Study to Assess Potential Immune Interference When GlaxoSmithKline (GSK) Biologicals' MenABCWY Vaccine is Administered to Healthy Subjects Aged 10-25 Years

Immunogenicity and Safety of Meningococcal MenABCWY Vaccine, and of rMenB+OMV NZ and MenACWY Administered Concomitantly in the Same Arm or in 2 Different Arms, or Alone

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03587207

Enrollment

520

Registered

2018-07-16

Start date

2018-07-09

Completion date

2018-12-19

Last updated

2020-02-12

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

Conditions

Meningitis, Meningococcal

Keywords

Meningitis, Concomitantly, Adolescent, Neisseria meningitidis, Healthy subjects, Adult

Brief summary

The purpose of the current study is to evaluate whether there is immune interference when MenABCWY \[consisting of MenACWY lyophilized component and rMenB+OMV NZ (Bexsero) liquid component\] is administered to healthy adolescents and adults following a 2-dose vaccination schedule with MenABCWY administered 2 months apart.

Interventions

BIOLOGICALrMenB+OMV NZ (Bexsero) vaccine

Two doses administered 2 months apart intramuscularly in the deltoid region of the non-dominant arm to subjects randomised to the rMenBOMV+ACWY\_S Group, rMenBOMV+ACWY\_D Group and rMenBOMV Group

BIOLOGICALMenABCWY vaccine

Two doses administered intramuscularly in the deltoid region of the non-dominant arm.

BIOLOGICALMenACWY (Menveo) vaccine

Two doses administered intramuscularly in the deltoid region of the dominant/non-dominant arm to subjects randomised to the rMenBOMV+ACWY\_S Group and rMenBOMV+ACWY\_D Group and one dose administered intramuscularly in the deltoid region of the dominant/non-dominant arm to subjects randomised to the MenACWY Group

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

10 Years to 25 Years

Healthy volunteers

Yes

Inclusion criteria

* Subjects and/or subjects' parent(s)/Legally Acceptable Representative(s) (LARs) who, in the opinion of the investigator, can and will comply, with the requirements of the protocol (e.g. completion of the paper diary (pDiary), return for follow-up visits, availability for all visits scheduled in the study). * Written informed consent obtained from the subject and/or from the parent(s)/LAR(s) of the subject prior to performing any study specific procedure. * Written informed assent obtained from subjects below the legal age of consent prior to performing any study specific procedure. * A male or female between, and including, 10 to 25 years of age at the time of the first vaccination. * Healthy subjects as established by medical history and clinical examination before entering into the study. * Female subjects of non-childbearing potential may be enrolled in the study. * Non-childbearing potential is defined as pre menarche, current bilateral tubal ligation or occlusion, hysterectomy, or bilateral ovariectomy. * Female subjects of childbearing potential may be enrolled in the study, if the subject: * has practiced highly effective contraception for 30 days prior to vaccination, and * has a negative pregnancy test on the day of vaccination, and * has agreed to continue highly effective contraception during the entire treatment period and for 2 months after completion of the vaccination series.

Exclusion criteria

* Female planning to become pregnant or planning to discontinue contraceptive precautions * Pregnant or lactating female * Child in care * Current or previous, confirmed or suspected disease caused by N. meningitidis. * Known contact to an individual with any laboratory confirmed N. meningitidis infection within 60 days prior to enrolment. * Previous vaccination against N. meningitidis at any time prior to informed consent. * Progressive, unstable or uncontrolled clinical conditions. * Hypersensitivity, including allergy, to any component of vaccines, medicinal products or medical equipment whose use is foreseen in this study. * Clinical conditions representing a contraindication to IM vaccination and blood draws. * Abnormal function of the immune system resulting from: * Clinical conditions. * Systemic administration of corticosteroids (oral/intravenous/IM) for more than 14 consecutive days within 90 days prior to informed consent. * Administration of antineoplastic and immune modulating agents or radiotherapy within 90 days prior to informed consent. * Received immunoglobulins or any blood products within 180 days prior to informed consent. * Received an investigational or non registered medicinal product within 30 days prior to informed consent. * Any other clinical condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study. * Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non investigational vaccine/product. * Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic, or renal functional abnormality, as determined by physical examination. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. * Are obese at screening. * Family history of congenital or hereditary immunodeficiency. * History of neuroinflammatory or autoimmune condition. * History of significant neurological disorder or seizure. * Serious chronic illness. * History of chronic alcohol consumption and/or drug abuse. * Any study personnel as an immediate family or household member. * Administration of a vaccine not foreseen by the study protocol in the period starting 14 days (for inactivated vaccines), 28 days (for live vaccines), or 7 days (for influenza vaccines) before each dose and ending 14 days (for inactivated vaccines), 28 days (for live vaccines), or 7 days (for influenza vaccines) after each dose of study vaccine(s) administration. * Thrombocytopenia, bleeding disorders, or be receiving anticoagulant therapy.

Design outcomes

Primary

Measure	Time frame	Description
Human Serum Bactericidal Activity (hSBA) Adjusted Geometric Mean Titers (GMTs) Against All of N. Meningitidis Serogroup B Test Strains (Pooled), One Month After Last Vaccination.	1 month after last vaccination i.e.: at Day 91 for all groups except for the MenACWY Group	hSBA titers against all of N. meningitidis serogroup B test strains were calculated in terms of GMTs. Serogroup B strains tested were M14459 (factor H binding protein; fHbp), 96217 (Neisserial adhesin A; NadA), NZ98/254 (PorA), and M070241084 (Neisseria heparin binding antigen; NHBA). The serogroup B strains were grouped together to perform a pooled analysis. Adjusted means were obtained from ANCOVA model fitted to all of the Serogroup B test strains, study group, test strain and center as fixed effects; zero-centered pre-vaccination log-transformed titer was included as a continuous covariate.
hSBA Adjusted GMTs Against Each of the N. Meningitidis Serogroup B Test Strains and N. Meningitidis Serogroups A, C, W-135, and Y, One Month After Last Vaccination.	1 month after last vaccination i.e.: at Day 91 for all groups except the MenACWY Group, and at Day 31 for the MenACWY Group.	hSBA titers against each of the N. meningitidis serogroup B test strains and N. meningitidis serogroups A, C, W-135, and Y were calculated in terms of GMTs. Serogroup B strains tested were M14459 (factor H binding protein; fHbp), 96217 (Neisserial adhesin A; NadA), NZ98/254 (PorA), and M070241084 (Neisseria heparin binding antigen; NHBA). Adjusted means were obtained from ANCOVA model fitted to each Serogroup (Strain) individually, study group and center as fixed effects and zero-centered pre-vaccination log-transformed titer as a continuous covariate.
Percentage of Subjects With hSBA Titers Greater Than or Equal to(≥) the Lower Limit of Quantitation (LLOQ) Against Each of the N. Meningitidis Serogroup B Test Strains and Serogroups A, C, W-135 and Y,One Month After Last Vaccination.	1 month after last vaccination i.e.: at Day 91 for all groups except the MenACWY Group, and at Day 31 for the MenACWY Group.	Immune responses against N. meningitidis serogroup B test strains and N. meningitidis serogroups A, C, W-135, and Y, were calculated in terms of percentage of subjects with hSBA titers ≥ LLOQ. Serogroup B strains tested were M14459 (factor H binding protein; fHbp), 96217 (Neisserial adhesin A; NadA), NZ98/254 (PorA), and M070241084 (Neisseria heparin binding antigen; NHBA).
Percentage of Subjects With a 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination.	1 month after last vaccination versus baseline (i.e.: at Day 91 versus Day 1 for all groups except the MenACWY Group, and at Day 31 versus Day 1 for the MenACWY Group).	Immune responses against N. meningitidis serogroup B test strains and N. meningitidis serogroups A, C, W-135, and Y, were calculated in terms of percentage of subjects with a 4-fold increase in hSBA titers. A 4-fold rise was defined as: a) for individuals whose pre-vaccination titers were less than (\<) the limit of detection (LOD), the post-vaccination titers must have been ≥4-fold the LOD or ≥ the LLOQ, whichever was greater; b) for individuals whose pre-vaccination titers were ≥ the LOD and less than (\<) the LLOQ, the post-vaccination titers must have been at least 4 times the LLOQ; and c) for individuals whose pre-vaccination titers were ≥ the LLOQ, the post-vaccination titers must have been at least 4 times the pre-vaccination titer. Serogroup B strains tested were M14459 (factor H binding protein; fHbp), 96217 (Neisserial adhesin A; NadA), NZ98/254 (PorA), and M070241084 (Neisseria heparin binding antigen; NHBA).
hSBA Adjusted Geometric Mean Ratios (GMRs) Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination.	1 month after last vaccination versus baseline (i.e.: at Day 91 versus Day 1 for all groups except the MenACWY Group, and at Day 31 versus Day 1 for the MenACWY Group).	hSBA mean ratios at 1 month after the last vaccination versus baseline were calculated in terms of GMRs i.e. as the anti-logarithm of the mean of the change from baseline of log-transformed titer values at 1 month after last vaccination and Baseline. Serogroup B strains tested were M14459 (factor H binding protein; fHbp), 96217 (Neisserial adhesin A; NadA), NZ98/254 (PorA), and M070241084 (Neisseria heparin binding antigen; NHBA). Adjusted means were obtained from ANCOVA model fitted to each Serogroup (Strain) individually, study group and center as fixed effects and zero-centered pre-vaccination log-transformed titer as a continuous covariate.

Secondary

Measure	Time frame	Description
Number of Subjects With Any Solicited Local Adverse Events (AEs)	During the 7 days (including the day of vaccination) after each vaccination i.e after Dose 1 administered at Day 1 (for all groups) and after Dose 2 administered at Day 61 (for all groups except for MenACWY Group)	Assessed local AEs were erythema, swelling, induration and pain. Any erythema, swelling and induration is defined as a symptom with a surface diameter equal to or greater than 25 millimeters.
Number of Subjects With Any Solicited Systemic AEs	During the 7 days (including the day of vaccination) after each vaccination i.e after Dose 1 administered at Day 1 (for all groups) and after Dose 2 administered at Day 61 (for all groups except for MenACWY Group)	Assessed systemic AEs were arthralgia, fatigue, nausea, headache, myalgia and fever. Any fever is defined as body temperature equal or greater than 38 degrees Celsius.
hSBA Adjusted GMTs Against All of N. Meningitidis Serogroup B Test Strains (Pooled), One Month After First Vaccination	1 month after first vaccination i.e.: at Day 31 for all groups except for the MenACWY Group	hSBA titers against all of N. meningitidis serogroup B test strains were calculated in terms of GMTs. Serogroup B strains tested were M14459 (factor H binding protein; fHbp), 96217 (Neisserial adhesin A; NadA), NZ98/254 (PorA), and M070241084 (Neisseria heparin binding antigen; NHBA). The serogroup B strains were grouped together to perform a pooled analysis. Adjusted means were obtained from ANCOVA model fitted to all of the Serogroup B test strains, study group, test strain and center as fixed effects; zero-centered pre-vaccination log-transformed titer was included as a continuous covariate.
Number of Subjects With Serious Adverse Events (SAEs), Medically Attended AEs (MAEs), AEs Leading to Withdrawal, and Adverse Events of Special Interest (AESIs)	During the whole study period i.e from Day 1 to Day 91	SAE is defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability or incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Medically attended AEs are defined as symptoms or illnesses requiring hospitalization, or emergency room visit, or visit to/by a health care provider. AESIs are predefined (serious or non-serious) adverse events of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation in order to characterize and understand it.
Number of Subjects With Unsolicited AEs	During the 30 days (including the day of vaccination) after each vaccination i.e after Dose 1 administered at Day 1 (for all groups) and after Dose 2 administered at Day 61 (for all groups except for MenACWY Group)	An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. An unsolicited AE is an AE that was not solicited using a Subject Diary and that was spontaneously communicated by a subjects/parent(s)/ Legally Acceptable Representative who has signed the informed consent or a solicited local or systemic adverse event that continues beyond the solicited period at day 7 after vaccination.
hSBA Adjusted GMTs Against Each of the N. Meningitidis Serogroup B Test Strains and N. Meningitidis Serogroups A, C, W-135 and Y, One Month After First Vaccination.	1 month after first vaccination i.e.: at Day 31 for all groups except for the MenACWY Group.	hSBA titers against each of the N. meningitidis serogroup B test strains and N. meningitidis serogroups A, C, W-135, and Y were calculated in terms of GMTs. Serogroup B strains tested were M14459 (factor H binding protein; fHbp), 96217 (Neisserial adhesin A; NadA), NZ98/254 (PorA), and M070241084 (Neisseria heparin binding antigen; NHBA). Adjusted means were obtained from ANCOVA model fitted to each Serogroup (Strain) individually, study group and center as fixed effects and zero-centered pre-vaccination log-transformed titer as a continuous covariate.
Percentage of Subjects With hSBA Titers Greater Than or Equal to (≥) the LLOQ Against Each of the N. Meningitidis Serogroup B Test Strains and Against Serogroups A, C, W-135, and Y, One Month After First Vaccination	1 month after first vaccination i.e.: at Day 31 for all groups except for the MenACWY Group	Immune responses against N. meningitidis serogroup B test strains and N. meningitidis serogroups A, C, W-135, and Y, were calculated in terms of percentage of subjects with hSBA titers ≥ LLOQ. Serogroup B strains tested were M14459 (factor H binding protein; fHbp), 96217 (Neisserial adhesin A; NadA), NZ98/254 (PorA), and M070241084 (Neisseria heparin binding antigen; NHBA).
Percentage of Subjects With a 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135, and Y, One Month After First Vaccination	1 month after first vaccination versus baseline (i.e.: at Day 31 versus Day 1 for all groups except for the MenACWY Group)	Immune responses against N. meningitidis serogroup B test strains and N. meningitidis serogroups A, C, W-135, and Y, were calculated in terms of percentage of subjects with a 4-fold increase in hSBA titers. A 4-fold rise is defined as: a) for individuals whose pre-vaccination titers were less than (\<) the limit of detection (LOD), the post-vaccination titers must have been ≥4-fold the LOD or ≥ the LLOQ, whichever was greater; b) for individuals whose pre-vaccination titers were ≥ the LOD and less than (\<) the LLOQ, the post-vaccination titers must have been at least 4 times the LLOQ; and c) for individuals whose pre-vaccination titers were ≥ the LLOQ, the post-vaccination titers must have been at least 4 times the pre-vaccination titer. Serogroup B strains tested were M14459 (factor H binding protein; fHbp), 96217 (Neisserial adhesin A; NadA), NZ98/254 (PorA), and M070241084 (Neisseria heparin binding antigen; NHBA).
hSBA Adjusted GMRs Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135, and Y, One Month After First Vaccination	1 month after first vaccination versus baseline (i.e.: at Day 31 versus Day 1 for all groups except for the MenACWY Group)	hSBA mean ratios at 1 month after the first vaccination versus baseline were calculated in terms of GMRs. i.e. as the anti-logarithm of the mean of the change from baseline of log-transformed titer values at 1 month after first vaccination and Baseline. Serogroup B strains tested were M14459 (factor H binding protein; fHbp), 96217 (Neisserial adhesin A; NadA), NZ98/254 (PorA), and M070241084 (Neisseria heparin binding antigen; NHBA). Adjusted mean were obtained from ANCOVA model fitted to each Serogroup (Strain) individually, study group and center as fixed effects and zero-centered pre-vaccination log-transformed titer as a continuous covariate.

Countries

Czechia

Participant flow

Recruitment details

Subjects were recruited from 1 center at Czechia.

Pre-assignment details

Out of the total 520 subjects enrolled in this study, 500 subjects received the vaccination. Among the 20 subjects that were not vaccinated, 15 did not fuflill eligibility criteria and 5 were excluded due to other reasons.

Participants by arm

Arm	Count
MenABCWY Group Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) received one dose of MenABCWY twice, 2 months apart (Day 1 and Day 61).	100
rMenBOMV+ACWY_S Group Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) concomitantly received one dose of rMenB+OMV NZ (Bexsero) and one dose of MenACWY (Menveo) in the same arm twice, 2 months apart (Day 1 and Day 61).	104
rMenBOMV+ACWY_D Group Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) concomitantly received one dose of rMenB+OMV NZ (Bexsero) and one dose of MenACWY (Menveo) in 2 different arms twice, 2 months apart (Day 1 and Day 61).	100
rMenBOMV Group Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) received one dose of rMenB+OMV NZ (Bexsero) twice, 2 months apart (Day 1 and Day 61).	94
MenACWY Group Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) received one dose of MenACWY (Menveo) once at Day 1, which was the first and last vaccination for MenACWY group.	102
Total	500

Baseline characteristics

Characteristic	MenABCWY Group	rMenBOMV+ACWY_S Group	rMenBOMV+ACWY_D Group	rMenBOMV Group	MenACWY Group	Total
Age, Continuous	17.1 Years STANDARD_DEVIATION 4.34	16.9 Years STANDARD_DEVIATION 4.28	17.1 Years STANDARD_DEVIATION 4.49	17.4 Years STANDARD_DEVIATION 4.64	17.1 Years STANDARD_DEVIATION 4.57	17.1 Years STANDARD_DEVIATION 4.45
Race/Ethnicity, Customized Race WHITE	100 Participants	104 Participants	100 Participants	94 Participants	102 Participants	500 Participants
Sex: Female, Male Female	47 Participants	48 Participants	49 Participants	53 Participants	49 Participants	246 Participants
Sex: Female, Male Male	53 Participants	56 Participants	51 Participants	41 Participants	53 Participants	254 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
deaths Total, all-cause mortality	0 / 100	0 / 104	0 / 100	0 / 94	0 / 102
other Total, other adverse events	94 / 100	103 / 104	98 / 100	94 / 94	80 / 102
serious Total, serious adverse events	0 / 100	2 / 104	1 / 100	2 / 94	0 / 102

Outcome results

Primary

hSBA Adjusted Geometric Mean Ratios (GMRs) Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination.

hSBA mean ratios at 1 month after the last vaccination versus baseline were calculated in terms of GMRs i.e. as the anti-logarithm of the mean of the change from baseline of log-transformed titer values at 1 month after last vaccination and Baseline. Serogroup B strains tested were M14459 (factor H binding protein; fHbp), 96217 (Neisserial adhesin A; NadA), NZ98/254 (PorA), and M070241084 (Neisseria heparin binding antigen; NHBA). Adjusted means were obtained from ANCOVA model fitted to each Serogroup (Strain) individually, study group and center as fixed effects and zero-centered pre-vaccination log-transformed titer as a continuous covariate.

Time frame: 1 month after last vaccination versus baseline (i.e.: at Day 91 versus Day 1 for all groups except the MenACWY Group, and at Day 31 versus Day 1 for the MenACWY Group).

Population: Analysis was performed on PPS for immunogenicity that included subjects who had no major protocol violations and whose assay results were available for at least 1 serogroup or B strain at Day 91 for all study groups except MenACWY Group or at Day 31 for the MenACWY Group and at baseline for all study groups.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
MenABCWY Group	hSBA Adjusted Geometric Mean Ratios (GMRs) Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination.	Meningitis B M14459 (fHbp)	11.17 Ratio
MenABCWY Group	hSBA Adjusted Geometric Mean Ratios (GMRs) Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination.	Meningitis C	34.34 Ratio
MenABCWY Group	hSBA Adjusted Geometric Mean Ratios (GMRs) Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination.	Meningitis W	24.58 Ratio
MenABCWY Group	hSBA Adjusted Geometric Mean Ratios (GMRs) Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination.	Meningitis Y	106.87 Ratio
MenABCWY Group	hSBA Adjusted Geometric Mean Ratios (GMRs) Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination.	Meningitis A	33.21 Ratio
MenABCWY Group	hSBA Adjusted Geometric Mean Ratios (GMRs) Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination.	Meningitis B NZ98/254(PorA)	7.28 Ratio
MenABCWY Group	hSBA Adjusted Geometric Mean Ratios (GMRs) Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination.	Meningitis B M07-0241084(NHBA)	3.60 Ratio
MenABCWY Group	hSBA Adjusted Geometric Mean Ratios (GMRs) Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination.	Meningitis B 96217(NadA)	21.33 Ratio
rMenBOMV+ACWY_S Group	hSBA Adjusted Geometric Mean Ratios (GMRs) Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination.	Meningitis B NZ98/254(PorA)	9.20 Ratio
rMenBOMV+ACWY_S Group	hSBA Adjusted Geometric Mean Ratios (GMRs) Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination.	Meningitis B M07-0241084(NHBA)	4.96 Ratio
rMenBOMV+ACWY_S Group	hSBA Adjusted Geometric Mean Ratios (GMRs) Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination.	Meningitis A	59.36 Ratio
rMenBOMV+ACWY_S Group	hSBA Adjusted Geometric Mean Ratios (GMRs) Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination.	Meningitis C	28.74 Ratio
rMenBOMV+ACWY_S Group	hSBA Adjusted Geometric Mean Ratios (GMRs) Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination.	Meningitis W	23.21 Ratio
rMenBOMV+ACWY_S Group	hSBA Adjusted Geometric Mean Ratios (GMRs) Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination.	Meningitis Y	90.59 Ratio
rMenBOMV+ACWY_S Group	hSBA Adjusted Geometric Mean Ratios (GMRs) Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination.	Meningitis B M14459 (fHbp)	10.90 Ratio
rMenBOMV+ACWY_S Group	hSBA Adjusted Geometric Mean Ratios (GMRs) Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination.	Meningitis B 96217(NadA)	27.02 Ratio
rMenBOMV+ACWY_D Group	hSBA Adjusted Geometric Mean Ratios (GMRs) Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination.	Meningitis B 96217(NadA)	25.66 Ratio
rMenBOMV+ACWY_D Group	hSBA Adjusted Geometric Mean Ratios (GMRs) Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination.	Meningitis B M14459 (fHbp)	10.85 Ratio
rMenBOMV+ACWY_D Group	hSBA Adjusted Geometric Mean Ratios (GMRs) Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination.	Meningitis W	24.02 Ratio
rMenBOMV+ACWY_D Group	hSBA Adjusted Geometric Mean Ratios (GMRs) Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination.	Meningitis A	64.58 Ratio
rMenBOMV+ACWY_D Group	hSBA Adjusted Geometric Mean Ratios (GMRs) Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination.	Meningitis B NZ98/254(PorA)	11.85 Ratio
rMenBOMV+ACWY_D Group	hSBA Adjusted Geometric Mean Ratios (GMRs) Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination.	Meningitis C	28.86 Ratio
rMenBOMV+ACWY_D Group	hSBA Adjusted Geometric Mean Ratios (GMRs) Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination.	Meningitis B M07-0241084(NHBA)	6.22 Ratio
rMenBOMV+ACWY_D Group	hSBA Adjusted Geometric Mean Ratios (GMRs) Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination.	Meningitis Y	99.76 Ratio
rMenBOMV Group	hSBA Adjusted Geometric Mean Ratios (GMRs) Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination.	Meningitis B 96217(NadA)	29.87 Ratio
rMenBOMV Group	hSBA Adjusted Geometric Mean Ratios (GMRs) Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination.	Meningitis A	30.05 Ratio
rMenBOMV Group	hSBA Adjusted Geometric Mean Ratios (GMRs) Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination.	Meningitis B M14459 (fHbp)	10.69 Ratio
rMenBOMV Group	hSBA Adjusted Geometric Mean Ratios (GMRs) Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination.	Meningitis B NZ98/254(PorA)	11.77 Ratio
rMenBOMV Group	hSBA Adjusted Geometric Mean Ratios (GMRs) Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination.	Meningitis B M07-0241084(NHBA)	6.98 Ratio
rMenBOMV Group	hSBA Adjusted Geometric Mean Ratios (GMRs) Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination.	Meningitis C	6.35 Ratio
rMenBOMV Group	hSBA Adjusted Geometric Mean Ratios (GMRs) Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination.	Meningitis W	18.29 Ratio
rMenBOMV Group	hSBA Adjusted Geometric Mean Ratios (GMRs) Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination.	Meningitis Y	1.78 Ratio
MenACWY Group	hSBA Adjusted Geometric Mean Ratios (GMRs) Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination.	Meningitis B M14459 (fHbp)	1.16 Ratio
MenACWY Group	hSBA Adjusted Geometric Mean Ratios (GMRs) Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination.	Meningitis C	6.88 Ratio
MenACWY Group	hSBA Adjusted Geometric Mean Ratios (GMRs) Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination.	Meningitis B NZ98/254(PorA)	1.21 Ratio
MenACWY Group	hSBA Adjusted Geometric Mean Ratios (GMRs) Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination.	Meningitis Y	44.99 Ratio
MenACWY Group	hSBA Adjusted Geometric Mean Ratios (GMRs) Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination.	Meningitis W	7.57 Ratio
MenACWY Group	hSBA Adjusted Geometric Mean Ratios (GMRs) Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination.	Meningitis B M07-0241084(NHBA)	1.12 Ratio
MenACWY Group	hSBA Adjusted Geometric Mean Ratios (GMRs) Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination.	Meningitis A	16.47 Ratio
MenACWY Group	hSBA Adjusted Geometric Mean Ratios (GMRs) Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination.	Meningitis B 96217(NadA)	1.09 Ratio

Primary

hSBA Adjusted GMTs Against Each of the N. Meningitidis Serogroup B Test Strains and N. Meningitidis Serogroups A, C, W-135, and Y, One Month After Last Vaccination.

hSBA titers against each of the N. meningitidis serogroup B test strains and N. meningitidis serogroups A, C, W-135, and Y were calculated in terms of GMTs. Serogroup B strains tested were M14459 (factor H binding protein; fHbp), 96217 (Neisserial adhesin A; NadA), NZ98/254 (PorA), and M070241084 (Neisseria heparin binding antigen; NHBA). Adjusted means were obtained from ANCOVA model fitted to each Serogroup (Strain) individually, study group and center as fixed effects and zero-centered pre-vaccination log-transformed titer as a continuous covariate.

Time frame: 1 month after last vaccination i.e.: at Day 91 for all groups except the MenACWY Group, and at Day 31 for the MenACWY Group.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
MenABCWY Group	hSBA Adjusted GMTs Against Each of the N. Meningitidis Serogroup B Test Strains and N. Meningitidis Serogroups A, C, W-135, and Y, One Month After Last Vaccination.	Meningitis B M07-0241084(NHBA)	13.08 titers
MenABCWY Group	hSBA Adjusted GMTs Against Each of the N. Meningitidis Serogroup B Test Strains and N. Meningitidis Serogroups A, C, W-135, and Y, One Month After Last Vaccination.	Meningitis A	104.90 titers
MenABCWY Group	hSBA Adjusted GMTs Against Each of the N. Meningitidis Serogroup B Test Strains and N. Meningitidis Serogroups A, C, W-135, and Y, One Month After Last Vaccination.	Meningitis B 96217(NadA)	81.09 titers
MenABCWY Group	hSBA Adjusted GMTs Against Each of the N. Meningitidis Serogroup B Test Strains and N. Meningitidis Serogroups A, C, W-135, and Y, One Month After Last Vaccination.	Meningitis Y	219.52 titers
MenABCWY Group	hSBA Adjusted GMTs Against Each of the N. Meningitidis Serogroup B Test Strains and N. Meningitidis Serogroups A, C, W-135, and Y, One Month After Last Vaccination.	Meningitis W	260.11 titers
MenABCWY Group	hSBA Adjusted GMTs Against Each of the N. Meningitidis Serogroup B Test Strains and N. Meningitidis Serogroups A, C, W-135, and Y, One Month After Last Vaccination.	Meningitis B NZ98/254(PorA)	12.97 titers
MenABCWY Group	hSBA Adjusted GMTs Against Each of the N. Meningitidis Serogroup B Test Strains and N. Meningitidis Serogroups A, C, W-135, and Y, One Month After Last Vaccination.	Meningitis C	172.99 titers
MenABCWY Group	hSBA Adjusted GMTs Against Each of the N. Meningitidis Serogroup B Test Strains and N. Meningitidis Serogroups A, C, W-135, and Y, One Month After Last Vaccination.	Meningitis B M14459 (fHbp)	23.91 titers
rMenBOMV+ACWY_S Group	hSBA Adjusted GMTs Against Each of the N. Meningitidis Serogroup B Test Strains and N. Meningitidis Serogroups A, C, W-135, and Y, One Month After Last Vaccination.	Meningitis B M07-0241084(NHBA)	18.00 titers
rMenBOMV+ACWY_S Group	hSBA Adjusted GMTs Against Each of the N. Meningitidis Serogroup B Test Strains and N. Meningitidis Serogroups A, C, W-135, and Y, One Month After Last Vaccination.	Meningitis B M14459 (fHbp)	23.34 titers
rMenBOMV+ACWY_S Group	hSBA Adjusted GMTs Against Each of the N. Meningitidis Serogroup B Test Strains and N. Meningitidis Serogroups A, C, W-135, and Y, One Month After Last Vaccination.	Meningitis Y	186.08 titers
rMenBOMV+ACWY_S Group	hSBA Adjusted GMTs Against Each of the N. Meningitidis Serogroup B Test Strains and N. Meningitidis Serogroups A, C, W-135, and Y, One Month After Last Vaccination.	Meningitis W	245.63 titers
rMenBOMV+ACWY_S Group	hSBA Adjusted GMTs Against Each of the N. Meningitidis Serogroup B Test Strains and N. Meningitidis Serogroups A, C, W-135, and Y, One Month After Last Vaccination.	Meningitis B NZ98/254(PorA)	16.39 titers
rMenBOMV+ACWY_S Group	hSBA Adjusted GMTs Against Each of the N. Meningitidis Serogroup B Test Strains and N. Meningitidis Serogroups A, C, W-135, and Y, One Month After Last Vaccination.	Meningitis A	187.52 titers
rMenBOMV+ACWY_S Group	hSBA Adjusted GMTs Against Each of the N. Meningitidis Serogroup B Test Strains and N. Meningitidis Serogroups A, C, W-135, and Y, One Month After Last Vaccination.	Meningitis C	144.80 titers
rMenBOMV+ACWY_S Group	hSBA Adjusted GMTs Against Each of the N. Meningitidis Serogroup B Test Strains and N. Meningitidis Serogroups A, C, W-135, and Y, One Month After Last Vaccination.	Meningitis B 96217(NadA)	102.68 titers
rMenBOMV+ACWY_D Group	hSBA Adjusted GMTs Against Each of the N. Meningitidis Serogroup B Test Strains and N. Meningitidis Serogroups A, C, W-135, and Y, One Month After Last Vaccination.	Meningitis B M14459 (fHbp)	23.23 titers
rMenBOMV+ACWY_D Group	hSBA Adjusted GMTs Against Each of the N. Meningitidis Serogroup B Test Strains and N. Meningitidis Serogroups A, C, W-135, and Y, One Month After Last Vaccination.	Meningitis B 96217(NadA)	97.54 titers
rMenBOMV+ACWY_D Group	hSBA Adjusted GMTs Against Each of the N. Meningitidis Serogroup B Test Strains and N. Meningitidis Serogroups A, C, W-135, and Y, One Month After Last Vaccination.	Meningitis A	204.01 titers
rMenBOMV+ACWY_D Group	hSBA Adjusted GMTs Against Each of the N. Meningitidis Serogroup B Test Strains and N. Meningitidis Serogroups A, C, W-135, and Y, One Month After Last Vaccination.	Meningitis Y	204.92 titers
rMenBOMV+ACWY_D Group	hSBA Adjusted GMTs Against Each of the N. Meningitidis Serogroup B Test Strains and N. Meningitidis Serogroups A, C, W-135, and Y, One Month After Last Vaccination.	Meningitis B NZ98/254(PorA)	21.12 titers
rMenBOMV+ACWY_D Group	hSBA Adjusted GMTs Against Each of the N. Meningitidis Serogroup B Test Strains and N. Meningitidis Serogroups A, C, W-135, and Y, One Month After Last Vaccination.	Meningitis B M07-0241084(NHBA)	22.59 titers
rMenBOMV+ACWY_D Group	hSBA Adjusted GMTs Against Each of the N. Meningitidis Serogroup B Test Strains and N. Meningitidis Serogroups A, C, W-135, and Y, One Month After Last Vaccination.	Meningitis C	145.42 titers
rMenBOMV+ACWY_D Group	hSBA Adjusted GMTs Against Each of the N. Meningitidis Serogroup B Test Strains and N. Meningitidis Serogroups A, C, W-135, and Y, One Month After Last Vaccination.	Meningitis W	254.20 titers
rMenBOMV Group	hSBA Adjusted GMTs Against Each of the N. Meningitidis Serogroup B Test Strains and N. Meningitidis Serogroups A, C, W-135, and Y, One Month After Last Vaccination.	Meningitis Y	3.66 titers
rMenBOMV Group	hSBA Adjusted GMTs Against Each of the N. Meningitidis Serogroup B Test Strains and N. Meningitidis Serogroups A, C, W-135, and Y, One Month After Last Vaccination.	Meningitis A	94.91 titers
rMenBOMV Group	hSBA Adjusted GMTs Against Each of the N. Meningitidis Serogroup B Test Strains and N. Meningitidis Serogroups A, C, W-135, and Y, One Month After Last Vaccination.	Meningitis B 96217(NadA)	113.54 titers
rMenBOMV Group	hSBA Adjusted GMTs Against Each of the N. Meningitidis Serogroup B Test Strains and N. Meningitidis Serogroups A, C, W-135, and Y, One Month After Last Vaccination.	Meningitis B M14459 (fHbp)	22.87 titers
rMenBOMV Group	hSBA Adjusted GMTs Against Each of the N. Meningitidis Serogroup B Test Strains and N. Meningitidis Serogroups A, C, W-135, and Y, One Month After Last Vaccination.	Meningitis W	193.58 titers
rMenBOMV Group	hSBA Adjusted GMTs Against Each of the N. Meningitidis Serogroup B Test Strains and N. Meningitidis Serogroups A, C, W-135, and Y, One Month After Last Vaccination.	Meningitis B M07-0241084(NHBA)	25.34 titers
rMenBOMV Group	hSBA Adjusted GMTs Against Each of the N. Meningitidis Serogroup B Test Strains and N. Meningitidis Serogroups A, C, W-135, and Y, One Month After Last Vaccination.	Meningitis B NZ98/254(PorA)	20.97 titers
rMenBOMV Group	hSBA Adjusted GMTs Against Each of the N. Meningitidis Serogroup B Test Strains and N. Meningitidis Serogroups A, C, W-135, and Y, One Month After Last Vaccination.	Meningitis C	32.01 titers
MenACWY Group	hSBA Adjusted GMTs Against Each of the N. Meningitidis Serogroup B Test Strains and N. Meningitidis Serogroups A, C, W-135, and Y, One Month After Last Vaccination.	Meningitis Y	92.41 titers
MenACWY Group	hSBA Adjusted GMTs Against Each of the N. Meningitidis Serogroup B Test Strains and N. Meningitidis Serogroups A, C, W-135, and Y, One Month After Last Vaccination.	Meningitis B M07-0241084(NHBA)	4.08 titers
MenACWY Group	hSBA Adjusted GMTs Against Each of the N. Meningitidis Serogroup B Test Strains and N. Meningitidis Serogroups A, C, W-135, and Y, One Month After Last Vaccination.	Meningitis A	52.03 titers
MenACWY Group	hSBA Adjusted GMTs Against Each of the N. Meningitidis Serogroup B Test Strains and N. Meningitidis Serogroups A, C, W-135, and Y, One Month After Last Vaccination.	Meningitis B M14459 (fHbp)	2.48 titers
MenACWY Group	hSBA Adjusted GMTs Against Each of the N. Meningitidis Serogroup B Test Strains and N. Meningitidis Serogroups A, C, W-135, and Y, One Month After Last Vaccination.	Meningitis C	34.66 titers
MenACWY Group	hSBA Adjusted GMTs Against Each of the N. Meningitidis Serogroup B Test Strains and N. Meningitidis Serogroups A, C, W-135, and Y, One Month After Last Vaccination.	Meningitis B 96217(NadA)	4.15 titers
MenACWY Group	hSBA Adjusted GMTs Against Each of the N. Meningitidis Serogroup B Test Strains and N. Meningitidis Serogroups A, C, W-135, and Y, One Month After Last Vaccination.	Meningitis B NZ98/254(PorA)	2.15 titers
MenACWY Group	hSBA Adjusted GMTs Against Each of the N. Meningitidis Serogroup B Test Strains and N. Meningitidis Serogroups A, C, W-135, and Y, One Month After Last Vaccination.	Meningitis W	80.11 titers

Comparison: Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY\_S versus rMenBOMV+ACWY\_D study groups, on the Meningitis B M14459 (fHbp) strain, one month after last vaccination.80% CI: [0.84, 1.2]ANCOVA

Comparison: Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY\_S versus rMenBOMV+ACWY\_D study groups, on the Meningitis B 96217 (NadA) strain, one month after last vaccination.80% CI: [0.88, 1.26]ANCOVA

Comparison: Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY\_S versus rMenBOMV+ACWY\_D study groups, on the Meningitis B NZ98/254 (PorA) strain, one month after last vaccination.80% CI: [0.64, 0.95]ANCOVA

Comparison: Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY\_S versus rMenBOMV+ACWY\_D study groups, on the Meningitis B M07-0241084 (NHBA) strain, one month after last vaccination.80% CI: [0.66, 0.96]ANCOVA

Comparison: Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY\_S versus rMenBOMV+ACWY\_D study groups, on the Meningitis serogroup A, one month after last vaccination.80% CI: [0.74, 1.14]ANCOVA

Comparison: Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY\_S versus rMenBOMV+ACWY\_D study groups, on the Meningitis serogroup C, one month after last vaccination.80% CI: [0.78, 1.27]ANCOVA

Comparison: Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY\_S versus rMenBOMV+ACWY\_D study groups, on the Meningitis serogroup W, one month after last vaccination.80% CI: [0.79, 1.18]ANCOVA

Comparison: Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY\_S versus rMenBOMV+ACWY\_D study groups, on the Meningitis serogroup Y, one month after last vaccination.80% CI: [0.69, 1.19]ANCOVA

Comparison: Other unknown interference in MenABCWY versus rMenBOMV+ACWY\_S study groups, on the Meningitis B M14459 (fHbp) strain, one month after last vaccination.80% CI: [0.86, 1.22]ANCOVA

Comparison: Other unknown interference in MenABCWY versus rMenBOMV+ACWY\_S study groups, on the Meningitis B 96217 (NadA)strain, one month after last vaccination.80% CI: [0.66, 0.95]ANCOVA

Comparison: Other unknown interference in MenABCWY versus rMenBOMV+ACWY\_S study groups, on the Meningitis B NZ98/254 (PorA) strain, one month after last vaccination.80% CI: [0.65, 0.97]ANCOVA

Comparison: Other unknown interference in MenABCWY versus rMenBOMV+ACWY\_S study groups, on the Meningitis B M07-0241084 (NHBA) strain, one month after last vaccination.80% CI: [0.6, 0.88]ANCOVA

Comparison: Other unknown interference in MenABCWY versus rMenBOMV+ACWY\_S study groups, on the Meningitis serogrpoup A, one month after last vaccination.80% CI: [0.45, 0.69]ANCOVA

Comparison: Other unknown interference in MenABCWY versus rMenBOMV+ACWY\_S study groups, on the Meningitis serogroup C, one month after last vaccination.80% CI: [0.94, 1.52]ANCOVA

Comparison: Other unknown interference in MenABCWY versus rMenBOMV+ACWY\_S study groups, on the Meningitis serogroup W, one month after last vaccination.80% CI: [0.87, 1.29]ANCOVA

Comparison: Other unknown interference in MenABCWY versus rMenBOMV+ACWY\_S study groups, on the Meningitis serogroup Y, one month after last vaccination.80% CI: [0.9, 1.55]ANCOVA

Comparison: To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_S versus rMenBOMV study groups, on the Meningitis B M14459(fHbp) strain, one month after last vaccination.80% CI: [0.85, 1.22]ANCOVA

Comparison: To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_S versus rMenBOMV study groups, on the Meningitis B 96217 (NadA) strain, one month after last vaccination.80% CI: [0.75, 1.09]ANCOVA

Comparison: To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_S versus rMenBOMV study groups, on the Meningitis B NZ98/254 (PorA) strain, one month after last vaccination.80% CI: [0.64, 0.96]ANCOVA

Comparison: To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_S versus rMenBOMV study groups, on the Meningitis B M07-0241084 (NHBA) strain, one month after last vaccination.80% CI: [0.58, 0.86]ANCOVA

Comparison: To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_S versus MenACWY study groups, on the Meningitis serogroup A, one month after last vaccination.80% CI: [2.9, 4.47]ANCOVA

Comparison: To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_S versus MenACWY study groups, on the Meningitis serogroup C, one month after last vaccination.80% CI: [3.28, 5.31]ANCOVA

Comparison: To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_S versus MenACWY study groups, on the Meningitis serogroup W, one month after last vaccination.80% CI: [2.52, 3.73]ANCOVA

Comparison: To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_S versus MenACWY study groups, on the Meningitis serogroup Y, one month after last vaccination.80% CI: [1.53, 2.65]ANCOVA

Comparison: To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_D versus rMenBOMV study groups, on the Meningitis B M14459 (fHbp) strain, one month after last vaccination.80% CI: [0.85, 1.22]ANCOVA

Comparison: To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_D versus rMenBOMV study groups, on the Meningitis B 96217 (NadA) strain, one month after last vaccination.80% CI: [0.71, 1.04]ANCOVA

Comparison: To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_D versus rMenBOMV study groups, on the Meningitis B NZ98/254 (PorA) strain, one month after last vaccination.80% CI: [0.82, 1.24]ANCOVA

Comparison: To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_D versus rMenBOMV study groups, on the Meningitis B M07-0241084 (NHBA) strain, one month after last vaccination.80% CI: [0.73, 1.09]ANCOVA

Comparison: To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_D versus MenACWY study groups, on the Meningitis serogroup A, one month after last vaccination.80% CI: [3.15, 4.88]ANCOVA

Comparison: To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_D versus MenACWY study groups, on the Meningitis serogroup C, one month after last vaccination.80% CI: [3.3, 5.34]ANCOVA

Comparison: To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_D versus MenACWY study groups, on the Meningitis serogroup W, one month after last vaccination.80% CI: [2.6, 3.87]ANCOVA

Comparison: To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_D versus MenACWY study groups, on the Meningitis serogroup Y, one month after last vaccination.80% CI: [1.68, 2.92]ANCOVA

Comparison: To investigate possible effects on the immune response based on strains common to MenABCWY versus rMenBOMV study groups, on the Meningitis B M14459 (fHbp) strain, one month after last vaccination.80% CI: [0.87, 1.25]ANCOVA

Comparison: To investigate possible effects on the immune response based on strains common to MenABCWY versus rMenBOMV study groups, on the Meningitis B 96217 (NadA) strain, one month after last vaccination.80% CI: [0.59, 0.86]ANCOVA

Comparison: To investigate possible effects on the immune response based on strains common to MenABCWY versus rMenBOMV study groups, on the Meningitis B NZ98/254 (PorA) strain, one month after last vaccination.80% CI: [0.5, 0.76]ANCOVA

Comparison: To investigate possible effects on the immune response based on strains common to MenABCWY versus rMenBOMV study groups, on the Meningitis B M07-0241084 (NHBA) strain, one month after last vaccination.80% CI: [0.42, 0.63]ANCOVA

Comparison: To investigate possible effects on the immune response based on strains common to MenABCWY versus MenACWY study groups, on the Meningitis serogroup A, one month after last vaccination.80% CI: [1.62, 2.51]ANCOVA

Comparison: To investigate possible effects on the immune response based on strains common to MenABCWY versus MenACWY study groups, on the Meningitis serogroup C, one month after last vaccination.80% CI: [3.92, 6.35]ANCOVA

Comparison: To investigate possible effects on the immune response based on strains common to MenABCWY versus MenACWY study groups, on the Meningitis serogroup W, one month after last vaccination.80% CI: [2.66, 3.96]ANCOVA

Comparison: To investigate possible effects on the immune response based on strains common to MenABCWY versus MenACWY study groups, on the Meningitis serogroup Y, one month after last vaccination.80% CI: [1.81, 3.12]ANCOVA

Primary

Human Serum Bactericidal Activity (hSBA) Adjusted Geometric Mean Titers (GMTs) Against All of N. Meningitidis Serogroup B Test Strains (Pooled), One Month After Last Vaccination.

hSBA titers against all of N. meningitidis serogroup B test strains were calculated in terms of GMTs. Serogroup B strains tested were M14459 (factor H binding protein; fHbp), 96217 (Neisserial adhesin A; NadA), NZ98/254 (PorA), and M070241084 (Neisseria heparin binding antigen; NHBA). The serogroup B strains were grouped together to perform a pooled analysis. Adjusted means were obtained from ANCOVA model fitted to all of the Serogroup B test strains, study group, test strain and center as fixed effects; zero-centered pre-vaccination log-transformed titer was included as a continuous covariate.

Time frame: 1 month after last vaccination i.e.: at Day 91 for all groups except for the MenACWY Group

Population: Analysis performed on Per Protocol Set(PPS) for immunogenicity that included subjects without major protocol violations \& whose assay results were available for atleast 1 serogroup/B strain at Day 91 for all study groups except MenACWY group that was not considered for this analysis as only serogroup B strains were assessed in this outcome measure

Arm	Measure	Value (GEOMETRIC_MEAN)
MenABCWY Group	Human Serum Bactericidal Activity (hSBA) Adjusted Geometric Mean Titers (GMTs) Against All of N. Meningitidis Serogroup B Test Strains (Pooled), One Month After Last Vaccination.	31.84 titers
rMenBOMV+ACWY_S Group	Human Serum Bactericidal Activity (hSBA) Adjusted Geometric Mean Titers (GMTs) Against All of N. Meningitidis Serogroup B Test Strains (Pooled), One Month After Last Vaccination.	38.48 titers
rMenBOMV+ACWY_D Group	Human Serum Bactericidal Activity (hSBA) Adjusted Geometric Mean Titers (GMTs) Against All of N. Meningitidis Serogroup B Test Strains (Pooled), One Month After Last Vaccination.	40.08 titers
rMenBOMV Group	Human Serum Bactericidal Activity (hSBA) Adjusted Geometric Mean Titers (GMTs) Against All of N. Meningitidis Serogroup B Test Strains (Pooled), One Month After Last Vaccination.	42.38 titers

Comparison: Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY\_S versus rMenBOMV+ACWY\_D study groups, on the pooled B strains, one month after last vaccination.80% CI: [0.83, 1.1]ANCOVA

Primary

Percentage of Subjects With a 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination.

Immune responses against N. meningitidis serogroup B test strains and N. meningitidis serogroups A, C, W-135, and Y, were calculated in terms of percentage of subjects with a 4-fold increase in hSBA titers. A 4-fold rise was defined as: a) for individuals whose pre-vaccination titers were less than (\<) the limit of detection (LOD), the post-vaccination titers must have been ≥4-fold the LOD or ≥ the LLOQ, whichever was greater; b) for individuals whose pre-vaccination titers were ≥ the LOD and less than (\<) the LLOQ, the post-vaccination titers must have been at least 4 times the LLOQ; and c) for individuals whose pre-vaccination titers were ≥ the LLOQ, the post-vaccination titers must have been at least 4 times the pre-vaccination titer. Serogroup B strains tested were M14459 (factor H binding protein; fHbp), 96217 (Neisserial adhesin A; NadA), NZ98/254 (PorA), and M070241084 (Neisseria heparin binding antigen; NHBA).

Time frame: 1 month after last vaccination versus baseline (i.e.: at Day 91 versus Day 1 for all groups except the MenACWY Group, and at Day 31 versus Day 1 for the MenACWY Group).

Arm	Measure	Group	Value (NUMBER)
MenABCWY Group	Percentage of Subjects With a 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination.	Meningitis Y	95.9 Percentage of subjects
MenABCWY Group	Percentage of Subjects With a 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination.	Meningitis W	83.3 Percentage of subjects
MenABCWY Group	Percentage of Subjects With a 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination.	Meningitis C	90.8 Percentage of subjects
MenABCWY Group	Percentage of Subjects With a 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination.	Meningitis B 96217(NadA)	80.4 Percentage of subjects
MenABCWY Group	Percentage of Subjects With a 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination.	Meningitis A	92.7 Percentage of subjects
MenABCWY Group	Percentage of Subjects With a 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination.	Meningitis B NZ98/254 (PorA)	48.0 Percentage of subjects
MenABCWY Group	Percentage of Subjects With a 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination.	Meningitis B M14459 (fHbp)	66.0 Percentage of subjects
MenABCWY Group	Percentage of Subjects With a 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination.	Meningitis B M07-0241084(NHBA)	21.4 Percentage of subjects
rMenBOMV+ACWY_S Group	Percentage of Subjects With a 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination.	Meningitis B M14459 (fHbp)	69.0 Percentage of subjects
rMenBOMV+ACWY_S Group	Percentage of Subjects With a 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination.	Meningitis B M07-0241084(NHBA)	38.8 Percentage of subjects
rMenBOMV+ACWY_S Group	Percentage of Subjects With a 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination.	Meningitis A	99.0 Percentage of subjects
rMenBOMV+ACWY_S Group	Percentage of Subjects With a 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination.	Meningitis B 96217(NadA)	88.0 Percentage of subjects
rMenBOMV+ACWY_S Group	Percentage of Subjects With a 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination.	Meningitis B NZ98/254 (PorA)	60.0 Percentage of subjects
rMenBOMV+ACWY_S Group	Percentage of Subjects With a 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination.	Meningitis C	91.9 Percentage of subjects
rMenBOMV+ACWY_S Group	Percentage of Subjects With a 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination.	Meningitis W	78.6 Percentage of subjects
rMenBOMV+ACWY_S Group	Percentage of Subjects With a 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination.	Meningitis Y	91.9 Percentage of subjects
rMenBOMV+ACWY_D Group	Percentage of Subjects With a 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination.	Meningitis B M07-0241084(NHBA)	42.1 Percentage of subjects
rMenBOMV+ACWY_D Group	Percentage of Subjects With a 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination.	Meningitis B M14459 (fHbp)	66.3 Percentage of subjects
rMenBOMV+ACWY_D Group	Percentage of Subjects With a 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination.	Meningitis B NZ98/254 (PorA)	58.8 Percentage of subjects
rMenBOMV+ACWY_D Group	Percentage of Subjects With a 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination.	Meningitis B 96217(NadA)	90.5 Percentage of subjects
rMenBOMV+ACWY_D Group	Percentage of Subjects With a 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination.	Meningitis Y	93.7 Percentage of subjects
rMenBOMV+ACWY_D Group	Percentage of Subjects With a 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination.	Meningitis W	74.2 Percentage of subjects
rMenBOMV+ACWY_D Group	Percentage of Subjects With a 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination.	Meningitis A	98.9 Percentage of subjects
rMenBOMV+ACWY_D Group	Percentage of Subjects With a 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination.	Meningitis C	86.6 Percentage of subjects
rMenBOMV Group	Percentage of Subjects With a 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination.	Meningitis B NZ98/254 (PorA)	60.7 Percentage of subjects
rMenBOMV Group	Percentage of Subjects With a 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination.	Meningitis B M14459 (fHbp)	63.3 Percentage of subjects
rMenBOMV Group	Percentage of Subjects With a 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination.	Meningitis W	74.1 Percentage of subjects
rMenBOMV Group	Percentage of Subjects With a 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination.	Meningitis C	57.3 Percentage of subjects
rMenBOMV Group	Percentage of Subjects With a 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination.	Meningitis B 96217(NadA)	80.7 Percentage of subjects
rMenBOMV Group	Percentage of Subjects With a 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination.	Meningitis A	87.8 Percentage of subjects
rMenBOMV Group	Percentage of Subjects With a 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination.	Meningitis B M07-0241084(NHBA)	56.3 Percentage of subjects
rMenBOMV Group	Percentage of Subjects With a 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination.	Meningitis Y	11.4 Percentage of subjects
MenACWY Group	Percentage of Subjects With a 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination.	Meningitis B NZ98/254 (PorA)	1.0 Percentage of subjects
MenACWY Group	Percentage of Subjects With a 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination.	Meningitis A	67.4 Percentage of subjects
MenACWY Group	Percentage of Subjects With a 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination.	Meningitis B M14459 (fHbp)	2.1 Percentage of subjects
MenACWY Group	Percentage of Subjects With a 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination.	Meningitis W	41.1 Percentage of subjects
MenACWY Group	Percentage of Subjects With a 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination.	Meningitis C	52.1 Percentage of subjects
MenACWY Group	Percentage of Subjects With a 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination.	Meningitis B 96217(NadA)	2.1 Percentage of subjects
MenACWY Group	Percentage of Subjects With a 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination.	Meningitis Y	76.8 Percentage of subjects
MenACWY Group	Percentage of Subjects With a 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination.	Meningitis B M07-0241084(NHBA)	2.1 Percentage of subjects

Primary

Percentage of Subjects With hSBA Titers Greater Than or Equal to(≥) the Lower Limit of Quantitation (LLOQ) Against Each of the N. Meningitidis Serogroup B Test Strains and Serogroups A, C, W-135 and Y,One Month After Last Vaccination.

Immune responses against N. meningitidis serogroup B test strains and N. meningitidis serogroups A, C, W-135, and Y, were calculated in terms of percentage of subjects with hSBA titers ≥ LLOQ. Serogroup B strains tested were M14459 (factor H binding protein; fHbp), 96217 (Neisserial adhesin A; NadA), NZ98/254 (PorA), and M070241084 (Neisseria heparin binding antigen; NHBA).

Time frame: 1 month after last vaccination i.e.: at Day 91 for all groups except the MenACWY Group, and at Day 31 for the MenACWY Group.

Arm	Measure	Group	Value (NUMBER)
MenABCWY Group	Percentage of Subjects With hSBA Titers Greater Than or Equal to(≥) the Lower Limit of Quantitation (LLOQ) Against Each of the N. Meningitidis Serogroup B Test Strains and Serogroups A, C, W-135 and Y,One Month After Last Vaccination.	Meningitis B M14459 (fHbp)	83.5 Percentage of subjects
MenABCWY Group	Percentage of Subjects With hSBA Titers Greater Than or Equal to(≥) the Lower Limit of Quantitation (LLOQ) Against Each of the N. Meningitidis Serogroup B Test Strains and Serogroups A, C, W-135 and Y,One Month After Last Vaccination.	Mengitis B 96217(NadA)	96.9 Percentage of subjects
MenABCWY Group	Percentage of Subjects With hSBA Titers Greater Than or Equal to(≥) the Lower Limit of Quantitation (LLOQ) Against Each of the N. Meningitidis Serogroup B Test Strains and Serogroups A, C, W-135 and Y,One Month After Last Vaccination.	Meningitis B NZ98/254 (PorA)	59.2 Percentage of subjects
MenABCWY Group	Percentage of Subjects With hSBA Titers Greater Than or Equal to(≥) the Lower Limit of Quantitation (LLOQ) Against Each of the N. Meningitidis Serogroup B Test Strains and Serogroups A, C, W-135 and Y,One Month After Last Vaccination.	Meningitis C	100.0 Percentage of subjects
MenABCWY Group	Percentage of Subjects With hSBA Titers Greater Than or Equal to(≥) the Lower Limit of Quantitation (LLOQ) Against Each of the N. Meningitidis Serogroup B Test Strains and Serogroups A, C, W-135 and Y,One Month After Last Vaccination.	Meningitis W	98.0 Percentage of subjects
MenABCWY Group	Percentage of Subjects With hSBA Titers Greater Than or Equal to(≥) the Lower Limit of Quantitation (LLOQ) Against Each of the N. Meningitidis Serogroup B Test Strains and Serogroups A, C, W-135 and Y,One Month After Last Vaccination.	Menngitis Y	99.0 Percentage of subjects
MenABCWY Group	Percentage of Subjects With hSBA Titers Greater Than or Equal to(≥) the Lower Limit of Quantitation (LLOQ) Against Each of the N. Meningitidis Serogroup B Test Strains and Serogroups A, C, W-135 and Y,One Month After Last Vaccination.	Meningitis B M07-0241084 (NHBA)	59.2 Percentage of subjects
MenABCWY Group	Percentage of Subjects With hSBA Titers Greater Than or Equal to(≥) the Lower Limit of Quantitation (LLOQ) Against Each of the N. Meningitidis Serogroup B Test Strains and Serogroups A, C, W-135 and Y,One Month After Last Vaccination.	Meningitis A	94.8 Percentage of subjects
rMenBOMV+ACWY_S Group	Percentage of Subjects With hSBA Titers Greater Than or Equal to(≥) the Lower Limit of Quantitation (LLOQ) Against Each of the N. Meningitidis Serogroup B Test Strains and Serogroups A, C, W-135 and Y,One Month After Last Vaccination.	Meningitis B M14459 (fHbp)	86.0 Percentage of subjects
rMenBOMV+ACWY_S Group	Percentage of Subjects With hSBA Titers Greater Than or Equal to(≥) the Lower Limit of Quantitation (LLOQ) Against Each of the N. Meningitidis Serogroup B Test Strains and Serogroups A, C, W-135 and Y,One Month After Last Vaccination.	Meningitis A	100.0 Percentage of subjects
rMenBOMV+ACWY_S Group	Percentage of Subjects With hSBA Titers Greater Than or Equal to(≥) the Lower Limit of Quantitation (LLOQ) Against Each of the N. Meningitidis Serogroup B Test Strains and Serogroups A, C, W-135 and Y,One Month After Last Vaccination.	Menngitis Y	98.0 Percentage of subjects
rMenBOMV+ACWY_S Group	Percentage of Subjects With hSBA Titers Greater Than or Equal to(≥) the Lower Limit of Quantitation (LLOQ) Against Each of the N. Meningitidis Serogroup B Test Strains and Serogroups A, C, W-135 and Y,One Month After Last Vaccination.	Mengitis B 96217(NadA)	99.0 Percentage of subjects
rMenBOMV+ACWY_S Group	Percentage of Subjects With hSBA Titers Greater Than or Equal to(≥) the Lower Limit of Quantitation (LLOQ) Against Each of the N. Meningitidis Serogroup B Test Strains and Serogroups A, C, W-135 and Y,One Month After Last Vaccination.	Meningitis B M07-0241084 (NHBA)	74.0 Percentage of subjects
rMenBOMV+ACWY_S Group	Percentage of Subjects With hSBA Titers Greater Than or Equal to(≥) the Lower Limit of Quantitation (LLOQ) Against Each of the N. Meningitidis Serogroup B Test Strains and Serogroups A, C, W-135 and Y,One Month After Last Vaccination.	Meningitis C	100.0 Percentage of subjects
rMenBOMV+ACWY_S Group	Percentage of Subjects With hSBA Titers Greater Than or Equal to(≥) the Lower Limit of Quantitation (LLOQ) Against Each of the N. Meningitidis Serogroup B Test Strains and Serogroups A, C, W-135 and Y,One Month After Last Vaccination.	Meningitis B NZ98/254 (PorA)	76.0 Percentage of subjects
rMenBOMV+ACWY_S Group	Percentage of Subjects With hSBA Titers Greater Than or Equal to(≥) the Lower Limit of Quantitation (LLOQ) Against Each of the N. Meningitidis Serogroup B Test Strains and Serogroups A, C, W-135 and Y,One Month After Last Vaccination.	Meningitis W	96.0 Percentage of subjects
rMenBOMV+ACWY_D Group	Percentage of Subjects With hSBA Titers Greater Than or Equal to(≥) the Lower Limit of Quantitation (LLOQ) Against Each of the N. Meningitidis Serogroup B Test Strains and Serogroups A, C, W-135 and Y,One Month After Last Vaccination.	Mengitis B 96217(NadA)	99.0 Percentage of subjects
rMenBOMV+ACWY_D Group	Percentage of Subjects With hSBA Titers Greater Than or Equal to(≥) the Lower Limit of Quantitation (LLOQ) Against Each of the N. Meningitidis Serogroup B Test Strains and Serogroups A, C, W-135 and Y,One Month After Last Vaccination.	Meningitis C	100.0 Percentage of subjects
rMenBOMV+ACWY_D Group	Percentage of Subjects With hSBA Titers Greater Than or Equal to(≥) the Lower Limit of Quantitation (LLOQ) Against Each of the N. Meningitidis Serogroup B Test Strains and Serogroups A, C, W-135 and Y,One Month After Last Vaccination.	Meningitis W	99.0 Percentage of subjects
rMenBOMV+ACWY_D Group	Percentage of Subjects With hSBA Titers Greater Than or Equal to(≥) the Lower Limit of Quantitation (LLOQ) Against Each of the N. Meningitidis Serogroup B Test Strains and Serogroups A, C, W-135 and Y,One Month After Last Vaccination.	Menngitis Y	96.9 Percentage of subjects
rMenBOMV+ACWY_D Group	Percentage of Subjects With hSBA Titers Greater Than or Equal to(≥) the Lower Limit of Quantitation (LLOQ) Against Each of the N. Meningitidis Serogroup B Test Strains and Serogroups A, C, W-135 and Y,One Month After Last Vaccination.	Meningitis B M14459 (fHbp)	88.5 Percentage of subjects
rMenBOMV+ACWY_D Group	Percentage of Subjects With hSBA Titers Greater Than or Equal to(≥) the Lower Limit of Quantitation (LLOQ) Against Each of the N. Meningitidis Serogroup B Test Strains and Serogroups A, C, W-135 and Y,One Month After Last Vaccination.	Meningitis B NZ98/254 (PorA)	80.4 Percentage of subjects
rMenBOMV+ACWY_D Group	Percentage of Subjects With hSBA Titers Greater Than or Equal to(≥) the Lower Limit of Quantitation (LLOQ) Against Each of the N. Meningitidis Serogroup B Test Strains and Serogroups A, C, W-135 and Y,One Month After Last Vaccination.	Meningitis A	99.0 Percentage of subjects
rMenBOMV+ACWY_D Group	Percentage of Subjects With hSBA Titers Greater Than or Equal to(≥) the Lower Limit of Quantitation (LLOQ) Against Each of the N. Meningitidis Serogroup B Test Strains and Serogroups A, C, W-135 and Y,One Month After Last Vaccination.	Meningitis B M07-0241084 (NHBA)	77.1 Percentage of subjects
rMenBOMV Group	Percentage of Subjects With hSBA Titers Greater Than or Equal to(≥) the Lower Limit of Quantitation (LLOQ) Against Each of the N. Meningitidis Serogroup B Test Strains and Serogroups A, C, W-135 and Y,One Month After Last Vaccination.	Mengitis B 96217(NadA)	100.0 Percentage of subjects
rMenBOMV Group	Percentage of Subjects With hSBA Titers Greater Than or Equal to(≥) the Lower Limit of Quantitation (LLOQ) Against Each of the N. Meningitidis Serogroup B Test Strains and Serogroups A, C, W-135 and Y,One Month After Last Vaccination.	Meningitis B M07-0241084 (NHBA)	80.9 Percentage of subjects
rMenBOMV Group	Percentage of Subjects With hSBA Titers Greater Than or Equal to(≥) the Lower Limit of Quantitation (LLOQ) Against Each of the N. Meningitidis Serogroup B Test Strains and Serogroups A, C, W-135 and Y,One Month After Last Vaccination.	Meningitis B NZ98/254 (PorA)	78.7 Percentage of subjects
rMenBOMV Group	Percentage of Subjects With hSBA Titers Greater Than or Equal to(≥) the Lower Limit of Quantitation (LLOQ) Against Each of the N. Meningitidis Serogroup B Test Strains and Serogroups A, C, W-135 and Y,One Month After Last Vaccination.	Meningitis C	96.7 Percentage of subjects
rMenBOMV Group	Percentage of Subjects With hSBA Titers Greater Than or Equal to(≥) the Lower Limit of Quantitation (LLOQ) Against Each of the N. Meningitidis Serogroup B Test Strains and Serogroups A, C, W-135 and Y,One Month After Last Vaccination.	Meningitis A	91.1 Percentage of subjects
rMenBOMV Group	Percentage of Subjects With hSBA Titers Greater Than or Equal to(≥) the Lower Limit of Quantitation (LLOQ) Against Each of the N. Meningitidis Serogroup B Test Strains and Serogroups A, C, W-135 and Y,One Month After Last Vaccination.	Meningitis W	93.3 Percentage of subjects
rMenBOMV Group	Percentage of Subjects With hSBA Titers Greater Than or Equal to(≥) the Lower Limit of Quantitation (LLOQ) Against Each of the N. Meningitidis Serogroup B Test Strains and Serogroups A, C, W-135 and Y,One Month After Last Vaccination.	Menngitis Y	24.7 Percentage of subjects
rMenBOMV Group	Percentage of Subjects With hSBA Titers Greater Than or Equal to(≥) the Lower Limit of Quantitation (LLOQ) Against Each of the N. Meningitidis Serogroup B Test Strains and Serogroups A, C, W-135 and Y,One Month After Last Vaccination.	Meningitis B M14459 (fHbp)	83.3 Percentage of subjects
MenACWY Group	Percentage of Subjects With hSBA Titers Greater Than or Equal to(≥) the Lower Limit of Quantitation (LLOQ) Against Each of the N. Meningitidis Serogroup B Test Strains and Serogroups A, C, W-135 and Y,One Month After Last Vaccination.	Menngitis Y	85.4 Percentage of subjects
MenACWY Group	Percentage of Subjects With hSBA Titers Greater Than or Equal to(≥) the Lower Limit of Quantitation (LLOQ) Against Each of the N. Meningitidis Serogroup B Test Strains and Serogroups A, C, W-135 and Y,One Month After Last Vaccination.	Meningitis W	66.0 Percentage of subjects
MenACWY Group	Percentage of Subjects With hSBA Titers Greater Than or Equal to(≥) the Lower Limit of Quantitation (LLOQ) Against Each of the N. Meningitidis Serogroup B Test Strains and Serogroups A, C, W-135 and Y,One Month After Last Vaccination.	Meningitis C	86.6 Percentage of subjects
MenACWY Group	Percentage of Subjects With hSBA Titers Greater Than or Equal to(≥) the Lower Limit of Quantitation (LLOQ) Against Each of the N. Meningitidis Serogroup B Test Strains and Serogroups A, C, W-135 and Y,One Month After Last Vaccination.	Mengitis B 96217(NadA)	33.3 Percentage of subjects
MenACWY Group	Percentage of Subjects With hSBA Titers Greater Than or Equal to(≥) the Lower Limit of Quantitation (LLOQ) Against Each of the N. Meningitidis Serogroup B Test Strains and Serogroups A, C, W-135 and Y,One Month After Last Vaccination.	Meningitis B M14459 (fHbp)	12.4 Percentage of subjects
MenACWY Group	Percentage of Subjects With hSBA Titers Greater Than or Equal to(≥) the Lower Limit of Quantitation (LLOQ) Against Each of the N. Meningitidis Serogroup B Test Strains and Serogroups A, C, W-135 and Y,One Month After Last Vaccination.	Meningitis B M07-0241084 (NHBA)	23.2 Percentage of subjects
MenACWY Group	Percentage of Subjects With hSBA Titers Greater Than or Equal to(≥) the Lower Limit of Quantitation (LLOQ) Against Each of the N. Meningitidis Serogroup B Test Strains and Serogroups A, C, W-135 and Y,One Month After Last Vaccination.	Meningitis A	68.8 Percentage of subjects
MenACWY Group	Percentage of Subjects With hSBA Titers Greater Than or Equal to(≥) the Lower Limit of Quantitation (LLOQ) Against Each of the N. Meningitidis Serogroup B Test Strains and Serogroups A, C, W-135 and Y,One Month After Last Vaccination.	Meningitis B NZ98/254 (PorA)	5.2 Percentage of subjects

Secondary

hSBA Adjusted GMRs Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135, and Y, One Month After First Vaccination

hSBA mean ratios at 1 month after the first vaccination versus baseline were calculated in terms of GMRs. i.e. as the anti-logarithm of the mean of the change from baseline of log-transformed titer values at 1 month after first vaccination and Baseline. Serogroup B strains tested were M14459 (factor H binding protein; fHbp), 96217 (Neisserial adhesin A; NadA), NZ98/254 (PorA), and M070241084 (Neisseria heparin binding antigen; NHBA). Adjusted mean were obtained from ANCOVA model fitted to each Serogroup (Strain) individually, study group and center as fixed effects and zero-centered pre-vaccination log-transformed titer as a continuous covariate.

Time frame: 1 month after first vaccination versus baseline (i.e.: at Day 31 versus Day 1 for all groups except for the MenACWY Group)

Population: Analysis was performed on PPS for immunogenicity that included subjects who had no major protocol violations and whose assay results were available for at least 1 serogroup/B strain after first vaccination for all study groups except for MenACWY Group for which results were included in the last vaccination analysis (see primary outcome measure 5).

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
MenABCWY Group	hSBA Adjusted GMRs Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135, and Y, One Month After First Vaccination	Meningitis Y	36.58 Ratio
MenABCWY Group	hSBA Adjusted GMRs Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135, and Y, One Month After First Vaccination	Meningitis B M14459 (fHbp)	2.59 Ratio
MenABCWY Group	hSBA Adjusted GMRs Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135, and Y, One Month After First Vaccination	Meningitis C	8.08 Ratio
MenABCWY Group	hSBA Adjusted GMRs Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135, and Y, One Month After First Vaccination	Meningitis W	11.08 Ratio
MenABCWY Group	hSBA Adjusted GMRs Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135, and Y, One Month After First Vaccination	Meningitis B NZ98/254 (PorA)	2.16 Ratio
MenABCWY Group	hSBA Adjusted GMRs Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135, and Y, One Month After First Vaccination	Meningitis B 96217(NadA)	2.15 Ratio
MenABCWY Group	hSBA Adjusted GMRs Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135, and Y, One Month After First Vaccination	Meningitis A	10.15 Ratio
MenABCWY Group	hSBA Adjusted GMRs Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135, and Y, One Month After First Vaccination	Meningitis B M07-0241084 (NHBA)	1.73 Ratio
rMenBOMV+ACWY_S Group	hSBA Adjusted GMRs Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135, and Y, One Month After First Vaccination	Meningitis B NZ98/254 (PorA)	2.76 Ratio
rMenBOMV+ACWY_S Group	hSBA Adjusted GMRs Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135, and Y, One Month After First Vaccination	Meningitis Y	37.26 Ratio
rMenBOMV+ACWY_S Group	hSBA Adjusted GMRs Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135, and Y, One Month After First Vaccination	Meningitis B M07-0241084 (NHBA)	2.01 Ratio
rMenBOMV+ACWY_S Group	hSBA Adjusted GMRs Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135, and Y, One Month After First Vaccination	Meningitis B M14459 (fHbp)	3.00 Ratio
rMenBOMV+ACWY_S Group	hSBA Adjusted GMRs Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135, and Y, One Month After First Vaccination	Meningitis B 96217(NadA)	2.96 Ratio
rMenBOMV+ACWY_S Group	hSBA Adjusted GMRs Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135, and Y, One Month After First Vaccination	Meningitis C	6.59 Ratio
rMenBOMV+ACWY_S Group	hSBA Adjusted GMRs Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135, and Y, One Month After First Vaccination	Meningitis A	21.97 Ratio
rMenBOMV+ACWY_S Group	hSBA Adjusted GMRs Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135, and Y, One Month After First Vaccination	Meningitis W	8.28 Ratio
rMenBOMV+ACWY_D Group	hSBA Adjusted GMRs Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135, and Y, One Month After First Vaccination	Meningitis B 96217(NadA)	3.19 Ratio
rMenBOMV+ACWY_D Group	hSBA Adjusted GMRs Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135, and Y, One Month After First Vaccination	Meningitis B M07-0241084 (NHBA)	1.86 Ratio
rMenBOMV+ACWY_D Group	hSBA Adjusted GMRs Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135, and Y, One Month After First Vaccination	Meningitis A	28.55 Ratio
rMenBOMV+ACWY_D Group	hSBA Adjusted GMRs Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135, and Y, One Month After First Vaccination	Meningitis C	7.88 Ratio
rMenBOMV+ACWY_D Group	hSBA Adjusted GMRs Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135, and Y, One Month After First Vaccination	Meningitis W	9.44 Ratio
rMenBOMV+ACWY_D Group	hSBA Adjusted GMRs Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135, and Y, One Month After First Vaccination	Meningitis Y	48.87 Ratio
rMenBOMV+ACWY_D Group	hSBA Adjusted GMRs Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135, and Y, One Month After First Vaccination	Meningitis B M14459 (fHbp)	2.33 Ratio
rMenBOMV+ACWY_D Group	hSBA Adjusted GMRs Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135, and Y, One Month After First Vaccination	Meningitis B NZ98/254 (PorA)	2.72 Ratio
rMenBOMV Group	hSBA Adjusted GMRs Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135, and Y, One Month After First Vaccination	Meningitis B M07-0241084 (NHBA)	2.12 Ratio
rMenBOMV Group	hSBA Adjusted GMRs Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135, and Y, One Month After First Vaccination	Meningitis B M14459 (fHbp)	2.87 Ratio
rMenBOMV Group	hSBA Adjusted GMRs Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135, and Y, One Month After First Vaccination	Meningitis C	2.24 Ratio
rMenBOMV Group	hSBA Adjusted GMRs Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135, and Y, One Month After First Vaccination	Meningitis A	2.66 Ratio
rMenBOMV Group	hSBA Adjusted GMRs Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135, and Y, One Month After First Vaccination	Meningitis B 96217(NadA)	3.68 Ratio
rMenBOMV Group	hSBA Adjusted GMRs Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135, and Y, One Month After First Vaccination	Meningitis B NZ98/254 (PorA)	3.13 Ratio
rMenBOMV Group	hSBA Adjusted GMRs Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135, and Y, One Month After First Vaccination	Meningitis Y	1.94 Ratio
rMenBOMV Group	hSBA Adjusted GMRs Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135, and Y, One Month After First Vaccination	Meningitis W	4.37 Ratio

Secondary

hSBA Adjusted GMTs Against All of N. Meningitidis Serogroup B Test Strains (Pooled), One Month After First Vaccination

Time frame: 1 month after first vaccination i.e.: at Day 31 for all groups except for the MenACWY Group

Population: Analysis was performed on PPS for immunogenicity that included subjects who had no major protocol violations and whose assay results were available for at least 1 serogroup or B strain after first vaccination for all study groups except for MenACWY group that was not considered for this analysis as only serogroup B strains assessed in this outcome.

Arm	Measure	Value (GEOMETRIC_MEAN)
MenABCWY Group	hSBA Adjusted GMTs Against All of N. Meningitidis Serogroup B Test Strains (Pooled), One Month After First Vaccination	6.51 Titers
rMenBOMV+ACWY_S Group	hSBA Adjusted GMTs Against All of N. Meningitidis Serogroup B Test Strains (Pooled), One Month After First Vaccination	8.33 Titers
rMenBOMV+ACWY_D Group	hSBA Adjusted GMTs Against All of N. Meningitidis Serogroup B Test Strains (Pooled), One Month After First Vaccination	8.16 Titers
rMenBOMV Group	hSBA Adjusted GMTs Against All of N. Meningitidis Serogroup B Test Strains (Pooled), One Month After First Vaccination	9.45 Titers

Secondary

hSBA Adjusted GMTs Against Each of the N. Meningitidis Serogroup B Test Strains and N. Meningitidis Serogroups A, C, W-135 and Y, One Month After First Vaccination.

Time frame: 1 month after first vaccination i.e.: at Day 31 for all groups except for the MenACWY Group.

Population: Analysis was performed on PPS for immunogenicity that included subjects who had no major protocol violations and whose assay results were available for at least 1 serogroup/ B strain after first vaccination for all study groups except for MenACWY Group for which results were included in the last vaccination analysis (see primary outcome measure 2).

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
MenABCWY Group	hSBA Adjusted GMTs Against Each of the N. Meningitidis Serogroup B Test Strains and N. Meningitidis Serogroups A, C, W-135 and Y, One Month After First Vaccination.	Meningitis W	108.91 Titers
MenABCWY Group	hSBA Adjusted GMTs Against Each of the N. Meningitidis Serogroup B Test Strains and N. Meningitidis Serogroups A, C, W-135 and Y, One Month After First Vaccination.	Meningitis Y	75.07 Titers
MenABCWY Group	hSBA Adjusted GMTs Against Each of the N. Meningitidis Serogroup B Test Strains and N. Meningitidis Serogroups A, C, W-135 and Y, One Month After First Vaccination.	Meningitis C	41.35 Titers
MenABCWY Group	hSBA Adjusted GMTs Against Each of the N. Meningitidis Serogroup B Test Strains and N. Meningitidis Serogroups A, C, W-135 and Y, One Month After First Vaccination.	Meningitis B M07-0241084 (NHBA)	6.27 Titers
MenABCWY Group	hSBA Adjusted GMTs Against Each of the N. Meningitidis Serogroup B Test Strains and N. Meningitidis Serogroups A, C, W-135 and Y, One Month After First Vaccination.	Meningitis B NZ98/254 (PorA)	3.79 Titers
MenABCWY Group	hSBA Adjusted GMTs Against Each of the N. Meningitidis Serogroup B Test Strains and N. Meningitidis Serogroups A, C, W-135 and Y, One Month After First Vaccination.	Meningitis B M14459(fHbp)	5.50 Titers
MenABCWY Group	hSBA Adjusted GMTs Against Each of the N. Meningitidis Serogroup B Test Strains and N. Meningitidis Serogroups A, C, W-135 and Y, One Month After First Vaccination.	Meningitis A	31.38 Titers
MenABCWY Group	hSBA Adjusted GMTs Against Each of the N. Meningitidis Serogroup B Test Strains and N. Meningitidis Serogroups A, C, W-135 and Y, One Month After First Vaccination.	Meningitis B 96217 (NadA)	8.21 Titers
rMenBOMV+ACWY_S Group	hSBA Adjusted GMTs Against Each of the N. Meningitidis Serogroup B Test Strains and N. Meningitidis Serogroups A, C, W-135 and Y, One Month After First Vaccination.	Meningitis B 96217 (NadA)	11.30 Titers
rMenBOMV+ACWY_S Group	hSBA Adjusted GMTs Against Each of the N. Meningitidis Serogroup B Test Strains and N. Meningitidis Serogroups A, C, W-135 and Y, One Month After First Vaccination.	Meningitis W	81.38 Titers
rMenBOMV+ACWY_S Group	hSBA Adjusted GMTs Against Each of the N. Meningitidis Serogroup B Test Strains and N. Meningitidis Serogroups A, C, W-135 and Y, One Month After First Vaccination.	Meningitis B M14459(fHbp)	6.36 Titers
rMenBOMV+ACWY_S Group	hSBA Adjusted GMTs Against Each of the N. Meningitidis Serogroup B Test Strains and N. Meningitidis Serogroups A, C, W-135 and Y, One Month After First Vaccination.	Meningitis B NZ98/254 (PorA)	4.83 Titers
rMenBOMV+ACWY_S Group	hSBA Adjusted GMTs Against Each of the N. Meningitidis Serogroup B Test Strains and N. Meningitidis Serogroups A, C, W-135 and Y, One Month After First Vaccination.	Meningitis B M07-0241084 (NHBA)	7.31 Titers
rMenBOMV+ACWY_S Group	hSBA Adjusted GMTs Against Each of the N. Meningitidis Serogroup B Test Strains and N. Meningitidis Serogroups A, C, W-135 and Y, One Month After First Vaccination.	Meningitis A	67.95 Titers
rMenBOMV+ACWY_S Group	hSBA Adjusted GMTs Against Each of the N. Meningitidis Serogroup B Test Strains and N. Meningitidis Serogroups A, C, W-135 and Y, One Month After First Vaccination.	Meningitis C	33.76 Titers
rMenBOMV+ACWY_S Group	hSBA Adjusted GMTs Against Each of the N. Meningitidis Serogroup B Test Strains and N. Meningitidis Serogroups A, C, W-135 and Y, One Month After First Vaccination.	Meningitis Y	76.48 Titers
rMenBOMV+ACWY_D Group	hSBA Adjusted GMTs Against Each of the N. Meningitidis Serogroup B Test Strains and N. Meningitidis Serogroups A, C, W-135 and Y, One Month After First Vaccination.	Meningitis A	88.29 Titers
rMenBOMV+ACWY_D Group	hSBA Adjusted GMTs Against Each of the N. Meningitidis Serogroup B Test Strains and N. Meningitidis Serogroups A, C, W-135 and Y, One Month After First Vaccination.	Meningitis B 96217 (NadA)	12.18 Titers
rMenBOMV+ACWY_D Group	hSBA Adjusted GMTs Against Each of the N. Meningitidis Serogroup B Test Strains and N. Meningitidis Serogroups A, C, W-135 and Y, One Month After First Vaccination.	Meningitis B M07-0241084 (NHBA)	6.75 Titers
rMenBOMV+ACWY_D Group	hSBA Adjusted GMTs Against Each of the N. Meningitidis Serogroup B Test Strains and N. Meningitidis Serogroups A, C, W-135 and Y, One Month After First Vaccination.	Meningitis B M14459(fHbp)	4.94 Titers
rMenBOMV+ACWY_D Group	hSBA Adjusted GMTs Against Each of the N. Meningitidis Serogroup B Test Strains and N. Meningitidis Serogroups A, C, W-135 and Y, One Month After First Vaccination.	Meningitis B NZ98/254 (PorA)	4.76 Titers
rMenBOMV+ACWY_D Group	hSBA Adjusted GMTs Against Each of the N. Meningitidis Serogroup B Test Strains and N. Meningitidis Serogroups A, C, W-135 and Y, One Month After First Vaccination.	Meningitis C	40.33 Titers
rMenBOMV+ACWY_D Group	hSBA Adjusted GMTs Against Each of the N. Meningitidis Serogroup B Test Strains and N. Meningitidis Serogroups A, C, W-135 and Y, One Month After First Vaccination.	Meningitis Y	100.30 Titers
rMenBOMV+ACWY_D Group	hSBA Adjusted GMTs Against Each of the N. Meningitidis Serogroup B Test Strains and N. Meningitidis Serogroups A, C, W-135 and Y, One Month After First Vaccination.	Meningitis W	92.84 Titers
rMenBOMV Group	hSBA Adjusted GMTs Against Each of the N. Meningitidis Serogroup B Test Strains and N. Meningitidis Serogroups A, C, W-135 and Y, One Month After First Vaccination.	Meningitis B M14459(fHbp)	6.08 Titers
rMenBOMV Group	hSBA Adjusted GMTs Against Each of the N. Meningitidis Serogroup B Test Strains and N. Meningitidis Serogroups A, C, W-135 and Y, One Month After First Vaccination.	Meningitis B M07-0241084 (NHBA)	7.69 Titers
rMenBOMV Group	hSBA Adjusted GMTs Against Each of the N. Meningitidis Serogroup B Test Strains and N. Meningitidis Serogroups A, C, W-135 and Y, One Month After First Vaccination.	Meningitis B 96217 (NadA)	14.07 Titers
rMenBOMV Group	hSBA Adjusted GMTs Against Each of the N. Meningitidis Serogroup B Test Strains and N. Meningitidis Serogroups A, C, W-135 and Y, One Month After First Vaccination.	Meningitis C	11.47 Titers
rMenBOMV Group	hSBA Adjusted GMTs Against Each of the N. Meningitidis Serogroup B Test Strains and N. Meningitidis Serogroups A, C, W-135 and Y, One Month After First Vaccination.	Meningitis W	42.99 Titers
rMenBOMV Group	hSBA Adjusted GMTs Against Each of the N. Meningitidis Serogroup B Test Strains and N. Meningitidis Serogroups A, C, W-135 and Y, One Month After First Vaccination.	Meningitis B NZ98/254 (PorA)	5.48 Titers
rMenBOMV Group	hSBA Adjusted GMTs Against Each of the N. Meningitidis Serogroup B Test Strains and N. Meningitidis Serogroups A, C, W-135 and Y, One Month After First Vaccination.	Meningitis A	8.22 Titers
rMenBOMV Group	hSBA Adjusted GMTs Against Each of the N. Meningitidis Serogroup B Test Strains and N. Meningitidis Serogroups A, C, W-135 and Y, One Month After First Vaccination.	Meningitis Y	3.98 Titers

Comparison: Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY\_S versus rMenBOMV+ACWY\_D study groups, on the Meningitis B NZ98/254 (PorA)strain, one month after first vaccination.80% CI: [0.8, 1.29]ANCOVA

Comparison: Other unknown interference in MenABCWY versus rMenBOMV+ACWY\_S study groups, on the Meningitis B M14459 (fHbp) strain, one month after first vaccination.80% CI: [0.69, 1.09]ANCOVA

Comparison: Other unknown interference in MenABCWY versus rMenBOMV+ACWY\_S study groups, on the Meningitis B 96217 (NadA) strain, one month after first vaccination.80% CI: [0.58, 0.9]ANCOVA

Comparison: Other unknown interference in MenABCWY versus rMenBOMV+ACWY\_S study groups, on the Meningitis B NZ98/254 (PorA) strain, one month after first vaccination.80% CI: [0.61, 1]ANCOVA

Comparison: Other unknown interference in MenABCWY versus rMenBOMV+ACWY\_S study groups, on the Meningitis B M07-0241084 (NHBA) strain, one month after first vaccination.80% CI: [0.68, 1.07]ANCOVA

Comparison: Other unknown interference in MenABCWY versus rMenBOMV+ACWY\_S study groups, on the Meningitis serogroup A, one month after first vaccination.80% CI: [0.35, 0.62]ANCOVA

Comparison: Other unknown interference in MenABCWY versus rMenBOMV+ACWY\_S study groups, on the Meningitis serogroup C, one month after first vaccination.80% CI: [0.91, 1.65]ANCOVA

Comparison: Other unknown interference in MenABCWY versus rMenBOMV+ACWY\_S study groups, on the Meningitis serogroup W, one month after first vaccination.80% CI: [1.04, 1.72]ANCOVA

Comparison: Other unknown interference in MenABCWY versus rMenBOMV+ACWY\_S study groups, on the Meningitis serogroup Y, one month after first vaccination.80% CI: [0.7, 1.38]ANCOVA

Comparison: To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_S versus rMenBOMV study groups, on the Meningitis B M14459 (fHbp) strain, one month after first vaccination.80% CI: [0.83, 1.32]ANCOVA

Comparison: To investigate possible effects on the immune response based on strains common to MenABCWY versus rMenBOMV study groups, on the Meningitis B M14459 (fHbp)strain, one month after first vaccination.80% CI: [0.71, 1.15]ANCOVA

Secondary

Number of Subjects With Any Solicited Local Adverse Events (AEs)

Assessed local AEs were erythema, swelling, induration and pain. Any erythema, swelling and induration is defined as a symptom with a surface diameter equal to or greater than 25 millimeters.

Time frame: During the 7 days (including the day of vaccination) after each vaccination i.e after Dose 1 administered at Day 1 (for all groups) and after Dose 2 administered at Day 61 (for all groups except for MenACWY Group)

Population: Analysis was performed on solicited safety set that included all subjects who provided informed consent,underwent screening procedures,had a subject number assigned,received a study vaccination \& was reported with any solicited adverse event data.No results for dose 2 categories for subjects of MenACWY Group as they received only 1 dose at day 1.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
MenABCWY Group	Number of Subjects With Any Solicited Local Adverse Events (AEs)	Erythema at Dose 1	17 Participants
MenABCWY Group	Number of Subjects With Any Solicited Local Adverse Events (AEs)	Induration at Dose 2	6 Participants
MenABCWY Group	Number of Subjects With Any Solicited Local Adverse Events (AEs)	Pain at Dose 2	87 Participants
MenABCWY Group	Number of Subjects With Any Solicited Local Adverse Events (AEs)	Swelling at Dose 2	13 Participants
MenABCWY Group	Number of Subjects With Any Solicited Local Adverse Events (AEs)	Erythema at Dose 2	15 Participants
MenABCWY Group	Number of Subjects With Any Solicited Local Adverse Events (AEs)	Pain at Dose 1	89 Participants
MenABCWY Group	Number of Subjects With Any Solicited Local Adverse Events (AEs)	Induration at Dose 1	9 Participants
MenABCWY Group	Number of Subjects With Any Solicited Local Adverse Events (AEs)	Swelling at Dose 1	20 Participants
rMenBOMV+ACWY_S Group	Number of Subjects With Any Solicited Local Adverse Events (AEs)	Induration at Dose 2	11 Participants
rMenBOMV+ACWY_S Group	Number of Subjects With Any Solicited Local Adverse Events (AEs)	Induration at Dose 1	15 Participants
rMenBOMV+ACWY_S Group	Number of Subjects With Any Solicited Local Adverse Events (AEs)	Pain at Dose 1	100 Participants
rMenBOMV+ACWY_S Group	Number of Subjects With Any Solicited Local Adverse Events (AEs)	Erythema at Dose 2	18 Participants
rMenBOMV+ACWY_S Group	Number of Subjects With Any Solicited Local Adverse Events (AEs)	Swelling at Dose 2	14 Participants
rMenBOMV+ACWY_S Group	Number of Subjects With Any Solicited Local Adverse Events (AEs)	Erythema at Dose 1	19 Participants
rMenBOMV+ACWY_S Group	Number of Subjects With Any Solicited Local Adverse Events (AEs)	Swelling at Dose 1	21 Participants
rMenBOMV+ACWY_S Group	Number of Subjects With Any Solicited Local Adverse Events (AEs)	Pain at Dose 2	97 Participants
rMenBOMV+ACWY_D Group	Number of Subjects With Any Solicited Local Adverse Events (AEs)	Swelling at Dose 2	15 Participants
rMenBOMV+ACWY_D Group	Number of Subjects With Any Solicited Local Adverse Events (AEs)	Induration at Dose 2	12 Participants
rMenBOMV+ACWY_D Group	Number of Subjects With Any Solicited Local Adverse Events (AEs)	Erythema at Dose 1	18 Participants
rMenBOMV+ACWY_D Group	Number of Subjects With Any Solicited Local Adverse Events (AEs)	Pain at Dose 1	95 Participants
rMenBOMV+ACWY_D Group	Number of Subjects With Any Solicited Local Adverse Events (AEs)	Pain at Dose 2	95 Participants
rMenBOMV+ACWY_D Group	Number of Subjects With Any Solicited Local Adverse Events (AEs)	Swelling at Dose 1	16 Participants
rMenBOMV+ACWY_D Group	Number of Subjects With Any Solicited Local Adverse Events (AEs)	Erythema at Dose 2	15 Participants
rMenBOMV+ACWY_D Group	Number of Subjects With Any Solicited Local Adverse Events (AEs)	Induration at Dose 1	12 Participants
rMenBOMV Group	Number of Subjects With Any Solicited Local Adverse Events (AEs)	Erythema at Dose 1	9 Participants
rMenBOMV Group	Number of Subjects With Any Solicited Local Adverse Events (AEs)	Pain at Dose 1	88 Participants
rMenBOMV Group	Number of Subjects With Any Solicited Local Adverse Events (AEs)	Induration at Dose 2	12 Participants
rMenBOMV Group	Number of Subjects With Any Solicited Local Adverse Events (AEs)	Swelling at Dose 1	13 Participants
rMenBOMV Group	Number of Subjects With Any Solicited Local Adverse Events (AEs)	Pain at Dose 2	87 Participants
rMenBOMV Group	Number of Subjects With Any Solicited Local Adverse Events (AEs)	Induration at Dose 1	6 Participants
rMenBOMV Group	Number of Subjects With Any Solicited Local Adverse Events (AEs)	Erythema at Dose 2	10 Participants
rMenBOMV Group	Number of Subjects With Any Solicited Local Adverse Events (AEs)	Swelling at Dose 2	12 Participants
MenACWY Group	Number of Subjects With Any Solicited Local Adverse Events (AEs)	Erythema at Dose 1	7 Participants
MenACWY Group	Number of Subjects With Any Solicited Local Adverse Events (AEs)	Pain at Dose 1	52 Participants
MenACWY Group	Number of Subjects With Any Solicited Local Adverse Events (AEs)	Induration at Dose 1	4 Participants
MenACWY Group	Number of Subjects With Any Solicited Local Adverse Events (AEs)	Swelling at Dose 1	10 Participants

Secondary

Number of Subjects With Any Solicited Systemic AEs

Assessed systemic AEs were arthralgia, fatigue, nausea, headache, myalgia and fever. Any fever is defined as body temperature equal or greater than 38 degrees Celsius.

Population: Analysis was performed on solicited safety set that included all subjects who provided informed consent,underwent screening procedures,had a subject number assigned,received a study vaccination \& was reported with any solicited adverse event data.No results for dose 2 category for subjects of MenACWY Group as they received only 1 dose at day 1.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
MenABCWY Group	Number of Subjects With Any Solicited Systemic AEs	Arthralgia at Dose 2	22 Participants
MenABCWY Group	Number of Subjects With Any Solicited Systemic AEs	Fatigue at Dose 2	58 Participants
MenABCWY Group	Number of Subjects With Any Solicited Systemic AEs	Nausea at Dose 2	16 Participants
MenABCWY Group	Number of Subjects With Any Solicited Systemic AEs	Headache at Dose 2	52 Participants
MenABCWY Group	Number of Subjects With Any Solicited Systemic AEs	Arthralgia at Dose 1	20 Participants
MenABCWY Group	Number of Subjects With Any Solicited Systemic AEs	Fatigue at Dose 1	56 Participants
MenABCWY Group	Number of Subjects With Any Solicited Systemic AEs	Nausea at Dose 1	16 Participants
MenABCWY Group	Number of Subjects With Any Solicited Systemic AEs	Headache at Dose 1	40 Participants
MenABCWY Group	Number of Subjects With Any Solicited Systemic AEs	Myalgia at Dose 1	34 Participants
MenABCWY Group	Number of Subjects With Any Solicited Systemic AEs	Fever at Dose 1	6 Participants
MenABCWY Group	Number of Subjects With Any Solicited Systemic AEs	Myalgia at Dose 2	41 Participants
MenABCWY Group	Number of Subjects With Any Solicited Systemic AEs	Fever at Dose 2	6 Participants
rMenBOMV+ACWY_S Group	Number of Subjects With Any Solicited Systemic AEs	Fever at Dose 1	5 Participants
rMenBOMV+ACWY_S Group	Number of Subjects With Any Solicited Systemic AEs	Fever at Dose 2	3 Participants
rMenBOMV+ACWY_S Group	Number of Subjects With Any Solicited Systemic AEs	Arthralgia at Dose 1	15 Participants
rMenBOMV+ACWY_S Group	Number of Subjects With Any Solicited Systemic AEs	Nausea at Dose 1	23 Participants
rMenBOMV+ACWY_S Group	Number of Subjects With Any Solicited Systemic AEs	Fatigue at Dose 2	61 Participants
rMenBOMV+ACWY_S Group	Number of Subjects With Any Solicited Systemic AEs	Myalgia at Dose 1	29 Participants
rMenBOMV+ACWY_S Group	Number of Subjects With Any Solicited Systemic AEs	Headache at Dose 1	46 Participants
rMenBOMV+ACWY_S Group	Number of Subjects With Any Solicited Systemic AEs	Headache at Dose 2	36 Participants
rMenBOMV+ACWY_S Group	Number of Subjects With Any Solicited Systemic AEs	Arthralgia at Dose 2	19 Participants
rMenBOMV+ACWY_S Group	Number of Subjects With Any Solicited Systemic AEs	Myalgia at Dose 2	38 Participants
rMenBOMV+ACWY_S Group	Number of Subjects With Any Solicited Systemic AEs	Fatigue at Dose 1	61 Participants
rMenBOMV+ACWY_S Group	Number of Subjects With Any Solicited Systemic AEs	Nausea at Dose 2	13 Participants
rMenBOMV+ACWY_D Group	Number of Subjects With Any Solicited Systemic AEs	Fatigue at Dose 2	62 Participants
rMenBOMV+ACWY_D Group	Number of Subjects With Any Solicited Systemic AEs	Headache at Dose 1	38 Participants
rMenBOMV+ACWY_D Group	Number of Subjects With Any Solicited Systemic AEs	Fever at Dose 2	3 Participants
rMenBOMV+ACWY_D Group	Number of Subjects With Any Solicited Systemic AEs	Arthralgia at Dose 1	9 Participants
rMenBOMV+ACWY_D Group	Number of Subjects With Any Solicited Systemic AEs	Fatigue at Dose 1	55 Participants
rMenBOMV+ACWY_D Group	Number of Subjects With Any Solicited Systemic AEs	Myalgia at Dose 2	35 Participants
rMenBOMV+ACWY_D Group	Number of Subjects With Any Solicited Systemic AEs	Nausea at Dose 1	14 Participants
rMenBOMV+ACWY_D Group	Number of Subjects With Any Solicited Systemic AEs	Myalgia at Dose 1	27 Participants
rMenBOMV+ACWY_D Group	Number of Subjects With Any Solicited Systemic AEs	Fever at Dose 1	5 Participants
rMenBOMV+ACWY_D Group	Number of Subjects With Any Solicited Systemic AEs	Arthralgia at Dose 2	12 Participants
rMenBOMV+ACWY_D Group	Number of Subjects With Any Solicited Systemic AEs	Headache at Dose 2	37 Participants
rMenBOMV+ACWY_D Group	Number of Subjects With Any Solicited Systemic AEs	Nausea at Dose 2	15 Participants
rMenBOMV Group	Number of Subjects With Any Solicited Systemic AEs	Fatigue at Dose 2	56 Participants
rMenBOMV Group	Number of Subjects With Any Solicited Systemic AEs	Arthralgia at Dose 1	9 Participants
rMenBOMV Group	Number of Subjects With Any Solicited Systemic AEs	Headache at Dose 2	39 Participants
rMenBOMV Group	Number of Subjects With Any Solicited Systemic AEs	Myalgia at Dose 2	38 Participants
rMenBOMV Group	Number of Subjects With Any Solicited Systemic AEs	Fever at Dose 2	1 Participants
rMenBOMV Group	Number of Subjects With Any Solicited Systemic AEs	Nausea at Dose 1	13 Participants
rMenBOMV Group	Number of Subjects With Any Solicited Systemic AEs	Myalgia at Dose 1	21 Participants
rMenBOMV Group	Number of Subjects With Any Solicited Systemic AEs	Fatigue at Dose 1	46 Participants
rMenBOMV Group	Number of Subjects With Any Solicited Systemic AEs	Nausea at Dose 2	17 Participants
rMenBOMV Group	Number of Subjects With Any Solicited Systemic AEs	Fever at Dose 1	1 Participants
rMenBOMV Group	Number of Subjects With Any Solicited Systemic AEs	Headache at Dose 1	36 Participants
rMenBOMV Group	Number of Subjects With Any Solicited Systemic AEs	Arthralgia at Dose 2	17 Participants
MenACWY Group	Number of Subjects With Any Solicited Systemic AEs	Myalgia at Dose 1	28 Participants
MenACWY Group	Number of Subjects With Any Solicited Systemic AEs	Fatigue at Dose 1	50 Participants
MenACWY Group	Number of Subjects With Any Solicited Systemic AEs	Arthralgia at Dose 1	18 Participants
MenACWY Group	Number of Subjects With Any Solicited Systemic AEs	Nausea at Dose 1	14 Participants
MenACWY Group	Number of Subjects With Any Solicited Systemic AEs	Headache at Dose 1	36 Participants
MenACWY Group	Number of Subjects With Any Solicited Systemic AEs	Fever at Dose 1	3 Participants

Secondary

Number of Subjects With Serious Adverse Events (SAEs), Medically Attended AEs (MAEs), AEs Leading to Withdrawal, and Adverse Events of Special Interest (AESIs)

SAE is defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability or incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Medically attended AEs are defined as symptoms or illnesses requiring hospitalization, or emergency room visit, or visit to/by a health care provider. AESIs are predefined (serious or non-serious) adverse events of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation in order to characterize and understand it.

Time frame: During the whole study period i.e from Day 1 to Day 91

Population: Analysis was performed on the unsolicited safety set that included all subjects who provided informed consent, underwent screening procedures, had a subject number assigned, received any study vaccination and was reported with any adverse event data.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
MenABCWY Group	Number of Subjects With Serious Adverse Events (SAEs), Medically Attended AEs (MAEs), AEs Leading to Withdrawal, and Adverse Events of Special Interest (AESIs)	AESI(s)	0 Participants
MenABCWY Group	Number of Subjects With Serious Adverse Events (SAEs), Medically Attended AEs (MAEs), AEs Leading to Withdrawal, and Adverse Events of Special Interest (AESIs)	AE(s) leading to withdrawal	0 Participants
MenABCWY Group	Number of Subjects With Serious Adverse Events (SAEs), Medically Attended AEs (MAEs), AEs Leading to Withdrawal, and Adverse Events of Special Interest (AESIs)	SAE(s)	0 Participants
MenABCWY Group	Number of Subjects With Serious Adverse Events (SAEs), Medically Attended AEs (MAEs), AEs Leading to Withdrawal, and Adverse Events of Special Interest (AESIs)	MAE(s)	14 Participants
rMenBOMV+ACWY_S Group	Number of Subjects With Serious Adverse Events (SAEs), Medically Attended AEs (MAEs), AEs Leading to Withdrawal, and Adverse Events of Special Interest (AESIs)	AESI(s)	0 Participants
rMenBOMV+ACWY_S Group	Number of Subjects With Serious Adverse Events (SAEs), Medically Attended AEs (MAEs), AEs Leading to Withdrawal, and Adverse Events of Special Interest (AESIs)	MAE(s)	17 Participants
rMenBOMV+ACWY_S Group	Number of Subjects With Serious Adverse Events (SAEs), Medically Attended AEs (MAEs), AEs Leading to Withdrawal, and Adverse Events of Special Interest (AESIs)	AE(s) leading to withdrawal	0 Participants
rMenBOMV+ACWY_S Group	Number of Subjects With Serious Adverse Events (SAEs), Medically Attended AEs (MAEs), AEs Leading to Withdrawal, and Adverse Events of Special Interest (AESIs)	SAE(s)	2 Participants
rMenBOMV+ACWY_D Group	Number of Subjects With Serious Adverse Events (SAEs), Medically Attended AEs (MAEs), AEs Leading to Withdrawal, and Adverse Events of Special Interest (AESIs)	MAE(s)	14 Participants
rMenBOMV+ACWY_D Group	Number of Subjects With Serious Adverse Events (SAEs), Medically Attended AEs (MAEs), AEs Leading to Withdrawal, and Adverse Events of Special Interest (AESIs)	AE(s) leading to withdrawal	0 Participants
rMenBOMV+ACWY_D Group	Number of Subjects With Serious Adverse Events (SAEs), Medically Attended AEs (MAEs), AEs Leading to Withdrawal, and Adverse Events of Special Interest (AESIs)	SAE(s)	1 Participants
rMenBOMV+ACWY_D Group	Number of Subjects With Serious Adverse Events (SAEs), Medically Attended AEs (MAEs), AEs Leading to Withdrawal, and Adverse Events of Special Interest (AESIs)	AESI(s)	0 Participants
rMenBOMV Group	Number of Subjects With Serious Adverse Events (SAEs), Medically Attended AEs (MAEs), AEs Leading to Withdrawal, and Adverse Events of Special Interest (AESIs)	AE(s) leading to withdrawal	0 Participants
rMenBOMV Group	Number of Subjects With Serious Adverse Events (SAEs), Medically Attended AEs (MAEs), AEs Leading to Withdrawal, and Adverse Events of Special Interest (AESIs)	AESI(s)	0 Participants
rMenBOMV Group	Number of Subjects With Serious Adverse Events (SAEs), Medically Attended AEs (MAEs), AEs Leading to Withdrawal, and Adverse Events of Special Interest (AESIs)	SAE(s)	2 Participants
rMenBOMV Group	Number of Subjects With Serious Adverse Events (SAEs), Medically Attended AEs (MAEs), AEs Leading to Withdrawal, and Adverse Events of Special Interest (AESIs)	MAE(s)	13 Participants
MenACWY Group	Number of Subjects With Serious Adverse Events (SAEs), Medically Attended AEs (MAEs), AEs Leading to Withdrawal, and Adverse Events of Special Interest (AESIs)	MAE(s)	6 Participants
MenACWY Group	Number of Subjects With Serious Adverse Events (SAEs), Medically Attended AEs (MAEs), AEs Leading to Withdrawal, and Adverse Events of Special Interest (AESIs)	AESI(s)	0 Participants
MenACWY Group	Number of Subjects With Serious Adverse Events (SAEs), Medically Attended AEs (MAEs), AEs Leading to Withdrawal, and Adverse Events of Special Interest (AESIs)	SAE(s)	0 Participants
MenACWY Group	Number of Subjects With Serious Adverse Events (SAEs), Medically Attended AEs (MAEs), AEs Leading to Withdrawal, and Adverse Events of Special Interest (AESIs)	AE(s) leading to withdrawal	0 Participants

Secondary

Number of Subjects With Unsolicited AEs

An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. An unsolicited AE is an AE that was not solicited using a Subject Diary and that was spontaneously communicated by a subjects/parent(s)/ Legally Acceptable Representative who has signed the informed consent or a solicited local or systemic adverse event that continues beyond the solicited period at day 7 after vaccination.

Time frame: During the 30 days (including the day of vaccination) after each vaccination i.e after Dose 1 administered at Day 1 (for all groups) and after Dose 2 administered at Day 61 (for all groups except for MenACWY Group)

Population: Analysis was performed on unsolicited safety set that included all subjects who provided informed consent,underwent screening procedures,had a subject number assigned,received any study vaccination \& was reported with any unsolicited AE data.No results for dose 2 category for subjects of MenACWY Group as they received only 1 dose at day 1.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
MenABCWY Group	Number of Subjects With Unsolicited AEs	Any unsolicited AEs- Dose 2	11 Participants
MenABCWY Group	Number of Subjects With Unsolicited AEs	Any unsolicited AEs- Dose 1	16 Participants
rMenBOMV+ACWY_S Group	Number of Subjects With Unsolicited AEs	Any unsolicited AEs- Dose 1	19 Participants
rMenBOMV+ACWY_S Group	Number of Subjects With Unsolicited AEs	Any unsolicited AEs- Dose 2	14 Participants
rMenBOMV+ACWY_D Group	Number of Subjects With Unsolicited AEs	Any unsolicited AEs- Dose 2	13 Participants
rMenBOMV+ACWY_D Group	Number of Subjects With Unsolicited AEs	Any unsolicited AEs- Dose 1	16 Participants
rMenBOMV Group	Number of Subjects With Unsolicited AEs	Any unsolicited AEs- Dose 2	10 Participants
rMenBOMV Group	Number of Subjects With Unsolicited AEs	Any unsolicited AEs- Dose 1	16 Participants
MenACWY Group	Number of Subjects With Unsolicited AEs	Any unsolicited AEs- Dose 1	15 Participants

Secondary

Percentage of Subjects With a 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135, and Y, One Month After First Vaccination

Immune responses against N. meningitidis serogroup B test strains and N. meningitidis serogroups A, C, W-135, and Y, were calculated in terms of percentage of subjects with a 4-fold increase in hSBA titers. A 4-fold rise is defined as: a) for individuals whose pre-vaccination titers were less than (\<) the limit of detection (LOD), the post-vaccination titers must have been ≥4-fold the LOD or ≥ the LLOQ, whichever was greater; b) for individuals whose pre-vaccination titers were ≥ the LOD and less than (\<) the LLOQ, the post-vaccination titers must have been at least 4 times the LLOQ; and c) for individuals whose pre-vaccination titers were ≥ the LLOQ, the post-vaccination titers must have been at least 4 times the pre-vaccination titer. Serogroup B strains tested were M14459 (factor H binding protein; fHbp), 96217 (Neisserial adhesin A; NadA), NZ98/254 (PorA), and M070241084 (Neisseria heparin binding antigen; NHBA).

Time frame: 1 month after first vaccination versus baseline (i.e.: at Day 31 versus Day 1 for all groups except for the MenACWY Group)

Population: Analysis was performed on PPS for immunogenicity that included subjects who had no major protocol violations and whose assay results were available for at least 1 serogroup/B strain after first vaccination for all study groups except for MenACWY Group for which results were included in the last vaccination analysis (see primary outcome measure 4).

Arm	Measure	Group	Value (NUMBER)
MenABCWY Group	Percentage of Subjects With a 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135, and Y, One Month After First Vaccination	Meningitis B M14459 (fHbp)	24.2 Percentage of subjects
MenABCWY Group	Percentage of Subjects With a 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135, and Y, One Month After First Vaccination	Meningitis A	61.7 Percentage of subjects
MenABCWY Group	Percentage of Subjects With a 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135, and Y, One Month After First Vaccination	Meningitis B 96217 (NadA)	22.1 Percentage of subjects
MenABCWY Group	Percentage of Subjects With a 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135, and Y, One Month After First Vaccination	Meningitis B NZ98/254 (PorA)	20.8 Percentage of subjects
MenABCWY Group	Percentage of Subjects With a 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135, and Y, One Month After First Vaccination	Meningitis B M07-0241084 (NHBA)	9.6 Percentage of subjects
MenABCWY Group	Percentage of Subjects With a 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135, and Y, One Month After First Vaccination	Meningitis C	54.2 Percentage of subjects
MenABCWY Group	Percentage of Subjects With a 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135, and Y, One Month After First Vaccination	Meningitis W	60.6 Percentage of subjects
MenABCWY Group	Percentage of Subjects With a 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135, and Y, One Month After First Vaccination	Meningitis Y	77.9 Percentage of subjects
rMenBOMV+ACWY_S Group	Percentage of Subjects With a 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135, and Y, One Month After First Vaccination	Meningitis B NZ98/254 (PorA)	26.2 Percentage of subjects
rMenBOMV+ACWY_S Group	Percentage of Subjects With a 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135, and Y, One Month After First Vaccination	Meningitis A	71.3 Percentage of subjects
rMenBOMV+ACWY_S Group	Percentage of Subjects With a 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135, and Y, One Month After First Vaccination	Meningitis C	46.5 Percentage of subjects
rMenBOMV+ACWY_S Group	Percentage of Subjects With a 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135, and Y, One Month After First Vaccination	Meningitis W	52.0 Percentage of subjects
rMenBOMV+ACWY_S Group	Percentage of Subjects With a 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135, and Y, One Month After First Vaccination	Meningitis B M07-0241084 (NHBA)	20.6 Percentage of subjects
rMenBOMV+ACWY_S Group	Percentage of Subjects With a 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135, and Y, One Month After First Vaccination	Meningitis Y	75.5 Percentage of subjects
rMenBOMV+ACWY_S Group	Percentage of Subjects With a 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135, and Y, One Month After First Vaccination	Meningitis B M14459 (fHbp)	24.3 Percentage of subjects
rMenBOMV+ACWY_S Group	Percentage of Subjects With a 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135, and Y, One Month After First Vaccination	Meningitis B 96217 (NadA)	34.0 Percentage of subjects
rMenBOMV+ACWY_D Group	Percentage of Subjects With a 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135, and Y, One Month After First Vaccination	Meningitis B NZ98/254 (PorA)	26.8 Percentage of subjects
rMenBOMV+ACWY_D Group	Percentage of Subjects With a 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135, and Y, One Month After First Vaccination	Meningitis Y	78.3 Percentage of subjects
rMenBOMV+ACWY_D Group	Percentage of Subjects With a 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135, and Y, One Month After First Vaccination	Meningitis B M07-0241084 (NHBA)	13.8 Percentage of subjects
rMenBOMV+ACWY_D Group	Percentage of Subjects With a 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135, and Y, One Month After First Vaccination	Meningitis A	80.6 Percentage of subjects
rMenBOMV+ACWY_D Group	Percentage of Subjects With a 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135, and Y, One Month After First Vaccination	Meningitis B 96217 (NadA)	30.5 Percentage of subjects
rMenBOMV+ACWY_D Group	Percentage of Subjects With a 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135, and Y, One Month After First Vaccination	Meningitis B M14459 (fHbp)	18.8 Percentage of subjects
rMenBOMV+ACWY_D Group	Percentage of Subjects With a 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135, and Y, One Month After First Vaccination	Meningitis W	51.6 Percentage of subjects
rMenBOMV+ACWY_D Group	Percentage of Subjects With a 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135, and Y, One Month After First Vaccination	Meningitis C	51.0 Percentage of subjects
rMenBOMV Group	Percentage of Subjects With a 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135, and Y, One Month After First Vaccination	Meningitis B M14459 (fHbp)	25.6 Percentage of subjects
rMenBOMV Group	Percentage of Subjects With a 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135, and Y, One Month After First Vaccination	Meningitis B NZ98/254 (PorA)	27.8 Percentage of subjects
rMenBOMV Group	Percentage of Subjects With a 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135, and Y, One Month After First Vaccination	Meningitis Y	9.0 Percentage of subjects
rMenBOMV Group	Percentage of Subjects With a 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135, and Y, One Month After First Vaccination	Meningitis B M07-0241084 (NHBA)	20.5 Percentage of subjects
rMenBOMV Group	Percentage of Subjects With a 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135, and Y, One Month After First Vaccination	Meningitis C	24.7 Percentage of subjects
rMenBOMV Group	Percentage of Subjects With a 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135, and Y, One Month After First Vaccination	Meningitis B 96217 (NadA)	32.6 Percentage of subjects
rMenBOMV Group	Percentage of Subjects With a 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135, and Y, One Month After First Vaccination	Meningitis A	23.3 Percentage of subjects
rMenBOMV Group	Percentage of Subjects With a 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135, and Y, One Month After First Vaccination	Meningitis W	39.8 Percentage of subjects

Secondary

Percentage of Subjects With hSBA Titers Greater Than or Equal to (≥) the LLOQ Against Each of the N. Meningitidis Serogroup B Test Strains and Against Serogroups A, C, W-135, and Y, One Month After First Vaccination

Time frame: 1 month after first vaccination i.e.: at Day 31 for all groups except for the MenACWY Group

Population: Analysis was performed on PPS for immunogenicity that included subjects who had no major protocol violations and whose assay results were available for at least 1 serogroup/B strain after first vaccination for all study groups except for MenACWY Group for which results were included in the last vaccination analysis (see primary outcome measure 3).

Arm	Measure	Group	Value (NUMBER)
MenABCWY Group	Percentage of Subjects With hSBA Titers Greater Than or Equal to (≥) the LLOQ Against Each of the N. Meningitidis Serogroup B Test Strains and Against Serogroups A, C, W-135, and Y, One Month After First Vaccination	Meningitis B 96217 (NadA)	57.3 Percentage of subjects
MenABCWY Group	Percentage of Subjects With hSBA Titers Greater Than or Equal to (≥) the LLOQ Against Each of the N. Meningitidis Serogroup B Test Strains and Against Serogroups A, C, W-135, and Y, One Month After First Vaccination	Meningitis Y	83.2 Percentage of subjects
MenABCWY Group	Percentage of Subjects With hSBA Titers Greater Than or Equal to (≥) the LLOQ Against Each of the N. Meningitidis Serogroup B Test Strains and Against Serogroups A, C, W-135, and Y, One Month After First Vaccination	Meningitis B M14459 (fHbp)	36.8 Percentage of subjects
MenABCWY Group	Percentage of Subjects With hSBA Titers Greater Than or Equal to (≥) the LLOQ Against Each of the N. Meningitidis Serogroup B Test Strains and Against Serogroups A, C, W-135, and Y, One Month After First Vaccination	Meningitis W	71.9 Percentage of subjects
MenABCWY Group	Percentage of Subjects With hSBA Titers Greater Than or Equal to (≥) the LLOQ Against Each of the N. Meningitidis Serogroup B Test Strains and Against Serogroups A, C, W-135, and Y, One Month After First Vaccination	Meningitis C	89.6 Percentage of subjects
MenABCWY Group	Percentage of Subjects With hSBA Titers Greater Than or Equal to (≥) the LLOQ Against Each of the N. Meningitidis Serogroup B Test Strains and Against Serogroups A, C, W-135, and Y, One Month After First Vaccination	Meningitis A	65.3 Percentage of subjects
MenABCWY Group	Percentage of Subjects With hSBA Titers Greater Than or Equal to (≥) the LLOQ Against Each of the N. Meningitidis Serogroup B Test Strains and Against Serogroups A, C, W-135, and Y, One Month After First Vaccination	Meningitis B M07-0241084 (NHBA)	35.1 Percentage of subjects
MenABCWY Group	Percentage of Subjects With hSBA Titers Greater Than or Equal to (≥) the LLOQ Against Each of the N. Meningitidis Serogroup B Test Strains and Against Serogroups A, C, W-135, and Y, One Month After First Vaccination	Meningitis B NZ98/254 (PorA)	29.2 Percentage of subjects
rMenBOMV+ACWY_S Group	Percentage of Subjects With hSBA Titers Greater Than or Equal to (≥) the LLOQ Against Each of the N. Meningitidis Serogroup B Test Strains and Against Serogroups A, C, W-135, and Y, One Month After First Vaccination	Meningitis W	70.6 Percentage of subjects
rMenBOMV+ACWY_S Group	Percentage of Subjects With hSBA Titers Greater Than or Equal to (≥) the LLOQ Against Each of the N. Meningitidis Serogroup B Test Strains and Against Serogroups A, C, W-135, and Y, One Month After First Vaccination	Meningitis B NZ98/254 (PorA)	37.9 Percentage of subjects
rMenBOMV+ACWY_S Group	Percentage of Subjects With hSBA Titers Greater Than or Equal to (≥) the LLOQ Against Each of the N. Meningitidis Serogroup B Test Strains and Against Serogroups A, C, W-135, and Y, One Month After First Vaccination	Meningitis Y	81.8 Percentage of subjects
rMenBOMV+ACWY_S Group	Percentage of Subjects With hSBA Titers Greater Than or Equal to (≥) the LLOQ Against Each of the N. Meningitidis Serogroup B Test Strains and Against Serogroups A, C, W-135, and Y, One Month After First Vaccination	Meningitis B M14459 (fHbp)	49.5 Percentage of subjects
rMenBOMV+ACWY_S Group	Percentage of Subjects With hSBA Titers Greater Than or Equal to (≥) the LLOQ Against Each of the N. Meningitidis Serogroup B Test Strains and Against Serogroups A, C, W-135, and Y, One Month After First Vaccination	Meningitis B 96217 (NadA)	66.0 Percentage of subjects
rMenBOMV+ACWY_S Group	Percentage of Subjects With hSBA Titers Greater Than or Equal to (≥) the LLOQ Against Each of the N. Meningitidis Serogroup B Test Strains and Against Serogroups A, C, W-135, and Y, One Month After First Vaccination	Meningitis B M07-0241084 (NHBA)	49.5 Percentage of subjects
rMenBOMV+ACWY_S Group	Percentage of Subjects With hSBA Titers Greater Than or Equal to (≥) the LLOQ Against Each of the N. Meningitidis Serogroup B Test Strains and Against Serogroups A, C, W-135, and Y, One Month After First Vaccination	Meningitis A	73.5 Percentage of subjects
rMenBOMV+ACWY_S Group	Percentage of Subjects With hSBA Titers Greater Than or Equal to (≥) the LLOQ Against Each of the N. Meningitidis Serogroup B Test Strains and Against Serogroups A, C, W-135, and Y, One Month After First Vaccination	Meningitis C	94.1 Percentage of subjects
rMenBOMV+ACWY_D Group	Percentage of Subjects With hSBA Titers Greater Than or Equal to (≥) the LLOQ Against Each of the N. Meningitidis Serogroup B Test Strains and Against Serogroups A, C, W-135, and Y, One Month After First Vaccination	Meningitis B M14459 (fHbp)	37.8 Percentage of subjects
rMenBOMV+ACWY_D Group	Percentage of Subjects With hSBA Titers Greater Than or Equal to (≥) the LLOQ Against Each of the N. Meningitidis Serogroup B Test Strains and Against Serogroups A, C, W-135, and Y, One Month After First Vaccination	Meningitis W	74.2 Percentage of subjects
rMenBOMV+ACWY_D Group	Percentage of Subjects With hSBA Titers Greater Than or Equal to (≥) the LLOQ Against Each of the N. Meningitidis Serogroup B Test Strains and Against Serogroups A, C, W-135, and Y, One Month After First Vaccination	Meningitis A	80.2 Percentage of subjects
rMenBOMV+ACWY_D Group	Percentage of Subjects With hSBA Titers Greater Than or Equal to (≥) the LLOQ Against Each of the N. Meningitidis Serogroup B Test Strains and Against Serogroups A, C, W-135, and Y, One Month After First Vaccination	Meningitis B 96217 (NadA)	69.4 Percentage of subjects
rMenBOMV+ACWY_D Group	Percentage of Subjects With hSBA Titers Greater Than or Equal to (≥) the LLOQ Against Each of the N. Meningitidis Serogroup B Test Strains and Against Serogroups A, C, W-135, and Y, One Month After First Vaccination	Meningitis C	92.8 Percentage of subjects
rMenBOMV+ACWY_D Group	Percentage of Subjects With hSBA Titers Greater Than or Equal to (≥) the LLOQ Against Each of the N. Meningitidis Serogroup B Test Strains and Against Serogroups A, C, W-135, and Y, One Month After First Vaccination	Meningitis B NZ98/254 (PorA)	33.7 Percentage of subjects
rMenBOMV+ACWY_D Group	Percentage of Subjects With hSBA Titers Greater Than or Equal to (≥) the LLOQ Against Each of the N. Meningitidis Serogroup B Test Strains and Against Serogroups A, C, W-135, and Y, One Month After First Vaccination	Meningitis B M07-0241084 (NHBA)	37.5 Percentage of subjects
rMenBOMV+ACWY_D Group	Percentage of Subjects With hSBA Titers Greater Than or Equal to (≥) the LLOQ Against Each of the N. Meningitidis Serogroup B Test Strains and Against Serogroups A, C, W-135, and Y, One Month After First Vaccination	Meningitis Y	88.4 Percentage of subjects
rMenBOMV Group	Percentage of Subjects With hSBA Titers Greater Than or Equal to (≥) the LLOQ Against Each of the N. Meningitidis Serogroup B Test Strains and Against Serogroups A, C, W-135, and Y, One Month After First Vaccination	Meningitis B NZ98/254 (PorA)	37.8 Percentage of subjects
rMenBOMV Group	Percentage of Subjects With hSBA Titers Greater Than or Equal to (≥) the LLOQ Against Each of the N. Meningitidis Serogroup B Test Strains and Against Serogroups A, C, W-135, and Y, One Month After First Vaccination	Meningitis B M07-0241084 (NHBA)	44.4 Percentage of subjects
rMenBOMV Group	Percentage of Subjects With hSBA Titers Greater Than or Equal to (≥) the LLOQ Against Each of the N. Meningitidis Serogroup B Test Strains and Against Serogroups A, C, W-135, and Y, One Month After First Vaccination	Meningitis W	52.3 Percentage of subjects
rMenBOMV Group	Percentage of Subjects With hSBA Titers Greater Than or Equal to (≥) the LLOQ Against Each of the N. Meningitidis Serogroup B Test Strains and Against Serogroups A, C, W-135, and Y, One Month After First Vaccination	Meningitis A	25.6 Percentage of subjects
rMenBOMV Group	Percentage of Subjects With hSBA Titers Greater Than or Equal to (≥) the LLOQ Against Each of the N. Meningitidis Serogroup B Test Strains and Against Serogroups A, C, W-135, and Y, One Month After First Vaccination	Meningitis B 96217 (NadA)	75.8 Percentage of subjects
rMenBOMV Group	Percentage of Subjects With hSBA Titers Greater Than or Equal to (≥) the LLOQ Against Each of the N. Meningitidis Serogroup B Test Strains and Against Serogroups A, C, W-135, and Y, One Month After First Vaccination	Meningitis C	70.0 Percentage of subjects
rMenBOMV Group	Percentage of Subjects With hSBA Titers Greater Than or Equal to (≥) the LLOQ Against Each of the N. Meningitidis Serogroup B Test Strains and Against Serogroups A, C, W-135, and Y, One Month After First Vaccination	Meningitis B M14459 (fHbp)	42.2 Percentage of subjects
rMenBOMV Group	Percentage of Subjects With hSBA Titers Greater Than or Equal to (≥) the LLOQ Against Each of the N. Meningitidis Serogroup B Test Strains and Against Serogroups A, C, W-135, and Y, One Month After First Vaccination	Meningitis Y	20.0 Percentage of subjects

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026

Study to Assess Potential Immune Interference When GlaxoSmithKline (GSK) Biologicals' MenABCWY Vaccine is Administered to Healthy Subjects Aged 10-25 Years

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Study design

Eligibility

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Exclusion criteria

Design outcomes

Primary

Secondary

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Participant flow

Recruitment details

Pre-assignment details

Participants by arm

Baseline characteristics

Adverse events

Outcome results

hSBA Adjusted Geometric Mean Ratios (GMRs) Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination.

hSBA Adjusted GMTs Against Each of the N. Meningitidis Serogroup B Test Strains and N. Meningitidis Serogroups A, C, W-135, and Y, One Month After Last Vaccination.

Human Serum Bactericidal Activity (hSBA) Adjusted Geometric Mean Titers (GMTs) Against All of N. Meningitidis Serogroup B Test Strains (Pooled), One Month After Last Vaccination.

Percentage of Subjects With a 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination.

Percentage of Subjects With hSBA Titers Greater Than or Equal to(≥) the Lower Limit of Quantitation (LLOQ) Against Each of the N. Meningitidis Serogroup B Test Strains and Serogroups A, C, W-135 and Y,One Month After Last Vaccination.

hSBA Adjusted GMRs Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135, and Y, One Month After First Vaccination

hSBA Adjusted GMTs Against All of N. Meningitidis Serogroup B Test Strains (Pooled), One Month After First Vaccination

hSBA Adjusted GMTs Against Each of the N. Meningitidis Serogroup B Test Strains and N. Meningitidis Serogroups A, C, W-135 and Y, One Month After First Vaccination.

Number of Subjects With Any Solicited Local Adverse Events (AEs)

Number of Subjects With Any Solicited Systemic AEs

Number of Subjects With Serious Adverse Events (SAEs), Medically Attended AEs (MAEs), AEs Leading to Withdrawal, and Adverse Events of Special Interest (AESIs)

Number of Subjects With Unsolicited AEs

Percentage of Subjects With a 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135, and Y, One Month After First Vaccination

Percentage of Subjects With hSBA Titers Greater Than or Equal to (≥) the LLOQ Against Each of the N. Meningitidis Serogroup B Test Strains and Against Serogroups A, C, W-135, and Y, One Month After First Vaccination