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

• Sponsor: Novartis Vaccines (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02140762
• Collaborator: GlaxoSmithKline (Industry)
• Enrollment: 305
• Locations: 8
• Arms: 2
• Duration (Months): 9.1
• Patients Per Site: 38.1
• Patients Per Site Per Month: 4.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Meningococcal Disease	Biological: MenABCWY; Other: Placebo; Biological: MenACWY	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 305 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: 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.
• Study Start Date: May 1, 2014
• Actual Primary Completion Date: Nov 1, 2014
• Actual Study Completion Date: Feb 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MenABCWY Subjects received one dose of MenABCWY vaccine at day 1 and a second dose after 2 months	Biological: MenABCWY; Subjects received one dose of 0.5 mL MenABCWY vaccine (intramuscular (IM) injection) at day 1 and a second dose after 2 months.; Other Names: MenACWY conjugate combined with rMenB + OMV
Active Comparator: Placebo/MenACWY Subjects received one dose of placebo at day 1 and one dose of MenACWY vaccine after 2 months	Other: Placebo; 0.5 mL saline solution (IM); Other Names: saline solution ; Biological: MenACWY; 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.; Other Names: Menveo

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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.

5. Percentages of N. Meningitidis Serogroup B Invasive Disease Strains Killed at 1:4 and 1:8 Dilutions, for Each Subject [Baseline, four months after second vaccination (month 6)]

   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.

6. 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.

7. 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.

8. 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.

9. 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.

10. 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.

11. 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.

12. 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.

13. 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.

14. 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

15. 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.

16. 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.

17. 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.

18. 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.

19. 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.

20. 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

21. 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.

22. 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.

23. 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.

24. 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.

25. 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.

26. 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.

27. 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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 10 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Accelovance, Inc	Huntsville	Alabama	United States	35802
2	The Children's Clinic of Jonesboro, P.A.	Jonesboro	Arkansas	United States	72401
3	Accelovance, Inc	Melbourne	Florida	United States	32935
4	Heartland Research Associates LLC	Newton	Kansas	United States	67114
5	Heartland Research Associates, LLC	Wichita	Kansas	United States	67207
6	Bluegrass Clinical Research, Inc.	Louisville	Kentucky	United States	40291
7	Meridian Clinical Research	Omaha	Nebraska	United States	68134
8	Senders Pediatrics	Cleveland	Ohio	United States	44121

Sponsors and Collaborators

• Novartis Vaccines
• GlaxoSmithKline

Investigators

• Study Chair: Novartis Vaccines, Novartis Vaccines

Study Documents (Full-Text)

None provided.

More Information

Publications

• Adu-Bobie J, Capecchi B, Serruto D, Rappuoli R, Pizza M. Two years into reverse vaccinology. Vaccine. 2003 Jan 30;21(7-8):605-10.
• Bai X, Findlow J, Borrow R. Recombinant protein meningococcal serogroup B vaccine combined with outer membrane vesicles. Expert Opin Biol Ther. 2011 Jul;11(7):969-85. doi: 10.1517/14712598.2011.585965. Epub 2011 May 26. Review.

• Responsible Party: Novartis Vaccines
• ClinicalTrials.gov Identifier: NCT02140762
• Other Study ID Numbers: V102_16
• First Posted: May 16, 2014
• Last Update Posted: Sep 12, 2018
• Last Verified: Aug 1, 2018

• Keywords provided by Novartis Vaccines: Meningitis ABCWY; Adolescents; Vaccination; Meningococcal disease
• Additional relevant MeSH terms: Meningococcal Infections

Study Results

Participant Flow

Recruitment Details	Subjects were recruited from 8 study sites in USA.
Pre-assignment Detail	All enrolled subjects were included in the trial.

Arm/Group Title	MenABCWY	Placebo/MenACWY
Arm/Group Description	Subjects received one dose of MenABCWY vaccine at visit day 1 and a second dose at visit month 2.	Subjects received one dose of placebo at visit day 1 and one dose of MenACWY vaccine at visit month 2.
Period Title: Overall Study
STARTED	154	151
COMPLETED	137	139
NOT COMPLETED	17	12

Baseline Characteristics

Arm/Group Title	MenABCWY	Placebo/MenACWY	Total
Arm/Group Description	Subjects received one dose of MenABCWY vaccine at visit day 1 and a second dose at visit month 2.	Subjects received one dose of placebo at visit day 1 and one dose of MenACWY vaccine at visit month 2.	Total of all reporting groups
Overall Participants	154	151	305
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	11.9 (2.18)	12.2 (2.42)	12 (2.3)
Sex/Gender, Customized (participants) [Number]
FEMALE	67 43.5%	61 40.4%	128 42%
MALE	87 56.5%	90 59.6%	177 58%

Outcome Measures

1. Primary Outcome

Title	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.
Description	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)

Outcome Measure Data

Analysis Population Description

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/Group Title	MenABCWY	Placebo/MenACWY
Arm/Group Description	Subjects received one dose of MenABCWY vaccine at visit day 1 and a second dose at visit month 2.	Subjects received one dose of placebo at visit day 1 and one dose of MenACWY vaccine at visit month 2.
Measure Participants	139	135
Mean (Standard Deviation) [Percentages of subjects]	25.17 (30.77)	76.19 (27.32)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	MenABCWY, Placebo/MenACWY
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Generalized Linear Model
	Comments
Method of Estimation	Estimation Parameter	Vaccine Effectiveness
	Estimated Value	67
	Confidence Interval	(2-Sided) 95%; 65 to 69
	Parameter Dispersion	Type: Value:
	Estimation Comments	VE is based on the relative risk (RR). The Poisson Distribution and Log Link options were used in the generalized linear model to compute the log10 RR and the corresponding confidence interval. Fixed effects: treatment group, strain (and center).

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	MenABCWY, Placebo/MenACWY
	Comments	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].
	Type of Statistical Test	Other
	Comments	Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Vaccine Effectiveness
	Estimated Value	4.6
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	MenABCWY, Placebo/MenACWY
	Comments	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].
	Type of Statistical Test	Other
	Comments	Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Vaccine Effectiveness
	Estimated Value	12.7
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	MenABCWY, Placebo/MenACWY
	Comments	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].
	Type of Statistical Test	Other
	Comments	Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Vaccine Effectiveness
	Estimated Value	18.2
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	MenABCWY, Placebo/MenACWY
	Comments	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].
	Type of Statistical Test	Other
	Comments	Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Vaccine Effectiveness
	Estimated Value	59.1
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	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.
Description	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)

Outcome Measure Data

Analysis Population Description

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/Group Title	MenABCWY	Placebo/MenACWY
Arm/Group Description	Subjects received one dose of MenABCWY vaccine at day 1 and a second dose after 2 months MenABCWY: Subjects received one dose of 0.5 mL MenABCWY vaccine (intramuscular (IM) injection) at day 1 and a second dose after 2 months.	Subjects received one dose of placebo at day 1 and one dose of MenACWY vaccine after 2 months Placebo: 0.5 mL saline solution (IM) MenACWY: 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.
Measure Participants	136	135
Mean (Standard Deviation) [Percentage of subjects]	42.91 (33.429)	76.67 (27.706)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	MenABCWY, Placebo/MenACWY
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	< 0.0001
	Comments
	Method	General Linear Model (GLM)
	Comments
Method of Estimation	Estimation Parameter	Vaccine effectiveness
	Estimated Value	44
	Confidence Interval	(2-Sided) 95%; 41 to 47
	Parameter Dispersion	Type: Value:
	Estimation Comments	VE is based on the relative risk (RR). The POISSON DISTRIBUTION and LOG LINK options was used in the generalized linear model to compute the log10 RR and the corresponding confidence interval. Fixed effects: treatment group, strain (and center).

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	MenABCWY, Placebo/MenACWY
	Comments	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].
	Type of Statistical Test	Other
	Comments	Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Vaccine Effectiveness
	Estimated Value	9.1
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	MenABCWY, Placebo/MenACWY
	Comments	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].
	Type of Statistical Test	Other
	Comments	Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Vaccine Effectiveness
	Estimated Value	22.7
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	MenABCWY, Placebo/MenACWY
	Comments	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].
	Type of Statistical Test	Other
	Comments	Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Vaccine Effectiveness
	Estimated Value	19.1
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	MenABCWY, Placebo/MenACWY
	Comments	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].
	Type of Statistical Test	Other
	Comments	Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Vaccine Effectiveness
	Estimated Value	38.2
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	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
Description	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)

Outcome Measure Data

Analysis Population Description

Analysis was done on FAS effectiveness ( month 3)

Arm/Group Title	MenABCWY	Placebo/MenACWY
Arm/Group Description	Subjects received one dose of MenABCWY vaccine at visit day 1 and a second dose at visit month 2.	Subjects received one dose of placebo at visit day 1 and one dose of MenACWY vaccine at visit month 2.
Measure Participants	139	135
Mean (Standard Deviation) [Percentage of subjects]	47.7 (37.04)	88.28 (22.05)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	MenABCWY, Placebo/MenACWY
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Generalized Linear Model
	Comments
Method of Estimation	Estimation Parameter	Vaccine Effectiveness
	Estimated Value	46
	Confidence Interval	(2-Sided) 95%; 43 to 49
	Parameter Dispersion	Type: Value:
	Estimation Comments	VE is based on the relative risk (RR).The Poisson Distribution and Log Link options were used in the generalized linear model to compute the log10 RR and the corresponding confidence interval. Fixed effects:treatment group, strain (and center).

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	MenABCWY, Placebo/MenACWY
	Comments	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].
	Type of Statistical Test	Other
	Comments	Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Vaccine Effectiveness
	Estimated Value	25.5
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	MenABCWY, Placebo/MenACWY
	Comments	Vaccine effectiveness<30%
	Type of Statistical Test	Other
	Comments	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].
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Vaccine Effectiveness
	Estimated Value	19.1
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	MenABCWY, Placebo/MenACWY
	Comments	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].
	Type of Statistical Test	Other
	Comments	Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Vaccine Effectiveness
	Estimated Value	10.9
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	MenABCWY, Placebo/MenACWY
	Comments	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].
	Type of Statistical Test	Other
	Comments	Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Vaccine Effectiveness
	Estimated Value	40.9
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	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.
Description	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)

Outcome Measure Data

Analysis Population Description

Analysis was done on FAS effectiveness (month 6).

Arm/Group Title	MenABCWY	Placebo/MenACWY
Arm/Group Description	Subjects received one dose of MenABCWY vaccine at visit day 1 and a second dose at visit month 2.	Subjects received one dose of placebo at visit day 1 and one dose of MenACWY vaccine at visit month 2.
Measure Participants	136	135
Mean (Standard Deviation) [Percentage of subjects]	70.89 (29.625)	88.53 (21.442)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	MenABCWY, Placebo/MenACWY
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	< 0.0001
	Comments	VE is based on the relative risk (RR). The POISSON DISTRIBUTION and LOG LINK options was used in the generalized linear model to compute the log10 RR and the corresponding confidence interval. Fixed effects: treatment group, strain (and center).
	Method	Generalized Linear Model
	Comments
Method of Estimation	Estimation Parameter	Vaccine Effectiveness
	Estimated Value	20
	Confidence Interval	(2-Sided) 95%; 16 to 23
	Parameter Dispersion	Type: Value:
	Estimation Comments	VE is based on the relative risk (RR). The POISSON DISTRIBUTION and LOG LINK options was used in the generalized linear model to compute the log10 RR and the corresponding confidence interval. Fixed effects: treatment group, strain (and center).

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	MenABCWY, Placebo/MenACWY
	Comments	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].
	Type of Statistical Test	Other
	Comments	Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Vaccine Effectiveness
	Estimated Value	36.4
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	MenABCWY, Placebo/MenACWY
	Comments	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].
	Type of Statistical Test	Other
	Comments	Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Vaccine Effectiveness
	Estimated Value	15.5
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	MenABCWY, Placebo/MenACWY
	Comments	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].
	Type of Statistical Test	Other
	Comments	Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Vaccine Effectiveness
	Estimated Value	20.9
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	MenABCWY, Placebo/MenACWY
	Comments	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].
	Type of Statistical Test	Other
	Comments	Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Vaccine Effectiveness
	Estimated Value	11.8
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Analysis was done on FAS effectiveness (month 3)

Arm/Group Title	MenABCWY	Placebo/MenACWY
Arm/Group Description	Subjects received one dose of MenABCWY vaccine at visit day 1 and a second dose at visit month 2.	Subjects received one dose of placebo at visit day 1 and one dose of MenACWY vaccine at visit month 2.
Measure Participants	139	135
Baseline (1:4) (N=136, 132)	20.08 (16.25)	19.76 (15.48)
1 month after 2nd vaccination (1:4)	74.47 (14.55)	22.93 (16.11)
Baseline (1:8) (N=136, 132)	9.25 (8.35)	9.54 (9.49)
1 month after 2nd vaccination (1:8)	52.16 (17.11)	11.39 (10.35)

6. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Analysis was done on FAS effectiveness (month 6).

Arm/Group Title	MenABCWY	Placebo/MenACWY
Arm/Group Description	Subjects received one dose of MenABCWY vaccine at visit day 1 and a second dose at visit month 2.	Subjects received one dose of placebo at visit day 1 and one dose of MenACWY vaccine at visit month 2.
Measure Participants	136	135
Baseline (1:4) (N=133, 132)	19.82 (16.227)	19.73 (15.079)
4 months after 2nd vaccination (1:4)	56.38 (18.703)	22.66 (16.593)
Baseline (1:8) (N=133, 132)	9.19 (8.336)	9.52 (9.346)
4 months after 2nd vaccination (1:8)	28.52 (18.484)	11.19 (11.078)

7. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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/Group Title	MenABCWY	Placebo/MenACWY
Arm/Group Description	Subjects received one dose of MenABCWY vaccine at visit day 1 and a second dose at visit month 2.	Subjects received one dose of placebo at visit day 1 and one dose of MenACWY vaccine at visit month 2.
Measure Participants	134	130
NZ98/254 (1:4, 1 month after 2nd vacc) (N=132,130)	67	1
NZ98/254 (1:8, 1 month after 2nd vacc) (N=132,130)	24	0
M14459 (1:4, 1 month after 2nd vacc) (N=134,129)	96	12
M14459 (1:8, 1 month after 2nd vacc) (N=134,129)	64	3
M07-0241084(1:4,1 month after 2nd vacc)(N=131,120)	59	20
M07-0241084(1:8,1 month after 2nd vacc)(N=131,120)	21	7
96217 (1:4, 1 month after 2nd vacc) (N=93,82)	100	49
96217 (1:8, 1 month after 2nd vacc) (N=93,82)	99	15

8. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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/Group Title	MenABCWY	Placebo/MenACWY
Arm/Group Description	Subjects received one dose of MenABCWY vaccine at visit day 1 and a second dose at visit month 2.	Subjects received one dose of placebo at visit day 1 and one dose of MenACWY vaccine at visit month 2.
Measure Participants	132	131
NZ98/254(1:4) (N=132,131)	14	5
NZ98/254(1:8) (N=132,131)	3	2
M14459 (1:4) (N=103,119)	83	20
M14459(1:8) (N=103,119)	26	3
M07-0241084 (1:4) (N=121,120)	33	19
M07-0241084(1:8) (N=121,120)	7	7
96217 (1:4) (N=87,76)	100	64
96217 (1:8) (N=87,76)	94	14

9. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	MenABCWY	Placebo/MenACWY
Arm/Group Description	Subjects received one dose of MenABCWY vaccine at visit day 1 and a second dose at visit month 2.	Subjects received one dose of placebo at visit day 1 and one dose of MenACWY vaccine at visit month 2.
Measure Participants	138	133
NZ98/254 (1 month after 2nd vacc)	6.03	1.04
M14459 (1 month after 2nd vacc) (N=138,132)	13.4	1.08
M07-0241084 (1 month after 2nd vacc) (N=124,122)	5.05	1.65
96217 (1 month after 2nd vacc) (N=124,118)	169.22	3.16

10. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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/Group Title	MenABCWY	Placebo/MenACWY
Arm/Group Description	Subjects received one dose of MenABCWY vaccine at visit day 1 and a second dose at visit month 2.	Subjects received one dose of placebo at visit day 1 and one dose of MenACWY vaccine at visit month 2.
Measure Participants	133	134
NZ98/254 (N=133,134)	1.75	1.06
M14459 (N=133,134)	3.04	1.12
M07-0241084 (N=126,127)	1.77	1.56
96217 (N=131,133)	57.85	3

11. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Analysis was done on FAS Immunogenicity (Month 3)

Arm/Group Title	MenABCWY	Placebo/MenACWY
Arm/Group Description	Subjects received one dose of MenABCWY vaccine at visit day 1 and a second dose at visit month 2.	Subjects received one dose of placebo at visit day 1 and one dose of MenACWY vaccine at visit month 2.
Measure Participants	137	125
Men A (1 month after 2nd vacc) (N=137,115)	77.02	22.08
Men C (1 month after 2nd vacc) (N=134,125)	235.88	38.61
Men W (1 month after 2nd vacc) (N=119,115)	157.72	37.51
Men Y (1 month after 2nd vacc) (N=107,94)	155.43	27.76

12. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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/Group Title	MenABCWY	Placebo/MenACWY
Arm/Group Description	Subjects received one dose of MenABCWY vaccine at visit day 1 and a second dose at visit month 2.	Subjects received one dose of placebo at visit day 1 and one dose of MenACWY vaccine at visit month 2.
Measure Participants	133	133
Men A (N=124,130)	12.91	5.56
Men C (N=133,133)	117.18	25.64
Men W (N=131,130)	91.22	42.97
Men Y (N=132,132)	59.51	19.53

13. Secondary Outcome

Title	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.
Description	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)

Outcome Measure Data

Analysis Population Description

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/Group Title	MenABCWY	Placebo/MenACWY
Arm/Group Description	Subjects received one dose of MenABCWY vaccine at visit day 1 and a second dose at visit month 2.	Subjects received one dose of placebo at visit day 1 and one dose of MenACWY vaccine at visit month 2.
Measure Participants	132	131
96217 -Baseline (N=108,112)	30	32
96217- Month 3 (N=119,114)	99	30
M07-0241084-Baseline (N=123,128)	3	7
M07-0241084-Month 3 (N=117,118)	34	10
M14459-baseline(N=132,131)	1	1
M14459-month 3 (N=131,128)	73	2
NZ98/254-Baseline(N=131,131)	1	0
NZ98/254-Month 3(N=131,129)	44	2

14. Secondary Outcome

Title	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
Description	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)

Outcome Measure Data

Analysis Population Description

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/Group Title	MenABCWY	Placebo/MenACWY
Arm/Group Description	Subjects received one dose of MenABCWY vaccine at visit day 1 and a second dose at visit month 2.	Subjects received one dose of placebo at visit day 1 and one dose of MenACWY vaccine at visit month 2.
Measure Participants	130	131
Men A -baseline(N=128,129)	2	1
Men A- Month 3(N=130,112)	93	63
Men C-baseline(N=130,131)	32	43
Men C-Month 3(N=127,121)	100	82
Men W-baseline(N=116,119)	12	16
Men W-Month 3 (N=112,111)	90	52
Men Y-baseline(N=122,123)	10	11
Men Y-Month 3(N=102,91)	96	70

15. Secondary Outcome

Title	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.
Description	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)

Outcome Measure Data

Analysis Population Description

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/Group Title	MenABCWY	Placebo/MenACWY
Arm/Group Description	Subjects received one dose of MenABCWY vaccine at visit day 1 and a second dose at visit month 2.	Subjects received one dose of placebo at visit day 1 and one dose of MenACWY vaccine at visit month 2.
Measure Participants	133	134
96217 (N=131,133)	95	30
M14459(N=133,134)	26	1
M07-0231084 (N=126,127)	10	10
NZ98/254(N=133,134)	9	1

16. Secondary Outcome

Title	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.
Description	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)

Outcome Measure Data

Analysis Population Description

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/Group Title	MenABCWY	Placebo/MenACWY
Arm/Group Description	Subjects received one dose of MenABCWY vaccine at visit day 1 and a second dose at visit month 2.	Subjects received one dose of placebo at visit day 1 and one dose of MenACWY vaccine at visit month 2.
Measure Participants	133	133
Men A (N=124, 130)	48	32
Men C (N=133,133)	98	78
Men W (N=131,130)	77	58
Men Y (N=132,132)	85	63

17. Secondary Outcome

Title	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.
Description	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)

Outcome Measure Data

Analysis Population Description

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/Group Title	MenABCWY	Placebo/MenACWY
Arm/Group Description	Subjects received one dose of MenABCWY vaccine at visit day 1 and a second dose at visit month 2.	Subjects received one dose of placebo at day 1 and one dose of MenACWY vaccine after 2 months.
Measure Participants	133	134
NZ98/254 ≥ 5 (N=133,134)	14	2
NZ98/254 ≥ 8 (N=133,134)	9	1
NZ98/254 ≥ 16 (N=133,134)	3	0
NZ98/254 ≥ 32 (N=133,134)	2	0
NZ98/254 ≥ 64 (N=133,134)	2	0
NZ98/254 ≥ 128 (N=133,134)	1	0
M14459 ≥ 5 (N=133,134)	39	3
M14459 ≥ 8 (N=133,134)	26	1
M14459 ≥ 16 (N=133,134)	9	1
M14459 ≥ 32 (N=133,134)	2	0
M14459 ≥ 64 (N=133,134)	1	0
M14459 ≥ 128 (N=133,134)	0	0
M07-0241084 ≥ 5 (N=126,127)	16	13
M07-0241084 ≥ 8 (N=126,127)	11	11
M07-0241084 ≥ 16 (N=126,127)	6	8
M07-0241084 ≥ 32 (N=126,127)	2	2
M07-0241084 ≥ 64 (N=126,127)	1	0
M07-0241084 ≥128 (N=126,127)	0	0
96217 ≥ 5 (N=131,133)	95	35
96217 ≥ 8 (N=131,133)	95	32
96217 ≥ 16 (N=131,133)	93	22
96217 ≥ 32 (N=131,133)	77	8
96217 ≥ 64 (N=131,133)	48	5
96217 ≥ 128 (N=131,133)	19	2

18. Secondary Outcome

Title	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
Description	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)

Outcome Measure Data

Analysis Population Description

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/Group Title	MenABCWY	Placebo/MenACWY
Arm/Group Description	Subjects received one dose of MenABCWY vaccine at visit day 1 and a second dose after visit month 2	Subjects received one dose of placebo at visit day 1 and one dose of MenACWY vaccine at visit month 2
Measure Participants	133	133
Men A ≥ 8 (N=124,130)	72	43
Men A ≥ 16 (N=124,130)	65	38
Men A ≥ 32 (N=124,130)	36	29
Men A ≥ 64 (N=124,130)	16	17
Men A ≥ 128 (N=124,130)	5	8
Men C ≥ 8 (N=133,133)	97	75
Men C ≥ 16 (N=133,133)	93	55
Men C ≥ 32 (N=133,133)	82	44
Men C ≥ 64 (N=133,133)	67	32
Men C ≥ 128 (N=133,133)	47	26
Men W ≥ 8 (N=131,130)	96	87
Men W ≥ 16 (N=131,130)	95	82
Men W ≥ 32 (N=131,130)	84	66
Men W ≥ 64 (N=131,130)	61	39
Men W ≥ 128 (N=131,130)	36	24
Men Y ≥ 8 (N=132,132)	89	67
Men Y ≥ 16 (N=132,132)	83	61
Men Y ≥ 32 (N=132,132)	72	48
Men Y ≥ 64 (N=132,132)	50	37
Men Y ≥ 128 (N=132,132)	32	19

19. Secondary Outcome

Title	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
Description	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)

Outcome Measure Data

Analysis Population Description

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/Group Title	MenABCWY	Placebo/MenACWY
Arm/Group Description	Subjects received one dose of MenABCWY vaccine at visit day 1 and a second dose at visit month 2.	Subjects received one dose of placebo at day 1 and one dose of MenACWY vaccine after 2 months.
Measure Participants	138	133
NZ98/254 ≥ 5 (N=138,133)	60	2
NZ98/254 ≥ 8 (N=138,133)	45	2
NZ98/254 ≥ 16 (N=138,133)	17	0
NZ98/254 ≥ 32 (N=138,133)	5	0
NZ98/254 ≥ 64 (N=138,133)	2	0
NZ98/254 ≥ 128 (N=138,133)	1	0
M14459 ≥ 5 (N=138,132)	83	4
M14459 ≥ 8 (N=138,132)	73	2
M14459 ≥ 16 (N=138,132)	56	1
M14459 ≥ 32 (N=138,132)	22	0
M14459 ≥ 64 (N=138,132)	7	0
M14459 ≥ 128 (N=138,132)	0	0
M07-0241084 ≥ 5 (N=124,122)	50	16
M07-0241084 ≥ 8 (N=124,122)	40	12
M07-0241084 ≥ 16 (N=124,122)	20	7
M07-0241084 ≥ 32 (N=124,122)	5	2
M07-0241084 ≥ 64 (N=124,122)	2	1
M07-0241084 ≥128 (N=124,122)	2	0
96217 ≥ 5 (N=124,118)	99	34
96217 ≥ 8 (N=124,118)	99	31
96217 ≥ 16 (N=124,118)	98	21
96217 ≥ 32 (N=124,118)	96	13
96217 ≥ 64 (N=124,118)	88	4
96217 ≥ 128 (N=124,118)	66	2

20. Secondary Outcome

Title	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
Description	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)

Outcome Measure Data

Analysis Population Description

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/Group Title	MenABCWY	Placebo/MenACWY
Arm/Group Description	Subjects received one dose of MenABCWY vaccine at visit day 1 and a second dose at visit month 2.	Subjects received one dose of placebo at day 1 and one dose of MenACWY vaccine after 2 months.
Measure Participants	137	125
Men A ≥ 8 (N=137,115)	98	72
Men A ≥ 16 (N=137,115)	96	69
Men A ≥ 32 (N=137,115)	90	57
Men A ≥ 64 (N=137,115)	66	42
Men A ≥ 128 (N=137,115)	31	19
Men C ≥ 8 (N=134,125)	99	74
Men C ≥ 16 (N=134,125)	99	64
Men C ≥ 32 (N=134,125)	98	52
Men C ≥ 64 (N=134,125)	84	39
Men C ≥ 128 (N=134,125)	68	30
Men W ≥ 8 (N=119,115)	99	86
Men W ≥ 16 (N=119,115)	98	81
Men W ≥ 32 (N=119,115)	92	61
Men W ≥ 64 (N=119,115)	79	36
Men W ≥ 128 (N=119,115)	58	23
Men Y ≥ 8 (N=107,94)	96	71
Men Y ≥ 16 (N=107,94)	95	69
Men Y ≥ 32 (N=107,94)	92	63
Men Y ≥ 64 (N=107,94)	79	48
Men Y ≥ 128 (N=107,94)	60	30

21. Secondary Outcome

Title	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.
Description	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)

Outcome Measure Data

Analysis Population Description

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/Group Title	MenABCWY	Placebo/MenACWY
Arm/Group Description	Subjects received one dose of MenABCWY vaccine at day 1 and a second dose after 2 months MenABCWY: Subjects received one dose of 0.5 mL MenABCWY vaccine (intramuscular (IM) injection) at day 1 and a second dose after 2 months.	Subjects received one dose of placebo at day 1 and one dose of MenACWY vaccine after 2 months Placebo: 0.5 mL saline solution (IM) MenACWY: 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.
Measure Participants	137	131
96217-Month 3(N=101,99)	92	6
M07-0241084-Month 3(N=115,119)	13	2
M14459-Month 3(N=137,130)	55	0
NZ98/254-Month 3(N=136,131)	17	0
96217-Month 6(N=106,111)	81	5
M07-0241084-Month 6(N=117,121)	3	1
M14459-Month 6(N=132,131)	9	1
NZ98/254-Month 6(N=131,131)	2	0

22. Secondary Outcome

Title	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.
Description	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)

Outcome Measure Data

Analysis Population Description

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/Group Title	MenABCWY	Placebo/MenACWY
Arm/Group Description	Subjects received one dose of MenABCWY vaccine at day 1 and a second dose after 2 months MenABCWY: Subjects received one dose of 0.5 mL MenABCWY vaccine (intramuscular (IM) injection) at day 1 and a second dose after 2 months.	Subjects received one dose of placebo at day 1 and one dose of MenACWY vaccine after 2 months Placebo: 0.5 mL saline solution (IM) MenACWY: 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.
Measure Participants	137	131
96217-month 3(N=101,99)	91	2
M07-0231084-month 3(N=115,119)	8	0
M14459-month 3(N=137,130)	34	0
NZ98/254-month 3(N=136,131)	10	0
96217-Month 6(N=106,111)	70	2
M07-0241084-Month 6(N=117,121)	2	1
M14459-Month 6(N=132,131)	4	0
NZ98/254-Month 6(N=131,131)	2	0

23. Secondary Outcome

Title	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.
Description	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)

Outcome Measure Data

Analysis Population Description

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/Group Title	MenABCWY	Placebo/MenACWY
Arm/Group Description	Subjects received one dose of MenABCWY vaccine at day 1 and a second dose after 2 months MenABCWY: Subjects received one dose of 0.5 mL MenABCWY vaccine (intramuscular (IM) injection) at day 1 and a second dose after 2 months.	Subjects received one dose of placebo at day 1 and one dose of MenACWY vaccine after 2 months Placebo: 0.5 mL saline solution (IM) MenACWY: 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.
Measure Participants	137	131
96217-month 3(N=101,99)	87	1
M07-0231084-month 3(N=115,119)	2	0
M14459-month 3(N=137,130)	22	0
NZ98/25-month 3(N=136,131)	5	0
96217-Month 6(N=106,111)	63	1
M07-0241084-Month 6(N=117,121)	2	0
M14459-Month 6(N=132,131)	2	0
NZ98/254-Month 6(N=131,131)	2	0

24. Secondary Outcome

Title	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.
Description	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)

Outcome Measure Data

Analysis Population Description

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/Group Title	MenABCWY	Placebo/MenACWY
Arm/Group Description	Subjects received one dose of MenABCWY vaccine at day 1 and a second dose after 2 months MenABCWY: Subjects received one dose of 0.5 mL MenABCWY vaccine (intramuscular (IM) injection) at day 1 and a second dose after 2 months.	Subjects received one dose of placebo at day 1 and one dose of MenACWY vaccine after 2 months Placebo: 0.5 mL saline solution (IM) MenACWY: 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.
Measure Participants	132	130
Men A-month 3(N=132,110)	81	48
Men C-month 3(N=131,123)	98	66
Men W-month 3(N=107,103)	74	25
Men Y-Month 3(N=99,86)	92	59
Men A-Month 6(N=119,126)	23	21
Men C-Month 6(N=130,130)	94	55
Men W-Month 6(N=114,116)	54	30
Men Y-Month 6(N=122,121)	72	47

25. Secondary Outcome

Title	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.
Description	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)

Outcome Measure Data

Analysis Population Description

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/Group Title	MenABCWY	Placebo/MenACWY
Arm/Group Description	Subjects received one dose of MenABCWY vaccine at day 1 and a second dose after 2 months MenABCWY: Subjects received one dose of 0.5 mL MenABCWY vaccine (intramuscular (IM) injection) at day 1 and a second dose after 2 months.	Subjects received one dose of placebo at day 1 and one dose of MenACWY vaccine after 2 months Placebo: 0.5 mL saline solution (IM) MenACWY: 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.
Measure Participants	132	130
Men A-Month 6(N=119,126)	13	14
Men C-Month 6(N=130,130)	88	48
Men W-Month 6(N=114,116)	32	22
Men Y-Month 6(N=122,121)	61	40
Men A-Month 3(N=132,110)	61	36
Men C-Month 3(N=131,123)	98	58
Men W-Month 3(N=107,103)	56	19
Men Y-Month 3(N=99,86)	85	50

26. Secondary Outcome

Title	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.
Description	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)

Outcome Measure Data

Analysis Population Description

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/Group Title	MenABCWY	Placebo/MenACWY
Arm/Group Description	Subjects received one dose of MenABCWY vaccine at day 1 and a second dose after 2 months MenABCWY: Subjects received one dose of 0.5 mL MenABCWY vaccine (intramuscular (IM) injection) at day 1 and a second dose after 2 months.	Subjects received one dose of placebo at day 1 and one dose of MenACWY vaccine after 2 months Placebo: 0.5 mL saline solution (IM) MenACWY: 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.
Measure Participants	132	130
Men A-Month 3(N=132,110)	45	26
Men C-month 3(N=131,123)	95	54
Men W-Month 3(N=107,103)	50	15
Men Y-month 3(N=99,86)	81	47
Men A-Month 6(N=119,126)	8	11
Men C-Month 6(N=130,130)	86	43
Men W-Month 6(N=114,116)	27	17
Men Y-Month 6(N=122,121)	49	35

27. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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/Group Title	MenABCWY	Placebo/MenACWY
Arm/Group Description	Subjects received one dose of MenABCWY vaccine at visit day 1 and a second dose at visit month 2.	Subjects received one dose of placebo at visit day 1 and one dose of MenACWY vaccine at visit month 2.
Measure Participants	149	146
Any	129	92
Any Local Reactions	128	65
Any Systemic Reactions	70	66
Induration (mm) (N=149,145)	21	8
Erythema (mm) (N=149,145)	23	5
Pain (N=149,145)	127	63
Nausea	9	19
Fatigue	40	35
Myalgia	20	14
Arthralgia	18	5
Headache	40	42
Fever (N=148,146)	9	0
Chills	15	8
Loss of appetite	23	12
Prevention of pain/fever (N=149,144)	4	2
Treatment of pain/fever (N=149,144)	60	9

28. Secondary Outcome

Title	Number of Subjects Reporting Unsolicited AEs.
Description	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.

Outcome Measure Data

Analysis Population Description

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/Group Title	MenABCWY	Placebo/MenACWY
Arm/Group Description	Subjects received one dose of MenABCWY vaccine at visit day 1 and a second dose at visit month 2.	Subjects received one dose of placebo at day 1 and one dose of MenACWY vaccine after 2 months.
Measure Participants	150	146
Any unsolicited AEs	28	28
Possibly or probably related AEs	7	3
Medically-attended AEs	37	44
AEs leading to withdrawal	1	1
Any SAEs	0	1
SAE leading to death	0	0

Adverse Events

Time Frame	Solicited adverse events (AEs): from Day 1 to Day 7 of each study vaccination. Unsolicited AEs from Day 1 to Day 30 after each vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were collected for the whole duration of the study.
Adverse Event Reporting Description	Data are presented in terms of number of subjects reporting AEs and in terms of number of subjects reporting AEs with a frequency >5% in at least one group. For serious AEs, analysis was done on Unsolicited Safety set. For solicited/unsolicited AEs with a frequency >5%, analysis was done on Overall Safety Set.
Arm/Group Title	MenABCWY		Placebo/MenACWY
Arm/Group Description	Subjects received one dose of MenABCWY vaccine at visit day 1 and a second dose at visit month 2.		Subjects received one dose of placebo at visit day 1 and one dose of MenACWY vaccine at visit month 2.
All Cause Mortality
	MenABCWY		Placebo/MenACWY
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/150 (0%)		0/146 (0%)
Serious Adverse Events
	MenABCWY		Placebo/MenACWY
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/150 (0%)		1/146 (0.7%)
Infections and infestations
PHARYNGITIS	0/150 (0%)		1/146 (0.7%)
Other (Not Including Serious) Adverse Events
	MenABCWY		Placebo/MenACWY
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	132/151 (87.4%)		100/147 (68%)
Gastrointestinal disorders
NAUSEA	10/151 (6.6%)		20/147 (13.6%)
General disorders
CHILLS	15/151 (9.9%)		9/147 (6.1%)
FATIGUE	42/151 (27.8%)		40/147 (27.2%)
INJECTION SITE ERYTHEMA	60/151 (39.7%)		24/147 (16.3%)
INJECTION SITE INDURATION	51/151 (33.8%)		16/147 (10.9%)
INJECTION SITE PAIN	130/151 (86.1%)		71/147 (48.3%)
PYREXIA	11/151 (7.3%)		0/147 (0%)
Metabolism and nutrition disorders
DECREASED APPETITE	24/151 (15.9%)		12/147 (8.2%)
Musculoskeletal and connective tissue disorders
ARTHRALGIA	19/151 (12.6%)		7/147 (4.8%)
MYALGIA	23/151 (15.2%)		15/147 (10.2%)
Nervous system disorders
HEADACHE	42/151 (27.8%)		44/147 (29.9%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.