Trial Outcomes & Findings for Assessing the Effectiveness, Immunogenicity and Safety of Meningococcal ABCWY Vaccine Administered to Healthy Adolescents (NCT NCT02285777)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

189 participants

Primary outcome timeframe

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

Results posted on

2018-09-24

Participant Flow

189 subjects were enrolled from 1 center in United States

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.

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	95	94
Overall Study COMPLETED	90	91
Overall Study NOT COMPLETED	5	3

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Overall Study Withdrawal by Subject	1	1
Overall Study Lost to Follow-up	4	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MenABCWY Group n=95 Participants Subjects who received 2 doses of MenABCWY vaccine in the parent study and a 3rd dose of MenABCWY vaccine in the current study.	MenACWY Group n=94 Participants 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.	Total n=189 Participants Total of all reporting groups
Age, Continuous	12.8 Years STANDARD_DEVIATION 2.36 • n=93 Participants	12.4 Years STANDARD_DEVIATION 2.4 • n=4 Participants	12.6 Years STANDARD_DEVIATION 2.38 • n=27 Participants
Sex: Female, Male Female	40 Participants n=93 Participants	33 Participants n=4 Participants	73 Participants n=27 Participants
Sex: Female, Male Male	55 Participants n=93 Participants	61 Participants n=4 Participants	116 Participants n=27 Participants
Race/Ethnicity, Customized AMERICAN INDIAN OR ALASKA NATIVE	0 Participants n=93 Participants	2 Participants n=4 Participants	2 Participants n=27 Participants
Race/Ethnicity, Customized ASIAN	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race/Ethnicity, Customized BLACK OR AFRICAN AMERICAN	16 Participants n=93 Participants	21 Participants n=4 Participants	37 Participants n=27 Participants
Race/Ethnicity, Customized NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race/Ethnicity, Customized WHITE	74 Participants n=93 Participants	66 Participants n=4 Participants	140 Participants n=27 Participants
Race/Ethnicity, Customized OTHER	4 Participants n=93 Participants	5 Participants n=4 Participants	9 Participants n=27 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	MenACWY Group n=93 Participants 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.	MenABCWY Group n=93 Participants Subjects who received 2 doses of MenABCWY vaccine in the parent study and a 3rd dose of MenABCWY vaccine in the current study.
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	21.1 Percentages of subjects

SECONDARY outcome

Timeframe: 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

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.

Outcome measures

Outcome measures
Measure	MenACWY Group n=90 Participants 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.	MenABCWY Group n=90 Participants Subjects who received 2 doses of MenABCWY vaccine in the parent study and a 3rd dose of MenABCWY vaccine in the current study.
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	33.9 Percentages of subjects

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	MenACWY Group n=93 Participants 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.	MenABCWY Group n=93 Participants Subjects who received 2 doses of MenABCWY vaccine in the parent study and a 3rd dose of MenABCWY vaccine in the current study.
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	36.9 Percentages of subjects
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	60.3 Percentages of subjects

SECONDARY outcome

Timeframe: 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

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).

Outcome measures

Outcome measures
Measure	MenACWY Group n=93 Participants 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.	MenABCWY Group n=93 Participants Subjects who received 2 doses of MenABCWY vaccine in the parent study and a 3rd dose of MenABCWY vaccine in the current study.
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	62.37 Percentage Standard Deviation 15.976
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	56.97 Percentage Standard Deviation 18.134
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	77.78 Percentage Standard Deviation 10.041
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	28.81 Percentage Standard Deviation 17.086
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	56.95 Percentage Standard Deviation 14.389
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	31.46 Percentage Standard Deviation 19.434

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	MenACWY Group n=91 Participants 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.	MenABCWY Group n=92 Participants Subjects who received 2 doses of MenABCWY vaccine in the parent study and a 3rd dose of MenABCWY vaccine in the current study.
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 Interval 6.3 to 20.8	98 Percentages of subjects Interval 92.3 to 99.73
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 Interval 6.3 to 20.8	72 Percentages of subjects Interval 61.8 to 81.5
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 Interval 0.27 to 7.8	67 Percentages of subjects Interval 56.4 to 76.5
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 Interval 0.03 to 6.0	21 Percentages of subjects Interval 12.7 to 30.7
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 Interval 13.1 to 31.4	81 Percentages of subjects Interval 71.5 to 88.6
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 Interval 13.2 to 32.6	46 Percentages of subjects Interval 34.3 to 57.2
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 Interval 1.3 to 11.6	38 Percentages of subjects Interval 27.8 to 48.6
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 Interval 2.1 to 14.3	11 Percentages of subjects Interval 5.3 to 20.5
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 Interval 37.0 to 58.6	99 Percentages of subjects Interval 93.9 to 99.97
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 Interval 30.5 to 51.9	100 Percentages of subjects Interval 95.8 to 100.0
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 Interval 9.9 to 26.6	99 Percentages of subjects Interval 93.9 to 99.97
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 Interval 9.0 to 25.2	99 Percentages of subjects Interval 93.8 to 99.97
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 Interval 0.03 to 6.2	76 Percentages of subjects Interval 65.7 to 84.8
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 Interval 0.03 to 6.5	34 Percentages of subjects Interval 23.6 to 45.2
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 Interval 0.03 to 6.2	39 Percentages of subjects Interval 28.8 to 50.5
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 Interval 0.0 to 4.3	4 Percentages of subjects Interval 0.8 to 10.6

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	MenACWY Group n=91 Participants 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.	MenABCWY Group n=91 Participants Subjects who received 2 doses of MenABCWY vaccine in the parent study and a 3rd dose of MenABCWY vaccine in the current study.
HT-hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroup B Test Strains M07-0241084, Month 10	1.68 Titers Interval 1.31 to 2.14	3.04 Titers Interval 2.36 to 3.92
HT-hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroup B Test Strains M14459, Month 7	1.1 Titers Interval 0.94 to 1.29	23.12 Titers Interval 20.0 to 27.0
HT-hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroup B Test Strains M14459, Month 10	1.18 Titers Interval 0.95 to 1.46	3.93 Titers Interval 3.14 to 4.91
HT-hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroup B Test Strains M07-0241084, Month 7	1.74 Titers Interval 1.37 to 2.2	12.26 Titers Interval 9.59 to 16.0
HT-hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroup B Test Strains 96217, Month 7	4.02 Titers Interval 3.03 to 5.32	367.29 Titers Interval 277.0 to 486.0
HT-hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroup B Test Strains 96217, Month 10	3.32 Titers Interval 2.46 to 4.48	142.06 Titers Interval 105.0 to 191.0
HT-hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroup B Test Strains NZ98/254, Month 7	1.02 Titers Interval 0.85 to 1.23	19.69 Titers Interval 16.0 to 24.0
HT-hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroup B Test Strains NZ98/254, Month 10	1.04 Titers Interval 0.84 to 1.29	3.75 Titers Interval 3.01 to 4.68

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	MenACWY Group n=90 Participants 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.	MenABCWY Group n=91 Participants Subjects who received 2 doses of MenABCWY vaccine in the parent study and a 3rd dose of MenABCWY vaccine in the current study.
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 Interval 6.3 to 20.8	63 Percentages of subjects Interval 52.0 to 72.9
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 Interval 0.03 to 6.2	90 Percentages of subjects Interval 82.1 to 95.4
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 Interval 0.03 to 6.1	79 Percentages of subjects Interval 68.7 to 86.6
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 Interval 26.7 to 47.8	100 Percentages of subjects Interval 96.0 to 100.0

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	MenACWY Group n=91 Participants 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.	MenABCWY Group n=88 Participants Subjects who received 2 doses of MenABCWY vaccine in the parent study and a 3rd dose of MenABCWY vaccine in the current study.
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 Interval 22.1 to 42.8	99 Percentages of subjects Interval 93.8 to 99.97
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 Interval 6.3 to 20.8	23 Percentages of subjects Interval 14.8 to 33.6
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 Interval 0.7 to 9.3	36 Percentages of subjects Interval 26.4 to 47.3
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 Interval 0.03 to 6.0	33 Percentages of subjects Interval 23.6 to 44.3

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	MenACWY Group n=90 Participants 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.	MenABCWY Group n=90 Participants Subjects who received 2 doses of MenABCWY vaccine in the parent study and a 3rd dose of MenABCWY vaccine in the current study.
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 Interval 5.7 to 20.4	87 Percentage of subjects Interval 78.5 to 93.5
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 Interval 0.03 to 6.4	38 Percentage of subjects Interval 27.7 to 49.3
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 Interval 0.0 to 4.1	67 Percentage of subjects Interval 56.0 to 76.3
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 Interval 0.0 to 4.1	56 Percentage of subjects Interval 44.7 to 66.3
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 Interval 2.7 to 14.9	54 Percentage of subjects Interval 42.4 to 64.5
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 Interval 0.7 to 10.0	0 Percentage of subjects Interval 0.0 to 4.4
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 Interval 0.0 to 4.0	7 Percentage of subjects Interval 2.6 to 14.4
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 Interval 0.0 to 4.1	13 Percentage of subjects Interval 6.6 to 21.7

SECONDARY outcome

Timeframe: At months 7 and 10 (1 and 4 months after 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.

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.

Outcome measures

Outcome measures
Measure	MenACWY Group n=90 Participants 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.	MenABCWY Group n=90 Participants Subjects who received 2 doses of MenABCWY vaccine in the parent study and a 3rd dose of MenABCWY vaccine in the current study.
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 Interval 1.3 to 11.5	79 Percentage of subjects Interval 69.3 to 87.3
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 Interval 0.03 to 6.4	23 Percentage of subjects Interval 14.2 to 33.1
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 Interval 0.0 to 4.1	41 Percentage of subjects Interval 30.8 to 52.0
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 Interval 0.0 to 4.1	41 Percentage of subjects Interval 30.5 to 51.9
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 Interval 1.3 to 11.8	27 Percentage of subjects Interval 18.2 to 38.2
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 Interval 0.29 to 8.2	0 Percentage of subjects Interval 0.0 to 4.4
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 Interval 0.0 to 4.0	3 Percentage of subjects Interval 0.7 to 9.8
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 Interval 0.0 to 4.1	5 Percentage of subjects Interval 1.3 to 11.5

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	MenACWY Group n=90 Participants 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.	MenABCWY Group n=90 Participants Subjects who received 2 doses of MenABCWY vaccine in the parent study and a 3rd dose of MenABCWY vaccine in the current study.
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 Interval 0.0 to 4.2	12 Percentages of subjects Interval 5.9 to 20.8
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 Interval 0.7 to 9.9	63 Percentages of subjects Interval 52.2 to 73.3
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 Interval 0.0 to 4.1	23 Percentages of subjects Interval 15.1 to 33.4
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 Interval 0.0 to 4.1	33 Percentages of subjects Interval 23.3 to 43.8
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 Interval 1.3 to 11.8	15 Percentages of subjects Interval 8.5 to 25.0
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 Interval 0.03 to 6.4	0 Percentages of subjects Interval 0.0 to 4.4
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 Interval 0.0 to 4.0	3 Percentages of subjects Interval 0.7 to 9.8
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 Interval 0.0 to 4.1	2 Percentages of subjects Interval 0.28 to 8.2

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	MenACWY Group n=91 Participants 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.	MenABCWY Group n=91 Participants Subjects who received 2 doses of MenABCWY vaccine in the parent study and a 3rd dose of MenABCWY vaccine in the current study.
HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W and Y. Men A, Month 7	3.37 Titers Interval 2.41 to 4.73	127.92 Titers Interval 91.0 to 179.0
HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W and Y. Men A, Month 10	2.73 Titers Interval 1.89 to 3.94	36.5 Titers Interval 25.0 to 53.0
HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W and Y. Men C, Month 7	18.34 Titers Interval 13.0 to 26.0	521.64 Titers Interval 365.0 to 745.0
HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W and Y. Men C, Month 10	15.4 Titers Interval 11.0 to 22.0	291.19 Titers Interval 201.0 to 421.0
HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W and Y. Men W, Month 7	40.22 Titers Interval 30.0 to 54.0	424.8 Titers Interval 310.0 to 581.0
HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W and Y. Men W, Month 10	23.01 Titers Interval 16.0 to 33.0	147.4 Titers Interval 104.0 to 209.0
HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W and Y. Men Y, Month 7	13.27 Titers Interval 9.21 to 19.0	204.84 Titers Interval 142.0 to 296.0
HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W and Y. Men Y, Month 10	11.85 Titers Interval 7.93 to 18.0	83.42 Titers Interval 55.0 to 126.0

SECONDARY outcome

Timeframe: 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 A, C, W and Y test strain.

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.

Outcome measures

Outcome measures
Measure	MenACWY Group n=88 Participants 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.	MenABCWY Group n=91 Participants Subjects who received 2 doses of MenABCWY vaccine in the parent study and a 3rd dose of MenABCWY vaccine in the current study.
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 Interval 15.6 to 34.5	98 Percentages of subjects Interval 92.3 to 99.73
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 Interval 62.6 to 82.2	100 Percentages of subjects Interval 95.8 to 100.0
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 Interval 49.2 to 70.5	99 Percentages of subjects Interval 93.5 to 99.97
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 Interval 45.8 to 67.3	100 Percentages of subjects Interval 96.0 to 100.0

SECONDARY outcome

Timeframe: 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 B strain

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.

Outcome measures

Outcome measures
Measure	MenACWY Group n=91 Participants 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.	MenABCWY Group n=86 Participants Subjects who received 2 doses of MenABCWY vaccine in the parent study and a 3rd dose of MenABCWY vaccine in the current study.
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 Interval 10.8 to 27.8	81 Percentages of subjects Interval 71.2 to 88.8
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 Interval 57.8 to 78.0	100 Percentages of subjects Interval 95.8 to 100.0
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 Interval 39.4 to 61.8	89 Percentages of subjects Interval 80.9 to 95.0
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 Interval 42.0 to 63.3	86 Percentages of subjects Interval 76.9 to 92.6

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	MenACWY Group n=88 Participants 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.	MenABCWY Group n=89 Participants Subjects who received 2 doses of MenABCWY vaccine in the parent study and a 3rd dose of MenABCWY vaccine in the current study.
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 Interval 0.03 to 6.9	24 Percentage of subjects Interval 15.4 to 34.7
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 Interval 0.7 to 9.6	26 Percentage of subjects Interval 17.2 to 36.9
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 Interval 0.29 to 8.2	88 Percentage of subjects Interval 79.0 to 94.1
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 Interval 0.29 to 8.3	87 Percentage of subjects Interval 77.8 to 93.3
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 Interval 1.3 to 11.8	83 Percentage of subjects Interval 72.7 to 90.2
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 Interval 0.29 to 8.2	57 Percentage of subjects Interval 46.4 to 67.7
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 Interval 0.03 to 6.3	32 Percentage of subjects Interval 22.2 to 44.1
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 Interval 3.3 to 15.9	56 Percentage of subjects Interval 45.3 to 67.2

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	MenACWY Group n=88 Participants 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.	MenABCWY Group n=89 Participants Subjects who received 2 doses of MenABCWY vaccine in the parent study and a 3rd dose of MenABCWY vaccine in the current study.
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 Interval 0.0 to 4.2	69 Percentage of subjects Interval 57.6 to 78.4
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 Interval 0.03 to 6.5	60 Percentage of subjects Interval 48.3 to 70.1
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 Interval 0.0 to 4.3	67 Percentage of subjects Interval 55.3 to 76.8
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 Interval 0.0 to 4.2	39 Percentage of subjects Interval 29.1 to 50.3
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 Interval 0.03 to 6.3	16 Percentage of subjects Interval 8.3 to 25.6
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 Interval 1.3 to 11.4	29 Percentage of subjects Interval 20.0 to 40.3
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 Interval 0.0 to 4.6	13 Percentage of subjects Interval 6.8 to 22.5
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 Interval 0.28 to 8.0	15 Percentage of subjects Interval 8.5 to 25.0

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	MenACWY Group n=88 Participants 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.	MenABCWY Group n=89 Participants Subjects who received 2 doses of MenABCWY vaccine in the parent study and a 3rd dose of MenABCWY vaccine in the current study.
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 Interval 0.0 to 4.2	53 Percentage of subjects Interval 41.7 to 64.1
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 Interval 0.03 to 6.5	49 Percentage of subjects Interval 37.7 to 60.0
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 Interval 0.0 to 4.3	49 Percentage of subjects Interval 38.1 to 60.7
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 Interval 0.0 to 4.2	28 Percentage of subjects Interval 19.1 to 38.6
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 Interval 0.03 to 6.3	6 Percentage of subjects Interval 2.1 to 14.5
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 Interval 0.28 to 8.1	21 Percentage of subjects Interval 13.1 to 31.4
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 Interval 0.0 to 4.6	8 Percentage of subjects Interval 3.5 to 16.6
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 Interval 0.03 to 6.2	6 Percentage of subjects Interval 2.0 to 13.4

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	MenACWY Group n=90 Participants 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.	MenABCWY Group n=91 Participants Subjects who received 2 doses of MenABCWY vaccine in the parent study and a 3rd dose of MenABCWY vaccine in the current study.
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 Interval 27.7 to 49.0	100 Percentage of subjects Interval 96.0 to 100.0
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 Interval 26.7 to 47.8	100 Percentage of subjects Interval 96.0 to 100.0
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 Interval 16.6 to 35.7	100 Percentage of subjects Interval 96.0 to 100.0
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 Interval 8.2 to 24.2	100 Percentage of subjects Interval 96.0 to 100.0
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 Interval 3.3 to 15.9	99 Percentage of subjects Interval 94.0 to 99.97
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 Interval 0.7 to 9.7	93 Percentage of subjects Interval 86.1 to 97.5
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 Interval 8.8 to 24.7	82 Percentage of subjects Interval 72.5 to 89.4
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 Interval 6.3 to 20.8	67 Percentage of subjects Interval 56.7 to 77.0
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 Interval 3.2 to 15.4	46 Percentage of subjects Interval 35.4 to 57.0
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 Interval 0.7 to 9.4	20 Percentage of subjects Interval 12.4 to 30.1
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 Interval 0.27 to 7.8	6 Percentage of subjects Interval 1.8 to 12.6
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 Interval 0.0 to 4.0	0 Percentage of subjects Interval 0.0 to 4.1
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 Interval 0.03 to 6.2	95 Percentage of subjects Interval 87.6 to 98.2
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 Interval 0.03 to 6.2	90 Percentage of subjects Interval 82.1 to 95.4
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 Interval 0.03 to 6.2	71 Percentage of subjects Interval 61.0 to 80.4
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 Interval 0.03 to 6.2	34 Percentage of subjects Interval 24.5 to 44.7
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 Interval 0.0 to 4.1	11 Percentage of subjects Interval 5.4 to 19.3
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 Interval 0.0 to 4.1	3 Percentage of subjects Interval 0.7 to 9.3
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 Interval 0.03 to 6.1	89 Percentage of subjects Interval 80.3 to 94.5
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 Interval 0.03 to 6.1	79 Percentage of subjects Interval 68.7 to 86.6
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 Interval 0.0 to 4.1	61 Percentage of subjects Interval 49.7 to 70.9
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 Interval 0.0 to 4.1	37 Percentage of subjects Interval 27.1 to 48.0
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 Interval 0.0 to 4.1	10 Percentage of subjects Interval 4.7 to 18.3
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 Interval 0.0 to 4.1	4 Percentage of subjects Interval 1.2 to 11.1

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	MenACWY Group n=91 Participants 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.	MenABCWY Group n=88 Participants Subjects who received 2 doses of MenABCWY vaccine in the parent study and a 3rd dose of MenABCWY vaccine in the current study.
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 Interval 25.2 to 46.4	99 Percentage of subjects Interval 93.8 to 99.97
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 Interval 23.1 to 44.0	99 Percentage of subjects Interval 93.8 to 99.97
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 Interval 13.1 to 31.4	98 Percentage of subjects Interval 91.9 to 99.72
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 Interval 9.3 to 26.1	94 Percentage of subjects Interval 87.1 to 98.1
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 Interval 1.9 to 13.2	85 Percentage of subjects Interval 75.8 to 91.8
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 Interval 0.29 to 8.2	56 Percentage of subjects Interval 45.3 to 66.9
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 Interval 9.6 to 26.0	38 Percentage of subjects Interval 28.1 to 49.5
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 Interval 6.3 to 20.8	24 Percentage of subjects Interval 15.8 to 34.9
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 Interval 3.9 to 16.8	9 Percentage of subjects Interval 4.1 to 17.5
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 Interval 0.7 to 9.4	1 Percentage of subjects Interval 0.03 to 6.3
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 Interval 0.27 to 7.8	1 Percentage of subjects Interval 0.03 to 6.3
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 Interval 0.03 to 6.0	0 Percentage of subjects Interval 0.0 to 4.2
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 Interval 1.2 to 10.9	49 Percentage of subjects Interval 38.1 to 59.8
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 Interval 0.7 to 9.3	36 Percentage of subjects Interval 26.4 to 47.3
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 Interval 0.03 to 6.0	17 Percentage of subjects Interval 9.9 to 26.6
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 Interval 0.0 to 4.0	6 Percentage of subjects Interval 1.9 to 12.8
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 Interval 0.0 to 4.0	1 Percentage of subjects Interval 0.03 to 6.2
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 Interval 0.0 to 4.0	0 Percentage of subjects Interval 0.0 to 4.1
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 Interval 0.03 to 6.0	44 Percentage of subjects Interval 33.1 to 54.7
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 Interval 0.03 to 6.0	34 Percentage of subjects Interval 24.6 to 45.4
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 Interval 0.0 to 4.0	16 Percentage of subjects Interval 9.1 to 25.5
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 Interval 0.0 to 4.0	5 Percentage of subjects Interval 1.3 to 11.4
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 Interval 0.0 to 4.0	2 Percentage of subjects Interval 0.28 to 8.1
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 Interval 0.0 to 4.0	2 Percentage of subjects Interval 0.28 to 8.1

SECONDARY outcome

Timeframe: 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 A, C, W and Y test strain.

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.

Outcome measures

Outcome measures
Measure	MenACWY Group n=88 Participants 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.	MenABCWY Group n=91 Participants Subjects who received 2 doses of MenABCWY vaccine in the parent study and a 3rd dose of MenABCWY vaccine in the current study.
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 Interval 20.5 to 40.6	98 Percentage of subjects Interval 92.3 to 99.73
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 Interval 17.6 to 37.0	98 Percentage of subjects Interval 92.3 to 99.73
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 Interval 13.7 to 32.0	98 Percentage of subjects Interval 92.3 to 99.73
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 Interval 6.5 to 21.5	86 Percentage of subjects Interval 76.8 to 92.2
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 Interval 3.3 to 15.9	56 Percentage of subjects Interval 45.2 to 66.4
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 Interval 60.1 to 80.2	100 Percentage of subjects Interval 95.8 to 100.0
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 Interval 40.1 to 62.1	99 Percentage of subjects Interval 93.6 to 99.97
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 Interval 22.8 to 43.5	99 Percentage of subjects Interval 93.6 to 99.97
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 Interval 16.8 to 36.1	99 Percentage of subjects Interval 93.6 to 99.97
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 Interval 11.0 to 28.4	91 Percentage of subjects Interval 82.3 to 95.8
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 Interval 77.4 to 92.8	100 Percentage of subjects Interval 95.7 to 100.0
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 Interval 67.1 to 85.5	100 Percentage of subjects Interval 95.7 to 100.0
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 Interval 50.4 to 71.6	99 Percentage of subjects Interval 93.5 to 99.97
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 Interval 34.8 to 56.4	99 Percentage of subjects Interval 93.5 to 99.97
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 Interval 15.4 to 34.1	89 Percentage of subjects Interval 80.4 to 94.9
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 Interval 50.4 to 71.6	100 Percentage of subjects Interval 96.0 to 100.0
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 Interval 44.7 to 66.3	100 Percentage of subjects Interval 96.0 to 100.0
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 Interval 33.7 to 55.3	95 Percentage of subjects Interval 87.6 to 98.2
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 Interval 18.3 to 37.8	81 Percentage of subjects Interval 71.8 to 88.7
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 Interval 7.2 to 22.6	65 Percentage of subjects Interval 54.1 to 74.6

SECONDARY outcome

Timeframe: 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 A, C, W and Y test strain.

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.

Outcome measures

Outcome measures
Measure	MenACWY Group n=91 Participants 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.	MenABCWY Group n=86 Participants Subjects who received 2 doses of MenABCWY vaccine in the parent study and a 3rd dose of MenABCWY vaccine in the current study.
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 Interval 47.4 to 68.5	91 Percentage of subjects Interval 82.5 to 95.9
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 Interval 16.4 to 35.4	86 Percentage of subjects Interval 76.6 to 92.5
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 Interval 14.5 to 32.9	84 Percentage of subjects Interval 73.9 to 90.7
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 Interval 10.8 to 27.8	72 Percentage of subjects Interval 61.0 to 81.0
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 Interval 3.3 to 15.7	46 Percentage of subjects Interval 35.0 to 57.0
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 Interval 2.5 to 14.3	14 Percentage of subjects Interval 7.5 to 23.4
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 Interval 54.3 to 75.0	100 Percentage of subjects Interval 95.8 to 100.0
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 Interval 37.6 to 59.2	98 Percentage of subjects Interval 91.9 to 99.72
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 Interval 24.0 to 44.5	97 Percentage of subjects Interval 90.1 to 99.3
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 Interval 17.1 to 36.2	86 Percentage of subjects Interval 76.9 to 92.6
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 Interval 8.9 to 25.0	74 Percentage of subjects Interval 63.9 to 83.2
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 Interval 64.0 to 83.6	99 Percentage of subjects Interval 93.6 to 99.97
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 Interval 55.1 to 76.3	98 Percentage of subjects Interval 91.8 to 99.71
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 Interval 46.5 to 68.6	94 Percentage of subjects Interval 86.8 to 98.1
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 Interval 25.9 to 47.4	75 Percentage of subjects Interval 64.7 to 84.0
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 Interval 10.5 to 28.0	52 Percentage of subjects Interval 40.7 to 62.7
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 Interval 39.9 to 61.2	86 Percentage of subjects Interval 76.9 to 92.6
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 Interval 28.4 to 49.2	77 Percentage of subjects Interval 66.4 to 85.2
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 Interval 12.2 to 29.4	62 Percentage of subjects Interval 50.5 to 71.9
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 Interval 3.9 to 16.6	40 Percentage of subjects Interval 29.2 to 50.7

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	MenACWY Group n=87 Participants 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.	MenABCWY Group n=90 Participants Subjects who received 2 doses of MenABCWY vaccine in the parent study and a 3rd dose of MenABCWY vaccine in the current study.
Number of Subjects Reporting Any Solicited Local or Systemic Adverse Events (AEs) Any	25 Participants	62 Participants
Number of Subjects Reporting Any Solicited Local or Systemic Adverse Events (AEs) Any Local Reactions	15 Participants	60 Participants
Number of Subjects Reporting Any Solicited Local or Systemic Adverse Events (AEs) Any Systemic Reactions	15 Participants	27 Participants
Number of Subjects Reporting Any Solicited Local or Systemic Adverse Events (AEs) Induration (mm)	0 Participants	6 Participants
Number of Subjects Reporting Any Solicited Local or Systemic Adverse Events (AEs) Erythema (mm)	0 Participants	6 Participants
Number of Subjects Reporting Any Solicited Local or Systemic Adverse Events (AEs) Pain	15 Participants	59 Participants
Number of Subjects Reporting Any Solicited Local or Systemic Adverse Events (AEs) Nausea	5 Participants	5 Participants
Number of Subjects Reporting Any Solicited Local or Systemic Adverse Events (AEs) Fatigue	11 Participants	14 Participants
Number of Subjects Reporting Any Solicited Local or Systemic Adverse Events (AEs) Myalgia	3 Participants	13 Participants
Number of Subjects Reporting Any Solicited Local or Systemic Adverse Events (AEs) Arthralgia	0 Participants	9 Participants
Number of Subjects Reporting Any Solicited Local or Systemic Adverse Events (AEs) Headache	9 Participants	13 Participants
Number of Subjects Reporting Any Solicited Local or Systemic Adverse Events (AEs) Fever	1 Participants	0 Participants
Number of Subjects Reporting Any Solicited Local or Systemic Adverse Events (AEs) Chills	3 Participants	2 Participants
Number of Subjects Reporting Any Solicited Local or Systemic Adverse Events (AEs) Loss of appetite	3 Participants	3 Participants
Number of Subjects Reporting Any Solicited Local or Systemic Adverse Events (AEs) Prevention of pain/fever	0 Participants	0 Participants
Number of Subjects Reporting Any Solicited Local or Systemic Adverse Events (AEs) Treatment of pain/fever	3 Participants	12 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	MenACWY Group n=93 Participants 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.	MenABCWY Group n=93 Participants Subjects who received 2 doses of MenABCWY vaccine in the parent study and a 3rd dose of MenABCWY vaccine in the current study.
Number of Subjects Reporting Any Unsolicited AEs	11 Participants	14 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	MenACWY Group n=94 Participants 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.	MenABCWY Group n=95 Participants Subjects who received 2 doses of MenABCWY vaccine in the parent study and a 3rd dose of MenABCWY vaccine in the current study.
Number of Subjects Reporting Any Serious Adverse Events (SAEs), Medically-attended AEs and AEs Leading to Premature Withdrawal. Any SAEs	0 Participants	0 Participants
Number of Subjects Reporting Any Serious Adverse Events (SAEs), Medically-attended AEs and AEs Leading to Premature Withdrawal. Any Medically Attended AEs	20 Participants	14 Participants
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	0 Participants

Adverse Events

MenABCWY Group

Serious events: 0 serious events

Other events: 63 other events

Deaths: 0 deaths

MenACWY Group

Serious events: 0 serious events

Other events: 27 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	MenABCWY Group n=95 participants at risk Subjects who received 2 doses of MenABCWY vaccine in the parent study and a 3rd dose of MenABCWY vaccine in the current study.	MenACWY Group n=94 participants at risk 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.
Nervous system disorders Headache	15.1% 14/93 • Number of events 25 • Solicited local and general AEs were collected from Day 1 to Day 7. Unsolicited AEs were collected from Day 1 to Day 30. SAEs, medically-attended AEs and AEs leading to withdrawal are collected for the entire duration of the study (from Day 0 to Month 10). Data are presented in terms of number of subjects reporting AEs. The total number of subjects at risk for the frequent adverse events were analysed from the exposed set and the number of subjects at risk for each of the adverse event were analysed from the overall safety set. Therefore, the number of subjects at risk for each adverse event is lesser than the total number of subjects at risk.	9.7% 9/93 • Number of events 27 • Solicited local and general AEs were collected from Day 1 to Day 7. Unsolicited AEs were collected from Day 1 to Day 30. SAEs, medically-attended AEs and AEs leading to withdrawal are collected for the entire duration of the study (from Day 0 to Month 10). Data are presented in terms of number of subjects reporting AEs. The total number of subjects at risk for the frequent adverse events were analysed from the exposed set and the number of subjects at risk for each of the adverse event were analysed from the overall safety set. Therefore, the number of subjects at risk for each adverse event is lesser than the total number of subjects at risk.
General disorders Fatigue	15.1% 14/93 • Number of events 32 • Solicited local and general AEs were collected from Day 1 to Day 7. Unsolicited AEs were collected from Day 1 to Day 30. SAEs, medically-attended AEs and AEs leading to withdrawal are collected for the entire duration of the study (from Day 0 to Month 10). Data are presented in terms of number of subjects reporting AEs. The total number of subjects at risk for the frequent adverse events were analysed from the exposed set and the number of subjects at risk for each of the adverse event were analysed from the overall safety set. Therefore, the number of subjects at risk for each adverse event is lesser than the total number of subjects at risk.	11.8% 11/93 • Number of events 24 • Solicited local and general AEs were collected from Day 1 to Day 7. Unsolicited AEs were collected from Day 1 to Day 30. SAEs, medically-attended AEs and AEs leading to withdrawal are collected for the entire duration of the study (from Day 0 to Month 10). Data are presented in terms of number of subjects reporting AEs. The total number of subjects at risk for the frequent adverse events were analysed from the exposed set and the number of subjects at risk for each of the adverse event were analysed from the overall safety set. Therefore, the number of subjects at risk for each adverse event is lesser than the total number of subjects at risk.
General disorders Injection site erythema	17.2% 16/93 • Number of events 44 • Solicited local and general AEs were collected from Day 1 to Day 7. Unsolicited AEs were collected from Day 1 to Day 30. SAEs, medically-attended AEs and AEs leading to withdrawal are collected for the entire duration of the study (from Day 0 to Month 10). Data are presented in terms of number of subjects reporting AEs. The total number of subjects at risk for the frequent adverse events were analysed from the exposed set and the number of subjects at risk for each of the adverse event were analysed from the overall safety set. Therefore, the number of subjects at risk for each adverse event is lesser than the total number of subjects at risk.	4.3% 4/93 • Number of events 12 • Solicited local and general AEs were collected from Day 1 to Day 7. Unsolicited AEs were collected from Day 1 to Day 30. SAEs, medically-attended AEs and AEs leading to withdrawal are collected for the entire duration of the study (from Day 0 to Month 10). Data are presented in terms of number of subjects reporting AEs. The total number of subjects at risk for the frequent adverse events were analysed from the exposed set and the number of subjects at risk for each of the adverse event were analysed from the overall safety set. Therefore, the number of subjects at risk for each adverse event is lesser than the total number of subjects at risk.
General disorders Injection site induration	17.2% 16/93 • Number of events 57 • Solicited local and general AEs were collected from Day 1 to Day 7. Unsolicited AEs were collected from Day 1 to Day 30. SAEs, medically-attended AEs and AEs leading to withdrawal are collected for the entire duration of the study (from Day 0 to Month 10). Data are presented in terms of number of subjects reporting AEs. The total number of subjects at risk for the frequent adverse events were analysed from the exposed set and the number of subjects at risk for each of the adverse event were analysed from the overall safety set. Therefore, the number of subjects at risk for each adverse event is lesser than the total number of subjects at risk.	3.2% 3/93 • Number of events 10 • Solicited local and general AEs were collected from Day 1 to Day 7. Unsolicited AEs were collected from Day 1 to Day 30. SAEs, medically-attended AEs and AEs leading to withdrawal are collected for the entire duration of the study (from Day 0 to Month 10). Data are presented in terms of number of subjects reporting AEs. The total number of subjects at risk for the frequent adverse events were analysed from the exposed set and the number of subjects at risk for each of the adverse event were analysed from the overall safety set. Therefore, the number of subjects at risk for each adverse event is lesser than the total number of subjects at risk.
General disorders Injection site pain	64.5% 60/93 • Number of events 155 • Solicited local and general AEs were collected from Day 1 to Day 7. Unsolicited AEs were collected from Day 1 to Day 30. SAEs, medically-attended AEs and AEs leading to withdrawal are collected for the entire duration of the study (from Day 0 to Month 10). Data are presented in terms of number of subjects reporting AEs. The total number of subjects at risk for the frequent adverse events were analysed from the exposed set and the number of subjects at risk for each of the adverse event were analysed from the overall safety set. Therefore, the number of subjects at risk for each adverse event is lesser than the total number of subjects at risk.	16.1% 15/93 • Number of events 23 • Solicited local and general AEs were collected from Day 1 to Day 7. Unsolicited AEs were collected from Day 1 to Day 30. SAEs, medically-attended AEs and AEs leading to withdrawal are collected for the entire duration of the study (from Day 0 to Month 10). Data are presented in terms of number of subjects reporting AEs. The total number of subjects at risk for the frequent adverse events were analysed from the exposed set and the number of subjects at risk for each of the adverse event were analysed from the overall safety set. Therefore, the number of subjects at risk for each adverse event is lesser than the total number of subjects at risk.
Gastrointestinal disorders Nausea	5.4% 5/93 • Number of events 9 • Solicited local and general AEs were collected from Day 1 to Day 7. Unsolicited AEs were collected from Day 1 to Day 30. SAEs, medically-attended AEs and AEs leading to withdrawal are collected for the entire duration of the study (from Day 0 to Month 10). Data are presented in terms of number of subjects reporting AEs. The total number of subjects at risk for the frequent adverse events were analysed from the exposed set and the number of subjects at risk for each of the adverse event were analysed from the overall safety set. Therefore, the number of subjects at risk for each adverse event is lesser than the total number of subjects at risk.	5.4% 5/93 • Number of events 7 • Solicited local and general AEs were collected from Day 1 to Day 7. Unsolicited AEs were collected from Day 1 to Day 30. SAEs, medically-attended AEs and AEs leading to withdrawal are collected for the entire duration of the study (from Day 0 to Month 10). Data are presented in terms of number of subjects reporting AEs. The total number of subjects at risk for the frequent adverse events were analysed from the exposed set and the number of subjects at risk for each of the adverse event were analysed from the overall safety set. Therefore, the number of subjects at risk for each adverse event is lesser than the total number of subjects at risk.
Musculoskeletal and connective tissue disorders Arthralgia	9.7% 9/93 • Number of events 21 • Solicited local and general AEs were collected from Day 1 to Day 7. Unsolicited AEs were collected from Day 1 to Day 30. SAEs, medically-attended AEs and AEs leading to withdrawal are collected for the entire duration of the study (from Day 0 to Month 10). Data are presented in terms of number of subjects reporting AEs. The total number of subjects at risk for the frequent adverse events were analysed from the exposed set and the number of subjects at risk for each of the adverse event were analysed from the overall safety set. Therefore, the number of subjects at risk for each adverse event is lesser than the total number of subjects at risk.	1.1% 1/93 • Number of events 1 • Solicited local and general AEs were collected from Day 1 to Day 7. Unsolicited AEs were collected from Day 1 to Day 30. SAEs, medically-attended AEs and AEs leading to withdrawal are collected for the entire duration of the study (from Day 0 to Month 10). Data are presented in terms of number of subjects reporting AEs. The total number of subjects at risk for the frequent adverse events were analysed from the exposed set and the number of subjects at risk for each of the adverse event were analysed from the overall safety set. Therefore, the number of subjects at risk for each adverse event is lesser than the total number of subjects at risk.
Musculoskeletal and connective tissue disorders Myalgia	14.0% 13/93 • Number of events 33 • Solicited local and general AEs were collected from Day 1 to Day 7. Unsolicited AEs were collected from Day 1 to Day 30. SAEs, medically-attended AEs and AEs leading to withdrawal are collected for the entire duration of the study (from Day 0 to Month 10). Data are presented in terms of number of subjects reporting AEs. The total number of subjects at risk for the frequent adverse events were analysed from the exposed set and the number of subjects at risk for each of the adverse event were analysed from the overall safety set. Therefore, the number of subjects at risk for each adverse event is lesser than the total number of subjects at risk.	3.2% 3/93 • Number of events 10 • Solicited local and general AEs were collected from Day 1 to Day 7. Unsolicited AEs were collected from Day 1 to Day 30. SAEs, medically-attended AEs and AEs leading to withdrawal are collected for the entire duration of the study (from Day 0 to Month 10). Data are presented in terms of number of subjects reporting AEs. The total number of subjects at risk for the frequent adverse events were analysed from the exposed set and the number of subjects at risk for each of the adverse event were analysed from the overall safety set. Therefore, the number of subjects at risk for each adverse event is lesser than the total number of subjects at risk.
Infections and infestations Upper respiratory tract infection	6.5% 6/93 • Number of events 6 • Solicited local and general AEs were collected from Day 1 to Day 7. Unsolicited AEs were collected from Day 1 to Day 30. SAEs, medically-attended AEs and AEs leading to withdrawal are collected for the entire duration of the study (from Day 0 to Month 10). Data are presented in terms of number of subjects reporting AEs. The total number of subjects at risk for the frequent adverse events were analysed from the exposed set and the number of subjects at risk for each of the adverse event were analysed from the overall safety set. Therefore, the number of subjects at risk for each adverse event is lesser than the total number of subjects at risk.	1.1% 1/93 • Number of events 1 • Solicited local and general AEs were collected from Day 1 to Day 7. Unsolicited AEs were collected from Day 1 to Day 30. SAEs, medically-attended AEs and AEs leading to withdrawal are collected for the entire duration of the study (from Day 0 to Month 10). Data are presented in terms of number of subjects reporting AEs. The total number of subjects at risk for the frequent adverse events were analysed from the exposed set and the number of subjects at risk for each of the adverse event were analysed from the overall safety set. Therefore, the number of subjects at risk for each adverse event is lesser than the total number of subjects at risk.

Additional Information

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