Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine Administered to Healthy Adolescents According to Different Vaccination Schedules

A Phase 2b/3, Multi-Center, Observer-Blind, Controlled Study of the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine Administered to Healthy Adolescents Aged 11-17 Years According to Different Vaccination Schedules

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00661713

Enrollment

1631

Registered

2008-04-18

Start date

2008-06-30

Completion date

2010-12-31

Last updated

2019-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Meningococcal Disease

Keywords

Meningococcal disease, Neisseria meningitidis serogroup B, prevention, vaccination, adolescents

Brief summary

The proposed study is aimed to assess the antibody response and short-term persistence of Novartis Meningococcal B Vaccine after one, two or three doses and to evaluate the optimal vaccination schedule in an adolescent population.

Interventions

BIOLOGICALrMenB+OMV NZ

BIOLOGICALPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

11 Years to 17 Years

Healthy volunteers

Yes

Inclusion criteria

1)11-17 years of age inclusive who have given their written assent and whose parents or legal guardians have given written informed consent at the time of enrollment; 2)who are available for all the visits scheduled in the study (i.e., not planning to leave the area before the end of the study period); 3)in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator.

Exclusion criteria

1. History of any meningococcal B vaccine administration; 2. Current or previous, confirmed or suspected disease caused by N. meningitidis; 3. Household contact with and/or intimate exposure to an individual with any laboratory confirmed N. meningitidis infection within 60 days of enrollment; 4. Significant acute or chronic infection within the previous 7 days or fever (defined as axillary temperature ≥38°C) within the previous day; 5. Antibiotics within 6 days prior to enrollment; 6. Pregnancy or nursing (breastfeeding) mothers; 7. Females of childbearing age who have not used or do not plan to use acceptable birth control measures, for the 7 months duration of the study. Oral, injected or implanted hormonal contraceptive, diaphragm, condom, intrauterine device or sexual abstinence are considered acceptable forms of birth control. If sexually active the subject must have been using one of the accepted birth control methods at least two months prior to study entry; 8. Any serious chronic or progressive disease (e.g., neoplasm, diabetes, cardiac disease, hepatic disease, progressive neurological disease or seizure disorder; autoimmune disease, HIV infection or AIDS, or blood dyscrasias or diathesis, signs of cardiac or renal failure or severe malnutrition). 9. Known or suspected impairment/alteration of the immune system, immunosuppressive therapy, including use of corticosteroids in immunosuppressive doses or chronic use of inhaled high-potency corticosteroids within the previous 60 days. \[Use of topical corticosteroids administered during the study in limited areas (i.e., eczema on knees or face or elbows) of the body is allowed\]; immunostimulants; 10. Receipt of blood, blood products and/or plasma derivatives, or a parenteral immunoglobulin preparation within the previous 90 days; 11. History of severe allergic reactions after previous vaccinations or hypersensitivity to any vaccine component; 12. Receipt of or intent to immunize with any other vaccine(s) within 30 days prior (60 days for live viral vaccines) and throughout the study period (exception: licensed fluvaccine should not be administered within 14 days prior to enrollment; routine vaccine administration may be administered after the blood draw at Study Month 7); 13. Participation in another clinical trial within the last 90 days or planned for during study; 14. Family members and household members of research staff; 15. Any condition which in the opinion of the investigator and/or the Regional MD may interfere with the evaluation of the study objectives.

Design outcomes

Primary

Measure	Time frame	Description
Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.	Month-1, 2, 3	Immunogenicity was evaluated by measuring the percentage of subjects with hSBA titter \>1:4 against 44/76-SL, 5/99, NZ98/254 strains at months 1, 2, 3.
Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination	1 to 7 days after each vaccination	Safety was assessed as the number of subjects who reported local and systemic reactions during day 1 to day 7 after any vaccination with rMenB+OMV

Secondary

Measure	Time frame	Description
Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.	Month-1, month-2, month-3 and month-7	Immunogenicity was evaluated by measuring the percentage of subjects with at least a fourfold rise in hSBA titer over the prevaccination and after booster vaccination against 44/76-SL, 5/99, NZ98/254 strains at month-1, month-2, month-3 and month-7.
Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	month-1, month-2, month-3, month-6 and month-7	Immunogenicity was evaluated by measuring the Geometric mean titers (GMTs) after primary and booster vaccination against 44/76-SL, 5/99, NZ98/254.
Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	month-1, month-2, month-3, month-6 and month-7	Immunogenicity was evaluated by measuring the Geometric mean ratios (GMRs) after primary and booster vaccination against 44/76-SL, 5/99, NZ98/254.
Percentages of Subjects With hSBA Titer ≥1:4 After Receiving a Booster Dose of rMenB+OMV NZ Vaccine at Month 6.	Month-6 & 7	Immunogenicity was evaluated by measuring the percentage of subjects with hSBA titter \>1:4 agains 44/76-SL, 5/99, NZ98/254 strains at months 6 & 7.
GMRs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination	month-1, month-2, month-3, month-6 and month-7	Immunogenicity was evaluated by measuring the Geometric mean Ratios (GMRs) after primary and booster vaccination against 287-953Antigen
Number of Subjects Reporting Unsolicited AEs Throughout the Study.	Throughout the study	Safety was assessed as the number of subjects who reported unsolicited AEs throughout the study.
GMCs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination.	month-1, month-2, month-3, month-6 and month-7	Immunogenicity was evaluated by measuring the Geometric mean Concentration (GMCs) after primary and booster vaccination against Antigen 287-953 Antigen.
Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	at baseline, month-1, month-2, month-3, month-6 and month-7.	Immunogenicity was evaluated by measuring the percentage of subjects with hSBA titer ≥1:8 against 44/76-SL, 5/99, NZ98/254 strains.

Countries

Chile

Participant flow

Recruitment details

Subjects were enrolled at 10 study centers in Chile.

Pre-assignment details

All enrolled subjects were included in the trial.

Participants by arm

Arm	Count
rMenB06 Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months.	128
rMenB0 Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months.	247
rMenB016 Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months.	128
rMenB01 Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months.	247
rMenB026 Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month.	127
rMenB02 Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months.	253
rMenB012 Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months.	373
rMenB6 Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months.	128
Total	1,631

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003	FG004	FG005	FG006	FG007
Overall Study	Administrative Reason	0	1	0	2	2	2	1	0
Overall Study	Adverse Event	0	0	0	0	0	0	1	0
Overall Study	Death	1	0	0	0	1	0	0	0
Overall Study	Inappropriate Enrollment	0	0	0	0	0	0	1	0
Overall Study	Lost to Follow-up	2	7	2	2	5	7	14	1
Overall Study	Protocol Violation	1	6	3	3	0	2	2	1
Overall Study	Unable to Classify	1	0	0	0	0	0	0	0
Overall Study	Withdrawal by Subject	11	25	12	21	12	26	45	9

Baseline characteristics

Characteristic	rMenB06	rMenB0	rMenB016	rMenB01	rMenB026	rMenB02	rMenB012	rMenB6	Total
Age, Continuous	13.8 years STANDARD_DEVIATION 1.9	13.8 years STANDARD_DEVIATION 1.9	13.9 years STANDARD_DEVIATION 1.9	13.9 years STANDARD_DEVIATION 1.9	13.7 years STANDARD_DEVIATION 1.9	13.7 years STANDARD_DEVIATION 1.8	13.8 years STANDARD_DEVIATION 1.9	13.8 years STANDARD_DEVIATION 2	13.8 years STANDARD_DEVIATION 1.9
Sex: Female, Male Female	76 Participants	147 Participants	76 Participants	138 Participants	73 Participants	138 Participants	199 Participants	66 Participants	913 Participants
Sex: Female, Male Male	52 Participants	100 Participants	52 Participants	109 Participants	54 Participants	115 Participants	174 Participants	62 Participants	718 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk	EG005 affected / at risk	EG006 affected / at risk	EG007 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —	— / —	— / —	— / —	— / —	— / —
other Total, other adverse events	123 / 128	238 / 247	126 / 128	242 / 247	118 / 127	240 / 253	354 / 373	125 / 128
serious Total, serious adverse events	5 / 128	4 / 247	2 / 128	4 / 247	2 / 127	4 / 253	11 / 373	3 / 128

Outcome results

Primary

Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination

Safety was assessed as the number of subjects who reported local and systemic reactions during day 1 to day 7 after any vaccination with rMenB+OMV

Time frame: 1 to 7 days after each vaccination

Population: Analysis was performed as per the safety dataset.

Arm	Measure	Group	Value (NUMBER)
rMenB06	Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination	Induration (Local)	71 participants
rMenB06	Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination	Nausea(Systemic)	41 participants
rMenB06	Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination	Swelling (Local)	72 participants
rMenB06	Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination	Fever(Systemic)	12 participants
rMenB06	Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination	Med.Att Fever (Systemic)	1 participants
rMenB06	Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination	Malaise (Systemic)	92 participants
rMenB06	Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination	Headache(Systemic)	79 participants
rMenB06	Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination	erythema (local)	93 participants
rMenB06	Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination	Arthralgia(Systemic)	55 participants
rMenB06	Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination	Myalgia(Systemic)	85 participants
rMenB06	Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination	Pain (Local)	122 participants
rMenB0	Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination	erythema (local)	162 participants
rMenB0	Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination	Induration (Local)	130 participants
rMenB0	Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination	Headache(Systemic)	139 participants
rMenB0	Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination	Myalgia(Systemic)	141 participants
rMenB0	Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination	Malaise (Systemic)	181 participants
rMenB0	Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination	Nausea(Systemic)	80 participants
rMenB0	Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination	Med.Att Fever (Systemic)	0 participants
rMenB0	Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination	Fever(Systemic)	8 participants
rMenB0	Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination	Pain (Local)	236 participants
rMenB0	Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination	Swelling (Local)	132 participants
rMenB0	Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination	Arthralgia(Systemic)	76 participants
rMenB016	Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination	Fever(Systemic)	11 participants
rMenB016	Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination	Arthralgia(Systemic)	55 participants
rMenB016	Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination	Myalgia(Systemic)	91 participants
rMenB016	Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination	Malaise (Systemic)	96 participants
rMenB016	Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination	Swelling (Local)	81 participants
rMenB016	Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination	Induration (Local)	75 participants
rMenB016	Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination	Med.Att Fever (Systemic)	2 participants
rMenB016	Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination	Pain (Local)	124 participants
rMenB016	Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination	Headache(Systemic)	88 participants
rMenB016	Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination	Nausea(Systemic)	51 participants
rMenB016	Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination	erythema (local)	95 participants
rMenB01	Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination	Arthralgia(Systemic)	80 participants
rMenB01	Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination	Nausea(Systemic)	72 participants
rMenB01	Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination	Fever(Systemic)	21 participants
rMenB01	Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination	Pain (Local)	237 participants
rMenB01	Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination	erythema (local)	188 participants
rMenB01	Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination	Induration (Local)	151 participants
rMenB01	Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination	Swelling (Local)	144 participants
rMenB01	Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination	Med.Att Fever (Systemic)	0 participants
rMenB01	Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination	Malaise (Systemic)	172 participants
rMenB01	Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination	Myalgia(Systemic)	156 participants
rMenB01	Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination	Headache(Systemic)	160 participants
rMenB026	Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination	Malaise (Systemic)	87 participants
rMenB026	Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination	Fever(Systemic)	18 participants
rMenB026	Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination	Headache(Systemic)	73 participants
rMenB026	Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination	erythema (local)	94 participants
rMenB026	Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination	Myalgia(Systemic)	81 participants
rMenB026	Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination	Arthralgia(Systemic)	39 participants
rMenB026	Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination	Induration (Local)	82 participants
rMenB026	Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination	Swelling (Local)	76 participants
rMenB026	Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination	Pain (Local)	113 participants
rMenB026	Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination	Med.Att Fever (Systemic)	1 participants
rMenB026	Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination	Nausea(Systemic)	42 participants
rMenB02	Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination	Med.Att Fever (Systemic)	1 participants
rMenB02	Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination	Headache(Systemic)	165 participants
rMenB02	Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination	Arthralgia(Systemic)	105 participants
rMenB02	Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination	Malaise (Systemic)	185 participants
rMenB02	Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination	Swelling (Local)	115 participants
rMenB02	Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination	Myalgia(Systemic)	160 participants
rMenB02	Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination	Fever(Systemic)	26 participants
rMenB02	Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination	Pain (Local)	236 participants
rMenB02	Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination	Nausea(Systemic)	88 participants
rMenB02	Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination	erythema (local)	172 participants
rMenB02	Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination	Induration (Local)	121 participants
rMenB012	Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination	Med.Att Fever (Systemic)	1 participants
rMenB012	Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination	Induration (Local)	228 participants
rMenB012	Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination	Fever(Systemic)	38 participants
rMenB012	Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination	Swelling (Local)	226 participants
rMenB012	Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination	Pain (Local)	345 participants
rMenB012	Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination	Nausea(Systemic)	143 participants
rMenB012	Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination	Arthralgia(Systemic)	146 participants
rMenB012	Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination	Headache(Systemic)	244 participants
rMenB012	Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination	Malaise (Systemic)	272 participants
rMenB012	Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination	erythema (local)	282 participants
rMenB012	Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination	Myalgia(Systemic)	238 participants
rMenB6	Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination	Med.Att Fever (Systemic)	1 participants
rMenB6	Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination	Arthralgia(Systemic)	43 participants
rMenB6	Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination	Nausea(Systemic)	49 participants
rMenB6	Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination	Pain (Local)	123 participants
rMenB6	Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination	Swelling (Local)	54 participants
rMenB6	Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination	erythema (local)	85 participants
rMenB6	Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination	Induration (Local)	57 participants
rMenB6	Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination	Myalgia(Systemic)	91 participants
rMenB6	Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination	Fever(Systemic)	18 participants
rMenB6	Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination	Malaise (Systemic)	89 participants
rMenB6	Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination	Headache(Systemic)	74 participants

Primary

Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.

Immunogenicity was evaluated by measuring the percentage of subjects with hSBA titter \>1:4 against 44/76-SL, 5/99, NZ98/254 strains at months 1, 2, 3.

Time frame: Month-1, 2, 3

Population: Analysis was performed as per the protocol dataset

Arm	Measure	Group	Value (NUMBER)
rMenB06	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.	NZ98/254-mo 3	80 percentage of Subjects
rMenB06	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.	NZ98/254-mo 1	90 percentage of Subjects
rMenB06	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.	44/76-SL- Mo 3	84 percentage of Subjects
rMenB06	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.	NZ98/254-mo 0	32 percentage of Subjects
rMenB06	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.	5/99- Mo 2	95 percentage of Subjects
rMenB06	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.	44/76-SL- Mo 1	92 percentage of Subjects
rMenB06	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.	44/76-SL- Mo 2	88 percentage of Subjects
rMenB06	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.	5/99- Mo 3	92 percentage of Subjects
rMenB06	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.	NZ98/254-mo 2	81 percentage of Subjects
rMenB06	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.	5/99- Mo 0	29 percentage of Subjects
rMenB06	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.	44/76-SL- Mo 0	42 percentage of Subjects
rMenB06	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.	5/99- Mo 1	97 percentage of Subjects
rMenB0	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.	NZ98/254-mo 0	39 percentage of Subjects
rMenB0	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.	44/76-SL- Mo 1	92 percentage of Subjects
rMenB0	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.	44/76-SL- Mo 3	88 percentage of Subjects
rMenB0	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.	5/99- Mo 1	96 percentage of Subjects
rMenB0	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.	NZ98/254-mo 1	94 percentage of Subjects
rMenB0	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.	NZ98/254-mo 2	84 percentage of Subjects
rMenB0	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.	5/99- Mo 2	94 percentage of Subjects
rMenB0	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.	5/99- Mo 3	89 percentage of Subjects
rMenB0	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.	44/76-SL- Mo 2	92 percentage of Subjects
rMenB0	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.	5/99- Mo 0	41 percentage of Subjects
rMenB0	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.	NZ98/254-mo 3	76 percentage of Subjects
rMenB0	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.	44/76-SL- Mo 0	47 percentage of Subjects
rMenB016	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.	44/76-SL- Mo 3	99 percentage of Subjects
rMenB016	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.	NZ98/254-mo 0	33 percentage of Subjects
rMenB016	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.	44/76-SL- Mo 1	95 percentage of Subjects
rMenB016	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.	5/99- Mo 0	28 percentage of Subjects
rMenB016	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.	5/99- Mo 3	99 percentage of Subjects
rMenB016	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.	NZ98/254-mo 2	99 percentage of Subjects
rMenB016	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.	NZ98/254-mo 1	95 percentage of Subjects
rMenB016	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.	NZ98/254-mo 3	97 percentage of Subjects
rMenB016	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.	44/76-SL- Mo 0	41 percentage of Subjects
rMenB016	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.	5/99- Mo 2	100 percentage of Subjects
rMenB016	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.	5/99- Mo 1	96 percentage of Subjects
rMenB016	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.	44/76-SL- Mo 2	100 percentage of Subjects
rMenB01	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.	5/99- Mo 1	97 percentage of Subjects
rMenB01	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.	NZ98/254-mo 0	35 percentage of Subjects
rMenB01	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.	NZ98/254-mo 2	100 percentage of Subjects
rMenB01	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.	44/76-SL- Mo 3	100 percentage of Subjects
rMenB01	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.	NZ98/254-mo 3	97 percentage of Subjects
rMenB01	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.	5/99- Mo 2	100 percentage of Subjects
rMenB01	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.	5/99- Mo 3	100 percentage of Subjects
rMenB01	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.	44/76-SL- Mo 0	38 percentage of Subjects
rMenB01	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.	44/76-SL- Mo 1	93 percentage of Subjects
rMenB01	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.	5/99- Mo 0	31 percentage of Subjects
rMenB01	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.	NZ98/254-mo 1	94 percentage of Subjects
rMenB01	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.	44/76-SL- Mo 2	100 percentage of Subjects
rMenB026	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.	NZ98/254-mo 1	90 percentage of Subjects
rMenB026	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.	44/76-SL- Mo 0	37 percentage of Subjects
rMenB026	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.	5/99- Mo 3	98 percentage of Subjects
rMenB026	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.	5/99- Mo 2	97 percentage of Subjects
rMenB026	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.	44/76-SL- Mo 3	100 percentage of Subjects
rMenB026	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.	44/76-SL- Mo 2	88 percentage of Subjects
rMenB026	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.	5/99- Mo 0	30 percentage of Subjects
rMenB026	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.	5/99- Mo 1	97 percentage of Subjects
rMenB026	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.	NZ98/254-mo 0	34 percentage of Subjects
rMenB026	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.	44/76-SL- Mo 1	90 percentage of Subjects
rMenB026	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.	NZ98/254-mo 2	78 percentage of Subjects
rMenB026	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.	NZ98/254-mo 3	100 percentage of Subjects
rMenB02	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.	NZ98/254-mo 0	37 percentage of Subjects
rMenB02	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.	5/99- Mo 0	37 percentage of Subjects
rMenB02	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.	5/99- Mo 1	95 percentage of Subjects
rMenB02	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.	5/99- Mo 2	96 percentage of Subjects
rMenB02	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.	5/99- Mo 3	100 percentage of Subjects
rMenB02	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.	44/76-SL- Mo 0	47 percentage of Subjects
rMenB02	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.	44/76-SL- Mo 1	92 percentage of Subjects
rMenB02	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.	44/76-SL- Mo 2	89 percentage of Subjects
rMenB02	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.	44/76-SL- Mo 3	100 percentage of Subjects
rMenB02	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.	NZ98/254-mo 2	85 percentage of Subjects
rMenB02	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.	NZ98/254-mo 1	93 percentage of Subjects
rMenB02	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.	NZ98/254-mo 3	100 percentage of Subjects
rMenB012	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.	NZ98/254-mo 0	33 percentage of Subjects
rMenB012	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.	44/76-SL- Mo 2	100 percentage of Subjects
rMenB012	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.	44/76-SL- Mo 1	95 percentage of Subjects
rMenB012	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.	NZ98/254-mo 3	99 percentage of Subjects
rMenB012	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.	NZ98/254-mo 2	100 percentage of Subjects
rMenB012	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.	44/76-SL- Mo 0	46 percentage of Subjects
rMenB012	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.	5/99- Mo 3	100 percentage of Subjects
rMenB012	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.	NZ98/254-mo 1	95 percentage of Subjects
rMenB012	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.	5/99- Mo 2	100 percentage of Subjects
rMenB012	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.	5/99- Mo 1	97 percentage of Subjects
rMenB012	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.	5/99- Mo 0	36 percentage of Subjects
rMenB012	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.	44/76-SL- Mo 3	100 percentage of Subjects
rMenB6	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.	44/76-SL- Mo 3	48 percentage of Subjects
rMenB6	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.	NZ98/254-mo 0	38 percentage of Subjects
rMenB6	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.	44/76-SL- Mo 2	50 percentage of Subjects
rMenB6	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.	NZ98/254-mo 1	38 percentage of Subjects
rMenB6	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.	44/76-SL- Mo 1	43 percentage of Subjects
rMenB6	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.	5/99- Mo 2	31 percentage of Subjects
rMenB6	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.	44/76-SL- Mo 0	46 percentage of Subjects
rMenB6	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.	5/99- Mo 1	35 percentage of Subjects
rMenB6	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.	NZ98/254-mo 3	43 percentage of Subjects
rMenB6	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.	NZ98/254-mo 2	39 percentage of Subjects
rMenB6	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.	5/99- Mo 0	29 percentage of Subjects
rMenB6	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.	5/99- Mo 3	32 percentage of Subjects

Secondary

Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.

Immunogenicity was evaluated by measuring the Geometric mean ratios (GMRs) after primary and booster vaccination against 44/76-SL, 5/99, NZ98/254.

Time frame: month-1, month-2, month-3, month-6 and month-7

Population: Analysis was performed as per the protocol dataset.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
rMenB06	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	5/99 GMR Mo 2 to 0	15 Ratio
rMenB06	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	5/99 GMR Mo 1 to 0	31 Ratio
rMenB06	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	44/76 GMR Mo 7 to 6	18 Ratio
rMenB06	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	NZ98/254 GMR Mo 7 to 0	59 Ratio
rMenB06	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	44/76 GMR Mo 2 to 0	8.92 Ratio
rMenB06	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	NZ98/254 GMR Mo 6 to 0	4.75 Ratio
rMenB06	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	NZ98/254 GMR Mo 3 to 0	6.01 Ratio
rMenB06	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	NZ98/254 GMR Mo 2 to 0	7.69 Ratio
rMenB06	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	44/76 GMR Mo 3 to 0	5.98 Ratio
rMenB06	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	44/76 GMR Mo 1 to 0	13 Ratio
rMenB06	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	NZ98/254 GMR Mo 1 to 0	14 Ratio
rMenB06	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	5/99 GMR Mo 7 to 6	71 Ratio
rMenB06	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	44/76 GMR Mo 6 to 0	3.98 Ratio
rMenB06	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	5/99 GMR Mo 7 to 0	355 Ratio
rMenB06	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	5/99 GMR Mo 6 to 0	4.65 Ratio
rMenB06	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	5/99 GMR Mo 3 to 0	9.22 Ratio
rMenB06	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	44/76 GMR Mo 7 to 0	74 Ratio
rMenB06	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	NZ98/254 GMR Mo 7 to 6	11 Ratio
rMenB0	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	44/76 GMR Mo 7 to 0	3.09 Ratio
rMenB0	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	5/99 GMR Mo 1 to 0	20 Ratio
rMenB0	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	NZ98/254 GMR Mo 1 to 0	13 Ratio
rMenB0	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	44/76 GMR Mo 7 to 6	0.89 Ratio
rMenB0	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	5/99 GMR Mo 6 to 0	3.83 Ratio
rMenB0	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	NZ98/254 GMR Mo 7 to 0	3.32 Ratio
rMenB0	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	5/99 GMR Mo 7 to 6	0.83 Ratio
rMenB0	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	NZ98/254 GMR Mo 6 to 0	3.49 Ratio
rMenB0	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	5/99 GMR Mo 2 to 0	11 Ratio
rMenB0	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	44/76 GMR Mo 2 to 0	9.65 Ratio
rMenB0	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	44/76 GMR Mo 1 to 0	14 Ratio
rMenB0	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	5/99 GMR Mo 7 to 0	3.07 Ratio
rMenB0	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	NZ98/254 GMR Mo 3 to 0	5.5 Ratio
rMenB0	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	5/99 GMR Mo 3 to 0	7.37 Ratio
rMenB0	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	NZ98/254 GMR Mo 2 to 0	7.24 Ratio
rMenB0	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	44/76 GMR Mo 6 to 0	3.64 Ratio
rMenB0	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	NZ98/254 GMR Mo 7 to 6	0.99 Ratio
rMenB0	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	44/76 GMR Mo 3 to 0	7.31 Ratio
rMenB016	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	44/76 GMR Mo 3 to 0	37 Ratio
rMenB016	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	44/76 GMR Mo 1 to 0	17 Ratio
rMenB016	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	44/76 GMR Mo 2 to 0	53 Ratio
rMenB016	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	44/76 GMR Mo 6 to 0	17 Ratio
rMenB016	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	44/76 GMR Mo 7 to 0	92 Ratio
rMenB016	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	44/76 GMR Mo 7 to 6	5.36 Ratio
rMenB016	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	5/99 GMR Mo 1 to 0	25 Ratio
rMenB016	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	5/99 GMR Mo 2 to 0	198 Ratio
rMenB016	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	5/99 GMR Mo 3 to 0	115 Ratio
rMenB016	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	5/99 GMR Mo 6 to 0	49 Ratio
rMenB016	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	5/99 GMR Mo 7 to 0	430 Ratio
rMenB016	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	5/99 GMR Mo 7 to 6	8.98 Ratio
rMenB016	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	NZ98/254 GMR Mo 1 to 0	14 Ratio
rMenB016	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	NZ98/254 GMR Mo 2 to 0	29 Ratio
rMenB016	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	NZ98/254 GMR Mo 3 to 0	18 Ratio
rMenB016	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	NZ98/254 GMR Mo 6 to 0	9.26 Ratio
rMenB016	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	NZ98/254 GMR Mo 7 to 0	53 Ratio
rMenB016	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	NZ98/254 GMR Mo 7 to 6	5.86 Ratio
rMenB01	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	NZ98/254 GMR Mo 7 to 0	8.94 Ratio
rMenB01	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	NZ98/254 GMR Mo 6 to 0	10 Ratio
rMenB01	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	NZ98/254 GMR Mo 3 to 0	18 Ratio
rMenB01	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	44/76 GMR Mo 7 to 0	12 Ratio
rMenB01	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	44/76 GMR Mo 2 to 0	56 Ratio
rMenB01	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	5/99 GMR Mo 3 to 0	109 Ratio
rMenB01	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	5/99 GMR Mo 6 to 0	45 Ratio
rMenB01	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	5/99 GMR Mo 2 to 0	181 Ratio
rMenB01	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	44/76 GMR Mo 6 to 0	16 Ratio
rMenB01	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	5/99 GMR Mo 7 to 0	40 Ratio
rMenB01	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	44/76 GMR Mo 7 to 6	0.72 Ratio
rMenB01	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	44/76 GMR Mo 1 to 0	16 Ratio
rMenB01	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	5/99 GMR Mo 7 to 6	0.87 Ratio
rMenB01	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	44/76 GMR Mo 3 to 0	34 Ratio
rMenB01	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	NZ98/254 GMR Mo 1 to 0	15 Ratio
rMenB01	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	5/99 GMR Mo 1 to 0	29 Ratio
rMenB01	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	NZ98/254 GMR Mo 7 to 6	0.85 Ratio
rMenB01	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	NZ98/254 GMR Mo 2 to 0	30 Ratio
rMenB026	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	44/76 GMR Mo 7 to 6	5.08 Ratio
rMenB026	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	44/76 GMR Mo 1 to 0	13 Ratio
rMenB026	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	44/76 GMR Mo 7 to 0	79 Ratio
rMenB026	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	5/99 GMR Mo 1 to 0	23 Ratio
rMenB026	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	NZ98/254 GMR Mo 6 to 0	14 Ratio
rMenB026	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	44/76 GMR Mo 2 to 0	8.43 Ratio
rMenB026	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	NZ98/254 GMR Mo 7 to 6	3.95 Ratio
rMenB026	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	5/99 GMR Mo 7 to 6	7.92 Ratio
rMenB026	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	NZ98/254 GMR Mo 3 to 0	40 Ratio
rMenB026	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	5/99 GMR Mo 7 to 0	427 Ratio
rMenB026	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	44/76 GMR Mo 3 to 0	55 Ratio
rMenB026	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	5/99 GMR Mo 2 to 0	11 Ratio
rMenB026	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	NZ98/254 GMR Mo 1 to 0	12 Ratio
rMenB026	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	NZ98/254 GMR Mo 2 to 0	6.46 Ratio
rMenB026	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	5/99 GMR Mo 3 to 0	233 Ratio
rMenB026	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	5/99 GMR Mo 6 to 0	52 Ratio
rMenB026	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	44/76 GMR Mo 6 to 0	16 Ratio
rMenB026	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	NZ98/254 GMR Mo 7 to 0	57 Ratio
rMenB02	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	NZ98/254 GMR Mo 1 to 0	12 Ratio
rMenB02	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	44/76 GMR Mo 7 to 0	13 Ratio
rMenB02	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	5/99 GMR Mo 6 to 0	56 Ratio
rMenB02	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	NZ98/254 GMR Mo 6 to 0	15 Ratio
rMenB02	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	44/76 GMR Mo 7 to 6	0.67 Ratio
rMenB02	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	44/76 GMR Mo 1 to 0	14 Ratio
rMenB02	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	5/99 GMR Mo 7 to 0	46 Ratio
rMenB02	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	5/99 GMR Mo 2 to 0	15 Ratio
rMenB02	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	44/76 GMR Mo 3 to 0	58 Ratio
rMenB02	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	44/76 GMR Mo 6 to 0	20 Ratio
rMenB02	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	NZ98/254 GMR Mo 2 to 0	7.96 Ratio
rMenB02	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	44/76 GMR Mo 2 to 0	9.51 Ratio
rMenB02	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	NZ98/254 GMR Mo 3 to 0	38 Ratio
rMenB02	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	5/99 GMR Mo 7 to 6	0.83 Ratio
rMenB02	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	NZ98/254 GMR Mo 7 to 6	0.84 Ratio
rMenB02	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	5/99 GMR Mo 1 to 0	28 Ratio
rMenB02	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	5/99 GMR Mo 3 to 0	306 Ratio
rMenB02	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	NZ98/254 GMR Mo 7 to 0	13 Ratio
rMenB012	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	NZ98/254 GMR Mo 2 to 0	33 Ratio
rMenB012	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	5/99 GMR Mo 2 to 0	186 Ratio
rMenB012	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	44/76 GMR Mo 6 to 0	23 Ratio
rMenB012	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	NZ98/254 GMR Mo 7 to 0	15 Ratio
rMenB012	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	5/99 GMR Mo 3 to 0	225 Ratio
rMenB012	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	5/99 GMR Mo 6 to 0	74 Ratio
rMenB012	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	5/99 GMR Mo 7 to 0	65 Ratio
rMenB012	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	44/76 GMR Mo 3 to 0	62 Ratio
rMenB012	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	5/99 GMR Mo 7 to 6	0.86 Ratio
rMenB012	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	NZ98/254 GMR Mo 1 to 0	17 Ratio
rMenB012	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	44/76 GMR Mo 2 to 0	50 Ratio
rMenB012	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	5/99 GMR Mo 1 to 0	28 Ratio
rMenB012	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	NZ98/254 GMR Mo 3 to 0	44 Ratio
rMenB012	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	NZ98/254 GMR Mo 6 to 0	19 Ratio
rMenB012	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	44/76 GMR Mo 1 to 0	15 Ratio
rMenB012	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	NZ98/254 GMR Mo 7 to 6	0.81 Ratio
rMenB012	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	44/76 GMR Mo 7 to 6	0.67 Ratio
rMenB012	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	44/76 GMR Mo 7 to 0	16 Ratio
rMenB6	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	NZ98/254 GMR Mo 7 to 0	15 Ratio
rMenB6	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	NZ98/254 GMR Mo 6 to 0	1.28 Ratio
rMenB6	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	5/99 GMR Mo 3 to 0	1.09 Ratio
rMenB6	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	NZ98/254 GMR Mo 7 to 6	11 Ratio
rMenB6	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	44/76 GMR Mo 6 to 0	0.92 Ratio
rMenB6	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	44/76 GMR Mo 7 to 0	13 Ratio
rMenB6	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	5/99 GMR Mo 7 to 6	26 Ratio
rMenB6	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	5/99 GMR Mo 7 to 0	21 Ratio
rMenB6	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	44/76 GMR Mo 3 to 0	0.98 Ratio
rMenB6	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	5/99 GMR Mo 6 to 0	0.82 Ratio
rMenB6	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	5/99 GMR Mo 2 to 0	1.06 Ratio
rMenB6	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	44/76 GMR Mo 7 to 6	14 Ratio
rMenB6	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	5/99 GMR Mo 1 to 0	1.13 Ratio
rMenB6	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	44/76 GMR Mo 1 to 0	0.89 Ratio
rMenB6	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	NZ98/254 GMR Mo 3 to 0	1.13 Ratio
rMenB6	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	NZ98/254 GMR Mo 2 to 0	1.06 Ratio
rMenB6	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	44/76 GMR Mo 2 to 0	1.04 Ratio
rMenB6	Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	NZ98/254 GMR Mo 1 to 0	0.91 Ratio

Secondary

Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.

Immunogenicity was evaluated by measuring the Geometric mean titers (GMTs) after primary and booster vaccination against 44/76-SL, 5/99, NZ98/254.

Time frame: month-1, month-2, month-3, month-6 and month-7

Population: Analysis was performed as per the protocol dataset.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
rMenB06	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	5/99 GMT Mo 1	81 Titers
rMenB06	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	5/99 GMT Mo 6	12 Titers
rMenB06	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	NZ98/254 GMT Mo 2	23 Titers
rMenB06	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	44/76 GMT Mo 3	20 Titers
rMenB06	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	NZ98/254 GMT Mo1	42 Titers
rMenB06	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	44/76 GMT Mo 2	31 Titers
rMenB06	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	5/99 GMT Mo 2	40 Titers
rMenB06	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	44/76 GMT Mo 6	13 Titers
rMenB06	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	44/76 GMT Mo 7	218 Titers
rMenB06	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	NZ98/254 GMT Mo 7	140 Titers
rMenB06	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	5/99 GMT Mo 7	880 Titers
rMenB06	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	NZ98/254 GMT Mo 6	12 Titers
rMenB06	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	44/76 GMT Mo 0	3.41 Titers
rMenB06	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	5/99 GMT Mo 3	25 Titers
rMenB06	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	NZ98/254 GMT Mo 0	2.87 Titers
rMenB06	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	44/76 GMT Mo 1	46 Titers
rMenB06	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	5/99 GMT Mo 0	2.61 Titers
rMenB06	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	NZ98/254 GMT Mo 3	17 Titers
rMenB0	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	44/76 GMT Mo 7	12 Titers
rMenB0	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	44/76 GMT Mo 3	31 Titers
rMenB0	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	44/76 GMT Mo 2	41 Titers
rMenB0	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	5/99 GMT Mo 3	23 Titers
rMenB0	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	NZ98/254 GMT Mo 0	3.35 Titers
rMenB0	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	5/99 GMT Mo 2	34 Titers
rMenB0	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	NZ98/254 GMT Mo1	44 Titers
rMenB0	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	5/99 GMT Mo 6	11 Titers
rMenB0	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	NZ98/254 GMT Mo 2	25 Titers
rMenB0	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	5/99 GMT Mo 1	64 Titers
rMenB0	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	NZ98/254 GMT Mo 3	19 Titers
rMenB0	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	5/99 GMT Mo 0	3.15 Titers
rMenB0	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	NZ98/254 GMT Mo 6	11 Titers
rMenB0	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	44/76 GMT Mo 1	58 Titers
rMenB0	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	NZ98/254 GMT Mo 7	10 Titers
rMenB0	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	5/99 GMT Mo 7	8.61 Titers
rMenB0	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	44/76 GMT Mo 0	4.24 Titers
rMenB0	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	44/76 GMT Mo 6	15 Titers
rMenB016	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	5/99 GMT Mo 6	125 Titers
rMenB016	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	NZ98/254 GMT Mo 3	61 Titers
rMenB016	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	5/99 GMT Mo 0	2.59 Titers
rMenB016	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	44/76 GMT Mo 0	3.34 Titers
rMenB016	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	NZ98/254 GMT Mo 0	3.43 Titers
rMenB016	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	5/99 GMT Mo 3	303 Titers
rMenB016	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	NZ98/254 GMT Mo 6	31 Titers
rMenB016	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	44/76 GMT Mo 7	324 Titers
rMenB016	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	5/99 GMT Mo 7	1094 Titers
rMenB016	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	NZ98/254 GMT Mo 7	181 Titers
rMenB016	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	44/76 GMT Mo 2	182 Titers
rMenB016	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	44/76 GMT Mo 6	59 Titers
rMenB016	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	NZ98/254 GMT Mo1	47 Titers
rMenB016	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	5/99 GMT Mo 1	66 Titers
rMenB016	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	5/99 GMT Mo 2	505 Titers
rMenB016	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	44/76 GMT Mo 1	56 Titers
rMenB016	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	NZ98/254 GMT Mo 2	98 Titers
rMenB016	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	44/76 GMT Mo 3	132 Titers
rMenB01	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	44/76 GMT Mo 2	187 Titers
rMenB01	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	5/99 GMT Mo 0	2.52 Titers
rMenB01	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	NZ98/254 GMT Mo 0	2.98 Titers
rMenB01	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	44/76 GMT Mo 3	114 Titers
rMenB01	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	44/76 GMT Mo 1	52 Titers
rMenB01	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	NZ98/254 GMT Mo 3	52 Titers
rMenB01	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	5/99 GMT Mo 3	273 Titers
rMenB01	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	5/99 GMT Mo 2	451 Titers
rMenB01	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	NZ98/254 GMT Mo 7	24 Titers
rMenB01	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	5/99 GMT Mo 7	99 Titers
rMenB01	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	5/99 GMT Mo 1	72 Titers
rMenB01	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	44/76 GMT Mo 0	3.35 Titers
rMenB01	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	44/76 GMT Mo 6	50 Titers
rMenB01	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	NZ98/254 GMT Mo 6	29 Titers
rMenB01	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	5/99 GMT Mo 6	113 Titers
rMenB01	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	44/76 GMT Mo 7	36 Titers
rMenB01	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	NZ98/254 GMT Mo1	45 Titers
rMenB01	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	NZ98/254 GMT Mo 2	89 Titers
rMenB026	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	NZ98/254 GMT Mo 0	3.07 Titers
rMenB026	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	5/99 GMT Mo 6	124 Titers
rMenB026	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	5/99 GMT Mo 7	994 Titers
rMenB026	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	NZ98/254 GMT Mo1	37 Titers
rMenB026	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	NZ98/254 GMT Mo 2	19 Titers
rMenB026	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	NZ98/254 GMT Mo 3	117 Titers
rMenB026	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	NZ98/254 GMT Mo 6	44 Titers
rMenB026	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	NZ98/254 GMT Mo 7	168 Titers
rMenB026	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	44/76 GMT Mo 0	3.39 Titers
rMenB026	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	44/76 GMT Mo 1	44 Titers
rMenB026	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	44/76 GMT Mo 2	28 Titers
rMenB026	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	44/76 GMT Mo 3	182 Titers
rMenB026	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	44/76 GMT Mo 6	54 Titers
rMenB026	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	44/76 GMT Mo 7	259 Titers
rMenB026	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	5/99 GMT Mo 0	2.43 Titers
rMenB026	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	5/99 GMT Mo 1	57 Titers
rMenB026	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	5/99 GMT Mo 2	26 Titers
rMenB026	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	5/99 GMT Mo 3	540 Titers
rMenB02	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	44/76 GMT Mo 2	38 Titers
rMenB02	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	NZ98/254 GMT Mo 0	3.39 Titers
rMenB02	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	NZ98/254 GMT Mo1	42 Titers
rMenB02	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	5/99 GMT Mo 1	76 Titers
rMenB02	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	NZ98/254 GMT Mo 3	125 Titers
rMenB02	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	NZ98/254 GMT Mo 2	26 Titers
rMenB02	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	44/76 GMT Mo 1	57 Titers
rMenB02	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	5/99 GMT Mo 0	2.72 Titers
rMenB02	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	5/99 GMT Mo 6	147 Titers
rMenB02	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	44/76 GMT Mo 6	75 Titers
rMenB02	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	44/76 GMT Mo 3	230 Titers
rMenB02	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	5/99 GMT Mo 7	121 Titers
rMenB02	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	NZ98/254 GMT Mo 7	39 Titers
rMenB02	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	5/99 GMT Mo 2	40 Titers
rMenB02	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	44/76 GMT Mo 0	3.99 Titers
rMenB02	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	NZ98/254 GMT Mo 6	49 Titers
rMenB02	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	5/99 GMT Mo 3	822 Titers
rMenB02	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	44/76 GMT Mo 7	48 Titers
rMenB012	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	NZ98/254 GMT Mo 3	122 Titers
rMenB012	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	44/76 GMT Mo 3	240 Titers
rMenB012	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	44/76 GMT Mo 0	3.87 Titers
rMenB012	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	NZ98/254 GMT Mo 7	41 Titers
rMenB012	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	44/76 GMT Mo 6	86 Titers
rMenB012	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	NZ98/254 GMT Mo 6	52 Titers
rMenB012	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	44/76 GMT Mo 7	59 Titers
rMenB012	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	5/99 GMT Mo 3	584 Titers
rMenB012	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	5/99 GMT Mo 0	2.58 Titers
rMenB012	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	NZ98/254 GMT Mo 2	92 Titers
rMenB012	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	NZ98/254 GMT Mo1	49 Titers
rMenB012	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	5/99 GMT Mo 1	71 Titers
rMenB012	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	NZ98/254 GMT Mo 0	2.83 Titers
rMenB012	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	5/99 GMT Mo 6	186 Titers
rMenB012	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	5/99 GMT Mo 2	481 Titers
rMenB012	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	5/99 GMT Mo 7	164 Titers
rMenB012	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	44/76 GMT Mo 2	193 Titers
rMenB012	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	44/76 GMT Mo 1	60 Titers
rMenB6	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	NZ98/254 GMT Mo 3	3.57 Titers
rMenB6	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	NZ98/254 GMT Mo 0	3.12 Titers
rMenB6	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	44/76 GMT Mo 3	4.04 Titers
rMenB6	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	44/76 GMT Mo 7	56 Titers
rMenB6	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	44/76 GMT Mo 2	4.09 Titers
rMenB6	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	NZ98/254 GMT Mo 6	4.17 Titers
rMenB6	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	44/76 GMT Mo 1	3.39 Titers
rMenB6	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	5/99 GMT Mo 2	2.48 Titers
rMenB6	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	5/99 GMT Mo 7	53 Titers
rMenB6	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	5/99 GMT Mo 0	2.27 Titers
rMenB6	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	44/76 GMT Mo 0	3.89 Titers
rMenB6	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	NZ98/254 GMT Mo 2	3.28 Titers
rMenB6	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	NZ98/254 GMT Mo1	2.85 Titers
rMenB6	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	44/76 GMT Mo 6	3.9 Titers
rMenB6	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	5/99 GMT Mo 3	2.58 Titers
rMenB6	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	5/99 GMT Mo 6	2.03 Titers
rMenB6	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	NZ98/254 GMT Mo 7	47 Titers
rMenB6	Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	5/99 GMT Mo 1	2.56 Titers

Secondary

GMCs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination.

Immunogenicity was evaluated by measuring the Geometric mean Concentration (GMCs) after primary and booster vaccination against Antigen 287-953 Antigen.

Time frame: month-1, month-2, month-3, month-6 and month-7

Population: Analysis was performed as per the protocol dataset.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
rMenB06	GMCs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination.	GMC Mo 7	2240 IU/ml
rMenB06	GMCs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination.	GMC Mo 0	35 IU/ml
rMenB06	GMCs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination.	GMC Mo 1	190 IU/ml
rMenB06	GMCs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination.	GMC Mo 2	173 IU/ml
rMenB06	GMCs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination.	GMC Mo 6	91 IU/ml
rMenB06	GMCs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination.	GMC Mo 3	102 IU/ml
rMenB0	GMCs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination.	GMC Mo 2	154 IU/ml
rMenB0	GMCs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination.	GMC Mo 0	35 IU/ml
rMenB0	GMCs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination.	GMC Mo 3	124 IU/ml
rMenB0	GMCs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination.	GMC Mo 7	69 IU/ml
rMenB0	GMCs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination.	GMC Mo 1	204 IU/ml
rMenB0	GMCs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination.	GMC Mo 6	72 IU/ml
rMenB016	GMCs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination.	GMC Mo 6	565 IU/ml
rMenB016	GMCs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination.	GMC Mo 2	3025 IU/ml
rMenB016	GMCs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination.	GMC Mo 1	334 IU/ml
rMenB016	GMCs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination.	GMC Mo 3	1612 IU/ml
rMenB016	GMCs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination.	GMC Mo 7	3840 IU/ml
rMenB016	GMCs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination.	GMC Mo 0	43 IU/ml
rMenB01	GMCs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination.	GMC Mo 6	488 IU/ml
rMenB01	GMCs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination.	GMC Mo 0	37 IU/ml
rMenB01	GMCs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination.	GMC Mo 1	217 IU/ml
rMenB01	GMCs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination.	GMC Mo 2	3875 IU/ml
rMenB01	GMCs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination.	GMC Mo 3	1831 IU/ml
rMenB01	GMCs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination.	GMC Mo 7	383 IU/ml
rMenB026	GMCs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination.	GMC Mo 6	807 IU/ml
rMenB026	GMCs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination.	GMC Mo 1	234 IU/ml
rMenB026	GMCs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination.	GMC Mo 7	5492 IU/ml
rMenB026	GMCs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination.	GMC Mo 0	44 IU/ml
rMenB026	GMCs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination.	GMC Mo 3	3332 IU/ml
rMenB026	GMCs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination.	GMC Mo 2	175 IU/ml
rMenB02	GMCs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination.	GMC Mo 2	144 IU/ml
rMenB02	GMCs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination.	GMC Mo 3	2936 IU/ml
rMenB02	GMCs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination.	GMC Mo 1	220 IU/ml
rMenB02	GMCs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination.	GMC Mo 6	628 IU/ml
rMenB02	GMCs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination.	GMC Mo 0	32 IU/ml
rMenB02	GMCs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination.	GMC Mo 7	532 IU/ml
rMenB012	GMCs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination.	GMC Mo 3	5314 IU/ml
rMenB012	GMCs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination.	GMC Mo 6	1602 IU/ml
rMenB012	GMCs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination.	GMC Mo 0	32 IU/ml
rMenB012	GMCs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination.	GMC Mo 2	3693 IU/ml
rMenB012	GMCs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination.	GMC Mo 7	1111 IU/ml
rMenB012	GMCs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination.	GMC Mo 1	521 IU/ml
rMenB6	GMCs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination.	GMC Mo 3	42 IU/ml
rMenB6	GMCs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination.	GMC Mo 2	42 IU/ml
rMenB6	GMCs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination.	GMC Mo 7	283 IU/ml
rMenB6	GMCs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination.	GMC Mo 6	37 IU/ml
rMenB6	GMCs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination.	GMC Mo 0	48 IU/ml
rMenB6	GMCs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination.	GMC Mo 1	50 IU/ml

Secondary

GMRs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination

Immunogenicity was evaluated by measuring the Geometric mean Ratios (GMRs) after primary and booster vaccination against 287-953Antigen

Time frame: month-1, month-2, month-3, month-6 and month-7

Population: Analysis was performed as per the protocol dataset.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
rMenB06	GMRs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination	GMR Mo 1 to 0	5.73 Ratio
rMenB06	GMRs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination	GMR Mo 7 to 0	63 Ratio
rMenB06	GMRs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination	GMR Mo 6 to 0	2.56 Ratio
rMenB06	GMRs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination	GMR Mo 3 to 0	2.9 Ratio
rMenB06	GMRs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination	GMR Mo 2 to 0	4.9 Ratio
rMenB0	GMRs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination	GMR Mo 2 to 0	4.38 Ratio
rMenB0	GMRs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination	GMR Mo 6 to 0	2.06 Ratio
rMenB0	GMRs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination	GMR Mo 7 to 0	1.94 Ratio
rMenB0	GMRs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination	GMR Mo 3 to 0	3.54 Ratio
rMenB0	GMRs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination	GMR Mo 1 to 0	5.82 Ratio
rMenB016	GMRs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination	GMR Mo 2 to 0	70 Ratio
rMenB016	GMRs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination	GMR Mo 7 to 0	89 Ratio
rMenB016	GMRs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination	GMR Mo 1 to 0	7.75 Ratio
rMenB016	GMRs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination	GMR Mo 6 to 0	13 Ratio
rMenB016	GMRs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination	GMR Mo 3 to 0	37 Ratio
rMenB01	GMRs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination	GMR Mo 3 to 0	55 Ratio
rMenB01	GMRs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination	GMR Mo 7 to 0	11 Ratio
rMenB01	GMRs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination	GMR Mo 1 to 0	5.34 Ratio
rMenB01	GMRs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination	GMR Mo 2 to 0	112 Ratio
rMenB01	GMRs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination	GMR Mo 6 to 0	13 Ratio
rMenB026	GMRs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination	GMR Mo 3 to 0	75 Ratio
rMenB026	GMRs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination	GMR Mo 1 to 0	5.26 Ratio
rMenB026	GMRs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination	GMR Mo 2 to 0	3.94 Ratio
rMenB026	GMRs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination	GMR Mo 6 to 0	18 Ratio
rMenB026	GMRs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination	GMR Mo 7 to 0	123 Ratio
rMenB02	GMRs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination	GMR Mo 3 to 0	91 Ratio
rMenB02	GMRs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination	GMR Mo 6 to 0	20 Ratio
rMenB02	GMRs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination	GMR Mo 2 to 0	4.46 Ratio
rMenB02	GMRs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination	GMR Mo 1 to 0	6.85 Ratio
rMenB02	GMRs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination	GMR Mo 7 to 0	17 Ratio
rMenB012	GMRs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination	GMR Mo 3 to 0	167 Ratio
rMenB012	GMRs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination	GMR Mo 1 to 0	16 Ratio
rMenB012	GMRs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination	GMR Mo 2 to 0	116 Ratio
rMenB012	GMRs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination	GMR Mo 7 to 0	35 Ratio
rMenB012	GMRs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination	GMR Mo 6 to 0	50 Ratio
rMenB6	GMRs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination	GMR Mo 7 to 0	5.9 Ratio
rMenB6	GMRs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination	GMR Mo 6 to 0	0.77 Ratio
rMenB6	GMRs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination	GMR Mo 1 to 0	1.03 Ratio
rMenB6	GMRs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination	GMR Mo 3 to 0	0.88 Ratio
rMenB6	GMRs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination	GMR Mo 2 to 0	0.87 Ratio

Secondary

Number of Subjects Reporting Unsolicited AEs Throughout the Study.

Safety was assessed as the number of subjects who reported unsolicited AEs throughout the study.

Time frame: Throughout the study

Population: Analysis was performed as per the safety dataset.

Arm	Measure	Group	Value (NUMBER)
rMenB06	Number of Subjects Reporting Unsolicited AEs Throughout the Study.	Any AE's	65 participants
rMenB06	Number of Subjects Reporting Unsolicited AEs Throughout the Study.	AEs leading to discontinuation	1 participants
rMenB06	Number of Subjects Reporting Unsolicited AEs Throughout the Study.	At least possibly related SAEs	0 participants
rMenB06	Number of Subjects Reporting Unsolicited AEs Throughout the Study.	Serious AEs	5 participants
rMenB06	Number of Subjects Reporting Unsolicited AEs Throughout the Study.	At least possibly related AEs	22 participants
rMenB0	Number of Subjects Reporting Unsolicited AEs Throughout the Study.	At least possibly related AEs	36 participants
rMenB0	Number of Subjects Reporting Unsolicited AEs Throughout the Study.	At least possibly related SAEs	0 participants
rMenB0	Number of Subjects Reporting Unsolicited AEs Throughout the Study.	AEs leading to discontinuation	0 participants
rMenB0	Number of Subjects Reporting Unsolicited AEs Throughout the Study.	Serious AEs	4 participants
rMenB0	Number of Subjects Reporting Unsolicited AEs Throughout the Study.	Any AE's	137 participants
rMenB016	Number of Subjects Reporting Unsolicited AEs Throughout the Study.	At least possibly related AEs	30 participants
rMenB016	Number of Subjects Reporting Unsolicited AEs Throughout the Study.	AEs leading to discontinuation	0 participants
rMenB016	Number of Subjects Reporting Unsolicited AEs Throughout the Study.	Any AE's	73 participants
rMenB016	Number of Subjects Reporting Unsolicited AEs Throughout the Study.	At least possibly related SAEs	0 participants
rMenB016	Number of Subjects Reporting Unsolicited AEs Throughout the Study.	Serious AEs	2 participants
rMenB01	Number of Subjects Reporting Unsolicited AEs Throughout the Study.	Serious AEs	4 participants
rMenB01	Number of Subjects Reporting Unsolicited AEs Throughout the Study.	AEs leading to discontinuation	0 participants
rMenB01	Number of Subjects Reporting Unsolicited AEs Throughout the Study.	Any AE's	143 participants
rMenB01	Number of Subjects Reporting Unsolicited AEs Throughout the Study.	At least possibly related AEs	36 participants
rMenB01	Number of Subjects Reporting Unsolicited AEs Throughout the Study.	At least possibly related SAEs	0 participants
rMenB026	Number of Subjects Reporting Unsolicited AEs Throughout the Study.	Serious AEs	2 participants
rMenB026	Number of Subjects Reporting Unsolicited AEs Throughout the Study.	Any AE's	72 participants
rMenB026	Number of Subjects Reporting Unsolicited AEs Throughout the Study.	At least possibly related AEs	24 participants
rMenB026	Number of Subjects Reporting Unsolicited AEs Throughout the Study.	At least possibly related SAEs	0 participants
rMenB026	Number of Subjects Reporting Unsolicited AEs Throughout the Study.	AEs leading to discontinuation	1 participants
rMenB02	Number of Subjects Reporting Unsolicited AEs Throughout the Study.	Serious AEs	4 participants
rMenB02	Number of Subjects Reporting Unsolicited AEs Throughout the Study.	At least possibly related SAEs	0 participants
rMenB02	Number of Subjects Reporting Unsolicited AEs Throughout the Study.	At least possibly related AEs	43 participants
rMenB02	Number of Subjects Reporting Unsolicited AEs Throughout the Study.	Any AE's	148 participants
rMenB02	Number of Subjects Reporting Unsolicited AEs Throughout the Study.	AEs leading to discontinuation	0 participants
rMenB012	Number of Subjects Reporting Unsolicited AEs Throughout the Study.	Serious AEs	11 participants
rMenB012	Number of Subjects Reporting Unsolicited AEs Throughout the Study.	Any AE's	210 participants
rMenB012	Number of Subjects Reporting Unsolicited AEs Throughout the Study.	At least possibly related AEs	76 participants
rMenB012	Number of Subjects Reporting Unsolicited AEs Throughout the Study.	AEs leading to discontinuation	1 participants
rMenB012	Number of Subjects Reporting Unsolicited AEs Throughout the Study.	At least possibly related SAEs	2 participants
rMenB6	Number of Subjects Reporting Unsolicited AEs Throughout the Study.	AEs leading to discontinuation	0 participants
rMenB6	Number of Subjects Reporting Unsolicited AEs Throughout the Study.	At least possibly related SAEs	0 participants
rMenB6	Number of Subjects Reporting Unsolicited AEs Throughout the Study.	Any AE's	80 participants
rMenB6	Number of Subjects Reporting Unsolicited AEs Throughout the Study.	Serious AEs	3 participants
rMenB6	Number of Subjects Reporting Unsolicited AEs Throughout the Study.	At least possibly related AEs	26 participants

Secondary

Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.

Immunogenicity was evaluated by measuring the percentage of subjects with hSBA titer ≥1:8 against 44/76-SL, 5/99, NZ98/254 strains.

Time frame: at baseline, month-1, month-2, month-3, month-6 and month-7.

Population: Analysis was performed as per the protocol dataset.

Arm	Measure	Group	Value (NUMBER)
rMenB06	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	5/99- Mo 1	96 percentage of Subjects
rMenB06	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	44/76-SL- Mo 0	29 percentage of Subjects
rMenB06	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	NZ98/254 Mo 1	84 percentage of Subjects
rMenB06	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	44/76-SL- Mo 7	99 percentage of Subjects
rMenB06	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	5/99- Mo 3	81 percentage of Subjects
rMenB06	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	NZ98/254 Mo 2	72 percentage of Subjects
rMenB06	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	5/99- Mo 0	18 percentage of Subjects
rMenB06	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	NZ98/254 Mo 7	99 percentage of Subjects
rMenB06	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	5/99- Mo 2	89 percentage of Subjects
rMenB06	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	44/76-SL- Mo 2	79 percentage of Subjects
rMenB06	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	NZ98/254 Mo 0	22 percentage of Subjects
rMenB06	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	5/99- Mo 7	99 percentage of Subjects
rMenB06	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	NZ98/254 Mo 6	60 percentage of Subjects
rMenB06	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	44/76-SL- Mo 3	74 percentage of Subjects
rMenB06	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	44/76-SL- Mo 1	87 percentage of Subjects
rMenB06	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	NZ98/254 Mo 3	70 percentage of Subjects
rMenB06	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	44/76-SL- Mo 6	62 percentage of Subjects
rMenB06	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	5/99- Mo 6	60 percentage of Subjects
rMenB0	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	44/76-SL- Mo 2	84 percentage of Subjects
rMenB0	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	44/76-SL- Mo 1	87 percentage of Subjects
rMenB0	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	NZ98/254 Mo 7	49 percentage of Subjects
rMenB0	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	5/99- Mo 6	57 percentage of Subjects
rMenB0	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	NZ98/254 Mo 2	70 percentage of Subjects
rMenB0	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	5/99- Mo 1	91 percentage of Subjects
rMenB0	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	44/76-SL- Mo 7	57 percentage of Subjects
rMenB0	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	NZ98/254 Mo 6	54 percentage of Subjects
rMenB0	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	NZ98/254 Mo 1	83 percentage of Subjects
rMenB0	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	5/99- Mo 0	24 percentage of Subjects
rMenB0	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	5/99- Mo 3	77 percentage of Subjects
rMenB0	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	NZ98/254 Mo 0	30 percentage of Subjects
rMenB0	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	5/99- Mo 2	85 percentage of Subjects
rMenB0	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	44/76-SL- Mo 0	37 percentage of Subjects
rMenB0	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	NZ98/254 Mo 3	65 percentage of Subjects
rMenB0	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	44/76-SL- Mo 3	77 percentage of Subjects
rMenB0	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	5/99- Mo 7	48 percentage of Subjects
rMenB0	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	44/76-SL- Mo 6	62 percentage of Subjects
rMenB016	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	5/99- Mo 7	100 percentage of Subjects
rMenB016	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	5/99- Mo 3	99 percentage of Subjects
rMenB016	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	5/99- Mo 6	97 percentage of Subjects
rMenB016	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	44/76-SL- Mo 1	85 percentage of Subjects
rMenB016	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	NZ98/254 Mo 6	80 percentage of Subjects
rMenB016	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	44/76-SL- Mo 2	99 percentage of Subjects
rMenB016	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	44/76-SL- Mo 0	31 percentage of Subjects
rMenB016	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	44/76-SL- Mo 3	99 percentage of Subjects
rMenB016	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	NZ98/254 Mo 3	90 percentage of Subjects
rMenB016	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	44/76-SL- Mo 6	90 percentage of Subjects
rMenB016	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	NZ98/254 Mo 2	98 percentage of Subjects
rMenB016	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	44/76-SL- Mo 7	100 percentage of Subjects
rMenB016	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	NZ98/254 Mo 1	82 percentage of Subjects
rMenB016	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	5/99- Mo 0	20 percentage of Subjects
rMenB016	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	NZ98/254 Mo 7	99 percentage of Subjects
rMenB016	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	5/99- Mo 1	89 percentage of Subjects
rMenB016	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	NZ98/254 Mo 0	27 percentage of Subjects
rMenB016	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	5/99- Mo 2	100 percentage of Subjects
rMenB01	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	44/76-SL- Mo 7	82 percentage of Subjects
rMenB01	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	NZ98/254 Mo 2	99 percentage of Subjects
rMenB01	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	NZ98/254 Mo 0	25 percentage of Subjects
rMenB01	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	44/76-SL- Mo 6	83 percentage of Subjects
rMenB01	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	44/76-SL- Mo 0	32 percentage of Subjects
rMenB01	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	5/99- Mo 6	98 percentage of Subjects
rMenB01	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	5/99- Mo 1	94 percentage of Subjects
rMenB01	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	44/76-SL- Mo 3	98 percentage of Subjects
rMenB01	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	5/99- Mo 7	97 percentage of Subjects
rMenB01	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	NZ98/254 Mo 3	91 percentage of Subjects
rMenB01	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	44/76-SL- Mo 2	99 percentage of Subjects
rMenB01	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	NZ98/254 Mo 6	77 percentage of Subjects
rMenB01	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	44/76-SL- Mo 1	85 percentage of Subjects
rMenB01	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	NZ98/254 Mo 1	84 percentage of Subjects
rMenB01	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	NZ98/254 Mo 7	71 percentage of Subjects
rMenB01	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	5/99- Mo 3	100 percentage of Subjects
rMenB01	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	5/99- Mo 0	22 percentage of Subjects
rMenB01	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	5/99- Mo 2	100 percentage of Subjects
rMenB026	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	NZ98/254 Mo 3	98 percentage of Subjects
rMenB026	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	44/76-SL- Mo 0	30 percentage of Subjects
rMenB026	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	44/76-SL- Mo 1	81 percentage of Subjects
rMenB026	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	44/76-SL- Mo 2	80 percentage of Subjects
rMenB026	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	44/76-SL- Mo 3	99 percentage of Subjects
rMenB026	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	44/76-SL- Mo 6	90 percentage of Subjects
rMenB026	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	44/76-SL- Mo 7	100 percentage of Subjects
rMenB026	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	5/99- Mo 0	23 percentage of Subjects
rMenB026	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	5/99- Mo 1	91 percentage of Subjects
rMenB026	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	5/99- Mo 2	78 percentage of Subjects
rMenB026	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	5/99- Mo 3	98 percentage of Subjects
rMenB026	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	5/99- Mo 6	98 percentage of Subjects
rMenB026	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	5/99- Mo 7	100 percentage of Subjects
rMenB026	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	NZ98/254 Mo 0	24 percentage of Subjects
rMenB026	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	NZ98/254 Mo 1	75 percentage of Subjects
rMenB026	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	NZ98/254 Mo 2	65 percentage of Subjects
rMenB026	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	NZ98/254 Mo 6	86 percentage of Subjects
rMenB026	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	NZ98/254 Mo 7	100 percentage of Subjects
rMenB02	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	NZ98/254 Mo 7	81 percentage of Subjects
rMenB02	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	44/76-SL- Mo 0	35 percentage of Subjects
rMenB02	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	NZ98/254 Mo 1	80 percentage of Subjects
rMenB02	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	5/99- Mo 0	22 percentage of Subjects
rMenB02	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	NZ98/254 Mo 6	86 percentage of Subjects
rMenB02	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	44/76-SL- Mo 7	88 percentage of Subjects
rMenB02	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	44/76-SL- Mo 1	87 percentage of Subjects
rMenB02	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	5/99- Mo 6	99 percentage of Subjects
rMenB02	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	44/76-SL- Mo 6	91 percentage of Subjects
rMenB02	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	5/99- Mo 1	93 percentage of Subjects
rMenB02	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	NZ98/254 Mo 2	75 percentage of Subjects
rMenB02	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	44/76-SL- Mo 2	80 percentage of Subjects
rMenB02	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	5/99- Mo 7	97 percentage of Subjects
rMenB02	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	5/99- Mo 2	88 percentage of Subjects
rMenB02	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	5/99- Mo 3	100 percentage of Subjects
rMenB02	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	44/76-SL- Mo 3	100 percentage of Subjects
rMenB02	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	NZ98/254 Mo 0	26 percentage of Subjects
rMenB02	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	NZ98/254 Mo 3	100 percentage of Subjects
rMenB012	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	NZ98/254 Mo 7	84 percentage of Subjects
rMenB012	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	NZ98/254 Mo 3	98 percentage of Subjects
rMenB012	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	NZ98/254 Mo 0	25 percentage of Subjects
rMenB012	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	44/76-SL- Mo 2	99 percentage of Subjects
rMenB012	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	5/99- Mo 7	98 percentage of Subjects
rMenB012	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	44/76-SL- Mo 1	86 percentage of Subjects
rMenB012	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	NZ98/254 Mo 6	91 percentage of Subjects
rMenB012	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	5/99- Mo 0	22 percentage of Subjects
rMenB012	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	5/99- Mo 3	100 percentage of Subjects
rMenB012	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	5/99- Mo 6	99 percentage of Subjects
rMenB012	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	44/76-SL- Mo 7	91 percentage of Subjects
rMenB012	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	NZ98/254 Mo 1	86 percentage of Subjects
rMenB012	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	5/99- Mo 2	99 percentage of Subjects
rMenB012	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	5/99- Mo 1	94 percentage of Subjects
rMenB012	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	44/76-SL- Mo 6	93 percentage of Subjects
rMenB012	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	NZ98/254 Mo 2	99 percentage of Subjects
rMenB012	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	44/76-SL- Mo 0	33 percentage of Subjects
rMenB012	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	44/76-SL- Mo 3	99 percentage of Subjects
rMenB6	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	5/99- Mo 3	19 percentage of Subjects
rMenB6	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	44/76-SL- Mo 0	33 percentage of Subjects
rMenB6	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	5/99- Mo 7	86 percentage of Subjects
rMenB6	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	5/99- Mo 1	19 percentage of Subjects
rMenB6	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	5/99- Mo 0	14 percentage of Subjects
rMenB6	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	NZ98/254 Mo 0	29 percentage of Subjects
rMenB6	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	44/76-SL- Mo 7	89 percentage of Subjects
rMenB6	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	NZ98/254 Mo 1	26 percentage of Subjects
rMenB6	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	44/76-SL- Mo 6	34 percentage of Subjects
rMenB6	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	NZ98/254 Mo 7	86 percentage of Subjects
rMenB6	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	NZ98/254 Mo 2	31 percentage of Subjects
rMenB6	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	44/76-SL- Mo 3	36 percentage of Subjects
rMenB6	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	44/76-SL- Mo 2	33 percentage of Subjects
rMenB6	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	NZ98/254 Mo 3	30 percentage of Subjects
rMenB6	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	44/76-SL- Mo 1	30 percentage of Subjects
rMenB6	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	NZ98/254 Mo 6	38 percentage of Subjects
rMenB6	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	5/99- Mo 2	17 percentage of Subjects
rMenB6	Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	5/99- Mo 6	16 percentage of Subjects

Secondary

Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.

Immunogenicity was evaluated by measuring the percentage of subjects with at least a fourfold rise in hSBA titer over the prevaccination and after booster vaccination against 44/76-SL, 5/99, NZ98/254 strains at month-1, month-2, month-3 and month-7.

Time frame: Month-1, month-2, month-3 and month-7

Population: Analysis was performed as per the protocol dataset.

Arm	Measure	Group	Value (NUMBER)
rMenB06	Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.	44/76-SL Mo 7	95 percentage of Subjects
rMenB06	Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.	NZ98/254 Mo 7	94 percentage of Subjects
rMenB06	Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.	NZ98/254 Mo 3	50 percentage of Subjects
rMenB06	Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.	44/76-SL Mo 3	53 percentage of Subjects
rMenB06	Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.	44/76-SL Mo 1	73 percentage of Subjects
rMenB06	Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.	5/99 Mo 2	78 percentage of Subjects
rMenB06	Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.	5/99 Mo 3	65 percentage of Subjects
rMenB06	Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.	5/99- Mo 7	98 percentage of Subjects
rMenB06	Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.	44/76-SL Mo 2	62 percentage of Subjects
rMenB06	Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.	NZ98/254 Mo 1	72 percentage of Subjects
rMenB06	Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.	5/99 Mo 1	87 percentage of Subjects
rMenB06	Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.	NZ98/254 Mo 2	57 percentage of Subjects
rMenB0	Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.	5/99- Mo 7	27 percentage of Subjects
rMenB0	Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.	5/99 Mo 3	53 percentage of Subjects
rMenB0	Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.	NZ98/254 Mo 7	27 percentage of Subjects
rMenB0	Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.	44/76-SL Mo 2	67 percentage of Subjects
rMenB0	Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.	44/76-SL Mo 3	59 percentage of Subjects
rMenB0	Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.	NZ98/254 Mo 3	43 percentage of Subjects
rMenB0	Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.	44/76-SL Mo 7	33 percentage of Subjects
rMenB0	Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.	44/76-SL Mo 1	75 percentage of Subjects
rMenB0	Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.	NZ98/254 Mo 2	52 percentage of Subjects
rMenB0	Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.	5/99 Mo 1	79 percentage of Subjects
rMenB0	Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.	NZ98/254 Mo 1	70 percentage of Subjects
rMenB0	Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.	5/99 Mo 2	65 percentage of Subjects
rMenB016	Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.	NZ98/254 Mo 7	95 percentage of Subjects
rMenB016	Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.	5/99 Mo 2	98 percentage of Subjects
rMenB016	Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.	NZ98/254 Mo 1	65 percentage of Subjects
rMenB016	Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.	5/99 Mo 3	95 percentage of Subjects
rMenB016	Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.	NZ98/254 Mo 3	78 percentage of Subjects
rMenB016	Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.	5/99- Mo 7	99 percentage of Subjects
rMenB016	Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.	44/76-SL Mo 3	88 percentage of Subjects
rMenB016	Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.	44/76-SL Mo 2	94 percentage of Subjects
rMenB016	Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.	44/76-SL Mo 7	98 percentage of Subjects
rMenB016	Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.	5/99 Mo 1	81 percentage of Subjects
rMenB016	Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.	NZ98/254 Mo 2	89 percentage of Subjects
rMenB016	Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.	44/76-SL Mo 1	71 percentage of Subjects
rMenB01	Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.	NZ98/254 Mo 2	93 percentage of Subjects
rMenB01	Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.	44/76-SL Mo 7	73 percentage of Subjects
rMenB01	Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.	5/99 Mo 2	98 percentage of Subjects
rMenB01	Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.	44/76-SL Mo 2	96 percentage of Subjects
rMenB01	Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.	5/99 Mo 3	99 percentage of Subjects
rMenB01	Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.	5/99 Mo 1	85 percentage of Subjects
rMenB01	Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.	NZ98/254 Mo 7	62 percentage of Subjects
rMenB01	Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.	NZ98/254 Mo 1	74 percentage of Subjects
rMenB01	Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.	44/76-SL Mo 3	91 percentage of Subjects
rMenB01	Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.	44/76-SL Mo 1	77 percentage of Subjects
rMenB01	Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.	5/99- Mo 7	88 percentage of Subjects
rMenB01	Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.	NZ98/254 Mo 3	81 percentage of Subjects
rMenB026	Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.	5/99- Mo 7	99 percentage of Subjects
rMenB026	Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.	44/76-SL Mo 1	67 percentage of Subjects
rMenB026	Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.	44/76-SL Mo 2	65 percentage of Subjects
rMenB026	Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.	44/76-SL Mo 3	91 percentage of Subjects
rMenB026	Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.	44/76-SL Mo 7	93 percentage of Subjects
rMenB026	Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.	5/99 Mo 1	79 percentage of Subjects
rMenB026	Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.	5/99 Mo 2	63 percentage of Subjects
rMenB026	Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.	5/99 Mo 3	96 percentage of Subjects
rMenB026	Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.	NZ98/254 Mo 1	59 percentage of Subjects
rMenB026	Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.	NZ98/254 Mo 2	51 percentage of Subjects
rMenB026	Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.	NZ98/254 Mo 3	91 percentage of Subjects
rMenB026	Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.	NZ98/254 Mo 7	92 percentage of Subjects
rMenB02	Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.	44/76-SL Mo 3	95 percentage of Subjects
rMenB02	Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.	5/99 Mo 2	74 percentage of Subjects
rMenB02	Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.	44/76-SL Mo 7	76 percentage of Subjects
rMenB02	Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.	NZ98/254 Mo 2	57 percentage of Subjects
rMenB02	Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.	NZ98/254 Mo 7	69 percentage of Subjects
rMenB02	Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.	44/76-SL Mo 1	73 percentage of Subjects
rMenB02	Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.	5/99- Mo 7	90 percentage of Subjects
rMenB02	Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.	5/99 Mo 1	85 percentage of Subjects
rMenB02	Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.	44/76-SL Mo 2	61 percentage of Subjects
rMenB02	Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.	NZ98/254 Mo 1	64 percentage of Subjects
rMenB02	Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.	5/99 Mo 3	99 percentage of Subjects
rMenB02	Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.	NZ98/254 Mo 3	91 percentage of Subjects
rMenB012	Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.	5/99 Mo 2	98 percentage of Subjects
rMenB012	Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.	5/99- Mo 7	94 percentage of Subjects
rMenB012	Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.	5/99 Mo 1	85 percentage of Subjects
rMenB012	Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.	NZ98/254 Mo 1	73 percentage of Subjects
rMenB012	Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.	44/76-SL Mo 7	80 percentage of Subjects
rMenB012	Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.	NZ98/254 Mo 2	93 percentage of Subjects
rMenB012	Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.	44/76-SL Mo 3	95 percentage of Subjects
rMenB012	Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.	44/76-SL Mo 2	94 percentage of Subjects
rMenB012	Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.	NZ98/254 Mo 7	75 percentage of Subjects
rMenB012	Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.	NZ98/254 Mo 3	93 percentage of Subjects
rMenB012	Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.	44/76-SL Mo 1	72 percentage of Subjects
rMenB012	Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.	5/99 Mo 3	99 percentage of Subjects
rMenB6	Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.	5/99 Mo 3	6 percentage of Subjects
rMenB6	Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.	NZ98/254 Mo 1	3 percentage of Subjects
rMenB6	Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.	5/99 Mo 2	5 percentage of Subjects
rMenB6	Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.	NZ98/254 Mo 3	6 percentage of Subjects
rMenB6	Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.	NZ98/254 Mo 7	77 percentage of Subjects
rMenB6	Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.	44/76-SL Mo 3	3 percentage of Subjects
rMenB6	Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.	44/76-SL Mo 1	3 percentage of Subjects
rMenB6	Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.	NZ98/254 Mo 2	7 percentage of Subjects
rMenB6	Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.	5/99- Mo 7	82 percentage of Subjects
rMenB6	Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.	44/76-SL Mo 7	76 percentage of Subjects
rMenB6	Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.	44/76-SL Mo 2	6 percentage of Subjects
rMenB6	Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.	5/99 Mo 1	3 percentage of Subjects

Secondary

Percentages of Subjects With hSBA Titer ≥1:4 After Receiving a Booster Dose of rMenB+OMV NZ Vaccine at Month 6.

Immunogenicity was evaluated by measuring the percentage of subjects with hSBA titter \>1:4 agains 44/76-SL, 5/99, NZ98/254 strains at months 6 & 7.

Time frame: Month-6 & 7

Population: Analysis was performed as per the protocol dataset.

Arm	Measure	Group	Value (NUMBER)
rMenB06	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving a Booster Dose of rMenB+OMV NZ Vaccine at Month 6.	44/76-SL- Mo 7	100 percentage of Subjects
rMenB06	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving a Booster Dose of rMenB+OMV NZ Vaccine at Month 6.	NZ98/254-mo 6	81 percentage of Subjects
rMenB06	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving a Booster Dose of rMenB+OMV NZ Vaccine at Month 6.	44/76-SL- Mo 6	76 percentage of Subjects
rMenB06	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving a Booster Dose of rMenB+OMV NZ Vaccine at Month 6.	5/99- Mo 6	79 percentage of Subjects
rMenB06	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving a Booster Dose of rMenB+OMV NZ Vaccine at Month 6.	5/99- Mo 7	99 percentage of Subjects
rMenB06	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving a Booster Dose of rMenB+OMV NZ Vaccine at Month 6.	NZ98/254-mo 7	100 percentage of Subjects
rMenB0	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving a Booster Dose of rMenB+OMV NZ Vaccine at Month 6.	44/76-SL- Mo 6	72 percentage of Subjects
rMenB0	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving a Booster Dose of rMenB+OMV NZ Vaccine at Month 6.	5/99- Mo 7	67 percentage of Subjects
rMenB0	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving a Booster Dose of rMenB+OMV NZ Vaccine at Month 6.	NZ98/254-mo 6	69 percentage of Subjects
rMenB0	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving a Booster Dose of rMenB+OMV NZ Vaccine at Month 6.	5/99- Mo 6	74 percentage of Subjects
rMenB0	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving a Booster Dose of rMenB+OMV NZ Vaccine at Month 6.	44/76-SL- Mo 7	71 percentage of Subjects
rMenB0	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving a Booster Dose of rMenB+OMV NZ Vaccine at Month 6.	NZ98/254-mo 7	67 percentage of Subjects
rMenB016	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving a Booster Dose of rMenB+OMV NZ Vaccine at Month 6.	NZ98/254-mo 7	100 percentage of Subjects
rMenB016	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving a Booster Dose of rMenB+OMV NZ Vaccine at Month 6.	44/76-SL- Mo 6	93 percentage of Subjects
rMenB016	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving a Booster Dose of rMenB+OMV NZ Vaccine at Month 6.	5/99- Mo 7	100 percentage of Subjects
rMenB016	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving a Booster Dose of rMenB+OMV NZ Vaccine at Month 6.	44/76-SL- Mo 7	100 percentage of Subjects
rMenB016	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving a Booster Dose of rMenB+OMV NZ Vaccine at Month 6.	NZ98/254-mo 6	93 percentage of Subjects
rMenB016	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving a Booster Dose of rMenB+OMV NZ Vaccine at Month 6.	5/99- Mo 6	99 percentage of Subjects
rMenB01	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving a Booster Dose of rMenB+OMV NZ Vaccine at Month 6.	NZ98/254-mo 6	89 percentage of Subjects
rMenB01	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving a Booster Dose of rMenB+OMV NZ Vaccine at Month 6.	44/76-SL- Mo 7	90 percentage of Subjects
rMenB01	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving a Booster Dose of rMenB+OMV NZ Vaccine at Month 6.	44/76-SL- Mo 6	92 percentage of Subjects
rMenB01	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving a Booster Dose of rMenB+OMV NZ Vaccine at Month 6.	5/99- Mo 6	98 percentage of Subjects
rMenB01	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving a Booster Dose of rMenB+OMV NZ Vaccine at Month 6.	5/99- Mo 7	98 percentage of Subjects
rMenB01	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving a Booster Dose of rMenB+OMV NZ Vaccine at Month 6.	NZ98/254-mo 7	85 percentage of Subjects
rMenB026	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving a Booster Dose of rMenB+OMV NZ Vaccine at Month 6.	44/76-SL- Mo 7	100 percentage of Subjects
rMenB026	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving a Booster Dose of rMenB+OMV NZ Vaccine at Month 6.	5/99- Mo 6	99 percentage of Subjects
rMenB026	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving a Booster Dose of rMenB+OMV NZ Vaccine at Month 6.	5/99- Mo 7	100 percentage of Subjects
rMenB026	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving a Booster Dose of rMenB+OMV NZ Vaccine at Month 6.	NZ98/254-mo 6	97 percentage of Subjects
rMenB026	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving a Booster Dose of rMenB+OMV NZ Vaccine at Month 6.	NZ98/254-mo 7	100 percentage of Subjects
rMenB026	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving a Booster Dose of rMenB+OMV NZ Vaccine at Month 6.	44/76-SL- Mo 6	97 percentage of Subjects
rMenB02	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving a Booster Dose of rMenB+OMV NZ Vaccine at Month 6.	44/76-SL- Mo 7	95 percentage of Subjects
rMenB02	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving a Booster Dose of rMenB+OMV NZ Vaccine at Month 6.	44/76-SL- Mo 6	98 percentage of Subjects
rMenB02	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving a Booster Dose of rMenB+OMV NZ Vaccine at Month 6.	NZ98/254-mo 7	94 percentage of Subjects
rMenB02	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving a Booster Dose of rMenB+OMV NZ Vaccine at Month 6.	NZ98/254-mo 6	96 percentage of Subjects
rMenB02	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving a Booster Dose of rMenB+OMV NZ Vaccine at Month 6.	5/99- Mo 6	100 percentage of Subjects
rMenB02	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving a Booster Dose of rMenB+OMV NZ Vaccine at Month 6.	5/99- Mo 7	99 percentage of Subjects
rMenB012	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving a Booster Dose of rMenB+OMV NZ Vaccine at Month 6.	5/99- Mo 7	99 percentage of Subjects
rMenB012	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving a Booster Dose of rMenB+OMV NZ Vaccine at Month 6.	44/76-SL- Mo 7	95 percentage of Subjects
rMenB012	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving a Booster Dose of rMenB+OMV NZ Vaccine at Month 6.	NZ98/254-mo 6	97 percentage of Subjects
rMenB012	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving a Booster Dose of rMenB+OMV NZ Vaccine at Month 6.	44/76-SL- Mo 6	97 percentage of Subjects
rMenB012	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving a Booster Dose of rMenB+OMV NZ Vaccine at Month 6.	5/99- Mo 6	100 percentage of Subjects
rMenB012	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving a Booster Dose of rMenB+OMV NZ Vaccine at Month 6.	NZ98/254-mo 7	95 percentage of Subjects
rMenB6	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving a Booster Dose of rMenB+OMV NZ Vaccine at Month 6.	NZ98/254-mo 7	93 percentage of Subjects
rMenB6	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving a Booster Dose of rMenB+OMV NZ Vaccine at Month 6.	NZ98/254-mo 6	45 percentage of Subjects
rMenB6	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving a Booster Dose of rMenB+OMV NZ Vaccine at Month 6.	44/76-SL- Mo 6	46 percentage of Subjects
rMenB6	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving a Booster Dose of rMenB+OMV NZ Vaccine at Month 6.	5/99- Mo 7	93 percentage of Subjects
rMenB6	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving a Booster Dose of rMenB+OMV NZ Vaccine at Month 6.	44/76-SL- Mo 7	93 percentage of Subjects
rMenB6	Percentages of Subjects With hSBA Titer ≥1:4 After Receiving a Booster Dose of rMenB+OMV NZ Vaccine at Month 6.	5/99- Mo 6	28 percentage of Subjects

Post Hoc

Percentage of Subjects With hSBA Titers≥4 After Receiving Second Dose of Vaccination

Immunogenicity was evaluated by measuring the percentage of subjects with hSBA titter \>1:4 against M10713 strain at 1 month after second dose of vaccination (Month 3)

Time frame: At one month after second dose (Month 3)

Population: Analysis was performed as per the protocol dataset. Only groups rMenB01 and rMenB02 are applicable to this endpoint as the post-hoc outcome was assessed at an interval of 1 month (rMenB01) or 2 months (rMenB02 ) to kill M10713 strain.

Arm	Measure	Group	Value (NUMBER)
rMenB06	Percentage of Subjects With hSBA Titers≥4 After Receiving Second Dose of Vaccination	Baseline	96 Percentage of subjects
rMenB06	Percentage of Subjects With hSBA Titers≥4 After Receiving Second Dose of Vaccination	1 month after second dose	100 Percentage of subjects
rMenB0	Percentage of Subjects With hSBA Titers≥4 After Receiving Second Dose of Vaccination	1 month after second dose	100 Percentage of subjects
rMenB0	Percentage of Subjects With hSBA Titers≥4 After Receiving Second Dose of Vaccination	Baseline	80 Percentage of subjects

Source: ClinicalTrials.gov · Data processed: Mar 27, 2026

Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine Administered to Healthy Adolescents According to Different Vaccination Schedules

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Related papers

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Study design

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Secondary

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Participant flow

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Pre-assignment details

Participants by arm

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Baseline characteristics

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Outcome results

Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination

Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.

Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.

Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.

GMCs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination.

GMRs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination

Number of Subjects Reporting Unsolicited AEs Throughout the Study.

Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.

Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.

Percentages of Subjects With hSBA Titer ≥1:4 After Receiving a Booster Dose of rMenB+OMV NZ Vaccine at Month 6.

Percentage of Subjects With hSBA Titers≥4 After Receiving Second Dose of Vaccination