Effectiveness, Immunogenicity and Safety of Meningococcal ABCWY Vaccine Administered to Healthy Adolescents

A Phase 2b, Randomized, Controlled, Observer-Blind, Multi-Center Study Assessing the Effectiveness, Immunogenicity and Safety of Novartis Meningococcal ABCWY Vaccine Administered to Healthy Adolescents in the U.S.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02140762

Enrollment

305

Registered

2014-05-16

Start date

2014-05-31

Completion date

2015-02-28

Last updated

2018-09-12

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

Conditions

Meningococcal Disease

Keywords

Meningitis ABCWY, Adolescents, Vaccination, Meningococcal disease

Brief summary

Evaluate the effectiveness of 2 doses of MenABCWY vaccine in adolescents compared to a single dose of MenACWY vaccine.

Interventions

BIOLOGICALMenABCWY

Subjects received one dose of 0.5 mL MenABCWY vaccine (intramuscular (IM) injection) at day 1 and a second dose after 2 months.

OTHERPlacebo

0.5 mL saline solution (IM)

BIOLOGICALMenACWY

Subjects received one dose of 0.5 mL placebo (IM) at day 1 and one dose of 0.5 mL MenACWY vaccine (IM) after 2 months.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

10 Years to 18 Years

Healthy volunteers

Yes

Inclusion criteria

* Adolescents from 10-18 years of age, generally in good health, and available for all study visits, who/whose legally acceptable representative has given written informed consent at the time of enrollment. * Female subjects of childbearing potential must have a negative urine pregnancy test.

Exclusion criteria

* Serious, acute, or chronic illnesses. Previous or suspected disease caused by N. meningitidis. Previous immunization with any meningococcal vaccine. * Exposure to individuals with clinically proven meningococcal disease or clinical bacterial meningitis without further microbiologic characterization.

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Subjects Without Bactericidal Activity at 1:4 Dilution Against Each US Neisseria Meningitidis (N. Meningitidis) Serogroup B Strain at One Month After the Second Vaccination.	One month after the second vaccination (month 3)	The combined percentage of subjects without bactericidal activity at 1:4 dilution using the endogenous complement human Serum Bactericidal Assay (enc-hSBA) across all strains in MenABCWY group and MenACWY group is reported at one month after the second injection. The percentage of subjects without bactericidal activity at 1:4 dilution was used to assess the effectiveness of two doses of MenABCWY vaccine when compared to one dose of Men ACWY vaccine against a panel of US N. meningitidis serogroup B invasive disease strains. Least Square (LS)-mean computed from the generalized linear model.

Secondary

Measure	Time frame	Description
Percentages of Subjects Without Bactericidal Activity at 1:8 Dilution Against Each US N. Meningitidis Serogroup B Strain at One Month After the Second Vaccination	One month after the second vaccination (month 3)	The combined percentage of subjects without bactericidal activity at 1:8 dilution using the endogenous complement human Serum Bactericidal Assay (enc-hSBA) across all strains in MenABCWY group and MenACWY group is reported at one month after the second injection. The percentage of subjects without bactericidal activity at 1:8 dilution was used to assess the effectiveness of two doses of MenABCWY vaccine when compared to one dose of Men ACWY vaccine against a panel of US N. meningitidis serogroup B invasive disease strains. Least Square (LS)-mean computed from the generalized linear model.
Percentages of Subjects Without Bactericidal Activity at 1:8 Dilution Against Each US N. Meningitidis Serogroup B Strain at Four Months After the Second Vaccination.	Four months after the second vaccination (month 6)	The combined percentage of subjects without bactericidal activity at 1:8 dilution using the endogenous complement human Serum Bactericidal Assay (enc-hSBA) across all strains in MenABCWY group and MenACWY group is reported at four months after the second injection. The percentage of subjects without bactericidal activity at 1:8 dilution was used to assess the effectiveness of two doses of MenABCWY vaccine when compared to one dose of Men ACWY vaccine against a panel of US N. meningitidis serogroup B invasive disease strains. Least Square (LS)-mean computed from the generalized linear model.
Percentages of N. Meningitidis Serogroup B Invasive Disease Strains Killed at 1:4 and 1:8 Dilutions, for Each Subject	Baseline, one month after second vaccination (month 3)	The mean percentage of N. meningitidis serogroup B invasive disease strains killed by each subject, at 1:4 and 1:8 dilutions at one month after the 2-dose vaccination series is reported.
Percentages of Subjects With Enc-hSBA Titer >= 1:4 and Enc-hSBA Titer >= 1:8 at One Month After the 2-dose Vaccination Series	One month after the second vaccination (month 3)	The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY vaccine, in terms of percentages of subjects with enc-hSBA \>= 1:4 and enc-hSBA titer \>= 1:8 against four N. meningitidis serogroup B test strains at one month after the 2-dose vaccination series is reported.
Percentages of Subjects With Enc-hSBA Titer ≥ 1:4 and Enc-hSBA Titer ≥ 1:8 at Four Months After the 2-dose Vaccination Series	Four months after the second vaccination (month 6)	The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY vaccine, in terms of percentages of subjects with enc-hSBA ≥ 1:4 and enc-hSBA titer ≥ 1:8 against four N. meningitidis serogroup B test strains at four months after the 2-dose vaccination series is reported.
hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroup B Test Strains	One month after the second vaccination (month 3)	The immunogenicity of two doses of MenABCWY compared to a single dose of MenACWY vaccine, in terms of hSBA GMTs against serogroup B test strains, at one month after the 2-dose vaccination series.
HT-hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroup B Test Strains	Four months after the second vaccination (month 6)	The immunogenicity of two doses of MenABCWY compared to a single dose of MenACWY vaccine, in terms of HT-hSBA GMTs against serogroup B test strains, at four months after the 2-dose vaccination series.
hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroups A,C,W,Y	One month after the second vaccination (month 3)	The immunogenicity of two doses of MenABCWY compared to a single dose of MenACWY vaccine, in terms of hSBA GMTs to serogroups A, C, W, and Y, at one month after the 2-dose vaccination series.
HT-hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroups A, C, W, Y	Four months after the second vaccination (month 6)	The immunogenicity of two doses of MenABCWY compared to a single dose of MenACWY vaccine, in terms of HT-hSBA GMTs to serogroups A, C, W, and Y, at four months after the 2-dose vaccination series.
Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ Lower Limit of Quantitation (LLQ) at Baseline(Day 1) and One Month After the 2-dose Vaccination Series.	At baseline(day 1) and One month after the second vaccination (month 3)	The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with HT-hSBA titers against serogroup B test strains ≥ LLQ, at baseline(day 1) and one month after the 2-dose vaccination series, is reported. The LLQ cut off values for strains 96217, M07-0241084,M14459 and NZ98/254 were 8.6, 8.9, 8 and 8.2 respectively.
Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ LLQ at Baseline and One Month After the 2-dose Vaccination Series	At Baseline and One month after the second vaccination (month 3)	The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with HT-hSBA titers ≥ against serogroups A, C, W, Y, at baseline(day 1) and one month after the 2-dose vaccination series.The LLQ cut off values for serogroups A,C,W and Y were 22.7,5.2,39.6 and 14.7 respectively.
Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ Lower Limit of Quantitation (LLQ) at Four Months After the 2-dose Vaccination Series.	Four months after the second vaccination (month 6)	The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with HT-hSBA titers against serogroup B test strains ≥ LLQ, at four months after the 2-dose vaccination series, is reported. The LLQ cut off values for strains 96217, M07-0241084,M14459 and NZ98/254 were 8.6, 8.9, 8 and 8.2 respectively
Percentages of Subjects Without Bactericidal Activity at 1:4 Dilution Against Each US N. Meningitidis Serogroup B Strain at 4 Months After the Second Vaccination.	Four months after the second vaccination (month 6)	The combined percentage of subjects without bactericidal activity at 1:4 dilution using the endogenous complement human Serum Bactericidal Assay (enc-hSBA) across all strains in MenABCWY group and MenACWY group is reported at four months after the second injection. The percentage of subjects without bactericidal activity at 1:4 dilution was used to assess the effectiveness of two doses of MenABCWY vaccine when compared to one dose of Men ACWY vaccine against a panel of US N. meningitidis serogroup B invasive disease strains. Least Square (LS)-mean computed from the generalized linear model.
Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series.	Four months after the second vaccination (month 6)	The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with HT-hSBA titers against serogroup B test strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at four months after the 2-dose vaccination series, is reported.
Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series	Four months after the second vaccination (month 6)	The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with HT-hSBA titers ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 against serogroups A, C, W, Y at four months after the 2-dose vaccination series.
Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series	One month after the second vaccination (month 3)	The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with HT-hSBA titers against serogroup B test strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at one month after the 2-dose vaccination series, is reported.
Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series	One month after the second vaccination (month 3)	The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with HT-hSBA titers ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128, against serogroups A, C, W, Y, at one month after the 2-dose vaccination series.
Percentage of Subjects With 2-fold Rise in hSBA Titer Against N.Meningitidis Serogroup B Strains at One and Four Months After the 2-dose Vaccination Series.	At Month 3 and Month 6 ( one and four months after 2 doses of vaccination)	The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with a two-fold rise in HT-hSBA titers against the N.meningitidis serogroup B test strains, at 1 and 4 months after the 2-dose vaccination series.The 2-fold rise in titer is defined as follows: a)for subjects with prevaccination hSBA titers \<LLQ, a postvaccination hSBA ≥2 LLQ; b) for subjects with a prevaccination hSBA titers ≥LLQ, an increase of at least 2 times of the prevaccination hSBA
Percentage of Subjects With 3-fold Rise in hSBA Titer Against N.Meningitidis Serogroup B Strains at One and Four Months After the 2-dose Vaccination Series.	At Month 3 and Month 6 ( one and four months after 2 doses of vaccination)	The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with a 3-fold rise in HT-hSBA titers against the N.meningitidis serogroup B test strains, at 1 and 4 months after the 2-dose vaccination series.The 3-fold rise in titer is defined as follows: a)for subjects with prevaccination hSBA titers \<LLQ, a postvaccination hSBA ≥3 LLQ; b) for subjects with a prevaccination hSBA titers ≥LLQ, an increase of at least 3 times of the prevaccination hSBA.
Percentage of Subjects With 4-fold Rise in hSBA Titer Against N.Meningitidis Serogroup B Strains at One and Four Months After the 2-dose Vaccination Series.	At Month 3 and Month 6 ( one and four months after 2 doses of vaccination)	The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with a 4-fold rise in HT-hSBA titers against the N.meningitidis serogroup B test strains, at 1 and 4 months after the 2-dose vaccination series. The 4-fold rise in titer is defined as follows: a)for subjects with prevaccination hSBA titers \<LLQ, a postvaccination hSBA ≥4 LLQ; b) for subjects with a prevaccination hSBA titers ≥LLQ, an increase of at least 4 times of the prevaccination hSBA.
Percentage of Subjects With 2-fold Rise in hSBA Titer Against N.Meningitidis Serogroups A,C,W and Y at One and Four Months After the 2-dose Vaccination Series.	At Month 3 and Month 6 ( one and four months after 2 doses of vaccination)	The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with a two-fold rise in HT-hSBA titers against the N.meningitidis serogroups A,C,W and Y, at 1 and 4 months after the 2-dose vaccination series. The 2-fold rise in titer is defined as follows: a)for subjects with prevaccination hSBA titers \<LLQ, a postvaccination hSBA ≥2 LLQ; b) for subjects with a prevaccination hSBA titers ≥LLQ, an increase of at least 2 times of the prevaccination hSBA.
Percentage of Subjects With 3-fold Rise in hSBA Titer Against N.Meningitidis Serogroups A, C, W and Y at One and Four Months After the 2-dose Vaccination Series.	At Month 3 and Month 6 (one and four months after 2 doses of vaccination)	The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with a three-fold rise in HT-hSBA titers against the N.meningitidis serogroups A,C,W and Y at 1 and 4 months after the 2-dose vaccination series. The 3-fold rise in titer is defined as follows: a)for subjects with prevaccination hSBA titers \<LLQ, a postvaccination hSBA ≥3 LLQ; b) for subjects with a prevaccination hSBA titers ≥LLQ, an increase of at least 3 times of the prevaccination hSBA.
Percentage of Subjects With 4-fold Rise in hSBA Titer Against N.Meningitidis Serogroups A,C,W and Y at One and Four Months After the 2-dose Vaccination Series.	At Month 3 and Month 6 ( one and four months after 2 doses of vaccination)	The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with a 4-fold rise in HT-hSBA titers against the N.meningitidis serogroups A,C,W and Y, at 1 and 4 months after the 2-dose vaccination series. The 4-fold rise in titer is defined as follows: a)for subjects with prevaccination hSBA titers \<LLQ, a postvaccination hSBA ≥4 LLQ; b) for subjects with a prevaccination hSBA titers ≥LLQ, an increase of at least 4 times of the prevaccination hSBA.
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs)	From day 1 (6 hours) until day 7 after any vaccination	Reactogenicity was presented in terms of number of subjects reporting solicited local and systemic AEs and other indicators.
Number of Subjects Reporting Unsolicited AEs.	From day 1 to day 30 after any vaccination for any unsolicited AE. From day 1 to study termination (day 181) for all other categories.	Percentages of subjects reporting unsolicited AEs including serious adverse events (SAEs).
Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ Lower Limit of Quantitation (LLQ) at Four Months After the 2-dose Vaccination Series.	Four months after the second vaccination (month 6)	The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with HT-hSBA titers ≥ LLQ against serogroups A, C, W, Y at four months after the 2-dose vaccination series.The LLQ cut off values for serogroups A,C,W and Y were 22.7,5.2,39.6 and 14.7 respectively.

Countries

United States

Participant flow

Recruitment details

Subjects were recruited from 8 study sites in USA.

Pre-assignment details

All enrolled subjects were included in the trial.

Participants by arm

Arm	Count
MenABCWY Subjects received one dose of MenABCWY vaccine at visit day 1 and a second dose at visit month 2.	154
Placebo/MenACWY Subjects received one dose of placebo at visit day 1 and one dose of MenACWY vaccine at visit month 2.	151
Total	305

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Adverse Event	1	1
Overall Study	Lost to Follow-up	9	5
Overall Study	Other	0	1
Overall Study	Protocol Violation	1	1
Overall Study	Withdrawal by Subject	6	4

Baseline characteristics

Characteristic	MenABCWY	Placebo/MenACWY	Total
Age, Continuous	11.9 Years STANDARD_DEVIATION 2.18	12.2 Years STANDARD_DEVIATION 2.42	12 Years STANDARD_DEVIATION 2.3
Sex/Gender, Customized FEMALE	67 participants	61 participants	128 participants
Sex/Gender, Customized MALE	87 participants	90 participants	177 participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 150	0 / 146
other Total, other adverse events	132 / 151	100 / 147
serious Total, serious adverse events	0 / 150	1 / 146

Outcome results

Primary

Percentage of Subjects Without Bactericidal Activity at 1:4 Dilution Against Each US Neisseria Meningitidis (N. Meningitidis) Serogroup B Strain at One Month After the Second Vaccination.

The combined percentage of subjects without bactericidal activity at 1:4 dilution using the endogenous complement human Serum Bactericidal Assay (enc-hSBA) across all strains in MenABCWY group and MenACWY group is reported at one month after the second injection. The percentage of subjects without bactericidal activity at 1:4 dilution was used to assess the effectiveness of two doses of MenABCWY vaccine when compared to one dose of Men ACWY vaccine against a panel of US N. meningitidis serogroup B invasive disease strains. Least Square (LS)-mean computed from the generalized linear model.

Time frame: One month after the second vaccination (month 3)

Population: Analysis was done on Full Analysis Set (FAS) effectiveness (month 3): all subjects in the All Enrolled Set who received a study vaccination and provided evaluable serum sample with enc-hSBA for at least one N. meningitidis serogroup B invasive disease strain at one month after the 2-dose series (Visit Month 3).

Arm	Measure	Value (MEAN)	Dispersion
MenABCWY	Percentage of Subjects Without Bactericidal Activity at 1:4 Dilution Against Each US Neisseria Meningitidis (N. Meningitidis) Serogroup B Strain at One Month After the Second Vaccination.	25.17 Percentages of subjects	Standard Deviation 30.77
Placebo/MenACWY	Percentage of Subjects Without Bactericidal Activity at 1:4 Dilution Against Each US Neisseria Meningitidis (N. Meningitidis) Serogroup B Strain at One Month After the Second Vaccination.	76.19 Percentages of subjects	Standard Deviation 27.32

Comparison: H0 (Null Hypothesis): Vaccine Effectiveness (VE) ≤10%. If the lower limit of the 95% CI for VE is \> 10% the null hypothesis is to be rejected and effectiveness declared. The VE at 1 month after the 2nd injection for each strain is defined as \[1-(% of subjects without bactericidal activity at 1:4 dilution in MenABCWY group / % of subjects without bactericidal activity at 1:4 dilution in MenACWY group)\]x100. The combined VE across all strains will be computed by mean of a generalized linear model.p-value: <0.000195% CI: [65, 69]Generalized Linear Model

Comparison: vaccine effectiveness\<10% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= \[1- (% not killed/without bactericidal activity strains in ABCWY)/(% of not killed strains/without bactericidal activity strains in ACWY)\*100\].Generalized Linear Model

Comparison: Vaccine effectiveness \<30% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= \[1- (% not killed/without bactericidal activity strains in ABCWY)/(% of not killed strains/without bactericidal activity strains in ACWY)\*100\].generalized linear model.

Comparison: Vaccine effectiveness\<60% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= \[1- (% not killed/without bactericidal activity strains in ABCWY)/(% of not killed strains/without bactericidal activity strains in ACWY)\*100\].

Comparison: Vaccine effectiveness \<100% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= \[1- (% not killed/without bactericidal activity strains in ABCWY)/(% of not killed strains/without bactericidal activity strains in ACWY)\*100\].

Secondary

hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroup B Test Strains

The immunogenicity of two doses of MenABCWY compared to a single dose of MenACWY vaccine, in terms of hSBA GMTs against serogroup B test strains, at one month after the 2-dose vaccination series.

Time frame: One month after the second vaccination (month 3)

Population: Analysis was done on FAS Immunogenicity (Month 3). The number of participants analyzed is the number of subjects assessed for this particular endpoint.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
MenABCWY	hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroup B Test Strains	NZ98/254 (1 month after 2nd vacc)	6.03 Titers
MenABCWY	hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroup B Test Strains	M14459 (1 month after 2nd vacc) (N=138,132)	13.4 Titers
MenABCWY	hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroup B Test Strains	M07-0241084 (1 month after 2nd vacc) (N=124,122)	5.05 Titers
MenABCWY	hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroup B Test Strains	96217 (1 month after 2nd vacc) (N=124,118)	169.22 Titers
Placebo/MenACWY	hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroup B Test Strains	96217 (1 month after 2nd vacc) (N=124,118)	3.16 Titers
Placebo/MenACWY	hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroup B Test Strains	NZ98/254 (1 month after 2nd vacc)	1.04 Titers
Placebo/MenACWY	hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroup B Test Strains	M07-0241084 (1 month after 2nd vacc) (N=124,122)	1.65 Titers
Placebo/MenACWY	hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroup B Test Strains	M14459 (1 month after 2nd vacc) (N=138,132)	1.08 Titers

Secondary

hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroups A,C,W,Y

The immunogenicity of two doses of MenABCWY compared to a single dose of MenACWY vaccine, in terms of hSBA GMTs to serogroups A, C, W, and Y, at one month after the 2-dose vaccination series.

Time frame: One month after the second vaccination (month 3)

Population: Analysis was done on FAS Immunogenicity (Month 3)

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
MenABCWY	hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroups A,C,W,Y	Men A (1 month after 2nd vacc) (N=137,115)	77.02 Titers
MenABCWY	hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroups A,C,W,Y	Men C (1 month after 2nd vacc) (N=134,125)	235.88 Titers
MenABCWY	hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroups A,C,W,Y	Men W (1 month after 2nd vacc) (N=119,115)	157.72 Titers
MenABCWY	hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroups A,C,W,Y	Men Y (1 month after 2nd vacc) (N=107,94)	155.43 Titers
Placebo/MenACWY	hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroups A,C,W,Y	Men Y (1 month after 2nd vacc) (N=107,94)	27.76 Titers
Placebo/MenACWY	hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroups A,C,W,Y	Men A (1 month after 2nd vacc) (N=137,115)	22.08 Titers
Placebo/MenACWY	hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroups A,C,W,Y	Men W (1 month after 2nd vacc) (N=119,115)	37.51 Titers
Placebo/MenACWY	hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroups A,C,W,Y	Men C (1 month after 2nd vacc) (N=134,125)	38.61 Titers

Secondary

HT-hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroup B Test Strains

The immunogenicity of two doses of MenABCWY compared to a single dose of MenACWY vaccine, in terms of HT-hSBA GMTs against serogroup B test strains, at four months after the 2-dose vaccination series.

Time frame: Four months after the second vaccination (month 6)

Population: Analysis was done on the FAS immunogenicity (month 6). The number of participants analyzed is the number of subjects assessed for this particular endpoint.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
MenABCWY	HT-hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroup B Test Strains	NZ98/254 (N=133,134)	1.75 Titers
MenABCWY	HT-hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroup B Test Strains	M14459 (N=133,134)	3.04 Titers
MenABCWY	HT-hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroup B Test Strains	M07-0241084 (N=126,127)	1.77 Titers
MenABCWY	HT-hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroup B Test Strains	96217 (N=131,133)	57.85 Titers
Placebo/MenACWY	HT-hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroup B Test Strains	96217 (N=131,133)	3 Titers
Placebo/MenACWY	HT-hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroup B Test Strains	NZ98/254 (N=133,134)	1.06 Titers
Placebo/MenACWY	HT-hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroup B Test Strains	M07-0241084 (N=126,127)	1.56 Titers
Placebo/MenACWY	HT-hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroup B Test Strains	M14459 (N=133,134)	1.12 Titers

Secondary

HT-hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroups A, C, W, Y

The immunogenicity of two doses of MenABCWY compared to a single dose of MenACWY vaccine, in terms of HT-hSBA GMTs to serogroups A, C, W, and Y, at four months after the 2-dose vaccination series.

Time frame: Four months after the second vaccination (month 6)

Population: Analysis was done on the FAS immunogenicity (month 6). The number of participants analyzed is the number of subjects assessed for this particular endpoint.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
MenABCWY	HT-hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroups A, C, W, Y	Men A (N=124,130)	12.91 Titers
MenABCWY	HT-hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroups A, C, W, Y	Men W (N=131,130)	91.22 Titers
MenABCWY	HT-hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroups A, C, W, Y	Men Y (N=132,132)	59.51 Titers
MenABCWY	HT-hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroups A, C, W, Y	Men C (N=133,133)	117.18 Titers
Placebo/MenACWY	HT-hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroups A, C, W, Y	Men Y (N=132,132)	19.53 Titers
Placebo/MenACWY	HT-hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroups A, C, W, Y	Men A (N=124,130)	5.56 Titers
Placebo/MenACWY	HT-hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroups A, C, W, Y	Men C (N=133,133)	25.64 Titers
Placebo/MenACWY	HT-hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroups A, C, W, Y	Men W (N=131,130)	42.97 Titers

Secondary

Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs)

Reactogenicity was presented in terms of number of subjects reporting solicited local and systemic AEs and other indicators.

Time frame: From day 1 (6 hours) until day 7 after any vaccination

Population: Analysis was done on Solicited Safety Set: all subjects in the All Exposed Set who have provided any solicited adverse event data and/or other indicators or reactogenicity

Arm	Measure	Group	Value (NUMBER)
MenABCWY	Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs)	Pain (N=149,145)	127 subjects
MenABCWY	Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs)	Myalgia	20 subjects
MenABCWY	Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs)	Any Systemic Reactions	70 subjects
MenABCWY	Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs)	Arthralgia	18 subjects
MenABCWY	Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs)	Any	129 subjects
MenABCWY	Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs)	Headache	40 subjects
MenABCWY	Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs)	Induration (mm) (N=149,145)	21 subjects
MenABCWY	Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs)	Fever (N=148,146)	9 subjects
MenABCWY	Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs)	Chills	15 subjects
MenABCWY	Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs)	Nausea	9 subjects
MenABCWY	Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs)	Loss of appetite	23 subjects
MenABCWY	Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs)	Erythema (mm) (N=149,145)	23 subjects
MenABCWY	Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs)	Prevention of pain/fever (N=149,144)	4 subjects
MenABCWY	Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs)	Any Local Reactions	128 subjects
MenABCWY	Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs)	Treatment of pain/fever (N=149,144)	60 subjects
MenABCWY	Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs)	Fatigue	40 subjects
Placebo/MenACWY	Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs)	Treatment of pain/fever (N=149,144)	9 subjects
Placebo/MenACWY	Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs)	Pain (N=149,145)	63 subjects
Placebo/MenACWY	Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs)	Nausea	19 subjects
Placebo/MenACWY	Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs)	Any	92 subjects
Placebo/MenACWY	Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs)	Any Local Reactions	65 subjects
Placebo/MenACWY	Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs)	Any Systemic Reactions	66 subjects
Placebo/MenACWY	Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs)	Induration (mm) (N=149,145)	8 subjects
Placebo/MenACWY	Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs)	Erythema (mm) (N=149,145)	5 subjects
Placebo/MenACWY	Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs)	Fatigue	35 subjects
Placebo/MenACWY	Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs)	Myalgia	14 subjects
Placebo/MenACWY	Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs)	Arthralgia	5 subjects
Placebo/MenACWY	Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs)	Headache	42 subjects
Placebo/MenACWY	Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs)	Chills	8 subjects
Placebo/MenACWY	Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs)	Loss of appetite	12 subjects
Placebo/MenACWY	Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs)	Prevention of pain/fever (N=149,144)	2 subjects
Placebo/MenACWY	Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs)	Fever (N=148,146)	0 subjects

Secondary

Number of Subjects Reporting Unsolicited AEs.

Percentages of subjects reporting unsolicited AEs including serious adverse events (SAEs).

Time frame: From day 1 to day 30 after any vaccination for any unsolicited AE. From day 1 to study termination (day 181) for all other categories.

Population: Analysis was done on the unsolicited safety set, ie, all subjects in the exposed set with any unsolicited adverse event data and/or indicators of unsolicited adverse events. Analysis for AEs leading to withdrawal was done on All Enrolled Set population.

Arm	Measure	Group	Value (NUMBER)
MenABCWY	Number of Subjects Reporting Unsolicited AEs.	Any unsolicited AEs	28 Subjects
MenABCWY	Number of Subjects Reporting Unsolicited AEs.	Possibly or probably related AEs	7 Subjects
MenABCWY	Number of Subjects Reporting Unsolicited AEs.	Medically-attended AEs	37 Subjects
MenABCWY	Number of Subjects Reporting Unsolicited AEs.	AEs leading to withdrawal	1 Subjects
MenABCWY	Number of Subjects Reporting Unsolicited AEs.	Any SAEs	0 Subjects
MenABCWY	Number of Subjects Reporting Unsolicited AEs.	SAE leading to death	0 Subjects
Placebo/MenACWY	Number of Subjects Reporting Unsolicited AEs.	Any SAEs	1 Subjects
Placebo/MenACWY	Number of Subjects Reporting Unsolicited AEs.	Any unsolicited AEs	28 Subjects
Placebo/MenACWY	Number of Subjects Reporting Unsolicited AEs.	AEs leading to withdrawal	1 Subjects
Placebo/MenACWY	Number of Subjects Reporting Unsolicited AEs.	Possibly or probably related AEs	3 Subjects
Placebo/MenACWY	Number of Subjects Reporting Unsolicited AEs.	SAE leading to death	0 Subjects
Placebo/MenACWY	Number of Subjects Reporting Unsolicited AEs.	Medically-attended AEs	44 Subjects

Secondary

Percentage of Subjects With 2-fold Rise in hSBA Titer Against N.Meningitidis Serogroup B Strains at One and Four Months After the 2-dose Vaccination Series.

The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with a two-fold rise in HT-hSBA titers against the N.meningitidis serogroup B test strains, at 1 and 4 months after the 2-dose vaccination series.The 2-fold rise in titer is defined as follows: a)for subjects with prevaccination hSBA titers \<LLQ, a postvaccination hSBA ≥2 LLQ; b) for subjects with a prevaccination hSBA titers ≥LLQ, an increase of at least 2 times of the prevaccination hSBA

Time frame: At Month 3 and Month 6 ( one and four months after 2 doses of vaccination)

Population: Analysis was performed on FAS immunogenicity- month 3 and month 6. The number of participants analyzed is the number of subjects assessed for this particular endpoint.

Arm	Measure	Group	Value (NUMBER)
MenABCWY	Percentage of Subjects With 2-fold Rise in hSBA Titer Against N.Meningitidis Serogroup B Strains at One and Four Months After the 2-dose Vaccination Series.	96217-Month 3(N=101,99)	92 Percentage of subjects
MenABCWY	Percentage of Subjects With 2-fold Rise in hSBA Titer Against N.Meningitidis Serogroup B Strains at One and Four Months After the 2-dose Vaccination Series.	M07-0241084-Month 3(N=115,119)	13 Percentage of subjects
MenABCWY	Percentage of Subjects With 2-fold Rise in hSBA Titer Against N.Meningitidis Serogroup B Strains at One and Four Months After the 2-dose Vaccination Series.	M14459-Month 3(N=137,130)	55 Percentage of subjects
MenABCWY	Percentage of Subjects With 2-fold Rise in hSBA Titer Against N.Meningitidis Serogroup B Strains at One and Four Months After the 2-dose Vaccination Series.	NZ98/254-Month 3(N=136,131)	17 Percentage of subjects
MenABCWY	Percentage of Subjects With 2-fold Rise in hSBA Titer Against N.Meningitidis Serogroup B Strains at One and Four Months After the 2-dose Vaccination Series.	96217-Month 6(N=106,111)	81 Percentage of subjects
MenABCWY	Percentage of Subjects With 2-fold Rise in hSBA Titer Against N.Meningitidis Serogroup B Strains at One and Four Months After the 2-dose Vaccination Series.	M07-0241084-Month 6(N=117,121)	3 Percentage of subjects
MenABCWY	Percentage of Subjects With 2-fold Rise in hSBA Titer Against N.Meningitidis Serogroup B Strains at One and Four Months After the 2-dose Vaccination Series.	M14459-Month 6(N=132,131)	9 Percentage of subjects
MenABCWY	Percentage of Subjects With 2-fold Rise in hSBA Titer Against N.Meningitidis Serogroup B Strains at One and Four Months After the 2-dose Vaccination Series.	NZ98/254-Month 6(N=131,131)	2 Percentage of subjects
Placebo/MenACWY	Percentage of Subjects With 2-fold Rise in hSBA Titer Against N.Meningitidis Serogroup B Strains at One and Four Months After the 2-dose Vaccination Series.	NZ98/254-Month 6(N=131,131)	0 Percentage of subjects
Placebo/MenACWY	Percentage of Subjects With 2-fold Rise in hSBA Titer Against N.Meningitidis Serogroup B Strains at One and Four Months After the 2-dose Vaccination Series.	96217-Month 3(N=101,99)	6 Percentage of subjects
Placebo/MenACWY	Percentage of Subjects With 2-fold Rise in hSBA Titer Against N.Meningitidis Serogroup B Strains at One and Four Months After the 2-dose Vaccination Series.	96217-Month 6(N=106,111)	5 Percentage of subjects
Placebo/MenACWY	Percentage of Subjects With 2-fold Rise in hSBA Titer Against N.Meningitidis Serogroup B Strains at One and Four Months After the 2-dose Vaccination Series.	M07-0241084-Month 3(N=115,119)	2 Percentage of subjects
Placebo/MenACWY	Percentage of Subjects With 2-fold Rise in hSBA Titer Against N.Meningitidis Serogroup B Strains at One and Four Months After the 2-dose Vaccination Series.	M14459-Month 6(N=132,131)	1 Percentage of subjects
Placebo/MenACWY	Percentage of Subjects With 2-fold Rise in hSBA Titer Against N.Meningitidis Serogroup B Strains at One and Four Months After the 2-dose Vaccination Series.	M14459-Month 3(N=137,130)	0 Percentage of subjects
Placebo/MenACWY	Percentage of Subjects With 2-fold Rise in hSBA Titer Against N.Meningitidis Serogroup B Strains at One and Four Months After the 2-dose Vaccination Series.	M07-0241084-Month 6(N=117,121)	1 Percentage of subjects
Placebo/MenACWY	Percentage of Subjects With 2-fold Rise in hSBA Titer Against N.Meningitidis Serogroup B Strains at One and Four Months After the 2-dose Vaccination Series.	NZ98/254-Month 3(N=136,131)	0 Percentage of subjects

Secondary

Percentage of Subjects With 2-fold Rise in hSBA Titer Against N.Meningitidis Serogroups A,C,W and Y at One and Four Months After the 2-dose Vaccination Series.

The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with a two-fold rise in HT-hSBA titers against the N.meningitidis serogroups A,C,W and Y, at 1 and 4 months after the 2-dose vaccination series. The 2-fold rise in titer is defined as follows: a)for subjects with prevaccination hSBA titers \<LLQ, a postvaccination hSBA ≥2 LLQ; b) for subjects with a prevaccination hSBA titers ≥LLQ, an increase of at least 2 times of the prevaccination hSBA.

Time frame: At Month 3 and Month 6 ( one and four months after 2 doses of vaccination)

Population: Analysis was performed on FAS immunogenicity-Month 3 and Month 6. The number of participants analyzed is the number of subjects assessed for this particular endpoint.

Arm	Measure	Group	Value (NUMBER)
MenABCWY	Percentage of Subjects With 2-fold Rise in hSBA Titer Against N.Meningitidis Serogroups A,C,W and Y at One and Four Months After the 2-dose Vaccination Series.	Men A-month 3(N=132,110)	81 Percentage of subjects
MenABCWY	Percentage of Subjects With 2-fold Rise in hSBA Titer Against N.Meningitidis Serogroups A,C,W and Y at One and Four Months After the 2-dose Vaccination Series.	Men C-month 3(N=131,123)	98 Percentage of subjects
MenABCWY	Percentage of Subjects With 2-fold Rise in hSBA Titer Against N.Meningitidis Serogroups A,C,W and Y at One and Four Months After the 2-dose Vaccination Series.	Men W-month 3(N=107,103)	74 Percentage of subjects
MenABCWY	Percentage of Subjects With 2-fold Rise in hSBA Titer Against N.Meningitidis Serogroups A,C,W and Y at One and Four Months After the 2-dose Vaccination Series.	Men Y-Month 3(N=99,86)	92 Percentage of subjects
MenABCWY	Percentage of Subjects With 2-fold Rise in hSBA Titer Against N.Meningitidis Serogroups A,C,W and Y at One and Four Months After the 2-dose Vaccination Series.	Men A-Month 6(N=119,126)	23 Percentage of subjects
MenABCWY	Percentage of Subjects With 2-fold Rise in hSBA Titer Against N.Meningitidis Serogroups A,C,W and Y at One and Four Months After the 2-dose Vaccination Series.	Men C-Month 6(N=130,130)	94 Percentage of subjects
MenABCWY	Percentage of Subjects With 2-fold Rise in hSBA Titer Against N.Meningitidis Serogroups A,C,W and Y at One and Four Months After the 2-dose Vaccination Series.	Men W-Month 6(N=114,116)	54 Percentage of subjects
MenABCWY	Percentage of Subjects With 2-fold Rise in hSBA Titer Against N.Meningitidis Serogroups A,C,W and Y at One and Four Months After the 2-dose Vaccination Series.	Men Y-Month 6(N=122,121)	72 Percentage of subjects
Placebo/MenACWY	Percentage of Subjects With 2-fold Rise in hSBA Titer Against N.Meningitidis Serogroups A,C,W and Y at One and Four Months After the 2-dose Vaccination Series.	Men Y-Month 6(N=122,121)	47 Percentage of subjects
Placebo/MenACWY	Percentage of Subjects With 2-fold Rise in hSBA Titer Against N.Meningitidis Serogroups A,C,W and Y at One and Four Months After the 2-dose Vaccination Series.	Men A-month 3(N=132,110)	48 Percentage of subjects
Placebo/MenACWY	Percentage of Subjects With 2-fold Rise in hSBA Titer Against N.Meningitidis Serogroups A,C,W and Y at One and Four Months After the 2-dose Vaccination Series.	Men A-Month 6(N=119,126)	21 Percentage of subjects
Placebo/MenACWY	Percentage of Subjects With 2-fold Rise in hSBA Titer Against N.Meningitidis Serogroups A,C,W and Y at One and Four Months After the 2-dose Vaccination Series.	Men C-month 3(N=131,123)	66 Percentage of subjects
Placebo/MenACWY	Percentage of Subjects With 2-fold Rise in hSBA Titer Against N.Meningitidis Serogroups A,C,W and Y at One and Four Months After the 2-dose Vaccination Series.	Men W-Month 6(N=114,116)	30 Percentage of subjects
Placebo/MenACWY	Percentage of Subjects With 2-fold Rise in hSBA Titer Against N.Meningitidis Serogroups A,C,W and Y at One and Four Months After the 2-dose Vaccination Series.	Men W-month 3(N=107,103)	25 Percentage of subjects
Placebo/MenACWY	Percentage of Subjects With 2-fold Rise in hSBA Titer Against N.Meningitidis Serogroups A,C,W and Y at One and Four Months After the 2-dose Vaccination Series.	Men C-Month 6(N=130,130)	55 Percentage of subjects
Placebo/MenACWY	Percentage of Subjects With 2-fold Rise in hSBA Titer Against N.Meningitidis Serogroups A,C,W and Y at One and Four Months After the 2-dose Vaccination Series.	Men Y-Month 3(N=99,86)	59 Percentage of subjects

Secondary

Percentage of Subjects With 3-fold Rise in hSBA Titer Against N.Meningitidis Serogroup B Strains at One and Four Months After the 2-dose Vaccination Series.

The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with a 3-fold rise in HT-hSBA titers against the N.meningitidis serogroup B test strains, at 1 and 4 months after the 2-dose vaccination series.The 3-fold rise in titer is defined as follows: a)for subjects with prevaccination hSBA titers \<LLQ, a postvaccination hSBA ≥3 LLQ; b) for subjects with a prevaccination hSBA titers ≥LLQ, an increase of at least 3 times of the prevaccination hSBA.

Time frame: At Month 3 and Month 6 ( one and four months after 2 doses of vaccination)

Population: Analysis was performed on FAS immunogenicity-month 3 and month 6. The number of participants analyzed is the number of subjects assessed for this particular endpoint.

Arm	Measure	Group	Value (NUMBER)
MenABCWY	Percentage of Subjects With 3-fold Rise in hSBA Titer Against N.Meningitidis Serogroup B Strains at One and Four Months After the 2-dose Vaccination Series.	96217-month 3(N=101,99)	91 Percentage of subjects
MenABCWY	Percentage of Subjects With 3-fold Rise in hSBA Titer Against N.Meningitidis Serogroup B Strains at One and Four Months After the 2-dose Vaccination Series.	M07-0231084-month 3(N=115,119)	8 Percentage of subjects
MenABCWY	Percentage of Subjects With 3-fold Rise in hSBA Titer Against N.Meningitidis Serogroup B Strains at One and Four Months After the 2-dose Vaccination Series.	M14459-month 3(N=137,130)	34 Percentage of subjects
MenABCWY	Percentage of Subjects With 3-fold Rise in hSBA Titer Against N.Meningitidis Serogroup B Strains at One and Four Months After the 2-dose Vaccination Series.	NZ98/254-month 3(N=136,131)	10 Percentage of subjects
MenABCWY	Percentage of Subjects With 3-fold Rise in hSBA Titer Against N.Meningitidis Serogroup B Strains at One and Four Months After the 2-dose Vaccination Series.	96217-Month 6(N=106,111)	70 Percentage of subjects
MenABCWY	Percentage of Subjects With 3-fold Rise in hSBA Titer Against N.Meningitidis Serogroup B Strains at One and Four Months After the 2-dose Vaccination Series.	M07-0241084-Month 6(N=117,121)	2 Percentage of subjects
MenABCWY	Percentage of Subjects With 3-fold Rise in hSBA Titer Against N.Meningitidis Serogroup B Strains at One and Four Months After the 2-dose Vaccination Series.	M14459-Month 6(N=132,131)	4 Percentage of subjects
MenABCWY	Percentage of Subjects With 3-fold Rise in hSBA Titer Against N.Meningitidis Serogroup B Strains at One and Four Months After the 2-dose Vaccination Series.	NZ98/254-Month 6(N=131,131)	2 Percentage of subjects
Placebo/MenACWY	Percentage of Subjects With 3-fold Rise in hSBA Titer Against N.Meningitidis Serogroup B Strains at One and Four Months After the 2-dose Vaccination Series.	NZ98/254-Month 6(N=131,131)	0 Percentage of subjects
Placebo/MenACWY	Percentage of Subjects With 3-fold Rise in hSBA Titer Against N.Meningitidis Serogroup B Strains at One and Four Months After the 2-dose Vaccination Series.	96217-month 3(N=101,99)	2 Percentage of subjects
Placebo/MenACWY	Percentage of Subjects With 3-fold Rise in hSBA Titer Against N.Meningitidis Serogroup B Strains at One and Four Months After the 2-dose Vaccination Series.	96217-Month 6(N=106,111)	2 Percentage of subjects
Placebo/MenACWY	Percentage of Subjects With 3-fold Rise in hSBA Titer Against N.Meningitidis Serogroup B Strains at One and Four Months After the 2-dose Vaccination Series.	M07-0231084-month 3(N=115,119)	0 Percentage of subjects
Placebo/MenACWY	Percentage of Subjects With 3-fold Rise in hSBA Titer Against N.Meningitidis Serogroup B Strains at One and Four Months After the 2-dose Vaccination Series.	M14459-Month 6(N=132,131)	0 Percentage of subjects
Placebo/MenACWY	Percentage of Subjects With 3-fold Rise in hSBA Titer Against N.Meningitidis Serogroup B Strains at One and Four Months After the 2-dose Vaccination Series.	M14459-month 3(N=137,130)	0 Percentage of subjects
Placebo/MenACWY	Percentage of Subjects With 3-fold Rise in hSBA Titer Against N.Meningitidis Serogroup B Strains at One and Four Months After the 2-dose Vaccination Series.	M07-0241084-Month 6(N=117,121)	1 Percentage of subjects
Placebo/MenACWY	Percentage of Subjects With 3-fold Rise in hSBA Titer Against N.Meningitidis Serogroup B Strains at One and Four Months After the 2-dose Vaccination Series.	NZ98/254-month 3(N=136,131)	0 Percentage of subjects

Secondary

Percentage of Subjects With 3-fold Rise in hSBA Titer Against N.Meningitidis Serogroups A, C, W and Y at One and Four Months After the 2-dose Vaccination Series.

The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with a three-fold rise in HT-hSBA titers against the N.meningitidis serogroups A,C,W and Y at 1 and 4 months after the 2-dose vaccination series. The 3-fold rise in titer is defined as follows: a)for subjects with prevaccination hSBA titers \<LLQ, a postvaccination hSBA ≥3 LLQ; b) for subjects with a prevaccination hSBA titers ≥LLQ, an increase of at least 3 times of the prevaccination hSBA.

Time frame: At Month 3 and Month 6 (one and four months after 2 doses of vaccination)

Population: Analysis was performed on FAS immunogenicity-Month 3 and Month 6. The number of participants analyzed is the number of subjects assessed for this particular endpoint.

Arm	Measure	Group	Value (NUMBER)
MenABCWY	Percentage of Subjects With 3-fold Rise in hSBA Titer Against N.Meningitidis Serogroups A, C, W and Y at One and Four Months After the 2-dose Vaccination Series.	Men A-Month 6(N=119,126)	13 Percentage of subjects
MenABCWY	Percentage of Subjects With 3-fold Rise in hSBA Titer Against N.Meningitidis Serogroups A, C, W and Y at One and Four Months After the 2-dose Vaccination Series.	Men C-Month 6(N=130,130)	88 Percentage of subjects
MenABCWY	Percentage of Subjects With 3-fold Rise in hSBA Titer Against N.Meningitidis Serogroups A, C, W and Y at One and Four Months After the 2-dose Vaccination Series.	Men W-Month 6(N=114,116)	32 Percentage of subjects
MenABCWY	Percentage of Subjects With 3-fold Rise in hSBA Titer Against N.Meningitidis Serogroups A, C, W and Y at One and Four Months After the 2-dose Vaccination Series.	Men Y-Month 6(N=122,121)	61 Percentage of subjects
MenABCWY	Percentage of Subjects With 3-fold Rise in hSBA Titer Against N.Meningitidis Serogroups A, C, W and Y at One and Four Months After the 2-dose Vaccination Series.	Men A-Month 3(N=132,110)	61 Percentage of subjects
MenABCWY	Percentage of Subjects With 3-fold Rise in hSBA Titer Against N.Meningitidis Serogroups A, C, W and Y at One and Four Months After the 2-dose Vaccination Series.	Men C-Month 3(N=131,123)	98 Percentage of subjects
MenABCWY	Percentage of Subjects With 3-fold Rise in hSBA Titer Against N.Meningitidis Serogroups A, C, W and Y at One and Four Months After the 2-dose Vaccination Series.	Men W-Month 3(N=107,103)	56 Percentage of subjects
MenABCWY	Percentage of Subjects With 3-fold Rise in hSBA Titer Against N.Meningitidis Serogroups A, C, W and Y at One and Four Months After the 2-dose Vaccination Series.	Men Y-Month 3(N=99,86)	85 Percentage of subjects
Placebo/MenACWY	Percentage of Subjects With 3-fold Rise in hSBA Titer Against N.Meningitidis Serogroups A, C, W and Y at One and Four Months After the 2-dose Vaccination Series.	Men Y-Month 3(N=99,86)	50 Percentage of subjects
Placebo/MenACWY	Percentage of Subjects With 3-fold Rise in hSBA Titer Against N.Meningitidis Serogroups A, C, W and Y at One and Four Months After the 2-dose Vaccination Series.	Men A-Month 6(N=119,126)	14 Percentage of subjects
Placebo/MenACWY	Percentage of Subjects With 3-fold Rise in hSBA Titer Against N.Meningitidis Serogroups A, C, W and Y at One and Four Months After the 2-dose Vaccination Series.	Men A-Month 3(N=132,110)	36 Percentage of subjects
Placebo/MenACWY	Percentage of Subjects With 3-fold Rise in hSBA Titer Against N.Meningitidis Serogroups A, C, W and Y at One and Four Months After the 2-dose Vaccination Series.	Men C-Month 6(N=130,130)	48 Percentage of subjects
Placebo/MenACWY	Percentage of Subjects With 3-fold Rise in hSBA Titer Against N.Meningitidis Serogroups A, C, W and Y at One and Four Months After the 2-dose Vaccination Series.	Men W-Month 3(N=107,103)	19 Percentage of subjects
Placebo/MenACWY	Percentage of Subjects With 3-fold Rise in hSBA Titer Against N.Meningitidis Serogroups A, C, W and Y at One and Four Months After the 2-dose Vaccination Series.	Men W-Month 6(N=114,116)	22 Percentage of subjects
Placebo/MenACWY	Percentage of Subjects With 3-fold Rise in hSBA Titer Against N.Meningitidis Serogroups A, C, W and Y at One and Four Months After the 2-dose Vaccination Series.	Men C-Month 3(N=131,123)	58 Percentage of subjects
Placebo/MenACWY	Percentage of Subjects With 3-fold Rise in hSBA Titer Against N.Meningitidis Serogroups A, C, W and Y at One and Four Months After the 2-dose Vaccination Series.	Men Y-Month 6(N=122,121)	40 Percentage of subjects

Secondary

Percentage of Subjects With 4-fold Rise in hSBA Titer Against N.Meningitidis Serogroup B Strains at One and Four Months After the 2-dose Vaccination Series.

The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with a 4-fold rise in HT-hSBA titers against the N.meningitidis serogroup B test strains, at 1 and 4 months after the 2-dose vaccination series. The 4-fold rise in titer is defined as follows: a)for subjects with prevaccination hSBA titers \<LLQ, a postvaccination hSBA ≥4 LLQ; b) for subjects with a prevaccination hSBA titers ≥LLQ, an increase of at least 4 times of the prevaccination hSBA.

Time frame: At Month 3 and Month 6 ( one and four months after 2 doses of vaccination)

Population: Analaysis was performed on FAS immunogenicity-Month 3 and Month 6. The number of participants analyzed is the number of subjects assessed for this particular endpoint.

Arm	Measure	Group	Value (NUMBER)
MenABCWY	Percentage of Subjects With 4-fold Rise in hSBA Titer Against N.Meningitidis Serogroup B Strains at One and Four Months After the 2-dose Vaccination Series.	96217-month 3(N=101,99)	87 Percentage of subjects
MenABCWY	Percentage of Subjects With 4-fold Rise in hSBA Titer Against N.Meningitidis Serogroup B Strains at One and Four Months After the 2-dose Vaccination Series.	M07-0231084-month 3(N=115,119)	2 Percentage of subjects
MenABCWY	Percentage of Subjects With 4-fold Rise in hSBA Titer Against N.Meningitidis Serogroup B Strains at One and Four Months After the 2-dose Vaccination Series.	M14459-month 3(N=137,130)	22 Percentage of subjects
MenABCWY	Percentage of Subjects With 4-fold Rise in hSBA Titer Against N.Meningitidis Serogroup B Strains at One and Four Months After the 2-dose Vaccination Series.	NZ98/25-month 3(N=136,131)	5 Percentage of subjects
MenABCWY	Percentage of Subjects With 4-fold Rise in hSBA Titer Against N.Meningitidis Serogroup B Strains at One and Four Months After the 2-dose Vaccination Series.	96217-Month 6(N=106,111)	63 Percentage of subjects
MenABCWY	Percentage of Subjects With 4-fold Rise in hSBA Titer Against N.Meningitidis Serogroup B Strains at One and Four Months After the 2-dose Vaccination Series.	M07-0241084-Month 6(N=117,121)	2 Percentage of subjects
MenABCWY	Percentage of Subjects With 4-fold Rise in hSBA Titer Against N.Meningitidis Serogroup B Strains at One and Four Months After the 2-dose Vaccination Series.	M14459-Month 6(N=132,131)	2 Percentage of subjects
MenABCWY	Percentage of Subjects With 4-fold Rise in hSBA Titer Against N.Meningitidis Serogroup B Strains at One and Four Months After the 2-dose Vaccination Series.	NZ98/254-Month 6(N=131,131)	2 Percentage of subjects
Placebo/MenACWY	Percentage of Subjects With 4-fold Rise in hSBA Titer Against N.Meningitidis Serogroup B Strains at One and Four Months After the 2-dose Vaccination Series.	NZ98/254-Month 6(N=131,131)	0 Percentage of subjects
Placebo/MenACWY	Percentage of Subjects With 4-fold Rise in hSBA Titer Against N.Meningitidis Serogroup B Strains at One and Four Months After the 2-dose Vaccination Series.	96217-month 3(N=101,99)	1 Percentage of subjects
Placebo/MenACWY	Percentage of Subjects With 4-fold Rise in hSBA Titer Against N.Meningitidis Serogroup B Strains at One and Four Months After the 2-dose Vaccination Series.	96217-Month 6(N=106,111)	1 Percentage of subjects
Placebo/MenACWY	Percentage of Subjects With 4-fold Rise in hSBA Titer Against N.Meningitidis Serogroup B Strains at One and Four Months After the 2-dose Vaccination Series.	M07-0231084-month 3(N=115,119)	0 Percentage of subjects
Placebo/MenACWY	Percentage of Subjects With 4-fold Rise in hSBA Titer Against N.Meningitidis Serogroup B Strains at One and Four Months After the 2-dose Vaccination Series.	M14459-Month 6(N=132,131)	0 Percentage of subjects
Placebo/MenACWY	Percentage of Subjects With 4-fold Rise in hSBA Titer Against N.Meningitidis Serogroup B Strains at One and Four Months After the 2-dose Vaccination Series.	M14459-month 3(N=137,130)	0 Percentage of subjects
Placebo/MenACWY	Percentage of Subjects With 4-fold Rise in hSBA Titer Against N.Meningitidis Serogroup B Strains at One and Four Months After the 2-dose Vaccination Series.	M07-0241084-Month 6(N=117,121)	0 Percentage of subjects
Placebo/MenACWY	Percentage of Subjects With 4-fold Rise in hSBA Titer Against N.Meningitidis Serogroup B Strains at One and Four Months After the 2-dose Vaccination Series.	NZ98/25-month 3(N=136,131)	0 Percentage of subjects

Secondary

Percentage of Subjects With 4-fold Rise in hSBA Titer Against N.Meningitidis Serogroups A,C,W and Y at One and Four Months After the 2-dose Vaccination Series.

The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with a 4-fold rise in HT-hSBA titers against the N.meningitidis serogroups A,C,W and Y, at 1 and 4 months after the 2-dose vaccination series. The 4-fold rise in titer is defined as follows: a)for subjects with prevaccination hSBA titers \<LLQ, a postvaccination hSBA ≥4 LLQ; b) for subjects with a prevaccination hSBA titers ≥LLQ, an increase of at least 4 times of the prevaccination hSBA.

Time frame: At Month 3 and Month 6 ( one and four months after 2 doses of vaccination)

Population: Analysis was performed on FAS immunogenicity- Month 3 and Month 6. The number of participants analyzed is the number of subjects assessed for this particular endpoint.

Arm	Measure	Group	Value (NUMBER)
MenABCWY	Percentage of Subjects With 4-fold Rise in hSBA Titer Against N.Meningitidis Serogroups A,C,W and Y at One and Four Months After the 2-dose Vaccination Series.	Men A-Month 3(N=132,110)	45 Percentage of subjects
MenABCWY	Percentage of Subjects With 4-fold Rise in hSBA Titer Against N.Meningitidis Serogroups A,C,W and Y at One and Four Months After the 2-dose Vaccination Series.	Men C-month 3(N=131,123)	95 Percentage of subjects
MenABCWY	Percentage of Subjects With 4-fold Rise in hSBA Titer Against N.Meningitidis Serogroups A,C,W and Y at One and Four Months After the 2-dose Vaccination Series.	Men W-Month 3(N=107,103)	50 Percentage of subjects
MenABCWY	Percentage of Subjects With 4-fold Rise in hSBA Titer Against N.Meningitidis Serogroups A,C,W and Y at One and Four Months After the 2-dose Vaccination Series.	Men Y-month 3(N=99,86)	81 Percentage of subjects
MenABCWY	Percentage of Subjects With 4-fold Rise in hSBA Titer Against N.Meningitidis Serogroups A,C,W and Y at One and Four Months After the 2-dose Vaccination Series.	Men A-Month 6(N=119,126)	8 Percentage of subjects
MenABCWY	Percentage of Subjects With 4-fold Rise in hSBA Titer Against N.Meningitidis Serogroups A,C,W and Y at One and Four Months After the 2-dose Vaccination Series.	Men C-Month 6(N=130,130)	86 Percentage of subjects
MenABCWY	Percentage of Subjects With 4-fold Rise in hSBA Titer Against N.Meningitidis Serogroups A,C,W and Y at One and Four Months After the 2-dose Vaccination Series.	Men W-Month 6(N=114,116)	27 Percentage of subjects
MenABCWY	Percentage of Subjects With 4-fold Rise in hSBA Titer Against N.Meningitidis Serogroups A,C,W and Y at One and Four Months After the 2-dose Vaccination Series.	Men Y-Month 6(N=122,121)	49 Percentage of subjects
Placebo/MenACWY	Percentage of Subjects With 4-fold Rise in hSBA Titer Against N.Meningitidis Serogroups A,C,W and Y at One and Four Months After the 2-dose Vaccination Series.	Men Y-Month 6(N=122,121)	35 Percentage of subjects
Placebo/MenACWY	Percentage of Subjects With 4-fold Rise in hSBA Titer Against N.Meningitidis Serogroups A,C,W and Y at One and Four Months After the 2-dose Vaccination Series.	Men A-Month 3(N=132,110)	26 Percentage of subjects
Placebo/MenACWY	Percentage of Subjects With 4-fold Rise in hSBA Titer Against N.Meningitidis Serogroups A,C,W and Y at One and Four Months After the 2-dose Vaccination Series.	Men A-Month 6(N=119,126)	11 Percentage of subjects
Placebo/MenACWY	Percentage of Subjects With 4-fold Rise in hSBA Titer Against N.Meningitidis Serogroups A,C,W and Y at One and Four Months After the 2-dose Vaccination Series.	Men C-month 3(N=131,123)	54 Percentage of subjects
Placebo/MenACWY	Percentage of Subjects With 4-fold Rise in hSBA Titer Against N.Meningitidis Serogroups A,C,W and Y at One and Four Months After the 2-dose Vaccination Series.	Men W-Month 6(N=114,116)	17 Percentage of subjects
Placebo/MenACWY	Percentage of Subjects With 4-fold Rise in hSBA Titer Against N.Meningitidis Serogroups A,C,W and Y at One and Four Months After the 2-dose Vaccination Series.	Men W-Month 3(N=107,103)	15 Percentage of subjects
Placebo/MenACWY	Percentage of Subjects With 4-fold Rise in hSBA Titer Against N.Meningitidis Serogroups A,C,W and Y at One and Four Months After the 2-dose Vaccination Series.	Men C-Month 6(N=130,130)	43 Percentage of subjects
Placebo/MenACWY	Percentage of Subjects With 4-fold Rise in hSBA Titer Against N.Meningitidis Serogroups A,C,W and Y at One and Four Months After the 2-dose Vaccination Series.	Men Y-month 3(N=99,86)	47 Percentage of subjects

Secondary

Percentages of N. Meningitidis Serogroup B Invasive Disease Strains Killed at 1:4 and 1:8 Dilutions, for Each Subject

The mean percentage of N. meningitidis serogroup B invasive disease strains killed by each subject, at 1:4 and 1:8 dilutions at one month after the 2-dose vaccination series is reported.

Time frame: Baseline, one month after second vaccination (month 3)

Population: Analysis was done on FAS effectiveness (month 3)

Arm	Measure	Group	Value (MEAN)	Dispersion
MenABCWY	Percentages of N. Meningitidis Serogroup B Invasive Disease Strains Killed at 1:4 and 1:8 Dilutions, for Each Subject	Baseline (1:4) (N=136, 132)	20.08 Mean percentages of strains	Standard Deviation 16.25
MenABCWY	Percentages of N. Meningitidis Serogroup B Invasive Disease Strains Killed at 1:4 and 1:8 Dilutions, for Each Subject	1 month after 2nd vaccination (1:4)	74.47 Mean percentages of strains	Standard Deviation 14.55
MenABCWY	Percentages of N. Meningitidis Serogroup B Invasive Disease Strains Killed at 1:4 and 1:8 Dilutions, for Each Subject	Baseline (1:8) (N=136, 132)	9.25 Mean percentages of strains	Standard Deviation 8.35
MenABCWY	Percentages of N. Meningitidis Serogroup B Invasive Disease Strains Killed at 1:4 and 1:8 Dilutions, for Each Subject	1 month after 2nd vaccination (1:8)	52.16 Mean percentages of strains	Standard Deviation 17.11
Placebo/MenACWY	Percentages of N. Meningitidis Serogroup B Invasive Disease Strains Killed at 1:4 and 1:8 Dilutions, for Each Subject	1 month after 2nd vaccination (1:8)	11.39 Mean percentages of strains	Standard Deviation 10.35
Placebo/MenACWY	Percentages of N. Meningitidis Serogroup B Invasive Disease Strains Killed at 1:4 and 1:8 Dilutions, for Each Subject	Baseline (1:4) (N=136, 132)	19.76 Mean percentages of strains	Standard Deviation 15.48
Placebo/MenACWY	Percentages of N. Meningitidis Serogroup B Invasive Disease Strains Killed at 1:4 and 1:8 Dilutions, for Each Subject	Baseline (1:8) (N=136, 132)	9.54 Mean percentages of strains	Standard Deviation 9.49
Placebo/MenACWY	Percentages of N. Meningitidis Serogroup B Invasive Disease Strains Killed at 1:4 and 1:8 Dilutions, for Each Subject	1 month after 2nd vaccination (1:4)	22.93 Mean percentages of strains	Standard Deviation 16.11

Secondary

Percentages of N. Meningitidis Serogroup B Invasive Disease Strains Killed at 1:4 and 1:8 Dilutions, for Each Subject

The mean percentage of N. meningitidis serogroup B invasive disease strains killed by each subject, at 1:4 and 1:8 dilutions at four months after the 2-dose vaccination series is reported.

Time frame: Baseline, four months after second vaccination (month 6)

Population: Analysis was done on FAS effectiveness (month 6).

Arm	Measure	Group	Value (MEAN)	Dispersion
MenABCWY	Percentages of N. Meningitidis Serogroup B Invasive Disease Strains Killed at 1:4 and 1:8 Dilutions, for Each Subject	Baseline (1:4) (N=133, 132)	19.82 Mean percentage of strains	Standard Deviation 16.227
MenABCWY	Percentages of N. Meningitidis Serogroup B Invasive Disease Strains Killed at 1:4 and 1:8 Dilutions, for Each Subject	4 months after 2nd vaccination (1:4)	56.38 Mean percentage of strains	Standard Deviation 18.703
MenABCWY	Percentages of N. Meningitidis Serogroup B Invasive Disease Strains Killed at 1:4 and 1:8 Dilutions, for Each Subject	Baseline (1:8) (N=133, 132)	9.19 Mean percentage of strains	Standard Deviation 8.336
MenABCWY	Percentages of N. Meningitidis Serogroup B Invasive Disease Strains Killed at 1:4 and 1:8 Dilutions, for Each Subject	4 months after 2nd vaccination (1:8)	28.52 Mean percentage of strains	Standard Deviation 18.484
Placebo/MenACWY	Percentages of N. Meningitidis Serogroup B Invasive Disease Strains Killed at 1:4 and 1:8 Dilutions, for Each Subject	4 months after 2nd vaccination (1:8)	11.19 Mean percentage of strains	Standard Deviation 11.078
Placebo/MenACWY	Percentages of N. Meningitidis Serogroup B Invasive Disease Strains Killed at 1:4 and 1:8 Dilutions, for Each Subject	Baseline (1:4) (N=133, 132)	19.73 Mean percentage of strains	Standard Deviation 15.079
Placebo/MenACWY	Percentages of N. Meningitidis Serogroup B Invasive Disease Strains Killed at 1:4 and 1:8 Dilutions, for Each Subject	Baseline (1:8) (N=133, 132)	9.52 Mean percentage of strains	Standard Deviation 9.346
Placebo/MenACWY	Percentages of N. Meningitidis Serogroup B Invasive Disease Strains Killed at 1:4 and 1:8 Dilutions, for Each Subject	4 months after 2nd vaccination (1:4)	22.66 Mean percentage of strains	Standard Deviation 16.593

Secondary

Percentages of Subjects With Enc-hSBA Titer ≥ 1:4 and Enc-hSBA Titer ≥ 1:8 at Four Months After the 2-dose Vaccination Series

The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY vaccine, in terms of percentages of subjects with enc-hSBA ≥ 1:4 and enc-hSBA titer ≥ 1:8 against four N. meningitidis serogroup B test strains at four months after the 2-dose vaccination series is reported.

Time frame: Four months after the second vaccination (month 6)

Population: Analysis was done on the FAS immunogenicity (month 6). The number of participants analyzed is the number of subjects assessed for this particular endpoint.

Arm	Measure	Group	Value (NUMBER)
MenABCWY	Percentages of Subjects With Enc-hSBA Titer ≥ 1:4 and Enc-hSBA Titer ≥ 1:8 at Four Months After the 2-dose Vaccination Series	NZ98/254(1:4) (N=132,131)	14 Percentage of subjects
MenABCWY	Percentages of Subjects With Enc-hSBA Titer ≥ 1:4 and Enc-hSBA Titer ≥ 1:8 at Four Months After the 2-dose Vaccination Series	NZ98/254(1:8) (N=132,131)	3 Percentage of subjects
MenABCWY	Percentages of Subjects With Enc-hSBA Titer ≥ 1:4 and Enc-hSBA Titer ≥ 1:8 at Four Months After the 2-dose Vaccination Series	M14459 (1:4) (N=103,119)	83 Percentage of subjects
MenABCWY	Percentages of Subjects With Enc-hSBA Titer ≥ 1:4 and Enc-hSBA Titer ≥ 1:8 at Four Months After the 2-dose Vaccination Series	M14459(1:8) (N=103,119)	26 Percentage of subjects
MenABCWY	Percentages of Subjects With Enc-hSBA Titer ≥ 1:4 and Enc-hSBA Titer ≥ 1:8 at Four Months After the 2-dose Vaccination Series	M07-0241084 (1:4) (N=121,120)	33 Percentage of subjects
MenABCWY	Percentages of Subjects With Enc-hSBA Titer ≥ 1:4 and Enc-hSBA Titer ≥ 1:8 at Four Months After the 2-dose Vaccination Series	M07-0241084(1:8) (N=121,120)	7 Percentage of subjects
MenABCWY	Percentages of Subjects With Enc-hSBA Titer ≥ 1:4 and Enc-hSBA Titer ≥ 1:8 at Four Months After the 2-dose Vaccination Series	96217 (1:4) (N=87,76)	100 Percentage of subjects
MenABCWY	Percentages of Subjects With Enc-hSBA Titer ≥ 1:4 and Enc-hSBA Titer ≥ 1:8 at Four Months After the 2-dose Vaccination Series	96217 (1:8) (N=87,76)	94 Percentage of subjects
Placebo/MenACWY	Percentages of Subjects With Enc-hSBA Titer ≥ 1:4 and Enc-hSBA Titer ≥ 1:8 at Four Months After the 2-dose Vaccination Series	96217 (1:8) (N=87,76)	14 Percentage of subjects
Placebo/MenACWY	Percentages of Subjects With Enc-hSBA Titer ≥ 1:4 and Enc-hSBA Titer ≥ 1:8 at Four Months After the 2-dose Vaccination Series	NZ98/254(1:4) (N=132,131)	5 Percentage of subjects
Placebo/MenACWY	Percentages of Subjects With Enc-hSBA Titer ≥ 1:4 and Enc-hSBA Titer ≥ 1:8 at Four Months After the 2-dose Vaccination Series	M07-0241084 (1:4) (N=121,120)	19 Percentage of subjects
Placebo/MenACWY	Percentages of Subjects With Enc-hSBA Titer ≥ 1:4 and Enc-hSBA Titer ≥ 1:8 at Four Months After the 2-dose Vaccination Series	NZ98/254(1:8) (N=132,131)	2 Percentage of subjects
Placebo/MenACWY	Percentages of Subjects With Enc-hSBA Titer ≥ 1:4 and Enc-hSBA Titer ≥ 1:8 at Four Months After the 2-dose Vaccination Series	96217 (1:4) (N=87,76)	64 Percentage of subjects
Placebo/MenACWY	Percentages of Subjects With Enc-hSBA Titer ≥ 1:4 and Enc-hSBA Titer ≥ 1:8 at Four Months After the 2-dose Vaccination Series	M14459 (1:4) (N=103,119)	20 Percentage of subjects
Placebo/MenACWY	Percentages of Subjects With Enc-hSBA Titer ≥ 1:4 and Enc-hSBA Titer ≥ 1:8 at Four Months After the 2-dose Vaccination Series	M07-0241084(1:8) (N=121,120)	7 Percentage of subjects
Placebo/MenACWY	Percentages of Subjects With Enc-hSBA Titer ≥ 1:4 and Enc-hSBA Titer ≥ 1:8 at Four Months After the 2-dose Vaccination Series	M14459(1:8) (N=103,119)	3 Percentage of subjects

Secondary

Percentages of Subjects With Enc-hSBA Titer >= 1:4 and Enc-hSBA Titer >= 1:8 at One Month After the 2-dose Vaccination Series

The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY vaccine, in terms of percentages of subjects with enc-hSBA \>= 1:4 and enc-hSBA titer \>= 1:8 against four N. meningitidis serogroup B test strains at one month after the 2-dose vaccination series is reported.

Time frame: One month after the second vaccination (month 3)

Population: Analysis was done on FAS Immunogenicity (Month 3): all subjects in the All Enrolled Set who received a study vaccination, provided evaluable serum samples respectively at 1 month post-second vaccination (Visit Month 3) whose immunogenicity assay result is available for at least one N. meningitidis serogroup B test strain or serogroups A, C, W or Y.

Arm	Measure	Group	Value (NUMBER)
MenABCWY	Percentages of Subjects With Enc-hSBA Titer >= 1:4 and Enc-hSBA Titer >= 1:8 at One Month After the 2-dose Vaccination Series	NZ98/254 (1:4, 1 month after 2nd vacc) (N=132,130)	67 Percentage of Subjects
MenABCWY	Percentages of Subjects With Enc-hSBA Titer >= 1:4 and Enc-hSBA Titer >= 1:8 at One Month After the 2-dose Vaccination Series	NZ98/254 (1:8, 1 month after 2nd vacc) (N=132,130)	24 Percentage of Subjects
MenABCWY	Percentages of Subjects With Enc-hSBA Titer >= 1:4 and Enc-hSBA Titer >= 1:8 at One Month After the 2-dose Vaccination Series	M14459 (1:4, 1 month after 2nd vacc) (N=134,129)	96 Percentage of Subjects
MenABCWY	Percentages of Subjects With Enc-hSBA Titer >= 1:4 and Enc-hSBA Titer >= 1:8 at One Month After the 2-dose Vaccination Series	M14459 (1:8, 1 month after 2nd vacc) (N=134,129)	64 Percentage of Subjects
MenABCWY	Percentages of Subjects With Enc-hSBA Titer >= 1:4 and Enc-hSBA Titer >= 1:8 at One Month After the 2-dose Vaccination Series	M07-0241084(1:4,1 month after 2nd vacc)(N=131,120)	59 Percentage of Subjects
MenABCWY	Percentages of Subjects With Enc-hSBA Titer >= 1:4 and Enc-hSBA Titer >= 1:8 at One Month After the 2-dose Vaccination Series	M07-0241084(1:8,1 month after 2nd vacc)(N=131,120)	21 Percentage of Subjects
MenABCWY	Percentages of Subjects With Enc-hSBA Titer >= 1:4 and Enc-hSBA Titer >= 1:8 at One Month After the 2-dose Vaccination Series	96217 (1:4, 1 month after 2nd vacc) (N=93,82)	100 Percentage of Subjects
MenABCWY	Percentages of Subjects With Enc-hSBA Titer >= 1:4 and Enc-hSBA Titer >= 1:8 at One Month After the 2-dose Vaccination Series	96217 (1:8, 1 month after 2nd vacc) (N=93,82)	99 Percentage of Subjects
Placebo/MenACWY	Percentages of Subjects With Enc-hSBA Titer >= 1:4 and Enc-hSBA Titer >= 1:8 at One Month After the 2-dose Vaccination Series	96217 (1:8, 1 month after 2nd vacc) (N=93,82)	15 Percentage of Subjects
Placebo/MenACWY	Percentages of Subjects With Enc-hSBA Titer >= 1:4 and Enc-hSBA Titer >= 1:8 at One Month After the 2-dose Vaccination Series	NZ98/254 (1:4, 1 month after 2nd vacc) (N=132,130)	1 Percentage of Subjects
Placebo/MenACWY	Percentages of Subjects With Enc-hSBA Titer >= 1:4 and Enc-hSBA Titer >= 1:8 at One Month After the 2-dose Vaccination Series	M07-0241084(1:4,1 month after 2nd vacc)(N=131,120)	20 Percentage of Subjects
Placebo/MenACWY	Percentages of Subjects With Enc-hSBA Titer >= 1:4 and Enc-hSBA Titer >= 1:8 at One Month After the 2-dose Vaccination Series	NZ98/254 (1:8, 1 month after 2nd vacc) (N=132,130)	0 Percentage of Subjects
Placebo/MenACWY	Percentages of Subjects With Enc-hSBA Titer >= 1:4 and Enc-hSBA Titer >= 1:8 at One Month After the 2-dose Vaccination Series	96217 (1:4, 1 month after 2nd vacc) (N=93,82)	49 Percentage of Subjects
Placebo/MenACWY	Percentages of Subjects With Enc-hSBA Titer >= 1:4 and Enc-hSBA Titer >= 1:8 at One Month After the 2-dose Vaccination Series	M14459 (1:4, 1 month after 2nd vacc) (N=134,129)	12 Percentage of Subjects
Placebo/MenACWY	Percentages of Subjects With Enc-hSBA Titer >= 1:4 and Enc-hSBA Titer >= 1:8 at One Month After the 2-dose Vaccination Series	M07-0241084(1:8,1 month after 2nd vacc)(N=131,120)	7 Percentage of Subjects
Placebo/MenACWY	Percentages of Subjects With Enc-hSBA Titer >= 1:4 and Enc-hSBA Titer >= 1:8 at One Month After the 2-dose Vaccination Series	M14459 (1:8, 1 month after 2nd vacc) (N=134,129)	3 Percentage of Subjects

Secondary

Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series

The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with HT-hSBA titers ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 against serogroups A, C, W, Y at four months after the 2-dose vaccination series.

Time frame: Four months after the second vaccination (month 6)

Population: Analysis was done on the FAS immunogenicity (month 6). The number of participants analyzed is the number of subjects assessed for this particular endpoint.

Arm	Measure	Group	Value (NUMBER)
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series	Men A ≥ 8 (N=124,130)	72 Percentage of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series	Men A ≥ 16 (N=124,130)	65 Percentage of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series	Men A ≥ 32 (N=124,130)	36 Percentage of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series	Men A ≥ 64 (N=124,130)	16 Percentage of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series	Men A ≥ 128 (N=124,130)	5 Percentage of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series	Men C ≥ 8 (N=133,133)	97 Percentage of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series	Men C ≥ 16 (N=133,133)	93 Percentage of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series	Men C ≥ 32 (N=133,133)	82 Percentage of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series	Men C ≥ 64 (N=133,133)	67 Percentage of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series	Men C ≥ 128 (N=133,133)	47 Percentage of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series	Men W ≥ 8 (N=131,130)	96 Percentage of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series	Men W ≥ 16 (N=131,130)	95 Percentage of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series	Men W ≥ 32 (N=131,130)	84 Percentage of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series	Men W ≥ 64 (N=131,130)	61 Percentage of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series	Men W ≥ 128 (N=131,130)	36 Percentage of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series	Men Y ≥ 8 (N=132,132)	89 Percentage of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series	Men Y ≥ 16 (N=132,132)	83 Percentage of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series	Men Y ≥ 32 (N=132,132)	72 Percentage of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series	Men Y ≥ 64 (N=132,132)	50 Percentage of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series	Men Y ≥ 128 (N=132,132)	32 Percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series	Men Y ≥ 32 (N=132,132)	48 Percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series	Men A ≥ 8 (N=124,130)	43 Percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series	Men W ≥ 8 (N=131,130)	87 Percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series	Men A ≥ 16 (N=124,130)	38 Percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series	Men Y ≥ 8 (N=132,132)	67 Percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series	Men A ≥ 32 (N=124,130)	29 Percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series	Men W ≥ 16 (N=131,130)	82 Percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series	Men A ≥ 64 (N=124,130)	17 Percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series	Men Y ≥ 128 (N=132,132)	19 Percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series	Men A ≥ 128 (N=124,130)	8 Percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series	Men W ≥ 32 (N=131,130)	66 Percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series	Men C ≥ 8 (N=133,133)	75 Percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series	Men Y ≥ 16 (N=132,132)	61 Percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series	Men C ≥ 16 (N=133,133)	55 Percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series	Men W ≥ 64 (N=131,130)	39 Percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series	Men C ≥ 32 (N=133,133)	44 Percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series	Men Y ≥ 64 (N=132,132)	37 Percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series	Men C ≥ 64 (N=133,133)	32 Percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series	Men W ≥ 128 (N=131,130)	24 Percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series	Men C ≥ 128 (N=133,133)	26 Percentage of subjects

Secondary

Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series

The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with HT-hSBA titers ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128, against serogroups A, C, W, Y, at one month after the 2-dose vaccination series.

Time frame: One month after the second vaccination (month 3)

Population: Analysis was done on the FAS immunogenicity (month 3). The number of participants analyzed is the number of subjects assessed for this particular endpoint.

Arm	Measure	Group	Value (NUMBER)
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series	Men A ≥ 8 (N=137,115)	98 Percentage of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series	Men A ≥ 16 (N=137,115)	96 Percentage of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series	Men A ≥ 32 (N=137,115)	90 Percentage of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series	Men A ≥ 64 (N=137,115)	66 Percentage of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series	Men A ≥ 128 (N=137,115)	31 Percentage of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series	Men C ≥ 8 (N=134,125)	99 Percentage of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series	Men C ≥ 16 (N=134,125)	99 Percentage of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series	Men C ≥ 32 (N=134,125)	98 Percentage of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series	Men C ≥ 64 (N=134,125)	84 Percentage of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series	Men C ≥ 128 (N=134,125)	68 Percentage of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series	Men W ≥ 8 (N=119,115)	99 Percentage of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series	Men W ≥ 16 (N=119,115)	98 Percentage of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series	Men W ≥ 32 (N=119,115)	92 Percentage of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series	Men W ≥ 64 (N=119,115)	79 Percentage of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series	Men W ≥ 128 (N=119,115)	58 Percentage of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series	Men Y ≥ 8 (N=107,94)	96 Percentage of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series	Men Y ≥ 16 (N=107,94)	95 Percentage of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series	Men Y ≥ 32 (N=107,94)	92 Percentage of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series	Men Y ≥ 64 (N=107,94)	79 Percentage of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series	Men Y ≥ 128 (N=107,94)	60 Percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series	Men Y ≥ 32 (N=107,94)	63 Percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series	Men A ≥ 8 (N=137,115)	72 Percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series	Men W ≥ 8 (N=119,115)	86 Percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series	Men A ≥ 16 (N=137,115)	69 Percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series	Men Y ≥ 8 (N=107,94)	71 Percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series	Men A ≥ 32 (N=137,115)	57 Percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series	Men W ≥ 16 (N=119,115)	81 Percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series	Men A ≥ 64 (N=137,115)	42 Percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series	Men Y ≥ 128 (N=107,94)	30 Percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series	Men A ≥ 128 (N=137,115)	19 Percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series	Men W ≥ 32 (N=119,115)	61 Percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series	Men C ≥ 8 (N=134,125)	74 Percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series	Men Y ≥ 16 (N=107,94)	69 Percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series	Men C ≥ 16 (N=134,125)	64 Percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series	Men W ≥ 64 (N=119,115)	36 Percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series	Men C ≥ 32 (N=134,125)	52 Percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series	Men Y ≥ 64 (N=107,94)	48 Percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series	Men C ≥ 64 (N=134,125)	39 Percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series	Men W ≥ 128 (N=119,115)	23 Percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series	Men C ≥ 128 (N=134,125)	30 Percentage of subjects

Secondary

Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ LLQ at Baseline and One Month After the 2-dose Vaccination Series

The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with HT-hSBA titers ≥ against serogroups A, C, W, Y, at baseline(day 1) and one month after the 2-dose vaccination series.The LLQ cut off values for serogroups A,C,W and Y were 22.7,5.2,39.6 and 14.7 respectively.

Time frame: At Baseline and One month after the second vaccination (month 3)

Population: Analysis was done on the FAS immunogenicity (month 6). The number of participants analyzed is the number of subjects assessed for this particular endpoint.

Arm	Measure	Group	Value (NUMBER)
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ LLQ at Baseline and One Month After the 2-dose Vaccination Series	Men A -baseline(N=128,129)	2 percentage of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ LLQ at Baseline and One Month After the 2-dose Vaccination Series	Men A- Month 3(N=130,112)	93 percentage of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ LLQ at Baseline and One Month After the 2-dose Vaccination Series	Men C-baseline(N=130,131)	32 percentage of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ LLQ at Baseline and One Month After the 2-dose Vaccination Series	Men C-Month 3(N=127,121)	100 percentage of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ LLQ at Baseline and One Month After the 2-dose Vaccination Series	Men W-baseline(N=116,119)	12 percentage of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ LLQ at Baseline and One Month After the 2-dose Vaccination Series	Men W-Month 3 (N=112,111)	90 percentage of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ LLQ at Baseline and One Month After the 2-dose Vaccination Series	Men Y-baseline(N=122,123)	10 percentage of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ LLQ at Baseline and One Month After the 2-dose Vaccination Series	Men Y-Month 3(N=102,91)	96 percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ LLQ at Baseline and One Month After the 2-dose Vaccination Series	Men Y-Month 3(N=102,91)	70 percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ LLQ at Baseline and One Month After the 2-dose Vaccination Series	Men A -baseline(N=128,129)	1 percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ LLQ at Baseline and One Month After the 2-dose Vaccination Series	Men W-baseline(N=116,119)	16 percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ LLQ at Baseline and One Month After the 2-dose Vaccination Series	Men A- Month 3(N=130,112)	63 percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ LLQ at Baseline and One Month After the 2-dose Vaccination Series	Men Y-baseline(N=122,123)	11 percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ LLQ at Baseline and One Month After the 2-dose Vaccination Series	Men C-baseline(N=130,131)	43 percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ LLQ at Baseline and One Month After the 2-dose Vaccination Series	Men W-Month 3 (N=112,111)	52 percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ LLQ at Baseline and One Month After the 2-dose Vaccination Series	Men C-Month 3(N=127,121)	82 percentage of subjects

Secondary

Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ Lower Limit of Quantitation (LLQ) at Four Months After the 2-dose Vaccination Series.

The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with HT-hSBA titers ≥ LLQ against serogroups A, C, W, Y at four months after the 2-dose vaccination series.The LLQ cut off values for serogroups A,C,W and Y were 22.7,5.2,39.6 and 14.7 respectively.

Time frame: Four months after the second vaccination (month 6)

Population: Analysis was done on the FAS immunogenicity (month 6). The number of participants analyzed is the number of subjects assessed for this particular endpoint.

Arm	Measure	Group	Value (NUMBER)
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ Lower Limit of Quantitation (LLQ) at Four Months After the 2-dose Vaccination Series.	Men A (N=124, 130)	48 Percentages of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ Lower Limit of Quantitation (LLQ) at Four Months After the 2-dose Vaccination Series.	Men C (N=133,133)	98 Percentages of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ Lower Limit of Quantitation (LLQ) at Four Months After the 2-dose Vaccination Series.	Men W (N=131,130)	77 Percentages of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ Lower Limit of Quantitation (LLQ) at Four Months After the 2-dose Vaccination Series.	Men Y (N=132,132)	85 Percentages of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ Lower Limit of Quantitation (LLQ) at Four Months After the 2-dose Vaccination Series.	Men Y (N=132,132)	63 Percentages of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ Lower Limit of Quantitation (LLQ) at Four Months After the 2-dose Vaccination Series.	Men A (N=124, 130)	32 Percentages of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ Lower Limit of Quantitation (LLQ) at Four Months After the 2-dose Vaccination Series.	Men W (N=131,130)	58 Percentages of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ Lower Limit of Quantitation (LLQ) at Four Months After the 2-dose Vaccination Series.	Men C (N=133,133)	78 Percentages of subjects

Secondary

Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series.

The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with HT-hSBA titers against serogroup B test strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at four months after the 2-dose vaccination series, is reported.

Time frame: Four months after the second vaccination (month 6)

Population: Analysis was done on the FAS immunogenicity (month 6). The number of participants analyzed is the number of subjects assessed for this particular endpoint.

Arm	Measure	Group	Value (NUMBER)
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series.	M14459 ≥ 5 (N=133,134)	39 Percentage of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series.	NZ98/254 ≥ 8 (N=133,134)	9 Percentage of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series.	NZ98/254 ≥ 16 (N=133,134)	3 Percentage of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series.	NZ98/254 ≥ 32 (N=133,134)	2 Percentage of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series.	NZ98/254 ≥ 64 (N=133,134)	2 Percentage of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series.	NZ98/254 ≥ 128 (N=133,134)	1 Percentage of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series.	NZ98/254 ≥ 5 (N=133,134)	14 Percentage of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series.	M14459 ≥ 8 (N=133,134)	26 Percentage of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series.	M14459 ≥ 16 (N=133,134)	9 Percentage of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series.	M14459 ≥ 32 (N=133,134)	2 Percentage of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series.	M14459 ≥ 64 (N=133,134)	1 Percentage of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series.	M14459 ≥ 128 (N=133,134)	0 Percentage of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series.	M07-0241084 ≥ 5 (N=126,127)	16 Percentage of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series.	M07-0241084 ≥ 8 (N=126,127)	11 Percentage of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series.	M07-0241084 ≥ 16 (N=126,127)	6 Percentage of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series.	M07-0241084 ≥ 32 (N=126,127)	2 Percentage of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series.	M07-0241084 ≥ 64 (N=126,127)	1 Percentage of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series.	M07-0241084 ≥128 (N=126,127)	0 Percentage of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series.	96217 ≥ 5 (N=131,133)	95 Percentage of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series.	96217 ≥ 8 (N=131,133)	95 Percentage of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series.	96217 ≥ 16 (N=131,133)	93 Percentage of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series.	96217 ≥ 32 (N=131,133)	77 Percentage of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series.	96217 ≥ 64 (N=131,133)	48 Percentage of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series.	96217 ≥ 128 (N=131,133)	19 Percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series.	96217 ≥ 64 (N=131,133)	5 Percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series.	NZ98/254 ≥ 5 (N=133,134)	2 Percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series.	M07-0241084 ≥ 5 (N=126,127)	13 Percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series.	NZ98/254 ≥ 8 (N=133,134)	1 Percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series.	96217 ≥ 5 (N=131,133)	35 Percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series.	NZ98/254 ≥ 16 (N=133,134)	0 Percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series.	M07-0241084 ≥ 8 (N=126,127)	11 Percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series.	NZ98/254 ≥ 32 (N=133,134)	0 Percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series.	96217 ≥ 32 (N=131,133)	8 Percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series.	NZ98/254 ≥ 64 (N=133,134)	0 Percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series.	M07-0241084 ≥ 16 (N=126,127)	8 Percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series.	NZ98/254 ≥ 128 (N=133,134)	0 Percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series.	96217 ≥ 8 (N=131,133)	32 Percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series.	M14459 ≥ 5 (N=133,134)	3 Percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series.	M07-0241084 ≥ 32 (N=126,127)	2 Percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series.	M14459 ≥ 8 (N=133,134)	1 Percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series.	96217 ≥ 128 (N=131,133)	2 Percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series.	M14459 ≥ 16 (N=133,134)	1 Percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series.	M07-0241084 ≥ 64 (N=126,127)	0 Percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series.	M14459 ≥ 32 (N=133,134)	0 Percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series.	96217 ≥ 16 (N=131,133)	22 Percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series.	M14459 ≥ 64 (N=133,134)	0 Percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series.	M07-0241084 ≥128 (N=126,127)	0 Percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series.	M14459 ≥ 128 (N=133,134)	0 Percentage of subjects

Secondary

Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series

The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with HT-hSBA titers against serogroup B test strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at one month after the 2-dose vaccination series, is reported.

Time frame: One month after the second vaccination (month 3)

Population: Analysis was done on the FAS immunogenicity (month 3). The number of participants analyzed is the number of subjects assessed for this particular endpoint.

Arm	Measure	Group	Value (NUMBER)
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series	M14459 ≥ 5 (N=138,132)	83 Percentage of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series	NZ98/254 ≥ 8 (N=138,133)	45 Percentage of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series	NZ98/254 ≥ 16 (N=138,133)	17 Percentage of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series	NZ98/254 ≥ 32 (N=138,133)	5 Percentage of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series	NZ98/254 ≥ 64 (N=138,133)	2 Percentage of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series	NZ98/254 ≥ 128 (N=138,133)	1 Percentage of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series	NZ98/254 ≥ 5 (N=138,133)	60 Percentage of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series	M14459 ≥ 8 (N=138,132)	73 Percentage of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series	M14459 ≥ 16 (N=138,132)	56 Percentage of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series	M14459 ≥ 32 (N=138,132)	22 Percentage of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series	M14459 ≥ 64 (N=138,132)	7 Percentage of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series	M14459 ≥ 128 (N=138,132)	0 Percentage of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series	M07-0241084 ≥ 5 (N=124,122)	50 Percentage of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series	M07-0241084 ≥ 8 (N=124,122)	40 Percentage of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series	M07-0241084 ≥ 16 (N=124,122)	20 Percentage of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series	M07-0241084 ≥ 32 (N=124,122)	5 Percentage of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series	M07-0241084 ≥ 64 (N=124,122)	2 Percentage of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series	M07-0241084 ≥128 (N=124,122)	2 Percentage of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series	96217 ≥ 5 (N=124,118)	99 Percentage of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series	96217 ≥ 8 (N=124,118)	99 Percentage of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series	96217 ≥ 16 (N=124,118)	98 Percentage of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series	96217 ≥ 32 (N=124,118)	96 Percentage of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series	96217 ≥ 64 (N=124,118)	88 Percentage of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series	96217 ≥ 128 (N=124,118)	66 Percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series	96217 ≥ 64 (N=124,118)	4 Percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series	NZ98/254 ≥ 5 (N=138,133)	2 Percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series	M07-0241084 ≥ 5 (N=124,122)	16 Percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series	NZ98/254 ≥ 8 (N=138,133)	2 Percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series	96217 ≥ 5 (N=124,118)	34 Percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series	NZ98/254 ≥ 16 (N=138,133)	0 Percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series	M07-0241084 ≥ 8 (N=124,122)	12 Percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series	NZ98/254 ≥ 32 (N=138,133)	0 Percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series	96217 ≥ 32 (N=124,118)	13 Percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series	NZ98/254 ≥ 64 (N=138,133)	0 Percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series	M07-0241084 ≥ 16 (N=124,122)	7 Percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series	NZ98/254 ≥ 128 (N=138,133)	0 Percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series	96217 ≥ 8 (N=124,118)	31 Percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series	M14459 ≥ 5 (N=138,132)	4 Percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series	M07-0241084 ≥ 32 (N=124,122)	2 Percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series	M14459 ≥ 8 (N=138,132)	2 Percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series	96217 ≥ 128 (N=124,118)	2 Percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series	M14459 ≥ 16 (N=138,132)	1 Percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series	M07-0241084 ≥ 64 (N=124,122)	1 Percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series	M14459 ≥ 32 (N=138,132)	0 Percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series	96217 ≥ 16 (N=124,118)	21 Percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series	M14459 ≥ 64 (N=138,132)	0 Percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series	M07-0241084 ≥128 (N=124,122)	0 Percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series	M14459 ≥ 128 (N=138,132)	0 Percentage of subjects

Secondary

Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ Lower Limit of Quantitation (LLQ) at Baseline(Day 1) and One Month After the 2-dose Vaccination Series.

The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with HT-hSBA titers against serogroup B test strains ≥ LLQ, at baseline(day 1) and one month after the 2-dose vaccination series, is reported. The LLQ cut off values for strains 96217, M07-0241084,M14459 and NZ98/254 were 8.6, 8.9, 8 and 8.2 respectively.

Time frame: At baseline(day 1) and One month after the second vaccination (month 3)

Population: Analysis was done on the FAS immunogenicity (month 6). The number of participants analyzed is the number of subjects assessed for this particular endpoint.

Arm	Measure	Group	Value (NUMBER)
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ Lower Limit of Quantitation (LLQ) at Baseline(Day 1) and One Month After the 2-dose Vaccination Series.	96217 -Baseline (N=108,112)	30 percentage of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ Lower Limit of Quantitation (LLQ) at Baseline(Day 1) and One Month After the 2-dose Vaccination Series.	96217- Month 3 (N=119,114)	99 percentage of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ Lower Limit of Quantitation (LLQ) at Baseline(Day 1) and One Month After the 2-dose Vaccination Series.	M07-0241084-Baseline (N=123,128)	3 percentage of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ Lower Limit of Quantitation (LLQ) at Baseline(Day 1) and One Month After the 2-dose Vaccination Series.	M07-0241084-Month 3 (N=117,118)	34 percentage of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ Lower Limit of Quantitation (LLQ) at Baseline(Day 1) and One Month After the 2-dose Vaccination Series.	M14459-baseline(N=132,131)	1 percentage of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ Lower Limit of Quantitation (LLQ) at Baseline(Day 1) and One Month After the 2-dose Vaccination Series.	M14459-month 3 (N=131,128)	73 percentage of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ Lower Limit of Quantitation (LLQ) at Baseline(Day 1) and One Month After the 2-dose Vaccination Series.	NZ98/254-Baseline(N=131,131)	1 percentage of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ Lower Limit of Quantitation (LLQ) at Baseline(Day 1) and One Month After the 2-dose Vaccination Series.	NZ98/254-Month 3(N=131,129)	44 percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ Lower Limit of Quantitation (LLQ) at Baseline(Day 1) and One Month After the 2-dose Vaccination Series.	NZ98/254-Month 3(N=131,129)	2 percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ Lower Limit of Quantitation (LLQ) at Baseline(Day 1) and One Month After the 2-dose Vaccination Series.	96217 -Baseline (N=108,112)	32 percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ Lower Limit of Quantitation (LLQ) at Baseline(Day 1) and One Month After the 2-dose Vaccination Series.	M14459-baseline(N=132,131)	1 percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ Lower Limit of Quantitation (LLQ) at Baseline(Day 1) and One Month After the 2-dose Vaccination Series.	96217- Month 3 (N=119,114)	30 percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ Lower Limit of Quantitation (LLQ) at Baseline(Day 1) and One Month After the 2-dose Vaccination Series.	NZ98/254-Baseline(N=131,131)	0 percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ Lower Limit of Quantitation (LLQ) at Baseline(Day 1) and One Month After the 2-dose Vaccination Series.	M07-0241084-Baseline (N=123,128)	7 percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ Lower Limit of Quantitation (LLQ) at Baseline(Day 1) and One Month After the 2-dose Vaccination Series.	M14459-month 3 (N=131,128)	2 percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ Lower Limit of Quantitation (LLQ) at Baseline(Day 1) and One Month After the 2-dose Vaccination Series.	M07-0241084-Month 3 (N=117,118)	10 percentage of subjects

Secondary

Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ Lower Limit of Quantitation (LLQ) at Four Months After the 2-dose Vaccination Series.

The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with HT-hSBA titers against serogroup B test strains ≥ LLQ, at four months after the 2-dose vaccination series, is reported. The LLQ cut off values for strains 96217, M07-0241084,M14459 and NZ98/254 were 8.6, 8.9, 8 and 8.2 respectively

Time frame: Four months after the second vaccination (month 6)

Population: Analysis was done on the FAS immunogenicity (month 6). The number of participants analyzed is the number of subjects assessed for this particular endpoint.

Arm	Measure	Group	Value (NUMBER)
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ Lower Limit of Quantitation (LLQ) at Four Months After the 2-dose Vaccination Series.	96217 (N=131,133)	95 percentage of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ Lower Limit of Quantitation (LLQ) at Four Months After the 2-dose Vaccination Series.	M14459(N=133,134)	26 percentage of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ Lower Limit of Quantitation (LLQ) at Four Months After the 2-dose Vaccination Series.	M07-0231084 (N=126,127)	10 percentage of subjects
MenABCWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ Lower Limit of Quantitation (LLQ) at Four Months After the 2-dose Vaccination Series.	NZ98/254(N=133,134)	9 percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ Lower Limit of Quantitation (LLQ) at Four Months After the 2-dose Vaccination Series.	NZ98/254(N=133,134)	1 percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ Lower Limit of Quantitation (LLQ) at Four Months After the 2-dose Vaccination Series.	96217 (N=131,133)	30 percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ Lower Limit of Quantitation (LLQ) at Four Months After the 2-dose Vaccination Series.	M07-0231084 (N=126,127)	10 percentage of subjects
Placebo/MenACWY	Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ Lower Limit of Quantitation (LLQ) at Four Months After the 2-dose Vaccination Series.	M14459(N=133,134)	1 percentage of subjects

Secondary

Percentages of Subjects Without Bactericidal Activity at 1:4 Dilution Against Each US N. Meningitidis Serogroup B Strain at 4 Months After the Second Vaccination.

The combined percentage of subjects without bactericidal activity at 1:4 dilution using the endogenous complement human Serum Bactericidal Assay (enc-hSBA) across all strains in MenABCWY group and MenACWY group is reported at four months after the second injection. The percentage of subjects without bactericidal activity at 1:4 dilution was used to assess the effectiveness of two doses of MenABCWY vaccine when compared to one dose of Men ACWY vaccine against a panel of US N. meningitidis serogroup B invasive disease strains. Least Square (LS)-mean computed from the generalized linear model.

Time frame: Four months after the second vaccination (month 6)

Population: Analysis was done on FAS effectiveness (month 6): All subjects in the All Enrolled Set who received a study vaccination and provided evaluable serum sample with enc-hSBA for at least one N. meningitidis serogroup B invasive disease strain at four months after the 2-dose series (Visit Month 6).

Arm	Measure	Value (MEAN)	Dispersion
MenABCWY	Percentages of Subjects Without Bactericidal Activity at 1:4 Dilution Against Each US N. Meningitidis Serogroup B Strain at 4 Months After the Second Vaccination.	42.91 Percentage of subjects	Standard Deviation 33.429
Placebo/MenACWY	Percentages of Subjects Without Bactericidal Activity at 1:4 Dilution Against Each US N. Meningitidis Serogroup B Strain at 4 Months After the Second Vaccination.	76.67 Percentage of subjects	Standard Deviation 27.706

Comparison: H0 (Null Hypothesis): Vaccine Effectiveness (VE) ≤10%. If the LL of the 95% CI for VE is \> 10% the null hypothesis is to be rejected and effectiveness declared. The VE at 4 months after the second injection for each strain is defined as \[1 - (% of subjects without bactericidal activity at 1:4 dilution in MenABCWY group / % of subjects without bactericidal activity at 1:4 dilution in MenACWY group)\] x 100.The combined VE across all strains will be computed by mean of a generalized linear model.p-value: <0.000195% CI: [41, 47]General Linear Model (GLM)

Comparison: Vaccine effectiveness\<10% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= \[1- (% not killed/without bactericidal activity at 1:4 dilution in MenABCWY group)/(% of not killed strains/without bactericidal activity in ACWY group)\*100\].

Comparison: Vaccine effectiveness\<30% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= \[1- (% not killed/without bactericidal activity at 1:4 dilution in MenABCWY group)/(% of not killed strains/without bactericidal activity in ACWY group)\*100\].

Comparison: Vaccine effectiveness\<60% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= \[1- (% not killed/without bactericidal activity at 1:4 dilution in MenABCWY group)/(% of not killed strains/without bactericidal activity in ACWY group)\*100\].

Comparison: Vaccine effectiveness\<100% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= \[1- (% not killed/without bactericidal activity at 1:4 dilution in MenABCWY group)/(% of not killed strains/without bactericidal activity in ACWY group)\*100\].

Secondary

Percentages of Subjects Without Bactericidal Activity at 1:8 Dilution Against Each US N. Meningitidis Serogroup B Strain at Four Months After the Second Vaccination.

The combined percentage of subjects without bactericidal activity at 1:8 dilution using the endogenous complement human Serum Bactericidal Assay (enc-hSBA) across all strains in MenABCWY group and MenACWY group is reported at four months after the second injection. The percentage of subjects without bactericidal activity at 1:8 dilution was used to assess the effectiveness of two doses of MenABCWY vaccine when compared to one dose of Men ACWY vaccine against a panel of US N. meningitidis serogroup B invasive disease strains. Least Square (LS)-mean computed from the generalized linear model.

Time frame: Four months after the second vaccination (month 6)

Population: Analysis was done on FAS effectiveness (month 6).

Arm	Measure	Value (MEAN)	Dispersion
MenABCWY	Percentages of Subjects Without Bactericidal Activity at 1:8 Dilution Against Each US N. Meningitidis Serogroup B Strain at Four Months After the Second Vaccination.	70.89 Percentage of subjects	Standard Deviation 29.625
Placebo/MenACWY	Percentages of Subjects Without Bactericidal Activity at 1:8 Dilution Against Each US N. Meningitidis Serogroup B Strain at Four Months After the Second Vaccination.	88.53 Percentage of subjects	Standard Deviation 21.442

Comparison: H0 (Null Hypothesis): Vaccine Effectiveness (VE) ≤10%. If the lower limit of 95% CI for VE is \> 10% the null hypothesis is to be rejected and effectiveness declared. The VE at 4 months after the 2nd injection for each strain is defined as \[1 - (% of subjects without bactericidal activity at 1:8 dilution in MenABCWY group/% of subjects without bactericidal activity at 1:8 dilution in MenACWY group)\] x 100. The combined VE across all strains was computed by mean of a generalized linear model.p-value: <0.000195% CI: [16, 23]Generalized Linear Model

Comparison: Vaccine effectiveness\<10% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= \[1- (% not killed/without bactericidal activity at 1:8 dilution in MenABCWY group)/(% of not killed strains/without bactericidal activity in ACWY group)\*100\].

Comparison: Vaccine effectiveness\<30% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= \[1- (% not killed/without bactericidal activity at 1:8 dilution in MenABCWY group)/(% of not killed strains/without bactericidal activity in ACWY group)\*100\].

Comparison: Vaccine effectiveness\<60% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= \[1- (% not killed/without bactericidal activity at 1:8 dilution in MenABCWY group)/(% of not killed strains/without bactericidal activity in ACWY group)\*100\].

Comparison: Vaccine effectiveness\<100% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= \[1- (% not killed/without bactericidal activity at 1:8 dilution in MenABCWY group)/(% of not killed strains/without bactericidal activity in ACWY group)\*100\].

Secondary

Percentages of Subjects Without Bactericidal Activity at 1:8 Dilution Against Each US N. Meningitidis Serogroup B Strain at One Month After the Second Vaccination

The combined percentage of subjects without bactericidal activity at 1:8 dilution using the endogenous complement human Serum Bactericidal Assay (enc-hSBA) across all strains in MenABCWY group and MenACWY group is reported at one month after the second injection. The percentage of subjects without bactericidal activity at 1:8 dilution was used to assess the effectiveness of two doses of MenABCWY vaccine when compared to one dose of Men ACWY vaccine against a panel of US N. meningitidis serogroup B invasive disease strains. Least Square (LS)-mean computed from the generalized linear model.

Time frame: One month after the second vaccination (month 3)

Population: Analysis was done on FAS effectiveness ( month 3)

Arm	Measure	Value (MEAN)	Dispersion
MenABCWY	Percentages of Subjects Without Bactericidal Activity at 1:8 Dilution Against Each US N. Meningitidis Serogroup B Strain at One Month After the Second Vaccination	47.7 Percentage of subjects	Standard Deviation 37.04
Placebo/MenACWY	Percentages of Subjects Without Bactericidal Activity at 1:8 Dilution Against Each US N. Meningitidis Serogroup B Strain at One Month After the Second Vaccination	88.28 Percentage of subjects	Standard Deviation 22.05

Comparison: H0 (Null Hypothesis): Vaccine Effectiveness (VE) ≤ 10%. If the lower limit of the 95% CI for VE is \>10% the null hypothesis is to be rejected and effectiveness declared. The VE at 1 month after the 2nd injection for each strain is defined as \[1-(% of subjects without bactericidal activity at 1:8 dilution in MenABCWY group / % of subjects without bactericidal activity at 1:8 dilution in MenACWY group)\]x100. The combined VE across all strains will be computed by mean of a generalized linear model.p-value: <0.000195% CI: [43, 49]Generalized Linear Model

Comparison: Vaccine effectiveness\<10% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= \[1- (% not killed/without bactericidal activity at 1:8 dilution in MenABCWY group)/(% of not killed strains/without bactericidal activity in ACWY group)\*100\].

Comparison: Vaccine effectiveness\<30%

Comparison: Vaccine effectiveness\<60% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= \[1- (% not killed/without bactericidal activity at 1:8 dilution in MenABCWY group)/(% of not killed strains/without bactericidal activity in ACWY group)\*100\].

Comparison: Vaccine effectiveness\<100% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= \[1- (% not killed/without bactericidal activity at 1:8 dilution in MenABCWY group)/(% of not killed strains/without bactericidal activity in ACWY group)\*100\].

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026

Effectiveness, Immunogenicity and Safety of Meningococcal ABCWY Vaccine Administered to Healthy Adolescents

Conditions

Keywords

Brief summary

Related papers

Interventions

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Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Recruitment details

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Percentage of Subjects Without Bactericidal Activity at 1:4 Dilution Against Each US Neisseria Meningitidis (N. Meningitidis) Serogroup B Strain at One Month After the Second Vaccination.

hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroup B Test Strains

hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroups A,C,W,Y

HT-hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroup B Test Strains

HT-hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroups A, C, W, Y

Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs)

Number of Subjects Reporting Unsolicited AEs.

Percentage of Subjects With 2-fold Rise in hSBA Titer Against N.Meningitidis Serogroup B Strains at One and Four Months After the 2-dose Vaccination Series.

Percentage of Subjects With 2-fold Rise in hSBA Titer Against N.Meningitidis Serogroups A,C,W and Y at One and Four Months After the 2-dose Vaccination Series.

Percentage of Subjects With 3-fold Rise in hSBA Titer Against N.Meningitidis Serogroup B Strains at One and Four Months After the 2-dose Vaccination Series.

Percentage of Subjects With 3-fold Rise in hSBA Titer Against N.Meningitidis Serogroups A, C, W and Y at One and Four Months After the 2-dose Vaccination Series.

Percentage of Subjects With 4-fold Rise in hSBA Titer Against N.Meningitidis Serogroup B Strains at One and Four Months After the 2-dose Vaccination Series.

Percentage of Subjects With 4-fold Rise in hSBA Titer Against N.Meningitidis Serogroups A,C,W and Y at One and Four Months After the 2-dose Vaccination Series.

Percentages of N. Meningitidis Serogroup B Invasive Disease Strains Killed at 1:4 and 1:8 Dilutions, for Each Subject

Percentages of N. Meningitidis Serogroup B Invasive Disease Strains Killed at 1:4 and 1:8 Dilutions, for Each Subject

Percentages of Subjects With Enc-hSBA Titer ≥ 1:4 and Enc-hSBA Titer ≥ 1:8 at Four Months After the 2-dose Vaccination Series

Percentages of Subjects With Enc-hSBA Titer >= 1:4 and Enc-hSBA Titer >= 1:8 at One Month After the 2-dose Vaccination Series

Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series

Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series

Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ LLQ at Baseline and One Month After the 2-dose Vaccination Series

Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ Lower Limit of Quantitation (LLQ) at Four Months After the 2-dose Vaccination Series.

Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series.

Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series

Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ Lower Limit of Quantitation (LLQ) at Baseline(Day 1) and One Month After the 2-dose Vaccination Series.

Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ Lower Limit of Quantitation (LLQ) at Four Months After the 2-dose Vaccination Series.

Percentages of Subjects Without Bactericidal Activity at 1:4 Dilution Against Each US N. Meningitidis Serogroup B Strain at 4 Months After the Second Vaccination.

Percentages of Subjects Without Bactericidal Activity at 1:8 Dilution Against Each US N. Meningitidis Serogroup B Strain at Four Months After the Second Vaccination.

Percentages of Subjects Without Bactericidal Activity at 1:8 Dilution Against Each US N. Meningitidis Serogroup B Strain at One Month After the Second Vaccination