 1/ day 1 \& day 31 (naive subjects) \& provided evaluable immunogenicity result at all of days 4, 8 \& 31 (for follow-on subjects) or at all of days 34,38 \& 61 (naive subjects).

Bactericidal activity was measured against the N. meningitidis group B indicator strains H44/76 and M10713. On day 1, subjects in the Group B_0_1 were to be randomized into 2 different blood draw schedules according to a 1:1 ratio : 2 blood samples at different time points:

Group B_0_1_1: blood draws at 3 and 30 days after the second dose. Group B_0_1_2: blood draws at 7 and 30 days after the second dose. This outcome measure was assessed only for strains H44/76 and M10713.

Outcome measures

Measure	Group 3B (V72_41) n=130 Participants Subjects who received two doses of rMenB+OMV NZ administered at 0,1-month schedule in study V72\_41 (NCT0142384) and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during study V72\_41, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.	Group 3B (V72P10) n=112 Participants Subjects who received two doses of rMenB+OMV NZ administered at 0,1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during study V72P10, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.	Group 3B n=242 Participants Subjects who received two doses of rMenB+OMV NZ administered at 0, 1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and at 0,1 month schedule in study V72\_41(NCT0142384), and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during parent studies, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.	Group B_0_1 (V72_41) n=94 Participants Naive subjects from Australia and Canada, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.	Group B_0_1 (V72P10) n=109 Participants Naive subjects from Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.	Group B_0_1 n=203 Participants Naive subjects from Australia,Canada and Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose
Percentage of Subjects With hSBA ≥1:5 After Booster Dose/Second Vaccination of rMenB+OMV NZ H44/76 3 days post vaccination	28 Percentage of subjects Interval 20.9 to 37.0	46 Percentage of subjects Interval 36.1 to 55.2	36 Percentage of subjects Interval 30.3 to 42.8	74 Percentage of subjects Interval 59.7 to 85.4	85 Percentage of subjects Interval 73.3 to 93.5	80 Percentage of subjects Interval 71.1 to 87.2
Percentage of Subjects With hSBA ≥1:5 After Booster Dose/Second Vaccination of rMenB+OMV NZ H44/76 7 days post vaccination	97 Percentage of subjects Interval 92.3 to 99.2	99 Percentage of subjects Interval 95.1 to 99.98	98 Percentage of subjects Interval 95.2 to 99.3	100 Percentage of subjects Interval 92.0 to 100.0	98 Percentage of subjects Interval 90.1 to 99.95	99 Percentage of subjects Interval 94.4 to 99.97
Percentage of Subjects With hSBA ≥1:5 After Booster Dose/Second Vaccination of rMenB+OMV NZ H44/76 1 month post vaccination	98 Percentage of subjects Interval 93.4 to 99.52	100 Percentage of subjects Interval 96.8 to 100.0	99 Percentage of subjects Interval 96.4 to 99.74	99 Percentage of subjects Interval 94.2 to 99.97	99 Percentage of subjects Interval 95.0 to 99.98	99 Percentage of subjects Interval 96.5 to 99.88
Percentage of Subjects With hSBA ≥1:5 After Booster Dose/Second Vaccination of rMenB+OMV NZ M10713- 3 days post-vaccination	71 Percentage of subjects Interval 62.7 to 78.9	86 Percentage of subjects Interval 77.8 to 91.6	78 Percentage of subjects Interval 72.2 to 83.1	76 Percentage of subjects Interval 61.8 to 86.9	87 Percentage of subjects Interval 75.5 to 94.7	82 Percentage of subjects Interval 73.2 to 88.7
Percentage of Subjects With hSBA ≥1:5 After Booster Dose/Second Vaccination of rMenB+OMV NZ M10713- 7 days post-vaccination	98 Percentage of subjects Interval 93.4 to 99.52	97 Percentage of subjects Interval 92.4 to 99.4	98 Percentage of subjects Interval 94.7 to 99.1	95 Percentage of subjects Interval 84.5 to 99.4	96 Percentage of subjects Interval 87.3 to 99.55	96 Percentage of subjects Interval 89.9 to 98.9
Percentage of Subjects With hSBA ≥1:5 After Booster Dose/Second Vaccination of rMenB+OMV NZ M10713- 1 month post-vaccination	99 Percentage of subjects Interval 95.8 to 99.98	99 Percentage of subjects Interval 95.1 to 99.98	99 Percentage of subjects Interval 97.0 to 99.9	90 Percentage of subjects Interval 82.6 to 95.5	95 Percentage of subjects Interval 89.6 to 98.5	93 Percentage of subjects Interval 88.7 to 96.2

SECONDARY outcome

Timeframe: Group 3B: 3, 7 and 30 days after third dose booster; Group B_0_1: At 3 (group B_0_1_1 only), 7 (sub-group B_0_1_2 only) and 30 days post-second dose.

Population: Analysis was performed on PPS kinetics which included all subjects who had no protocol deviations/any other reason defined prior to analysis, leading to exclusion \& correctly received the vaccination at day 1/day 31 \& day 1 \& provided evaluable immunogenicity result at all of days 4, 8 \& 31 (follow-on subjects)or at all of days 34, 38 \& 61(naive)

Bactericidal activity was measured against each of the four N. meningitidis group B indicator strains H44/76,5/99,NZ98/254 and M10713. On day 1, subjects in the Group B_0_1 were to be randomized into 2 different blood draw schedules according to a 1:1 ratio : 2 blood samples at different time points:

Group B_0_1_1: blood draws at 3 and 30 days after the second dose. Group B_0_1_2: blood draws at 7 and 30 days after the second dose.

Outcome measures

Measure	Group 3B (V72_41) n=130 Participants Subjects who received two doses of rMenB+OMV NZ administered at 0,1-month schedule in study V72\_41 (NCT0142384) and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during study V72\_41, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.	Group 3B (V72P10) n=112 Participants Subjects who received two doses of rMenB+OMV NZ administered at 0,1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during study V72P10, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.	Group 3B n=242 Participants Subjects who received two doses of rMenB+OMV NZ administered at 0, 1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and at 0,1 month schedule in study V72\_41(NCT0142384), and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during parent studies, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.	Group B_0_1 (V72_41) n=94 Participants Naive subjects from Australia and Canada, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.	Group B_0_1 (V72P10) n=109 Participants Naive subjects from Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.	Group B_0_1 n=203 Participants Naive subjects from Australia,Canada and Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose
Percentage of Subjects With hSBA ≥1:8 After Booster Dose/Second Vaccination of rMenB+OMV NZ M10713- 1 month post-vaccination	98 Percentage of subjects Interval 94.5 to 99.81	98 Percentage of subjects Interval 93.7 to 99.78	98 Percentage of subjects Interval 95.8 to 99.55	86 Percentage of subjects Interval 77.5 to 92.4	94 Percentage of subjects Interval 87.2 to 97.4	90 Percentage of subjects Interval 85.2 to 93.9
Percentage of Subjects With hSBA ≥1:8 After Booster Dose/Second Vaccination of rMenB+OMV NZ H44/76 3 days post vaccination	22 Percentage of subjects Interval 15.5 to 30.4	39 Percentage of subjects Interval 30.2 to 49.0	30 Percentage of subjects Interval 24.5 to 36.4	70 Percentage of subjects Interval 55.4 to 82.1	80 Percentage of subjects Interval 67.0 to 89.6	75 Percentage of subjects Interval 65.9 to 83.1
Percentage of Subjects With hSBA ≥1:8 After Booster Dose/Second Vaccination of rMenB+OMV NZ H44/76 7 days post vaccination	95 Percentage of subjects Interval 89.2 to 97.8	98 Percentage of subjects Interval 93.7 to 99.78	96 Percentage of subjects Interval 93.1 to 98.3	95 Percentage of subjects Interval 84.5 to 99.4	98 Percentage of subjects Interval 90.1 to 99.95	97 Percentage of subjects Interval 91.3 to 99.4
Percentage of Subjects With hSBA ≥1:8 After Booster Dose/Second Vaccination of rMenB+OMV NZ H44/76 1 month post vaccination	98 Percentage of subjects Interval 93.4 to 99.52	100 Percentage of subjects Interval 96.8 to 100.0	99 Percentage of subjects Interval 96.4 to 99.74	99 Percentage of subjects Interval 94.2 to 99.97	97 Percentage of subjects Interval 92.2 to 99.4	98 Percentage of subjects Interval 95.0 to 99.5
Percentage of Subjects With hSBA ≥1:8 After Booster Dose/Second Vaccination of rMenB+OMV NZ 5/99- 3 days post-vaccination	74 Percentage of subjects Interval 64.2 to 82.0	79 Percentage of subjects Interval 68.9 to 87.4	76 Percentage of subjects Interval 69.4 to 82.2	80 Percentage of subjects Interval 64.7 to 90.2	86 Percentage of subjects Interval 71.5 to 94.6	83 Percentage of subjects Interval 72.9 to 89.9
Percentage of Subjects With hSBA ≥1:8 After Booster Dose/Second Vaccination of rMenB+OMV NZ 5/99- 7 days post-vaccination	100 Percentage of subjects Interval 96.5 to 100.0	100 Percentage of subjects Interval 95.6 to 100.0	100 Percentage of subjects Interval 98.0 to 100.0	100 Percentage of subjects Interval 91.2 to 100.0	98 Percentage of subjects Interval 88.9 to 99.95	99 Percentage of subjects Interval 93.8 to 99.97
Percentage of Subjects With hSBA ≥1:8 After Booster Dose/Second Vaccination of rMenB+OMV NZ 5/99- 1 month post-vaccination	100 Percentage of subjects Interval 96.5 to 100.0	100 Percentage of subjects Interval 95.6 to 100.0	100 Percentage of subjects Interval 98.0 to 100.0	100 Percentage of subjects Interval 95.7 to 100.0	98 Percentage of subjects Interval 92.2 to 99.73	99 Percentage of subjects Interval 95.9 to 99.86
Percentage of Subjects With hSBA ≥1:8 After Booster Dose/Second Vaccination of rMenB+OMV NZ NZ98/254- 3 days post-vaccination	10 Percentage of subjects Interval 5.4 to 16.5	23 Percentage of subjects Interval 15.5 to 32.7	16 Percentage of subjects Interval 11.4 to 21.2	28 Percentage of subjects Interval 16.2 to 42.5	55 Percentage of subjects Interval 40.6 to 68.0	42 Percentage of subjects Interval 32.3 to 51.9
Percentage of Subjects With hSBA ≥1:8 After Booster Dose/Second Vaccination of rMenB+OMV NZ NZ98/254- 7 days post-vaccination	61 Percentage of subjects Interval 51.8 to 69.2	74 Percentage of subjects Interval 64.2 to 82.0	67 Percentage of subjects Interval 60.1 to 72.6	68 Percentage of subjects Interval 52.4 to 81.4	70 Percentage of subjects Interval 56.4 to 82.0	69 Percentage of subjects Interval 59.3 to 78.3
Percentage of Subjects With hSBA ≥1:8 After Booster Dose/Second Vaccination of rMenB+OMV NZ NZ98/254- 1 month post-vaccination	85 Percentage of subjects Interval 77.2 to 90.3	91 Percentage of subjects Interval 84.1 to 95.9	88 Percentage of subjects Interval 82.6 to 91.5	65 Percentage of subjects Interval 54.4 to 74.5	69 Percentage of subjects Interval 59.2 to 77.3	67 Percentage of subjects Interval 60.1 to 73.4
Percentage of Subjects With hSBA ≥1:8 After Booster Dose/Second Vaccination of rMenB+OMV NZ M10713- 3 days post-vaccination	62 Percentage of subjects Interval 53.1 to 70.4	79 Percentage of subjects Interval 69.8 to 85.8	70 Percentage of subjects Interval 63.5 to 75.4	62 Percentage of subjects Interval 47.2 to 75.3	84 Percentage of subjects Interval 71.2 to 92.2	73 Percentage of subjects Interval 63.8 to 81.5
Percentage of Subjects With hSBA ≥1:8 After Booster Dose/Second Vaccination of rMenB+OMV NZ M10713- 7 days post-vaccination	95 Percentage of subjects Interval 90.2 to 98.3	96 Percentage of subjects Interval 89.9 to 98.5	95 Percentage of subjects Interval 92.0 to 97.7	93 Percentage of subjects Interval 81.3 to 98.6	94 Percentage of subjects Interval 84.6 to 98.8	94 Percentage of subjects Interval 87.1 to 97.7

SECONDARY outcome

Timeframe: Group 3B: 3, 7 and 30 days after third dose booster; Group B_0_1: At 3 (group B_0_1_1 only), 7 (sub-group B_0_1_2 only) and 30 days post-second dose

Population: Analysis was performed on PPS kinetics which included all subjects who had no protocol deviations/any other reason defined prior to analysis, leading to exclusion \& correctly received the vaccination at day 1/day 31 \& day 1 \& provided evaluable immunogenicity result at all of days 4, 8 \& 31 (follow-on subjects)or at all of days 34, 38 \& 61(naive)

Bactericidal activity was measured against each of the four N. meningitidis group B indicator strains H44/76,5/99,NZ98/254 and M10713. On day 1, subjects in the Group B_0_1 were to be randomized into 2 different blood draw schedules according to a 1:1 ratio : 2 blood samples at different time points:

Group B_0_1_1: blood draws at 3 and 30 days after the second dose. Group B_0_1_2: blood draws at 7 and 30 days after the second dose

Outcome measures

Measure	Group 3B (V72_41) n=130 Participants Subjects who received two doses of rMenB+OMV NZ administered at 0,1-month schedule in study V72\_41 (NCT0142384) and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during study V72\_41, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.	Group 3B (V72P10) n=112 Participants Subjects who received two doses of rMenB+OMV NZ administered at 0,1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during study V72P10, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.	Group 3B n=242 Participants Subjects who received two doses of rMenB+OMV NZ administered at 0, 1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and at 0,1 month schedule in study V72\_41(NCT0142384), and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during parent studies, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.	Group B_0_1 (V72_41) n=94 Participants Naive subjects from Australia and Canada, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.	Group B_0_1 (V72P10) n=109 Participants Naive subjects from Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.	Group B_0_1 n=203 Participants Naive subjects from Australia,Canada and Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose
Percentage of Subjects With hSBA ≥1:16 After Booster Dose/Second Vaccination of rMenB+OMV NZ H44/76 3 days post vaccination	13 Percentage of subjects Interval 7.8 to 20.1	29 Percentage of subjects Interval 21.2 to 38.8	21 Percentage of subjects Interval 15.7 to 26.3	40 Percentage of subjects Interval 26.4 to 54.8	60 Percentage of subjects Interval 45.9 to 73.0	50 Percentage of subjects Interval 40.5 to 60.4
Percentage of Subjects With hSBA ≥1:16 After Booster Dose/Second Vaccination of rMenB+OMV NZ H44/76 7 days post vaccination	92 Percentage of subjects Interval 85.4 to 95.7	98 Percentage of subjects Interval 93.7 to 99.78	95 Percentage of subjects Interval 91.0 to 97.1	89 Percentage of subjects Interval 75.4 to 96.2	94 Percentage of subjects Interval 84.6 to 98.8	92 Percentage of subjects Interval 84.5 to 96.4
Percentage of Subjects With hSBA ≥1:16 After Booster Dose/Second Vaccination of rMenB+OMV NZ H44/76 1 month post vaccination	98 Percentage of subjects Interval 93.4 to 99.52	100 Percentage of subjects Interval 96.8 to 100.0	99 Percentage of subjects Interval 96.4 to 99.74	90 Percentage of subjects Interval 82.6 to 95.5	92 Percentage of subjects Interval 84.9 to 96.2	91 Percentage of subjects Interval 86.3 to 94.7
Percentage of Subjects With hSBA ≥1:16 After Booster Dose/Second Vaccination of rMenB+OMV NZ 5/99- 3 days post-vaccination	69 Percentage of subjects Interval 59.1 to 77.7	72 Percentage of subjects Interval 60.9 to 81.3	70 Percentage of subjects Interval 63.1 to 76.8	75 Percentage of subjects Interval 59.7 to 86.8	76 Percentage of subjects Interval 60.5 to 87.9	76 Percentage of subjects Interval 65.1 to 84.2
Percentage of Subjects With hSBA ≥1:16 After Booster Dose/Second Vaccination of rMenB+OMV NZ 5/99- 7 days post-vaccination	100 Percentage of subjects Interval 96.5 to 100.0	100 Percentage of subjects Interval 95.6 to 100.0	100 Percentage of subjects Interval 98.0 to 100.0	100 Percentage of subjects Interval 91.2 to 100.0	98 Percentage of subjects Interval 88.9 to 99.95	99 Percentage of subjects Interval 93.8 to 99.97
Percentage of Subjects With hSBA ≥1:16 After Booster Dose/Second Vaccination of rMenB+OMV NZ 5/99- 1 month post-vaccination	100 Percentage of subjects Interval 96.5 to 100.0	100 Percentage of subjects Interval 95.6 to 100.0	100 Percentage of subjects Interval 98.0 to 100.0	100 Percentage of subjects Interval 95.7 to 100.0	97 Percentage of subjects Interval 90.6 to 99.3	98 Percentage of subjects Interval 95.0 to 99.64
Percentage of Subjects With hSBA ≥1:16 After Booster Dose/Second Vaccination of rMenB+OMV NZ NZ98/254- 3 days post-vaccination	5 Percentage of subjects Interval 2.2 to 10.8	15 Percentage of subjects Interval 8.4 to 22.9	9 Percentage of subjects Interval 6.0 to 13.9	18 Percentage of subjects Interval 8.6 to 31.4	40 Percentage of subjects Interval 27.0 to 54.1	30 Percentage of subjects Interval 21.0 to 39.2
Percentage of Subjects With hSBA ≥1:16 After Booster Dose/Second Vaccination of rMenB+OMV NZ NZ98/254- 7 days post-vaccination	41 Percentage of subjects Interval 32.2 to 49.7	64 Percentage of subjects Interval 54.0 to 73.3	51 Percentage of subjects Interval 44.5 to 57.7	41 Percentage of subjects Interval 26.3 to 56.8	52 Percentage of subjects Interval 37.8 to 65.7	47 Percentage of subjects Interval 36.8 to 57.3
Percentage of Subjects With hSBA ≥1:16 After Booster Dose/Second Vaccination of rMenB+OMV NZ NZ98/254- 1 month post-vaccination	74 Percentage of subjects Interval 65.4 to 81.2	89 Percentage of subjects Interval 81.7 to 94.5	81 Percentage of subjects Interval 75.0 to 85.6	40 Percentage of subjects Interval 30.4 to 51.0	56 Percentage of subjects Interval 46.1 to 65.5	49 Percentage of subjects Interval 41.7 to 55.9
Percentage of Subjects With hSBA ≥1:16 After Booster Dose/Second Vaccination of rMenB+OMV NZ M10713- 3 days post-vaccination	48 Percentage of subjects Interval 39.2 to 57.0	71 Percentage of subjects Interval 61.2 to 78.8	59 Percentage of subjects Interval 52.0 to 64.8	50 Percentage of subjects Interval 35.5 to 64.5	76 Percentage of subjects Interval 63.0 to 86.8	64 Percentage of subjects Interval 53.9 to 73.0
Percentage of Subjects With hSBA ≥1:16 After Booster Dose/Second Vaccination of rMenB+OMV NZ M10713- 7 days post-vaccination	85 Percentage of subjects Interval 78.0 to 90.9	91 Percentage of subjects Interval 84.2 to 95.6	88 Percentage of subjects Interval 83.2 to 91.8	84 Percentage of subjects Interval 69.9 to 93.4	91 Percentage of subjects Interval 79.7 to 96.9	88 Percentage of subjects Interval 79.6 to 93.5
Percentage of Subjects With hSBA ≥1:16 After Booster Dose/Second Vaccination of rMenB+OMV NZ M10713- 1 month post-vaccination	93 Percentage of subjects Interval 87.2 to 96.8	97 Percentage of subjects Interval 92.4 to 99.4	95 Percentage of subjects Interval 91.5 to 97.4	76 Percentage of subjects Interval 65.6 to 83.8	92 Percentage of subjects Interval 84.9 to 96.2	84 Percentage of subjects Interval 78.5 to 89.0

SECONDARY outcome

Timeframe: Group 3B: Day 1 (pre-booster dose) and 3, 7 and 30 days after third dose booster; Group B_0_1: Pre 2nd dose and at 3 (group B_0_1_1 only), 7 (group B_0_1_2 only) and 30 days post second dose.

Population: Analysis was performed on PPS kinetics which included all subjects who had no protocol deviations/any other reason defined prior to analysis, leading to exclusion \& correctly received the vaccination at day 1/day 31 \& day 1 \& provided evaluable immunogenicity result at all of days 4, 8 \& 31 (follow-on subjects)or at all of days 34, 38 \& 61(naive)

Bactericidal activity was measured against each of the four N. meningitidis group B indicator strains H44/76,5/99,NZ98/254 and M10713. On day 1, subjects in the Group B_0_1 were to be randomized into 2 different blood draw schedules according to a 1:1 ratio : 2 blood samples at different time points:

Group B_0_1_1: blood draws at 3 and 30 days after the second dose. Group B_0_1_2: blood draws at 7 and 30 days after the second dose.

Outcome measures

Measure	Group 3B (V72_41) n=130 Participants Subjects who received two doses of rMenB+OMV NZ administered at 0,1-month schedule in study V72\_41 (NCT0142384) and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during study V72\_41, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.	Group 3B (V72P10) n=112 Participants Subjects who received two doses of rMenB+OMV NZ administered at 0,1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during study V72P10, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.	Group 3B n=242 Participants Subjects who received two doses of rMenB+OMV NZ administered at 0, 1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and at 0,1 month schedule in study V72\_41(NCT0142384), and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during parent studies, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.	Group B_0_1 (V72_41) n=94 Participants Naive subjects from Australia and Canada, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.	Group B_0_1 (V72P10) n=109 Participants Naive subjects from Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.	Group B_0_1 n=203 Participants Naive subjects from Australia,Canada and Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose
hSBA Geometric Mean Titers Prior to Booster/Second Dose of Vaccination & Post Booster/Second Dose of Vaccination. H44/76 - pre-vaccination	2.41 Titers Interval 1.86 to 3.13	4.61 Titers Interval 3.34 to 6.38	2.99 Titers Interval 2.41 to 3.7	14 Titers Interval 10.0 to 19.0	27 Titers Interval 19.0 to 37.0	17 Titers Interval 14.0 to 22.0
hSBA Geometric Mean Titers Prior to Booster/Second Dose of Vaccination & Post Booster/Second Dose of Vaccination. H44/76 - 3 days post-vacc	2.68 Titers Interval 2.06 to 3.48	4.57 Titers Interval 3.38 to 6.18	3.20 Titers Interval 2.6 to 3.94	14 Titers Interval 9.55 to 22.0	24 Titers Interval 16.0 to 37.0	17 Titers Interval 13.0 to 23.0
hSBA Geometric Mean Titers Prior to Booster/Second Dose of Vaccination & Post Booster/Second Dose of Vaccination. H44/76 - 7 days post-vacc	97 Titers Interval 77.0 to 123.0	153 Titers Interval 123.0 to 191.0	115 Titers Interval 98.0 to 136.0	62 Titers Interval 42.0 to 90.0	60 Titers Interval 44.0 to 83.0	57 Titers Interval 44.0 to 73.0
hSBA Geometric Mean Titers Prior to Booster/Second Dose of Vaccination & Post Booster/Second Dose of Vaccination. H44/76 - 1 month post-vacc.	157 Titers Interval 127.0 to 193.0	285 Titers Interval 234.0 to 345.0	196 Titers Interval 170.0 to 228.0	57 Titers Interval 45.0 to 73.0	64 Titers Interval 52.0 to 78.0	56 Titers Interval 48.0 to 66.0
hSBA Geometric Mean Titers Prior to Booster/Second Dose of Vaccination & Post Booster/Second Dose of Vaccination. 5/99- pre-vaccination	20 Titers Interval 14.0 to 29.0	30 Titers Interval 20.0 to 47.0	24 Titers Interval 18.0 to 32.0	33 Titers Interval 23.0 to 50.0	30 Titers Interval 20.0 to 44.0	31 Titers Interval 23.0 to 41.0
hSBA Geometric Mean Titers Prior to Booster/Second Dose of Vaccination & Post Booster/Second Dose of Vaccination. 5/99- 3 days post-vacc	23 Titers Interval 16.0 to 34.0	25 Titers Interval 17.0 to 35.0	24 Titers Interval 18.0 to 31.0	27 Titers Interval 15.0 to 49.0	28 Titers Interval 17.0 to 47.0	27 Titers Interval 19.0 to 41.0
hSBA Geometric Mean Titers Prior to Booster/Second Dose of Vaccination & Post Booster/Second Dose of Vaccination. 5/99- 7 days post-vacc	1969 Titers Interval 1516.0 to 2556.0	1547 Titers Interval 1191.0 to 2009.0	1787 Titers Interval 1477.0 to 2162.0	294 Titers Interval 197.0 to 439.0	365 Titers Interval 259.0 to 514.0	337 Titers Interval 257.0 to 442.0
hSBA Geometric Mean Titers Prior to Booster/Second Dose of Vaccination & Post Booster/Second Dose of Vaccination. 5/99- 1 month post-vacc.	2147 Titers Interval 1749.0 to 2635.0	1903 Titers Interval 1469.0 to 2466.0	2026 Titers Interval 1714.0 to 2395.0	224 Titers Interval 179.0 to 281.0	276 Titers Interval 215.0 to 353.0	248 Titers Interval 208.0 to 295.0
hSBA Geometric Mean Titers Prior to Booster/Second Dose of Vaccination & Post Booster/Second Dose of Vaccination. NZ98/254- pre-vaccination	1.31 Titers Interval 1.06 to 1.63	2.40 Titers Interval 1.72 to 3.37	1.57 Titers Interval 1.29 to 1.92	3.44 Titers Interval 2.66 to 4.43	9.79 Titers Interval 7.07 to 14.0	5.11 Titers Interval 4.1 to 6.38
hSBA Geometric Mean Titers Prior to Booster/Second Dose of Vaccination & Post Booster/Second Dose of Vaccination. NZ98/254- 3 days post-vacc	1.40 Titers Interval 1.15 to 1.7	2.34 Titers Interval 1.72 to 3.2	1.62 Titers Interval 1.35 to 1.96	2.75 Titers Interval 2.02 to 3.74	8.94 Titers Interval 5.84 to 14.0	4.45 Titers Interval 3.38 to 5.84
hSBA Geometric Mean Titers Prior to Booster/Second Dose of Vaccination & Post Booster/Second Dose of Vaccination. NZ98/254- 7 days post-vacc	10 Titers Interval 7.8 to 13.0	18 Titers Interval 13.0 to 25.0	12 Titers Interval 10.0 to 15.0	11 Titers Interval 6.96 to 17.0	15 Titers Interval 9.79 to 24.0	12 Titers Interval 8.46 to 16.0
hSBA Geometric Mean Titers Prior to Booster/Second Dose of Vaccination & Post Booster/Second Dose of Vaccination. NZ98/254- 1 month post-vacc.	32 Titers Interval 25.0 to 40.0	44 Titers Interval 33.0 to 59.0	35 Titers Interval 29.0 to 42.0	12 Titers Interval 9.04 to 16.0	17 Titers Interval 13.0 to 23.0	14 Titers Interval 11.0 to 17.0
hSBA Geometric Mean Titers Prior to Booster/Second Dose of Vaccination & Post Booster/Second Dose of Vaccination. M10713- pre-vaccination	13 Titers Interval 9.76 to 18.0	22 Titers Interval 16.0 to 29.0	15 Titers Interval 12.0 to 19.0	25 Titers Interval 18.0 to 35.0	50 Titers Interval 38.0 to 67.0	32 Titers Interval 25.0 to 41.0
hSBA Geometric Mean Titers Prior to Booster/Second Dose of Vaccination & Post Booster/Second Dose of Vaccination. M10713- 3 days post-vacc	14 Titers Interval 9.96 to 19.0	24 Titers Interval 18.0 to 32.0	16 Titers Interval 13.0 to 21.0	18 Titers Interval 11.0 to 30.0	37 Titers Interval 24.0 to 56.0	23 Titers Interval 17.0 to 33.0
hSBA Geometric Mean Titers Prior to Booster/Second Dose of Vaccination & Post Booster/Second Dose of Vaccination. M10713- 7 days post-vacc	48 Titers Interval 39.0 to 59.0	68 Titers Interval 56.0 to 82.0	54 Titers Interval 46.0 to 62.0	42 Titers Interval 30.0 to 59.0	56 Titers Interval 42.0 to 73.0	45 Titers Interval 36.0 to 57.0
hSBA Geometric Mean Titers Prior to Booster/Second Dose of Vaccination & Post Booster/Second Dose of Vaccination. M10713- 1 month post-vacc.	64 Titers Interval 52.0 to 80.0	116 Titers Interval 94.0 to 143.0	78 Titers Interval 67.0 to 92.0	34 Titers Interval 26.0 to 44.0	61 Titers Interval 49.0 to 75.0	41 Titers Interval 35.0 to 49.0

SECONDARY outcome

Timeframe: Group 3B: Day 1 and 30 days after third dose booster; Group B_0_1: 30 days post-first dose and at 30 days post-second dose

Population: Analysis was performed on PPS kinetics which included all subjects who had no protocol deviations/any other reason defined prior to analysis, leading to exclusion \& correctly received the vaccination at day 1/day 31 \& day 1 \& provided evaluable immunogenicity result at all of days 4, 8 \& 31 (follow-on subjects)or at all of days 34, 38 \& 61(naive)

Bactericidal activity was measured against each of the four N. meningitidis group B indicator strains H44/76,5/99,NZ98/254 and M10713 by calculating the GMRs of GMTs post-vaccination with a booster dose (Group 3B) versus pre-booster dose or second dose (Group B_0_1) of vaccination versus pre second dose.

Outcome measures

Measure	Group 3B (V72_41) n=130 Participants Subjects who received two doses of rMenB+OMV NZ administered at 0,1-month schedule in study V72\_41 (NCT0142384) and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during study V72\_41, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.	Group 3B (V72P10) n=112 Participants Subjects who received two doses of rMenB+OMV NZ administered at 0,1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during study V72P10, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.	Group 3B n=242 Participants Subjects who received two doses of rMenB+OMV NZ administered at 0, 1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and at 0,1 month schedule in study V72\_41(NCT0142384), and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during parent studies, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.	Group B_0_1 (V72_41) n=94 Participants Naive subjects from Australia and Canada, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.	Group B_0_1 (V72P10) n=109 Participants Naive subjects from Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.	Group B_0_1 n=203 Participants Naive subjects from Australia,Canada and Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose
Geometric Mean Ratios (GMRs) of GMTs After Booster/Second Vaccination Versus Before Booster/Second Vaccination. 5/99	105 Ratio Interval 76.0 to 145.0	62 Ratio Interval 41.0 to 96.0	85 Ratio Interval 65.0 to 111.0	6.86 Ratio Interval 4.82 to 9.78	9.09 Ratio Interval 6.1 to 14.0	8.10 Ratio Interval 6.12 to 11.0
Geometric Mean Ratios (GMRs) of GMTs After Booster/Second Vaccination Versus Before Booster/Second Vaccination. H44/76	65 Ratio Interval 49.0 to 85.0	62 Ratio Interval 49.0 to 78.0	66 Ratio Interval 55.0 to 79.0	4.21 Ratio Interval 3.05 to 5.8	2.37 Ratio Interval 1.87 to 3.0	3.27 Ratio Interval 2.66 to 4.03
Geometric Mean Ratios (GMRs) of GMTs After Booster/Second Vaccination Versus Before Booster/Second Vaccination. NZ98/25	24 Ratio Interval 19.0 to 30.0	18 Ratio Interval 14.0 to 24.0	22 Ratio Interval 19.0 to 27.0	3.42 Ratio Interval 2.59 to 4.51	1.76 Ratio Interval 1.36 to 2.29	2.63 Ratio Interval 2.15 to 3.21
Geometric Mean Ratios (GMRs) of GMTs After Booster/Second Vaccination Versus Before Booster/Second Vaccination. M10713	4.87 Ratio Interval 3.92 to 6.05	5.30 Ratio Interval 4.29 to 6.55	5.07 Ratio Interval 4.33 to 5.94	1.36 Ratio Interval 1.06 to 1.75	1.20 Ratio Interval 0.97 to 1.49	1.27 Ratio Interval 1.07 to 1.52

SECONDARY outcome

Timeframe: Group 3B: at 3, 7 and 30 days after third dose booster; Group B_0_1: at 3 (group B_0_1_1 only), 7 (group B_0_1_2 only) and 30 days post second dose

Population: Analysis was performed on PPS kinetics which included all subjects who had no protocol deviations/any other reason defined prior to analysis, leading to exclusion \& correctly received the vaccination at day 1/day 31 \& day 1 \& provided evaluable immunogenicity result at all of days 4, 8 \& 31 (follow-on subjects)or at all of days 34/38 \& 61(naive)

The percentage of subjects with 4-fold rise at 3, 7, 30 days post-vaccination with a booster dose (follow-on subjects) /second dose (naive subjects) of rMenB+OMV NZ with respect to day 1 (follow-on subjects) / pre-second dose of rMenB+OMV NZ (naïve subjects). Percentage of subjects with four-fold rise in hSBA titers relative to baseline were defined as: • for a pre-vaccination titer < 4, a post-vaccination titer of at least 16; • for a pre-vaccination titer ≥ 4 but <LLOQ, a post vaccination titer of at least fourfold the LLOQ; • for a pre-vaccination titer ≥LLOQ, a post vaccination titer of at least fourfold the pre-vaccination titer.

Outcome measures

Measure	Group 3B (V72_41) n=130 Participants Subjects who received two doses of rMenB+OMV NZ administered at 0,1-month schedule in study V72\_41 (NCT0142384) and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during study V72\_41, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.	Group 3B (V72P10) n=112 Participants Subjects who received two doses of rMenB+OMV NZ administered at 0,1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during study V72P10, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.	Group 3B n=242 Participants Subjects who received two doses of rMenB+OMV NZ administered at 0, 1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and at 0,1 month schedule in study V72\_41(NCT0142384), and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during parent studies, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.	Group B_0_1 (V72_41) n=94 Participants Naive subjects from Australia and Canada, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.	Group B_0_1 (V72P10) n=109 Participants Naive subjects from Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.	Group B_0_1 n=203 Participants Naive subjects from Australia,Canada and Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose
Percentages of Subjects With at Least Four-fold Increase in hSBA Titers Pre-booster/Second Dose Vaccination- Compared to 3, 7 and 30 Days Post- Booster/Second Vaccination H44/76 3 days post vaccination	2 Percentage of subjects Interval 0.48 to 6.6	2 Percentage of subjects Interval 0.22 to 6.3	2 Percentage of subjects Interval 0.7 to 4.8	6 Percentage of subjects Interval 1.3 to 16.5	2 Percentage of subjects Interval 0.05 to 9.7	4 Percentage of subjects Interval 1.0 to 9.5
Percentages of Subjects With at Least Four-fold Increase in hSBA Titers Pre-booster/Second Dose Vaccination- Compared to 3, 7 and 30 Days Post- Booster/Second Vaccination H44/76 - 7 days post-vacc	89 Percentage of subjects Interval 82.6 to 94.0	86 Percentage of subjects Interval 77.8 to 91.6	88 Percentage of subjects Interval 82.8 to 91.5	45 Percentage of subjects Interval 30.4 to 61.2	26 Percentage of subjects Interval 15.0 to 39.7	35 Percentage of subjects Interval 25.4 to 45.0
Percentages of Subjects With at Least Four-fold Increase in hSBA Titers Pre-booster/Second Dose Vaccination- Compared to 3, 7 and 30 Days Post- Booster/Second Vaccination H44/76 - 1 month post-vacc.	95 Percentage of subjects Interval 89.2 to 97.8	98 Percentage of subjects Interval 93.7 to 99.78	96 Percentage of subjects Interval 93.1 to 98.3	51 Percentage of subjects Interval 40.5 to 61.5	28 Percentage of subjects Interval 19.4 to 36.9	38 Percentage of subjects Interval 31.7 to 45.5
Percentages of Subjects With at Least Four-fold Increase in hSBA Titers Pre-booster/Second Dose Vaccination- Compared to 3, 7 and 30 Days Post- Booster/Second Vaccination 5/99- 3 days post-vacc	7 Percentage of subjects Interval 2.9 to 13.9	1 Percentage of subjects Interval 0.03 to 7.2	5 Percentage of subjects Interval 2.0 to 8.8	5 Percentage of subjects Interval 0.6 to 15.5	8 Percentage of subjects Interval 1.6 to 20.9	6 Percentage of subjects Interval 2.0 to 13.5
Percentages of Subjects With at Least Four-fold Increase in hSBA Titers Pre-booster/Second Dose Vaccination- Compared to 3, 7 and 30 Days Post- Booster/Second Vaccination 5/99- 7 days post-vacc	98 Percentage of subjects Interval 93.0 to 99.76	95 Percentage of subjects Interval 86.9 to 98.5	97 Percentage of subjects Interval 92.7 to 98.7	55 Percentage of subjects Interval 38.3 to 71.4	63 Percentage of subjects Interval 47.4 to 76.0	59 Percentage of subjects Interval 48.2 to 69.8
Percentages of Subjects With at Least Four-fold Increase in hSBA Titers Pre-booster/Second Dose Vaccination- Compared to 3, 7 and 30 Days Post- Booster/Second Vaccination 5/99- 1 month post-vacc.	98 Percentage of subjects Interval 93.0 to 99.76	96 Percentage of subjects Interval 88.8 to 99.2	97 Percentage of subjects Interval 93.5 to 99.1	56 Percentage of subjects Interval 44.7 to 67.0	72 Percentage of subjects Interval 61.8 to 81.5	64 Percentage of subjects Interval 56.8 to 71.7
Percentages of Subjects With at Least Four-fold Increase in hSBA Titers Pre-booster/Second Dose Vaccination- Compared to 3, 7 and 30 Days Post- Booster/Second Vaccination NZ98/254- 3 days post-vacc	2 Percentage of subjects Interval 0.48 to 6.6	2 Percentage of subjects Interval 0.24 to 7.0	2 Percentage of subjects Interval 0.7 to 5.0	2 Percentage of subjects Interval 0.05 to 10.6	2 Percentage of subjects Interval 0.05 to 9.9	2 Percentage of subjects Interval 0.23 to 6.8
Percentages of Subjects With at Least Four-fold Increase in hSBA Titers Pre-booster/Second Dose Vaccination- Compared to 3, 7 and 30 Days Post- Booster/Second Vaccination NZ98/254- 7 days post-vacc	55 Percentage of subjects Interval 45.7 to 63.4	55 Percentage of subjects Interval 45.2 to 65.3	55 Percentage of subjects Interval 48.3 to 61.5	26 Percentage of subjects Interval 13.5 to 41.2	13 Percentage of subjects Interval 5.4 to 24.9	19 Percentage of subjects Interval 11.4 to 27.7
Percentages of Subjects With at Least Four-fold Increase in hSBA Titers Pre-booster/Second Dose Vaccination- Compared to 3, 7 and 30 Days Post- Booster/Second Vaccination NZ98/254- 1 month post-vacc.	82 Percentage of subjects Interval 73.8 to 87.8	80 Percentage of subjects Interval 71.1 to 87.5	81 Percentage of subjects Interval 75.3 to 85.8	35 Percentage of subjects Interval 25.8 to 46.1	20 Percentage of subjects Interval 13.2 to 29.2	27 Percentage of subjects Interval 21.3 to 34.1
Percentages of Subjects With at Least Four-fold Increase in hSBA Titers Pre-booster/Second Dose Vaccination- Compared to 3, 7 and 30 Days Post- Booster/Second Vaccination M10713- 3 days post-vacc	2 Percentage of subjects Interval 0.49 to 6.7	3 Percentage of subjects Interval 0.6 to 7.6	3 Percentage of subjects Interval 0.9 to 5.4	0 Percentage of subjects Interval 0.0 to 7.1	0 Percentage of subjects Interval 0.0 to 6.5	0 Percentage of subjects Interval 0.0 to 3.5
Percentages of Subjects With at Least Four-fold Increase in hSBA Titers Pre-booster/Second Dose Vaccination- Compared to 3, 7 and 30 Days Post- Booster/Second Vaccination M10713- 7 days post-vacc	39 Percentage of subjects Interval 30.6 to 48.1	28 Percentage of subjects Interval 19.6 to 36.9	34 Percentage of subjects Interval 27.8 to 40.1	14 Percentage of subjects Interval 5.3 to 27.9	0 Percentage of subjects Interval 0.0 to 6.6	6 Percentage of subjects Interval 2.3 to 13.0
Percentages of Subjects With at Least Four-fold Increase in hSBA Titers Pre-booster/Second Dose Vaccination- Compared to 3, 7 and 30 Days Post- Booster/Second Vaccination M10713- 1 month post-vacc.	48 Percentage of subjects Interval 39.5 to 57.4	49 Percentage of subjects Interval 39.5 to 58.7	49 Percentage of subjects Interval 42.3 to 55.3	12 Percentage of subjects Interval 6.1 to 20.2	7 Percentage of subjects Interval 3.2 to 14.0	9 Percentage of subjects Interval 5.8 to 14.3

SECONDARY outcome

Timeframe: At Day 61 (30 days post second dose of vaccination.)

Population: Analysis was performed on the PPS( per protocol set) catch up. The PPS catch up included all subjects who were randomized to group B\_0\_1 who correctly received two vaccinations at day 1 and day 31 \& provided evaluable immunogenicity result at day 61 for atleast one indicator strain. The analysis was performed only on strains 5/99 and NZ98/254

Bactericidal activity was measured against the N. meningitidis group B indicator strains 5/99 and NZ98/254. Only subjects receiving a second vaccination (group B_0_1) were assessed for this outcome measure.

Outcome measures

Measure	Group 3B (V72_41) n=98 Participants Subjects who received two doses of rMenB+OMV NZ administered at 0,1-month schedule in study V72\_41 (NCT0142384) and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during study V72\_41, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.	Group 3B (V72P10) n=117 Participants Subjects who received two doses of rMenB+OMV NZ administered at 0,1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during study V72P10, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.	Group 3B n=215 Participants Subjects who received two doses of rMenB+OMV NZ administered at 0, 1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and at 0,1 month schedule in study V72\_41(NCT0142384), and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during parent studies, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.	Group B_0_1 (V72_41) Naive subjects from Australia and Canada, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.	Group B_0_1 (V72P10) Naive subjects from Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.	Group B_0_1 Naive subjects from Australia,Canada and Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose
Percentage of Subjects With hSBA ≥1:4 After Second Vaccination of rMenB+OMV NZ 5/99	100 Percentage of subjects Interval 96.0 to 100.0	97 Percentage of subjects Interval 91.8 to 99.4	98 Percentage of subjects Interval 95.6 to 99.68	—	—	—
Percentage of Subjects With hSBA ≥1:4 After Second Vaccination of rMenB+OMV NZ NZ98/254	82 Percentage of subjects Interval 72.5 to 88.7	79 Percentage of subjects Interval 71.0 to 86.4	80 Percentage of subjects Interval 74.5 to 85.5	—	—	—

SECONDARY outcome

Timeframe: At Day 61 (30 days post second dose of vaccination.)

Population: Analysis was performed on the PPS( per protocol set) catch up. The PPS catch up included all subjects who were randomized to group B\_0\_1 who correctly received two vaccinations at day 1 and day 31 \& provided evaluable immunogenicity result at day 61 for atleast one indicator strain. The analysis was performed only on strains H44/76 and M10713

Bactericidal activity was measured against each of the four N. meningitidis group B indicator strains H44/76 and M10713. Only subjects receiving a second vaccination (group B_0_1) were assessed for this outcome measure.

Outcome measures

Measure	Group 3B (V72_41) n=98 Participants Subjects who received two doses of rMenB+OMV NZ administered at 0,1-month schedule in study V72\_41 (NCT0142384) and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during study V72\_41, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.	Group 3B (V72P10) n=117 Participants Subjects who received two doses of rMenB+OMV NZ administered at 0,1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during study V72P10, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.	Group 3B n=215 Participants Subjects who received two doses of rMenB+OMV NZ administered at 0, 1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and at 0,1 month schedule in study V72\_41(NCT0142384), and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during parent studies, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.	Group B_0_1 (V72_41) Naive subjects from Australia and Canada, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.	Group B_0_1 (V72P10) Naive subjects from Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.	Group B_0_1 Naive subjects from Australia,Canada and Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose
Percentage of Subjects With hSBA ≥1:5 After Second Vaccination of rMenB+OMV NZ H44/76	99 Percentage of subjects Interval 94.4 to 99.97	99 Percentage of subjects Interval 95.3 to 99.98	99 Percentage of subjects Interval 96.7 to 99.89	—	—	—
Percentage of Subjects With hSBA ≥1:5 After Second Vaccination of rMenB+OMV NZ M10713	90 Percentage of subjects Interval 82.0 to 95.0	96 Percentage of subjects Interval 90.2 to 98.6	93 Percentage of subjects Interval 88.7 to 96.0	—	—	—

SECONDARY outcome

Timeframe: At Day 61 (30 days post second vaccination)

Population: Analysis was performed on the PPS( per protocol set) catch up. The PPS catch up included all subjects who were randomized to group B\_0\_1 who correctly received two vaccinations at day 1 and day 31 \& provided evaluable immunogenicity result at day 61 for atleast one indicator strain.

Bactericidal activity was measured against each of the four N. meningitidis group B indicator strains H44/76,5/99,NZ98/254 and M10713.

Only subjects receiving a second vaccination (group B_0_1) were assessed for this outcome measure.

Outcome measures

Measure	Group 3B (V72_41) n=98 Participants Subjects who received two doses of rMenB+OMV NZ administered at 0,1-month schedule in study V72\_41 (NCT0142384) and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during study V72\_41, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.	Group 3B (V72P10) n=117 Participants Subjects who received two doses of rMenB+OMV NZ administered at 0,1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during study V72P10, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.	Group 3B n=215 Participants Subjects who received two doses of rMenB+OMV NZ administered at 0, 1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and at 0,1 month schedule in study V72\_41(NCT0142384), and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during parent studies, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.	Group B_0_1 (V72_41) Naive subjects from Australia and Canada, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.	Group B_0_1 (V72P10) Naive subjects from Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.	Group B_0_1 Naive subjects from Australia,Canada and Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose
Percentage of Subjects With hSBA ≥1:8 After Second Vaccination of rMenB+OMV NZ. H44/76	99 Percentage of subjects Interval 94.4 to 99.97	97 Percentage of subjects Interval 92.7 to 99.5	98 Percentage of subjects Interval 95.3 to 99.5	—	—	—
Percentage of Subjects With hSBA ≥1:8 After Second Vaccination of rMenB+OMV NZ. 5/99	100 Percentage of subjects Interval 96.0 to 100.0	97 Percentage of subjects Interval 91.8 to 99.4	98 Percentage of subjects Interval 95.6 to 99.68	—	—	—
Percentage of Subjects With hSBA ≥1:8 After Second Vaccination of rMenB+OMV NZ. NZ98/254	64 Percentage of subjects Interval 54.0 to 73.7	69 Percentage of subjects Interval 60.0 to 77.4	67 Percentage of subjects Interval 60.3 to 73.2	—	—	—
Percentage of Subjects With hSBA ≥1:8 After Second Vaccination of rMenB+OMV NZ. M10713	86 Percentage of subjects Interval 77.2 to 92.0	94 Percentage of subjects Interval 88.0 to 97.5	90 Percentage of subjects Interval 85.4 to 93.8	—	—	—

SECONDARY outcome

Timeframe: At Day 61 (30 days post second vaccination)

Population: Analysis was performed on the PPS( per protocol set) catch up. The PPS catch up included all subjects who were randomized to group B\_0\_1 who correctly received two vaccinations at day 1 and day 31 \& provided evaluable immunogenicity result at day 61 for atleast one indicator strain.

Bactericidal activity was measured against each of the four N. meningitidis group B indicator strains H44/76,5/99,NZ98/254 and M10713.

Only subjects receiving a second vaccination (group B_0_1) were assessed for this outcome measure.

Outcome measures

Measure	Group 3B (V72_41) n=98 Participants Subjects who received two doses of rMenB+OMV NZ administered at 0,1-month schedule in study V72\_41 (NCT0142384) and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during study V72\_41, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.	Group 3B (V72P10) n=117 Participants Subjects who received two doses of rMenB+OMV NZ administered at 0,1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during study V72P10, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.	Group 3B n=215 Participants Subjects who received two doses of rMenB+OMV NZ administered at 0, 1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and at 0,1 month schedule in study V72\_41(NCT0142384), and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during parent studies, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.	Group B_0_1 (V72_41) Naive subjects from Australia and Canada, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.	Group B_0_1 (V72P10) Naive subjects from Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.	Group B_0_1 Naive subjects from Australia,Canada and Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose
Percentage of Subjects With hSBA ≥1:16 After Second Vaccination of rMenB+OMV NZ. H44/76	91 Percentage of subjects Interval 83.3 to 95.7	91 Percentage of subjects Interval 83.8 to 95.2	91 Percentage of subjects Interval 86.0 to 94.2	—	—	—
Percentage of Subjects With hSBA ≥1:16 After Second Vaccination of rMenB+OMV NZ. 5/99	100 Percentage of subjects Interval 96.0 to 100.0	96 Percentage of subjects Interval 90.4 to 98.9	98 Percentage of subjects Interval 94.8 to 99.4	—	—	—
Percentage of Subjects With hSBA ≥1:16 After Second Vaccination of rMenB+OMV NZ. NZ98/254	40 Percentage of subjects Interval 30.0 to 50.2	56 Percentage of subjects Interval 46.1 to 64.7	48 Percentage of subjects Interval 41.5 to 55.3	—	—	—
Percentage of Subjects With hSBA ≥1:16 After Second Vaccination of rMenB+OMV NZ. M10713	74 Percentage of subjects Interval 64.7 to 82.8	92 Percentage of subjects Interval 85.8 to 96.4	84 Percentage of subjects Interval 78.5 to 88.7	—	—	—

SECONDARY outcome

Timeframe: At Day 1 & Day 61 (30 days post second dose of vaccination)

Population: Analysis was performed on the PPS( per protocol set) catch up. The PPS catch up included all subjects who were randomized to group B\_0\_1 who correctly received two vaccinations at day 1 and day 31 \& provided evaluable immunogenicity result at day 61 for atleast one indicator strain.

Bactericidal activity was measured against each of the four N. meningitidis group B indicator strains H44/76,5/99,NZ98/254 and M10713.

Only subjects receiving a second vaccination (group B_0_1) were assessed for this outcome measure.

Outcome measures

Measure	Group 3B (V72_41) n=98 Participants Subjects who received two doses of rMenB+OMV NZ administered at 0,1-month schedule in study V72\_41 (NCT0142384) and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during study V72\_41, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.	Group 3B (V72P10) n=117 Participants Subjects who received two doses of rMenB+OMV NZ administered at 0,1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during study V72P10, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.	Group 3B n=215 Participants Subjects who received two doses of rMenB+OMV NZ administered at 0, 1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and at 0,1 month schedule in study V72\_41(NCT0142384), and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during parent studies, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.	Group B_0_1 (V72_41) Naive subjects from Australia and Canada, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.	Group B_0_1 (V72P10) Naive subjects from Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.	Group B_0_1 Naive subjects from Australia,Canada and Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose
hSBA Geometric Mean Titers (GMTs) After Second Vaccination of rMenB+OMV NZ. H44/76 Day 1	1.08 Titers Interval 1.0 to 1.17	1.56 Titers Interval 1.29 to 1.89	1.32 Titers Interval 1.18 to 1.47	—	—	—
hSBA Geometric Mean Titers (GMTs) After Second Vaccination of rMenB+OMV NZ. H44/76 1 month post 2nd vaccination	57 Titers Interval 47.0 to 68.0	64 Titers Interval 53.0 to 78.0	61 Titers Interval 53.0 to 70.0	—	—	—
hSBA Geometric Mean Titers (GMTs) After Second Vaccination of rMenB+OMV NZ. 5/99 Day 1	1.18 Titers Interval 1.03 to 1.35	2.18 Titers Interval 1.58 to 3.0	1.63 Titers Interval 1.35 to 1.96	—	—	—
hSBA Geometric Mean Titers (GMTs) After Second Vaccination of rMenB+OMV NZ. 5/99 1 month post 2nd vaccination	239 Titers Interval 200.0 to 285.0	274 Titers Interval 207.0 to 363.0	257 Titers Interval 217.0 to 305.0	—	—	—
hSBA Geometric Mean Titers (GMTs) After Second Vaccination of rMenB+OMV NZ. NZ98/254 Day 1	1.00 Titers Interval 1.0 to 1.0	1.58 Titers Interval 1.3 to 1.91	1.28 Titers Interval 1.15 to 1.42	—	—	—
hSBA Geometric Mean Titers (GMTs) After Second Vaccination of rMenB+OMV NZ. NZ98/254 1 month post 2nd vaccination	11 Titers Interval 8.41 to 14.0	18 Titers Interval 13.0 to 24.0	14 Titers Interval 11.0 to 17.0	—	—	—
hSBA Geometric Mean Titers (GMTs) After Second Vaccination of rMenB+OMV NZ. M10713 Day 1	10 Titers Interval 7.13 to 15.0	19 Titers Interval 14.0 to 26.0	14 Titers Interval 11.0 to 18.0	—	—	—
hSBA Geometric Mean Titers (GMTs) After Second Vaccination of rMenB+OMV NZ. M10713 1 month post 2nd vaccination	33 Titers Interval 25.0 to 44.0	60 Titers Interval 48.0 to 75.0	46 Titers Interval 38.0 to 55.0	—	—	—

SECONDARY outcome

Timeframe: At Day 1 & Day 61 (30 days post 2nd vaccination)

Population: Analysis was performed on the PPS( per protocol set) catch up. The PPS catch up included all subjects who were randomized to group B\_0\_1 who correctly received two vaccinations at day 1 and day 31 \& provided evaluable immunogenicity result at day 61 for atleast one indicator strain.

Bactericidal activity was measured against each of the four N. meningitidis group B indicator strains H44/76,5/99,NZ98/254 and M10713.

Only subjects receiving a second vaccination (group B_0_1) were assessed for this outcome measure.

Outcome measures

Measure	Group 3B (V72_41) n=98 Participants Subjects who received two doses of rMenB+OMV NZ administered at 0,1-month schedule in study V72\_41 (NCT0142384) and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during study V72\_41, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.	Group 3B (V72P10) n=117 Participants Subjects who received two doses of rMenB+OMV NZ administered at 0,1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during study V72P10, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.	Group 3B n=215 Participants Subjects who received two doses of rMenB+OMV NZ administered at 0, 1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and at 0,1 month schedule in study V72\_41(NCT0142384), and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during parent studies, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.	Group B_0_1 (V72_41) Naive subjects from Australia and Canada, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.	Group B_0_1 (V72P10) Naive subjects from Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.	Group B_0_1 Naive subjects from Australia,Canada and Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose
Geometric Mean Ratio (GMRs) of GMTs One Month Post Second Vaccination Versus Pre Vaccination at Day 1 H44/76	52 Ratio Interval 42.0 to 65.0	41 Ratio Interval 33.0 to 51.0	46 Ratio Interval 39.0 to 54.0	—	—	—
Geometric Mean Ratio (GMRs) of GMTs One Month Post Second Vaccination Versus Pre Vaccination at Day 1 5/99	204 Ratio Interval 162.0 to 257.0	123 Ratio Interval 74.0 to 204.0	156 Ratio Interval 117.0 to 209.0	—	—	—
Geometric Mean Ratio (GMRs) of GMTs One Month Post Second Vaccination Versus Pre Vaccination at Day 1 NZ98/254	11 Ratio Interval 8.41 to 14.0	11 Ratio Interval 7.94 to 16.0	11 Ratio Interval 8.88 to 14.0	—	—	—
Geometric Mean Ratio (GMRs) of GMTs One Month Post Second Vaccination Versus Pre Vaccination at Day 1 M10713	3.24 Ratio Interval 2.57 to 4.08	3.22 Ratio Interval 2.6 to 3.98	3.23 Ratio Interval 2.76 to 3.77	—	—	—

SECONDARY outcome

Timeframe: At Day 61 (30 days post second dose of vaccination)

Population: Analysis was performed on the PPS( per protocol set) catch up. The PPS catch up included all subjects who were randomized to group B\_0\_1 who correctly received two vaccinations at day 1 and day 31 \& provided evaluable immunogenicity result at day 61 for atleast one indicator strain.

The percentage of subjects with 4-fold rise at one month post-vaccination with a second dose (naïve subjects) of rMenB+OMV NZ with respect to day 1, to each and any one, two, three or all 4 indicator strains.

Percentage of subjects with four-fold rise in hSBA titers relative to baseline were defined as:

• for a pre-vaccination titer < 4, a post-vaccination titer of at least 16;
• for a pre-vaccination titer ≥ 4 but <LLOQ, a post vaccination titer of at least fourfold the LLOQ;
• for a pre-vaccination titer ≥LLOQ, a post vaccination titer of at least fourfold the pre-vaccination titer.

Only subjects receiving the second dose of vaccination(group B_0_1) were considered for this outcome measure.

Outcome measures

Measure	Group 3B (V72_41) n=98 Participants Subjects who received two doses of rMenB+OMV NZ administered at 0,1-month schedule in study V72\_41 (NCT0142384) and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during study V72\_41, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.	Group 3B (V72P10) n=117 Participants Subjects who received two doses of rMenB+OMV NZ administered at 0,1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during study V72P10, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.	Group 3B n=215 Participants Subjects who received two doses of rMenB+OMV NZ administered at 0, 1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and at 0,1 month schedule in study V72\_41(NCT0142384), and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during parent studies, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.	Group B_0_1 (V72_41) Naive subjects from Australia and Canada, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.	Group B_0_1 (V72P10) Naive subjects from Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.	Group B_0_1 Naive subjects from Australia,Canada and Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose
Percentages of Subjects With at Least Four-fold Increase in hSBA Titers at Pre-First Vaccination Compared to One Month Post-Second Vaccination H44/76	97 Percentage of Subjects Interval 91.3 to 99.4	94 Percentage of Subjects Interval 88.1 to 97.6	95 Percentage of Subjects Interval 91.6 to 97.7	—	—	—
Percentages of Subjects With at Least Four-fold Increase in hSBA Titers at Pre-First Vaccination Compared to One Month Post-Second Vaccination 5/99	100 Percentage of Subjects Interval 95.8 to 100.0	94 Percentage of Subjects Interval 86.8 to 97.6	97 Percentage of Subjects Interval 92.9 to 98.8	—	—	—
Percentages of Subjects With at Least Four-fold Increase in hSBA Titers at Pre-First Vaccination Compared to One Month Post-Second Vaccination NZ98/254	64 Percentage of Subjects Interval 54.0 to 73.7	69 Percentage of Subjects Interval 59.4 to 77.0	67 Percentage of Subjects Interval 59.9 to 73.0	—	—	—
Percentages of Subjects With at Least Four-fold Increase in hSBA Titers at Pre-First Vaccination Compared to One Month Post-Second Vaccination M10713	37 Percentage of Subjects Interval 27.2 to 47.1	33 Percentage of Subjects Interval 24.3 to 42.1	35 Percentage of Subjects Interval 28.2 to 41.4	—	—	—

Adverse Events

Group 3B

Serious events: 0 serious events

Other events: 266 other events

Deaths: 0 deaths

Group B_0_1

Serious events: 1 serious events

Other events: 253 other events

Deaths: 0 deaths

Serious adverse events

Measure	Group 3B n=275 participants at risk Subjects who received two doses of rMenB+OMV NZ administered at 0, 1 month schedule in studies V72\_41 or V72P10, and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during parent studies, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.	Group B_0_1 n=255 participants at risk Naive subjects from V72\_41 or V72P10 studies, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.
Infections and infestations Appendicitis	0.00% 0/275 • Solicited AEs were collected until 7 days after vaccinations. Unsolicited AEs were collected 30 days after each vaccination at day 31 (all subjects) and at day 61 (group B_0_1 subjects only). Serious Adverse Events (SAEs) were collected until study termination (1 month for group 3B subjects/ 2 months for group B\_0\_1 subjects)	0.39% 1/255 • Solicited AEs were collected until 7 days after vaccinations. Unsolicited AEs were collected 30 days after each vaccination at day 31 (all subjects) and at day 61 (group B_0_1 subjects only). Serious Adverse Events (SAEs) were collected until study termination (1 month for group 3B subjects/ 2 months for group B\_0\_1 subjects)

Other adverse events

Measure	Group 3B n=275 participants at risk Subjects who received two doses of rMenB+OMV NZ administered at 0, 1 month schedule in studies V72\_41 or V72P10, and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during parent studies, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.	Group B_0_1 n=255 participants at risk Naive subjects from V72\_41 or V72P10 studies, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.
Gastrointestinal disorders Nausea	20.4% 56/275 • Solicited AEs were collected until 7 days after vaccinations. Unsolicited AEs were collected 30 days after each vaccination at day 31 (all subjects) and at day 61 (group B_0_1 subjects only). Serious Adverse Events (SAEs) were collected until study termination (1 month for group 3B subjects/ 2 months for group B\_0\_1 subjects)	20.8% 53/255 • Solicited AEs were collected until 7 days after vaccinations. Unsolicited AEs were collected 30 days after each vaccination at day 31 (all subjects) and at day 61 (group B_0_1 subjects only). Serious Adverse Events (SAEs) were collected until study termination (1 month for group 3B subjects/ 2 months for group B\_0\_1 subjects)
General disorders Injectioon site pain	94.2% 259/275 • Solicited AEs were collected until 7 days after vaccinations. Unsolicited AEs were collected 30 days after each vaccination at day 31 (all subjects) and at day 61 (group B_0_1 subjects only). Serious Adverse Events (SAEs) were collected until study termination (1 month for group 3B subjects/ 2 months for group B\_0\_1 subjects)	98.4% 251/255 • Solicited AEs were collected until 7 days after vaccinations. Unsolicited AEs were collected 30 days after each vaccination at day 31 (all subjects) and at day 61 (group B_0_1 subjects only). Serious Adverse Events (SAEs) were collected until study termination (1 month for group 3B subjects/ 2 months for group B\_0\_1 subjects)
General disorders Injection site erythema	58.9% 162/275 • Solicited AEs were collected until 7 days after vaccinations. Unsolicited AEs were collected 30 days after each vaccination at day 31 (all subjects) and at day 61 (group B_0_1 subjects only). Serious Adverse Events (SAEs) were collected until study termination (1 month for group 3B subjects/ 2 months for group B\_0\_1 subjects)	52.9% 135/255 • Solicited AEs were collected until 7 days after vaccinations. Unsolicited AEs were collected 30 days after each vaccination at day 31 (all subjects) and at day 61 (group B_0_1 subjects only). Serious Adverse Events (SAEs) were collected until study termination (1 month for group 3B subjects/ 2 months for group B\_0\_1 subjects)
General disorders Fatigue	56.7% 156/275 • Solicited AEs were collected until 7 days after vaccinations. Unsolicited AEs were collected 30 days after each vaccination at day 31 (all subjects) and at day 61 (group B_0_1 subjects only). Serious Adverse Events (SAEs) were collected until study termination (1 month for group 3B subjects/ 2 months for group B\_0\_1 subjects)	55.3% 141/255 • Solicited AEs were collected until 7 days after vaccinations. Unsolicited AEs were collected 30 days after each vaccination at day 31 (all subjects) and at day 61 (group B_0_1 subjects only). Serious Adverse Events (SAEs) were collected until study termination (1 month for group 3B subjects/ 2 months for group B\_0\_1 subjects)
General disorders Injection site induration	49.1% 135/275 • Solicited AEs were collected until 7 days after vaccinations. Unsolicited AEs were collected 30 days after each vaccination at day 31 (all subjects) and at day 61 (group B_0_1 subjects only). Serious Adverse Events (SAEs) were collected until study termination (1 month for group 3B subjects/ 2 months for group B\_0\_1 subjects)	53.3% 136/255 • Solicited AEs were collected until 7 days after vaccinations. Unsolicited AEs were collected 30 days after each vaccination at day 31 (all subjects) and at day 61 (group B_0_1 subjects only). Serious Adverse Events (SAEs) were collected until study termination (1 month for group 3B subjects/ 2 months for group B\_0\_1 subjects)
General disorders Injection site swelling	44.7% 123/275 • Solicited AEs were collected until 7 days after vaccinations. Unsolicited AEs were collected 30 days after each vaccination at day 31 (all subjects) and at day 61 (group B_0_1 subjects only). Serious Adverse Events (SAEs) were collected until study termination (1 month for group 3B subjects/ 2 months for group B\_0\_1 subjects)	43.5% 111/255 • Solicited AEs were collected until 7 days after vaccinations. Unsolicited AEs were collected 30 days after each vaccination at day 31 (all subjects) and at day 61 (group B_0_1 subjects only). Serious Adverse Events (SAEs) were collected until study termination (1 month for group 3B subjects/ 2 months for group B\_0\_1 subjects)
General disorders Pyrexia	6.2% 17/275 • Solicited AEs were collected until 7 days after vaccinations. Unsolicited AEs were collected 30 days after each vaccination at day 31 (all subjects) and at day 61 (group B_0_1 subjects only). Serious Adverse Events (SAEs) were collected until study termination (1 month for group 3B subjects/ 2 months for group B\_0\_1 subjects)	3.5% 9/255 • Solicited AEs were collected until 7 days after vaccinations. Unsolicited AEs were collected 30 days after each vaccination at day 31 (all subjects) and at day 61 (group B_0_1 subjects only). Serious Adverse Events (SAEs) were collected until study termination (1 month for group 3B subjects/ 2 months for group B\_0\_1 subjects)
Infections and infestations Viral upper respiratory tract infection	4.7% 13/275 • Solicited AEs were collected until 7 days after vaccinations. Unsolicited AEs were collected 30 days after each vaccination at day 31 (all subjects) and at day 61 (group B_0_1 subjects only). Serious Adverse Events (SAEs) were collected until study termination (1 month for group 3B subjects/ 2 months for group B\_0\_1 subjects)	9.0% 23/255 • Solicited AEs were collected until 7 days after vaccinations. Unsolicited AEs were collected 30 days after each vaccination at day 31 (all subjects) and at day 61 (group B_0_1 subjects only). Serious Adverse Events (SAEs) were collected until study termination (1 month for group 3B subjects/ 2 months for group B\_0\_1 subjects)
Musculoskeletal and connective tissue disorders Myalgia	44.0% 121/275 • Solicited AEs were collected until 7 days after vaccinations. Unsolicited AEs were collected 30 days after each vaccination at day 31 (all subjects) and at day 61 (group B_0_1 subjects only). Serious Adverse Events (SAEs) were collected until study termination (1 month for group 3B subjects/ 2 months for group B\_0\_1 subjects)	39.2% 100/255 • Solicited AEs were collected until 7 days after vaccinations. Unsolicited AEs were collected 30 days after each vaccination at day 31 (all subjects) and at day 61 (group B_0_1 subjects only). Serious Adverse Events (SAEs) were collected until study termination (1 month for group 3B subjects/ 2 months for group B\_0\_1 subjects)
Musculoskeletal and connective tissue disorders Arthralgia	30.9% 85/275 • Solicited AEs were collected until 7 days after vaccinations. Unsolicited AEs were collected 30 days after each vaccination at day 31 (all subjects) and at day 61 (group B_0_1 subjects only). Serious Adverse Events (SAEs) were collected until study termination (1 month for group 3B subjects/ 2 months for group B\_0\_1 subjects)	24.7% 63/255 • Solicited AEs were collected until 7 days after vaccinations. Unsolicited AEs were collected 30 days after each vaccination at day 31 (all subjects) and at day 61 (group B_0_1 subjects only). Serious Adverse Events (SAEs) were collected until study termination (1 month for group 3B subjects/ 2 months for group B\_0\_1 subjects)
Nervous system disorders Headache	54.5% 150/275 • Solicited AEs were collected until 7 days after vaccinations. Unsolicited AEs were collected 30 days after each vaccination at day 31 (all subjects) and at day 61 (group B_0_1 subjects only). Serious Adverse Events (SAEs) were collected until study termination (1 month for group 3B subjects/ 2 months for group B\_0\_1 subjects)	49.4% 126/255 • Solicited AEs were collected until 7 days after vaccinations. Unsolicited AEs were collected 30 days after each vaccination at day 31 (all subjects) and at day 61 (group B_0_1 subjects only). Serious Adverse Events (SAEs) were collected until study termination (1 month for group 3B subjects/ 2 months for group B\_0\_1 subjects)

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