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

A Phase 2b, Controlled, Observer-Blind, Multi-Center Study Assessing the Effectiveness, Immunogenicity and Safety of the 3rd Dose 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

NCT02285777

Enrollment

189

Registered

2014-11-07

Start date

2014-12-01

Completion date

2015-06-11

Last updated

2018-09-24

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

Conditions

Meningococcal Disease

Brief summary

This is extension of the V102\_16 study (NCT02140762). V102\_16E1 is designed to assess the effectiveness of a 3-dose vaccination series of MenABCWY, administered according to 0, 2, 6 month schedule, against the same panel of endemic US N. meningitidis serogroup B strains, as measured by enc-hSBA assay. The subjects who completed the parent V102\_16 study will be invited at the time of their last study visit to participate in this extension study.

Interventions

BIOLOGICALMeningococcal ABCWY

One dose administered intramuscularly in the deltoid area of a non-dominant arm at Month 6 (Visit 1)

BIOLOGICALPlacebo

One dose of placebo administered intramuscularly in the deltoid area of a non-dominant arm at Month 6 (Visit 1)

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 19 Years

Healthy volunteers

Inclusion criteria

* Adolescents who completed V102\_16 study and received the study vaccines as assigned in the protocol (either two doses of the MenABCWY or one dose each of MenACWY and Placebo).

Exclusion criteria

* Serious, acute, or chronic illnesses. Previous or suspected disease caused by N. meningitidis. * History of any meningococcal vaccine administration other than vaccination given in the parent V102\_16 protocol.

Design outcomes

Primary

Measure	Time frame	Description
Percentages of Subjects Without Bactericidal Activity at 1:4 Dilution Against Each US Neisseria Meningitides (N. Meningitidis) Serogroup B Strain at 1 Month After the 3-dose Vaccination Series.	At Month 7 (1 month after the 3-dose vaccination series)	The effectiveness of three doses of MenABCWY vaccine when compared to one dose of MenACWY vaccine against a panel of US N. meningitidis serogroup B invasive disease strains at 1 month after the 3-dose vaccination series was evaluated in terms of: the combined percentage of subjects without bactericidal activity at 1:4 dilution using the human Serum Bactericidal Assay (hSBA) against each strain in MenABCWY group and MenACWY group. The data provided is an average of the percentage of subjects without bactericidal activity at 1:4 dilution across all 110 strains.

Secondary

Measure	Time frame	Description
Percentages of Subjects Without Bactericidal Activity at 1:8 Dilution Against Each US N. Meningitidis Serogroup B Strain at 1 and 4 Months After the 3-dose Vaccination Series.	At Months 7 and 10 (1 and 4 months after the 3-dose vaccination series)	The effectiveness of three doses of MenABCWY vaccine when compared to one dose of MenACWY vaccine against a panel of US N. meningitidis serogroup B invasive disease strains at 1 and 4 months after the 3-dose vaccination series were evaluated in terms of: the combined percentage of subjects without bactericidal activity at 1:8 dilution using the hSBA against each strain in MenABCWY Group and MenACWY Group. The data provided is an average of the percentage of subjects without bactericidal activity at 1:8 dilution across all 110 strains.
Percentages of US N. Meningitidis Serogroup B Strains Killed at 1:4 and 1:8 Dilutions at 1 and 4 Months After the 3-dose Vaccination Series	At Month 6 (before the 3-dose vaccination series) and at Months 7 and 10 (1 and 4 months after the 3-dose vaccination series)	The mean percentage of US N. meningitidis serogroup B strains killed by each subject, at 1:4 and 1:8 dilutions before the 3-dose vaccination series, at Month 6 (PRE) and at 1 and 4 months after the 3-dose vaccination series (Month 7 and Month 10).
Percentages of Subjects With Enc-hSBA ≥ 1:4 and Enc-hSBA ≥1:8 at 1 and 4 Months After the 3-dose Vaccination Series	At Months 7 and 10 (1 and 4 months after the 3-dose vaccination series)	The immunogenicity of three 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 ≥ 1:8 against four N. meningitidis serogroup B test strains (M14459, M07-0241084, 96217 and NZ98/254) at 1 and 4 months after the 3-dose vaccination series (Month 7 and Month 10).
HT-hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroup B Test Strains	At Months 7 and 10 (1 and 4 months after the 3-dose vaccination series)	The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY vaccine, in terms of HT-hSBA GMTs against four N. meningitidis serogroup B test strains (M14459, M07-0241084, 96217 and NZ98/254) after the 3-dose vaccination series.
Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains ≥ Lower Limit of Quantitation (LLQ) at 1 Month After the 3-dose Vaccination Series.	At Month 7 (1 month after the 3-dose vaccination series)	The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of percentages of subjects with HT-hSBA titers ≥ LLQ against serogroup N. meningitidis B test strains (M14459, M07-0241084, 96217 and NZ98/254), at 1 month after the 3-dose vaccination series.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 Serogroup B Test Strains ≥ LLQ at 4 Months After the 3-dose Vaccination Series	At Month 10 (4 months after the 3-dose vaccination series)	The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of percentages of subjects with HT-hSBA titers ≥ LLQ against serogroup N. meningitidis B test strains (M14459, M07-0241084, 96217 and NZ98/254), at 4 months after the 3-dose vaccination series. The LLQ cut off values for the strains 96217, M07-0241084,M14459 and NZ98/254 were 8.6,8.9, 8 and 8.2 respectively.
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 3-dose Vaccination Series.	At Months 7 and 10 (1 and 4 months after the 3-dose vaccination series)	The immunogenicity of three 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 3-dose vaccination series. The two-fold titers rise is defined as: a) for subjects with pre-vaccination (month 6 from the parent study) HT-hSBA titers \< LLQ, postvaccination HT-hSBA titers ≥ 2 LLQ; b) for subjects with pre-vaccination (month 6 from the parent study) HT-hSBA titers ≥ LLQ, an increase of at least two times the pre-vaccination HT-hSBA titers.
Percentages of Subjects With a Three-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroup B Test Strains at 1 and 4 Months After the 3-dose Vaccination Series.	At months 7 and 10 (1 and 4 months after 3-dose vaccination series)	The immunogenicity of three 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 serogroup B test strains, at 1 and 4 months after the 3-dose vaccination series. The three-fold titers rise is defined as: a) for subjects with pre-vaccination (Month 6 from the parent study) HT-hSBA titers \< LLQ, postvaccination HT-hSBA titers ≥ 3 LLQ; b) for subjects with pre-vaccination (Month 6 from the parent study) HT-hSBA titers ≥ LLQ, an increase of at least three times the pre-vaccination HT-hSBA titers.
Percentages of Subjects With a Four-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroup B Test Strains at 1 and 4 Months After the 3-dose Vaccination Series.	At Months 7 and 10 (1 and 4 months after the 3-dose vaccination series)	The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with a four-fold rise in HT-hSBA titers against the N. meningitidis serogroup B test strains, at 1 and 4 months after the 3-dose vaccination series. The four-fold titers rise is defined as: a) for subjects with pre-vaccination (Month 6 from the parent study) HT-hSBA titers \< LLQ, postvaccination HT-hSBA titers ≥ 4 LLQ; b) for subjects with pre-vaccination (Month 6 from the parent study) HT-hSBA titers ≥ LLQ, an increase of at least four times the pre-vaccination HT-hSBA titers.
HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W and Y.	At Months 7 and 10 (1 and 4 months after the 3-dose vaccination series)	The immunogenicity of three 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 1 and 4 months after the 3-dose vaccination series.
Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥ LLQ at 1 Month After the 3- Dose Vaccination Series	At Month 7 (1 month after the 3-dose vaccination series)	The immunogenicity of three 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 1 month after the 3-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 Without Bactericidal Activity at 1:4 Dilution Against Each US N. Meningitidis Serogroup B Strain at 4 Months After the 3-dose Vaccination Series.	At Month 10 (4 months after the 3-dose vaccination series)	The effectiveness of three doses of MenABCWY vaccine when compared to one dose of MenACWY vaccine against a panel of US N. meningitidis serogroup B invasive disease strains at 4 months after the 3-dose vaccination series was evaluated in terms of: the combined percentage of subjects without bactericidal activity at 1:4 dilution using the hSBA against each strain in MenABCWY Group and MenACWY Group. The data provided is an average of the percentage of subjects without bactericidal activity at 1:4 dilution across all 110 strains.
Percentage of Subjects With Two-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroups A, C,W and Y at 1 and 4 Months After the 3-dose Vaccination Series.	At Months 7 and 10 (1 and 4 months after the 3-dose vaccination series)	The immunogenicity of three 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 3-dose vaccination series. The two-fold titers rise is defined as: a) for subjects with pre-vaccination (Month 6 from the parent study) HT-hSBA titers \< LLQ, postvaccination HT-hSBA titers ≥ 2 LLQ; b) for subjects with pre-vaccination (Month 6 from the parent study) HT-hSBA titers ≥ LLQ, an increase of at least two times the pre-vaccination HT-hSBA titers.
Percentage of Subjects With Three-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroups A, C, W and Y at 1 and 4 Months After the 3-dose Vaccination Series.	At Months 7 and 10 (1 and 4 months after the 3-dose vaccination series)	The immunogenicity of three 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 3-dose vaccination series. The three-fold titers rise is defined as: a) for subjects with pre-vaccination (Month 6 from the parent study) HT-hSBA titers \< LLQ, postvaccination HT-hSBA titers ≥ 3 LLQ; b) for subjects with pre-vaccination (Month 6 from the parent study) HT-hSBA titers ≥ LLQ, an increase of at least three times the pre-vaccination HT-hSBA titers.
Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroups A, C, W and Y at 1 and 4 Months After the 3-dose Vaccination Series.	At Months 7 and 10 (1 and 4 months after the 3-dose vaccination series)	The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with a four-fold rise in HT-hSBA titers against the N. meningitidis serogroups A, C, W and Y, at 1 and 4 months after the 3-dose vaccination series. The four-fold titers rise is defined as: a) for subjects with pre-vaccination (Month 6 from the parent study) HT-hSBA titers \< LLQ, postvaccination HT-hSBA titers ≥ 4 LLQ; b) for subjects with pre-vaccination (Month 6 from the parent study) HT-hSBA titers ≥ LLQ, an increase of at least four times the pre-vaccination HT-hSBA titers.
Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 1 Month After the 3-dose Vaccination Series	At Month 7 (1 month after the 3-dose vaccination series)	The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of percentages of subjects with HT-hSBA titers ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 against serogroup N. meningitidis B test strains (M14459, M07-0241084, 96217 and NZ98/254), at 1 month after the 3-dose vaccination series.
Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 4 Months After the 3-dose Vaccination Series	At Month 10 (4 months after the 3-dose vaccination series)	The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of percentages of subjects with HT-hSBA titers ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 against serogroup N. meningitidis B test strains (M14459, M07-0241084, 96217 and NZ98/254), at 4 months after the 3-dose vaccination series.
Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥128 at 1 Month After the 3- Dose Vaccination Series	At Month 7 (1 month after the 3-dose vaccination series)	The immunogenicity of three 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 1 month after the 3-dose vaccination series.
Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥8, ≥ 16, ≥ 32, ≥ 64, ≥128 at 4 Months After the 3-dose Vaccination Series	At Month 10 (4 months after the 3-dose vaccination series)	The immunogenicity of three 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 4 months after the 3-dose vaccination series.
Number of Subjects Reporting Any Solicited Local or Systemic Adverse Events (AEs)	Day 1 (6 hours) to Day 7 after vaccination	Number of subjects reporting any solicited local or systemic AEs from Day 1 (6 hours) to Day 7 after any meningococcal vaccination is reported. Assessed solicited local symptoms were induration, erythema and pain. Assessed solicited general symptoms were fatigue, myalgia, arthralgia, headache, fever, chills and loss of appetite. Other solicited data included prevention of pain/fever and treatment of pain/fever. Any = occurrence of the symptom regardless of intensity grade.
Number of Subjects Reporting Any Unsolicited AEs	Day 1 to Day 30 after any vaccination	The number of subjects reporting unsolicited AEs after any vaccination is reported. An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Number of Subjects Reporting Any Serious Adverse Events (SAEs), Medically-attended AEs and AEs Leading to Premature Withdrawal.	During the entire study period (from Day 0 up to Month 10)	The number of subjects reporting any SAEs, medically-attended AEs and AEs leading to premature withdrawal during the entire study period is reported. SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any was defined as the occurrence of any unsolicited AE regardless of intensitygrade or relation to vaccination.
Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥ LLQ at 4 Months After the 3-dose Vaccination Series	At Month 10 (4 months after the 3-dose vaccination series)	The immunogenicity of three 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 4 months after the 3-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

189 subjects were enrolled from 1 center in United States

Pre-assignment details

An Interactive Response Technology (IRT) was used in the study. At Month 6 Visit of the parent study, IRT allocated the study vaccines (either MenABCWY or placebo) to the subject. Subject received either a 3rd dose of MenABCWY or one dose of a placebo, depending on their assigned vaccine group in parent study.

Participants by arm

Arm	Count
MenABCWY Group Subjects who received 2 doses of MenABCWY vaccine in the parent study and a 3rd dose of MenABCWY vaccine in the current study.	95
MenACWY Group Subjects who received 1 dose of placebo and 1 dose of MenACWY vaccine in the parent study and 1 dose of placebo in the current study.	94
Total	189

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Lost to Follow-up	4	2
Overall Study	Withdrawal by Subject	1	1

Baseline characteristics

Characteristic	MenACWY Group	Total	MenABCWY Group
Age, Continuous	12.4 Years STANDARD_DEVIATION 2.4	12.6 Years STANDARD_DEVIATION 2.38	12.8 Years STANDARD_DEVIATION 2.36
Race/Ethnicity, Customized AMERICAN INDIAN OR ALASKA NATIVE	2 Participants	2 Participants	0 Participants
Race/Ethnicity, Customized ASIAN	0 Participants	1 Participants	1 Participants
Race/Ethnicity, Customized BLACK OR AFRICAN AMERICAN	21 Participants	37 Participants	16 Participants
Race/Ethnicity, Customized NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER	0 Participants	0 Participants	0 Participants
Race/Ethnicity, Customized OTHER	5 Participants	9 Participants	4 Participants
Race/Ethnicity, Customized WHITE	66 Participants	140 Participants	74 Participants
Sex: Female, Male Female	33 Participants	73 Participants	40 Participants
Sex: Female, Male Male	61 Participants	116 Participants	55 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 95	0 / 94
other Total, other adverse events	63 / 95	27 / 94
serious Total, serious adverse events	0 / 95	0 / 94

Outcome results

Primary

Percentages of Subjects Without Bactericidal Activity at 1:4 Dilution Against Each US Neisseria Meningitides (N. Meningitidis) Serogroup B Strain at 1 Month After the 3-dose Vaccination Series.

The effectiveness of three doses of MenABCWY vaccine when compared to one dose of MenACWY vaccine against a panel of US N. meningitidis serogroup B invasive disease strains at 1 month after the 3-dose vaccination series was evaluated in terms of: the combined percentage of subjects without bactericidal activity at 1:4 dilution using the human Serum Bactericidal Assay (hSBA) against each strain in MenABCWY group and MenACWY group. The data provided is an average of the percentage of subjects without bactericidal activity at 1:4 dilution across all 110 strains.

Time frame: At Month 7 (1 month after the 3-dose vaccination series)

Population: Analysis was performed on FAS-Effectiveness (Month 7)- included all screened subjects who provided informed consent \& demographic \&/or baseline screening assessments, received a subject ID \& vaccination,\& who provided evaluable serum sample with enc-hSBA result for at least 1 endemic N. meningitidis serogroup B invasive disease strain at Month 7.

Arm	Measure	Value (NUMBER)
MenABCWY Group	Percentages of Subjects Without Bactericidal Activity at 1:4 Dilution Against Each US Neisseria Meningitides (N. Meningitidis) Serogroup B Strain at 1 Month After the 3-dose Vaccination Series.	21.1 Percentages of subjects
MenACWY Group	Percentages of Subjects Without Bactericidal Activity at 1:4 Dilution Against Each US Neisseria Meningitides (N. Meningitidis) Serogroup B Strain at 1 Month After the 3-dose Vaccination Series.	73.7 Percentages of subjects

Comparison: The Vaccine Effectiveness (VE) at 1 month after the 3-dose vaccination series for each strain is defined as \[1 - (percentage of subjects without bactericidal activity at 1:4 dilution in MenABCWY group/percentage of subjects without bactericidal activity at 1:4 dilution in MenACWY group)\] x 100.The combined VE across all strains was computed by mean of a generalized linear model.p-value: 0.000195% CI: [69, 73]Generalized Linear Model

Secondary

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

The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY vaccine, in terms of HT-hSBA GMTs against four N. meningitidis serogroup B test strains (M14459, M07-0241084, 96217 and NZ98/254) after the 3-dose vaccination series.

Time frame: At Months 7 and 10 (1 and 4 months after the 3-dose vaccination series)

Population: Analysis was performed on FAS-Immunogenicity (Months 7 \&10)- included all screened subjects who provided consent \& demographic \&/or baseline screening assessments, received a subject ID \& vaccination, \& provided evaluable serum samples at Months 7 \& 10 \& whose immunogenicity assay result was available for at least one serogroup B test strain.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
MenABCWY Group	HT-hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroup B Test Strains	M14459, Month 7	23.12 Titers
MenABCWY Group	HT-hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroup B Test Strains	M14459, Month 10	3.93 Titers
MenABCWY Group	HT-hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroup B Test Strains	M07-0241084, Month 7	12.26 Titers
MenABCWY Group	HT-hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroup B Test Strains	M07-0241084, Month 10	3.04 Titers
MenABCWY Group	HT-hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroup B Test Strains	96217, Month 7	367.29 Titers
MenABCWY Group	HT-hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroup B Test Strains	96217, Month 10	142.06 Titers
MenABCWY Group	HT-hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroup B Test Strains	NZ98/254, Month 7	19.69 Titers
MenABCWY Group	HT-hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroup B Test Strains	NZ98/254, Month 10	3.75 Titers
MenACWY Group	HT-hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroup B Test Strains	NZ98/254, Month 10	1.04 Titers
MenACWY Group	HT-hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroup B Test Strains	M14459, Month 7	1.1 Titers
MenACWY Group	HT-hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroup B Test Strains	96217, Month 7	4.02 Titers
MenACWY Group	HT-hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroup B Test Strains	M14459, Month 10	1.18 Titers
MenACWY Group	HT-hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroup B Test Strains	NZ98/254, Month 7	1.02 Titers
MenACWY Group	HT-hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroup B Test Strains	M07-0241084, Month 7	1.74 Titers
MenACWY Group	HT-hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroup B Test Strains	96217, Month 10	3.32 Titers
MenACWY Group	HT-hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroup B Test Strains	M07-0241084, Month 10	1.68 Titers

Secondary

HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W and Y.

The immunogenicity of three 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 1 and 4 months after the 3-dose vaccination series.

Time frame: At Months 7 and 10 (1 and 4 months after the 3-dose vaccination series)

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
MenABCWY Group	HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W and Y.	Men A, Month 7	127.92 Titers
MenABCWY Group	HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W and Y.	Men A, Month 10	36.5 Titers
MenABCWY Group	HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W and Y.	Men C, Month 7	521.64 Titers
MenABCWY Group	HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W and Y.	Men C, Month 10	291.19 Titers
MenABCWY Group	HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W and Y.	Men W, Month 7	424.8 Titers
MenABCWY Group	HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W and Y.	Men W, Month 10	147.4 Titers
MenABCWY Group	HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W and Y.	Men Y, Month 7	204.84 Titers
MenABCWY Group	HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W and Y.	Men Y, Month 10	83.42 Titers
MenACWY Group	HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W and Y.	Men Y, Month 10	11.85 Titers
MenACWY Group	HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W and Y.	Men A, Month 7	3.37 Titers
MenACWY Group	HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W and Y.	Men W, Month 7	40.22 Titers
MenACWY Group	HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W and Y.	Men A, Month 10	2.73 Titers
MenACWY Group	HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W and Y.	Men Y, Month 7	13.27 Titers
MenACWY Group	HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W and Y.	Men C, Month 7	18.34 Titers
MenACWY Group	HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W and Y.	Men W, Month 10	23.01 Titers
MenACWY Group	HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W and Y.	Men C, Month 10	15.4 Titers

Secondary

Number of Subjects Reporting Any Serious Adverse Events (SAEs), Medically-attended AEs and AEs Leading to Premature Withdrawal.

The number of subjects reporting any SAEs, medically-attended AEs and AEs leading to premature withdrawal during the entire study period is reported. SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any was defined as the occurrence of any unsolicited AE regardless of intensitygrade or relation to vaccination.

Time frame: During the entire study period (from Day 0 up to Month 10)

Population: Analysis was performed on Safety Set (overall)- included all screened subjects who provide informed consent and demographic and/or baseline screening assessments, received a subject ID and a study vaccination, and have either post-vaccination reactogenicity data or post-vaccination unsolicited adverse event records.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
MenABCWY Group	Number of Subjects Reporting Any Serious Adverse Events (SAEs), Medically-attended AEs and AEs Leading to Premature Withdrawal.	Any SAEs	0 Participants
MenABCWY Group	Number of Subjects Reporting Any Serious Adverse Events (SAEs), Medically-attended AEs and AEs Leading to Premature Withdrawal.	Any Medically Attended AEs	14 Participants
MenABCWY Group	Number of Subjects Reporting Any Serious Adverse Events (SAEs), Medically-attended AEs and AEs Leading to Premature Withdrawal.	Any AEs leading to premature withdrawal	0 Participants
MenACWY Group	Number of Subjects Reporting Any Serious Adverse Events (SAEs), Medically-attended AEs and AEs Leading to Premature Withdrawal.	Any AEs leading to premature withdrawal	0 Participants
MenACWY Group	Number of Subjects Reporting Any Serious Adverse Events (SAEs), Medically-attended AEs and AEs Leading to Premature Withdrawal.	Any SAEs	0 Participants
MenACWY Group	Number of Subjects Reporting Any Serious Adverse Events (SAEs), Medically-attended AEs and AEs Leading to Premature Withdrawal.	Any Medically Attended AEs	20 Participants

Secondary

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

Number of subjects reporting any solicited local or systemic AEs from Day 1 (6 hours) to Day 7 after any meningococcal vaccination is reported. Assessed solicited local symptoms were induration, erythema and pain. Assessed solicited general symptoms were fatigue, myalgia, arthralgia, headache, fever, chills and loss of appetite. Other solicited data included prevention of pain/fever and treatment of pain/fever. Any = occurrence of the symptom regardless of intensity grade.

Time frame: Day 1 (6 hours) to Day 7 after vaccination

Population: Analysis was performed on Safety Set (solicited AEs \& other solicited reactions)-included all screened subjects who provided consent \& demographic \&/or baseline screening assessments, received a subject ID \& a study vaccination, \& provided post-vaccination reactogenicity data.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
MenABCWY Group	Number of Subjects Reporting Any Solicited Local or Systemic Adverse Events (AEs)	Any	62 Participants
MenABCWY Group	Number of Subjects Reporting Any Solicited Local or Systemic Adverse Events (AEs)	Myalgia	13 Participants
MenABCWY Group	Number of Subjects Reporting Any Solicited Local or Systemic Adverse Events (AEs)	Erythema (mm)	6 Participants
MenABCWY Group	Number of Subjects Reporting Any Solicited Local or Systemic Adverse Events (AEs)	Arthralgia	9 Participants
MenABCWY Group	Number of Subjects Reporting Any Solicited Local or Systemic Adverse Events (AEs)	Any Systemic Reactions	27 Participants
MenABCWY Group	Number of Subjects Reporting Any Solicited Local or Systemic Adverse Events (AEs)	Headache	13 Participants
MenABCWY Group	Number of Subjects Reporting Any Solicited Local or Systemic Adverse Events (AEs)	Pain	59 Participants
MenABCWY Group	Number of Subjects Reporting Any Solicited Local or Systemic Adverse Events (AEs)	Fever	0 Participants
MenABCWY Group	Number of Subjects Reporting Any Solicited Local or Systemic Adverse Events (AEs)	Any Local Reactions	60 Participants
MenABCWY Group	Number of Subjects Reporting Any Solicited Local or Systemic Adverse Events (AEs)	Chills	2 Participants
MenABCWY Group	Number of Subjects Reporting Any Solicited Local or Systemic Adverse Events (AEs)	Nausea	5 Participants
MenABCWY Group	Number of Subjects Reporting Any Solicited Local or Systemic Adverse Events (AEs)	Loss of appetite	3 Participants
MenABCWY Group	Number of Subjects Reporting Any Solicited Local or Systemic Adverse Events (AEs)	Induration (mm)	6 Participants
MenABCWY Group	Number of Subjects Reporting Any Solicited Local or Systemic Adverse Events (AEs)	Prevention of pain/fever	0 Participants
MenABCWY Group	Number of Subjects Reporting Any Solicited Local or Systemic Adverse Events (AEs)	Fatigue	14 Participants
MenABCWY Group	Number of Subjects Reporting Any Solicited Local or Systemic Adverse Events (AEs)	Treatment of pain/fever	12 Participants
MenACWY Group	Number of Subjects Reporting Any Solicited Local or Systemic Adverse Events (AEs)	Fatigue	11 Participants
MenACWY Group	Number of Subjects Reporting Any Solicited Local or Systemic Adverse Events (AEs)	Any	25 Participants
MenACWY Group	Number of Subjects Reporting Any Solicited Local or Systemic Adverse Events (AEs)	Any Local Reactions	15 Participants
MenACWY Group	Number of Subjects Reporting Any Solicited Local or Systemic Adverse Events (AEs)	Any Systemic Reactions	15 Participants
MenACWY Group	Number of Subjects Reporting Any Solicited Local or Systemic Adverse Events (AEs)	Induration (mm)	0 Participants
MenACWY Group	Number of Subjects Reporting Any Solicited Local or Systemic Adverse Events (AEs)	Erythema (mm)	0 Participants
MenACWY Group	Number of Subjects Reporting Any Solicited Local or Systemic Adverse Events (AEs)	Pain	15 Participants
MenACWY Group	Number of Subjects Reporting Any Solicited Local or Systemic Adverse Events (AEs)	Nausea	5 Participants
MenACWY Group	Number of Subjects Reporting Any Solicited Local or Systemic Adverse Events (AEs)	Treatment of pain/fever	3 Participants
MenACWY Group	Number of Subjects Reporting Any Solicited Local or Systemic Adverse Events (AEs)	Myalgia	3 Participants
MenACWY Group	Number of Subjects Reporting Any Solicited Local or Systemic Adverse Events (AEs)	Arthralgia	0 Participants
MenACWY Group	Number of Subjects Reporting Any Solicited Local or Systemic Adverse Events (AEs)	Headache	9 Participants
MenACWY Group	Number of Subjects Reporting Any Solicited Local or Systemic Adverse Events (AEs)	Fever	1 Participants
MenACWY Group	Number of Subjects Reporting Any Solicited Local or Systemic Adverse Events (AEs)	Chills	3 Participants
MenACWY Group	Number of Subjects Reporting Any Solicited Local or Systemic Adverse Events (AEs)	Loss of appetite	3 Participants
MenACWY Group	Number of Subjects Reporting Any Solicited Local or Systemic Adverse Events (AEs)	Prevention of pain/fever	0 Participants

Secondary

Number of Subjects Reporting Any Unsolicited AEs

The number of subjects reporting unsolicited AEs after any vaccination is reported. An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.

Time frame: Day 1 to Day 30 after any vaccination

Population: Analysis was performed on Safety set (unsolicited AEs)- included all screened subjects who provided informed consent \& demographic and/or baseline screening assessments, received a subject ID and a study vaccination, and had post-vaccination unsolicited adverse event records.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
MenABCWY Group	Number of Subjects Reporting Any Unsolicited AEs	14 Participants
MenACWY Group	Number of Subjects Reporting Any Unsolicited AEs	11 Participants

Secondary

Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroups A, C, W and Y at 1 and 4 Months After the 3-dose Vaccination Series.

The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with a four-fold rise in HT-hSBA titers against the N. meningitidis serogroups A, C, W and Y, at 1 and 4 months after the 3-dose vaccination series. The four-fold titers rise is defined as: a) for subjects with pre-vaccination (Month 6 from the parent study) HT-hSBA titers \< LLQ, postvaccination HT-hSBA titers ≥ 4 LLQ; b) for subjects with pre-vaccination (Month 6 from the parent study) HT-hSBA titers ≥ LLQ, an increase of at least four times the pre-vaccination HT-hSBA titers.

Time frame: At Months 7 and 10 (1 and 4 months after the 3-dose vaccination series)

Arm	Measure	Group	Value (NUMBER)
MenABCWY Group	Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroups A, C, W and Y at 1 and 4 Months After the 3-dose Vaccination Series.	Men A, Month 7	53 Percentage of subjects
MenABCWY Group	Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroups A, C, W and Y at 1 and 4 Months After the 3-dose Vaccination Series.	Men C, Month 7	49 Percentage of subjects
MenABCWY Group	Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroups A, C, W and Y at 1 and 4 Months After the 3-dose Vaccination Series.	Men W, Month 7	49 Percentage of subjects
MenABCWY Group	Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroups A, C, W and Y at 1 and 4 Months After the 3-dose Vaccination Series.	Men Y, Month 7	28 Percentage of subjects
MenABCWY Group	Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroups A, C, W and Y at 1 and 4 Months After the 3-dose Vaccination Series.	Men A, Month 10	6 Percentage of subjects
MenABCWY Group	Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroups A, C, W and Y at 1 and 4 Months After the 3-dose Vaccination Series.	Men C, Month 10	21 Percentage of subjects
MenABCWY Group	Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroups A, C, W and Y at 1 and 4 Months After the 3-dose Vaccination Series.	Men W, Month 10	8 Percentage of subjects
MenABCWY Group	Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroups A, C, W and Y at 1 and 4 Months After the 3-dose Vaccination Series.	Men Y, Month 10	6 Percentage of subjects
MenACWY Group	Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroups A, C, W and Y at 1 and 4 Months After the 3-dose Vaccination Series.	Men Y, Month 10	1 Percentage of subjects
MenACWY Group	Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroups A, C, W and Y at 1 and 4 Months After the 3-dose Vaccination Series.	Men A, Month 7	0 Percentage of subjects
MenACWY Group	Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroups A, C, W and Y at 1 and 4 Months After the 3-dose Vaccination Series.	Men A, Month 10	1 Percentage of subjects
MenACWY Group	Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroups A, C, W and Y at 1 and 4 Months After the 3-dose Vaccination Series.	Men C, Month 7	1 Percentage of subjects
MenACWY Group	Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroups A, C, W and Y at 1 and 4 Months After the 3-dose Vaccination Series.	Men W, Month 10	0 Percentage of subjects
MenACWY Group	Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroups A, C, W and Y at 1 and 4 Months After the 3-dose Vaccination Series.	Men W, Month 7	0 Percentage of subjects
MenACWY Group	Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroups A, C, W and Y at 1 and 4 Months After the 3-dose Vaccination Series.	Men C, Month 10	2 Percentage of subjects
MenACWY Group	Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroups A, C, W and Y at 1 and 4 Months After the 3-dose Vaccination Series.	Men Y, Month 7	0 Percentage of subjects

Secondary

Percentage of Subjects With Three-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroups A, C, W and Y at 1 and 4 Months After the 3-dose Vaccination Series.

The immunogenicity of three 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 3-dose vaccination series. The three-fold titers rise is defined as: a) for subjects with pre-vaccination (Month 6 from the parent study) HT-hSBA titers \< LLQ, postvaccination HT-hSBA titers ≥ 3 LLQ; b) for subjects with pre-vaccination (Month 6 from the parent study) HT-hSBA titers ≥ LLQ, an increase of at least three times the pre-vaccination HT-hSBA titers.

Time frame: At Months 7 and 10 (1 and 4 months after the 3-dose vaccination series)

Arm	Measure	Group	Value (NUMBER)
MenABCWY Group	Percentage of Subjects With Three-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroups A, C, W and Y at 1 and 4 Months After the 3-dose Vaccination Series.	Men A, Month 7	69 Percentage of subjects
MenABCWY Group	Percentage of Subjects With Three-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroups A, C, W and Y at 1 and 4 Months After the 3-dose Vaccination Series.	Men C, Month 7	60 Percentage of subjects
MenABCWY Group	Percentage of Subjects With Three-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroups A, C, W and Y at 1 and 4 Months After the 3-dose Vaccination Series.	Men W, Month 7	67 Percentage of subjects
MenABCWY Group	Percentage of Subjects With Three-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroups A, C, W and Y at 1 and 4 Months After the 3-dose Vaccination Series.	Men Y, Month 7	39 Percentage of subjects
MenABCWY Group	Percentage of Subjects With Three-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroups A, C, W and Y at 1 and 4 Months After the 3-dose Vaccination Series.	Men A, Month 10	16 Percentage of subjects
MenABCWY Group	Percentage of Subjects With Three-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroups A, C, W and Y at 1 and 4 Months After the 3-dose Vaccination Series.	Men C, Month 10	29 Percentage of subjects
MenABCWY Group	Percentage of Subjects With Three-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroups A, C, W and Y at 1 and 4 Months After the 3-dose Vaccination Series.	Men W, Month 10	13 Percentage of subjects
MenABCWY Group	Percentage of Subjects With Three-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroups A, C, W and Y at 1 and 4 Months After the 3-dose Vaccination Series.	Men Y, Month 10	15 Percentage of subjects
MenACWY Group	Percentage of Subjects With Three-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroups A, C, W and Y at 1 and 4 Months After the 3-dose Vaccination Series.	Men Y, Month 10	2 Percentage of subjects
MenACWY Group	Percentage of Subjects With Three-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroups A, C, W and Y at 1 and 4 Months After the 3-dose Vaccination Series.	Men A, Month 7	0 Percentage of subjects
MenACWY Group	Percentage of Subjects With Three-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroups A, C, W and Y at 1 and 4 Months After the 3-dose Vaccination Series.	Men A, Month 10	1 Percentage of subjects
MenACWY Group	Percentage of Subjects With Three-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroups A, C, W and Y at 1 and 4 Months After the 3-dose Vaccination Series.	Men C, Month 7	1 Percentage of subjects
MenACWY Group	Percentage of Subjects With Three-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroups A, C, W and Y at 1 and 4 Months After the 3-dose Vaccination Series.	Men W, Month 10	0 Percentage of subjects
MenACWY Group	Percentage of Subjects With Three-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroups A, C, W and Y at 1 and 4 Months After the 3-dose Vaccination Series.	Men W, Month 7	0 Percentage of subjects
MenACWY Group	Percentage of Subjects With Three-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroups A, C, W and Y at 1 and 4 Months After the 3-dose Vaccination Series.	Men C, Month 10	5 Percentage of subjects
MenACWY Group	Percentage of Subjects With Three-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroups A, C, W and Y at 1 and 4 Months After the 3-dose Vaccination Series.	Men Y, Month 7	0 Percentage of subjects

Secondary

Percentage of Subjects With Two-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroups A, C,W and Y at 1 and 4 Months After the 3-dose Vaccination Series.

The immunogenicity of three 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 3-dose vaccination series. The two-fold titers rise is defined as: a) for subjects with pre-vaccination (Month 6 from the parent study) HT-hSBA titers \< LLQ, postvaccination HT-hSBA titers ≥ 2 LLQ; b) for subjects with pre-vaccination (Month 6 from the parent study) HT-hSBA titers ≥ LLQ, an increase of at least two times the pre-vaccination HT-hSBA titers.

Time frame: At Months 7 and 10 (1 and 4 months after the 3-dose vaccination series)

Population: Analysis was performed on the FAS-Immunogenicity (months 7 and 10)- included all screened subjects who provided consent \& demographic \&/baseline screening assessments, received a subject ID \& vaccination, \& provided evaluable serum samples at months 7 \& 10 \& whose immunogenicity assay result was available for at least one serogroup B strain.

Arm	Measure	Group	Value (NUMBER)
MenABCWY Group	Percentage of Subjects With Two-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroups A, C,W and Y at 1 and 4 Months After the 3-dose Vaccination Series.	Men A, Month 7	88 Percentage of subjects
MenABCWY Group	Percentage of Subjects With Two-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroups A, C,W and Y at 1 and 4 Months After the 3-dose Vaccination Series.	Men C, Month 7	87 Percentage of subjects
MenABCWY Group	Percentage of Subjects With Two-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroups A, C,W and Y at 1 and 4 Months After the 3-dose Vaccination Series.	Men W, Month 7	83 Percentage of subjects
MenABCWY Group	Percentage of Subjects With Two-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroups A, C,W and Y at 1 and 4 Months After the 3-dose Vaccination Series.	Men Y, Month 7	57 Percentage of subjects
MenABCWY Group	Percentage of Subjects With Two-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroups A, C,W and Y at 1 and 4 Months After the 3-dose Vaccination Series.	Men A, Month 10	32 Percentage of subjects
MenABCWY Group	Percentage of Subjects With Two-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroups A, C,W and Y at 1 and 4 Months After the 3-dose Vaccination Series.	Men C, Month 10	56 Percentage of subjects
MenABCWY Group	Percentage of Subjects With Two-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroups A, C,W and Y at 1 and 4 Months After the 3-dose Vaccination Series.	Men W, Month 10	24 Percentage of subjects
MenABCWY Group	Percentage of Subjects With Two-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroups A, C,W and Y at 1 and 4 Months After the 3-dose Vaccination Series.	Men Y, Month 10	26 Percentage of subjects
MenACWY Group	Percentage of Subjects With Two-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroups A, C,W and Y at 1 and 4 Months After the 3-dose Vaccination Series.	Men Y, Month 10	3 Percentage of subjects
MenACWY Group	Percentage of Subjects With Two-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroups A, C,W and Y at 1 and 4 Months After the 3-dose Vaccination Series.	Men A, Month 7	2 Percentage of subjects
MenACWY Group	Percentage of Subjects With Two-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroups A, C,W and Y at 1 and 4 Months After the 3-dose Vaccination Series.	Men A, Month 10	1 Percentage of subjects
MenACWY Group	Percentage of Subjects With Two-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroups A, C,W and Y at 1 and 4 Months After the 3-dose Vaccination Series.	Men C, Month 7	2 Percentage of subjects
MenACWY Group	Percentage of Subjects With Two-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroups A, C,W and Y at 1 and 4 Months After the 3-dose Vaccination Series.	Men W, Month 10	1 Percentage of subjects
MenACWY Group	Percentage of Subjects With Two-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroups A, C,W and Y at 1 and 4 Months After the 3-dose Vaccination Series.	Men W, Month 7	5 Percentage of subjects
MenACWY Group	Percentage of Subjects With Two-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroups A, C,W and Y at 1 and 4 Months After the 3-dose Vaccination Series.	Men C, Month 10	8 Percentage of subjects
MenACWY Group	Percentage of Subjects With Two-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroups A, C,W and Y at 1 and 4 Months After the 3-dose Vaccination Series.	Men Y, Month 7	2 Percentage of subjects

Secondary

Percentages of Subjects With a Four-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroup B Test Strains at 1 and 4 Months After the 3-dose Vaccination Series.

The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with a four-fold rise in HT-hSBA titers against the N. meningitidis serogroup B test strains, at 1 and 4 months after the 3-dose vaccination series. The four-fold titers rise is defined as: a) for subjects with pre-vaccination (Month 6 from the parent study) HT-hSBA titers \< LLQ, postvaccination HT-hSBA titers ≥ 4 LLQ; b) for subjects with pre-vaccination (Month 6 from the parent study) HT-hSBA titers ≥ LLQ, an increase of at least four times the pre-vaccination HT-hSBA titers.

Time frame: At Months 7 and 10 (1 and 4 months after the 3-dose vaccination series)

Arm	Measure	Group	Value (NUMBER)
MenABCWY Group	Percentages of Subjects With a Four-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroup B Test Strains at 1 and 4 Months After the 3-dose Vaccination Series.	96217 (Month 7)	63 Percentages of subjects
MenABCWY Group	Percentages of Subjects With a Four-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroup B Test Strains at 1 and 4 Months After the 3-dose Vaccination Series.	M07-0241084 (Month 7)	12 Percentages of subjects
MenABCWY Group	Percentages of Subjects With a Four-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroup B Test Strains at 1 and 4 Months After the 3-dose Vaccination Series.	M14459 (Month 7)	23 Percentages of subjects
MenABCWY Group	Percentages of Subjects With a Four-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroup B Test Strains at 1 and 4 Months After the 3-dose Vaccination Series.	NZ98/254 (Month 7)	33 Percentages of subjects
MenABCWY Group	Percentages of Subjects With a Four-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroup B Test Strains at 1 and 4 Months After the 3-dose Vaccination Series.	96217 (Month 10)	15 Percentages of subjects
MenABCWY Group	Percentages of Subjects With a Four-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroup B Test Strains at 1 and 4 Months After the 3-dose Vaccination Series.	M07-0241084 (Month 10)	0 Percentages of subjects
MenABCWY Group	Percentages of Subjects With a Four-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroup B Test Strains at 1 and 4 Months After the 3-dose Vaccination Series.	M14459 (Month 10)	3 Percentages of subjects
MenABCWY Group	Percentages of Subjects With a Four-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroup B Test Strains at 1 and 4 Months After the 3-dose Vaccination Series.	NZ98/254 (Month 10)	2 Percentages of subjects
MenACWY Group	Percentages of Subjects With a Four-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroup B Test Strains at 1 and 4 Months After the 3-dose Vaccination Series.	NZ98/254 (Month 10)	0 Percentages of subjects
MenACWY Group	Percentages of Subjects With a Four-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroup B Test Strains at 1 and 4 Months After the 3-dose Vaccination Series.	96217 (Month 7)	3 Percentages of subjects
MenACWY Group	Percentages of Subjects With a Four-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroup B Test Strains at 1 and 4 Months After the 3-dose Vaccination Series.	96217 (Month 10)	5 Percentages of subjects
MenACWY Group	Percentages of Subjects With a Four-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroup B Test Strains at 1 and 4 Months After the 3-dose Vaccination Series.	M07-0241084 (Month 7)	0 Percentages of subjects
MenACWY Group	Percentages of Subjects With a Four-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroup B Test Strains at 1 and 4 Months After the 3-dose Vaccination Series.	M14459 (Month 10)	0 Percentages of subjects
MenACWY Group	Percentages of Subjects With a Four-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroup B Test Strains at 1 and 4 Months After the 3-dose Vaccination Series.	M14459 (Month 7)	0 Percentages of subjects
MenACWY Group	Percentages of Subjects With a Four-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroup B Test Strains at 1 and 4 Months After the 3-dose Vaccination Series.	M07-0241084 (Month 10)	1 Percentages of subjects
MenACWY Group	Percentages of Subjects With a Four-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroup B Test Strains at 1 and 4 Months After the 3-dose Vaccination Series.	NZ98/254 (Month 7)	0 Percentages of subjects

Secondary

Percentages of Subjects With a Three-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroup B Test Strains at 1 and 4 Months After the 3-dose Vaccination Series.

The immunogenicity of three 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 serogroup B test strains, at 1 and 4 months after the 3-dose vaccination series. The three-fold titers rise is defined as: a) for subjects with pre-vaccination (Month 6 from the parent study) HT-hSBA titers \< LLQ, postvaccination HT-hSBA titers ≥ 3 LLQ; b) for subjects with pre-vaccination (Month 6 from the parent study) HT-hSBA titers ≥ LLQ, an increase of at least three times the pre-vaccination HT-hSBA titers.

Time frame: At months 7 and 10 (1 and 4 months after 3-dose vaccination series)

Arm	Measure	Group	Value (NUMBER)
MenABCWY Group	Percentages of Subjects With a Three-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroup B Test Strains at 1 and 4 Months After the 3-dose Vaccination Series.	96217 (Month 7)	79 Percentage of subjects
MenABCWY Group	Percentages of Subjects With a Three-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroup B Test Strains at 1 and 4 Months After the 3-dose Vaccination Series.	M07-0241084 (Month 7)	23 Percentage of subjects
MenABCWY Group	Percentages of Subjects With a Three-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroup B Test Strains at 1 and 4 Months After the 3-dose Vaccination Series.	M14459 (Month 7)	41 Percentage of subjects
MenABCWY Group	Percentages of Subjects With a Three-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroup B Test Strains at 1 and 4 Months After the 3-dose Vaccination Series.	NZ98/254 (Month 7)	41 Percentage of subjects
MenABCWY Group	Percentages of Subjects With a Three-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroup B Test Strains at 1 and 4 Months After the 3-dose Vaccination Series.	96217 (Month 10)	27 Percentage of subjects
MenABCWY Group	Percentages of Subjects With a Three-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroup B Test Strains at 1 and 4 Months After the 3-dose Vaccination Series.	M07-0241084 (Month 10)	0 Percentage of subjects
MenABCWY Group	Percentages of Subjects With a Three-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroup B Test Strains at 1 and 4 Months After the 3-dose Vaccination Series.	M14459 (Month 10)	3 Percentage of subjects
MenABCWY Group	Percentages of Subjects With a Three-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroup B Test Strains at 1 and 4 Months After the 3-dose Vaccination Series.	NZ98/254 (Month 10)	5 Percentage of subjects
MenACWY Group	Percentages of Subjects With a Three-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroup B Test Strains at 1 and 4 Months After the 3-dose Vaccination Series.	NZ98/254 (Month 10)	0 Percentage of subjects
MenACWY Group	Percentages of Subjects With a Three-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroup B Test Strains at 1 and 4 Months After the 3-dose Vaccination Series.	96217 (Month 7)	5 Percentage of subjects
MenACWY Group	Percentages of Subjects With a Three-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroup B Test Strains at 1 and 4 Months After the 3-dose Vaccination Series.	96217 (Month 10)	5 Percentage of subjects
MenACWY Group	Percentages of Subjects With a Three-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroup B Test Strains at 1 and 4 Months After the 3-dose Vaccination Series.	M07-0241084 (Month 7)	1 Percentage of subjects
MenACWY Group	Percentages of Subjects With a Three-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroup B Test Strains at 1 and 4 Months After the 3-dose Vaccination Series.	M14459 (Month 10)	0 Percentage of subjects
MenACWY Group	Percentages of Subjects With a Three-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroup B Test Strains at 1 and 4 Months After the 3-dose Vaccination Series.	M14459 (Month 7)	0 Percentage of subjects
MenACWY Group	Percentages of Subjects With a Three-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroup B Test Strains at 1 and 4 Months After the 3-dose Vaccination Series.	M07-0241084 (Month 10)	2 Percentage of subjects
MenACWY Group	Percentages of Subjects With a Three-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroup B Test Strains at 1 and 4 Months After the 3-dose Vaccination Series.	NZ98/254 (Month 7)	0 Percentage of subjects

Secondary

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 3-dose Vaccination Series.

The immunogenicity of three 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 3-dose vaccination series. The two-fold titers rise is defined as: a) for subjects with pre-vaccination (month 6 from the parent study) HT-hSBA titers \< LLQ, postvaccination HT-hSBA titers ≥ 2 LLQ; b) for subjects with pre-vaccination (month 6 from the parent study) HT-hSBA titers ≥ LLQ, an increase of at least two times the pre-vaccination HT-hSBA titers.

Time frame: At Months 7 and 10 (1 and 4 months after the 3-dose vaccination series)

Population: Analysis was performed on the FAS-Immunogenicity (months 7 and 10)- included all screened subjects who provided consent \& demographic \&/baseline screening assessments, received a subjects D \& vaccination, \& provided evaluable serum samples at months 7 \& 10 \& whose immunogenicity assay result was available for at least one serogroup B strain.

Arm	Measure	Group	Value (NUMBER)
MenABCWY Group	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 3-dose Vaccination Series.	96217 (Month 7)	87 Percentage of subjects
MenABCWY Group	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 3-dose Vaccination Series.	M07-0241084 (Month 7)	38 Percentage of subjects
MenABCWY Group	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 3-dose Vaccination Series.	M14459 (Month 7)	67 Percentage of subjects
MenABCWY Group	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 3-dose Vaccination Series.	NZ98/254 (Month 7)	56 Percentage of subjects
MenABCWY Group	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 3-dose Vaccination Series.	96217 (Month 10)	54 Percentage of subjects
MenABCWY Group	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 3-dose Vaccination Series.	M07-0241084 (Month 10)	0 Percentage of subjects
MenABCWY Group	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 3-dose Vaccination Series.	M14459 (Month 10)	7 Percentage of subjects
MenABCWY Group	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 3-dose Vaccination Series.	NZ98/254 (Month 10)	13 Percentage of subjects
MenACWY Group	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 3-dose Vaccination Series.	NZ98/254 (Month 10)	0 Percentage of subjects
MenACWY Group	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 3-dose Vaccination Series.	96217 (Month 7)	12 Percentage of subjects
MenACWY Group	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 3-dose Vaccination Series.	96217 (Month 10)	7 Percentage of subjects
MenACWY Group	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 3-dose Vaccination Series.	M07-0241084 (Month 7)	1 Percentage of subjects
MenACWY Group	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 3-dose Vaccination Series.	M14459 (Month 10)	0 Percentage of subjects
MenACWY Group	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 3-dose Vaccination Series.	M14459 (Month 7)	0 Percentage of subjects
MenACWY Group	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 3-dose Vaccination Series.	M07-0241084 (Month 10)	4 Percentage of subjects
MenACWY Group	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 3-dose Vaccination Series.	NZ98/254 (Month 7)	0 Percentage of subjects

Secondary

Percentages of Subjects With Enc-hSBA ≥ 1:4 and Enc-hSBA ≥1:8 at 1 and 4 Months After the 3-dose Vaccination Series

The immunogenicity of three 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 ≥ 1:8 against four N. meningitidis serogroup B test strains (M14459, M07-0241084, 96217 and NZ98/254) at 1 and 4 months after the 3-dose vaccination series (Month 7 and Month 10).

Time frame: At Months 7 and 10 (1 and 4 months after the 3-dose vaccination series)

Arm	Measure	Group	Value (NUMBER)
MenABCWY Group	Percentages of Subjects With Enc-hSBA ≥ 1:4 and Enc-hSBA ≥1:8 at 1 and 4 Months After the 3-dose Vaccination Series	M14459 (≥ 1:4, Month 7)	98 Percentages of subjects
MenABCWY Group	Percentages of Subjects With Enc-hSBA ≥ 1:4 and Enc-hSBA ≥1:8 at 1 and 4 Months After the 3-dose Vaccination Series	M14459 (≥ 1:4, Month 10)	72 Percentages of subjects
MenABCWY Group	Percentages of Subjects With Enc-hSBA ≥ 1:4 and Enc-hSBA ≥1:8 at 1 and 4 Months After the 3-dose Vaccination Series	M14459 (≥ 1:8, Month 7)	67 Percentages of subjects
MenABCWY Group	Percentages of Subjects With Enc-hSBA ≥ 1:4 and Enc-hSBA ≥1:8 at 1 and 4 Months After the 3-dose Vaccination Series	M14459 (≥ 1:8, Month 10)	21 Percentages of subjects
MenABCWY Group	Percentages of Subjects With Enc-hSBA ≥ 1:4 and Enc-hSBA ≥1:8 at 1 and 4 Months After the 3-dose Vaccination Series	M07-0241084 (≥ 1:4, Month 7)	81 Percentages of subjects
MenABCWY Group	Percentages of Subjects With Enc-hSBA ≥ 1:4 and Enc-hSBA ≥1:8 at 1 and 4 Months After the 3-dose Vaccination Series	M07-0241084 (≥ 1:4, Month 10)	46 Percentages of subjects
MenABCWY Group	Percentages of Subjects With Enc-hSBA ≥ 1:4 and Enc-hSBA ≥1:8 at 1 and 4 Months After the 3-dose Vaccination Series	M07-0241084 (≥ 1:8, Month 7)	38 Percentages of subjects
MenABCWY Group	Percentages of Subjects With Enc-hSBA ≥ 1:4 and Enc-hSBA ≥1:8 at 1 and 4 Months After the 3-dose Vaccination Series	M07-0241084 (≥ 1:8, Month 10)	11 Percentages of subjects
MenABCWY Group	Percentages of Subjects With Enc-hSBA ≥ 1:4 and Enc-hSBA ≥1:8 at 1 and 4 Months After the 3-dose Vaccination Series	96217 (≥ 1:4, Month 7)	99 Percentages of subjects
MenABCWY Group	Percentages of Subjects With Enc-hSBA ≥ 1:4 and Enc-hSBA ≥1:8 at 1 and 4 Months After the 3-dose Vaccination Series	96217 (≥ 1:4, Month 10)	100 Percentages of subjects
MenABCWY Group	Percentages of Subjects With Enc-hSBA ≥ 1:4 and Enc-hSBA ≥1:8 at 1 and 4 Months After the 3-dose Vaccination Series	96217 (≥ 1:8, Month 7)	99 Percentages of subjects
MenABCWY Group	Percentages of Subjects With Enc-hSBA ≥ 1:4 and Enc-hSBA ≥1:8 at 1 and 4 Months After the 3-dose Vaccination Series	96217 (≥ 1:8, Month 10)	99 Percentages of subjects
MenABCWY Group	Percentages of Subjects With Enc-hSBA ≥ 1:4 and Enc-hSBA ≥1:8 at 1 and 4 Months After the 3-dose Vaccination Series	NZ98/254 (≥ 1:4, Month 7)	76 Percentages of subjects
MenABCWY Group	Percentages of Subjects With Enc-hSBA ≥ 1:4 and Enc-hSBA ≥1:8 at 1 and 4 Months After the 3-dose Vaccination Series	NZ98/254 (≥ 1:4, Month 10)	34 Percentages of subjects
MenABCWY Group	Percentages of Subjects With Enc-hSBA ≥ 1:4 and Enc-hSBA ≥1:8 at 1 and 4 Months After the 3-dose Vaccination Series	NZ98/254 (≥ 1:8, Month 7)	39 Percentages of subjects
MenABCWY Group	Percentages of Subjects With Enc-hSBA ≥ 1:4 and Enc-hSBA ≥1:8 at 1 and 4 Months After the 3-dose Vaccination Series	NZ98/254 (≥ 1:8, Month 10)	4 Percentages of subjects
MenACWY Group	Percentages of Subjects With Enc-hSBA ≥ 1:4 and Enc-hSBA ≥1:8 at 1 and 4 Months After the 3-dose Vaccination Series	NZ98/254 (≥ 1:8, Month 10)	0 Percentages of subjects
MenACWY Group	Percentages of Subjects With Enc-hSBA ≥ 1:4 and Enc-hSBA ≥1:8 at 1 and 4 Months After the 3-dose Vaccination Series	M14459 (≥ 1:4, Month 7)	12 Percentages of subjects
MenACWY Group	Percentages of Subjects With Enc-hSBA ≥ 1:4 and Enc-hSBA ≥1:8 at 1 and 4 Months After the 3-dose Vaccination Series	96217 (≥ 1:4, Month 7)	48 Percentages of subjects
MenACWY Group	Percentages of Subjects With Enc-hSBA ≥ 1:4 and Enc-hSBA ≥1:8 at 1 and 4 Months After the 3-dose Vaccination Series	M14459 (≥ 1:4, Month 10)	12 Percentages of subjects
MenACWY Group	Percentages of Subjects With Enc-hSBA ≥ 1:4 and Enc-hSBA ≥1:8 at 1 and 4 Months After the 3-dose Vaccination Series	NZ98/254 (≥ 1:4, Month 7)	1 Percentages of subjects
MenACWY Group	Percentages of Subjects With Enc-hSBA ≥ 1:4 and Enc-hSBA ≥1:8 at 1 and 4 Months After the 3-dose Vaccination Series	M14459 (≥ 1:8, Month 7)	2 Percentages of subjects
MenACWY Group	Percentages of Subjects With Enc-hSBA ≥ 1:4 and Enc-hSBA ≥1:8 at 1 and 4 Months After the 3-dose Vaccination Series	96217 (≥ 1:4, Month 10)	41 Percentages of subjects
MenACWY Group	Percentages of Subjects With Enc-hSBA ≥ 1:4 and Enc-hSBA ≥1:8 at 1 and 4 Months After the 3-dose Vaccination Series	M14459 (≥ 1:8, Month 10)	1 Percentages of subjects
MenACWY Group	Percentages of Subjects With Enc-hSBA ≥ 1:4 and Enc-hSBA ≥1:8 at 1 and 4 Months After the 3-dose Vaccination Series	NZ98/254 (≥ 1:8, Month 7)	1 Percentages of subjects
MenACWY Group	Percentages of Subjects With Enc-hSBA ≥ 1:4 and Enc-hSBA ≥1:8 at 1 and 4 Months After the 3-dose Vaccination Series	M07-0241084 (≥ 1:4, Month 7)	21 Percentages of subjects
MenACWY Group	Percentages of Subjects With Enc-hSBA ≥ 1:4 and Enc-hSBA ≥1:8 at 1 and 4 Months After the 3-dose Vaccination Series	96217 (≥ 1:8, Month 7)	17 Percentages of subjects
MenACWY Group	Percentages of Subjects With Enc-hSBA ≥ 1:4 and Enc-hSBA ≥1:8 at 1 and 4 Months After the 3-dose Vaccination Series	M07-0241084 (≥ 1:4, Month 10)	22 Percentages of subjects
MenACWY Group	Percentages of Subjects With Enc-hSBA ≥ 1:4 and Enc-hSBA ≥1:8 at 1 and 4 Months After the 3-dose Vaccination Series	NZ98/254 (≥ 1:4, Month 10)	1 Percentages of subjects
MenACWY Group	Percentages of Subjects With Enc-hSBA ≥ 1:4 and Enc-hSBA ≥1:8 at 1 and 4 Months After the 3-dose Vaccination Series	M07-0241084 (≥ 1:8, Month 7)	5 Percentages of subjects
MenACWY Group	Percentages of Subjects With Enc-hSBA ≥ 1:4 and Enc-hSBA ≥1:8 at 1 and 4 Months After the 3-dose Vaccination Series	96217 (≥ 1:8, Month 10)	16 Percentages of subjects
MenACWY Group	Percentages of Subjects With Enc-hSBA ≥ 1:4 and Enc-hSBA ≥1:8 at 1 and 4 Months After the 3-dose Vaccination Series	M07-0241084 (≥ 1:8, Month 10)	6 Percentages of subjects

Secondary

Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 1 Month After the 3-dose Vaccination Series

The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of percentages of subjects with HT-hSBA titers ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 against serogroup N. meningitidis B test strains (M14459, M07-0241084, 96217 and NZ98/254), at 1 month after the 3-dose vaccination series.

Time frame: At Month 7 (1 month after the 3-dose vaccination series)

Population: Analysis was performed on FAS-Immunogenicity (Month 7)- included all screened subjects who provided consent \& demographic \&/or baseline screening assessments, received a subject ID \& vaccination, \& provided evaluable serum samples at Month 7 \& whose immunogenicity assay result was available for at least one serogroup B test strain.

Arm	Measure	Group	Value (NUMBER)
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 1 Month After the 3-dose Vaccination Series	M07-0241084, ≥ 5	82 Percentage of subjects
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 1 Month After the 3-dose Vaccination Series	96217, ≥ 8	100 Percentage of subjects
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 1 Month After the 3-dose Vaccination Series	96217, ≥ 16	100 Percentage of subjects
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 1 Month After the 3-dose Vaccination Series	96217, ≥ 32	100 Percentage of subjects
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 1 Month After the 3-dose Vaccination Series	96217, ≥ 64	99 Percentage of subjects
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 1 Month After the 3-dose Vaccination Series	96217, ≥ 128	93 Percentage of subjects
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 1 Month After the 3-dose Vaccination Series	96217, ≥ 5	100 Percentage of subjects
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 1 Month After the 3-dose Vaccination Series	M07-0241084, ≥ 8	67 Percentage of subjects
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 1 Month After the 3-dose Vaccination Series	M07-0241084, ≥ 16	46 Percentage of subjects
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 1 Month After the 3-dose Vaccination Series	M07-0241084, ≥ 32	20 Percentage of subjects
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 1 Month After the 3-dose Vaccination Series	M07-0241084, ≥ 64	6 Percentage of subjects
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 1 Month After the 3-dose Vaccination Series	M07-0241084, ≥ 128	0 Percentage of subjects
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 1 Month After the 3-dose Vaccination Series	M14459, ≥ 5	95 Percentage of subjects
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 1 Month After the 3-dose Vaccination Series	M14459, ≥ 8	90 Percentage of subjects
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 1 Month After the 3-dose Vaccination Series	M14459, ≥ 16	71 Percentage of subjects
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 1 Month After the 3-dose Vaccination Series	M14459, ≥ 32	34 Percentage of subjects
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 1 Month After the 3-dose Vaccination Series	M14459, ≥ 64	11 Percentage of subjects
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 1 Month After the 3-dose Vaccination Series	M14459, ≥ 128	3 Percentage of subjects
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 1 Month After the 3-dose Vaccination Series	NZ98/254, ≥ 5	89 Percentage of subjects
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 1 Month After the 3-dose Vaccination Series	NZ98/254, ≥ 8	79 Percentage of subjects
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 1 Month After the 3-dose Vaccination Series	NZ98/254, ≥ 16	61 Percentage of subjects
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 1 Month After the 3-dose Vaccination Series	NZ98/254, ≥ 32	37 Percentage of subjects
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 1 Month After the 3-dose Vaccination Series	NZ98/254, ≥ 64	10 Percentage of subjects
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 1 Month After the 3-dose Vaccination Series	NZ98/254, ≥ 128	4 Percentage of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 1 Month After the 3-dose Vaccination Series	NZ98/254, ≥ 64	0 Percentage of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 1 Month After the 3-dose Vaccination Series	96217, ≥ 5	38 Percentage of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 1 Month After the 3-dose Vaccination Series	M14459, ≥ 5	1 Percentage of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 1 Month After the 3-dose Vaccination Series	96217, ≥ 8	37 Percentage of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 1 Month After the 3-dose Vaccination Series	NZ98/254, ≥ 5	1 Percentage of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 1 Month After the 3-dose Vaccination Series	96217, ≥ 16	25 Percentage of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 1 Month After the 3-dose Vaccination Series	M14459, ≥ 8	1 Percentage of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 1 Month After the 3-dose Vaccination Series	96217, ≥ 32	15 Percentage of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 1 Month After the 3-dose Vaccination Series	NZ98/254, ≥ 32	0 Percentage of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 1 Month After the 3-dose Vaccination Series	96217, ≥ 64	8 Percentage of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 1 Month After the 3-dose Vaccination Series	M14459, ≥ 16	1 Percentage of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 1 Month After the 3-dose Vaccination Series	96217, ≥ 128	3 Percentage of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 1 Month After the 3-dose Vaccination Series	NZ98/254, ≥ 8	1 Percentage of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 1 Month After the 3-dose Vaccination Series	M07-0241084, ≥ 5	16 Percentage of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 1 Month After the 3-dose Vaccination Series	M14459, ≥ 32	1 Percentage of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 1 Month After the 3-dose Vaccination Series	M07-0241084, ≥ 8	12 Percentage of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 1 Month After the 3-dose Vaccination Series	NZ98/254, ≥ 128	0 Percentage of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 1 Month After the 3-dose Vaccination Series	M07-0241084, ≥ 16	8 Percentage of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 1 Month After the 3-dose Vaccination Series	M14459, ≥ 64	0 Percentage of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 1 Month After the 3-dose Vaccination Series	M07-0241084, ≥ 32	3 Percentage of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 1 Month After the 3-dose Vaccination Series	NZ98/254, ≥ 16	0 Percentage of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 1 Month After the 3-dose Vaccination Series	M07-0241084, ≥ 64	2 Percentage of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 1 Month After the 3-dose Vaccination Series	M14459, ≥ 128	0 Percentage of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 1 Month After the 3-dose Vaccination Series	M07-0241084, ≥ 128	0 Percentage of subjects

Secondary

Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 4 Months After the 3-dose Vaccination Series

Time frame: At Month 10 (4 months after the 3-dose vaccination series)

Population: Analysis was performed on FAS-Immunogenicity (Month 10)- included all screened subjects who provided consent \& demographic \&/or baseline screening assessments, received a subject ID \& vaccination, \& provided evaluable serum samples at Month 10 \& whose immunogenicity assay result was available for at least one serogroup B test strain.

Arm	Measure	Group	Value (NUMBER)
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 4 Months After the 3-dose Vaccination Series	M07-0241084, ≥ 5	38 Percentage of subjects
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 4 Months After the 3-dose Vaccination Series	96217, ≥ 8	99 Percentage of subjects
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 4 Months After the 3-dose Vaccination Series	96217, ≥ 16	98 Percentage of subjects
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 4 Months After the 3-dose Vaccination Series	96217, ≥ 32	94 Percentage of subjects
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 4 Months After the 3-dose Vaccination Series	96217, ≥ 64	85 Percentage of subjects
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 4 Months After the 3-dose Vaccination Series	96217, ≥ 128	56 Percentage of subjects
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 4 Months After the 3-dose Vaccination Series	96217, ≥ 5	99 Percentage of subjects
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 4 Months After the 3-dose Vaccination Series	M07-0241084, ≥ 8	24 Percentage of subjects
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 4 Months After the 3-dose Vaccination Series	M07-0241084, ≥ 16	9 Percentage of subjects
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 4 Months After the 3-dose Vaccination Series	M07-0241084, ≥ 32	1 Percentage of subjects
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 4 Months After the 3-dose Vaccination Series	M07-0241084, ≥ 64	1 Percentage of subjects
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 4 Months After the 3-dose Vaccination Series	M07-0241084, ≥ 128	0 Percentage of subjects
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 4 Months After the 3-dose Vaccination Series	M14459, ≥ 5	49 Percentage of subjects
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 4 Months After the 3-dose Vaccination Series	M14459, ≥ 8	36 Percentage of subjects
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 4 Months After the 3-dose Vaccination Series	M14459, ≥ 16	17 Percentage of subjects
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 4 Months After the 3-dose Vaccination Series	M14459, ≥ 32	6 Percentage of subjects
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 4 Months After the 3-dose Vaccination Series	M14459, ≥ 64	1 Percentage of subjects
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 4 Months After the 3-dose Vaccination Series	M14459, ≥ 128	0 Percentage of subjects
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 4 Months After the 3-dose Vaccination Series	NZ98/254, ≥ 5	44 Percentage of subjects
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 4 Months After the 3-dose Vaccination Series	NZ98/254, ≥ 8	34 Percentage of subjects
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 4 Months After the 3-dose Vaccination Series	NZ98/254, ≥ 16	16 Percentage of subjects
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 4 Months After the 3-dose Vaccination Series	NZ98/254, ≥ 32	5 Percentage of subjects
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 4 Months After the 3-dose Vaccination Series	NZ98/254, ≥ 64	2 Percentage of subjects
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 4 Months After the 3-dose Vaccination Series	NZ98/254, ≥ 128	2 Percentage of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 4 Months After the 3-dose Vaccination Series	NZ98/254, ≥ 64	0 Percentage of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 4 Months After the 3-dose Vaccination Series	96217, ≥ 5	35 Percentage of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 4 Months After the 3-dose Vaccination Series	M14459, ≥ 5	4 Percentage of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 4 Months After the 3-dose Vaccination Series	96217, ≥ 8	33 Percentage of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 4 Months After the 3-dose Vaccination Series	NZ98/254, ≥ 5	1 Percentage of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 4 Months After the 3-dose Vaccination Series	96217, ≥ 16	21 Percentage of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 4 Months After the 3-dose Vaccination Series	M14459, ≥ 8	3 Percentage of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 4 Months After the 3-dose Vaccination Series	96217, ≥ 32	16 Percentage of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 4 Months After the 3-dose Vaccination Series	NZ98/254, ≥ 32	0 Percentage of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 4 Months After the 3-dose Vaccination Series	96217, ≥ 64	6 Percentage of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 4 Months After the 3-dose Vaccination Series	M14459, ≥ 16	1 Percentage of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 4 Months After the 3-dose Vaccination Series	96217, ≥ 128	2 Percentage of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 4 Months After the 3-dose Vaccination Series	NZ98/254, ≥ 8	1 Percentage of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 4 Months After the 3-dose Vaccination Series	M07-0241084, ≥ 5	17 Percentage of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 4 Months After the 3-dose Vaccination Series	M14459, ≥ 32	0 Percentage of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 4 Months After the 3-dose Vaccination Series	M07-0241084, ≥ 8	12 Percentage of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 4 Months After the 3-dose Vaccination Series	NZ98/254, ≥ 128	0 Percentage of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 4 Months After the 3-dose Vaccination Series	M07-0241084, ≥ 16	9 Percentage of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 4 Months After the 3-dose Vaccination Series	M14459, ≥ 64	0 Percentage of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 4 Months After the 3-dose Vaccination Series	M07-0241084, ≥ 32	3 Percentage of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 4 Months After the 3-dose Vaccination Series	NZ98/254, ≥ 16	0 Percentage of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 4 Months After the 3-dose Vaccination Series	M07-0241084, ≥ 64	2 Percentage of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 4 Months After the 3-dose Vaccination Series	M14459, ≥ 128	0 Percentage of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 4 Months After the 3-dose Vaccination Series	M07-0241084, ≥ 128	1 Percentage of subjects

Secondary

Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains ≥ LLQ at 4 Months After the 3-dose Vaccination Series

The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of percentages of subjects with HT-hSBA titers ≥ LLQ against serogroup N. meningitidis B test strains (M14459, M07-0241084, 96217 and NZ98/254), at 4 months after the 3-dose vaccination series. The LLQ cut off values for the strains 96217, M07-0241084,M14459 and NZ98/254 were 8.6,8.9, 8 and 8.2 respectively.

Time frame: At Month 10 (4 months after the 3-dose vaccination series)

Population: Analysis was performed on FAS-Immunogenicity (Month 10)- included all screened subjects who provided informed consent \& demographic \&/or baseline screening assessments, received a subject ID \& vaccination, \& provided evaluable serum samples at Month 10 and whose immunogenicity assay result was available for at least one serogroup strain.

Arm	Measure	Group	Value (NUMBER)
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains ≥ LLQ at 4 Months After the 3-dose Vaccination Series	96217	99 Percentages of subjects
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains ≥ LLQ at 4 Months After the 3-dose Vaccination Series	M07-0241084	23 Percentages of subjects
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains ≥ LLQ at 4 Months After the 3-dose Vaccination Series	M14459	36 Percentages of subjects
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains ≥ LLQ at 4 Months After the 3-dose Vaccination Series	NZ98/254	33 Percentages of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains ≥ LLQ at 4 Months After the 3-dose Vaccination Series	NZ98/254	1 Percentages of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains ≥ LLQ at 4 Months After the 3-dose Vaccination Series	96217	32 Percentages of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains ≥ LLQ at 4 Months After the 3-dose Vaccination Series	M14459	3 Percentages of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains ≥ LLQ at 4 Months After the 3-dose Vaccination Series	M07-0241084	12 Percentages of subjects

Secondary

Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains ≥ Lower Limit of Quantitation (LLQ) at 1 Month After the 3-dose Vaccination Series.

The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of percentages of subjects with HT-hSBA titers ≥ LLQ against serogroup N. meningitidis B test strains (M14459, M07-0241084, 96217 and NZ98/254), at 1 month after the 3-dose vaccination series.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 Month 7 (1 month after the 3-dose vaccination series)

Arm	Measure	Group	Value (NUMBER)
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains ≥ Lower Limit of Quantitation (LLQ) at 1 Month After the 3-dose Vaccination Series.	M07-0241084, Month 7	63 Percentages of subjects
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains ≥ Lower Limit of Quantitation (LLQ) at 1 Month After the 3-dose Vaccination Series.	M14459, Month 7	90 Percentages of subjects
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains ≥ Lower Limit of Quantitation (LLQ) at 1 Month After the 3-dose Vaccination Series.	NZ98/254, Month 7	79 Percentages of subjects
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains ≥ Lower Limit of Quantitation (LLQ) at 1 Month After the 3-dose Vaccination Series.	96217, Month 7	100 Percentages of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains ≥ Lower Limit of Quantitation (LLQ) at 1 Month After the 3-dose Vaccination Series.	96217, Month 7	37 Percentages of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains ≥ Lower Limit of Quantitation (LLQ) at 1 Month After the 3-dose Vaccination Series.	M07-0241084, Month 7	12 Percentages of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains ≥ Lower Limit of Quantitation (LLQ) at 1 Month After the 3-dose Vaccination Series.	NZ98/254, Month 7	1 Percentages of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains ≥ Lower Limit of Quantitation (LLQ) at 1 Month After the 3-dose Vaccination Series.	M14459, Month 7	1 Percentages of subjects

Secondary

Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥128 at 1 Month After the 3- Dose Vaccination Series

The immunogenicity of three 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 1 month after the 3-dose vaccination series.

Time frame: At Month 7 (1 month after the 3-dose vaccination series)

Arm	Measure	Group	Value (NUMBER)
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥128 at 1 Month After the 3- Dose Vaccination Series	Men A, ≥ 8	98 Percentage of subjects
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥128 at 1 Month After the 3- Dose Vaccination Series	Men A, ≥ 16	98 Percentage of subjects
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥128 at 1 Month After the 3- Dose Vaccination Series	Men A, ≥ 32	98 Percentage of subjects
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥128 at 1 Month After the 3- Dose Vaccination Series	Men A, ≥ 64	86 Percentage of subjects
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥128 at 1 Month After the 3- Dose Vaccination Series	Men A, ≥ 128	56 Percentage of subjects
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥128 at 1 Month After the 3- Dose Vaccination Series	Men C, ≥ 8	100 Percentage of subjects
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥128 at 1 Month After the 3- Dose Vaccination Series	Men C, ≥ 16	99 Percentage of subjects
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥128 at 1 Month After the 3- Dose Vaccination Series	Men C, ≥ 32	99 Percentage of subjects
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥128 at 1 Month After the 3- Dose Vaccination Series	Men C, ≥ 64	99 Percentage of subjects
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥128 at 1 Month After the 3- Dose Vaccination Series	Men C, ≥ 128	91 Percentage of subjects
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥128 at 1 Month After the 3- Dose Vaccination Series	Men W, ≥ 8	100 Percentage of subjects
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥128 at 1 Month After the 3- Dose Vaccination Series	Men W, ≥ 16	100 Percentage of subjects
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥128 at 1 Month After the 3- Dose Vaccination Series	Men W, ≥ 32	99 Percentage of subjects
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥128 at 1 Month After the 3- Dose Vaccination Series	Men W, ≥ 64	99 Percentage of subjects
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥128 at 1 Month After the 3- Dose Vaccination Series	Men W, ≥ 128	89 Percentage of subjects
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥128 at 1 Month After the 3- Dose Vaccination Series	Men Y, ≥ 8	100 Percentage of subjects
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥128 at 1 Month After the 3- Dose Vaccination Series	Men Y, ≥ 16	100 Percentage of subjects
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥128 at 1 Month After the 3- Dose Vaccination Series	Men Y, ≥ 32	95 Percentage of subjects
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥128 at 1 Month After the 3- Dose Vaccination Series	Men Y, ≥ 64	81 Percentage of subjects
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥128 at 1 Month After the 3- Dose Vaccination Series	Men Y, ≥ 128	65 Percentage of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥128 at 1 Month After the 3- Dose Vaccination Series	Men Y, ≥ 32	44 Percentage of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥128 at 1 Month After the 3- Dose Vaccination Series	Men A, ≥ 8	30 Percentage of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥128 at 1 Month After the 3- Dose Vaccination Series	Men W, ≥ 8	86 Percentage of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥128 at 1 Month After the 3- Dose Vaccination Series	Men A, ≥ 16	26 Percentage of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥128 at 1 Month After the 3- Dose Vaccination Series	Men Y, ≥ 8	61 Percentage of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥128 at 1 Month After the 3- Dose Vaccination Series	Men A, ≥ 32	22 Percentage of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥128 at 1 Month After the 3- Dose Vaccination Series	Men W, ≥ 16	77 Percentage of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥128 at 1 Month After the 3- Dose Vaccination Series	Men A, ≥ 64	13 Percentage of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥128 at 1 Month After the 3- Dose Vaccination Series	Men Y, ≥ 128	14 Percentage of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥128 at 1 Month After the 3- Dose Vaccination Series	Men A, ≥ 128	8 Percentage of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥128 at 1 Month After the 3- Dose Vaccination Series	Men W, ≥ 32	61 Percentage of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥128 at 1 Month After the 3- Dose Vaccination Series	Men C, ≥ 8	71 Percentage of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥128 at 1 Month After the 3- Dose Vaccination Series	Men Y, ≥ 16	56 Percentage of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥128 at 1 Month After the 3- Dose Vaccination Series	Men C, ≥ 16	51 Percentage of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥128 at 1 Month After the 3- Dose Vaccination Series	Men W, ≥ 64	45 Percentage of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥128 at 1 Month After the 3- Dose Vaccination Series	Men C, ≥ 32	33 Percentage of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥128 at 1 Month After the 3- Dose Vaccination Series	Men Y, ≥ 64	27 Percentage of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥128 at 1 Month After the 3- Dose Vaccination Series	Men C, ≥ 64	26 Percentage of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥128 at 1 Month After the 3- Dose Vaccination Series	Men W, ≥ 128	24 Percentage of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥128 at 1 Month After the 3- Dose Vaccination Series	Men C, ≥ 128	19 Percentage of subjects

Secondary

Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥8, ≥ 16, ≥ 32, ≥ 64, ≥128 at 4 Months After the 3-dose Vaccination Series

The immunogenicity of three 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 4 months after the 3-dose vaccination series.

Time frame: At Month 10 (4 months after the 3-dose vaccination series)

Arm	Measure	Group	Value (NUMBER)
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥8, ≥ 16, ≥ 32, ≥ 64, ≥128 at 4 Months After the 3-dose Vaccination Series	Men A, ≥ 8	86 Percentage of subjects
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥8, ≥ 16, ≥ 32, ≥ 64, ≥128 at 4 Months After the 3-dose Vaccination Series	Men A, ≥ 16	84 Percentage of subjects
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥8, ≥ 16, ≥ 32, ≥ 64, ≥128 at 4 Months After the 3-dose Vaccination Series	Men A, ≥ 32	72 Percentage of subjects
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥8, ≥ 16, ≥ 32, ≥ 64, ≥128 at 4 Months After the 3-dose Vaccination Series	Men A, ≥ 64	46 Percentage of subjects
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥8, ≥ 16, ≥ 32, ≥ 64, ≥128 at 4 Months After the 3-dose Vaccination Series	Men A, ≥128	14 Percentage of subjects
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥8, ≥ 16, ≥ 32, ≥ 64, ≥128 at 4 Months After the 3-dose Vaccination Series	Men C, ≥ 8	100 Percentage of subjects
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥8, ≥ 16, ≥ 32, ≥ 64, ≥128 at 4 Months After the 3-dose Vaccination Series	Men C, ≥ 16	98 Percentage of subjects
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥8, ≥ 16, ≥ 32, ≥ 64, ≥128 at 4 Months After the 3-dose Vaccination Series	Men C, ≥ 32	97 Percentage of subjects
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥8, ≥ 16, ≥ 32, ≥ 64, ≥128 at 4 Months After the 3-dose Vaccination Series	Men C, ≥ 64	86 Percentage of subjects
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥8, ≥ 16, ≥ 32, ≥ 64, ≥128 at 4 Months After the 3-dose Vaccination Series	Men C, ≥ 128	74 Percentage of subjects
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥8, ≥ 16, ≥ 32, ≥ 64, ≥128 at 4 Months After the 3-dose Vaccination Series	Men W, ≥ 8	99 Percentage of subjects
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥8, ≥ 16, ≥ 32, ≥ 64, ≥128 at 4 Months After the 3-dose Vaccination Series	Men W, ≥ 16	98 Percentage of subjects
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥8, ≥ 16, ≥ 32, ≥ 64, ≥128 at 4 Months After the 3-dose Vaccination Series	Men W, ≥ 32	94 Percentage of subjects
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥8, ≥ 16, ≥ 32, ≥ 64, ≥128 at 4 Months After the 3-dose Vaccination Series	Men W, ≥ 64	75 Percentage of subjects
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥8, ≥ 16, ≥ 32, ≥ 64, ≥128 at 4 Months After the 3-dose Vaccination Series	Men W, ≥ 128	52 Percentage of subjects
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥8, ≥ 16, ≥ 32, ≥ 64, ≥128 at 4 Months After the 3-dose Vaccination Series	Men Y, ≥ 8	91 Percentage of subjects
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥8, ≥ 16, ≥ 32, ≥ 64, ≥128 at 4 Months After the 3-dose Vaccination Series	Men Y, ≥ 16	86 Percentage of subjects
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥8, ≥ 16, ≥ 32, ≥ 64, ≥128 at 4 Months After the 3-dose Vaccination Series	Men Y, ≥ 32	77 Percentage of subjects
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥8, ≥ 16, ≥ 32, ≥ 64, ≥128 at 4 Months After the 3-dose Vaccination Series	Men Y, ≥ 64	62 Percentage of subjects
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥8, ≥ 16, ≥ 32, ≥ 64, ≥128 at 4 Months After the 3-dose Vaccination Series	Men Y, ≥ 128	40 Percentage of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥8, ≥ 16, ≥ 32, ≥ 64, ≥128 at 4 Months After the 3-dose Vaccination Series	Men Y, ≥ 32	38 Percentage of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥8, ≥ 16, ≥ 32, ≥ 64, ≥128 at 4 Months After the 3-dose Vaccination Series	Men A, ≥ 8	25 Percentage of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥8, ≥ 16, ≥ 32, ≥ 64, ≥128 at 4 Months After the 3-dose Vaccination Series	Men W, ≥ 8	75 Percentage of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥8, ≥ 16, ≥ 32, ≥ 64, ≥128 at 4 Months After the 3-dose Vaccination Series	Men A, ≥ 16	23 Percentage of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥8, ≥ 16, ≥ 32, ≥ 64, ≥128 at 4 Months After the 3-dose Vaccination Series	Men Y, ≥ 8	58 Percentage of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥8, ≥ 16, ≥ 32, ≥ 64, ≥128 at 4 Months After the 3-dose Vaccination Series	Men A, ≥ 32	18 Percentage of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥8, ≥ 16, ≥ 32, ≥ 64, ≥128 at 4 Months After the 3-dose Vaccination Series	Men W, ≥ 16	66 Percentage of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥8, ≥ 16, ≥ 32, ≥ 64, ≥128 at 4 Months After the 3-dose Vaccination Series	Men A, ≥ 64	8 Percentage of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥8, ≥ 16, ≥ 32, ≥ 64, ≥128 at 4 Months After the 3-dose Vaccination Series	Men Y, ≥ 128	9 Percentage of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥8, ≥ 16, ≥ 32, ≥ 64, ≥128 at 4 Months After the 3-dose Vaccination Series	Men A, ≥128	7 Percentage of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥8, ≥ 16, ≥ 32, ≥ 64, ≥128 at 4 Months After the 3-dose Vaccination Series	Men W, ≥ 32	58 Percentage of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥8, ≥ 16, ≥ 32, ≥ 64, ≥128 at 4 Months After the 3-dose Vaccination Series	Men C, ≥ 8	65 Percentage of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥8, ≥ 16, ≥ 32, ≥ 64, ≥128 at 4 Months After the 3-dose Vaccination Series	Men Y, ≥ 16	51 Percentage of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥8, ≥ 16, ≥ 32, ≥ 64, ≥128 at 4 Months After the 3-dose Vaccination Series	Men C, ≥ 16	48 Percentage of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥8, ≥ 16, ≥ 32, ≥ 64, ≥128 at 4 Months After the 3-dose Vaccination Series	Men W, ≥ 64	36 Percentage of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥8, ≥ 16, ≥ 32, ≥ 64, ≥128 at 4 Months After the 3-dose Vaccination Series	Men C, ≥ 32	34 Percentage of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥8, ≥ 16, ≥ 32, ≥ 64, ≥128 at 4 Months After the 3-dose Vaccination Series	Men Y, ≥ 64	20 Percentage of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥8, ≥ 16, ≥ 32, ≥ 64, ≥128 at 4 Months After the 3-dose Vaccination Series	Men C, ≥ 64	26 Percentage of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥8, ≥ 16, ≥ 32, ≥ 64, ≥128 at 4 Months After the 3-dose Vaccination Series	Men W, ≥ 128	18 Percentage of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥8, ≥ 16, ≥ 32, ≥ 64, ≥128 at 4 Months After the 3-dose Vaccination Series	Men C, ≥ 128	16 Percentage of subjects

Secondary

Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥ LLQ at 1 Month After the 3- Dose Vaccination Series

The immunogenicity of three 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 1 month after the 3-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 Month 7 (1 month after the 3-dose vaccination series)

Arm	Measure	Group	Value (NUMBER)
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥ LLQ at 1 Month After the 3- Dose Vaccination Series	Men A	98 Percentages of subjects
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥ LLQ at 1 Month After the 3- Dose Vaccination Series	Men C	100 Percentages of subjects
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥ LLQ at 1 Month After the 3- Dose Vaccination Series	Men W	99 Percentages of subjects
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥ LLQ at 1 Month After the 3- Dose Vaccination Series	Men Y	100 Percentages of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥ LLQ at 1 Month After the 3- Dose Vaccination Series	Men Y	57 Percentages of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥ LLQ at 1 Month After the 3- Dose Vaccination Series	Men A	24 Percentages of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥ LLQ at 1 Month After the 3- Dose Vaccination Series	Men W	60 Percentages of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥ LLQ at 1 Month After the 3- Dose Vaccination Series	Men C	73 Percentages of subjects

Secondary

Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥ LLQ at 4 Months After the 3-dose Vaccination Series

The immunogenicity of three 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 4 months after the 3-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 Month 10 (4 months after the 3-dose vaccination series)

Arm	Measure	Group	Value (NUMBER)
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥ LLQ at 4 Months After the 3-dose Vaccination Series	Men A	81 Percentages of subjects
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥ LLQ at 4 Months After the 3-dose Vaccination Series	Men C	100 Percentages of subjects
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥ LLQ at 4 Months After the 3-dose Vaccination Series	Men W	89 Percentages of subjects
MenABCWY Group	Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥ LLQ at 4 Months After the 3-dose Vaccination Series	Men Y	86 Percentages of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥ LLQ at 4 Months After the 3-dose Vaccination Series	Men Y	53 Percentages of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥ LLQ at 4 Months After the 3-dose Vaccination Series	Men A	18 Percentages of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥ LLQ at 4 Months After the 3-dose Vaccination Series	Men W	51 Percentages of subjects
MenACWY Group	Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥ LLQ at 4 Months After the 3-dose Vaccination Series	Men C	69 Percentages 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 3-dose Vaccination Series.

The effectiveness of three doses of MenABCWY vaccine when compared to one dose of MenACWY vaccine against a panel of US N. meningitidis serogroup B invasive disease strains at 4 months after the 3-dose vaccination series was evaluated in terms of: the combined percentage of subjects without bactericidal activity at 1:4 dilution using the hSBA against each strain in MenABCWY Group and MenACWY Group. The data provided is an average of the percentage of subjects without bactericidal activity at 1:4 dilution across all 110 strains.

Time frame: At Month 10 (4 months after the 3-dose vaccination series)

Population: Analysis was performed on FAS-Effectiveness (Month 10)- included all screened subjects who provided informed consent \& demographic \&/or baseline screening assessments, received a subject ID \& vaccination, \& provided evaluable serum sample with the enc-hSBA result for at least 1 endemic N. meningitidis serogroup B invasive disease strain at Month 10

Arm	Measure	Value (NUMBER)
MenABCWY Group	Percentages of Subjects Without Bactericidal Activity at 1:4 Dilution Against Each US N. Meningitidis Serogroup B Strain at 4 Months After the 3-dose Vaccination Series.	33.9 Percentages of subjects
MenACWY Group	Percentages of Subjects Without Bactericidal Activity at 1:4 Dilution Against Each US N. Meningitidis Serogroup B Strain at 4 Months After the 3-dose Vaccination Series.	69.9 Percentages of subjects

Comparison: The Vaccine Effectiveness (VE) at 4 months after the 3-dose vaccination series for each strain is defined as \[1 - (percentage of subjects without bactericidal activity at 1:4 dilution in MenABCWY group/percentage of subjects without bactericidal activity at 1:4 dilution in MenACWY group)\] x 100. The combined VE across all strains was computed by mean of a generalized linear model.p-value: 0.000195% CI: [48, 55]Generalized Linear Model

Secondary

Percentages of Subjects Without Bactericidal Activity at 1:8 Dilution Against Each US N. Meningitidis Serogroup B Strain at 1 and 4 Months After the 3-dose Vaccination Series.

The effectiveness of three doses of MenABCWY vaccine when compared to one dose of MenACWY vaccine against a panel of US N. meningitidis serogroup B invasive disease strains at 1 and 4 months after the 3-dose vaccination series were evaluated in terms of: the combined percentage of subjects without bactericidal activity at 1:8 dilution using the hSBA against each strain in MenABCWY Group and MenACWY Group. The data provided is an average of the percentage of subjects without bactericidal activity at 1:8 dilution across all 110 strains.

Time frame: At Months 7 and 10 (1 and 4 months after the 3-dose vaccination series)

Population: Analysis was performed on FAS-Effectiveness (Months 7 \& 10)- included all screened subjects who provided consent \& demographic \&/or baseline screening assessments, received subject ID \& vaccination, \& provided evaluable serum sample with the enc-hSBA result for at least 1 endemic N. meningitidis serogroup B invasive disease strain at Months 7 \& 10.

Arm	Measure	Group	Value (NUMBER)
MenABCWY Group	Percentages of Subjects Without Bactericidal Activity at 1:8 Dilution Against Each US N. Meningitidis Serogroup B Strain at 1 and 4 Months After the 3-dose Vaccination Series.	Combined Serogroup B Strains (Month 7)	36.9 Percentages of subjects
MenABCWY Group	Percentages of Subjects Without Bactericidal Activity at 1:8 Dilution Against Each US N. Meningitidis Serogroup B Strain at 1 and 4 Months After the 3-dose Vaccination Series.	Combined Serogroup B Strains (Month 10)	60.3 Percentages of subjects
MenACWY Group	Percentages of Subjects Without Bactericidal Activity at 1:8 Dilution Against Each US N. Meningitidis Serogroup B Strain at 1 and 4 Months After the 3-dose Vaccination Series.	Combined Serogroup B Strains (Month 7)	75.8 Percentages of subjects
MenACWY Group	Percentages of Subjects Without Bactericidal Activity at 1:8 Dilution Against Each US N. Meningitidis Serogroup B Strain at 1 and 4 Months After the 3-dose Vaccination Series.	Combined Serogroup B Strains (Month 10)	79.6 Percentages of subjects

Comparison: The Vaccine Effectiveness (VE) at 1 month after the 3-dose vaccination series for each strain is defined as \[1 - (percentage of subjects without bactericidal activity at 1:8 dilution in MenABCWY group/percentage of subjects without bactericidal activity at 1:8 dilution in MenACWY group)\] x 100. The combined VE across all strains was computed by mean of a generalized linear model.p-value: 0.000195% CI: [48, 54]Generalized Linear Model

Comparison: The Vaccine Effectiveness (VE) at 4 months after the 3-dose vaccination series for each strain is defined as \[1 - (percentage of subjects without bactericidal activity at 1:8 dilution in MenABCWY group/percentage of subjects without bactericidal activity at 1:8 dilution in MenACWY group)\] x 100. The combined VE across all strains was computed by mean of a generalized linear model.p-value: 0.000195% CI: [20, 28]Generalized Linear Model

Secondary

Percentages of US N. Meningitidis Serogroup B Strains Killed at 1:4 and 1:8 Dilutions at 1 and 4 Months After the 3-dose Vaccination Series

The mean percentage of US N. meningitidis serogroup B strains killed by each subject, at 1:4 and 1:8 dilutions before the 3-dose vaccination series, at Month 6 (PRE) and at 1 and 4 months after the 3-dose vaccination series (Month 7 and Month 10).

Time frame: At Month 6 (before the 3-dose vaccination series) and at Months 7 and 10 (1 and 4 months after the 3-dose vaccination series)

Population: Analysis was performed on FAS-Effectiveness (Months 6, 7 \& 10)- included all screened subjects who provided consent \& demographic \&/or baseline screening assessments, got subject ID \& vaccination, \& provided serum sample with enc-hSBA result for at least 1 endemic N. meningitidis serogroup B invasive disease strain before Month 6 \& at Months 7 \& 10

Arm	Measure	Group	Value (MEAN)	Dispersion
MenABCWY Group	Percentages of US N. Meningitidis Serogroup B Strains Killed at 1:4 and 1:8 Dilutions at 1 and 4 Months After the 3-dose Vaccination Series	1:4, PRE	56.97 Percentage	Standard Deviation 18.134
MenABCWY Group	Percentages of US N. Meningitidis Serogroup B Strains Killed at 1:4 and 1:8 Dilutions at 1 and 4 Months After the 3-dose Vaccination Series	1:4, Month 7	77.78 Percentage	Standard Deviation 10.041
MenABCWY Group	Percentages of US N. Meningitidis Serogroup B Strains Killed at 1:4 and 1:8 Dilutions at 1 and 4 Months After the 3-dose Vaccination Series	1:4, Month 10	62.37 Percentage	Standard Deviation 15.976
MenABCWY Group	Percentages of US N. Meningitidis Serogroup B Strains Killed at 1:4 and 1:8 Dilutions at 1 and 4 Months After the 3-dose Vaccination Series	1:8, PRE	28.81 Percentage	Standard Deviation 17.086
MenABCWY Group	Percentages of US N. Meningitidis Serogroup B Strains Killed at 1:4 and 1:8 Dilutions at 1 and 4 Months After the 3-dose Vaccination Series	1:8, Month 7	56.95 Percentage	Standard Deviation 14.389
MenABCWY Group	Percentages of US N. Meningitidis Serogroup B Strains Killed at 1:4 and 1:8 Dilutions at 1 and 4 Months After the 3-dose Vaccination Series	1:8, Month 10	31.46 Percentage	Standard Deviation 19.434
MenACWY Group	Percentages of US N. Meningitidis Serogroup B Strains Killed at 1:4 and 1:8 Dilutions at 1 and 4 Months After the 3-dose Vaccination Series	1:8, Month 7	11.4 Percentage	Standard Deviation 11.266
MenACWY Group	Percentages of US N. Meningitidis Serogroup B Strains Killed at 1:4 and 1:8 Dilutions at 1 and 4 Months After the 3-dose Vaccination Series	1:4, PRE	22.94 Percentage	Standard Deviation 17.764
MenACWY Group	Percentages of US N. Meningitidis Serogroup B Strains Killed at 1:4 and 1:8 Dilutions at 1 and 4 Months After the 3-dose Vaccination Series	1:8, PRE	11.53 Percentage	Standard Deviation 11.705
MenACWY Group	Percentages of US N. Meningitidis Serogroup B Strains Killed at 1:4 and 1:8 Dilutions at 1 and 4 Months After the 3-dose Vaccination Series	1:4, Month 7	21.91 Percentage	Standard Deviation 16.885
MenACWY Group	Percentages of US N. Meningitidis Serogroup B Strains Killed at 1:4 and 1:8 Dilutions at 1 and 4 Months After the 3-dose Vaccination Series	1:8, Month 10	11.15 Percentage	Standard Deviation 10.774
MenACWY Group	Percentages of US N. Meningitidis Serogroup B Strains Killed at 1:4 and 1:8 Dilutions at 1 and 4 Months After the 3-dose Vaccination Series	1:4, Month 10	22.49 Percentage	Standard Deviation 17.094

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

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

Conditions

Brief summary

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Interventions

Sponsors

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

Percentages of Subjects Without Bactericidal Activity at 1:4 Dilution Against Each US Neisseria Meningitides (N. Meningitidis) Serogroup B Strain at 1 Month After the 3-dose Vaccination Series.

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

HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W and Y.

Number of Subjects Reporting Any Serious Adverse Events (SAEs), Medically-attended AEs and AEs Leading to Premature Withdrawal.

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

Number of Subjects Reporting Any Unsolicited AEs

Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroups A, C, W and Y at 1 and 4 Months After the 3-dose Vaccination Series.

Percentage of Subjects With Three-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroups A, C, W and Y at 1 and 4 Months After the 3-dose Vaccination Series.

Percentage of Subjects With Two-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroups A, C,W and Y at 1 and 4 Months After the 3-dose Vaccination Series.

Percentages of Subjects With a Four-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroup B Test Strains at 1 and 4 Months After the 3-dose Vaccination Series.

Percentages of Subjects With a Three-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroup B Test Strains at 1 and 4 Months After the 3-dose Vaccination Series.

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 3-dose Vaccination Series.

Percentages of Subjects With Enc-hSBA ≥ 1:4 and Enc-hSBA ≥1:8 at 1 and 4 Months After the 3-dose Vaccination Series

Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 1 Month After the 3-dose Vaccination Series

Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 4 Months After the 3-dose Vaccination Series

Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains ≥ LLQ at 4 Months After the 3-dose Vaccination Series

Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains ≥ Lower Limit of Quantitation (LLQ) at 1 Month After the 3-dose Vaccination Series.

Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥128 at 1 Month After the 3- Dose Vaccination Series

Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥8, ≥ 16, ≥ 32, ≥ 64, ≥128 at 4 Months After the 3-dose Vaccination Series

Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥ LLQ at 1 Month After the 3- Dose Vaccination Series

Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥ LLQ at 4 Months After the 3-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 3-dose Vaccination Series.

Percentages of Subjects Without Bactericidal Activity at 1:8 Dilution Against Each US N. Meningitidis Serogroup B Strain at 1 and 4 Months After the 3-dose Vaccination Series.

Percentages of US N. Meningitidis Serogroup B Strains Killed at 1:4 and 1:8 Dilutions at 1 and 4 Months After the 3-dose Vaccination Series