Trial Outcomes & Findings for Study in Children to Evaluate Non-Inferiority and Persistence up to 5 Years of GSK Bio Meningococcal Vaccine 134612 (NCT NCT00427908)

Results Overview

Vaccine response was defined as: * for initially seronegative subjects, post vaccination rSBA titer ≥ 1:32 * for initially seropositive subjects, at least 4-fold increase in rSBA titer from pre to post vaccination.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

613 participants

Primary outcome timeframe

One Month after vaccination

Results posted on

2018-06-04

Participant Flow

During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.

Participant milestones

Participant milestones
Measure	Nimenrix 1-2 Years of Age Group Subjects from 1 to 2 years of age who received one dose of Nimenrix™ vaccine administrated intramuscularly (IM) by injection in the non-dominant deltoid or the thigh region.	Nimenrix 2-11 Years of Age Group Subjects from 2 to 11 years of age who received one dose of Nimenrix™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Meningitec 1-2 Years of Age Group Subjects from 1 to 2 years of age who received one dose of Meningitec™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Mencevax 2-11 Years of Age Group Subjects from 2 to 11 years of age who received one dose Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.
Primary Phase STARTED	229	231	75	78
Primary Phase COMPLETED	224	228	72	78
Primary Phase NOT COMPLETED	5	3	3	0
Persistence Phase Year 1 STARTED	222	221	71	78
Persistence Phase Year 1 COMPLETED	222	221	71	78
Persistence Phase Year 1 NOT COMPLETED	0	0	0	0
Persistence Phase Year 2 STARTED	208	215	53	61
Persistence Phase Year 2 COMPLETED	208	215	53	61
Persistence Phase Year 2 NOT COMPLETED	0	0	0	0
Persistence Phase Year 3 STARTED	185	201	38	38
Persistence Phase Year 3 COMPLETED	185	201	38	38
Persistence Phase Year 3 NOT COMPLETED	0	0	0	0
Persistence Phase Year 4 STARTED	165	192	34	32
Persistence Phase Year 4 COMPLETED	165	192	34	32
Persistence Phase Year 4 NOT COMPLETED	0	0	0	0
Persistence Phase Year 5 STARTED	52	99	12	13
Persistence Phase Year 5 COMPLETED	52	99	12	13
Persistence Phase Year 5 NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Nimenrix 1-2 Years of Age Group Subjects from 1 to 2 years of age who received one dose of Nimenrix™ vaccine administrated intramuscularly (IM) by injection in the non-dominant deltoid or the thigh region.	Nimenrix 2-11 Years of Age Group Subjects from 2 to 11 years of age who received one dose of Nimenrix™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Meningitec 1-2 Years of Age Group Subjects from 1 to 2 years of age who received one dose of Meningitec™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.
Primary Phase Lost to Follow-up	4	0	2
Primary Phase Withdrawal by Subject	1	2	1
Primary Phase Adverse Event	0	1	0

Baseline Characteristics

Study in Children to Evaluate Non-Inferiority and Persistence up to 5 Years of GSK Bio Meningococcal Vaccine 134612

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nimenrix 1-2 Years of Age Group n=229 Participants Subjects from 1 to 2 years of age who received one dose of Nimenrix™ vaccine administrated intramuscularly (IM) by injection in the non-dominant deltoid or the thigh region.	Nimenrix 2-11 Years of Age Group n=231 Participants Subjects from 2 to 11 years of age who received one dose of Nimenrix™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Meningitec 1-2 Years of Age Group n=75 Participants Subjects from 1 to 2 years of age who received one dose of Meningitec™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Mencevax 2-11 Years of Age Group n=78 Participants Subjects from 2 to 11 years of age who received one dose Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.	Total n=613 Participants Total of all reporting groups
Age, Continuous	19.1 Months STANDARD_DEVIATION 2.96 • n=5 Participants	71.9 Months STANDARD_DEVIATION 31.19 • n=7 Participants	19.3 Months STANDARD_DEVIATION 3.07 • n=5 Participants	71.8 Months STANDARD_DEVIATION 30.90 • n=4 Participants	45.73 Months STANDARD_DEVIATION 34.44 • n=21 Participants
Sex: Female, Male Female	116 Participants n=5 Participants	115 Participants n=7 Participants	39 Participants n=5 Participants	37 Participants n=4 Participants	307 Participants n=21 Participants
Sex: Female, Male Male	113 Participants n=5 Participants	116 Participants n=7 Participants	36 Participants n=5 Participants	41 Participants n=4 Participants	306 Participants n=21 Participants
Race/Ethnicity, Customized Geographic ancestry · African heritage/African American	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized Geographic ancestry · Asian-East Asian heritage	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized Geographic ancestry · White-Arabic/North African heritage	2 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants
Race/Ethnicity, Customized Geographic ancestry · White-Caucasian/European heritage	224 Participants n=5 Participants	225 Participants n=7 Participants	74 Participants n=5 Participants	76 Participants n=4 Participants	599 Participants n=21 Participants
Race/Ethnicity, Customized Geographic ancestry · Unspecified	3 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	9 Participants n=21 Participants

PRIMARY outcome

Timeframe: One Month after vaccination

Population: The analysis was performed on subjects of 2 years and above from the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.

Vaccine response was defined as: * for initially seronegative subjects, post vaccination rSBA titer ≥ 1:32 * for initially seropositive subjects, at least 4-fold increase in rSBA titer from pre to post vaccination.

Outcome measures

Outcome measures
Measure	Nimenrix 2-11 Years of Age Primary Phase Group n=219 Participants Pooled group of subjects above 2 years of age, participating in the Primary Phase.	Mencevax 2-11 Years of Age Primary Phase Group n=70 Participants Pooled group of subjects above 2 years of age, participating in the Primary phase.	Nimenrix 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Nimenrix™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Meningitec 1- 2 Years of Age Group Subjects from 1 to 2 years of age who received one dose of Meningitec™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Mencevax 2- 6 Years of Age Group Subjects from 2 to 6 years of age who received one dose Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.	Mencevax 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.
Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibodies Vaccine Response rSBA-MenA	182 Participants	57 Participants	—	—	—	—
Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibodies Vaccine Response rSBA-MenC	200 Participants	56 Participants	—	—	—	—
Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibodies Vaccine Response rSBA-MenW-135	199 Participants	65 Participants	—	—	—	—
Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibodies Vaccine Response rSBA-MenY	217 Participants	58 Participants	—	—	—	—

PRIMARY outcome

Timeframe: Prior to (PRE) vaccination

Population: The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.

The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals' laboratory.

Outcome measures

Outcome measures
Measure	Nimenrix 2-11 Years of Age Primary Phase Group n=208 Participants Pooled group of subjects above 2 years of age, participating in the Primary Phase.	Mencevax 2-11 Years of Age Primary Phase Group n=67 Participants Pooled group of subjects above 2 years of age, participating in the Primary phase.	Nimenrix 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Nimenrix™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Meningitec 1- 2 Years of Age Group Subjects from 1 to 2 years of age who received one dose of Meningitec™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Mencevax 2- 6 Years of Age Group Subjects from 2 to 6 years of age who received one dose Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.	Mencevax 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenA	81 Participants	26 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenC	80 Participants	19 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenW-135	59 Participants	24 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenY	115 Participants	41 Participants	—	—	—	—

PRIMARY outcome

Timeframe: Prior to (PRE) to vaccination

Population: The analysis was performed on subjects of 1 to 2 years of age from the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.

The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals' laboratory.

Outcome measures

Outcome measures
Measure	Nimenrix 2-11 Years of Age Primary Phase Group n=208 Participants Pooled group of subjects above 2 years of age, participating in the Primary Phase.	Mencevax 2-11 Years of Age Primary Phase Group n=67 Participants Pooled group of subjects above 2 years of age, participating in the Primary phase.	Nimenrix 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Nimenrix™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Meningitec 1- 2 Years of Age Group Subjects from 1 to 2 years of age who received one dose of Meningitec™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Mencevax 2- 6 Years of Age Group Subjects from 2 to 6 years of age who received one dose Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.	Mencevax 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.
Percentage of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenY	55.3 Percentage Interval 48.3 to 62.2	61.2 Percentage Interval 48.5 to 72.9	—	—	—	—
Percentage of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenA	42.4 Percentage Interval 35.3 to 49.8	40.0 Percentage Interval 28.0 to 52.9	—	—	—	—
Percentage of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenC	39.4 Percentage Interval 32.6 to 46.5	31.1 Percentage Interval 19.9 to 44.3	—	—	—	—
Percentage of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenW-135	28.4 Percentage Interval 22.3 to 35.0	38.7 Percentage Interval 26.6 to 51.9	—	—	—	—

PRIMARY outcome

Timeframe: One month after vaccination [PI(M1)]

Population: The analysis was performed on subjects of 1 to 2 years of age from the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.

The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals' laboratory.

Outcome measures

Outcome measures
Measure	Nimenrix 2-11 Years of Age Primary Phase Group n=222 Participants Pooled group of subjects above 2 years of age, participating in the Primary Phase.	Mencevax 2-11 Years of Age Primary Phase Group n=68 Participants Pooled group of subjects above 2 years of age, participating in the Primary phase.	Nimenrix 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Nimenrix™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Meningitec 1- 2 Years of Age Group Subjects from 1 to 2 years of age who received one dose of Meningitec™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Mencevax 2- 6 Years of Age Group Subjects from 2 to 6 years of age who received one dose Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.	Mencevax 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenA	222 Participants	22 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenC	220 Participants	67 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenW-135	222 Participants	27 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenY	222 Participants	49 Participants	—	—	—	—

PRIMARY outcome

Timeframe: One month after vaccination [PI(M1)]

Population: The analysis was performed on subjects of 1 to 2 years of age from the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.

The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals' laboratory.

Outcome measures

Outcome measures
Measure	Nimenrix 2-11 Years of Age Primary Phase Group n=222 Participants Pooled group of subjects above 2 years of age, participating in the Primary Phase.	Mencevax 2-11 Years of Age Primary Phase Group n=68 Participants Pooled group of subjects above 2 years of age, participating in the Primary phase.	Nimenrix 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Nimenrix™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Meningitec 1- 2 Years of Age Group Subjects from 1 to 2 years of age who received one dose of Meningitec™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Mencevax 2- 6 Years of Age Group Subjects from 2 to 6 years of age who received one dose Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.	Mencevax 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.
Percentage of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenA	100 Percentage Interval 98.4 to 100.0	34.9 Percentage Interval 23.3 to 48.0	—	—	—	—
Percentage of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenC	100 Percentage Interval 98.3 to 100.0	98.5 Percentage Interval 92.1 to 100.0	—	—	—	—
Percentage of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenW-135	100 Percentage Interval 98.4 to 100.0	42.9 Percentage Interval 30.5 to 56.0	—	—	—	—
Percentage of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenY	100 Percentage Interval 98.4 to 100.0	74.2 Percentage Interval 62.0 to 84.2	—	—	—	—

SECONDARY outcome

Timeframe: Prior to (PRE) and one month after vaccination [PI(M1)]

Population: The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.

The cut-off value for the rSBA titers was greater than or equal to (≥) 1:128. This analysis was performed by the GSK Biologicals' laboratory.

Outcome measures

Outcome measures
Measure	Nimenrix 2-11 Years of Age Primary Phase Group n=222 Participants Pooled group of subjects above 2 years of age, participating in the Primary Phase.	Mencevax 2-11 Years of Age Primary Phase Group n=68 Participants Pooled group of subjects above 2 years of age, participating in the Primary phase.	Nimenrix 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Nimenrix™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Meningitec 1- 2 Years of Age Group Subjects from 1 to 2 years of age who received one dose of Meningitec™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Mencevax 2- 6 Years of Age Group Subjects from 2 to 6 years of age who received one dose Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.	Mencevax 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenC, PI(M1)	218 Participants	56 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenW-135, PRE	38 Participants	16 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenW-135, PI(M1)	222 Participants	18 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenA, PRE	59 Participants	20 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenA, PI(M1)	222 Participants	16 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenC, PRE	29 Participants	4 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenY, PRE	77 Participants	28 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenY, PI(M1)	221 Participants	31 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Prior to (PRE) and one month after vaccination [PI(M1)]

Population: The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.

Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the GSK Biologicals' laboratory.

Outcome measures

Outcome measures
Measure	Nimenrix 2-11 Years of Age Primary Phase Group n=222 Participants Pooled group of subjects above 2 years of age, participating in the Primary Phase.	Mencevax 2-11 Years of Age Primary Phase Group n=68 Participants Pooled group of subjects above 2 years of age, participating in the Primary phase.	Nimenrix 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Nimenrix™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Meningitec 1- 2 Years of Age Group Subjects from 1 to 2 years of age who received one dose of Meningitec™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Mencevax 2- 6 Years of Age Group Subjects from 2 to 6 years of age who received one dose Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.	Mencevax 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.
rSBA Antibody Titers rSBA-MenA, PRE	21.6 Titers Interval 16.1 to 29.0	20.2 Titers Interval 12.1 to 33.8	—	—	—	—
rSBA Antibody Titers rSBA-MenA, PI(M1)	3706.5 Titers Interval 3327.2 to 4128.9	17.1 Titers Interval 10.1 to 29.0	—	—	—	—
rSBA Antibody Titers rSBA-MenC, PRE	13.9 Titers Interval 11.0 to 17.5	9.7 Titers Interval 6.8 to 13.9	—	—	—	—
rSBA Antibody Titers rSBA-MenC, PI(M1)	878.7 Titers Interval 779.4 to 990.7	415 Titers Interval 296.9 to 580.0	—	—	—	—
rSBA Antibody Titers rSBA-MenW-135, PRE	11.3 Titers Interval 8.9 to 14.3	16.5 Titers Interval 10.2 to 26.7	—	—	—	—
rSBA Antibody Titers rSBA-MenW-135, PI(M1)	5394.6 Titers Interval 4869.9 to 5975.7	20.3 Titers Interval 12.5 to 33.2	—	—	—	—
rSBA Antibody Titers rSBA-MenY, PRE	33.8 Titers Interval 25.6 to 44.6	45.3 Titers Interval 27.0 to 75.8	—	—	—	—
rSBA Antibody Titers rSBA-MenY, PI(M1)	2823.8 Titers Interval 2529.0 to 3153.1	77.1 Titers Interval 46.3 to 128.2	—	—	—	—

SECONDARY outcome

Timeframe: Prior to (PRE) and one month after vaccination [PI(M1)]

Population: The analysis was performed on subjects of 2 years and above from the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.

The cut-off value for the rSBA titers were greater than or equal to ≥ 1:8 and ≥ 1:128. These analyses were performed by the GSK Biologicals' laboratory.

Outcome measures

Outcome measures
Measure	Nimenrix 2-11 Years of Age Primary Phase Group n=225 Participants Pooled group of subjects above 2 years of age, participating in the Primary Phase.	Mencevax 2-11 Years of Age Primary Phase Group n=75 Participants Pooled group of subjects above 2 years of age, participating in the Primary phase.	Nimenrix 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Nimenrix™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Meningitec 1- 2 Years of Age Group Subjects from 1 to 2 years of age who received one dose of Meningitec™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Mencevax 2- 6 Years of Age Group Subjects from 2 to 6 years of age who received one dose Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.	Mencevax 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Values rSBA-MenA (PRE) ≥ 1:8	124 Participants	40 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Values rSBA-MenA (PRE) ≥ 1:128	96 Participants	32 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Values rSBA-MenA (PI[M1]) ≥ 1:8	225 Participants	75 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Values rSBA-MenA (PI[M1]) ≥ 1:128	224 Participants	75 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Values rSBA-MenC (PRE) ≥ 1:8	133 Participants	36 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Values rSBA-MenC (PRE) ≥ 1:128	59 Participants	19 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Values rSBA-MenC (PI[M1]) ≥ 1:8	225 Participants	74 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Values rSBA-MenC (PI[M1]) ≥ 1:128	224 Participants	70 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Values rSBA-MenW-135 (PRE) ≥ 1:8	120 Participants	39 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Values rSBA-MenW-135 (PRE) ≥ 1:128	90 Participants	24 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Values rSBA-MenW-135 (PI[M1]) ≥ 1:8	225 Participants	75 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Values rSBA-MenW-135 (PI[M1]) ≥ 1:128	225 Participants	75 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Values rSBA-MenY (PRE) ≥ 1:8	147 Participants	42 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Values rSBA-MenY (PRE) ≥ 1:128	98 Participants	28 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Values rSBA-MenY (PI[M1]) ≥ 1:8	225 Participants	75 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Values rSBA-MenY (PI[M1]) ≥ 1:128	224 Participants	73 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Prior to (PRE) and one month post vaccination [PI(M1)]

Population: The analysis was performed on subjects of 2 years and above from the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.

Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the GSK Biologicals' laboratory.

Outcome measures

Outcome measures
Measure	Nimenrix 2-11 Years of Age Primary Phase Group n=225 Participants Pooled group of subjects above 2 years of age, participating in the Primary Phase.	Mencevax 2-11 Years of Age Primary Phase Group n=75 Participants Pooled group of subjects above 2 years of age, participating in the Primary phase.	Nimenrix 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Nimenrix™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Meningitec 1- 2 Years of Age Group Subjects from 1 to 2 years of age who received one dose of Meningitec™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Mencevax 2- 6 Years of Age Group Subjects from 2 to 6 years of age who received one dose Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.	Mencevax 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.
rSBA Antibody Titers rSBA-MenA (PRE)	57.9 Titer Interval 43.3 to 77.5	58.2 Titer Interval 33.8 to 100.1	—	—	—	—
rSBA Antibody Titers rSBA-MenA (PI[M1])	7300.9 Titer Interval 6586.0 to 8093.4	2033.4 Titer Interval 1667.1 to 2480.2	—	—	—	—
rSBA Antibody Titers rSBA-MenC (PRE)	33.5 Titer Interval 26.0 to 43.1	24.1 Titer Interval 15.2 to 38.2	—	—	—	—
rSBA Antibody Titers rSBA-MenC (PI[M1])	2435.3 Titer Interval 2105.8 to 2816.3	750.2 Titer Interval 555.2 to 1013.7	—	—	—	—
rSBA Antibody Titers rSBA-MenW-135 (PRE)	43.1 Titer Interval 32.4 to 57.4	40.1 Titer Interval 23.9 to 67.3	—	—	—	—
rSBA Antibody Titers rSBA-MenW-135 (PI[M1])	11777 Titer Interval 10666.2 to 13003.5	2186.3 Titer Interval 1723.1 to 2773.9	—	—	—	—
rSBA Antibody Titers rSBA-MenY (PRE)	57.3 Titer Interval 43.7 to 75.2	45.5 Titer Interval 26.8 to 77.0	—	—	—	—
rSBA Antibody Titers rSBA-MenY (PI[M1])	6641.4 Titer Interval 6044.3 to 7297.4	1409.9 Titer Interval 1085.9 to 1830.5	—	—	—	—

SECONDARY outcome

Timeframe: Prior to (PRE) and one month after vaccination [PI(M1)]

Population: The analysis was performed on subjects of 1 to 2 years of age from the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.

The cut-off value for the anti-polysaccharide concentrations were greater than or equal to (≥) 0.3 micrograms per milliliter (μg/mL) and ≥ 2.0 μg/mL.

Outcome measures

Outcome measures
Measure	Nimenrix 2-11 Years of Age Primary Phase Group n=168 Participants Pooled group of subjects above 2 years of age, participating in the Primary Phase.	Mencevax 2-11 Years of Age Primary Phase Group n=51 Participants Pooled group of subjects above 2 years of age, participating in the Primary phase.	Nimenrix 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Nimenrix™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Meningitec 1- 2 Years of Age Group Subjects from 1 to 2 years of age who received one dose of Meningitec™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Mencevax 2- 6 Years of Age Group Subjects from 2 to 6 years of age who received one dose Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.	Mencevax 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.
Number of Subjects With Anti-polysaccharide Meningococcal Serogroup A (Anti-PSA), Serogroup C (Anti-PSC), Serogroup W-135 (Anti-PSW-135) and Serogroup Y (Anti-PSY) Antibody Concentrations Greater Than or Equal to the Cut-off Value Anti-PSA (PRE) ≥ 0.3 μg/mL	10 Participants	4 Participants	—	—	—	—
Number of Subjects With Anti-polysaccharide Meningococcal Serogroup A (Anti-PSA), Serogroup C (Anti-PSC), Serogroup W-135 (Anti-PSW-135) and Serogroup Y (Anti-PSY) Antibody Concentrations Greater Than or Equal to the Cut-off Value Anti-PSA (PRE) ≥ 2.0 μg/mL	2 Participants	1 Participants	—	—	—	—
Number of Subjects With Anti-polysaccharide Meningococcal Serogroup A (Anti-PSA), Serogroup C (Anti-PSC), Serogroup W-135 (Anti-PSW-135) and Serogroup Y (Anti-PSY) Antibody Concentrations Greater Than or Equal to the Cut-off Value Anti-PSA [PI(M1)] ≥ 0.3 μg/mL	162 Participants	2 Participants	—	—	—	—
Number of Subjects With Anti-polysaccharide Meningococcal Serogroup A (Anti-PSA), Serogroup C (Anti-PSC), Serogroup W-135 (Anti-PSW-135) and Serogroup Y (Anti-PSY) Antibody Concentrations Greater Than or Equal to the Cut-off Value Anti-PSA [PI(M1)] ≥ 2.0 μg/mL	162 Participants	1 Participants	—	—	—	—
Number of Subjects With Anti-polysaccharide Meningococcal Serogroup A (Anti-PSA), Serogroup C (Anti-PSC), Serogroup W-135 (Anti-PSW-135) and Serogroup Y (Anti-PSY) Antibody Concentrations Greater Than or Equal to the Cut-off Value Anti-PSC (PRE) ≥ 0.3 μg/mL	3 Participants	1 Participants	—	—	—	—
Number of Subjects With Anti-polysaccharide Meningococcal Serogroup A (Anti-PSA), Serogroup C (Anti-PSC), Serogroup W-135 (Anti-PSW-135) and Serogroup Y (Anti-PSY) Antibody Concentrations Greater Than or Equal to the Cut-off Value Anti-PSC (PRE) ≥ 2.0 μg/mL	1 Participants	1 Participants	—	—	—	—
Number of Subjects With Anti-polysaccharide Meningococcal Serogroup A (Anti-PSA), Serogroup C (Anti-PSC), Serogroup W-135 (Anti-PSW-135) and Serogroup Y (Anti-PSY) Antibody Concentrations Greater Than or Equal to the Cut-off Value Anti-PSC [PI(M1)] ≥ 0.3 μg/mL	168 Participants	51 Participants	—	—	—	—
Number of Subjects With Anti-polysaccharide Meningococcal Serogroup A (Anti-PSA), Serogroup C (Anti-PSC), Serogroup W-135 (Anti-PSW-135) and Serogroup Y (Anti-PSY) Antibody Concentrations Greater Than or Equal to the Cut-off Value Anti-PSC [PI(M1)] ≥ 2.0 μg/mL	166 Participants	50 Participants	—	—	—	—
Number of Subjects With Anti-polysaccharide Meningococcal Serogroup A (Anti-PSA), Serogroup C (Anti-PSC), Serogroup W-135 (Anti-PSW-135) and Serogroup Y (Anti-PSY) Antibody Concentrations Greater Than or Equal to the Cut-off Value Anti-PSW-135 (PRE) ≥ 0.3 μg/mL	2 Participants	0 Participants	—	—	—	—
Number of Subjects With Anti-polysaccharide Meningococcal Serogroup A (Anti-PSA), Serogroup C (Anti-PSC), Serogroup W-135 (Anti-PSW-135) and Serogroup Y (Anti-PSY) Antibody Concentrations Greater Than or Equal to the Cut-off Value Anti-PSW-135 (PRE) ≥ 2.0 μg/mL	1 Participants	0 Participants	—	—	—	—
Number of Subjects With Anti-polysaccharide Meningococcal Serogroup A (Anti-PSA), Serogroup C (Anti-PSC), Serogroup W-135 (Anti-PSW-135) and Serogroup Y (Anti-PSY) Antibody Concentrations Greater Than or Equal to the Cut-off Value Anti-PSW-135 [PI(M1)] ≥ 0.3 μg/mL	143 Participants	0 Participants	—	—	—	—
Number of Subjects With Anti-polysaccharide Meningococcal Serogroup A (Anti-PSA), Serogroup C (Anti-PSC), Serogroup W-135 (Anti-PSW-135) and Serogroup Y (Anti-PSY) Antibody Concentrations Greater Than or Equal to the Cut-off Value Anti-PSW-135 [PI(M1)] ≥ 2.0 μg/mL	131 Participants	0 Participants	—	—	—	—
Number of Subjects With Anti-polysaccharide Meningococcal Serogroup A (Anti-PSA), Serogroup C (Anti-PSC), Serogroup W-135 (Anti-PSW-135) and Serogroup Y (Anti-PSY) Antibody Concentrations Greater Than or Equal to the Cut-off Value Anti-PSY (PRE) ≥ 0.3 μg/mL	1 Participants	1 Participants	—	—	—	—
Number of Subjects With Anti-polysaccharide Meningococcal Serogroup A (Anti-PSA), Serogroup C (Anti-PSC), Serogroup W-135 (Anti-PSW-135) and Serogroup Y (Anti-PSY) Antibody Concentrations Greater Than or Equal to the Cut-off Value Anti-PSY (PRE) ≥ 2.0 μg/mL	0 Participants	0 Participants	—	—	—	—
Number of Subjects With Anti-polysaccharide Meningococcal Serogroup A (Anti-PSA), Serogroup C (Anti-PSC), Serogroup W-135 (Anti-PSW-135) and Serogroup Y (Anti-PSY) Antibody Concentrations Greater Than or Equal to the Cut-off Value Anti-PSY [PI(M1)] ≥ 0.3 μg/mL	152 Participants	0 Participants	—	—	—	—
Number of Subjects With Anti-polysaccharide Meningococcal Serogroup A (Anti-PSA), Serogroup C (Anti-PSC), Serogroup W-135 (Anti-PSW-135) and Serogroup Y (Anti-PSY) Antibody Concentrations Greater Than or Equal to the Cut-off Value Anti-PSY [PI(M1)] ≥ 2.0 μg/mL	147 Participants	0 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Prior to (PRE) and one month after vaccination [PI(M1)]

Population: The analysis was performed on subjects of 1 to 2 years of age from the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.

Antibody concentrations are presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL).

Outcome measures

Outcome measures
Measure	Nimenrix 2-11 Years of Age Primary Phase Group n=168 Participants Pooled group of subjects above 2 years of age, participating in the Primary Phase.	Mencevax 2-11 Years of Age Primary Phase Group n=51 Participants Pooled group of subjects above 2 years of age, participating in the Primary phase.	Nimenrix 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Nimenrix™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Meningitec 1- 2 Years of Age Group Subjects from 1 to 2 years of age who received one dose of Meningitec™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Mencevax 2- 6 Years of Age Group Subjects from 2 to 6 years of age who received one dose Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.	Mencevax 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.
Anti-PS Antibody Concentrations Anti-PSA (PRE)	0.17 μg/mL Interval 0.15 to 0.18	0.18 μg/mL Interval 0.14 to 0.23	—	—	—	—
Anti-PS Antibody Concentrations Anti-PSA [PI(M1)]	33.36 μg/mL Interval 29.07 to 38.27	0.17 μg/mL Interval 0.14 to 0.2	—	—	—	—
Anti-PS Antibody Concentrations Anti-PSC (PRE)	0.16 μg/mL Interval 0.15 to 0.17	0.16 μg/mL Interval 0.14 to 0.18	—	—	—	—
Anti-PS Antibody Concentrations Anti-PSC [PI(M1)]	13.47 μg/mL Interval 12.0 to 15.12	8.29 μg/mL Interval 6.8 to 10.1	—	—	—	—
Anti-PS Antibody Concentrations Anti-PSW-135 (PRE)	0.15 μg/mL Interval 0.15 to 0.16	0.15 μg/mL Interval 0.15 to 0.15	—	—	—	—
Anti-PS Antibody Concentrations Anti-PSW-135 [PI(M1)]	6.86 μg/mL Interval 5.87 to 8.02	0.15 μg/mL Interval 0.15 to 0.15	—	—	—	—
Anti-PS Antibody Concentrations Anti-PSY (PRE)	0.15 μg/mL Interval 0.15 to 0.15	0.16 μg/mL Interval 0.14 to 0.17	—	—	—	—
Anti-PS Antibody Concentrations Anti-PSY [PI(M1)]	10.35 μg/mL Interval 9.12 to 11.74	0.15 μg/mL Interval 0.15 to 0.15	—	—	—	—

SECONDARY outcome

Timeframe: Prior to (PRE) and one month after vaccination [PI(M1)]

Population: The analysis was performed on subjects of 2 years and above from the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.

The cut-off value for the anti-polysaccharide concentrations were greater than or equal to (≥) 0.3 micrograms per milliliter (μg/mL) and (≥) 2.0 μg/mL.

Outcome measures

Outcome measures
Measure	Nimenrix 2-11 Years of Age Primary Phase Group n=225 Participants Pooled group of subjects above 2 years of age, participating in the Primary Phase.	Mencevax 2-11 Years of Age Primary Phase Group n=75 Participants Pooled group of subjects above 2 years of age, participating in the Primary phase.	Nimenrix 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Nimenrix™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Meningitec 1- 2 Years of Age Group Subjects from 1 to 2 years of age who received one dose of Meningitec™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Mencevax 2- 6 Years of Age Group Subjects from 2 to 6 years of age who received one dose Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.	Mencevax 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.
Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value Anti-PSA ≥0.3μg/mL, PRE	29 Participants	12 Participants	—	—	—	—
Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value Anti-PSA ≥0.3μg/mL, PI(M1)	224 Participants	73 Participants	—	—	—	—
Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value Anti-PSA ≥2.0μg/mL, PRE	9 Participants	2 Participants	—	—	—	—
Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value Anti-PSA ≥2.0μg/mL, PI(M1)	224 Participants	68 Participants	—	—	—	—
Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value Anti-PSC ≥0.3μg/mL , PRE	28 Participants	6 Participants	—	—	—	—
Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value Anti-PSC ≥0.3μg/mL, PI(M1)	224 Participants	74 Participants	—	—	—	—
Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value Anti-PSC ≥2.0μg/mL, PRE	9 Participants	2 Participants	—	—	—	—
Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value Anti-PSC ≥2.0μg/mL, PI(M1)	223 Participants	71 Participants	—	—	—	—
Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value Anti-PSW-135 ≥0.3μg/mL, PRE	3 Participants	1 Participants	—	—	—	—
Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value Anti-PSW-135 ≥0.3μg/mL, PI(M1)	224 Participants	72 Participants	—	—	—	—
Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value Anti-PSW-135 ≥2.0μg/mL, PRE	0 Participants	0 Participants	—	—	—	—
Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value Anti-PSW-135 ≥2.0μg/mL, PI(M1)	197 Participants	54 Participants	—	—	—	—
Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value Anti-PSY ≥0.3μg/mL, PRE	6 Participants	0 Participants	—	—	—	—
Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value Anti-PSY ≥0.3μg/mL, PI(M1)	225 Participants	72 Participants	—	—	—	—
Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value Anti-PSY ≥2.0μg/mL, PRE	1 Participants	0 Participants	—	—	—	—
Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value Anti-PSY ≥2.0μg/mL, PI(M1)	217 Participants	71 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Prior to (PRE) and one month post vaccination [PI(M1)]

Population: The analysis was performed on subjects of 2 years and above from the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.

Antibody concentrations were presented as micrograms per milliliter (μg/mL).

Outcome measures

Outcome measures
Measure	Nimenrix 2-11 Years of Age Primary Phase Group n=225 Participants Pooled group of subjects above 2 years of age, participating in the Primary Phase.	Mencevax 2-11 Years of Age Primary Phase Group n=75 Participants Pooled group of subjects above 2 years of age, participating in the Primary phase.	Nimenrix 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Nimenrix™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Meningitec 1- 2 Years of Age Group Subjects from 1 to 2 years of age who received one dose of Meningitec™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Mencevax 2- 6 Years of Age Group Subjects from 2 to 6 years of age who received one dose Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.	Mencevax 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.
Anti-PS Antibody Concentrations Anti-PSW-135, PRE	0.15 μg/mL Interval 0.15 to 0.15	0.15 μg/mL Interval 0.15 to 0.16	—	—	—	—
Anti-PS Antibody Concentrations Anti-PSW-135, PI(M1)	6.35 μg/mL Interval 5.53 to 7.29	4.62 μg/mL Interval 3.37 to 6.35	—	—	—	—
Anti-PS Antibody Concentrations Anti-PSY, PRE	0.16 μg/mL Interval 0.15 to 0.16	0.15 μg/mL Interval 0.15 to 0.15	—	—	—	—
Anti-PS Antibody Concentrations Anti-PSA, PRE	0.19 μg/mL Interval 0.17 to 0.21	0.2 μg/mL Interval 0.16 to 0.23	—	—	—	—
Anti-PS Antibody Concentrations Anti-PSA, PI(M1)	36.35 μg/mL Interval 32.3 to 40.91	10.34 μg/mL Interval 7.79 to 13.72	—	—	—	—
Anti-PS Antibody Concentrations Anti-PSC, PRE	0.2 μg/mL Interval 0.18 to 0.22	0.19 μg/mL Interval 0.15 to 0.22	—	—	—	—
Anti-PS Antibody Concentrations Anti-PSC, PI(M1)	13.33 μg/mL Interval 11.75 to 15.12	14.53 μg/mL Interval 11.13 to 18.95	—	—	—	—
Anti-PS Antibody Concentrations Anti-PSY, PI(M1)	11.35 μg/mL Interval 10.01 to 12.87	15.45 μg/mL Interval 11.42 to 20.91	—	—	—	—

SECONDARY outcome

Timeframe: Prior to (PRE) and one month after vaccination [PI(M1)]

Population: The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.

The cut-off value for the anti-TT concentrations was greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).

Outcome measures

Outcome measures
Measure	Nimenrix 2-11 Years of Age Primary Phase Group n=30 Participants Pooled group of subjects above 2 years of age, participating in the Primary Phase.	Mencevax 2-11 Years of Age Primary Phase Group n=6 Participants Pooled group of subjects above 2 years of age, participating in the Primary phase.	Nimenrix 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Nimenrix™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Meningitec 1- 2 Years of Age Group Subjects from 1 to 2 years of age who received one dose of Meningitec™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Mencevax 2- 6 Years of Age Group Subjects from 2 to 6 years of age who received one dose Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.	Mencevax 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.
Number of Subjects With Anti-tetanus (Anti-TT) Antibody Concentrations Greater Than or Equal to the Cut-off Value Anti-TT (PRE)	18 Participants	5 Participants	—	—	—	—
Number of Subjects With Anti-tetanus (Anti-TT) Antibody Concentrations Greater Than or Equal to the Cut-off Value Anti-TT [PI(M1)]	30 Participants	4 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Prior to (PRE) and one month after vaccination [PI(M1)]

Population: The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.

Concentrations are presented as geometric mean concentrations (GMCs) expressed in international units per milliliter (IU/mL).

Outcome measures

Outcome measures
Measure	Nimenrix 2-11 Years of Age Primary Phase Group n=30 Participants Pooled group of subjects above 2 years of age, participating in the Primary Phase.	Mencevax 2-11 Years of Age Primary Phase Group n=6 Participants Pooled group of subjects above 2 years of age, participating in the Primary phase.	Nimenrix 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Nimenrix™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Meningitec 1- 2 Years of Age Group Subjects from 1 to 2 years of age who received one dose of Meningitec™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Mencevax 2- 6 Years of Age Group Subjects from 2 to 6 years of age who received one dose Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.	Mencevax 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.
Anti-TT Antibody Concentrations Anti-TT (PRE)	1.226 IU/mL Interval 0.609 to 2.47	0.57 IU/mL Interval 0.102 to 3.188	—	—	—	—
Anti-TT Antibody Concentrations Anti-TT [PI(M1)]	14.199 IU/mL Interval 9.628 to 20.94	1.341 IU/mL Interval 0.316 to 5.686	—	—	—	—

SECONDARY outcome

Timeframe: Prior to (PRE) and one month after vaccination [PI(M1)]

Population: The analysis was performed on subjects of 2 years and above from the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.

Cut-off values assessed were greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).

Outcome measures

Outcome measures
Measure	Nimenrix 2-11 Years of Age Primary Phase Group n=32 Participants Pooled group of subjects above 2 years of age, participating in the Primary Phase.	Mencevax 2-11 Years of Age Primary Phase Group n=7 Participants Pooled group of subjects above 2 years of age, participating in the Primary phase.	Nimenrix 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Nimenrix™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Meningitec 1- 2 Years of Age Group Subjects from 1 to 2 years of age who received one dose of Meningitec™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Mencevax 2- 6 Years of Age Group Subjects from 2 to 6 years of age who received one dose Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.	Mencevax 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.
Number of Subjects With Anti-TT Antibody Concentrations Anti-TT, PRE	19 Participants	4 Participants	—	—	—	—
Number of Subjects With Anti-TT Antibody Concentrations Anti-TT, PI(M1)	32 Participants	7 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Prior to (PRE) and one month post vaccination [PI(M1)]

Population: The analysis was performed on subjects of 2 years and above from the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.

Concentrations are presented as geometric mean concentrations (GMCs) expressed in international units per milliliter (IU/mL).

Outcome measures

Outcome measures
Measure	Nimenrix 2-11 Years of Age Primary Phase Group n=32 Participants Pooled group of subjects above 2 years of age, participating in the Primary Phase.	Mencevax 2-11 Years of Age Primary Phase Group n=7 Participants Pooled group of subjects above 2 years of age, participating in the Primary phase.	Nimenrix 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Nimenrix™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Meningitec 1- 2 Years of Age Group Subjects from 1 to 2 years of age who received one dose of Meningitec™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Mencevax 2- 6 Years of Age Group Subjects from 2 to 6 years of age who received one dose Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.	Mencevax 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.
Anti-TT Antibody Concentrations Anti-TT, PRE	1.541 IU/mL Interval 0.856 to 2.775	2.103 IU/mL Interval 0.129 to 34.398	—	—	—	—
Anti-TT Antibody Concentrations Anti-TT, PI(M1)	20.951 IU/mL Interval 14.656 to 29.949	1.74 IU/mL Interval 0.536 to 5.642	—	—	—	—

SECONDARY outcome

Timeframe: Prior to (PRE) and one month after vaccination [PI(M1)]

Population: The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.

The cut-off value for the hSBA titers was greater than or equal to (≥) 1:4.

Outcome measures

Outcome measures
Measure	Nimenrix 2-11 Years of Age Primary Phase Group n=221 Participants Pooled group of subjects above 2 years of age, participating in the Primary Phase.	Mencevax 2-11 Years of Age Primary Phase Group n=68 Participants Pooled group of subjects above 2 years of age, participating in the Primary phase.	Nimenrix 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Nimenrix™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Meningitec 1- 2 Years of Age Group Subjects from 1 to 2 years of age who received one dose of Meningitec™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Mencevax 2- 6 Years of Age Group Subjects from 2 to 6 years of age who received one dose Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.	Mencevax 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.
Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenA, PRE	3 Participants	3 Participants	—	—	—	—
Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Greater Than or Equal to the Cut-off Value hBA-MenA, PI(M1)	203 Participants	4 Participants	—	—	—	—
Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenC, PRE	3 Participants	1 Participants	—	—	—	—
Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenC, PI(M1)	219 Participants	49 Participants	—	—	—	—
Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenW-135, PRE	2 Participants	3 Participants	—	—	—	—
Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenW-135, PI(M1)	145 Participants	1 Participants	—	—	—	—
Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenY, PRE	7 Participants	2 Participants	—	—	—	—
Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenY, PI(M1)	135 Participants	3 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Prior to (PRE) and one month after vaccination [PI(M1)]

Population: The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.

Antibody titers are presented as geometric mean titers (GMTs).

Outcome measures

Outcome measures
Measure	Nimenrix 2-11 Years of Age Primary Phase Group n=221 Participants Pooled group of subjects above 2 years of age, participating in the Primary Phase.	Mencevax 2-11 Years of Age Primary Phase Group n=68 Participants Pooled group of subjects above 2 years of age, participating in the Primary phase.	Nimenrix 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Nimenrix™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Meningitec 1- 2 Years of Age Group Subjects from 1 to 2 years of age who received one dose of Meningitec™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Mencevax 2- 6 Years of Age Group Subjects from 2 to 6 years of age who received one dose Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.	Mencevax 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.
hSBA Antibody Titers hSBA-MenA, PRE	2 Titers Interval 2.0 to 2.1	2.2 Titers Interval 2.0 to 2.3	—	—	—	—
hSBA Antibody Titers hBA-MenA, PI(M1)	59 Titers Interval 49.3 to 70.6	2.3 Titers Interval 2.0 to 2.6	—	—	—	—
hSBA Antibody Titers hSBA-MenC, PRE	2.1 Titers Interval 2.0 to 2.2	2.1 Titers Interval 1.9 to 2.3	—	—	—	—
hSBA Antibody Titers hSBA-MenC, PI(M1)	190 Titers Interval 164.7 to 219.2	21.2 Titers Interval 13.9 to 32.3	—	—	—	—
hSBA Antibody Titers hSBA-MenW-135, PRE	2.1 Titers Interval 2.0 to 2.1	2.2 Titers Interval 2.0 to 2.4	—	—	—	—
hSBA Antibody Titers hSBA-MenW-135, PI(M1)	38.8 Titers Interval 29.7 to 50.6	2 Titers Interval 2.0 to 2.1	—	—	—	—
hSBA Antibody Titers hSBA-MenY, PRE	2.2 Titers Interval 2.0 to 2.3	2.1 Titers Interval 2.0 to 2.2	—	—	—	—
hSBA Antibody Titers hSBA-MenY, PI(M1)	24.4 Titers Interval 18.6 to 32.1	2.4 Titers Interval 1.9 to 3.1	—	—	—	—

SECONDARY outcome

Timeframe: Prior to (PRE) and one month after vaccination [PI(M1)]

Population: The analysis was performed on subjects from 6 to below 11 years of age from the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.

The cut-off value for the hSBA titers was greater than or equal to (≥) 1:4.

Outcome measures

Outcome measures
Measure	Nimenrix 2-11 Years of Age Primary Phase Group n=112 Participants Pooled group of subjects above 2 years of age, participating in the Primary Phase.	Mencevax 2-11 Years of Age Primary Phase Group n=38 Participants Pooled group of subjects above 2 years of age, participating in the Primary phase.	Nimenrix 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Nimenrix™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Meningitec 1- 2 Years of Age Group Subjects from 1 to 2 years of age who received one dose of Meningitec™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Mencevax 2- 6 Years of Age Group Subjects from 2 to 6 years of age who received one dose Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.	Mencevax 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.
Number of Subjects With hSBA Antibody Titers ≥ the Cut-off Value hSBA-MenA (PRE)	2 Participants	2 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers ≥ the Cut-off Value hSBA-MenA (PI[M1])	91 Participants	9 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers ≥ the Cut-off Value hSBA-MenC (PRE)	35 Participants	9 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers ≥ the Cut-off Value hSBA-MenC (PI[M1])	96 Participants	15 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers ≥ the Cut-off Value hSBA-MenW-135 (PRE)	13 Participants	2 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers ≥ the Cut-off Value hSBA-MenW-135 (PI[M1])	102 Participants	12 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers ≥ the Cut-off Value hSBA-MenY (PRE)	24 Participants	8 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers ≥ the Cut-off Value hSBA-MenY (PI[M1])	79 Participants	14 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Prior to (PRE) and one month post vaccination [PI(M1)]

Population: The analysis was performed on subjects from 6 to below 11 years of age from the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.

Antibody titers are presented as geometric mean titers (GMTs).

Outcome measures

Outcome measures
Measure	Nimenrix 2-11 Years of Age Primary Phase Group n=112 Participants Pooled group of subjects above 2 years of age, participating in the Primary Phase.	Mencevax 2-11 Years of Age Primary Phase Group n=38 Participants Pooled group of subjects above 2 years of age, participating in the Primary phase.	Nimenrix 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Nimenrix™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Meningitec 1- 2 Years of Age Group Subjects from 1 to 2 years of age who received one dose of Meningitec™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Mencevax 2- 6 Years of Age Group Subjects from 2 to 6 years of age who received one dose Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.	Mencevax 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.
hSBA Antibody Titers hSBA-MenY (PRE)	5.6 Titer Interval 3.8 to 8.2	6.1 Titer Interval 3.0 to 12.6	—	—	—	—
hSBA Antibody Titers hSBA-MenA (PRE)	2.1 Titer Interval 2.0 to 2.1	2.2 Titer Interval 1.9 to 2.5	—	—	—	—
hSBA Antibody Titers hSBA-MenA (PI[M1])	57.0 Titer Interval 40.3 to 80.6	4.1 Titer Interval 2.6 to 6.5	—	—	—	—
hSBA Antibody Titers hSBA-MenC (PRE)	5.1 Titer Interval 3.8 to 6.7	4.4 Titer Interval 2.7 to 7.2	—	—	—	—
hSBA Antibody Titers hSBA-MenC (PI[M1])	154.8 Titer Interval 101.1 to 237.1	13.1 Titer Interval 5.4 to 32.0	—	—	—	—
hSBA Antibody Titers hSBA-MenW-135 (PRE)	3.2 Titer Interval 2.5 to 4.1	2.6 Titer Interval 1.8 to 3.7	—	—	—	—
hSBA Antibody Titers hSBA-MenW-135 (PI[M1])	134.2 Titer Interval 101.4 to 177.6	5.8 Titer Interval 3.3 to 9.9	—	—	—	—
hSBA Antibody Titers hSBA-MenY (PI[M1])	93.7 Titer Interval 62.1 to 141.4	12.5 Titer Interval 5.6 to 27.7	—	—	—	—

SECONDARY outcome

Timeframe: Prior to (PRE), one month after vaccination [PI(M1)] and Persistence Year 1 [PI(M12)]

Population: The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 1, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 1 time point.

The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals' laboratory.

Outcome measures

Outcome measures
Measure	Nimenrix 2-11 Years of Age Primary Phase Group n=216 Participants Pooled group of subjects above 2 years of age, participating in the Primary Phase.	Mencevax 2-11 Years of Age Primary Phase Group n=66 Participants Pooled group of subjects above 2 years of age, participating in the Primary phase.	Nimenrix 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Nimenrix™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Meningitec 1- 2 Years of Age Group Subjects from 1 to 2 years of age who received one dose of Meningitec™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Mencevax 2- 6 Years of Age Group Subjects from 2 to 6 years of age who received one dose Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.	Mencevax 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenA (PRE)	80 Participants	26 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenA (PI[M1])	216 Participants	21 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenA (PI[M12])	210 Participants	16 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenC (PRE)	78 Participants	20 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenC (PI[M1])	214 Participants	66 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenC (PI[M12])	203 Participants	50 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenW-135 (PRE)	57 Participants	23 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenW-135 (PI[M1])	216 Participants	26 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenW-135 (PI[M12])	216 Participants	38 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenY (PRE)	113 Participants	40 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenY (PI[M1])	216 Participants	48 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenY (PI[M12])	214 Participants	42 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Prior to (PRE), one month after vaccination [PI(M1)] and Persistence Year 1 [PI(M12)]

Population: The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 1, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 1 time point.

Antibody titers are presented as GMTs. This analysis was performed by the GSK Biologicals' laboratory.

Outcome measures

Outcome measures
Measure	Nimenrix 2-11 Years of Age Primary Phase Group n=216 Participants Pooled group of subjects above 2 years of age, participating in the Primary Phase.	Mencevax 2-11 Years of Age Primary Phase Group n=66 Participants Pooled group of subjects above 2 years of age, participating in the Primary phase.	Nimenrix 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Nimenrix™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Meningitec 1- 2 Years of Age Group Subjects from 1 to 2 years of age who received one dose of Meningitec™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Mencevax 2- 6 Years of Age Group Subjects from 2 to 6 years of age who received one dose Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.	Mencevax 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.
rSBA Antibody Titers rSBA-MenW-135 (PI[M1])	5386.9 Titer Interval 4859.3 to 5971.7	20.2 Titer Interval 12.3 to 33.2	—	—	—	—
rSBA Antibody Titers rSBA-MenW-135 (PI[M12])	855.1 Titer Interval 757.1 to 965.9	36.7 Titer Interval 22.6 to 59.7	—	—	—	—
rSBA Antibody Titers rSBA-MenY (PRE)	34.6 Titer Interval 26.1 to 45.9	44.1 Titer Interval 26.2 to 74.3	—	—	—	—
rSBA Antibody Titers rSBA-MenY (PI[M1])	2836.5 Titer Interval 2536.4 to 3172.0	78.1 Titer Interval 46.6 to 130.9	—	—	—	—
rSBA Antibody Titers rSBA-MenY (PI[M12])	766.4 Titer Interval 661.0 to 888.5	65.1 Titer Interval 36.9 to 114.7	—	—	—	—
rSBA Antibody Titers rSBA-MenA (PRE)	22.6 Titer Interval 16.7 to 30.6	20.7 Titer Interval 12.3 to 34.9	—	—	—	—
rSBA Antibody Titers rSBA-MenA (PI[M1])	3684.2 Titer Interval 3302.8 to 4109.5	16.9 Titer Interval 9.9 to 29.0	—	—	—	—
rSBA Antibody Titers rSBA-MenA (PI[M12])	967 Titer Interval 843.0 to 1109.3	18.3 Titer Interval 9.5 to 35.1	—	—	—	—
rSBA Antibody Titers rSBA-MenC (PRE)	14 Titer Interval 11.0 to 17.6	10.2 Titer Interval 7.1 to 14.7	—	—	—	—
rSBA Antibody Titers rSBA-MenC (PI[M1])	864.2 Titer Interval 763.6 to 978.2	448.2 Titer Interval 327.5 to 613.6	—	—	—	—
rSBA Antibody Titers rSBA-MenC (PI[M12])	195.3 Titer Interval 166.3 to 229.3	77.1 Titer Interval 49.1 to 121.1	—	—	—	—
rSBA Antibody Titers rSBA-MenW-135 (PRE)	11.3 Titer Interval 8.9 to 14.4	15.5 Titer Interval 9.6 to 24.9	—	—	—	—

SECONDARY outcome

Timeframe: Prior to (PRE), one month after vaccination [PI(M1)] and Persistence Year 1 [PI(M12)]

Population: The analysis was performed on subjects of 2 years and above from the ATP cohort for persistence Year 1, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 1 time point.

The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals' laboratory.

Outcome measures

Outcome measures
Measure	Nimenrix 2-11 Years of Age Primary Phase Group n=216 Participants Pooled group of subjects above 2 years of age, participating in the Primary Phase.	Mencevax 2-11 Years of Age Primary Phase Group n=75 Participants Pooled group of subjects above 2 years of age, participating in the Primary phase.	Nimenrix 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Nimenrix™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Meningitec 1- 2 Years of Age Group Subjects from 1 to 2 years of age who received one dose of Meningitec™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Mencevax 2- 6 Years of Age Group Subjects from 2 to 6 years of age who received one dose Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.	Mencevax 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenA (PRE)	118 Participants	40 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenA (PI[M1])	214 Participants	75 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenA (PI[M12])	215 Participants	64 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenC (PRE)	128 Participants	36 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenC (PI[M1])	214 Participants	74 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenC (PI[M12])	214 Participants	52 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenW-135 (PRE)	113 Participants	39 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenW-135 (PI[M1])	214 Participants	75 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenW-135 (PI[M12])	216 Participants	75 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenY (PRE)	141 Participants	42 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenY (PI[M1])	214 Participants	75 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenY (PI[M12])	216 Participants	64 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Prior to (PRE), one month post vaccination [PI(M1)] and Persistence Year 1 [PI(M12)]

Population: The analysis was performed on subjects of 2 years and above from the ATP cohort for persistence Year 1, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 1 time point.

Antibody titers are presented as geometric mean titers (GMTs). The analysis was performed by the GSK Biologicals' laboratory.

Outcome measures

Outcome measures
Measure	Nimenrix 2-11 Years of Age Primary Phase Group n=216 Participants Pooled group of subjects above 2 years of age, participating in the Primary Phase.	Mencevax 2-11 Years of Age Primary Phase Group n=75 Participants Pooled group of subjects above 2 years of age, participating in the Primary phase.	Nimenrix 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Nimenrix™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Meningitec 1- 2 Years of Age Group Subjects from 1 to 2 years of age who received one dose of Meningitec™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Mencevax 2- 6 Years of Age Group Subjects from 2 to 6 years of age who received one dose Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.	Mencevax 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.
rSBA Antibody Titers rSBA-MenA (PRE)	59.6 Titers Interval 44.1 to 80.3	58.2 Titers Interval 33.8 to 100.1	—	—	—	—
rSBA Antibody Titers rSBA-MenA (PI[M1])	7395.3 Titers Interval 6652.7 to 8220.7	2033.4 Titers Interval 1667.1 to 2480.2	—	—	—	—
rSBA Antibody Titers rSBA-MenA (PI[M12])	2448.1 Titers Interval 2149.6 to 2788.1	358.5 Titers Interval 230.2 to 558.4	—	—	—	—
rSBA Antibody Titers rSBA-MenC (PRE)	34.4 Titers Interval 26.6 to 44.5	24.1 Titers Interval 15.2 to 38.2	—	—	—	—
rSBA Antibody Titers rSBA-MenC (PI[M1])	2488.5 Titers Interval 2145.0 to 2887.0	750.2 Titers Interval 555.2 to 1013.7	—	—	—	—
rSBA Antibody Titers rSBA-MenC (PI[M12])	489.5 Titers Interval 419.5 to 571.1	113.5 Titers Interval 67.3 to 191.5	—	—	—	—
rSBA Antibody Titers rSBA-MenW-135 (PRE)	41.6 Titers Interval 31.1 to 55.8	40.1 Titers Interval 23.9 to 67.3	—	—	—	—
rSBA Antibody Titers rSBA-MenW-135 (PI[M1])	11943.7 Titers Interval 10782.7 to 13229.7	2186.3 Titers Interval 1723.1 to 2773.9	—	—	—	—
rSBA Antibody Titers rSBA-MenW-135 (PI[M12])	2983.3 Titers Interval 2628.2 to 3386.3	463 Titers Interval 367.4 to 583.5	—	—	—	—
rSBA Antibody Titers rSBA-MenY (PRE)	57.4 Titers Interval 43.5 to 75.9	45.5 Titers Interval 26.8 to 77.0	—	—	—	—
rSBA Antibody Titers rSBA-MenY (PI[M1])	6666.3 Titers Interval 6057.7 to 7336.1	1409.9 Titers Interval 1085.9 to 1830.5	—	—	—	—
rSBA Antibody Titers rSBA-MenY (PI[M12])	2172.1 Titers Interval 1939.6 to 2432.5	332.4 Titers Interval 213.5 to 517.7	—	—	—	—

SECONDARY outcome

Timeframe: Prior to (PRE), one month after vaccination [PI(M1)] and Persistence Year 1 [PI(M12)]

Population: The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 1, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 1 time point.

The cut-off value for the anti-polysaccharide concentrations was greater than or equal to (≥) 0.3 micrograms per milliliter (μg/mL).

Outcome measures

Outcome measures
Measure	Nimenrix 2-11 Years of Age Primary Phase Group n=161 Participants Pooled group of subjects above 2 years of age, participating in the Primary Phase.	Mencevax 2-11 Years of Age Primary Phase Group n=49 Participants Pooled group of subjects above 2 years of age, participating in the Primary phase.	Nimenrix 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Nimenrix™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Meningitec 1- 2 Years of Age Group Subjects from 1 to 2 years of age who received one dose of Meningitec™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Mencevax 2- 6 Years of Age Group Subjects from 2 to 6 years of age who received one dose Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.	Mencevax 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.
Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value Anti-PSA (PRE)	9 Participants	4 Participants	—	—	—	—
Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value Anti-PSA (PI[M1])	155 Participants	2 Participants	—	—	—	—
Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value Anti-PSA (PI[M12])	118 Participants	3 Participants	—	—	—	—
Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value Anti-PSC (PRE)	3 Participants	1 Participants	—	—	—	—
Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value Anti-PSC (PI[M1])	161 Participants	49 Participants	—	—	—	—
Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value Anti-PSC (PI[M12])	73 Participants	17 Participants	—	—	—	—
Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value Anti-PSW-135 (PRE)	2 Participants	0 Participants	—	—	—	—
Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value Anti-PSW-135 (PI[M1])	138 Participants	0 Participants	—	—	—	—
Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value Anti-PSW-135 (PI[M12])	124 Participants	0 Participants	—	—	—	—
Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value Anti-PSY (PRE)	1 Participants	1 Participants	—	—	—	—
Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value Anti-PSY (PI[M1])	145 Participants	0 Participants	—	—	—	—
Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value Anti-PSY (PI[M12])	153 Participants	2 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Prior to (PRE), one month after vaccination [PI(M1)] and Persistence Year 1 [PI(M12)]

Population: The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 1, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 1 time point.

Antibody concentrations are presented as GMCs and expressed in micrograms per milliliter (μg/mL).

Outcome measures

Outcome measures
Measure	Nimenrix 2-11 Years of Age Primary Phase Group n=161 Participants Pooled group of subjects above 2 years of age, participating in the Primary Phase.	Mencevax 2-11 Years of Age Primary Phase Group n=49 Participants Pooled group of subjects above 2 years of age, participating in the Primary phase.	Nimenrix 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Nimenrix™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Meningitec 1- 2 Years of Age Group Subjects from 1 to 2 years of age who received one dose of Meningitec™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Mencevax 2- 6 Years of Age Group Subjects from 2 to 6 years of age who received one dose Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.	Mencevax 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.
Anti-PS Antibody Concentrations Anti-PSA (PRE)	0.17 μg/mL Interval 0.15 to 0.18	0.18 μg/mL Interval 0.14 to 0.23	—	—	—	—
Anti-PS Antibody Concentrations Anti-PSA (PI[M1])	33.31 μg/mL Interval 28.94 to 38.35	0.17 μg/mL Interval 0.14 to 0.2	—	—	—	—
Anti-PS Antibody Concentrations Anti-PSA (PI[M12])	1.07 μg/mL Interval 0.89 to 1.3	0.17 μg/mL Interval 0.15 to 0.18	—	—	—	—
Anti-PS Antibody Concentrations Anti-PSC (PRE)	0.16 μg/mL Interval 0.15 to 0.17	0.16 μg/mL Interval 0.14 to 0.19	—	—	—	—
Anti-PS Antibody Concentrations Anti-PSC (PI[M1])	13.44 μg/mL Interval 11.93 to 15.14	8.53 μg/mL Interval 6.97 to 10.43	—	—	—	—
Anti-PS Antibody Concentrations Anti-PSC (PI[M12])	0.39 μg/mL Interval 0.33 to 0.46	0.34 μg/mL Interval 0.24 to 0.47	—	—	—	—
Anti-PS Antibody Concentrations Anti-PSW-135 (PRE)	0.15 μg/mL Interval 0.15 to 0.16	0.15 μg/mL Interval 0.15 to 0.15	—	—	—	—
Anti-PS Antibody Concentrations Anti-PSW-135 (PI[M1])	6.87 μg/mL Interval 5.85 to 8.07	0.15 μg/mL Interval 0.15 to 0.15	—	—	—	—
Anti-PS Antibody Concentrations Anti-PSW-135 (PI[M12])	1.33 μg/mL Interval 1.13 to 1.56	0.15 μg/mL Interval 0.15 to 0.15	—	—	—	—
Anti-PS Antibody Concentrations Anti-PSY (PRE)	0.15 μg/mL Interval 0.15 to 0.15	0.16 μg/mL Interval 0.14 to 0.17	—	—	—	—
Anti-PS Antibody Concentrations Anti-PSY (PI[M1])	10.21 μg/mL Interval 8.96 to 11.62	0.15 μg/mL Interval 0.15 to 0.15	—	—	—	—
Anti-PS Antibody Concentrations Anti-PSY (PI[M12])	1.97 μg/mL Interval 1.7 to 2.28	0.16 μg/mL Interval 0.15 to 0.17	—	—	—	—

SECONDARY outcome

Timeframe: Prior to (PRE), one month after vaccination [PI(M1)] and Persistence Year 1 [PI(M12)]

Population: The analysis was performed on subjects of 2 years and above from the ATP cohort for persistence Year 1, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 1 time point.

The cut-off value for the anti-polysaccharide concentrations was ≥ 0.3 μg/mL.

Outcome measures

Outcome measures
Measure	Nimenrix 2-11 Years of Age Primary Phase Group n=216 Participants Pooled group of subjects above 2 years of age, participating in the Primary Phase.	Mencevax 2-11 Years of Age Primary Phase Group n=75 Participants Pooled group of subjects above 2 years of age, participating in the Primary phase.	Nimenrix 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Nimenrix™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Meningitec 1- 2 Years of Age Group Subjects from 1 to 2 years of age who received one dose of Meningitec™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Mencevax 2- 6 Years of Age Group Subjects from 2 to 6 years of age who received one dose Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.	Mencevax 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.
Number of Subjects With Anti-PS Antibody Concentrations ≥ the Cut-off Value Anti-PSA (PRE)	26 Participants	12 Participants	—	—	—	—
Number of Subjects With Anti-PS Antibody Concentrations ≥ the Cut-off Value Anti-PSA (PI[M1])	213 Participants	73 Participants	—	—	—	—
Number of Subjects With Anti-PS Antibody Concentrations ≥ the Cut-off Value Anti-PSA (PI[M12])	209 Participants	70 Participants	—	—	—	—
Number of Subjects With Anti-PS Antibody Concentrations ≥ the Cut-off Value Anti-PSC (PRE)	29 Participants	6 Participants	—	—	—	—
Number of Subjects With Anti-PS Antibody Concentrations ≥ the Cut-off Value Anti-PSC (PI[M1])	213 Participants	74 Participants	—	—	—	—
Number of Subjects With Anti-PS Antibody Concentrations ≥ the Cut-off Value Anti-PSC (PI[M12])	169 Participants	74 Participants	—	—	—	—
Number of Subjects With Anti-PS Antibody Concentrations ≥ the Cut-off Value Anti-PSW-135 (PRE)	2 Participants	1 Participants	—	—	—	—
Number of Subjects With Anti-PS Antibody Concentrations ≥ the Cut-off Value Anti-PSW-135 (PI[M1])	213 Participants	72 Participants	—	—	—	—
Number of Subjects With Anti-PS Antibody Concentrations ≥ the Cut-off Value Anti-PSW-135 (PI[M12])	206 Participants	65 Participants	—	—	—	—
Number of Subjects With Anti-PS Antibody Concentrations ≥ the Cut-off Value Anti-PSY (PRE)	4 Participants	0 Participants	—	—	—	—
Number of Subjects With Anti-PS Antibody Concentrations ≥ the Cut-off Value Anti-PSY (PI[M1])	214 Participants	72 Participants	—	—	—	—
Number of Subjects With Anti-PS Antibody Concentrations ≥ the Cut-off Value Anti-PSY (PI[M12])	213 Participants	71 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Prior to (PRE), one month post vaccination [PI(M1)] and at Persistence Year 1 [PI(M12)]

Population: The analysis was performed on subjects of 2 years and above from the ATP cohort for persistence Year 1, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 1 time point.

Antibody concentrations are presented as GMCs and expressed in μg/mL.

Outcome measures

Outcome measures
Measure	Nimenrix 2-11 Years of Age Primary Phase Group n=216 Participants Pooled group of subjects above 2 years of age, participating in the Primary Phase.	Mencevax 2-11 Years of Age Primary Phase Group n=75 Participants Pooled group of subjects above 2 years of age, participating in the Primary phase.	Nimenrix 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Nimenrix™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Meningitec 1- 2 Years of Age Group Subjects from 1 to 2 years of age who received one dose of Meningitec™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Mencevax 2- 6 Years of Age Group Subjects from 2 to 6 years of age who received one dose Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.	Mencevax 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.
Anti-PS Antibody Concentrations Anti-PSY (PRE)	0.15 μg/mL Interval 0.15 to 0.16	0.15 μg/mL Interval 0.15 to 0.15	—	—	—	—
Anti-PS Antibody Concentrations Anti-PSA (PRE)	0.19 μg/mL Interval 0.17 to 0.21	0.2 μg/mL Interval 0.16 to 0.23	—	—	—	—
Anti-PS Antibody Concentrations Anti-PSA (PI[M1])	35.95 μg/mL Interval 31.79 to 40.65	10.34 μg/mL Interval 7.79 to 13.72	—	—	—	—
Anti-PS Antibody Concentrations Anti-PSA (PI[M12])	2.33 μg/mL Interval 1.94 to 2.79	4.05 μg/mL Interval 2.88 to 5.68	—	—	—	—
Anti-PS Antibody Concentrations Anti-PSC (PRE)	0.2 μg/mL Interval 0.18 to 0.23	0.19 μg/mL Interval 0.15 to 0.22	—	—	—	—
Anti-PS Antibody Concentrations Anti-PSC (PI[M1])	13.34 μg/mL Interval 11.7 to 15.2	14.53 μg/mL Interval 11.13 to 18.95	—	—	—	—
Anti-PS Antibody Concentrations Anti-PSC (PI[M12])	0.76 μg/mL Interval 0.64 to 0.91	4.4 μg/mL Interval 3.2 to 6.04	—	—	—	—
Anti-PS Antibody Concentrations Anti-PSW-135 (PRE)	0.15 μg/mL Interval 0.15 to 0.15	0.15 μg/mL Interval 0.15 to 0.16	—	—	—	—
Anti-PS Antibody Concentrations Anti-PSW-135 (PI[M1])	6.26 μg/mL Interval 5.43 to 7.22	4.62 μg/mL Interval 3.37 to 6.35	—	—	—	—
Anti-PS Antibody Concentrations Anti-PSW-135 (PI[M12])	1.94 μg/mL Interval 1.7 to 2.22	2.21 μg/mL Interval 1.54 to 3.15	—	—	—	—
Anti-PS Antibody Concentrations Anti-PSY (PI[M1])	11.2 μg/mL Interval 9.86 to 12.71	15.45 μg/mL Interval 11.42 to 20.91	—	—	—	—
Anti-PS Antibody Concentrations Anti-PSY (PI[M12])	2.76 μg/mL Interval 2.43 to 3.15	5.77 μg/mL Interval 4.2 to 7.93	—	—	—	—

SECONDARY outcome

Timeframe: Prior to (PRE), one month post vaccination [PI(M1)] and Persistence Year 1 [PI(M12)]

Population: The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 1, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 1 time point.

The cut-off value for the hSBA titers was greater than or equal to (≥) 1:4.

Outcome measures

Outcome measures
Measure	Nimenrix 2-11 Years of Age Primary Phase Group n=215 Participants Pooled group of subjects above 2 years of age, participating in the Primary Phase.	Mencevax 2-11 Years of Age Primary Phase Group n=68 Participants Pooled group of subjects above 2 years of age, participating in the Primary phase.	Nimenrix 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Nimenrix™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Meningitec 1- 2 Years of Age Group Subjects from 1 to 2 years of age who received one dose of Meningitec™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Mencevax 2- 6 Years of Age Group Subjects from 2 to 6 years of age who received one dose Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.	Mencevax 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenA (PRE)	3 Participants	3 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenA (PI[M1])	196 Participants	3 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenA (PI[M12])	47 Participants	3 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenC (PRE)	3 Participants	1 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenC (PI[M1])	213 Participants	48 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenC (PI[M12])	192 Participants	34 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenW-135 (PRE)	2 Participants	3 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenW-135 (PI[M1])	141 Participants	1 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenW-135 (PI[M12])	172 Participants	3 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenY (PRE)	7 Participants	2 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenY (PI[M1])	131 Participants	3 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenY (PI[M12])	200 Participants	8 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Prior to (PRE), one month post vaccination [PI(M1)] and Persistence Year 1 [PI(M12)]

Population: The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 1, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 1 time point.

Antibody titers are presented as geometric mean titers (GMTs).

Outcome measures

Outcome measures
Measure	Nimenrix 2-11 Years of Age Primary Phase Group n=215 Participants Pooled group of subjects above 2 years of age, participating in the Primary Phase.	Mencevax 2-11 Years of Age Primary Phase Group n=68 Participants Pooled group of subjects above 2 years of age, participating in the Primary phase.	Nimenrix 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Nimenrix™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Meningitec 1- 2 Years of Age Group Subjects from 1 to 2 years of age who received one dose of Meningitec™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Mencevax 2- 6 Years of Age Group Subjects from 2 to 6 years of age who received one dose Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.	Mencevax 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.
hSBA Antibody Titers hSBA-MenA (PRE)	2 Titers Interval 2.0 to 2.1	2.2 Titers Interval 2.0 to 2.4	—	—	—	—
hSBA Antibody Titers hSBA-MenA (PI[M1])	57.6 Titers Interval 47.9 to 69.3	2.2 Titers Interval 1.9 to 2.5	—	—	—	—
hSBA Antibody Titers hSBA-MenA (PI[M12])	3.6 Titers Interval 3.1 to 4.2	2.2 Titers Interval 2.0 to 2.4	—	—	—	—
hSBA Antibody Titers hSBA-MenC (PRE)	2.1 Titers Interval 2.0 to 2.2	2.1 Titers Interval 1.9 to 2.3	—	—	—	—
hSBA Antibody Titers hSBA-MenC (PI[M1])	187 Titers Interval 161.6 to 216.5	22 Titers Interval 14.3 to 33.8	—	—	—	—
hSBA Antibody Titers hSBA-MenC (PI[M12])	88.7 Titers Interval 73.8 to 106.5	12.2 Titers Interval 7.6 to 19.5	—	—	—	—
hSBA Antibody Titers hSBA-MenW-135 (PRE)	2.1 Titers Interval 2.0 to 2.2	2.2 Titers Interval 2.0 to 2.4	—	—	—	—
hSBA Antibody Titers hSBA-MenW-135 (PI[M1])	38.5 Titers Interval 29.3 to 50.5	2.1 Titers Interval 2.0 to 2.2	—	—	—	—
hSBA Antibody Titers hSBA-MenW-135 (PI[M12])	225.1 Titers Interval 184.5 to 274.7	2.4 Titers Interval 1.9 to 3.0	—	—	—	—
hSBA Antibody Titers hSBA-MenY (PRE)	2.2 Titers Interval 2.0 to 2.3	2.1 Titers Interval 2.0 to 2.2	—	—	—	—
hSBA Antibody Titers hSBA-MenY (PI[M1])	23.8 Titers Interval 18.1 to 31.4	2.5 Titers Interval 1.9 to 3.2	—	—	—	—
hSBA Antibody Titers hSBA-MenY (PI[M12])	105.1 Titers Interval 85.2 to 129.7	3.2 Titers Interval 2.3 to 4.4	—	—	—	—

SECONDARY outcome

Timeframe: Prior to (PRE), one month post vaccination [PI(M1)] and Persistence Year 1 [PI(M12)]

Population: The analysis was performed on subjects from 6 to below 11 years of age from the ATP cohort for persistence Year 1, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 1 time point.

The cut-off value for the hSBA titers was greater or equal to (≥) 1:4.

Outcome measures

Outcome measures
Measure	Nimenrix 2-11 Years of Age Primary Phase Group n=109 Participants Pooled group of subjects above 2 years of age, participating in the Primary Phase.	Mencevax 2-11 Years of Age Primary Phase Group n=38 Participants Pooled group of subjects above 2 years of age, participating in the Primary phase.	Nimenrix 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Nimenrix™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Meningitec 1- 2 Years of Age Group Subjects from 1 to 2 years of age who received one dose of Meningitec™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Mencevax 2- 6 Years of Age Group Subjects from 2 to 6 years of age who received one dose Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.	Mencevax 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.
Number of Subjects With hSBA Antibody Titers ≥ to the Cut-off Value hSBA-MenA (PRE)	2 Participants	2 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers ≥ to the Cut-off Value hSBA-MenA (PI[M1])	85 Participants	9 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers ≥ to the Cut-off Value hSBA-MenA (PI[M12])	19 Participants	4 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers ≥ to the Cut-off Value hSBA-MenC (PRE])	32 Participants	9 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers ≥ to the Cut-off Value hSBA-MenC (PI[M1])	90 Participants	15 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers ≥ to the Cut-off Value hSBA-MenC (PI[M12])	100 Participants	10 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers ≥ to the Cut-off Value hSBA-MenW-135 (PRE)	10 Participants	2 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers ≥ to the Cut-off Value hSBA-MenW-135 (PI[M1])	98 Participants	12 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers ≥ to the Cut-off Value hSBA-MenW-135 (PI[M12])	103 Participants	4 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers ≥ to the Cut-off Value hSBA-MenY (PRE)	22 Participants	8 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers ≥ to the Cut-off Value hSBA-MenY (PI[M1])	75 Participants	14 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers ≥ to the Cut-off Value hSBA-MenY (PI[M12])	105 Participants	12 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Prior to (PRE), one month after vaccination [PI(M1)] and at Persistence Year 1 [PI(M12)]

Population: The analysis was performed on subjects from 6 to below 11 years of age from the ATP cohort for persistence Year 1, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 1 time point.

Antibody titers are presented as geometric mean titers (GMTs).

Outcome measures

Outcome measures
Measure	Nimenrix 2-11 Years of Age Primary Phase Group n=109 Participants Pooled group of subjects above 2 years of age, participating in the Primary Phase.	Mencevax 2-11 Years of Age Primary Phase Group n=38 Participants Pooled group of subjects above 2 years of age, participating in the Primary phase.	Nimenrix 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Nimenrix™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Meningitec 1- 2 Years of Age Group Subjects from 1 to 2 years of age who received one dose of Meningitec™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Mencevax 2- 6 Years of Age Group Subjects from 2 to 6 years of age who received one dose Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.	Mencevax 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.
hSBA Antibody Titers hSBA-MenA (PRE)	2.1 Titer Interval 2.0 to 2.2	2.2 Titer Interval 1.9 to 2.5	—	—	—	—
hSBA Antibody Titers hSBA-MenA (PI[M1])	53.4 Titer Interval 37.3 to 76.2	4.1 Titer Interval 2.6 to 6.5	—	—	—	—
hSBA Antibody Titers hSBA-MenA (PI[M12])	3.5 Titer Interval 2.7 to 4.4	2.5 Titer Interval 1.9 to 3.3	—	—	—	—
hSBA Antibody Titers hSBA-MenC (PRE)	4.7 Titer Interval 3.6 to 6.2	4.4 Titer Interval 2.7 to 7.2	—	—	—	—
hSBA Antibody Titers hSBA-MenC (PI[M1])	155.8 Titer Interval 99.3 to 244.3	13.1 Titer Interval 5.4 to 32.0	—	—	—	—
hSBA Antibody Titers hSBA-MenC (PI[M12])	129.5 Titer Interval 95.4 to 175.9	7.7 Titer Interval 3.5 to 17.3	—	—	—	—
hSBA Antibody Titers hSBA-MenW-135 (PRE)	3.0 Titer Interval 2.3 to 3.8	2.6 Titer Interval 1.8 to 3.7	—	—	—	—
hSBA Antibody Titers hSBA-MenW-135 (PI[M1])	133.5 Titer Interval 99.9 to 178.4	5.8 Titer Interval 3.3 to 9.9	—	—	—	—
hSBA Antibody Titers hSBA-MenW-135 (PI[M12])	256.7 Titer Interval 218.2 to 301.9	3.4 Titer Interval 2.0 to 5.8	—	—	—	—
hSBA Antibody Titers hSBA-MenY (PRE)	5.3 Titer Interval 3.6 to 7.8	6.1 Titer Interval 3.0 to 12.6	—	—	—	—
hSBA Antibody Titers hSBA-MenY (PI[M1])	95.1 Titer Interval 62.4 to 145.1	12.5 Titer Interval 5.6 to 27.7	—	—	—	—
hSBA Antibody Titers hSBA-MenY (PI[M12])	265.0 Titer Interval 213.0 to 329.6	9.3 Titer Interval 4.3 to 19.9	—	—	—	—

SECONDARY outcome

Timeframe: Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)] and Persistence Year 2 [PI(M24)]

Population: The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 2, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 2 time point.

The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals' laboratory.

Outcome measures

Outcome measures
Measure	Nimenrix 2-11 Years of Age Primary Phase Group n=199 Participants Pooled group of subjects above 2 years of age, participating in the Primary Phase.	Mencevax 2-11 Years of Age Primary Phase Group n=52 Participants Pooled group of subjects above 2 years of age, participating in the Primary phase.	Nimenrix 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Nimenrix™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Meningitec 1- 2 Years of Age Group Subjects from 1 to 2 years of age who received one dose of Meningitec™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Mencevax 2- 6 Years of Age Group Subjects from 2 to 6 years of age who received one dose Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.	Mencevax 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenA (PRE)	73 Participants	21 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenA (PI[M1])	199 Participants	18 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenA (PI[M12])	193 Participants	13 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenA (PI[M24])	188 Participants	30 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenC (PRE)	72 Participants	16 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenC (PI[M1])	197 Participants	50 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenC (PI[M12])	188 Participants	47 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenC (PI[M24])	185 Participants	38 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenW-135 (PRE)	54 Participants	16 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenW-135 (PI[M1])	199 Participants	19 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenW-135 (PI[M12])	198 Participants	29 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenW-135 (PI[M24])	198 Participants	24 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenY (PRE)	104 Participants	31 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenY (PI[M1])	199 Participants	38 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenY (PI[M12])	196 Participants	35 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenY (PI[M24])	193 Participants	37 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)] and Persistence Year 2 [PI(M24)]

Population: The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 2, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 2 time point.

Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the GSK Biologicals' laboratory.

Outcome measures

Outcome measures
Measure	Nimenrix 2-11 Years of Age Primary Phase Group n=199 Participants Pooled group of subjects above 2 years of age, participating in the Primary Phase.	Mencevax 2-11 Years of Age Primary Phase Group n=52 Participants Pooled group of subjects above 2 years of age, participating in the Primary phase.	Nimenrix 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Nimenrix™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Meningitec 1- 2 Years of Age Group Subjects from 1 to 2 years of age who received one dose of Meningitec™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Mencevax 2- 6 Years of Age Group Subjects from 2 to 6 years of age who received one dose Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.	Mencevax 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.
rSBA Antibody Titers rSBA-MenA (PRE)	22.7 Titers Interval 16.5 to 31.2	24 Titers Interval 12.9 to 44.6	—	—	—	—
rSBA Antibody Titers rSBA-MenA (PI[M1])	3743 Titers Interval 3341.1 to 4193.2	20 Titers Interval 10.6 to 37.8	—	—	—	—
rSBA Antibody Titers rSBA-MenA (PI[M12])	961.4 Titers Interval 830.0 to 1113.5	21.5 Titers Interval 9.8 to 47.0	—	—	—	—
rSBA Antibody Titers rSBA-MenA (PI[M24])	567.7 Titers Interval 489.8 to 658.0	51.3 Titers Interval 29.0 to 90.8	—	—	—	—
rSBA Antibody Titers rSBA-MenC (PRE)	13.7 Titers Interval 10.8 to 17.5	11.2 Titers Interval 7.2 to 17.4	—	—	—	—
rSBA Antibody Titers rSBA-MenC (PI[M1])	870.9 Titers Interval 766.0 to 990.1	626.4 Titers Interval 442.7 to 886.3	—	—	—	—
rSBA Antibody Titers rSBA-MenC (PI[M12])	203.9 Titers Interval 174.2 to 238.6	163.7 Titers Interval 118.6 to 226.0	—	—	—	—
rSBA Antibody Titers rSBA-MenC (PI[M24])	117.4 Titers Interval 97.1 to 141.9	57.7 Titers Interval 33.5 to 99.3	—	—	—	—
rSBA Antibody Titers rSBA-MenW-135 (PRE)	11.5 Titers Interval 8.9 to 14.7	13 Titers Interval 7.8 to 21.8	—	—	—	—
rSBA Antibody Titers rSBA-MenW-135 (PI[M1])	5424.4 Titers Interval 4867.9 to 6044.4	17.6 Titers Interval 10.2 to 30.5	—	—	—	—
rSBA Antibody Titers rSBA-MenW-135 (PI[M12])	856.6 Titers Interval 755.4 to 971.3	35.4 Titers Interval 20.4 to 61.5	—	—	—	—
rSBA Antibody Titers rSBA-MenW-135 (PI[M24])	415.9 Titers Interval 362.4 to 477.3	27.5 Titers Interval 15.7 to 48.1	—	—	—	—
rSBA Antibody Titers rSBA-MenY (PRE)	34 Titers Interval 25.4 to 45.5	44.6 Titers Interval 24.8 to 80.2	—	—	—	—
rSBA Antibody Titers rSBA-MenY (PI[M1])	2797.6 Titers Interval 2494.9 to 3137.1	86 Titers Interval 49.3 to 150.0	—	—	—	—
rSBA Antibody Titers rSBA-MenY (PI[M12])	749.4 Titers Interval 642.9 to 873.6	82.7 Titers Interval 44.7 to 152.9	—	—	—	—
rSBA Antibody Titers rSBA-MenY (PI[M24])	504.1 Titers Interval 421.0 to 603.6	93.5 Titers Interval 51.8 to 168.7	—	—	—	—

SECONDARY outcome

Timeframe: Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)] and Persistence Year 2 [PI(M24)]

Population: The analysis was performed on subjects of 2 years and above from the ATP cohort for persistence Year 2, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 2 time point.

The cut-off value for the rSBA titers was ≥ 1:8. This analysis was performed by the GSK Biologicals' laboratory.

Outcome measures

Outcome measures
Measure	Nimenrix 2-11 Years of Age Primary Phase Group n=210 Participants Pooled group of subjects above 2 years of age, participating in the Primary Phase.	Mencevax 2-11 Years of Age Primary Phase Group n=59 Participants Pooled group of subjects above 2 years of age, participating in the Primary phase.	Nimenrix 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Nimenrix™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Meningitec 1- 2 Years of Age Group Subjects from 1 to 2 years of age who received one dose of Meningitec™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Mencevax 2- 6 Years of Age Group Subjects from 2 to 6 years of age who received one dose Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.	Mencevax 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenA (PRE)	113 Participants	32 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenA (PI[M1])	209 Participants	59 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenA (PI[M12])	207 Participants	53 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenA (PI[M24])	208 Participants	51 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenC (PRE)	125 Participants	34 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenC (PI[M1])	209 Participants	59 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenC (PI[M12])	207 Participants	49 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenC (PI[M24])	207 Participants	39 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenW-135 (PRE)	115 Participants	32 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenW-135 (PI[M1])	209 Participants	59 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenW-135 (PI[M12])	208 Participants	59 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenW-135 (PI[M24])	209 Participants	46 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenY (PRE)	138 Participants	31 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenY (PI[M1])	209 Participants	59 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenY (PI[M12])	208 Participants	52 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenY (PI[M24])	210 Participants	41 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)] and Persistence Year 2 [PI(M24)]

Population: The analysis was performed on subjects of 2 years and above from the ATP cohort for persistence Year 2, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 2 time point.

Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the GSK Biologicals' laboratory.

Outcome measures

Outcome measures
Measure	Nimenrix 2-11 Years of Age Primary Phase Group n=210 Participants Pooled group of subjects above 2 years of age, participating in the Primary Phase.	Mencevax 2-11 Years of Age Primary Phase Group n=59 Participants Pooled group of subjects above 2 years of age, participating in the Primary phase.	Nimenrix 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Nimenrix™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Meningitec 1- 2 Years of Age Group Subjects from 1 to 2 years of age who received one dose of Meningitec™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Mencevax 2- 6 Years of Age Group Subjects from 2 to 6 years of age who received one dose Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.	Mencevax 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.
rSBA Antibody Titers rSBA-MenA (PRE)	57.1 Titers Interval 42.1 to 77.4	64.5 Titers Interval 34.9 to 119.0	—	—	—	—
rSBA Antibody Titers rSBA-MenA (PI[M1])	7392.2 Titers Interval 6645.0 to 8223.3	2230.8 Titers Interval 1797.6 to 2768.3	—	—	—	—
rSBA Antibody Titers rSBA-MenA (PI[M12])	2475.3 Titers Interval 2170.5 to 2822.9	450.6 Titers Interval 289.0 to 702.7	—	—	—	—
rSBA Antibody Titers rSBA-MenA (PI[M24])	1333.4 Titers Interval 1181.9 to 1504.2	202.5 Titers Interval 135.3 to 303.0	—	—	—	—
rSBA Antibody Titers rSBA-MenC (PRE)	35.4 Titers Interval 27.2 to 46.0	33.7 Titers Interval 20.0 to 56.8	—	—	—	—
rSBA Antibody Titers rSBA-MenC (PI[M1])	2475.6 Titers Interval 2128.8 to 2878.9	966.7 Titers Interval 695.7 to 1343.2	—	—	—	—
rSBA Antibody Titers rSBA-MenC (PI[M12])	490.3 Titers Interval 421.7 to 570.2	277 Titers Interval 187.4 to 409.6	—	—	—	—
rSBA Antibody Titers rSBA-MenC (PI[M24])	256 Titers Interval 213.9 to 306.2	59.9 Titers Interval 33.0 to 108.7	—	—	—	—
rSBA Antibody Titers rSBA-MenW-135 (PRE)	43.9 Titers Interval 32.8 to 58.8	46.2 Titers Interval 25.7 to 83.0	—	—	—	—
rSBA Antibody Titers rSBA-MenW-135 (PI[M1])	11892.6 Titers Interval 10744.2 to 13163.7	2215 Titers Interval 1679.2 to 2921.7	—	—	—	—
rSBA Antibody Titers rSBA-MenW-135 (PI[M12])	2969.7 Titers Interval 2612.5 to 3375.9	496.2 Titers Interval 383.5 to 641.9	—	—	—	—
rSBA Antibody Titers rSBA-MenW-135 (PI[M24])	1298 Titers Interval 1135.5 to 1483.7	144 Titers Interval 90.1 to 230.2	—	—	—	—
rSBA Antibody Titers rSBA-MenY (PRE)	58.3 Titers Interval 44.0 to 77.3	40.9 Titers Interval 22.3 to 75.0	—	—	—	—
rSBA Antibody Titers rSBA-MenY (PI[M1])	6594.5 Titers Interval 5971.2 to 7282.9	1574.2 Titers Interval 1177.1 to 2105.3	—	—	—	—
rSBA Antibody Titers rSBA-MenY (PI[M12])	2115.5 Titers Interval 1886.4 to 2372.5	418 Titers Interval 269.2 to 649.2	—	—	—	—
rSBA Antibody Titers rSBA-MenY (PI[M24])	1530.2 Titers Interval 1339.2 to 1748.4	96.9 Titers Interval 54.1 to 173.6	—	—	—	—

SECONDARY outcome

Timeframe: Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)] and Persistence Year 2 [PI(M24)]

Population: The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 2, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 2 time point.

Antibody concentrations are presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL).

Outcome measures

Outcome measures
Measure	Nimenrix 2-11 Years of Age Primary Phase Group n=161 Participants Pooled group of subjects above 2 years of age, participating in the Primary Phase.	Mencevax 2-11 Years of Age Primary Phase Group n=39 Participants Pooled group of subjects above 2 years of age, participating in the Primary phase.	Nimenrix 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Nimenrix™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Meningitec 1- 2 Years of Age Group Subjects from 1 to 2 years of age who received one dose of Meningitec™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Mencevax 2- 6 Years of Age Group Subjects from 2 to 6 years of age who received one dose Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.	Mencevax 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.
Anti-PS Antibody Concentrations Anti-PSA (PRE)	0.16 μg/mL Interval 0.15 to 0.18	0.19 μg/mL Interval 0.14 to 0.25	—	—	—	—
Anti-PS Antibody Concentrations Anti-PSA (PI[M1])	32.63 μg/mL Interval 28.2 to 37.75	0.18 μg/mL Interval 0.14 to 0.22	—	—	—	—
Anti-PS Antibody Concentrations Anti-PSA (PI[M12])	1.08 μg/mL Interval 0.89 to 1.32	0.16 μg/mL Interval 0.14 to 0.18	—	—	—	—
Anti-PS Antibody Concentrations Anti-PSA (PI[M24])	0.59 μg/mL Interval 0.5 to 0.69	0.19 μg/mL Interval 0.16 to 0.23	—	—	—	—
Anti-PS Antibody Concentrations Anti-PSC (PRE)	0.16 μg/mL Interval 0.15 to 0.17	0.16 μg/mL Interval 0.14 to 0.2	—	—	—	—
Anti-PS Antibody Concentrations Anti-PSC (PI[M1])	13.58 μg/mL Interval 12.01 to 15.36	9.16 μg/mL Interval 7.31 to 11.47	—	—	—	—
Anti-PS Antibody Concentrations Anti-PSC (PI[M12])	0.39 μg/mL Interval 0.33 to 0.47	0.36 μg/mL Interval 0.24 to 0.53	—	—	—	—
Anti-PS Antibody Concentrations Anti-PSC (PI[M24])	0.26 μg/mL Interval 0.22 to 0.3	0.24 μg/mL Interval 0.17 to 0.36	—	—	—	—
Anti-PS Antibody Concentrations Anti-PSW-135 (PRE)	0.15 μg/mL Interval 0.15 to 0.15	0.15 μg/mL Interval 0.15 to 0.15	—	—	—	—
Anti-PS Antibody Concentrations Anti-PSW-135 (PI[M1])	6.58 μg/mL Interval 5.6 to 7.74	0.15 μg/mL Interval 0.15 to 0.15	—	—	—	—
Anti-PS Antibody Concentrations Anti-PSW-135 (PI[M12])	1.33 μg/mL Interval 1.12 to 1.58	0.15 μg/mL Interval 0.15 to 0.15	—	—	—	—
Anti-PS Antibody Concentrations Anti-PSW-135 (PI[M24])	0.65 μg/mL Interval 0.54 to 0.79	0.15 μg/mL Interval 0.15 to 0.15	—	—	—	—
Anti-PS Antibody Concentrations Anti-PSY (PRE)	0.15 μg/mL Interval 0.15 to 0.15	0.16 μg/mL Interval 0.14 to 0.18	—	—	—	—
Anti-PS Antibody Concentrations Anti-PSY (PI[M1])	10.22 μg/mL Interval 8.96 to 11.67	0.15 μg/mL Interval 0.15 to 0.15	—	—	—	—
Anti-PS Antibody Concentrations Anti-PSY (PI[M12])	1.95 μg/mL Interval 1.67 to 2.27	0.15 μg/mL Interval 0.15 to 0.17	—	—	—	—
Anti-PS Antibody Concentrations Anti-PSY (PI[M24])	1.12 μg/mL Interval 0.96 to 1.3	0.16 μg/mL Interval 0.14 to 0.19	—	—	—	—

SECONDARY outcome

Timeframe: Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)] and Persistence Year 2 [PI(M24)]

Population: The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 2, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 2 time point.

The cut-off value for the anti-polysaccharide concentrations was ≥ 0.3 micrograms per milliliter (μg/mL).

Outcome measures

Outcome measures
Measure	Nimenrix 2-11 Years of Age Primary Phase Group n=161 Participants Pooled group of subjects above 2 years of age, participating in the Primary Phase.	Mencevax 2-11 Years of Age Primary Phase Group n=39 Participants Pooled group of subjects above 2 years of age, participating in the Primary phase.	Nimenrix 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Nimenrix™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Meningitec 1- 2 Years of Age Group Subjects from 1 to 2 years of age who received one dose of Meningitec™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Mencevax 2- 6 Years of Age Group Subjects from 2 to 6 years of age who received one dose Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.	Mencevax 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.
Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value Anti-PSA (PRE)	7 Participants	4 Participants	—	—	—	—
Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value Anti-PSA (PI[M1])	143 Participants	2 Participants	—	—	—	—
Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value Anti-PSA (PI[M12])	109 Participants	2 Participants	—	—	—	—
Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value Anti-PSA (PI[M24])	107 Participants	7 Participants	—	—	—	—
Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value Anti-PSC (PRE)	3 Participants	1 Participants	—	—	—	—
Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value Anti-PSC (PI[M1])	148 Participants	35 Participants	—	—	—	—
Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value Anti-PSC (PI[M12])	68 Participants	15 Participants	—	—	—	—
Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value Anti-PSC (PI[M24])	38 Participants	6 Participants	—	—	—	—
Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value Anti-PSW-135 (PRE)	1 Participants	0 Participants	—	—	—	—
Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value Anti-PSW-135 (PI[M1])	129 Participants	0 Participants	—	—	—	—
Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value Anti-PSW-135 (PI[M12])	114 Participants	0 Participants	—	—	—	—
Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value Anti-PSW-135 (PI[M24])	98 Participants	0 Participants	—	—	—	—
Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value Anti-PSY (PRE)	1 Participants	1 Participants	—	—	—	—
Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value Anti-PSY (PI[M1])	135 Participants	0 Participants	—	—	—	—
Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value Anti-PSY (PI[M12])	140 Participants	1 Participants	—	—	—	—
Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value Anti-PSY (PI[M24])	144 Participants	1 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)] and Persistence Year 2 [PI(M24)]

Population: The analysis was performed on subjects of 2 years and above from the ATP cohort for persistence Year 2, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 2 time point.

The cut-off value for the anti-polysaccharide concentrations was ≥ 0.3 micrograms per milliliter (μg/mL).

Outcome measures

Outcome measures
Measure	Nimenrix 2-11 Years of Age Primary Phase Group n=210 Participants Pooled group of subjects above 2 years of age, participating in the Primary Phase.	Mencevax 2-11 Years of Age Primary Phase Group n=59 Participants Pooled group of subjects above 2 years of age, participating in the Primary phase.	Nimenrix 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Nimenrix™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Meningitec 1- 2 Years of Age Group Subjects from 1 to 2 years of age who received one dose of Meningitec™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Mencevax 2- 6 Years of Age Group Subjects from 2 to 6 years of age who received one dose Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.	Mencevax 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.
Number of Subjects With Anti-PS Antibody Concentrations ≥ the Cut-off Value Anti-PSA (PRE)	24 Participants	11 Participants	—	—	—	—
Number of Subjects With Anti-PS Antibody Concentrations ≥ the Cut-off Value Anti-PSA (PI[M1])	208 Participants	58 Participants	—	—	—	—
Number of Subjects With Anti-PS Antibody Concentrations ≥ the Cut-off Value Anti-PSA (PI[M12])	201 Participants	54 Participants	—	—	—	—
Number of Subjects With Anti-PS Antibody Concentrations ≥ the Cut-off Value Anti-PSA (PI[M24])	187 Participants	54 Participants	—	—	—	—
Number of Subjects With Anti-PS Antibody Concentrations ≥ the Cut-off Value Anti-PSC (PRE)	29 Participants	6 Participants	—	—	—	—
Number of Subjects With Anti-PS Antibody Concentrations ≥ the Cut-off Value Anti-PSC (PI[M1])	208 Participants	59 Participants	—	—	—	—
Number of Subjects With Anti-PS Antibody Concentrations ≥ the Cut-off Value Anti-PSC (PI[M12])	163 Participants	58 Participants	—	—	—	—
Number of Subjects With Anti-PS Antibody Concentrations ≥ the Cut-off Value Anti-PSC (PI[M24])	131 Participants	57 Participants	—	—	—	—
Number of Subjects With Anti-PS Antibody Concentrations ≥ the Cut-off Value Anti-PSW-135 (PRE)	3 Participants	1 Participants	—	—	—	—
Number of Subjects With Anti-PS Antibody Concentrations ≥ the Cut-off Value Anti-PSW-135 (PI[M1])	208 Participants	57 Participants	—	—	—	—
Number of Subjects With Anti-PS Antibody Concentrations ≥ the Cut-off Value Anti-PSW-135 (PI[M12])	198 Participants	52 Participants	—	—	—	—
Number of Subjects With Anti-PS Antibody Concentrations ≥ the Cut-off Value Anti-PSW-135 (PI[M24])	181 Participants	52 Participants	—	—	—	—
Number of Subjects With Anti-PS Antibody Concentrations ≥ the Cut-off Value Anti-PSY (PRE)	5 Participants	0 Participants	—	—	—	—
Number of Subjects With Anti-PS Antibody Concentrations ≥ the Cut-off Value Anti-PSY (PI[M1])	209 Participants	56 Participants	—	—	—	—
Number of Subjects With Anti-PS Antibody Concentrations ≥ the Cut-off Value Anti-PSY (PI[M12])	205 Participants	56 Participants	—	—	—	—
Number of Subjects With Anti-PS Antibody Concentrations ≥ the Cut-off Value Anti-PSY (PI[M24])	198 Participants	50 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)] and Persistence Year 2 [PI(M24)]

Population: The analysis was performed on subjects of 2 years and above from the ATP cohort for persistence Year 2, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 2 time point.

Antibody concentrations are presented as GMCs and expressed in micrograms per milliliter (μg/mL).

Outcome measures

Outcome measures
Measure	Nimenrix 2-11 Years of Age Primary Phase Group n=210 Participants Pooled group of subjects above 2 years of age, participating in the Primary Phase.	Mencevax 2-11 Years of Age Primary Phase Group n=59 Participants Pooled group of subjects above 2 years of age, participating in the Primary phase.	Nimenrix 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Nimenrix™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Meningitec 1- 2 Years of Age Group Subjects from 1 to 2 years of age who received one dose of Meningitec™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Mencevax 2- 6 Years of Age Group Subjects from 2 to 6 years of age who received one dose Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.	Mencevax 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.
Anti-PS Antibody Concentrations Anti-PSA (PRE)	0.18 μg/mL Interval 0.17 to 0.2	0.21 μg/mL Interval 0.17 to 0.26	—	—	—	—
Anti-PS Antibody Concentrations Anti-PSA (PI[M1])	34.76 μg/mL Interval 30.83 to 39.19	11.2 μg/mL Interval 8.1 to 15.47	—	—	—	—
Anti-PS Antibody Concentrations Anti-PSA (PI[M12])	2.27 μg/mL Interval 1.9 to 2.71	4.62 μg/mL Interval 3.13 to 6.82	—	—	—	—
Anti-PS Antibody Concentrations Anti-PSA (PI[M24])	1.52 μg/mL Interval 1.28 to 1.81	2.93 μg/mL Interval 2.07 to 4.14	—	—	—	—
Anti-PS Antibody Concentrations Anti-PSC (PRE)	0.2 μg/mL Interval 0.18 to 0.23	0.2 μg/mL Interval 0.16 to 0.25	—	—	—	—
Anti-PS Antibody Concentrations Anti-PSC (PI[M1])	12.94 μg/mL Interval 11.37 to 14.72	15.28 μg/mL Interval 11.24 to 20.77	—	—	—	—
Anti-PS Antibody Concentrations Anti-PSC (PI[M12])	0.75 μg/mL Interval 0.63 to 0.9	4.98 μg/mL Interval 3.51 to 7.06	—	—	—	—
Anti-PS Antibody Concentrations Anti-PSC (PI[M24])	0.54 μg/mL Interval 0.45 to 0.64	2.81 μg/mL Interval 2.02 to 3.91	—	—	—	—
Anti-PS Antibody Concentrations Anti-PSW-135 (PRE)	0.15 μg/mL Interval 0.15 to 0.16	0.15 μg/mL Interval 0.15 to 0.16	—	—	—	—
Anti-PS Antibody Concentrations Anti-PSW-135 (PI[M1])	6.16 μg/mL Interval 5.34 to 7.11	4.5 μg/mL Interval 3.13 to 6.47	—	—	—	—
Anti-PS Antibody Concentrations Anti-PSW-135 (PI[M12])	1.9 μg/mL Interval 1.66 to 2.17	2.28 μg/mL Interval 1.53 to 3.4	—	—	—	—
Anti-PS Antibody Concentrations Anti-PSW-135 (PI[M24])	1.15 μg/mL Interval 0.99 to 1.34	1.32 μg/mL Interval 0.92 to 1.9	—	—	—	—
Anti-PS Antibody Concentrations Anti-PSY (PRE)	0.16 μg/mL Interval 0.15 to 0.16	0.15 μg/mL Interval 0.15 to 0.15	—	—	—	—
Anti-PS Antibody Concentrations Anti-PSY (PI[M1])	11.1 μg/mL Interval 9.76 to 12.63	14.91 μg/mL Interval 10.45 to 21.28	—	—	—	—
Anti-PS Antibody Concentrations Anti-PSY (PI[M12])	2.73 μg/mL Interval 2.39 to 3.11	5.8 μg/mL Interval 4.01 to 8.39	—	—	—	—
Anti-PS Antibody Concentrations Anti-PSY (PI[M24])	1.72 μg/mL Interval 1.49 to 1.98	2.9 μg/mL Interval 1.98 to 4.26	—	—	—	—

SECONDARY outcome

Timeframe: Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)] and Persistence Year 2 [PI(M24)]

Population: The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 2, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 2 time point.

The cut-off value for the hSBA titers was greater than or equal to (≥) 1:4.

Outcome measures

Outcome measures
Measure	Nimenrix 2-11 Years of Age Primary Phase Group n=198 Participants Pooled group of subjects above 2 years of age, participating in the Primary Phase.	Mencevax 2-11 Years of Age Primary Phase Group n=52 Participants Pooled group of subjects above 2 years of age, participating in the Primary phase.	Nimenrix 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Nimenrix™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Meningitec 1- 2 Years of Age Group Subjects from 1 to 2 years of age who received one dose of Meningitec™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Mencevax 2- 6 Years of Age Group Subjects from 2 to 6 years of age who received one dose Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.	Mencevax 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenA (PRE)	3 Participants	3 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenA (PI[M1])	180 Participants	2 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenA (PI[M12])	42 Participants	3 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenA (PI[M24])	73 Participants	6 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenC (PRE)	2 Participants	1 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenC (PI[M1])	196 Participants	38 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenC (PI[M12])	179 Participants	28 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenC (PI[M24])	179 Participants	28 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenW-135 (PRE)	2 Participants	2 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenW-135 (PI[M1])	130 Participants	1 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenW-135 (PI[M12])	156 Participants	3 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenW-135 (PI[M24])	171 Participants	5 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenY (PRE)	6 Participants	2 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenY (PI[M1])	121 Participants	3 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenY (PI[M12])	183 Participants	8 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenY (PI[M24])	157 Participants	13 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)] and Persistence Year 2 [PI(M24)]

Population: The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 2, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 2 time point.

Antibody titers are presented as geometric mean titers (GMTs).

Outcome measures

Outcome measures
Measure	Nimenrix 2-11 Years of Age Primary Phase Group n=198 Participants Pooled group of subjects above 2 years of age, participating in the Primary Phase.	Mencevax 2-11 Years of Age Primary Phase Group n=52 Participants Pooled group of subjects above 2 years of age, participating in the Primary phase.	Nimenrix 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Nimenrix™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Meningitec 1- 2 Years of Age Group Subjects from 1 to 2 years of age who received one dose of Meningitec™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Mencevax 2- 6 Years of Age Group Subjects from 2 to 6 years of age who received one dose Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.	Mencevax 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.
hSBA Antibody Titers hSBA-MenA (PRE)	2 Titers Interval 2.0 to 2.1	2.2 Titers Interval 2.0 to 2.5	—	—	—	—
hSBA Antibody Titers hSBA-MenA (PI[M1])	58.8 Titers Interval 48.5 to 71.3	2.2 Titers Interval 1.9 to 2.7	—	—	—	—
hSBA Antibody Titers hSBA-MenA (PI[M12])	3.6 Titers Interval 3.0 to 4.2	2.2 Titers Interval 2.0 to 2.6	—	—	—	—
hSBA Antibody Titers hSBA-MenA (PI[M24])	5.1 Titers Interval 4.2 to 6.1	2.3 Titers Interval 2.0 to 2.5	—	—	—	—
hSBA Antibody Titers hSBA-MenC (PRE)	2.1 Titers Interval 2.0 to 2.1	2.1 Titers Interval 1.9 to 2.4	—	—	—	—
hSBA Antibody Titers hSBA-MenC (PI[M1])	185.4 Titers Interval 159.3 to 215.9	26.7 Titers Interval 16.1 to 44.3	—	—	—	—
hSBA Antibody Titers hSBA-MenC (PI[M12])	88.6 Titers Interval 73.6 to 106.6	14.7 Titers Interval 8.4 to 25.6	—	—	—	—
hSBA Antibody Titers hSBA-MenC (PI[M24])	55.6 Titers Interval 45.1 to 68.5	11.8 Titers Interval 6.8 to 20.6	—	—	—	—
hSBA Antibody Titers hSBA-MenW-135 (PRE)	2.1 Titers Interval 2.0 to 2.2	2.1 Titers Interval 2.0 to 2.3	—	—	—	—
hSBA Antibody Titers hSBA-MenW-135 (PI[M1])	38.7 Titers Interval 29.2 to 51.2	2.1 Titers Interval 1.9 to 2.2	—	—	—	—
hSBA Antibody Titers hSBA-MenW-135 (PI[M12])	218.8 Titers Interval 177.1 to 270.5	2.6 Titers Interval 1.9 to 3.5	—	—	—	—
hSBA Antibody Titers hSBA-MenW-135 (PI[M24])	111.4 Titers Interval 90.9 to 136.5	2.9 Titers Interval 2.1 to 4.0	—	—	—	—
hSBA Antibody Titers hSBA-MenY (PRE)	2.1 Titers Interval 2.0 to 2.3	2.1 Titers Interval 2.0 to 2.2	—	—	—	—
hSBA Antibody Titers hSBA-MenY (PI[M1])	23.1 Titers Interval 17.4 to 30.8	2.6 Titers Interval 1.9 to 3.7	—	—	—	—
hSBA Antibody Titers hSBA-MenY (PI[M12])	99.8 Titers Interval 80.2 to 124.0	3.7 Titers Interval 2.4 to 5.6	—	—	—	—
hSBA Antibody Titers hSBA-MenY (PI[M24])	72.5 Titers Interval 57.0 to 92.4	5 Titers Interval 3.1 to 7.9	—	—	—	—

SECONDARY outcome

Timeframe: Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)] and Persistence Year 3 [PI(M36)]

Population: The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 3, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 3 time point.

The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals' laboratory.

Outcome measures

Outcome measures
Measure	Nimenrix 2-11 Years of Age Primary Phase Group n=177 Participants Pooled group of subjects above 2 years of age, participating in the Primary Phase.	Mencevax 2-11 Years of Age Primary Phase Group n=37 Participants Pooled group of subjects above 2 years of age, participating in the Primary phase.	Nimenrix 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Nimenrix™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Meningitec 1- 2 Years of Age Group Subjects from 1 to 2 years of age who received one dose of Meningitec™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Mencevax 2- 6 Years of Age Group Subjects from 2 to 6 years of age who received one dose Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.	Mencevax 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenA (PRE)	65 Participants	15 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenA (PI[M1])	177 Participants	10 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenA (PI[M12])	172 Participants	7 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenA (PI[M24])	164 Participants	21 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenA (PI[M36])	168 Participants	27 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenC (PRE)	71 Participants	12 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenC (PI[M1])	175 Participants	36 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenC (PI[M12])	169 Participants	35 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenC (PI[M24])	171 Participants	36 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenC (PI[M36])	158 Participants	36 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenW-135 (PRE)	50 Participants	11 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenW-135 (PI[M1])	177 Participants	14 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenW-135 (PI[M12])	176 Participants	22 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenW-135 (PI[M24])	172 Participants	15 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenW-135 (PI[M36])	172 Participants	24 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenY (PRE)	96 Participants	24 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenY (PI[M1])	177 Participants	29 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenY (PI[M12])	175 Participants	24 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenY (PI[M24])	168 Participants	27 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenY (PI[M36])	174 Participants	33 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)] and Persistence Year 3 [PI(M36)]

Population: The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 3, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 3 time point.

Antibody titers are presented as geometric mean titers (GMTs).This analysis was performed by the GSK Biologicals' laboratory.

Outcome measures

Outcome measures
Measure	Nimenrix 2-11 Years of Age Primary Phase Group n=177 Participants Pooled group of subjects above 2 years of age, participating in the Primary Phase.	Mencevax 2-11 Years of Age Primary Phase Group n=37 Participants Pooled group of subjects above 2 years of age, participating in the Primary phase.	Nimenrix 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Nimenrix™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Meningitec 1- 2 Years of Age Group Subjects from 1 to 2 years of age who received one dose of Meningitec™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Mencevax 2- 6 Years of Age Group Subjects from 2 to 6 years of age who received one dose Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.	Mencevax 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.
rSBA Antibody Titers rSBA-MenA (PRE)	23 Titers Interval 16.4 to 32.2	21.8 Titers Interval 10.8 to 44.1	—	—	—	—
rSBA Antibody Titers rSBA-MenA (PI[M1])	3787.4 Titers Interval 3353.2 to 4277.8	14.4 Titers Interval 7.0 to 29.4	—	—	—	—
rSBA Antibody Titers rSBA-MenA (PI[M12])	974.4 Titers Interval 831.0 to 1142.4	17.6 Titers Interval 6.5 to 47.6	—	—	—	—
rSBA Antibody Titers rSBA-MenA (PI[M24])	575.2 Titers Interval 494.0 to 669.9	56.5 Titers Interval 28.5 to 112.2	—	—	—	—
rSBA Antibody Titers rSBA-MenA (PI[M36])	518.6 Titers Interval 447.6 to 600.8	117.1 Titers Interval 65.0 to 211.2	—	—	—	—
rSBA Antibody Titers rSBA-MenC (PRE)	15.5 Titers Interval 11.9 to 20.0	12 Titers Interval 6.9 to 20.9	—	—	—	—
rSBA Antibody Titers rSBA-MenC (PI[M1])	887 Titers Interval 770.4 to 1021.2	727.6 Titers Interval 478.7 to 1105.8	—	—	—	—
rSBA Antibody Titers rSBA-MenC (PI[M12])	223.5 Titers Interval 192.2 to 259.8	218.3 Titers Interval 157.9 to 301.8	—	—	—	—
rSBA Antibody Titers rSBA-MenC (PI[M24])	141.2 Titers Interval 120.3 to 165.6	158.6 Titers Interval 103.8 to 242.2	—	—	—	—
rSBA Antibody Titers rSBA-MenC (PI[M36])	125.1 Titers Interval 96.7 to 162.0	185.7 Titers Interval 118.3 to 291.5	—	—	—	—
rSBA Antibody Titers rSBA-MenW-135 (PRE)	11.7 Titers Interval 9.0 to 15.1	12.6 Titers Interval 6.8 to 23.5	—	—	—	—
rSBA Antibody Titers rSBA-MenW-135 (PI[M1])	5563.5 Titers Interval 4976.9 to 6219.4	17.5 Titers Interval 9.2 to 33.6	—	—	—	—
rSBA Antibody Titers rSBA-MenW-135 (PI[M12])	904.9 Titers Interval 792.5 to 1033.2	37.9 Titers Interval 20.1 to 71.3	—	—	—	—
rSBA Antibody Titers rSBA-MenW-135 (PI[M24])	439.3 Titers Interval 379.0 to 509.4	22.9 Titers Interval 11.6 to 45.1	—	—	—	—
rSBA Antibody Titers rSBA-MenW-135 (PI[M36])	439.8 Titers Interval 370.5 to 522.0	64.5 Titers Interval 33.5 to 124.3	—	—	—	—
rSBA Antibody Titers rSBA-MenY (PRE)	37.4 Titers Interval 27.4 to 51.0	52.5 Titers Interval 26.7 to 103.3	—	—	—	—
rSBA Antibody Titers rSBA-MenY (PI[M1])	2875.6 Titers Interval 2540.0 to 3255.6	101.5 Titers Interval 54.3 to 189.7	—	—	—	—
rSBA Antibody Titers rSBA-MenY (PI[M12])	799.2 Titers Interval 683.3 to 934.7	75.7 Titers Interval 36.2 to 158.3	—	—	—	—
rSBA Antibody Titers rSBA-MenY (PI[M24])	532.8 Titers Interval 439.7 to 645.6	100.6 Titers Interval 50.6 to 200.0	—	—	—	—
rSBA Antibody Titers rSBA-MenY (PI[M36])	583.2 Titers Interval 479.0 to 709.9	176 Titers Interval 97.6 to 317.3	—	—	—	—

SECONDARY outcome

Timeframe: Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)] and at Persistence Year 3 [PI(M36)]

Population: The analysis was performed on subjects from of 2 years and above from the ATP cohort for persistence Year 3, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 3 time point.

Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the GSK Biologicals' laboratory.

Outcome measures

Outcome measures
Measure	Nimenrix 2-11 Years of Age Primary Phase Group n=196 Participants Pooled group of subjects above 2 years of age, participating in the Primary Phase.	Mencevax 2-11 Years of Age Primary Phase Group n=37 Participants Pooled group of subjects above 2 years of age, participating in the Primary phase.	Nimenrix 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Nimenrix™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Meningitec 1- 2 Years of Age Group Subjects from 1 to 2 years of age who received one dose of Meningitec™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Mencevax 2- 6 Years of Age Group Subjects from 2 to 6 years of age who received one dose Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.	Mencevax 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.
rSBA Antibody Titers rSBA-MenA (PRE)	58.4 Titers Interval 42.8 to 79.6	69.8 Titers Interval 30.6 to 158.8	—	—	—	—
rSBA Antibody Titers rSBA-MenA (PI[M1])	7513.7 Titers Interval 6740.4 to 8375.7	2244.3 Titers Interval 1737.7 to 2898.6	—	—	—	—
rSBA Antibody Titers rSBA-MenA (PI[M12])	2533.4 Titers Interval 2211.6 to 2902.1	576.2 Titers Interval 334.8 to 991.7	—	—	—	—
rSBA Antibody Titers rSBA-MenA (PI[M24])	1352.7 Titers Interval 1191.4 to 1535.7	240.1 Titers Interval 149.5 to 385.7	—	—	—	—
rSBA Antibody Titers rSBA-MenA (PI[M36])	1184.2 Titers Interval 1054.2 to 1330.3	218.8 Titers Interval 128.9 to 371.5	—	—	—	—
rSBA Antibody Titers rSBA-MenC (PRE)	36.5 Titers Interval 27.8 to 48.0	61.3 Titers Interval 31.4 to 119.7	—	—	—	—
rSBA Antibody Titers rSBA-MenC (PI[M1])	2524.9 Titers Interval 2162.1 to 2948.5	1433.7 Titers Interval 939.4 to 2188.0	—	—	—	—
rSBA Antibody Titers rSBA-MenC (PI[M12])	509.4 Titers Interval 439.4 to 590.6	437.6 Titers Interval 282.9 to 676.8	—	—	—	—
rSBA Antibody Titers rSBA-MenC (PI[M24])	273.1 Titers Interval 229.3 to 325.1	237.9 Titers Interval 144.0 to 393.0	—	—	—	—
rSBA Antibody Titers rSBA-MenC (PI[M36])	244.3 Titers Interval 200.8 to 297.3	163.5 Titers Interval 83.8 to 319.2	—	—	—	—
rSBA Antibody Titers rSBA-MenW-135 (PRE)	45.4 Titers Interval 33.5 to 61.5	57.4 Titers Interval 27.6 to 119.4	—	—	—	—
rSBA Antibody Titers rSBA-MenW-135 (PI[M1])	12158.8 Titers Interval 10949.9 to 13501.1	2602.6 Titers Interval 1795.6 to 3772.4	—	—	—	—
rSBA Antibody Titers rSBA-MenW-135 (PI[M12])	3064.7 Titers Interval 2692.8 to 3488.0	587 Titers Interval 411.3 to 837.9	—	—	—	—
rSBA Antibody Titers rSBA-MenW-135 (PI[M24])	1324.4 Titers Interval 1154.4 to 1519.4	182.8 Titers Interval 104.0 to 321.2	—	—	—	—
rSBA Antibody Titers rSBA-MenW-135 (PI[M36])	1737.1 Titers Interval 1503.8 to 2006.7	112.9 Titers Interval 59.9 to 212.6	—	—	—	—
rSBA Antibody Titers rSBA-MenY (PRE)	55.4 Titers Interval 41.3 to 74.3	37.2 Titers Interval 17.3 to 80.4	—	—	—	—
rSBA Antibody Titers rSBA-MenY (PI[M1])	6655.7 Titers Interval 6009.1 to 7372.0	1813.8 Titers Interval 1235.6 to 2662.5	—	—	—	—
rSBA Antibody Titers rSBA-MenY (PI[M12])	2164 Titers Interval 1924.2 to 2433.6	467.5 Titers Interval 261.3 to 836.5	—	—	—	—
rSBA Antibody Titers rSBA-MenY (PI[M24])	1556.4 Titers Interval 1355.9 to 1786.6	116.2 Titers Interval 59.3 to 227.7	—	—	—	—
rSBA Antibody Titers rSBA-MenY (PI[M36])	1551.6 Titers Interval 1381.2 to 1743.1	103.8 Titers Interval 54.3 to 198.3	—	—	—	—

SECONDARY outcome

Timeframe: Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)] and Persistence Year 3 [PI(M36)]

Population: The analysis was performed on subjects from of 2 years and above from the ATP cohort for persistence Year 3, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 3 time point.

The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals' laboratory.

Outcome measures

Outcome measures
Measure	Nimenrix 2-11 Years of Age Primary Phase Group n=196 Participants Pooled group of subjects above 2 years of age, participating in the Primary Phase.	Mencevax 2-11 Years of Age Primary Phase Group n=37 Participants Pooled group of subjects above 2 years of age, participating in the Primary phase.	Nimenrix 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Nimenrix™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Meningitec 1- 2 Years of Age Group Subjects from 1 to 2 years of age who received one dose of Meningitec™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Mencevax 2- 6 Years of Age Group Subjects from 2 to 6 years of age who received one dose Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.	Mencevax 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenA (PRE)	109 Participants	20 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenA (PI[M1])	196 Participants	37 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenA (PI[M12])	195 Participants	34 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenA (PI[M24])	193 Participants	33 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenA (PI[M36])	192 Participants	31 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenC (PRE)	118 Participants	26 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenC (PI[M1])	196 Participants	37 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenC (PI[M12])	195 Participants	34 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenC (PI[M24])	195 Participants	37 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenC (PI[M36])	189 Participants	31 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenW-135 (PRE)	107 Participants	22 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenW-135 (PI[M1])	196 Participants	37 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenW-135 (PI[M12])	196 Participants	37 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenW-135 (PI[M24])	194 Participants	30 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenW-135 (PI[M36])	196 Participants	29 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenY (PRE)	127 Participants	19 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenY (PI[M1])	196 Participants	37 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenY (PI[M12])	196 Participants	32 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenY (PI[M24])	195 Participants	30 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenY (PI[M36])	195 Participants	30 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)] and Persistence Year 3 [PI(M36)]

Population: The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 3, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 3 time point.

The cut-off value for the hSBA titers was greater than or equal to (≥) 1:4.

Outcome measures

Outcome measures
Measure	Nimenrix 2-11 Years of Age Primary Phase Group n=176 Participants Pooled group of subjects above 2 years of age, participating in the Primary Phase.	Mencevax 2-11 Years of Age Primary Phase Group n=37 Participants Pooled group of subjects above 2 years of age, participating in the Primary phase.	Nimenrix 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Nimenrix™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Meningitec 1- 2 Years of Age Group Subjects from 1 to 2 years of age who received one dose of Meningitec™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Mencevax 2- 6 Years of Age Group Subjects from 2 to 6 years of age who received one dose Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.	Mencevax 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenA (PRE)	1 Participants	3 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenA (PI[M1])	159 Participants	3 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenA (PI[M12])	35 Participants	2 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenA (PI[M24])	62 Participants	5 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenA (PI[M36])	37 Participants	2 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenC (PRE)	2 Participants	0 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenC (PI[M1])	174 Participants	31 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenC (PI[M12])	159 Participants	24 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenC (PI[M24])	158 Participants	23 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenC (PI[M36])	147 Participants	25 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenW-135 (PRE)	2 Participants	2 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenW-135 (PI[M1])	112 Participants	1 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenW-135 (PI[M12])	141 Participants	1 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenW-135 (PI[M24])	147 Participants	4 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenW-135 (PI[M36])	131 Participants	3 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenY (PRE)	5 Participants	2 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenY (PI[M1])	110 Participants	3 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenY (PI[M12])	163 Participants	6 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenY (PI[M24])	133 Participants	12 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenY (PI[M36])	117 Participants	9 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)] and Persistence Year 3 [PI(M36)]

Population: The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 3, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 3 time point.

Antibody titers are presented as geometric mean titers (GMTs).

Outcome measures

Outcome measures
Measure	Nimenrix 2-11 Years of Age Primary Phase Group n=176 Participants Pooled group of subjects above 2 years of age, participating in the Primary Phase.	Mencevax 2-11 Years of Age Primary Phase Group n=37 Participants Pooled group of subjects above 2 years of age, participating in the Primary phase.	Nimenrix 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Nimenrix™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Meningitec 1- 2 Years of Age Group Subjects from 1 to 2 years of age who received one dose of Meningitec™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Mencevax 2- 6 Years of Age Group Subjects from 2 to 6 years of age who received one dose Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.	Mencevax 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.
hSBA Antibody Titers hSBA-MenY (PI[M24])	70.4 Titers Interval 53.9 to 91.8	6.7 Titers Interval 3.7 to 12.3	—	—	—	—
hSBA Antibody Titers hSBA-MenY (PI[M36])	37.3 Titers Interval 27.2 to 51.2	6 Titers Interval 3.0 to 11.9	—	—	—	—
hSBA Antibody Titers hSBA-MenA (PRE)	2 Titers Interval 2.0 to 2.0	2.3 Titers Interval 2.0 to 2.7	—	—	—	—
hSBA Antibody Titers hSBA-MenA (PI[M1])	56.9 Titers Interval 46.4 to 69.9	2.4 Titers Interval 1.9 to 3.0	—	—	—	—
hSBA Antibody Titers hSBA-MenA (PI[M12])	3.4 Titers Interval 2.9 to 4.1	2.2 Titers Interval 1.9 to 2.7	—	—	—	—
hSBA Antibody Titers hSBA-MenA (PI[M24])	4.9 Titers Interval 4.0 to 6.0	2.3 Titers Interval 2.0 to 2.7	—	—	—	—
hSBA Antibody Titers hSBA-MenA (PI[M36])	3.3 Titers Interval 2.8 to 3.8	2.2 Titers Interval 1.9 to 2.6	—	—	—	—
hSBA Antibody Titers hSBA-MenC (PRE)	2.1 Titers Interval 2.0 to 2.2	2 Titers Interval 2.0 to 2.0	—	—	—	—
hSBA Antibody Titers hSBA-MenC (PI[M1])	182.7 Titers Interval 154.6 to 215.8	44.1 Titers Interval 25.2 to 77.3	—	—	—	—
hSBA Antibody Titers hSBA-MenC (PI[M12])	95.1 Titers Interval 79.1 to 114.5	23.8 Titers Interval 12.3 to 46.1	—	—	—	—
hSBA Antibody Titers hSBA-MenC (PI[M24])	62.9 Titers Interval 50.9 to 77.8	18.8 Titers Interval 9.2 to 38.4	—	—	—	—
hSBA Antibody Titers hSBA-MenC (PI[M36])	65.1 Titers Interval 49.6 to 85.5	32.5 Titers Interval 16.0 to 65.9	—	—	—	—
hSBA Antibody Titers hSBA-MenW-135 (PRE)	2.1 Titers Interval 2.0 to 2.2	2.2 Titers Interval 1.9 to 2.6	—	—	—	—
hSBA Antibody Titers hSBA-MenW-135 (PI[M1])	39.1 Titers Interval 28.8 to 53.1	2.1 Titers Interval 1.9 to 2.3	—	—	—	—
hSBA Antibody Titers hSBA-MenW-135 (PI[M12])	218.9 Titers Interval 176.3 to 271.9	2.1 Titers Interval 1.9 to 2.4	—	—	—	—
hSBA Antibody Titers hSBA-MenW-135 (PI[M24])	112.8 Titers Interval 90.6 to 140.4	3.1 Titers Interval 2.0 to 4.8	—	—	—	—
hSBA Antibody Titers hSBA-MenW-135 (PI[M36])	40.8 Titers Interval 31.1 to 53.6	3 Titers Interval 1.9 to 4.7	—	—	—	—
hSBA Antibody Titers hSBA-MenY (PRE)	2.1 Titers Interval 2.0 to 2.2	2.1 Titers Interval 1.9 to 2.3	—	—	—	—
hSBA Antibody Titers hSBA-MenY (PI[M1])	24.8 Titers Interval 18.3 to 33.5	2.8 Titers Interval 1.8 to 4.4	—	—	—	—
hSBA Antibody Titers hSBA-MenY (PI[M12])	103.5 Titers Interval 81.7 to 131.0	3.7 Titers Interval 2.3 to 5.9	—	—	—	—

SECONDARY outcome

Timeframe: Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)] and Persistence Year 4 [PI(M48)]

Population: The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 4, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 4 time point.

The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals' laboratory.

Outcome measures

Outcome measures
Measure	Nimenrix 2-11 Years of Age Primary Phase Group n=152 Participants Pooled group of subjects above 2 years of age, participating in the Primary Phase.	Mencevax 2-11 Years of Age Primary Phase Group n=31 Participants Pooled group of subjects above 2 years of age, participating in the Primary phase.	Nimenrix 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Nimenrix™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Meningitec 1- 2 Years of Age Group Subjects from 1 to 2 years of age who received one dose of Meningitec™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Mencevax 2- 6 Years of Age Group Subjects from 2 to 6 years of age who received one dose Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.	Mencevax 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenY (PI[M1])	152 Participants	25 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenY (PI[M12])	151 Participants	22 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenY (PI[M36])	148 Participants	27 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenY (PI[M48])	134 Participants	23 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenA (PI[M12])	148 Participants	6 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenA (PI[M24])	142 Participants	19 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenA (PI[M36])	143 Participants	22 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenA (PRE)	62 Participants	11 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenA (PI[M1])	152 Participants	7 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenA (PI[M48])	133 Participants	21 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenC (PRE)	57 Participants	13 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenC (PI[M1])	150 Participants	29 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenC (PI[M12])	146 Participants	29 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenC (PI[M24])	148 Participants	31 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenC (PI[M36])	147 Participants	30 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenC (PI[M48])	125 Participants	27 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenW-135 (PRE)	44 Participants	8 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenW-135 (PI[M1])	152 Participants	12 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenW-135 (PI[M12])	152 Participants	17 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenW-135 (PI[M24])	148 Participants	12 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenW-135 (PI[M36])	146 Participants	20 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenW-135 (PI[M48])	133 Participants	18 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenY (PRE)	83 Participants	21 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenY (PI[M24])	146 Participants	23 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)] and Persistence Year 4 [PI(M48)]

Population: The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 4, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 4 time point.

Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the GSK Biologicals' laboratory.

Outcome measures

Outcome measures
Measure	Nimenrix 2-11 Years of Age Primary Phase Group n=152 Participants Pooled group of subjects above 2 years of age, participating in the Primary Phase.	Mencevax 2-11 Years of Age Primary Phase Group n=31 Participants Pooled group of subjects above 2 years of age, participating in the Primary phase.	Nimenrix 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Nimenrix™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Meningitec 1- 2 Years of Age Group Subjects from 1 to 2 years of age who received one dose of Meningitec™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Mencevax 2- 6 Years of Age Group Subjects from 2 to 6 years of age who received one dose Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.	Mencevax 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.
rSBA Antibody Titers rSBA-MenA (PRE)	27.9 Titers Interval 19.2 to 40.4	18.1 Titers Interval 8.3 to 39.3	—	—	—	—
rSBA Antibody Titers rSBA-MenA (PI[M1])	3911.7 Titers Interval 3443.2 to 4444.0	12.4 Titers Interval 5.6 to 27.4	—	—	—	—
rSBA Antibody Titers rSBA-MenA (PI[M12])	938.4 Titers Interval 790.3 to 1114.3	15.9 Titers Interval 5.6 to 45.0	—	—	—	—
rSBA Antibody Titers rSBA-MenA (PI[M24])	533 Titers Interval 451.6 to 629.0	53.8 Titers Interval 25.9 to 112.0	—	—	—	—
rSBA Antibody Titers rSBA-MenA (PI[M36])	503 Titers Interval 432.3 to 585.3	129.3 Titers Interval 65.9 to 254.0	—	—	—	—
rSBA Antibody Titers rSBA-MenA (PI[M48])	623.9 Titers Interval 507.1 to 767.6	157.4 Titers Interval 79.1 to 313.0	—	—	—	—
rSBA Antibody Titers rSBA-MenC (PRE)	14.9 Titers Interval 11.2 to 19.9	15.4 Titers Interval 8.3 to 28.5	—	—	—	—
rSBA Antibody Titers rSBA-MenC (PI[M1])	922.5 Titers Interval 794.7 to 1070.8	846.2 Titers Interval 537.3 to 1332.8	—	—	—	—
rSBA Antibody Titers rSBA-MenC (PI[M12])	236.8 Titers Interval 199.7 to 280.7	233.9 Titers Interval 160.3 to 341.5	—	—	—	—
rSBA Antibody Titers rSBA-MenC (PI[M24])	162.5 Titers Interval 138.2 to 191.1	185.3 Titers Interval 116.9 to 293.6	—	—	—	—
rSBA Antibody Titers rSBA-MenC (PI[M36])	176.1 Titers Interval 138.6 to 223.9	210.3 Titers Interval 139.6 to 316.8	—	—	—	—
rSBA Antibody Titers rSBA-MenC (PI[M48])	141.9 Titers Interval 103.8 to 194.0	150.5 Titers Interval 73.4 to 308.6	—	—	—	—
rSBA Antibody Titers rSBA-MenW-135 (PRE)	11.9 Titers Interval 9.0 to 15.7	10.9 Titers Interval 5.6 to 21.3	—	—	—	—
rSBA Antibody Titers rSBA-MenW-135 (PI[M1])	5495.6 Titers Interval 4864.5 to 6208.6	19.8 Titers Interval 9.3 to 41.8	—	—	—	—
rSBA Antibody Titers rSBA-MenW-135 (PI[M12])	900.8 Titers Interval 782.6 to 1036.8	36.5 Titers Interval 17.5 to 76.1	—	—	—	—
rSBA Antibody Titers rSBA-MenW-135 (PI[M24])	426.3 Titers Interval 364.0 to 499.3	24.1 Titers Interval 10.8 to 54.1	—	—	—	—
rSBA Antibody Titers rSBA-MenW-135 (PI[M36])	454.9 Titers Interval 382.7 to 540.7	62.8 Titers Interval 30.4 to 129.5	—	—	—	—
rSBA Antibody Titers rSBA-MenW-135 (PI[M48])	400.9 Titers Interval 316.6 to 507.7	59.8 Titers Interval 26.5 to 135.1	—	—	—	—
rSBA Antibody Titers rSBA-MenY (PRE)	37.9 Titers Interval 27.1 to 53.1	52.7 Titers Interval 25.7 to 108.3	—	—	—	—
rSBA Antibody Titers rSBA-MenY (PI[M1])	2839.7 Titers Interval 2497.7 to 3228.4	123.9 Titers Interval 66.4 to 231.4	—	—	—	—
rSBA Antibody Titers rSBA-MenY (PI[M12])	776.5 Titers Interval 655.0 to 920.5	87.8 Titers Interval 40.7 to 189.5	—	—	—	—
rSBA Antibody Titers rSBA-MenY (PI[M24])	539.2 Titers Interval 444.7 to 653.7	100 Titers Interval 47.0 to 212.5	—	—	—	—
rSBA Antibody Titers rSBA-MenY (PI[M36])	581.5 Titers Interval 472.5 to 715.6	220.9 Titers Interval 117.8 to 414.2	—	—	—	—
rSBA Antibody Titers rSBA-MenY (PI[M48])	524.2 Titers Interval 417.0 to 658.9	174.1 Titers Interval 74.6 to 406.6	—	—	—	—

SECONDARY outcome

Timeframe: Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)] and Persistence Year 4 [PI(M48)]

Population: The analysis was performed on subjects of 2 years and above from the ATP cohort for persistence Year 4, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 4 time point.

The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals' laboratory.

Outcome measures

Outcome measures
Measure	Nimenrix 2-11 Years of Age Primary Phase Group n=188 Participants Pooled group of subjects above 2 years of age, participating in the Primary Phase.	Mencevax 2-11 Years of Age Primary Phase Group n=29 Participants Pooled group of subjects above 2 years of age, participating in the Primary phase.	Nimenrix 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Nimenrix™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Meningitec 1- 2 Years of Age Group Subjects from 1 to 2 years of age who received one dose of Meningitec™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Mencevax 2- 6 Years of Age Group Subjects from 2 to 6 years of age who received one dose Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.	Mencevax 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenA (PRE)	105 Participants	14 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenA (PI[M1])	187 Participants	29 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenA (PI[M12])	188 Participants	26 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenA (PI[M24])	185 Participants	25 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenA (PI[M36])	182 Participants	24 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenA (PI[M48])	188 Participants	24 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenC (PRE)	112 Participants	22 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenC (PI[M1])	187 Participants	29 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenC (PI[M12])	187 Participants	28 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenC (PI[M24])	186 Participants	29 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenC (PI[M36])	181 Participants	27 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenC (PI[M48])	182 Participants	26 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenW-135 (PRE)	104 Participants	19 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenW-135 (PI[M1])	187 Participants	29 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenW-135 (PI[M12])	188 Participants	29 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenW-135 (PI[M24])	185 Participants	22 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenW-135 (PI[M36])	185 Participants	22 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenW-135 (PI[M48])	188 Participants	22 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenY (PRE)	123 Participants	14 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenY (PI[M1])	187 Participants	29 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenY (PI[M12])	188 Participants	26 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenY (PI[M24])	186 Participants	23 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenY (PI[M36])	185 Participants	24 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenY (PI[M48])	188 Participants	24 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)] and Persistence Year 4 [PI(M48)]

Population: The analysis was performed on subjects of 2 years and above from the ATP cohort for persistence Year 4, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 4 time point.

Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the GSK Biologicals' laboratory.

Outcome measures

Outcome measures
Measure	Nimenrix 2-11 Years of Age Primary Phase Group n=188 Participants Pooled group of subjects above 2 years of age, participating in the Primary Phase.	Mencevax 2-11 Years of Age Primary Phase Group n=29 Participants Pooled group of subjects above 2 years of age, participating in the Primary phase.	Nimenrix 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Nimenrix™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Meningitec 1- 2 Years of Age Group Subjects from 1 to 2 years of age who received one dose of Meningitec™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Mencevax 2- 6 Years of Age Group Subjects from 2 to 6 years of age who received one dose Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.	Mencevax 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.
rSBA Antibody Titers rSBA-MenA (PRE)	59.5 Titers Interval 43.4 to 81.7	58.3 Titers Interval 21.1 to 160.9	—	—	—	—
rSBA Antibody Titers rSBA-MenA (PI[M1])	7593.9 Titers Interval 6848.5 to 8420.4	2075.1 Titers Interval 1544.1 to 2788.7	—	—	—	—
rSBA Antibody Titers rSBA-MenA (PI[M12])	2556.2 Titers Interval 2260.3 to 2890.9	488.7 Titers Interval 246.6 to 968.3	—	—	—	—
rSBA Antibody Titers rSBA-MenA (PI[M24])	1317.2 Titers Interval 1155.9 to 1500.9	203.2 Titers Interval 112.6 to 366.5	—	—	—	—
rSBA Antibody Titers rSBA-MenA (PI[M36])	1154.1 Titers Interval 1026.8 to 1297.2	193.8 Titers Interval 102.1 to 367.9	—	—	—	—
rSBA Antibody Titers rSBA-MenA (PI[M48])	1932.3 Titers Interval 1684.9 to 2216.1	182.8 Titers Interval 85.5 to 390.9	—	—	—	—
rSBA Antibody Titers rSBA-MenC (PRE)	35.8 Titers Interval 27.0 to 47.4	69.7 Titers Interval 34.0 to 142.9	—	—	—	—
rSBA Antibody Titers rSBA-MenC (PI[M1])	2578.5 Titers Interval 2221.9 to 2992.3	1371.7 Titers Interval 837.1 to 2247.7	—	—	—	—
rSBA Antibody Titers rSBA-MenC (PI[M12])	510.1 Titers Interval 439.3 to 592.4	444.8 Titers Interval 271.1 to 729.9	—	—	—	—
rSBA Antibody Titers rSBA-MenC (PI[M24])	278.5 Titers Interval 234.3 to 330.9	307.4 Titers Interval 179.2 to 527.4	—	—	—	—
rSBA Antibody Titers rSBA-MenC (PI[M36])	255.7 Titers Interval 211.3 to 309.4	260 Titers Interval 136.9 to 493.8	—	—	—	—
rSBA Antibody Titers rSBA-MenC (PI[M48])	203.6 Titers Interval 162.9 to 254.6	211.9 Titers Interval 104.8 to 428.7	—	—	—	—
rSBA Antibody Titers rSBA-MenW-135 (PRE)	47.4 Titers Interval 34.8 to 64.6	63.7 Titers Interval 28.7 to 141.5	—	—	—	—
rSBA Antibody Titers rSBA-MenW-135 (PI[M1])	12275.6 Titers Interval 11099.2 to 13576.7	2428 Titers Interval 1565.0 to 3767.1	—	—	—	—
rSBA Antibody Titers rSBA-MenW-135 (PI[M12])	3083.8 Titers Interval 2712.1 to 3506.3	564.2 Titers Interval 366.0 to 869.7	—	—	—	—
rSBA Antibody Titers rSBA-MenW-135 (PI[M24])	1324.2 Titers Interval 1150.3 to 1524.3	149.4 Titers Interval 72.4 to 308.1	—	—	—	—
rSBA Antibody Titers rSBA-MenW-135 (PI[M36])	1748.3 Titers Interval 1508.7 to 2025.9	95.7 Titers Interval 44.5 to 205.8	—	—	—	—
rSBA Antibody Titers rSBA-MenW-135 (PI[M48])	1807.5 Titers Interval 1568.9 to 2082.5	93.4 Titers Interval 44.2 to 197.5	—	—	—	—
rSBA Antibody Titers rSBA-MenY (PRE)	56.8 Titers Interval 42.2 to 76.6	34.7 Titers Interval 14.0 to 86.0	—	—	—	—
rSBA Antibody Titers rSBA-MenY (PI[M1])	6801.4 Titers Interval 6206.1 to 7453.9	1696.6 Titers Interval 1103.1 to 2609.4	—	—	—	—
rSBA Antibody Titers rSBA-MenY (PI[M12])	2169.8 Titers Interval 1930.4 to 2438.9	480.4 Titers Interval 260.9 to 884.9	—	—	—	—
rSBA Antibody Titers rSBA-MenY (PI[M24])	1550.8 Titers Interval 1352.6 to 1778.0	106.6 Titers Interval 48.5 to 234.1	—	—	—	—
rSBA Antibody Titers rSBA-MenY (PI[M36])	1551.5 Titers Interval 1378.9 to 1745.7	101.6 Titers Interval 50.0 to 206.5	—	—	—	—
rSBA Antibody Titers rSBA-MenY (PI[M48])	1545.5 Titers Interval 1356.6 to 1760.6	113.1 Titers Interval 55.1 to 232.3	—	—	—	—

SECONDARY outcome

Timeframe: At Persistence Year 4 [PI(M48)]

Population: The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 4, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 4 time point.

Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the Health Protection Agency (HPA) laboratory.

Outcome measures

Outcome measures
Measure	Nimenrix 2-11 Years of Age Primary Phase Group n=152 Participants Pooled group of subjects above 2 years of age, participating in the Primary Phase.	Mencevax 2-11 Years of Age Primary Phase Group n=31 Participants Pooled group of subjects above 2 years of age, participating in the Primary phase.	Nimenrix 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Nimenrix™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Meningitec 1- 2 Years of Age Group Subjects from 1 to 2 years of age who received one dose of Meningitec™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Mencevax 2- 6 Years of Age Group Subjects from 2 to 6 years of age who received one dose Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.	Mencevax 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.
rSBA Antibody Titers rSBA-MenA (PI[M48])	25.7 Titers Interval 19.1 to 34.7	4 Titers Interval 4.0 to 4.0	—	—	—	—
rSBA Antibody Titers rSBA-MenC (PI[M48])	11.2 Titers Interval 8.3 to 15.1	11.4 Titers Interval 5.2 to 25.0	—	—	—	—
rSBA Antibody Titers rSBA-MenW-135 (PI[M48])	31.3 Titers Interval 21.4 to 45.6	4 Titers Interval 4.0 to 4.0	—	—	—	—
rSBA Antibody Titers rSBA-MenY (PI[M48])	29.9 Titers Interval 21.5 to 41.6	12.5 Titers Interval 6.0 to 26.1	—	—	—	—

SECONDARY outcome

Timeframe: At Persistence Year 4 [PI(M48)]

Population: The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 4, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 4 time point.

The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the Health Protection Agency (HPA) laboratory.

Outcome measures

Outcome measures
Measure	Nimenrix 2-11 Years of Age Primary Phase Group n=152 Participants Pooled group of subjects above 2 years of age, participating in the Primary Phase.	Mencevax 2-11 Years of Age Primary Phase Group n=31 Participants Pooled group of subjects above 2 years of age, participating in the Primary phase.	Nimenrix 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Nimenrix™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Meningitec 1- 2 Years of Age Group Subjects from 1 to 2 years of age who received one dose of Meningitec™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Mencevax 2- 6 Years of Age Group Subjects from 2 to 6 years of age who received one dose Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.	Mencevax 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenA (PI[M48])	93 Participants	0 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenC (PI[M48])	46 Participants	8 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenW-135 (PI[M48])	78 Participants	0 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenY (PI[M48])	84 Participants	9 Participants	—	—	—	—

SECONDARY outcome

Timeframe: At Persistence Year 4 [PI(M48)]

Population: The analysis was performed on subjects of 2 years and above from the ATP cohort for persistence Year 4, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 4 time point.

The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the Health Protection Agency (HPA) laboratory.

Outcome measures

Outcome measures
Measure	Nimenrix 2-11 Years of Age Primary Phase Group n=188 Participants Pooled group of subjects above 2 years of age, participating in the Primary Phase.	Mencevax 2-11 Years of Age Primary Phase Group n=29 Participants Pooled group of subjects above 2 years of age, participating in the Primary phase.	Nimenrix 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Nimenrix™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Meningitec 1- 2 Years of Age Group Subjects from 1 to 2 years of age who received one dose of Meningitec™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Mencevax 2- 6 Years of Age Group Subjects from 2 to 6 years of age who received one dose Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.	Mencevax 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenW-135 (PI[M48])	169 Participants	4 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenY (PI[M48])	151 Participants	2 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenA (PI[M48])	157 Participants	5 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenC (PI[M48])	94 Participants	12 Participants	—	—	—	—

SECONDARY outcome

Timeframe: At Persistence Year 4 [PI(M48)]

Population: The analysis was performed on subjects of 2 years and above from the ATP cohort for persistence Year 4, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 4 time point.

Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the Health Protection Agency (HPA) laboratory.

Outcome measures

Outcome measures
Measure	Nimenrix 2-11 Years of Age Primary Phase Group n=188 Participants Pooled group of subjects above 2 years of age, participating in the Primary Phase.	Mencevax 2-11 Years of Age Primary Phase Group n=29 Participants Pooled group of subjects above 2 years of age, participating in the Primary phase.	Nimenrix 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Nimenrix™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Meningitec 1- 2 Years of Age Group Subjects from 1 to 2 years of age who received one dose of Meningitec™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Mencevax 2- 6 Years of Age Group Subjects from 2 to 6 years of age who received one dose Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.	Mencevax 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.
rSBA Antibody Titers (HPA Laboratory Assay) rSBA-MenA (PI[M48])	77.5 Titers Interval 59.3 to 101.3	7.3 Titers Interval 4.3 to 12.4	—	—	—	—
rSBA Antibody Titers (HPA Laboratory Assay) rSBA-MenC (PI[M48])	21.7 Titers Interval 16.2 to 29.1	23.5 Titers Interval 9.8 to 56.3	—	—	—	—
rSBA Antibody Titers (HPA Laboratory Assay) rSBA-MenW-135 (PI[M48])	671.1 Titers Interval 500.8 to 899.4	7.6 Titers Interval 4.0 to 14.4	—	—	—	—
rSBA Antibody Titers (HPA Laboratory Assay) rSBA-MenY (PI[M48])	134.8 Titers Interval 99.1 to 183.5	4.7 Titers Interval 3.5 to 6.4	—	—	—	—

SECONDARY outcome

Timeframe: Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)], Persistence Year 4 [PI(M48)]

Population: The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 4, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 4 time point.

The cut-off value for the hSBA titers was greater than or equal to (≥) 1:4.

Outcome measures

Outcome measures
Measure	Nimenrix 2-11 Years of Age Primary Phase Group n=151 Participants Pooled group of subjects above 2 years of age, participating in the Primary Phase.	Mencevax 2-11 Years of Age Primary Phase Group n=31 Participants Pooled group of subjects above 2 years of age, participating in the Primary phase.	Nimenrix 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Nimenrix™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Meningitec 1- 2 Years of Age Group Subjects from 1 to 2 years of age who received one dose of Meningitec™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Mencevax 2- 6 Years of Age Group Subjects from 2 to 6 years of age who received one dose Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.	Mencevax 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenA (PRE)	0 Participants	2 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenA (PI[M1])	137 Participants	1 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenA (PI[M12])	29 Participants	1 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenA (PI[M24])	53 Participants	4 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenA (PI[M36])	32 Participants	1 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenA (PI[M48])	57 Participants	8 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenC (PRE)	2 Participants	0 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenC (PI[M1])	149 Participants	25 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenC (PI[M12])	135 Participants	22 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenC (PI[M24])	135 Participants	22 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenC (PI[M36])	129 Participants	21 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenC (PI[M48])	126 Participants	24 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenW-135 (PRE)	2 Participants	1 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenW-135 (PI[M1])	100 Participants	1 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenW-135 (PI[M12])	118 Participants	1 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenW-135 (PI[M24])	129 Participants	5 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenW-135 (PI[M36])	114 Participants	2 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenW-135 (PI[M48])	117 Participants	3 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenY (PRE)	5 Participants	1 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenY (PI[M1])	93 Participants	2 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenY (PI[M12])	141 Participants	5 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenY (PI[M24])	119 Participants	10 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenY (PI[M36])	102 Participants	7 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenY (PI[M48])	100 Participants	12 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)], Persistence Year 4 [PI(M48)]

Population: The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 4, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 4 time point.

Antibody titers are presented as geometric mean titers (GMTs).

Outcome measures

Outcome measures
Measure	Nimenrix 2-11 Years of Age Primary Phase Group n=151 Participants Pooled group of subjects above 2 years of age, participating in the Primary Phase.	Mencevax 2-11 Years of Age Primary Phase Group n=31 Participants Pooled group of subjects above 2 years of age, participating in the Primary phase.	Nimenrix 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Nimenrix™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Meningitec 1- 2 Years of Age Group Subjects from 1 to 2 years of age who received one dose of Meningitec™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Mencevax 2- 6 Years of Age Group Subjects from 2 to 6 years of age who received one dose Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.	Mencevax 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.
hSBA Antibody Titers hSBA-MenA (PRE)	2 Titers Interval 2.0 to 2.0	2.2 Titers Interval 1.9 to 2.5	—	—	—	—
hSBA Antibody Titers hSBA-MenA (PI[M1])	57.7 Titers Interval 46.1 to 72.1	2.3 Titers Interval 1.8 to 2.9	—	—	—	—
hSBA Antibody Titers hSBA-MenA (PI[M12])	3.4 Titers Interval 2.8 to 4.1	2.1 Titers Interval 1.9 to 2.3	—	—	—	—
hSBA Antibody Titers hSBA-MenA (PI[M24])	4.9 Titers Interval 4.0 to 6.0	2.3 Titers Interval 2.0 to 2.6	—	—	—	—
hSBA Antibody Titers hSBA-MenA (PI[M36])	3.3 Titers Interval 2.8 to 3.9	2.1 Titers Interval 1.9 to 2.3	—	—	—	—
hSBA Antibody Titers hSBA-MenA (PI[M48])	6 Titers Interval 4.7 to 7.7	3.1 Titers Interval 2.3 to 4.0	—	—	—	—
hSBA Antibody Titers hSBA-MenC (PRE)	2.1 Titers Interval 2.0 to 2.2	2 Titers Interval 2.0 to 2.0	—	—	—	—
hSBA Antibody Titers hSBA-MenC (PI[M1])	192.5 Titers Interval 160.7 to 230.7	45 Titers Interval 23.3 to 86.9	—	—	—	—
hSBA Antibody Titers hSBA-MenC (PI[M12])	105.9 Titers Interval 85.6 to 131.1	28.6 Titers Interval 14.1 to 58.0	—	—	—	—
hSBA Antibody Titers hSBA-MenC (PI[M24])	72.5 Titers Interval 57.3 to 91.6	27.1 Titers Interval 12.5 to 58.9	—	—	—	—
hSBA Antibody Titers hSBA-MenC (PI[M36])	84.8 Titers Interval 63.7 to 112.9	32.4 Titers Interval 15.9 to 66.0	—	—	—	—
hSBA Antibody Titers hSBA-MenC (PI[M48])	51.4 Titers Interval 36.9 to 71.7	32.4 Titers Interval 14.8 to 71.1	—	—	—	—
hSBA Antibody Titers hSBA-MenW-135 (PRE)	2.1 Titers Interval 2.0 to 2.2	2.1 Titers Interval 1.9 to 2.3	—	—	—	—
hSBA Antibody Titers hSBA-MenW-135 (PI[M1])	41.7 Titers Interval 30.4 to 57.3	2.1 Titers Interval 1.9 to 2.3	—	—	—	—
hSBA Antibody Titers hSBA-MenW-135 (PI[M12])	227.9 Titers Interval 176.9 to 293.6	2.3 Titers Interval 1.7 to 3.1	—	—	—	—
hSBA Antibody Titers hSBA-MenW-135 (PI[M24])	116.5 Titers Interval 92.3 to 147.0	3.7 Titers Interval 2.2 to 6.4	—	—	—	—
hSBA Antibody Titers hSBA-MenW-135 (PI[M36])	44.5 Titers Interval 33.3 to 59.4	2.8 Titers Interval 1.7 to 4.7	—	—	—	—
hSBA Antibody Titers hSBA-MenW-135 (PI[M48])	48.3 Titers Interval 36.2 to 64.4	2.8 Titers Interval 1.9 to 4.2	—	—	—	—
hSBA Antibody Titers hSBA-MenY (PRE)	2.1 Titers Interval 2.0 to 2.2	2.1 Titers Interval 1.9 to 2.3	—	—	—	—
hSBA Antibody Titers hSBA-MenY (PI[M1])	22.5 Titers Interval 16.3 to 31.1	2.6 Titers Interval 1.7 to 4.1	—	—	—	—
hSBA Antibody Titers hSBA-MenY (PI[M12])	108.8 Titers Interval 84.6 to 140.0	3.8 Titers Interval 2.2 to 6.6	—	—	—	—
hSBA Antibody Titers hSBA-MenY (PI[M24])	76.3 Titers Interval 57.8 to 100.8	6.6 Titers Interval 3.4 to 12.9	—	—	—	—
hSBA Antibody Titers hSBA-MenY (PI[M36])	43.0 Titers Interval 30.6 to 60.4	5.9 Titers Interval 2.8 to 12.4	—	—	—	—
hSBA Antibody Titers hSBA-MenY (PI[M48])	42.1 Titers Interval 30.6 to 58.1	13.5 Titers Interval 5.6 to 32.3	—	—	—	—

SECONDARY outcome

Timeframe: Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)], Persistence Year 4 [PI(M48)]

Population: The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 5, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 5 time point.

The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals' laboratory, on the ATP cohort for persistence Year 5.

Outcome measures

Outcome measures
Measure	Nimenrix 2-11 Years of Age Primary Phase Group n=49 Participants Pooled group of subjects above 2 years of age, participating in the Primary Phase.	Mencevax 2-11 Years of Age Primary Phase Group n=11 Participants Pooled group of subjects above 2 years of age, participating in the Primary phase.	Nimenrix 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Nimenrix™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Meningitec 1- 2 Years of Age Group Subjects from 1 to 2 years of age who received one dose of Meningitec™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Mencevax 2- 6 Years of Age Group Subjects from 2 to 6 years of age who received one dose Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.	Mencevax 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenY (PI[M1])	49 Participants	8 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenY (PI[M12])	48 Participants	8 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenA (PRE)	17 Participants	5 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenA (PI[M1])	49 Participants	3 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenA (PI[M12])	48 Participants	1 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenA (PI[M24])	48 Participants	7 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenA (PI[M36])	45 Participants	9 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenA (PI[M48])	40 Participants	7 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenC (PRE)	15 Participants	3 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenC (PI[M1])	48 Participants	11 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenC (PI[M12])	47 Participants	10 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenC (PI[M24])	49 Participants	11 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenC (PI[M36])	46 Participants	10 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenC (PI[M48])	43 Participants	9 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenW-135 (PRE)	14 Participants	3 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenW-135 (PI[M1])	49 Participants	3 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenW-135 (PI[M12])	48 Participants	7 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenW-135 (PI[M24])	48 Participants	4 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenW-135 (PI[M36])	45 Participants	5 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenW-135 (PI[M48])	37 Participants	5 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenY (PRE)	30 Participants	8 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenY (PI[M24])	48 Participants	10 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenY (PI[M36])	47 Participants	8 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenY (PI[M48])	39 Participants	8 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)], Persistence Year 4 [PI(M48)]

Population: The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 5, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 5 time point.

Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the GSK Biologicals' laboratory, on the ATP cohort for persistence Year 5.

Outcome measures

Outcome measures
Measure	Nimenrix 2-11 Years of Age Primary Phase Group n=49 Participants Pooled group of subjects above 2 years of age, participating in the Primary Phase.	Mencevax 2-11 Years of Age Primary Phase Group n=11 Participants Pooled group of subjects above 2 years of age, participating in the Primary phase.	Nimenrix 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Nimenrix™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Meningitec 1- 2 Years of Age Group Subjects from 1 to 2 years of age who received one dose of Meningitec™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Mencevax 2- 6 Years of Age Group Subjects from 2 to 6 years of age who received one dose Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.	Mencevax 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.
rSBA Antibody Titers rSBA-MenA (PRE)	22.6 Titers Interval 11.4 to 44.4	45.7 Titers Interval 7.3 to 287.7	—	—	—	—
rSBA Antibody Titers rSBA-MenA (PI[M1])	4931.9 Titers Interval 4071.9 to 5973.6	16.7 Titers Interval 3.1 to 89.8	—	—	—	—
rSBA Antibody Titers rSBA-MenA (PI[M12])	1224.2 Titers Interval 958.4 to 1563.8	7.8 Titers Interval 1.4 to 43.7	—	—	—	—
rSBA Antibody Titers rSBA-MenA (PI[M24])	668.3 Titers Interval 511.6 to 873.0	119.5 Titers Interval 34.5 to 414.8	—	—	—	—
rSBA Antibody Titers rSBA-MenA (PI[M36])	578.5 Titers Interval 445.8 to 750.7	210.8 Titers Interval 128.8 to 345.2	—	—	—	—
rSBA Antibody Titers rSBA-MenA (PI[M48])	782.4 Titers Interval 551.3 to 1110.2	392 Titers Interval 192.7 to 797.6	—	—	—	—
rSBA Antibody Titers rSBA-MenC (PRE)	10.7 Titers Interval 6.7 to 17.1	9.4 Titers Interval 3.2 to 27.9	—	—	—	—
rSBA Antibody Titers rSBA-MenC (PI[M1])	1115.3 Titers Interval 878.3 to 1416.3	536.8 Titers Interval 278.6 to 1034.1	—	—	—	—
rSBA Antibody Titers rSBA-MenC (PI[M12])	352.4 Titers Interval 251.3 to 494.2	249.3 Titers Interval 128.8 to 482.4	—	—	—	—
rSBA Antibody Titers rSBA-MenC (PI[M24])	229.5 Titers Interval 169.0 to 311.6	215.6 Titers Interval 77.6 to 599.0	—	—	—	—
rSBA Antibody Titers rSBA-MenC (PI[M36])	472.4 Titers Interval 285.2 to 782.3	229.5 Titers Interval 82.0 to 642.1	—	—	—	—
rSBA Antibody Titers rSBA-MenC (PI[M48])	729.9 Titers Interval 468.4 to 1137.4	332 Titers Interval 61.2 to 1802.0	—	—	—	—
rSBA Antibody Titers rSBA-MenW-135 (PRE)	12.8 Titers Interval 7.4 to 22.2	8.4 Titers Interval 3.1 to 22.7	—	—	—	—
rSBA Antibody Titers rSBA-MenW-135 (PI[M1])	6805 Titers Interval 5432.2 to 8524.7	12.2 Titers Interval 3.4 to 43.8	—	—	—	—
rSBA Antibody Titers rSBA-MenW-135 (PI[M12])	956.5 Titers Interval 710.1 to 1288.3	49.4 Titers Interval 13.0 to 188.0	—	—	—	—
rSBA Antibody Titers rSBA-MenW-135 (PI[M24])	408.5 Titers Interval 287.2 to 581.1	25.9 Titers Interval 4.5 to 148.3	—	—	—	—
rSBA Antibody Titers rSBA-MenW-135 (PI[M36])	486 Titers Interval 316.5 to 746.5	52.9 Titers Interval 8.2 to 342.5	—	—	—	—
rSBA Antibody Titers rSBA-MenW-135 (PI[M48])	419 Titers Interval 235.1 to 746.7	31.3 Titers Interval 5.8 to 167.9	—	—	—	—
rSBA Antibody Titers rSBA-MenY (PRE)	43.7 Titers Interval 24.5 to 78.0	99.6 Titers Interval 23.0 to 431.0	—	—	—	—
rSBA Antibody Titers rSBA-MenY (PI[M1])	3555.6 Titers Interval 2928.3 to 4317.3	138.7 Titers Interval 29.8 to 645.6	—	—	—	—
rSBA Antibody Titers rSBA-MenY (PI[M12])	976.8 Titers Interval 716.8 to 1331.2	148 Titers Interval 30.5 to 717.9	—	—	—	—
rSBA Antibody Titers rSBA-MenY (PI[M24])	703 Titers Interval 500.8 to 986.9	185.1 Titers Interval 59.5 to 576.3	—	—	—	—
rSBA Antibody Titers rSBA-MenY (PI[M36])	684 Titers Interval 468.3 to 998.9	242.2 Titers Interval 45.3 to 1294.5	—	—	—	—
rSBA Antibody Titers rSBA-MenY (PI[M48])	601.5 Titers Interval 365.1 to 991.0	189 Titers Interval 35.8 to 998.1	—	—	—	—

SECONDARY outcome

Timeframe: Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)], Persistence Year 4 [PI(M48)]

Population: The analysis was performed on subjects of 2 years and above from the ATP cohort for persistence Year 5, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 5 time point.

The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals' laboratory, on the ATP cohort for persistence Year 5.

Outcome measures

Outcome measures
Measure	Nimenrix 2-11 Years of Age Primary Phase Group n=98 Participants Pooled group of subjects above 2 years of age, participating in the Primary Phase.	Mencevax 2-11 Years of Age Primary Phase Group n=13 Participants Pooled group of subjects above 2 years of age, participating in the Primary phase.	Nimenrix 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Nimenrix™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Meningitec 1- 2 Years of Age Group Subjects from 1 to 2 years of age who received one dose of Meningitec™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Mencevax 2- 6 Years of Age Group Subjects from 2 to 6 years of age who received one dose Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.	Mencevax 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenC (PRE)	65 Participants	12 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenC (PI[M1])	98 Participants	13 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenY (PI[M12])	98 Participants	12 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenY (PI[M24])	98 Participants	11 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenA (PRE)	57 Participants	4 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenA (PI[M1])	98 Participants	13 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenA (PI[M12])	98 Participants	12 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenA (PI[M24])	97 Participants	11 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenA (PI[M36])	95 Participants	12 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenA (PI[M48])	97 Participants	11 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenC (PI[M12])	97 Participants	12 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenC (PI[M24])	98 Participants	13 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenC (PI[M36])	96 Participants	13 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenC (PI[M48])	97 Participants	13 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenW-135 (PRE)	55 Participants	10 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenW-135 (PI[M1])	98 Participants	13 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenW-135 (PI[M12])	98 Participants	13 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenW-135 (PI[M24])	98 Participants	10 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenW-135 (PI[M36])	98 Participants	10 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenW-135 (PI[M48])	97 Participants	11 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenY (PRE)	62 Participants	6 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenY (PI[M1])	98 Participants	13 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenY (PI[M36])	97 Participants	11 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenY (PI[M48])	97 Participants	11 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)] and Persistence Year 4 [PI(M48)]

Population: The analysis was performed on subjects of 2 years and above from the ATP cohort for persistence Year 5, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 5 time point.

Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the GSK Biologicals' laboratory, on the ATP cohort for persistence Year 5.

Outcome measures

Outcome measures
Measure	Nimenrix 2-11 Years of Age Primary Phase Group n=98 Participants Pooled group of subjects above 2 years of age, participating in the Primary Phase.	Mencevax 2-11 Years of Age Primary Phase Group n=13 Participants Pooled group of subjects above 2 years of age, participating in the Primary phase.	Nimenrix 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Nimenrix™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Meningitec 1- 2 Years of Age Group Subjects from 1 to 2 years of age who received one dose of Meningitec™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Mencevax 2- 6 Years of Age Group Subjects from 2 to 6 years of age who received one dose Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.	Mencevax 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.
rSBA Antibody Titers rSBA-MenA (PI[M36])	1318.4 Titers Interval 1124.3 to 1545.9	219.9 Titers Interval 87.0 to 555.5	—	—	—	—
rSBA Antibody Titers rSBA-MenA (PI[M48])	2365 Titers Interval 1957.2 to 2857.7	135.4 Titers Interval 37.6 to 487.1	—	—	—	—
rSBA Antibody Titers rSBA-MenC (PRE)	44.7 Titers Interval 30.2 to 66.2	114 Titers Interval 41.5 to 313.6	—	—	—	—
rSBA Antibody Titers rSBA-MenC (PI[M1])	3604.6 Titers Interval 2921.3 to 4447.7	2361.1 Titers Interval 1010.1 to 5518.9	—	—	—	—
rSBA Antibody Titers rSBA-MenC (PI[M12])	777.4 Titers Interval 633.7 to 953.7	1002 Titers Interval 520.0 to 1931.0	—	—	—	—
rSBA Antibody Titers rSBA-MenC (PI[M24])	502.5 Titers Interval 402.0 to 628.1	627.1 Titers Interval 248.2 to 1584.1	—	—	—	—
rSBA Antibody Titers rSBA-MenC (PI[M36])	514.4 Titers Interval 409.4 to 646.4	865.2 Titers Interval 475.5 to 1574.0	—	—	—	—
rSBA Antibody Titers rSBA-MenC (PI[M48])	495.2 Titers Interval 386.7 to 634.1	742.7 Titers Interval 356.7 to 1546.6	—	—	—	—
rSBA Antibody Titers rSBA-MenY (PI[M1])	7167.2 Titers Interval 6324.9 to 8121.8	2085.3 Titers Interval 1028.6 to 4227.2	—	—	—	—
rSBA Antibody Titers rSBA-MenY (PI[M12])	2502.4 Titers Interval 2125.3 to 2946.3	322.7 Titers Interval 113.1 to 920.9	—	—	—	—
rSBA Antibody Titers rSBA-MenY (PI[M24])	1907.1 Titers Interval 1574.2 to 2310.4	112.3 Titers Interval 32.0 to 394.0	—	—	—	—
rSBA Antibody Titers rSBA-MenY (PI[M36])	1670.6 Titers Interval 1413.6 to 1974.3	92.2 Titers Interval 31.9 to 266.4	—	—	—	—
rSBA Antibody Titers rSBA-MenA (PRE)	64.3 Titers Interval 41.9 to 98.7	35.7 Titers Interval 4.6 to 277.8	—	—	—	—
rSBA Antibody Titers rSBA-MenA (PI[M1])	9195.5 Titers Interval 8097.2 to 10442.6	2319 Titers Interval 1337.7 to 4019.9	—	—	—	—
rSBA Antibody Titers rSBA-MenA (PI[M12])	3031.2 Titers Interval 2569.8 to 3575.5	491 Titers Interval 157.4 to 1531.1	—	—	—	—
rSBA Antibody Titers rSBA-MenA (PI[M24])	1641.7 Titers Interval 1375.5 to 1959.3	187.9 Titers Interval 61.2 to 576.6	—	—	—	—
rSBA Antibody Titers rSBA-MenW-135 (PRE)	50.5 Titers Interval 32.4 to 78.8	86.8 Titers Interval 29.7 to 253.8	—	—	—	—
rSBA Antibody Titers rSBA-MenW-135 (PI[M1])	13562 Titers Interval 11976.3 to 15357.6	2601 Titers Interval 1301.1 to 5199.6	—	—	—	—
rSBA Antibody Titers rSBA-MenW-135 (PI[M12])	3794.4 Titers Interval 3232.0 to 4454.6	462.2 Titers Interval 235.5 to 907.5	—	—	—	—
rSBA Antibody Titers rSBA-MenW-135 (PI[M24])	1637.9 Titers Interval 1385.7 to 1936.0	137.4 Titers Interval 42.5 to 443.9	—	—	—	—
rSBA Antibody Titers rSBA-MenW-135 (PI[M36])	2098.3 Titers Interval 1783.7 to 2468.3	96.6 Titers Interval 28.5 to 327.6	—	—	—	—
rSBA Antibody Titers rSBA-MenW-135 (PI[M48])	2178.4 Titers Interval 1843.2 to 2574.4	100.6 Titers Interval 37.9 to 267.0	—	—	—	—
rSBA Antibody Titers rSBA-MenY (PRE)	54.3 Titers Interval 35.4 to 83.2	15.7 Titers Interval 5.5 to 44.7	—	—	—	—
rSBA Antibody Titers rSBA-MenY (PI[M48])	1736 Titers Interval 1430.4 to 2106.8	83.3 Titers Interval 29.3 to 236.3	—	—	—	—

SECONDARY outcome

Timeframe: Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)], Persistence Year 4 [PI(M48)] and Persistence Year 5 [PI(M60)]

Population: The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 5, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 5 time point.

The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the Health Protection Agency (HPA) laboratory.

Outcome measures

Outcome measures
Measure	Nimenrix 2-11 Years of Age Primary Phase Group n=49 Participants Pooled group of subjects above 2 years of age, participating in the Primary Phase.	Mencevax 2-11 Years of Age Primary Phase Group n=11 Participants Pooled group of subjects above 2 years of age, participating in the Primary phase.	Nimenrix 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Nimenrix™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Meningitec 1- 2 Years of Age Group Subjects from 1 to 2 years of age who received one dose of Meningitec™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Mencevax 2- 6 Years of Age Group Subjects from 2 to 6 years of age who received one dose Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.	Mencevax 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenC (PI[M60])	38 Participants	7 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenA (PI[M48])	29 Participants	0 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenA (PI[M60])	36 Participants	0 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenC (PI[M48])	44 Participants	8 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenW-135 (PI[M48])	27 Participants	0 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenW-135 (PI[M60])	17 Participants	2 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenY (PI[M48])	28 Participants	3 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value rSBA-MenY (PI[M60])	21 Participants	2 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)], Persistence Year 4 [PI(M48)] and Persistence Year 5 [PI(M60)]

Population: The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 5, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 5 time point.

Antibody titers are presented as geometric mean titers (GMTs).This analysis was performed by the Health Protection Agency (HPA) laboratory.

Outcome measures

Outcome measures
Measure	Nimenrix 2-11 Years of Age Primary Phase Group n=49 Participants Pooled group of subjects above 2 years of age, participating in the Primary Phase.	Mencevax 2-11 Years of Age Primary Phase Group n=11 Participants Pooled group of subjects above 2 years of age, participating in the Primary phase.	Nimenrix 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Nimenrix™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Meningitec 1- 2 Years of Age Group Subjects from 1 to 2 years of age who received one dose of Meningitec™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Mencevax 2- 6 Years of Age Group Subjects from 2 to 6 years of age who received one dose Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.	Mencevax 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.
rSBA Antibody Titers rSBA-MenA (PI[M48])	35.1 Titers Interval 19.4 to 63.4	4 Titers Interval 4.0 to 4.0	—	—	—	—
rSBA Antibody Titers rSBA-MenA (PI[M60])	37.4 Titers Interval 22.1 to 63.2	4 Titers Interval 4.0 to 4.0	—	—	—	—
rSBA Antibody Titers rSBA-MenC (PI[M60])	48.9 Titers Interval 28.5 to 84.0	26.5 Titers Interval 6.5 to 107.2	—	—	—	—
rSBA Antibody Titers rSBA-MenW-135 (PI[M48])	50.8 Titers Interval 24.0 to 107.6	4 Titers Interval 4.0 to 4.0	—	—	—	—
rSBA Antibody Titers rSBA-MenC (PI[M48])	109.7 Titers Interval 62.7 to 192.0	137.2 Titers Interval 22.6 to 831.8	—	—	—	—
rSBA Antibody Titers rSBA-MenW-135 (PI[M60])	18.2 Titers Interval 9.3 to 35.3	7.1 Titers Interval 2.6 to 19.1	—	—	—	—
rSBA Antibody Titers rSBA-MenY (PI[M48])	44.9 Titers Interval 22.6 to 89.3	12.1 Titers Interval 2.3 to 63.5	—	—	—	—
rSBA Antibody Titers rSBA-MenY (PI[M60])	20.6 Titers Interval 10.9 to 39.2	11.7 Titers Interval 2.3 to 59.7	—	—	—	—

SECONDARY outcome

Timeframe: Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)], Persistence Year 4 [PI(M48)] and Persistence Year 5 [PI(M60)]

Population: The analysis was performed on subjects of 2 years and above from the ATP cohort for persistence Year 5, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 5 time point.

The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the Health Protection Agency (HPA) laboratory.

Outcome measures

Outcome measures
Measure	Nimenrix 2-11 Years of Age Primary Phase Group n=98 Participants Pooled group of subjects above 2 years of age, participating in the Primary Phase.	Mencevax 2-11 Years of Age Primary Phase Group n=13 Participants Pooled group of subjects above 2 years of age, participating in the Primary phase.	Nimenrix 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Nimenrix™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Meningitec 1- 2 Years of Age Group Subjects from 1 to 2 years of age who received one dose of Meningitec™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Mencevax 2- 6 Years of Age Group Subjects from 2 to 6 years of age who received one dose Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.	Mencevax 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenC (PI[M48])	96 Participants	12 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenW-135 (PI[M60])	77 Participants	0 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenY (PI[M48])	85 Participants	1 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenY (PI[M60])	77 Participants	1 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenA (PI[M48])	86 Participants	1 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenA (PI[M60])	89 Participants	2 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenC (PI[M60])	89 Participants	13 Participants	—	—	—	—
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenW-135 (PI[M48])	92 Participants	2 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)], Persistence Year 4 [PI(M48)] and at Persistence Year 5 [PI(M60)]

Population: The analysis was performed on subjects of 2 years and above from the ATP cohort for persistence Year 5, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 5 time point.

Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the Health Protection Agency (HPA) laboratory.

Outcome measures

Outcome measures
Measure	Nimenrix 2-11 Years of Age Primary Phase Group n=98 Participants Pooled group of subjects above 2 years of age, participating in the Primary Phase.	Mencevax 2-11 Years of Age Primary Phase Group n=13 Participants Pooled group of subjects above 2 years of age, participating in the Primary phase.	Nimenrix 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Nimenrix™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Meningitec 1- 2 Years of Age Group Subjects from 1 to 2 years of age who received one dose of Meningitec™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Mencevax 2- 6 Years of Age Group Subjects from 2 to 6 years of age who received one dose Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.	Mencevax 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.
rSBA Antibody Titers rSBA-MenA (PI[M48])	123.5 Titers Interval 85.4 to 178.6	5 Titers Interval 3.1 to 7.9	—	—	—	—
rSBA Antibody Titers rSBA-MenA (PI[M60])	141.3 Titers Interval 98.2 to 203.4	4.7 Titers Interval 3.7 to 6.0	—	—	—	—
rSBA Antibody Titers rSBA-MenC (PI[M48])	118.3 Titers Interval 86.0 to 162.8	206.8 Titers Interval 71.7 to 596.7	—	—	—	—
rSBA Antibody Titers rSBA-MenC (PI[M60])	79.7 Titers Interval 56.0 to 113.3	128 Titers Interval 56.4 to 290.7	—	—	—	—
rSBA Antibody Titers rSBA-MenW-135 (PI[M48])	1031.4 Titers Interval 731.0 to 1455.4	8.4 Titers Interval 2.8 to 25.7	—	—	—	—
rSBA Antibody Titers rSBA-MenW-135 (PI[M60])	208.5 Titers Interval 127.9 to 340.0	4 Titers Interval 4.0 to 4.0	—	—	—	—
rSBA Antibody Titers rSBA-MenY (PI[M48])	216.8 Titers Interval 147.3 to 319.1	4.2 Titers Interval 3.8 to 4.7	—	—	—	—
rSBA Antibody Titers rSBA-MenY (PI[M60])	143.3 Titers Interval 88.0 to 233.4	5.5 Titers Interval 2.7 to 11.1	—	—	—	—

SECONDARY outcome

Timeframe: Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)], Persistence Year 4 [PI(M48)] and Persistence Year 5 [PI(M60)]

Population: The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 5, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 5 time point.

The cut-off value for the hSBA titers was greater than or equal to (≥) 1:4.

Outcome measures

Outcome measures
Measure	Nimenrix 2-11 Years of Age Primary Phase Group n=49 Participants Pooled group of subjects above 2 years of age, participating in the Primary Phase.	Mencevax 2-11 Years of Age Primary Phase Group n=11 Participants Pooled group of subjects above 2 years of age, participating in the Primary phase.	Nimenrix 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Nimenrix™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Meningitec 1- 2 Years of Age Group Subjects from 1 to 2 years of age who received one dose of Meningitec™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Mencevax 2- 6 Years of Age Group Subjects from 2 to 6 years of age who received one dose Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.	Mencevax 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenC (PI[M12])	45 Participants	5 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenC (PI[M24])	43 Participants	7 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenC (PI[M36])	46 Participants	7 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenC (PI[M48])	44 Participants	7 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenW-135 (PI[M12])	41 Participants	0 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenW-135 (PI[M24])	40 Participants	1 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenW-135 (PI[M36])	39 Participants	0 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenW-135 (PI[M48])	38 Participants	0 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenY (PI[M36])	33 Participants	4 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenY (PI[M48])	36 Participants	4 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenY (PI[M60])	36 Participants	4 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenA (PRE)	0 Participants	0 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenA (PI[M1])	48 Participants	0 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenA (PI[M12])	12 Participants	0 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenA (PI[M24])	21 Participants	0 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenA (PI[M36])	15 Participants	1 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenA (PI[M48])	23 Participants	2 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenA (PI[M60])	16 Participants	3 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenC (PRE)	0 Participants	0 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenC (PI[M1])	48 Participants	9 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenC (PI[M60])	45 Participants	10 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenW-135 (PRE)	1 Participants	1 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenW-135 (PI[M1])	37 Participants	0 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenW-135 (PI[M60])	38 Participants	2 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenY (PRE)	2 Participants	2 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenY (PI[M1])	40 Participants	0 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenY (PI[M12])	47 Participants	1 Participants	—	—	—	—
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value hSBA-MenY (PI[M24])	38 Participants	4 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)], Persistence Year 4 [PI(M48)] and Persistence Year 5 [PI(M60)]

Population: The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 5, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 5 time point.

Antibody titers are presented as geometric mean titers (GMTs).

Outcome measures

Outcome measures
Measure	Nimenrix 2-11 Years of Age Primary Phase Group n=49 Participants Pooled group of subjects above 2 years of age, participating in the Primary Phase.	Mencevax 2-11 Years of Age Primary Phase Group n=11 Participants Pooled group of subjects above 2 years of age, participating in the Primary phase.	Nimenrix 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Nimenrix™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Meningitec 1- 2 Years of Age Group Subjects from 1 to 2 years of age who received one dose of Meningitec™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Mencevax 2- 6 Years of Age Group Subjects from 2 to 6 years of age who received one dose Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.	Mencevax 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.
hSBA Antibody Titers hSBA-MenA (PI[M12])	4.1 Titers Interval 2.8 to 6.1	2 Titers Interval 2.0 to 2.0	—	—	—	—
hSBA Antibody Titers hSBA-MenA (PI[M24])	6.7 Titers Interval 4.3 to 10.3	2 Titers Interval 2.0 to 2.0	—	—	—	—
hSBA Antibody Titers hSBA-MenA (PI[M36])	4.4 Titers Interval 3.0 to 6.3	2.3 Titers Interval 1.7 to 3.3	—	—	—	—
hSBA Antibody Titers hSBA-MenA (PI[M48])	8.8 Titers Interval 5.4 to 14.2	2.9 Titers Interval 1.6 to 5.3	—	—	—	—
hSBA Antibody Titers hSBA-MenA (PI[M60])	5.2 Titers Interval 3.4 to 7.8	3.6 Titers Interval 1.8 to 7.2	—	—	—	—
hSBA Antibody Titers hSBA-MenC (PRE)	2 Titers Interval 2.0 to 2.0	2 Titers Interval 2.0 to 2.0	—	—	—	—
hSBA Antibody Titers hSBA-MenW-135 (PI[M36])	70.2 Titers Interval 41.4 to 119.1	2 Titers Interval 2.0 to 2.0	—	—	—	—
hSBA Antibody Titers hSBA-MenW-135 (PI[M48])	76.9 Titers Interval 44.0 to 134.5	2 Titers Interval 2.0 to 2.0	—	—	—	—
hSBA Antibody Titers hSBA-MenY (PRE)	2.1 Titers Interval 1.9 to 2.4	2.6 Titers Interval 1.7 to 3.8	—	—	—	—
hSBA Antibody Titers hSBA-MenY (PI[M1])	46.1 Titers Interval 27.4 to 77.5	2 Titers Interval 2.0 to 2.0	—	—	—	—
hSBA Antibody Titers hSBA-MenA (PRE)	2 Titers Interval 2.0 to 2.0	2 Titers Interval 2.0 to 2.0	—	—	—	—
hSBA Antibody Titers hSBA-MenA (PI[M1])	78.5 Titers Interval 55.7 to 110.4	2 Titers Interval 2.0 to 2.0	—	—	—	—
hSBA Antibody Titers hSBA-MenC (PI[M1])	252 Titers Interval 193.2 to 328.6	38.7 Titers Interval 10.5 to 142.9	—	—	—	—
hSBA Antibody Titers hSBA-MenC (PI[M12])	180.1 Titers Interval 121.0 to 268.0	10.8 Titers Interval 2.5 to 47.7	—	—	—	—
hSBA Antibody Titers hSBA-MenC (PI[M24])	137.9 Titers Interval 85.3 to 223.0	33.4 Titers Interval 4.3 to 259.5	—	—	—	—
hSBA Antibody Titers hSBA-MenC (PI[M36])	337.9 Titers Interval 215.9 to 528.7	57.9 Titers Interval 14.8 to 226.4	—	—	—	—
hSBA Antibody Titers hSBA-MenC (PI[M48])	370.2 Titers Interval 214.1 to 640.0	91.9 Titers Interval 9.8 to 858.9	—	—	—	—
hSBA Antibody Titers hSBA-MenC (PI[M60])	216.5 Titers Interval 123.6 to 379.1	108.7 Titers Interval 21.2 to 557.2	—	—	—	—
hSBA Antibody Titers hSBA-MenW-135 (PRE)	2.2 Titers Interval 1.8 to 2.5	2.3 Titers Interval 1.6 to 3.3	—	—	—	—
hSBA Antibody Titers hSBA-MenW-135 (PI[M1])	81.3 Titers Interval 45.4 to 145.7	2 Titers Interval 2.0 to 2.0	—	—	—	—
hSBA Antibody Titers hSBA-MenW-135 (PI[M12])	300.5 Titers Interval 191.2 to 472.1	2 Titers Interval 2.0 to 2.0	—	—	—	—
hSBA Antibody Titers hSBA-MenW-135 (PI[M24])	168.2 Titers Interval 101.8 to 277.8	3.1 Titers Interval 1.2 to 8.1	—	—	—	—
hSBA Antibody Titers hSBA-MenW-135 (PI[M60])	59.7 Titers Interval 35.1 to 101.4	5.1 Titers Interval 1.2 to 20.9	—	—	—	—
hSBA Antibody Titers hSBA-MenY (PI[M12])	160 Titers Interval 107.7 to 237.7	3 Titers Interval 1.2 to 7.0	—	—	—	—
hSBA Antibody Titers hSBA-MenY (PI[M24])	121.9 Titers Interval 72.0 to 206.4	8.7 Titers Interval 2.2 to 34.2	—	—	—	—
hSBA Antibody Titers hSBA-MenY (PI[M36])	53.9 Titers Interval 28.2 to 102.8	7.1 Titers Interval 2.0 to 25.0	—	—	—	—
hSBA Antibody Titers hSBA-MenY (PI[M48])	74.6 Titers Interval 44.5 to 125.3	10 Titers Interval 2.2 to 46.1	—	—	—	—
hSBA Antibody Titers hSBA-MenY (PI[M60])	70.6 Titers Interval 38.7 to 128.8	11.6 Titers Interval 2.2 to 59.4	—	—	—	—

SECONDARY outcome

Timeframe: During the 4-day (Day 0-3) follow-up period

Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available for the vaccination.

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) (1 - \< 2 years of age and 2 - \< 6 years of age groups) and 50 mm (6 - \< 11 years of age groups) of injection site, respectively.

Outcome measures

Outcome measures
Measure	Nimenrix 2-11 Years of Age Primary Phase Group n=228 Participants Pooled group of subjects above 2 years of age, participating in the Primary Phase.	Mencevax 2-11 Years of Age Primary Phase Group n=113 Participants Pooled group of subjects above 2 years of age, participating in the Primary phase.	Nimenrix 6- 11 Years of Age Group n=117 Participants Subjects from 6 to 11 years of age who received one dose of Nimenrix™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Meningitec 1- 2 Years of Age Group n=73 Participants Subjects from 1 to 2 years of age who received one dose of Meningitec™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Mencevax 2- 6 Years of Age Group n=39 Participants Subjects from 2 to 6 years of age who received one dose Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.	Mencevax 6- 11 Years of Age Group n=39 Participants Subjects from 6 to 11 years of age who received one dose of Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.
Number of Subjects With Solicited Local Symptoms Any Pain	76 Participants	51 Participants	84 Participants	20 Participants	39 Participants	39 Participants
Number of Subjects With Solicited Local Symptoms Grade 3 Pain	3 Participants	2 Participants	7 Participants	0 Participants	1 Participants	1 Participants
Number of Subjects With Solicited Local Symptoms Any Redness	84 Participants	44 Participants	53 Participants	24 Participants	8 Participants	15 Participants
Number of Subjects With Solicited Local Symptoms Grade 3 Redness	8 Participants	12 Participants	19 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Solicited Local Symptoms Any Swelling	36 Participants	29 Participants	42 Participants	11 Participants	3 Participants	6 Participants
Number of Subjects With Solicited Local Symptoms Grade 3 Swelling	3 Participants	9 Participants	14 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: During the 4-day (Day 0-3) follow-up period

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available for the vaccination.

Assessed solicited general symptoms were drowsiness, fever \[defined as rectal temperature equal to or above 38.0 degrees Celsius (°C)\], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 40.0 °C. Related = symptom assessed by the investigator as related to the vaccination.

Outcome measures

Outcome measures
Measure	Nimenrix 2-11 Years of Age Primary Phase Group n=228 Participants Pooled group of subjects above 2 years of age, participating in the Primary Phase.	Mencevax 2-11 Years of Age Primary Phase Group n=113 Participants Pooled group of subjects above 2 years of age, participating in the Primary phase.	Nimenrix 6- 11 Years of Age Group n=117 Participants Subjects from 6 to 11 years of age who received one dose of Nimenrix™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Meningitec 1- 2 Years of Age Group n=73 Participants Subjects from 1 to 2 years of age who received one dose of Meningitec™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Mencevax 2- 6 Years of Age Group n=39 Participants Subjects from 2 to 6 years of age who received one dose Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.	Mencevax 6- 11 Years of Age Group n=39 Participants Subjects from 6 to 11 years of age who received one dose of Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.
Number of Subjects With Solicited General Symptoms Any Drowsiness	63 Participants	30 Participants	45 Participants	25 Participants	5 Participants	8 Participants
Number of Subjects With Solicited General Symptoms Grade 3 Drowsiness	2 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Solicited General Symptoms Related Drowsiness	61 Participants	29 Participants	45 Participants	25 Participants	5 Participants	8 Participants
Number of Subjects With Solicited General Symptoms Any Fever	36 Participants	7 Participants	11 Participants	9 Participants	2 Participants	1 Participants
Number of Subjects With Solicited General Symptoms Grade 3 Fever >40.0˚C	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Solicited General Symptoms Related Fever	32 Participants	7 Participants	11 Participants	9 Participants	2 Participants	0 Participants
Number of Subjects With Solicited General Symptoms Any Loss of appetite	54 Participants	16 Participants	31 Participants	17 Participants	6 Participants	6 Participants
Number of Subjects With Solicited General Symptoms Grade 3 Loss of appetite	2 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Solicited General Symptoms Related Loss of appetite	52 Participants	16 Participants	29 Participants	17 Participants	5 Participants	5 Participants
Number of Subjects With Solicited General Symptoms Any Irritability	88 Participants	18 Participants	23 Participants	29 Participants	11 Participants	5 Participants
Number of Subjects With Solicited General Symptoms Grade 3 Irritability	2 Participants	0 Participants	3 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Solicited General Symptoms Related Irritability	85 Participants	18 Participants	21 Participants	29 Participants	10 Participants	4 Participants

SECONDARY outcome

Timeframe: From administration of the vaccine dose until 6 months later

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available for the vaccination.

Rash assessed included hives, idiopathic thrombocytopenic purpura and petechiae.

Outcome measures

Outcome measures
Measure	Nimenrix 2-11 Years of Age Primary Phase Group n=229 Participants Pooled group of subjects above 2 years of age, participating in the Primary Phase.	Mencevax 2-11 Years of Age Primary Phase Group n=75 Participants Pooled group of subjects above 2 years of age, participating in the Primary phase.	Nimenrix 6- 11 Years of Age Group n=231 Participants Subjects from 6 to 11 years of age who received one dose of Nimenrix™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Meningitec 1- 2 Years of Age Group n=78 Participants Subjects from 1 to 2 years of age who received one dose of Meningitec™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Mencevax 2- 6 Years of Age Group Subjects from 2 to 6 years of age who received one dose Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.	Mencevax 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.
Number of Subjects With Rash	10 Participants	6 Participants	9 Participants	1 Participants	—	—

SECONDARY outcome

Timeframe: From administration of the vaccine dose until 6 months later

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available for the vaccination.

NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.

Outcome measures

Outcome measures
Measure	Nimenrix 2-11 Years of Age Primary Phase Group n=229 Participants Pooled group of subjects above 2 years of age, participating in the Primary Phase.	Mencevax 2-11 Years of Age Primary Phase Group n=75 Participants Pooled group of subjects above 2 years of age, participating in the Primary phase.	Nimenrix 6- 11 Years of Age Group n=231 Participants Subjects from 6 to 11 years of age who received one dose of Nimenrix™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Meningitec 1- 2 Years of Age Group n=78 Participants Subjects from 1 to 2 years of age who received one dose of Meningitec™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Mencevax 2- 6 Years of Age Group Subjects from 2 to 6 years of age who received one dose Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.	Mencevax 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.
Number of Subjects With New Onset of Chronic Illnesses (NOCIs)	1 Participants	0 Participants	2 Participants	4 Participants	—	—

SECONDARY outcome

Timeframe: From administration of the vaccine dose until 6 months later

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available for the vaccination.

Among AEs prompting emergency room visits were: infections, injuries, skin diseases and respiratory diseases.

Outcome measures

Outcome measures
Measure	Nimenrix 2-11 Years of Age Primary Phase Group n=229 Participants Pooled group of subjects above 2 years of age, participating in the Primary Phase.	Mencevax 2-11 Years of Age Primary Phase Group n=75 Participants Pooled group of subjects above 2 years of age, participating in the Primary phase.	Nimenrix 6- 11 Years of Age Group n=231 Participants Subjects from 6 to 11 years of age who received one dose of Nimenrix™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Meningitec 1- 2 Years of Age Group n=78 Participants Subjects from 1 to 2 years of age who received one dose of Meningitec™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Mencevax 2- 6 Years of Age Group Subjects from 2 to 6 years of age who received one dose Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.	Mencevax 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.
Number of Subjects With Adverse Events (AEs) Resulting in an Emergency Room (ER) Visit	21 Participants	8 Participants	15 Participants	5 Participants	—	—

SECONDARY outcome

Timeframe: During the 31-day (Days 0-30) post-vaccination period

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available for the vaccination.

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. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.

Outcome measures

Outcome measures
Measure	Nimenrix 2-11 Years of Age Primary Phase Group n=229 Participants Pooled group of subjects above 2 years of age, participating in the Primary Phase.	Mencevax 2-11 Years of Age Primary Phase Group n=75 Participants Pooled group of subjects above 2 years of age, participating in the Primary phase.	Nimenrix 6- 11 Years of Age Group n=231 Participants Subjects from 6 to 11 years of age who received one dose of Nimenrix™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Meningitec 1- 2 Years of Age Group n=78 Participants Subjects from 1 to 2 years of age who received one dose of Meningitec™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Mencevax 2- 6 Years of Age Group Subjects from 2 to 6 years of age who received one dose Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.	Mencevax 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.
Number of Subjects With Unsolicited AEs	121 Participants	38 Participants	83 Participants	24 Participants	—	—

SECONDARY outcome

Timeframe: Up to 6 Months after vaccination

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available for the vaccination.

SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Outcome measures

Outcome measures
Measure	Nimenrix 2-11 Years of Age Primary Phase Group n=229 Participants Pooled group of subjects above 2 years of age, participating in the Primary Phase.	Mencevax 2-11 Years of Age Primary Phase Group n=75 Participants Pooled group of subjects above 2 years of age, participating in the Primary phase.	Nimenrix 6- 11 Years of Age Group n=231 Participants Subjects from 6 to 11 years of age who received one dose of Nimenrix™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Meningitec 1- 2 Years of Age Group n=78 Participants Subjects from 1 to 2 years of age who received one dose of Meningitec™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Mencevax 2- 6 Years of Age Group Subjects from 2 to 6 years of age who received one dose Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.	Mencevax 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.
Number of Subjects With Serious Adverse Events (SAEs)	5 Participants	7 Participants	2 Participants	1 Participants	—	—

SECONDARY outcome

Timeframe: From 6 Months after vaccination up to Year 1

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available for the vaccination.

SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Outcome measures

Outcome measures
Measure	Nimenrix 2-11 Years of Age Primary Phase Group n=222 Participants Pooled group of subjects above 2 years of age, participating in the Primary Phase.	Mencevax 2-11 Years of Age Primary Phase Group n=221 Participants Pooled group of subjects above 2 years of age, participating in the Primary phase.	Nimenrix 6- 11 Years of Age Group n=71 Participants Subjects from 6 to 11 years of age who received one dose of Nimenrix™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Meningitec 1- 2 Years of Age Group n=78 Participants Subjects from 1 to 2 years of age who received one dose of Meningitec™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Mencevax 2- 6 Years of Age Group Subjects from 2 to 6 years of age who received one dose Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.	Mencevax 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.
Number of Subjects With SAE(s)	0 Participants	0 Participants	0 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: From 6 Months after vaccination up to Year 2

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available for the vaccination.

SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Outcome measures

Outcome measures
Measure	Nimenrix 2-11 Years of Age Primary Phase Group n=208 Participants Pooled group of subjects above 2 years of age, participating in the Primary Phase.	Mencevax 2-11 Years of Age Primary Phase Group n=215 Participants Pooled group of subjects above 2 years of age, participating in the Primary phase.	Nimenrix 6- 11 Years of Age Group n=53 Participants Subjects from 6 to 11 years of age who received one dose of Nimenrix™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Meningitec 1- 2 Years of Age Group n=61 Participants Subjects from 1 to 2 years of age who received one dose of Meningitec™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Mencevax 2- 6 Years of Age Group Subjects from 2 to 6 years of age who received one dose Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.	Mencevax 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.
Number of Subjects With SAE(s)	0 Participants	0 Participants	0 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: From 6 Months following vaccination up to Year 3

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available for the vaccination.

SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Outcome measures

Outcome measures
Measure	Nimenrix 2-11 Years of Age Primary Phase Group n=185 Participants Pooled group of subjects above 2 years of age, participating in the Primary Phase.	Mencevax 2-11 Years of Age Primary Phase Group n=201 Participants Pooled group of subjects above 2 years of age, participating in the Primary phase.	Nimenrix 6- 11 Years of Age Group n=38 Participants Subjects from 6 to 11 years of age who received one dose of Nimenrix™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Meningitec 1- 2 Years of Age Group n=38 Participants Subjects from 1 to 2 years of age who received one dose of Meningitec™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Mencevax 2- 6 Years of Age Group Subjects from 2 to 6 years of age who received one dose Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.	Mencevax 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.
Number of Subjects With SAE(s)	0 Participants	0 Participants	0 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: From 6 Months following vaccination up to Year 4

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available for the vaccination.

SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Outcome measures

Outcome measures
Measure	Nimenrix 2-11 Years of Age Primary Phase Group n=165 Participants Pooled group of subjects above 2 years of age, participating in the Primary Phase.	Mencevax 2-11 Years of Age Primary Phase Group n=192 Participants Pooled group of subjects above 2 years of age, participating in the Primary phase.	Nimenrix 6- 11 Years of Age Group n=34 Participants Subjects from 6 to 11 years of age who received one dose of Nimenrix™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Meningitec 1- 2 Years of Age Group n=32 Participants Subjects from 1 to 2 years of age who received one dose of Meningitec™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Mencevax 2- 6 Years of Age Group Subjects from 2 to 6 years of age who received one dose Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.	Mencevax 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.
Number of Subjects With SAE(s)	0 Participants	0 Participants	0 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: From 6 Months following vaccination up to Year 5

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available for the vaccination.

SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Outcome measures

Outcome measures
Measure	Nimenrix 2-11 Years of Age Primary Phase Group n=52 Participants Pooled group of subjects above 2 years of age, participating in the Primary Phase.	Mencevax 2-11 Years of Age Primary Phase Group n=99 Participants Pooled group of subjects above 2 years of age, participating in the Primary phase.	Nimenrix 6- 11 Years of Age Group n=12 Participants Subjects from 6 to 11 years of age who received one dose of Nimenrix™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Meningitec 1- 2 Years of Age Group n=13 Participants Subjects from 1 to 2 years of age who received one dose of Meningitec™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Mencevax 2- 6 Years of Age Group Subjects from 2 to 6 years of age who received one dose Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.	Mencevax 6- 11 Years of Age Group Subjects from 6 to 11 years of age who received one dose of Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.
Number of Subjects With SAE(s)	0 Participants	0 Participants	0 Participants	0 Participants	—	—

Adverse Events

Nimenrix 1-2 Years of Age Group

Serious events: 5 serious events

Other events: 193 other events

Deaths: 0 deaths

Nimenrix 2-11 Years of Age Group

Serious events: 2 serious events

Other events: 192 other events

Deaths: 0 deaths

Meningitec 1-2 Years of Age Group

Serious events: 7 serious events

Other events: 64 other events

Deaths: 0 deaths

Mencevax 2-11 Years of Age Group

Serious events: 1 serious events

Other events: 67 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Nimenrix 1-2 Years of Age Group n=229 participants at risk Subjects from 1 to 2 years of age who received one dose of Nimenrix™ vaccine administrated intramuscularly (IM) by injection in the non-dominant deltoid or the thigh region.	Nimenrix 2-11 Years of Age Group n=231 participants at risk Subjects from 2 to 11 years of age who received one dose of Nimenrix™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Meningitec 1-2 Years of Age Group n=75 participants at risk Subjects from 1 to 2 years of age who received one dose of Meningitec™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.	Mencevax 2-11 Years of Age Group n=78 participants at risk Subjects from 2 to 11 years of age who received one dose Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm.
Injury, poisoning and procedural complications Lower limb fracture	0.44% 1/229 • Solicited symptoms: during the 4-day (Day 0-3) follow-up vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Month 60). The solicited local and general symptoms were only collected for those subjects with their symptom sheets filled in.	0.00% 0/231 • Solicited symptoms: during the 4-day (Day 0-3) follow-up vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Month 60). The solicited local and general symptoms were only collected for those subjects with their symptom sheets filled in.	0.00% 0/75 • Solicited symptoms: during the 4-day (Day 0-3) follow-up vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Month 60). The solicited local and general symptoms were only collected for those subjects with their symptom sheets filled in.	0.00% 0/78 • Solicited symptoms: during the 4-day (Day 0-3) follow-up vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Month 60). The solicited local and general symptoms were only collected for those subjects with their symptom sheets filled in.
Respiratory, thoracic and mediastinal disorders Bronchitis chronic	0.44% 1/229 • Solicited symptoms: during the 4-day (Day 0-3) follow-up vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Month 60). The solicited local and general symptoms were only collected for those subjects with their symptom sheets filled in.	0.00% 0/231 • Solicited symptoms: during the 4-day (Day 0-3) follow-up vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Month 60). The solicited local and general symptoms were only collected for those subjects with their symptom sheets filled in.	2.7% 2/75 • Solicited symptoms: during the 4-day (Day 0-3) follow-up vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Month 60). The solicited local and general symptoms were only collected for those subjects with their symptom sheets filled in.	0.00% 0/78 • Solicited symptoms: during the 4-day (Day 0-3) follow-up vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Month 60). The solicited local and general symptoms were only collected for those subjects with their symptom sheets filled in.
Gastrointestinal disorders Stomatitis	0.44% 1/229 • Solicited symptoms: during the 4-day (Day 0-3) follow-up vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Month 60). The solicited local and general symptoms were only collected for those subjects with their symptom sheets filled in.	0.00% 0/231 • Solicited symptoms: during the 4-day (Day 0-3) follow-up vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Month 60). The solicited local and general symptoms were only collected for those subjects with their symptom sheets filled in.	0.00% 0/75 • Solicited symptoms: during the 4-day (Day 0-3) follow-up vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Month 60). The solicited local and general symptoms were only collected for those subjects with their symptom sheets filled in.	0.00% 0/78 • Solicited symptoms: during the 4-day (Day 0-3) follow-up vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Month 60). The solicited local and general symptoms were only collected for those subjects with their symptom sheets filled in.
Reproductive system and breast disorders Testicular torsion	0.00% 0/229 • Solicited symptoms: during the 4-day (Day 0-3) follow-up vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Month 60). The solicited local and general symptoms were only collected for those subjects with their symptom sheets filled in.	0.00% 0/231 • Solicited symptoms: during the 4-day (Day 0-3) follow-up vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Month 60). The solicited local and general symptoms were only collected for those subjects with their symptom sheets filled in.	0.00% 0/75 • Solicited symptoms: during the 4-day (Day 0-3) follow-up vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Month 60). The solicited local and general symptoms were only collected for those subjects with their symptom sheets filled in.	1.3% 1/78 • Solicited symptoms: during the 4-day (Day 0-3) follow-up vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Month 60). The solicited local and general symptoms were only collected for those subjects with their symptom sheets filled in.
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/229 • Solicited symptoms: during the 4-day (Day 0-3) follow-up vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Month 60). The solicited local and general symptoms were only collected for those subjects with their symptom sheets filled in.	0.43% 1/231 • Solicited symptoms: during the 4-day (Day 0-3) follow-up vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Month 60). The solicited local and general symptoms were only collected for those subjects with their symptom sheets filled in.	0.00% 0/75 • Solicited symptoms: during the 4-day (Day 0-3) follow-up vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Month 60). The solicited local and general symptoms were only collected for those subjects with their symptom sheets filled in.	0.00% 0/78 • Solicited symptoms: during the 4-day (Day 0-3) follow-up vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Month 60). The solicited local and general symptoms were only collected for those subjects with their symptom sheets filled in.
Infections and infestations Pneumonia	0.44% 1/229 • Solicited symptoms: during the 4-day (Day 0-3) follow-up vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Month 60). The solicited local and general symptoms were only collected for those subjects with their symptom sheets filled in.	0.43% 1/231 • Solicited symptoms: during the 4-day (Day 0-3) follow-up vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Month 60). The solicited local and general symptoms were only collected for those subjects with their symptom sheets filled in.	1.3% 1/75 • Solicited symptoms: during the 4-day (Day 0-3) follow-up vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Month 60). The solicited local and general symptoms were only collected for those subjects with their symptom sheets filled in.	0.00% 0/78 • Solicited symptoms: during the 4-day (Day 0-3) follow-up vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Month 60). The solicited local and general symptoms were only collected for those subjects with their symptom sheets filled in.
Infections and infestations Bronchitis	0.44% 1/229 • Solicited symptoms: during the 4-day (Day 0-3) follow-up vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Month 60). The solicited local and general symptoms were only collected for those subjects with their symptom sheets filled in.	0.00% 0/231 • Solicited symptoms: during the 4-day (Day 0-3) follow-up vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Month 60). The solicited local and general symptoms were only collected for those subjects with their symptom sheets filled in.	1.3% 1/75 • Solicited symptoms: during the 4-day (Day 0-3) follow-up vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Month 60). The solicited local and general symptoms were only collected for those subjects with their symptom sheets filled in.	0.00% 0/78 • Solicited symptoms: during the 4-day (Day 0-3) follow-up vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Month 60). The solicited local and general symptoms were only collected for those subjects with their symptom sheets filled in.
Infections and infestations Gastroenteritis	0.44% 1/229 • Solicited symptoms: during the 4-day (Day 0-3) follow-up vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Month 60). The solicited local and general symptoms were only collected for those subjects with their symptom sheets filled in.	0.00% 0/231 • Solicited symptoms: during the 4-day (Day 0-3) follow-up vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Month 60). The solicited local and general symptoms were only collected for those subjects with their symptom sheets filled in.	1.3% 1/75 • Solicited symptoms: during the 4-day (Day 0-3) follow-up vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Month 60). The solicited local and general symptoms were only collected for those subjects with their symptom sheets filled in.	0.00% 0/78 • Solicited symptoms: during the 4-day (Day 0-3) follow-up vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Month 60). The solicited local and general symptoms were only collected for those subjects with their symptom sheets filled in.
Infections and infestations Gastroenteritis rotavirus	0.00% 0/229 • Solicited symptoms: during the 4-day (Day 0-3) follow-up vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Month 60). The solicited local and general symptoms were only collected for those subjects with their symptom sheets filled in.	0.00% 0/231 • Solicited symptoms: during the 4-day (Day 0-3) follow-up vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Month 60). The solicited local and general symptoms were only collected for those subjects with their symptom sheets filled in.	2.7% 2/75 • Solicited symptoms: during the 4-day (Day 0-3) follow-up vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Month 60). The solicited local and general symptoms were only collected for those subjects with their symptom sheets filled in.	0.00% 0/78 • Solicited symptoms: during the 4-day (Day 0-3) follow-up vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Month 60). The solicited local and general symptoms were only collected for those subjects with their symptom sheets filled in.
Infections and infestations Laryngitis	0.00% 0/229 • Solicited symptoms: during the 4-day (Day 0-3) follow-up vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Month 60). The solicited local and general symptoms were only collected for those subjects with their symptom sheets filled in.	0.43% 1/231 • Solicited symptoms: during the 4-day (Day 0-3) follow-up vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Month 60). The solicited local and general symptoms were only collected for those subjects with their symptom sheets filled in.	0.00% 0/75 • Solicited symptoms: during the 4-day (Day 0-3) follow-up vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Month 60). The solicited local and general symptoms were only collected for those subjects with their symptom sheets filled in.	0.00% 0/78 • Solicited symptoms: during the 4-day (Day 0-3) follow-up vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Month 60). The solicited local and general symptoms were only collected for those subjects with their symptom sheets filled in.

Other adverse events

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER