Trial Outcomes & Findings for Study to Evaluate Persistence of Antibodies After Vaccination With Meningococcal Vaccine GSK134612 (NCT NCT00955682)

Results Overview

The cut-off value for the assay was greater than or equal to (≥) 1:8, as measured at the GlaxoSmithKline (GSK) laboratory.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

342 participants

Primary outcome timeframe

At Month 24 post primary vaccination

Results posted on

2021-02-26

Participant Flow

Not all study participants returned in time for every study visit, but they were allowed to continue the study nonetheless. The number of participants who started each study period depends on the actual rate of return of the subjects.

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 Group Subjects vaccinated with Nimenrix vaccine in the primary study 109670 \[NCT00474266\] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study.	Meningitec Group Subjects who received Meningitec vaccine in the primary vaccination study 109670 \[NCT00474266\] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study.
Year 2 Period STARTED	253	42
Year 2 Period COMPLETED	253	42
Year 2 Period NOT COMPLETED	0	0
Year 3 Period STARTED	273	47
Year 3 Period COMPLETED	273	47
Year 3 Period NOT COMPLETED	0	0
Year 4 Period STARTED	246	48
Year 4 Period COMPLETED	246	48
Year 4 Period NOT COMPLETED	0	0
Booster Period (Month 48- 49) STARTED	245	48
Booster Period (Month 48- 49) COMPLETED	244	47
Booster Period (Month 48- 49) NOT COMPLETED	1	1
Year 5 Period STARTED	239	47
Year 5 Period COMPLETED	239	47
Year 5 Period NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Nimenrix Group Subjects vaccinated with Nimenrix vaccine in the primary study 109670 \[NCT00474266\] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study.	Meningitec Group Subjects who received Meningitec vaccine in the primary vaccination study 109670 \[NCT00474266\] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study.
Booster Period (Month 48- 49) Lost to Follow-up	1	1

Baseline Characteristics

Note: The numbers analyzed in rows represent the number of subjects at the respective study periods.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: At Month 24 post primary vaccination

Population: The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) \[NCT00474266\], who complied with the protocol requirements and who had available assay results for at least one tested antigen.

The cut-off value for the assay was greater than or equal to (≥) 1:8, as measured at the GlaxoSmithKline (GSK) laboratory.

Outcome measures

Outcome measures
Measure	Nimenrix Group Y2 n=188 Participants Subjects from Year 2 Period vaccinated with Nimenrix vaccine in the primary study 109670 \[NCT00474266\] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study.	Meningitec Group Y2 n=30 Participants Subjects from Year 2 Period who received Meningitec vaccine in the primary vaccination study 109670 \[NCT00474266\] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study.
Number of Subjects With Serum Bactericidal Assay /Activity (rSBA) Against Neisseria Meningitidis Serogroup A, C, W-135 and Y (Using Baby Rabbit Complement) Titres ≥ the Cut-off rSBA-MenA [M24]	177 Participants	23 Participants
Number of Subjects With Serum Bactericidal Assay /Activity (rSBA) Against Neisseria Meningitidis Serogroup A, C, W-135 and Y (Using Baby Rabbit Complement) Titres ≥ the Cut-off rSBA-MenC [M24]	164 Participants	20 Participants
Number of Subjects With Serum Bactericidal Assay /Activity (rSBA) Against Neisseria Meningitidis Serogroup A, C, W-135 and Y (Using Baby Rabbit Complement) Titres ≥ the Cut-off rSBA-MenW-135 [M24]	186 Participants	17 Participants
Number of Subjects With Serum Bactericidal Assay /Activity (rSBA) Against Neisseria Meningitidis Serogroup A, C, W-135 and Y (Using Baby Rabbit Complement) Titres ≥ the Cut-off rSBA-MenY [M24]	184 Participants	24 Participants

PRIMARY outcome

Timeframe: At Month 36 post primary vaccination

Population: The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) \[NCT00474266\], who complied with the protocol requirements and who had available assay results for at least one tested antigen.

The cut-off value for the assay was ≥ 1:8. The analysis of this endpoint was performed by GSK.

Outcome measures

Outcome measures
Measure	Nimenrix Group Y2 n=237 Participants Subjects from Year 2 Period vaccinated with Nimenrix vaccine in the primary study 109670 \[NCT00474266\] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study.	Meningitec Group Y2 n=40 Participants Subjects from Year 2 Period who received Meningitec vaccine in the primary vaccination study 109670 \[NCT00474266\] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study.
Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off rSBA-MenA [M36]	224 Participants	32 Participants
Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off rSBA-MenC [M36]	210 Participants	28 Participants
Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off rSBA-MenW-135 [M36]	232 Participants	22 Participants
Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off rSBA-MenY [M36]	231 Participants	33 Participants

PRIMARY outcome

Timeframe: At Month 48 post primary vaccination

Population: The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) \[NCT00474266\] , who complied with the protocol requirements and who had available assay results for at least one tested antigen.

The cut-off value for the assay was ≥ 1:8. The analysis of this endpoint was performed by GSK.

Outcome measures

Outcome measures
Measure	Nimenrix Group Y2 n=195 Participants Subjects from Year 2 Period vaccinated with Nimenrix vaccine in the primary study 109670 \[NCT00474266\] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study.	Meningitec Group Y2 n=37 Participants Subjects from Year 2 Period who received Meningitec vaccine in the primary vaccination study 109670 \[NCT00474266\] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study.
Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off rSBA-MenA [M48]	185 Participants	29 Participants
Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off rSBA-MenC [M48]	175 Participants	24 Participants
Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off rSBA-MenW-135 [M48]	192 Participants	22 Participants
Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off rSBA-MenY [M48]	190 Participants	31 Participants

PRIMARY outcome

Timeframe: At Month 36 post-primary vaccination.

Population: The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) \[NCT00474266\], who complied with the protocol requirements and who had available assay results for at least one tested antigen.

The cut-off value for the assay was ≥ 1:8. The rSBA-MenA results for the Year 3 time point were obtained by re-testing the samples in parallel at Public Health England (PHE).

Outcome measures

Outcome measures
Measure	Nimenrix Group Y2 n=262 Participants Subjects from Year 2 Period vaccinated with Nimenrix vaccine in the primary study 109670 \[NCT00474266\] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study.	Meningitec Group Y2 n=46 Participants Subjects from Year 2 Period who received Meningitec vaccine in the primary vaccination study 109670 \[NCT00474266\] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study.
Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres rSBA-MenA [M36]	157 Participants	3 Participants
Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres rSBA-MenC [M36]	94 Participants	6 Participants
Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres rSBA-MenW-135 [M36]	130 Participants	2 Participants
Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres rSBA-MenY [M36]	141 Participants	6 Participants

PRIMARY outcome

Timeframe: At Month 48 post-primary vaccination

Population: The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) \[NCT00474266\], who complied with the protocol requirements and who had available assay results for at least one tested antigen.

The cut-off value for the aasay was ≥ 1:8. The rSBA-MenA results for the Year 4 time point were obtained by re-testing the samples in parallel at Public Health England (PHE).

Outcome measures

Outcome measures
Measure	Nimenrix Group Y2 n=225 Participants Subjects from Year 2 Period vaccinated with Nimenrix vaccine in the primary study 109670 \[NCT00474266\] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study.	Meningitec Group Y2 n=45 Participants Subjects from Year 2 Period who received Meningitec vaccine in the primary vaccination study 109670 \[NCT00474266\] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study.
Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres rSBA-MenW-135 [M48]	111 Participants	7 Participants
Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres rSBA-MenY [M48]	131 Participants	11 Participants
Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres rSBA-MenA [M48]	166 Participants	13 Participants
Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres rSBA-MenC [M48]	91 Participants	16 Participants

SECONDARY outcome

Timeframe: At Month 24 post primary vaccination

Population: The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) \[NCT00474266\], who complied with the protocol requirements and who had available assay results for at least one tested antigen.

The cut-off value for the assay was ≥ 1:128, as measured at the GlaxoSmithKline (GSK) laboratory.

Outcome measures

Outcome measures
Measure	Nimenrix Group Y2 n=188 Participants Subjects from Year 2 Period vaccinated with Nimenrix vaccine in the primary study 109670 \[NCT00474266\] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study.	Meningitec Group Y2 n=30 Participants Subjects from Year 2 Period who received Meningitec vaccine in the primary vaccination study 109670 \[NCT00474266\] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study.
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBAMenY Titres ≥ the Cut-off rSBA-MenA [M24]	166 Participants	16 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBAMenY Titres ≥ the Cut-off rSBA-MenC [M24]	90 Participants	14 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBAMenY Titres ≥ the Cut-off rSBA-MenW-135 [M24]	171 Participants	12 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBAMenY Titres ≥ the Cut-off rSBA-MenY [M24]	154 Participants	20 Participants

SECONDARY outcome

Timeframe: At Month 36 post primary vaccination

Population: The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) \[NCT00474266\], who complied with the protocol requirements and who had available assay results for at least one tested antigen.

The cut-off value for the assay was ≥ 1:128. The analysis of this endpoint was performed by GSK.

Outcome measures

Outcome measures
Measure	Nimenrix Group Y2 n=237 Participants Subjects from Year 2 Period vaccinated with Nimenrix vaccine in the primary study 109670 \[NCT00474266\] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study.	Meningitec Group Y2 n=40 Participants Subjects from Year 2 Period who received Meningitec vaccine in the primary vaccination study 109670 \[NCT00474266\] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study.
Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off rSBA-MenA [M36]	207 Participants	23 Participants
Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off rSBA-MenC [M36]	115 Participants	19 Participants
Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off rSBA-MenW-135 [M36]	211 Participants	16 Participants
Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off rSBA-MenY [M36]	195 Participants	26 Participants

SECONDARY outcome

Timeframe: At Month 48 post primary vaccination

Population: The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) \[NCT00474266\], who complied with the protocol requirements and who had available assay results for at least one tested antigen.

The cut-off value for the assay was ≥ 1:128. The analysis of this endpoint was performed by GSK.

Outcome measures

Outcome measures
Measure	Nimenrix Group Y2 n=195 Participants Subjects from Year 2 Period vaccinated with Nimenrix vaccine in the primary study 109670 \[NCT00474266\] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study.	Meningitec Group Y2 n=37 Participants Subjects from Year 2 Period who received Meningitec vaccine in the primary vaccination study 109670 \[NCT00474266\] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study.
Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off rSBA-MenA [M48]	175 Participants	22 Participants
Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off rSBA-MenC [M48]	97 Participants	18 Participants
Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off rSBA-MenW-135 [M48]	177 Participants	17 Participants
Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off rSBA-MenY [M48]	163 Participants	25 Participants

SECONDARY outcome

Timeframe: At Months 24 post primary vaccination

Population: The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) \[NCT00474266\], who complied with the protocol requirements and who had available assay results for at least one tested antigen.

The results for the assay were tabulated as geometric mean antibody titre calculated on all subjects, expressed in titres, as measured at the GlaxoSmithKline (GSK) laboratory

Outcome measures

Outcome measures
Measure	Nimenrix Group Y2 n=188 Participants Subjects from Year 2 Period vaccinated with Nimenrix vaccine in the primary study 109670 \[NCT00474266\] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study.	Meningitec Group Y2 n=30 Participants Subjects from Year 2 Period who received Meningitec vaccine in the primary vaccination study 109670 \[NCT00474266\] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study.
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres rSBA-MenW-135 [M24]	396.9 Titres Interval 342.0 to 460.5	42.2 Titres Interval 18.5 to 96.4
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres rSBA-MenY [M24]	396.6 Titres Interval 324.0 to 485.5	151.3 Titres Interval 69.2 to 330.6
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres rSBA-MenA [M24]	420.3 Titres Interval 356.1 to 495.9	90.6 Titres Interval 46.2 to 177.9
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres rSBA-MenC [M24]	98.1 Titres Interval 77.7 to 123.8	53.5 Titres Interval 25.5 to 112.0

SECONDARY outcome

Timeframe: At Month 36 post primary vaccination

Population: The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) \[NCT00474266\], who complied with the protocol requirements and who had available assay results for at least one tested antigen.

Results were tabulated as geometric mean antibody titre calculated on all subjects, expressed in titres. The analysis of this endpoint was performed by GSK.

Outcome measures

Outcome measures
Measure	Nimenrix Group Y2 n=237 Participants Subjects from Year 2 Period vaccinated with Nimenrix vaccine in the primary study 109670 \[NCT00474266\] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study.	Meningitec Group Y2 n=40 Participants Subjects from Year 2 Period who received Meningitec vaccine in the primary vaccination study 109670 \[NCT00474266\] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study.
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres rSBA-MenA [M36]	415.3 Titres Interval 360.9 to 478.0	102.3 Titres Interval 59.6 to 175.4
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres rSBA-MenY [M36]	405.4 Titres Interval 337.4 to 487.1	169.1 Titres Interval 89.6 to 319.1
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres rSBA-MenC [M36]	104.2 Titres Interval 84.7 to 128.2	58.5 Titres Interval 31.7 to 107.9
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres rSBA-MenW-135 [M36]	372.4 Titres Interval 323.4 to 428.9	39.7 Titres Interval 19.5 to 80.5

SECONDARY outcome

Timeframe: At Month 48 post primary vaccination

Population: The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) \[NCT00474266\], who complied with the protocol requirements and who had available assay results for at least one tested antigen.

Results were tabulated as geometric mean antibody titre calculated on all subjects, expressed in titres. The analysis of this endpoint was performed by GSK.

Outcome measures

Outcome measures
Measure	Nimenrix Group Y2 n=195 Participants Subjects from Year 2 Period vaccinated with Nimenrix vaccine in the primary study 109670 \[NCT00474266\] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study.	Meningitec Group Y2 n=37 Participants Subjects from Year 2 Period who received Meningitec vaccine in the primary vaccination study 109670 \[NCT00474266\] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study.
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres rSBA-MenA [M48]	437.1 Titres Interval 376.6 to 507.4	106.4 Titres Interval 58.8 to 192.4
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres rSBA-MenC [M48]	105.4 Titres Interval 84.6 to 131.3	53.6 Titres Interval 27.1 to 105.8
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres rSBA-MenW-135 [M48]	398.2 Titres Interval 343.1 to 462.1	49.1 Titres Interval 23.5 to 102.5
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres rSBA-MenY [M48]	411.1 Titres Interval 336.1 to 502.9	186.9 Titres Interval 98.1 to 355.8

SECONDARY outcome

Timeframe: At Month 36 post-primary vaccination

Population: The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) \[NCT00474266\], who complied with the protocol requirements and who had available assay results for at least one tested antigen.

The cut-off for the assay was ≥ 1:128. rSBA-MenA, MenC, MenW and MenY results for the Year 3 time point obtained by re-testing the samples in parallel at Public Health England (PHE).

Outcome measures

Outcome measures
Measure	Nimenrix Group Y2 n=262 Participants Subjects from Year 2 Period vaccinated with Nimenrix vaccine in the primary study 109670 \[NCT00474266\] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study.	Meningitec Group Y2 n=46 Participants Subjects from Year 2 Period who received Meningitec vaccine in the primary vaccination study 109670 \[NCT00474266\] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study.
Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off rSBA-MenY [M36]	75 Participants	2 Participants
Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off rSBA-MenA [M36]	60 Participants	3 Participants
Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off rSBA-MenC [M36]	23 Participants	3 Participants
Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off rSBA-MenW-135 [M36]	87 Participants	2 Participants

SECONDARY outcome

Timeframe: At Month 48 post-primary vaccination

Population: The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) \[NCT00474266\], who complied with the protocol requirements and who had available assay results for at least one tested antigen.

The cut-off value for the assay was ≥ 1:128. rSBA-MenA, MenC, MenW and MenY results for the Year 4 time point obtained by re-testing the samples in parallel at Public Health England (PHE).

Outcome measures

Outcome measures
Measure	Nimenrix Group Y2 n=225 Participants Subjects from Year 2 Period vaccinated with Nimenrix vaccine in the primary study 109670 \[NCT00474266\] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study.	Meningitec Group Y2 n=45 Participants Subjects from Year 2 Period who received Meningitec vaccine in the primary vaccination study 109670 \[NCT00474266\] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study.
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off rSBA-MenA [M48]	134 Participants	12 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off rSBA-MenC [M48]	34 Participants	10 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off rSBA-MenW-135 [M48]	88 Participants	7 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off rSBA-MenY [M48]	91 Participants	9 Participants

SECONDARY outcome

Timeframe: At Month 36 post-primary vaccination

Population: The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) \[NCT00474266\], who complied with the protocol requirements and who had available assay results for at least one tested antigen.

Results were tabulated as geometric mean antibody titre calculated on all subjects, expressed in titres. rSBA-MenA, MenC, MenW and MenY results for the Year 3 time point obtained by re-testing the samples in parallel at Public Health England (PHE).

Outcome measures

Outcome measures
Measure	Nimenrix Group Y2 n=262 Participants Subjects from Year 2 Period vaccinated with Nimenrix vaccine in the primary study 109670 \[NCT00474266\] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study.	Meningitec Group Y2 n=46 Participants Subjects from Year 2 Period who received Meningitec vaccine in the primary vaccination study 109670 \[NCT00474266\] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study.
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres rSBA-MenA [M36]	19.3 Titres Interval 15.7 to 23.6	5.2 Titres Interval 3.8 to 6.9
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres rSBA-MenC [M36]	9.8 Titres Interval 8.1 to 11.7	5.7 Titres Interval 4.2 to 7.7
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres rSBA-MenW-135 [M36]	24.9 Titres Interval 19.2 to 32.4	4.9 Titres Interval 3.7 to 6.7
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres rSBA-MenY [M36]	22.3 Titres Interval 17.6 to 28.4	5.7 Titres Interval 4.2 to 7.8

SECONDARY outcome

Timeframe: At Month 48 post-primary vaccination

Population: The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) \[NCT00474266\], who complied with the protocol requirements and who had available assay results for at least one tested antigen.

Results were tabulated as geometric mean antibody titre calculated on all subjects, expressed in titres. rSBA-MenA, MenC, MenW and MenY results for the Year 4 time point were obtained by re-testing the samples in parallel at Public Health England (PHE).

Outcome measures

Outcome measures
Measure	Nimenrix Group Y2 n=225 Participants Subjects from Year 2 Period vaccinated with Nimenrix vaccine in the primary study 109670 \[NCT00474266\] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study.	Meningitec Group Y2 n=45 Participants Subjects from Year 2 Period who received Meningitec vaccine in the primary vaccination study 109670 \[NCT00474266\] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study.
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres rSBA-MenY [M48]	36.2 Titres Interval 27.1 to 48.4	10.4 Titres Interval 6.0 to 18.0
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres rSBA-MenA [M48]	107.3 Titres Interval 77.6 to 148.3	18.4 Titres Interval 8.5 to 39.7
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres rSBA-MenC [M48]	12.3 Titres Interval 9.8 to 15.3	13.5 Titres Interval 7.4 to 24.5
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres rSBA-MenW-135 [M48]	30.5 Titres Interval 22.4 to 41.5	8 Titres Interval 4.8 to 13.3

SECONDARY outcome

Timeframe: At Month 24 post primary vaccination

Population: The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) \[NCT00474266\], who complied with the protocol requirements and who had available assay results for at least one tested antigen.

The cut-off values for the assay were ≥ 1:4 and 1:8, respectively. The analysis of this endpoint was performed by GSK.

Outcome measures

Outcome measures
Measure	Nimenrix Group Y2 n=183 Participants Subjects from Year 2 Period vaccinated with Nimenrix vaccine in the primary study 109670 \[NCT00474266\] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study.	Meningitec Group Y2 n=23 Participants Subjects from Year 2 Period who received Meningitec vaccine in the primary vaccination study 109670 \[NCT00474266\] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study.
Number of Subjects With Serum Bactericidal Assay/Activity Against Neisseria Meningitidis Serogroup A, C, W-135 and Y (Using Human Complement) Titres ≥ the Cut-off hSBA-MenA [M24], ≥ 1:4	46 Participants	2 Participants
Number of Subjects With Serum Bactericidal Assay/Activity Against Neisseria Meningitidis Serogroup A, C, W-135 and Y (Using Human Complement) Titres ≥ the Cut-off hSBA-MenA [M24], ≥ 1:8	42 Participants	0 Participants
Number of Subjects With Serum Bactericidal Assay/Activity Against Neisseria Meningitidis Serogroup A, C, W-135 and Y (Using Human Complement) Titres ≥ the Cut-off hSBA-MenC [M24], ≥ 1:4	154 Participants	11 Participants
Number of Subjects With Serum Bactericidal Assay/Activity Against Neisseria Meningitidis Serogroup A, C, W-135 and Y (Using Human Complement) Titres ≥ the Cut-off hSBA-MenC [M24], ≥ 1:8	152 Participants	10 Participants
Number of Subjects With Serum Bactericidal Assay/Activity Against Neisseria Meningitidis Serogroup A, C, W-135 and Y (Using Human Complement) Titres ≥ the Cut-off hSBA-MenW-135 [M24], ≥ 1:4	167 Participants	0 Participants
Number of Subjects With Serum Bactericidal Assay/Activity Against Neisseria Meningitidis Serogroup A, C, W-135 and Y (Using Human Complement) Titres ≥ the Cut-off hSBA-MenW-135 [M24], ≥ 1:8	164 Participants	0 Participants
Number of Subjects With Serum Bactericidal Assay/Activity Against Neisseria Meningitidis Serogroup A, C, W-135 and Y (Using Human Complement) Titres ≥ the Cut-off hSBA-MenY [M24], ≥ 1:4	134 Participants	5 Participants
Number of Subjects With Serum Bactericidal Assay/Activity Against Neisseria Meningitidis Serogroup A, C, W-135 and Y (Using Human Complement) Titres ≥ the Cut-off hSBA-MenY [M24], ≥ 1:8	134 Participants	5 Participants

SECONDARY outcome

Timeframe: At Month 36 post primary vaccination

Population: The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) \[NCT00474266\], who complied with the protocol requirements and who had available assay results for at least one tested antigen.

The cut-off for the assay were ≥ 1:4 and 1:8. The analysis of this endpoint was performed by GSK.

Outcome measures

Outcome measures
Measure	Nimenrix Group Y2 n=258 Participants Subjects from Year 2 Period vaccinated with Nimenrix vaccine in the primary study 109670 \[NCT00474266\] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study.	Meningitec Group Y2 n=35 Participants Subjects from Year 2 Period who received Meningitec vaccine in the primary vaccination study 109670 \[NCT00474266\] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study.
Number of Subjects With Serum Bactericidal Assay/Activity Against Neisseria Meningitidis Serogroup A, C, W-135 and Y (Using Human Complement) Titres ≥ the Cut-off hSBA-MenA [M36], ≥ 1:4	95 Participants	5 Participants
Number of Subjects With Serum Bactericidal Assay/Activity Against Neisseria Meningitidis Serogroup A, C, W-135 and Y (Using Human Complement) Titres ≥ the Cut-off hSBA-MenA [M36], ≥ 1:8	90 Participants	4 Participants
Number of Subjects With Serum Bactericidal Assay/Activity Against Neisseria Meningitidis Serogroup A, C, W-135 and Y (Using Human Complement) Titres ≥ the Cut-off hSBA-MenC [M36], ≥ 1:4	204 Participants	13 Participants
Number of Subjects With Serum Bactericidal Assay/Activity Against Neisseria Meningitidis Serogroup A, C, W-135 and Y (Using Human Complement) Titres ≥ the Cut-off hSBA-MenC [M36], ≥ 1:8	198 Participants	13 Participants
Number of Subjects With Serum Bactericidal Assay/Activity Against Neisseria Meningitidis Serogroup A, C, W-135 and Y (Using Human Complement) Titres ≥ the Cut-off hSBA-MenW-135 [M36], ≥ 1:4	209 Participants	2 Participants
Number of Subjects With Serum Bactericidal Assay/Activity Against Neisseria Meningitidis Serogroup A, C, W-135 and Y (Using Human Complement) Titres ≥ the Cut-off hSBA-MenW-135 [M36], ≥ 1:8	209 Participants	2 Participants
Number of Subjects With Serum Bactericidal Assay/Activity Against Neisseria Meningitidis Serogroup A, C, W-135 and Y (Using Human Complement) Titres ≥ the Cut-off hSBA-MenY [M36], ≥ 1:4	184 Participants	6 Participants
Number of Subjects With Serum Bactericidal Assay/Activity Against Neisseria Meningitidis Serogroup A, C, W-135 and Y (Using Human Complement) Titres ≥ the Cut-off hSBA-MenY [M36], ≥ 1:8	180 Participants	6 Participants

SECONDARY outcome

Timeframe: At Month 48 post primary vaccination

Population: The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) \[NCT00474266\], who complied with the protocol requirements and who had available assay results for at least one tested antigen.

The cut-off for the assay were ≥ 1:4 and 1:8, as assessed by the GSK laboratory.

Outcome measures

Outcome measures
Measure	Nimenrix Group Y2 n=209 Participants Subjects from Year 2 Period vaccinated with Nimenrix vaccine in the primary study 109670 \[NCT00474266\] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study.	Meningitec Group Y2 n=32 Participants Subjects from Year 2 Period who received Meningitec vaccine in the primary vaccination study 109670 \[NCT00474266\] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study.
Number of Subjects With Serum Bactericidal Assay/Activity Against Neisseria Meningitidis Serogroup A, C, W-135 and Y (Using Human Complement) Titres ≥ the Cut-off hSBA-MenY [M48], ≥ 1:4	85 Participants	6 Participants
Number of Subjects With Serum Bactericidal Assay/Activity Against Neisseria Meningitidis Serogroup A, C, W-135 and Y (Using Human Complement) Titres ≥ the Cut-off hSBA-MenY [M48], ≥ 1:8	85 Participants	6 Participants
Number of Subjects With Serum Bactericidal Assay/Activity Against Neisseria Meningitidis Serogroup A, C, W-135 and Y (Using Human Complement) Titres ≥ the Cut-off hSBA-MenA [M48], ≥ 1:4	58 Participants	4 Participants
Number of Subjects With Serum Bactericidal Assay/Activity Against Neisseria Meningitidis Serogroup A, C, W-135 and Y (Using Human Complement) Titres ≥ the Cut-off hSBA-MenA [M48], ≥ 1:8	57 Participants	4 Participants
Number of Subjects With Serum Bactericidal Assay/Activity Against Neisseria Meningitidis Serogroup A, C, W-135 and Y (Using Human Complement) Titres ≥ the Cut-off hSBA-MenC [M48], ≥ 1:4	154 Participants	15 Participants
Number of Subjects With Serum Bactericidal Assay/Activity Against Neisseria Meningitidis Serogroup A, C, W-135 and Y (Using Human Complement) Titres ≥ the Cut-off hSBA-MenC [M48], ≥ 1:8	153 Participants	15 Participants
Number of Subjects With Serum Bactericidal Assay/Activity Against Neisseria Meningitidis Serogroup A, C, W-135 and Y (Using Human Complement) Titres ≥ the Cut-off hSBA-MenW-135 [M48], ≥ 1:4	134 Participants	2 Participants
Number of Subjects With Serum Bactericidal Assay/Activity Against Neisseria Meningitidis Serogroup A, C, W-135 and Y (Using Human Complement) Titres ≥ the Cut-off hSBA-MenW-135 [M48], ≥ 1:8	133 Participants	2 Participants

SECONDARY outcome

Timeframe: At Month 24 post primary vaccination

Population: The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) \[NCT00474266\], who complied with the protocol requirements and who had available assay results for at least one tested antigen.

The results were tabulated as geometric mean antibody titre calculated on all subjects, expressed in titres, as assessed by the GSK laboratory.

Outcome measures

Outcome measures
Measure	Nimenrix Group Y2 n=183 Participants Subjects from Year 2 Period vaccinated with Nimenrix vaccine in the primary study 109670 \[NCT00474266\] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study.	Meningitec Group Y2 n=23 Participants Subjects from Year 2 Period who received Meningitec vaccine in the primary vaccination study 109670 \[NCT00474266\] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study.
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres hSBA-MenA [M24]	3.8 Titres Interval 3.2 to 4.5	2.2 Titres Interval 1.9 to 2.4
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres hSBA-MenC [M24]	50.2 Titres Interval 38.7 to 65.1	10.4 Titres Interval 4.7 to 22.8
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres hSBA-MenW-135 [M24]	77.7 Titres Interval 61.8 to 97.6	2 Titres Interval 2.0 to 2.0
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres hSBA-MenY [M24]	58.1 Titres Interval 44.5 to 75.8	5 Titres Interval 2.2 to 11.1

SECONDARY outcome

Timeframe: At Month 36 post primary vaccination

Population: The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) \[NCT00474266\], who complied with the protocol requirements and who had available assay results for at least one tested antigen.

The results were tabulated as geometric mean antibody titre calculated on all subjects, expressed in titres, as assessed by the GSK laboratory.

Outcome measures

Outcome measures
Measure	Nimenrix Group Y2 n=254 Participants Subjects from Year 2 Period vaccinated with Nimenrix vaccine in the primary study 109670 \[NCT00474266\] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study.	Meningitec Group Y2 n=33 Participants Subjects from Year 2 Period who received Meningitec vaccine in the primary vaccination study 109670 \[NCT00474266\] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study.
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres hSBA-MenA [M36]	5.8 Titres Interval 4.8 to 7.0	2.6 Titres Interval 2.1 to 3.3
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres hSBA-MenC [M36]	37.8 Titres Interval 29.4 to 48.6	6.2 Titres Interval 3.7 to 10.3
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres hSBA-MenW-135 [M36]	52 Titres Interval 41.4 to 65.2	2.4 Titres Interval 1.8 to 3.1
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres hSBA-MenY [M36]	33.2 Titres Interval 25.9 to 42.5	4.1 Titres Interval 2.4 to 7.1

SECONDARY outcome

Timeframe: At Month 48 post primary vaccination

Population: The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) \[NCT00474266\], who complied with the protocol requirements and who had available assay results for at least one tested antigen.

The results were tabulated as geometric mean antibody titre calculated on all subjects, expressed in titres, as measured by GSK.

Outcome measures

Outcome measures
Measure	Nimenrix Group Y2 n=209 Participants Subjects from Year 2 Period vaccinated with Nimenrix vaccine in the primary study 109670 \[NCT00474266\] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study.	Meningitec Group Y2 n=32 Participants Subjects from Year 2 Period who received Meningitec vaccine in the primary vaccination study 109670 \[NCT00474266\] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study.
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres hSBA-MenY [M48]	29.8 Titres Interval 20.2 to 44.1	4.4 Titres Interval 2.4 to 8.1
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres hSBA-MenA [M48]	4.9 Titres Interval 4.0 to 6.0	2.9 Titres Interval 2.0 to 4.0
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres hSBA-MenC [M48]	32 Titres Interval 23.8 to 43.0	11.3 Titres Interval 4.9 to 25.6
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres hSBA-MenW-135 [M48]	47.1 Titres Interval 35.7 to 62.2	2.6 Titres Interval 1.8 to 3.8

SECONDARY outcome

Timeframe: At Month 24 post primary vaccination

Population: The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) \[NCT00474266\], who complied with the protocol requirements and who had available assay results for at least one tested antigen.

The cut-off values for the assay were ≥ 0.3 microgram per milliliter (μg/mL) and ≥ 2.0 μg/mL, respectively, as measured at the GlaxoSmithKline (GSK) laboratory.

Outcome measures

Outcome measures
Measure	Nimenrix Group Y2 n=92 Participants Subjects from Year 2 Period vaccinated with Nimenrix vaccine in the primary study 109670 \[NCT00474266\] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study.	Meningitec Group Y2 n=17 Participants Subjects from Year 2 Period who received Meningitec vaccine in the primary vaccination study 109670 \[NCT00474266\] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study.
Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values Anti-PSA [M24], ≥ 0.3	50 Participants	5 Participants
Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values Anti-PSC [M24], ≥ 2.0	0 Participants	0 Participants
Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values Anti-PSW-135 [M24], ≥ 0.3	56 Participants	0 Participants
Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values Anti-PSY [M24], ≥ 0.3	72 Participants	0 Participants
Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values Anti-PSY [M24], ≥ 2.0	25 Participants	0 Participants
Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values Anti-PSA [M24], ≥ 2.0	8 Participants	2 Participants
Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values Anti-PSC [M24], ≥ 0.3	25 Participants	3 Participants
Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values Anti-PSW-135 [M24], ≥ 2.0	8 Participants	0 Participants

SECONDARY outcome

Timeframe: At Month 36 post primary vaccination

Population: The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) \[NCT00474266\], who complied with the protocol requirements and who had available assay results for at least one tested antigen.

The cut-off values for the assay were ≥ 0.3 μg/mL and ≥ 2.0 μg/mL, respectively, as measured by the GSK laboratory.

Outcome measures

Outcome measures
Measure	Nimenrix Group Y2 n=114 Participants Subjects from Year 2 Period vaccinated with Nimenrix vaccine in the primary study 109670 \[NCT00474266\] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study.	Meningitec Group Y2 n=21 Participants Subjects from Year 2 Period who received Meningitec vaccine in the primary vaccination study 109670 \[NCT00474266\] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study.
Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values Anti-PSA [M36], ≥ 0.3	61 Participants	6 Participants
Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values Anti-PSA [M36], ≥ 2.0	10 Participants	2 Participants
Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values Anti-PSC [M36], ≥ 0.3	28 Participants	4 Participants
Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values Anti-PSC [M36], ≥ 2.0	0 Participants	0 Participants
Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values Anti-PSW-135 [M36], ≥ 0.3	68 Participants	0 Participants
Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values Anti-PSW-135 [M36], ≥ 2.0	11 Participants	0 Participants
Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values Anti-PSY [M36], ≥ 0.3	89 Participants	1 Participants
Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values Anti-PSY [M36], ≥ 2.0	33 Participants	0 Participants

SECONDARY outcome

Timeframe: At Month 48 post primary vaccination

Population: The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) \[NCT00474266\], who complied with the protocol requirements and who had available assay results for at least one tested antigen.

The cut-off values for the assay were ≥ 0.3 μg/mL and ≥ 2.0 μg/mL, respectively, as measured by GSK.

Outcome measures

Outcome measures
Measure	Nimenrix Group Y2 n=93 Participants Subjects from Year 2 Period vaccinated with Nimenrix vaccine in the primary study 109670 \[NCT00474266\] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study.	Meningitec Group Y2 n=20 Participants Subjects from Year 2 Period who received Meningitec vaccine in the primary vaccination study 109670 \[NCT00474266\] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study.
Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values Anti-PSA [M48], ≥ 0.3	50 Participants	5 Participants
Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values Anti-PSA [M48], ≥ 2.0	9 Participants	2 Participants
Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values Anti-PSC [M48], ≥ 0.3	21 Participants	3 Participants
Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values Anti-PSC [M48], ≥ 2.0	0 Participants	0 Participants
Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values Anti-PSW-135 [M48], ≥ 0.3	55 Participants	0 Participants
Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values Anti-PSW-135 [M48], ≥ 2.0	8 Participants	0 Participants
Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values Anti-PSY [M48], ≥ 0.3	73 Participants	1 Participants
Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values Anti-PSY [M48], ≥ 2.0	26 Participants	0 Participants

SECONDARY outcome

Timeframe: At Month 24 post primary dose

Population: The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) \[NCT00474266\], who complied with the protocol requirements and who had available assay results for at least one tested antigen.

The results were tabulated as geometric mean antibody concentration calculated on all subjects, expressed in μg/mL, as measured at the GlaxoSmithKline (GSK) laboratory.

Outcome measures

Outcome measures
Measure	Nimenrix Group Y2 n=92 Participants Subjects from Year 2 Period vaccinated with Nimenrix vaccine in the primary study 109670 \[NCT00474266\] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study.	Meningitec Group Y2 n=17 Participants Subjects from Year 2 Period who received Meningitec vaccine in the primary vaccination study 109670 \[NCT00474266\] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study.
Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations Anti-PSA [M24]	0.4 μg/mL Interval 0.32 to 0.5	0.28 μg/mL Interval 0.16 to 0.49
Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations Anti-PSC [M24]	0.22 μg/mL Interval 0.19 to 0.25	0.19 μg/mL Interval 0.14 to 0.27
Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations Anti-PSW-135 [M24]	0.47 μg/mL Interval 0.37 to 0.59	0.15 μg/mL Interval 0.15 to 0.15
Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations Anti-PSY [M24]	0.85 μg/mL Interval 0.65 to 1.12	0.15 μg/mL Interval 0.15 to 0.15

SECONDARY outcome

Timeframe: At Month 36 post primary vaccination

Population: The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) \[NCT00474266\], who complied with the protocol requirements and who had available assay results for at least one tested antigen.

The results were tabulated as geometric mean antibody concentration calculated on all subjects, expresssed in μg/mL, as measured by GSK.

Outcome measures

Outcome measures
Measure	Nimenrix Group Y2 n=114 Participants Subjects from Year 2 Period vaccinated with Nimenrix vaccine in the primary study 109670 \[NCT00474266\] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study.	Meningitec Group Y2 n=21 Participants Subjects from Year 2 Period who received Meningitec vaccine in the primary vaccination study 109670 \[NCT00474266\] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study.
Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations Anti-PSA [M36]	0.39 μg/mL Interval 0.32 to 0.48	0.27 μg/mL Interval 0.17 to 0.43
Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations Anti-PSC [M36]	0.21 μg/mL Interval 0.19 to 0.24	0.19 μg/mL Interval 0.15 to 0.25
Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations Anti-PSW-135 [M36]	0.48 μg/mL Interval 0.39 to 0.59	0.15 μg/mL Interval 0.15 to 0.15
Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations Anti-PSY [M36]	0.89 μg/mL Interval 0.7 to 1.14	0.16 μg/mL Interval 0.14 to 0.17

SECONDARY outcome

Timeframe: At Month 48 post primary dose

Population: The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) \[NCT00474266\], who complied with the protocol requirements and who had available assay results for at least one tested antigen.

The results were tabulated as geometric mean antibody concentration calculated on all subjects, expresssed in μg/mL, as measured by GSK.

Outcome measures

Outcome measures
Measure	Nimenrix Group Y2 n=93 Participants Subjects from Year 2 Period vaccinated with Nimenrix vaccine in the primary study 109670 \[NCT00474266\] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study.	Meningitec Group Y2 n=20 Participants Subjects from Year 2 Period who received Meningitec vaccine in the primary vaccination study 109670 \[NCT00474266\] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study.
Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations Anti-PSY [M48]	0.89 μg/mL Interval 0.68 to 1.15	0.16 μg/mL Interval 0.14 to 0.17
Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations Anti-PSA [M48]	0.39 μg/mL Interval 0.31 to 0.5	0.26 μg/mL Interval 0.16 to 0.42
Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations Anti-PSC [M48]	0.2 μg/mL Interval 0.18 to 0.23	0.19 μg/mL Interval 0.14 to 0.25
Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations Anti-PSW-135 [M48]	0.46 μg/mL Interval 0.37 to 0.58	0.15 μg/mL Interval 0.15 to 0.15

SECONDARY outcome

Timeframe: At Month 36 post-primary vaccination

Population: The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) \[NCT00474266\], who complied with the protocol requirements and who had available assay results for at least one tested antigen.

The cut-off values for the assay were ≥ 0.3 μg/mL and ≥ 0.2 μg/mL. Anti-PS results for the Year 3 time point were obtained by re-testing the samples in parallel at Public Health England (PHE).

Outcome measures

Outcome measures
Measure	Nimenrix Group Y2 n=130 Participants Subjects from Year 2 Period vaccinated with Nimenrix vaccine in the primary study 109670 \[NCT00474266\] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study.	Meningitec Group Y2 n=26 Participants Subjects from Year 2 Period who received Meningitec vaccine in the primary vaccination study 109670 \[NCT00474266\] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study.
Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values Anti-PSA [M36], ≥ 0.3	128 Participants	20 Participants
Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values Anti-PSA [M36], ≥ 2.0	27 Participants	3 Participants
Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values Anti-PSC [M36], ≥ 0.3	37 Participants	5 Participants
Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values Anti-PSC [M36], ≥ 2.0	2 Participants	1 Participants
Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values Anti-PSW-135 [M36], ≥ 0.3	117 Participants	11 Participants
Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values Anti-PSW-135 [M36], ≥ 2.0	13 Participants	0 Participants
Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values Anti-PSY [M36], ≥ 0.3	102 Participants	19 Participants
Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values Anti-PSY [M36], ≥ 2.0	19 Participants	1 Participants

SECONDARY outcome

Timeframe: At Month 48 post-primary vaccination

Population: The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) \[NCT00474266\], who complied with the protocol requirements and who had available assay results for at least one tested antigen.

The cut-off values for the assay were ≥ 0.3 μg/mL and ≥ 2.0 μg/mL, respectively. Anti-PS results for the Year 4 time point were obtained by re-testing the samples in parallel at Public Health England (PHE).

Outcome measures

Outcome measures
Measure	Nimenrix Group Y2 n=56 Participants Subjects from Year 2 Period vaccinated with Nimenrix vaccine in the primary study 109670 \[NCT00474266\] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study.	Meningitec Group Y2 n=22 Participants Subjects from Year 2 Period who received Meningitec vaccine in the primary vaccination study 109670 \[NCT00474266\] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study.
Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values Anti-PSA [M48], ≥ 0.3	53 Participants	20 Participants
Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values Anti-PSA [M48], ≥ 2.0	26 Participants	9 Participants
Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values Anti-PSC [M48], ≥ 0.3	16 Participants	7 Participants
Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values Anti-PSC [M48], ≥ 2.0	3 Participants	3 Participants
Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values Anti-PSW-135 [M48], ≥ 0.3	56 Participants	17 Participants
Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values Anti-PSW-135 [M48], ≥ 2.0	5 Participants	0 Participants
Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values Anti-PSY [M48], ≥ 0.3	48 Participants	18 Participants
Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values Anti-PSY [M48], ≥ 2.0	7 Participants	3 Participants

SECONDARY outcome

Timeframe: At Month 36 post-primary vaccination

Population: The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) \[NCT00474266\], who complied with the protocol requirements and who had available assay results for at least one tested antigen.

The results were tabulated as geometric mean antibody titre calculated on all subjects, expressed in μg/mL. Anti-PS results for the Year 3 time point were obtained by re-testing the samples in parallel at Public Health England (PHE). Results were tabulated as geometric mean antibody concentration calculated on all subjects, expressed in μg/mL.

Outcome measures

Outcome measures
Measure	Nimenrix Group Y2 n=130 Participants Subjects from Year 2 Period vaccinated with Nimenrix vaccine in the primary study 109670 \[NCT00474266\] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study.	Meningitec Group Y2 n=26 Participants Subjects from Year 2 Period who received Meningitec vaccine in the primary vaccination study 109670 \[NCT00474266\] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study.
Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations Anti-PSA [M36]	1.16 μg/mL Interval 1.01 to 1.34	0.69 μg/mL Interval 0.45 to 1.06
Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations Anti-PSC [M36]	0.22 μg/mL Interval 0.2 to 0.25	0.19 μg/mL Interval 0.15 to 0.25
Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations Anti-PSW-135 [M36]	0.78 μg/mL Interval 0.69 to 0.89	0.24 μg/mL Interval 0.19 to 0.3
Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations Anti-PSY [M36]	1.12 μg/mL Interval 0.97 to 1.29	0.52 μg/mL Interval 0.37 to 0.72

SECONDARY outcome

Timeframe: At Month 48 post-primary vaccination.

Population: The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) \[NCT00474266\], who complied with the protocol requirements and who had available assay results for at least one tested antigen.

The results were tabulated as geometric mean antibody concentration calculated on all subjects, expressed in μg/mL. Anti-PS results for the Year 4 time point obtained by re-testing the samples in parallel at Public Health England (PHE).

Outcome measures

Outcome measures
Measure	Nimenrix Group Y2 n=56 Participants Subjects from Year 2 Period vaccinated with Nimenrix vaccine in the primary study 109670 \[NCT00474266\] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study.	Meningitec Group Y2 n=22 Participants Subjects from Year 2 Period who received Meningitec vaccine in the primary vaccination study 109670 \[NCT00474266\] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study.
Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations Anti-PSA [M48]	2.05 μg/mL Interval 1.61 to 2.61	1.65 μg/mL Interval 0.97 to 2.83
Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations Anti-PSC [M48]	0.25 μg/mL Interval 0.19 to 0.33	0.31 μg/mL Interval 0.18 to 0.54
Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations Anti-PSW-135 [M48]	0.85 μg/mL Interval 0.73 to 0.98	0.35 μg/mL Interval 0.28 to 0.46
Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations Anti-PSY [M48]	0.77 μg/mL Interval 0.63 to 0.93	0.83 μg/mL Interval 0.54 to 1.28

SECONDARY outcome

Timeframe: At one month (Month 49) post booster dose

Population: The analysis was performed on the Booster According-To-Protocol (ATP) cohort for immunogenicity 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 the booster vaccination.

The cut-off values for the assay were 1:8 and 1:128, as measured by the PHE laboratory.

Outcome measures

Outcome measures
Measure	Nimenrix Group Y2 n=215 Participants Subjects from Year 2 Period vaccinated with Nimenrix vaccine in the primary study 109670 \[NCT00474266\] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study.	Meningitec Group Y2 n=43 Participants Subjects from Year 2 Period who received Meningitec vaccine in the primary vaccination study 109670 \[NCT00474266\] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study.
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off rSBA-MenA [M49], ≥ 1:8	214 Participants	9 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off rSBA-MenA [M49], ≥ 1:128	214 Participants	8 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off rSBA-MenC [M49], ≥ 1:8	215 Participants	43 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off rSBA-MenC [M49], ≥ 1:128	215 Participants	43 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off rSBA-MenW-135 [M49], ≥ 1:8	215 Participants	8 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off rSBA-MenW-135 [M49], ≥ 1:128	215 Participants	7 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off rSBA-MenY [M49], ≥ 1:8	215 Participants	14 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off rSBA-MenY [M49], ≥ 1:128	215 Participants	14 Participants

SECONDARY outcome

Timeframe: At 12 months (Month 60) post booster dose

Population: The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) \[NCT00474266\], who complied with the protocol requirements and who had available assay results for at least one tested antigen.

The cut off values for the assay were 1:8 and 1:128, as measured by the PHE laboratory.

Outcome measures

Outcome measures
Measure	Nimenrix Group Y2 n=231 Participants Subjects from Year 2 Period vaccinated with Nimenrix vaccine in the primary study 109670 \[NCT00474266\] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study.	Meningitec Group Y2 n=46 Participants Subjects from Year 2 Period who received Meningitec vaccine in the primary vaccination study 109670 \[NCT00474266\] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study.
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres Above the Cut-off Values rSBA-MenA [M60], ≥ 1:8	231 Participants	3 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres Above the Cut-off Values rSBA-MenA [M60], ≥ 1:128	229 Participants	3 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres Above the Cut-off Values rSBA-MenC [M60], ≥ 1:8	225 Participants	45 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres Above the Cut-off Values rSBA-MenC [M60], ≥ 1:128	181 Participants	40 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres Above the Cut-off Values rSBA-MenW-135 [M60], ≥ 1:8	231 Participants	2 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres Above the Cut-off Values rSBA-MenW-135 [M60], ≥ 1:128	229 Participants	2 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres Above the Cut-off Values rSBA-MenY [M60], ≥ 1:8	231 Participants	11 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres Above the Cut-off Values rSBA-MenY [M60], ≥ 1:128	229 Participants	11 Participants

SECONDARY outcome

Timeframe: At one month (Month 49) post booster dose

Population: The analysis was performed on the Booster According-To-Protocol (ATP) cohort for immunogenicity 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 the booster vaccination.

Results were tabulated as geometric mean antibody titre calculated on all subjects, expressed in titres, as measured by the PHE laboratory.

Outcome measures

Outcome measures
Measure	Nimenrix Group Y2 n=215 Participants Subjects from Year 2 Period vaccinated with Nimenrix vaccine in the primary study 109670 \[NCT00474266\] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study.	Meningitec Group Y2 n=43 Participants Subjects from Year 2 Period who received Meningitec vaccine in the primary vaccination study 109670 \[NCT00474266\] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study.
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres rSBA-MenY [M49]	4585.3 Titres Interval 4128.6 to 5092.5	15 Titres Interval 8.0 to 28.0
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres rSBA-MenA [M49]	7173.3 Titres Interval 6389.2 to 8053.5	10.7 Titres Interval 5.6 to 20.4
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres rSBA-MenC [M49]	4511.9 Titres Interval 3935.9 to 5172.3	3718.4 Titres Interval 2596.0 to 5326.0
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres rSBA-MenW-135 [M49]	10949.7 Titres Interval 9531.4 to 12579.1	9.6 Titres Interval 5.3 to 17.3

SECONDARY outcome

Timeframe: At 12 months (Month 60) post booster dose

Population: The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) \[NCT00474266\], who complied with the protocol requirements and who had available assay results for at least one tested antigen.

Results were tabulated as geometric mean antibody titre (GMT) calculated on all subjects, as measured by the PHE laboratory.

Outcome measures

Outcome measures
Measure	Nimenrix Group Y2 n=231 Participants Subjects from Year 2 Period vaccinated with Nimenrix vaccine in the primary study 109670 \[NCT00474266\] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study.	Meningitec Group Y2 n=46 Participants Subjects from Year 2 Period who received Meningitec vaccine in the primary vaccination study 109670 \[NCT00474266\] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study.
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres rSBA-MenA [M60]	978.9 Titres Interval 860.2 to 1114.0	5.4 Titres Interval 3.8 to 7.6
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres rSBA-MenC [M60]	226.4 Titres Interval 183.7 to 279.0	320.9 Titres Interval 201.1 to 512.2
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres rSBA-MenW-135 [M60]	1390.7 Titres Interval 1203.2 to 1607.3	4.7 Titres Interval 3.8 to 5.7
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres rSBA-MenY [M60]	1071.1 Titres Interval 924.9 to 1240.5	13.4 Titres Interval 6.9 to 25.8

SECONDARY outcome

Timeframe: At one month (Month 49) post booster dose

Population: The analysis was performed on the Booster According-To-Protocol (ATP) cohort for immunogenicity 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 the booster vaccination.

The cut off values for the assay were ≥ 1:4 and ≥ 1:8 respectively, as measured by GSK.

Outcome measures

Outcome measures
Measure	Nimenrix Group Y2 n=209 Participants Subjects from Year 2 Period vaccinated with Nimenrix vaccine in the primary study 109670 \[NCT00474266\] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study.	Meningitec Group Y2 n=33 Participants Subjects from Year 2 Period who received Meningitec vaccine in the primary vaccination study 109670 \[NCT00474266\] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study.
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres Above the Cut-off Values hSBA-MenA [M49], ≥ 1:4	201 Participants	4 Participants
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres Above the Cut-off Values hSBA-MenA [M49], ≥ 1:8	201 Participants	4 Participants
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres Above the Cut-off Values hSBA-MenC [M49], ≥ 1:4	209 Participants	33 Participants
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres Above the Cut-off Values hSBA-MenC [M49], ≥ 1:8	209 Participants	33 Participants
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres Above the Cut-off Values hSBA-MenW-135 [M49], ≥ 1:4	192 Participants	1 Participants
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres Above the Cut-off Values hSBA-MenW-135 [M49], ≥ 1:8	192 Participants	1 Participants
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres Above the Cut-off Values hSBA-MenY [M49], ≥ 1:4	173 Participants	6 Participants
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres Above the Cut-off Values hSBA-MenY [M49], ≥ 1:8	173 Participants	6 Participants

SECONDARY outcome

Timeframe: At 12 months (Month 60) post booster dose.

Population: The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) \[NCT00474266\], who complied with the protocol requirements and who had available assay results for at least one tested antigen.

The cut off values for the assay were ≥ 1:4 and ≥ 1:8, respectively, as measured by GSK.

Outcome measures

Outcome measures
Measure	Nimenrix Group Y2 n=228 Participants Subjects from Year 2 Period vaccinated with Nimenrix vaccine in the primary study 109670 \[NCT00474266\] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study.	Meningitec Group Y2 n=33 Participants Subjects from Year 2 Period who received Meningitec vaccine in the primary vaccination study 109670 \[NCT00474266\] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study.
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres Above the Cut-off Values hSBA-MenA [M60], ≥ 1:4	211 Participants	3 Participants
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres Above the Cut-off Values hSBA-MenA [M60], ≥ 1:8	211 Participants	3 Participants
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres Above the Cut-off Values hSBA-MenC [M60], ≥ 1:4	228 Participants	33 Participants
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres Above the Cut-off Values hSBA-MenC [M60], ≥ 1:8	228 Participants	33 Participants
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres Above the Cut-off Values hSBA-MenW-135 [M60], ≥ 1:4	218 Participants	5 Participants
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres Above the Cut-off Values hSBA-MenW-135 [M60], ≥ 1:8	218 Participants	5 Participants
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres Above the Cut-off Values hSBA-MenY [M60], ≥ 1:4	206 Participants	10 Participants
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres Above the Cut-off Values hSBA-MenY [M60], ≥ 1:8	206 Participants	10 Participants

SECONDARY outcome

Timeframe: At one month (Month 49) post booster dose

Population: The analysis was performed on the Booster 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 the booster vaccination.

The results were tabulated as geometric mean antibody titre (GMT) calculated on all subjects, expressed in titres, as measured by GSK.

Outcome measures

Outcome measures
Measure	Nimenrix Group Y2 n=209 Participants Subjects from Year 2 Period vaccinated with Nimenrix vaccine in the primary study 109670 \[NCT00474266\] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study.	Meningitec Group Y2 n=33 Participants Subjects from Year 2 Period who received Meningitec vaccine in the primary vaccination study 109670 \[NCT00474266\] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study.
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres hSBA-MenA [M49]	1343.2 Titres Interval 1119.3 to 1612.0	2.8 Titres Interval 2.0 to 3.8
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres hSBA-MenC [M49]	15831.4 Titres Interval 13625.8 to 18394.0	8646.1 Titres Interval 5886.6 to 12699.3
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres hSBA-MenW-135 [M49]	14411.2 Titres Interval 12971.8 to 16010.2	2.3 Titres Interval 1.7 to 3.3
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres hSBA-MenY [M49]	6775.5 Titres Interval 5961.3 to 7700.9	4.9 Titres Interval 2.4 to 9.8

SECONDARY outcome

Timeframe: At 12 months (Month 60) post booster dose

Population: The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) \[NCT00474266\], who complied with the protocol requirements and who had available assay results for at least one tested antigen.

The results were tabulated as geometric mean antibody titre (GMT) calculated on all subjects, expressed in titres, as measured by GSK.

Outcome measures

Outcome measures
Measure	Nimenrix Group Y2 n=228 Participants Subjects from Year 2 Period vaccinated with Nimenrix vaccine in the primary study 109670 \[NCT00474266\] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study.	Meningitec Group Y2 n=33 Participants Subjects from Year 2 Period who received Meningitec vaccine in the primary vaccination study 109670 \[NCT00474266\] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study.
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres hSBA-MenA [M60]	88 Titres Interval 73.6 to 105.1	2.5 Titres Interval 1.9 to 3.2
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres hSBA-MenC [M60]	1342.3 Titres Interval 1134.6 to 1588.1	931.1 Titres Interval 572.8 to 1513.4
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres hSBA-MenW-135 [M60]	2196.6 Titres Interval 1955.7 to 2467.2	3.4 Titres Interval 2.2 to 5.4
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres hSBA-MenY [M60]	1110.8 Titres Interval 987.5 to 1249.6	7.5 Titres Interval 3.6 to 15.7

SECONDARY outcome

Timeframe: At one month (Month 49) post booster dose

Population: The analysis was performed on the Booster According-To-Protocol (ATP) cohort for immunogenicity 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 the booster vaccination.

The cut-off values for the assay were 0.3 μg/mL and 2.0 μg/mL, as measured by the PHE laboratory.

Outcome measures

Outcome measures
Measure	Nimenrix Group Y2 n=70 Participants Subjects from Year 2 Period vaccinated with Nimenrix vaccine in the primary study 109670 \[NCT00474266\] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study.	Meningitec Group Y2 n=19 Participants Subjects from Year 2 Period who received Meningitec vaccine in the primary vaccination study 109670 \[NCT00474266\] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study.
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Above the Cut-off Values Anti-PSA [M49], ≥ 0.3	67 Participants	15 Participants
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Above the Cut-off Values Anti-PSA [M49], ≥ 2.0	66 Participants	6 Participants
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Above the Cut-off Values Anti-PSC [M49], ≥ 0.3	70 Participants	18 Participants
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Above the Cut-off Values Anti-PSC [M49], ≥ 2.0	67 Participants	18 Participants
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Above the Cut-off Values Anti-PSW-135 [M49], ≥ 0.3	69 Participants	13 Participants
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Above the Cut-off Values Anti-PSW-135 [M49], ≥ 2.0	69 Participants	0 Participants
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Above the Cut-off Values Anti-PSY [M49], ≥ 0.3	63 Participants	9 Participants
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Above the Cut-off Values Anti-PSY [M49], ≥ 2.0	63 Participants	0 Participants

SECONDARY outcome

Timeframe: At 12 months (Month 60) post booster dose

Population: The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) \[NCT00474266\], who complied with the protocol requirements and who had available assay results for at least one tested antigen.

The cut-off for the assay were 0.3 μg/mL and 2.0 μg/mL, as measured by the PHE laboratory.

Outcome measures

Outcome measures
Measure	Nimenrix Group Y2 n=98 Participants Subjects from Year 2 Period vaccinated with Nimenrix vaccine in the primary study 109670 \[NCT00474266\] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study.	Meningitec Group Y2 n=22 Participants Subjects from Year 2 Period who received Meningitec vaccine in the primary vaccination study 109670 \[NCT00474266\] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study.
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values Anti-PSA [M60], ≥ 0.3	98 Participants	22 Participants
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values Anti-PSA [M60], ≥ 2.0	82 Participants	5 Participants
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values Anti-PSC [M60], ≥ 0.3	85 Participants	13 Participants
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values Anti-PSC [M60], ≥ 2.0	38 Participants	10 Participants
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values Anti-PSW-135 [M60], ≥ 0.3	98 Participants	8 Participants
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values Anti-PSW-135 [M60], ≥ 2.0	98 Participants	0 Participants
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values Anti-PSY [M60], ≥ 0.3	85 Participants	12 Participants
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values Anti-PSY [M60], ≥ 2.0	85 Participants	6 Participants

SECONDARY outcome

Timeframe: At one month (Month 49) post booster dose

Population: The analysis was performed on the Booster According-To-Protocol (ATP) cohort for immunogenicity 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 the booster vaccination.

The results were tabulated as geometric mean antibody concentration calculated on all subjects, expressed in μg/mL, as measured by the PHE laboratory.

Outcome measures

Outcome measures
Measure	Nimenrix Group Y2 n=70 Participants Subjects from Year 2 Period vaccinated with Nimenrix vaccine in the primary study 109670 \[NCT00474266\] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study.	Meningitec Group Y2 n=19 Participants Subjects from Year 2 Period who received Meningitec vaccine in the primary vaccination study 109670 \[NCT00474266\] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study.
Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations Anti-PSA [M49]	12.61 μg/mL Interval 10.39 to 15.29	1.76 μg/mL Interval 1.1 to 2.81
Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations Anti-PSC [M49]	8.64 μg/mL Interval 7.18 to 10.4	13.07 μg/mL Interval 9.09 to 18.8
Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations Anti-PSW-135 [M49]	59.06 μg/mL Interval 49.26 to 70.81	0.34 μg/mL Interval 0.24 to 0.48
Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations Anti-PSY [M49]	38.85 μg/mL Interval 30.2 to 49.98	0.56 μg/mL Interval 0.35 to 0.89

SECONDARY outcome

Timeframe: At 12 months (Month 60) post booster dose

Population: The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) \[NCT00474266\], who complied with the protocol requirements and who had available assay results for at least one tested antigen.

The results were tabulated as geometric mean antibody concentration calculated on all subjects, expressed in μg/mL, as measured by the PHE laboratory.

Outcome measures

Outcome measures
Measure	Nimenrix Group Y2 n=98 Participants Subjects from Year 2 Period vaccinated with Nimenrix vaccine in the primary study 109670 \[NCT00474266\] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study.	Meningitec Group Y2 n=22 Participants Subjects from Year 2 Period who received Meningitec vaccine in the primary vaccination study 109670 \[NCT00474266\] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study.
Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations Anti-PSY [M60]	10.31 μg/mL Interval 8.64 to 12.29	2.24 μg/mL Interval 1.25 to 4.02
Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations Anti-PSA [M60]	4.22 μg/mL Interval 3.64 to 4.88	1.41 μg/mL Interval 1.09 to 1.82
Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations Anti-PSC [M60]	1.81 μg/mL Interval 1.56 to 2.11	2.93 μg/mL Interval 1.47 to 5.86
Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations Anti-PSW-135 [M60]	9.44 μg/mL Interval 8.29 to 10.74	0.26 μg/mL Interval 0.18 to 0.37

SECONDARY outcome

Timeframe: During the 8-day period (Days 0-7) after booster vaccination

Population: The analysis was performed on the Booster Total Vaccinated cohort, which included all vaccinated subjects in the primary study (109670) \[NCT00474266\], with a booster vaccine administration documented and with their symptom sheet filled-in.

Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of any local symptom regardless of intensity grade.

Outcome measures

Outcome measures
Measure	Nimenrix Group Y2 n=244 Participants Subjects from Year 2 Period vaccinated with Nimenrix vaccine in the primary study 109670 \[NCT00474266\] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study.	Meningitec Group Y2 n=47 Participants Subjects from Year 2 Period who received Meningitec vaccine in the primary vaccination study 109670 \[NCT00474266\] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study.
Number of Subjects Reporting Any Solicited Local Symptoms Any pain	149 Participants	23 Participants
Number of Subjects Reporting Any Solicited Local Symptoms Any Redness	90 Participants	17 Participants
Number of Subjects Reporting Any Solicited Local Symptoms Any Swelling	70 Participants	11 Participants

SECONDARY outcome

Timeframe: During the 8-day period (Days 0-7) after the booster vaccination

Population: The analysis was performed on the Booster Total Vaccinated cohort, which included all vaccinated subjects in the primary study (109670) \[NCT00474266\], with a booster vaccine administration documented, and with the symptom sheet filled-in.

Solicited general symptoms assessed were drowsiness, irritability, loss of appetite, temperature (measured orally). Any was defined as occurrence of any general symptoms, regardless of their intensity grade or their relationship to vaccination

Outcome measures

Outcome measures
Measure	Nimenrix Group Y2 n=244 Participants Subjects from Year 2 Period vaccinated with Nimenrix vaccine in the primary study 109670 \[NCT00474266\] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study.	Meningitec Group Y2 n=47 Participants Subjects from Year 2 Period who received Meningitec vaccine in the primary vaccination study 109670 \[NCT00474266\] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study.
Number of Subjects Reporting Any Solicited General Symptoms Any drowsiness	41 Participants	10 Participants
Number of Subjects Reporting Any Solicited General Symptoms Any irritability	40 Participants	11 Participants
Number of Subjects Reporting Any Solicited General Symptoms Any loss of appetite	31 Participants	8 Participants
Number of Subjects Reporting Any Solicited General Symptoms Any temperature (orally, ≥ 37.5°C)	16 Participants	1 Participants

SECONDARY outcome

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

Population: The analysis was performed on the Booster Total Vaccinated cohort, which included all vaccinated subjects in the primary study (109670) \[NCT00474266\], with a booster vaccine administration documented, and with their symptom sheet filled-in.

Any was defined as the occurrence of any adverse event regardless of intensity grade or relation to 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 regard-less of intensity grade or relation to vaccination.

Outcome measures

Outcome measures
Measure	Nimenrix Group Y2 n=245 Participants Subjects from Year 2 Period vaccinated with Nimenrix vaccine in the primary study 109670 \[NCT00474266\] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study.	Meningitec Group Y2 n=48 Participants Subjects from Year 2 Period who received Meningitec vaccine in the primary vaccination study 109670 \[NCT00474266\] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study.
Number of Subjects Reporting Any Adverse Events (AEs)	106 Participants	18 Participants

SECONDARY outcome

Timeframe: At Month 24 post primary dose

Population: The analysis was performed on the Total cohort for each persistence time point, which included all vaccinated subjects in the primary study (109670) \[NCT00474266\], who came back to the visit at the considered time point.

Serious adverse events (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 Group Y2 n=253 Participants Subjects from Year 2 Period vaccinated with Nimenrix vaccine in the primary study 109670 \[NCT00474266\] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study.	Meningitec Group Y2 n=42 Participants Subjects from Year 2 Period who received Meningitec vaccine in the primary vaccination study 109670 \[NCT00474266\] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study.
Number of Subjects Reporting Any Serious Adverse Events (SAEs)	0 Participants	0 Participants

SECONDARY outcome

Timeframe: At Month 36

Population: The analysis was performed on the Total cohort for each persistence time point, which included all vaccinated subjects in the primary study (109670) \[NCT00474266\], who came back to the visit at the considered time point.

Serious adverse events (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 Group Y2 n=273 Participants Subjects from Year 2 Period vaccinated with Nimenrix vaccine in the primary study 109670 \[NCT00474266\] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study.	Meningitec Group Y2 n=47 Participants Subjects from Year 2 Period who received Meningitec vaccine in the primary vaccination study 109670 \[NCT00474266\] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study.
Number of Subjects Reporting Any Serious Adverse Events (SAEs)	0 Participants	0 Participants

SECONDARY outcome

Timeframe: At Month 48

Population: The analysis was performed on the Total cohort for each persistence time point, which included all vaccinated subjects in the primary study (109670) \[NCT00474266\], who came back to the visit at the considered time point.

Serious adverse events (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 Group Y2 n=246 Participants Subjects from Year 2 Period vaccinated with Nimenrix vaccine in the primary study 109670 \[NCT00474266\] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study.	Meningitec Group Y2 n=48 Participants Subjects from Year 2 Period who received Meningitec vaccine in the primary vaccination study 109670 \[NCT00474266\] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study.
Number of Subjects Reporting Any Serious Adverse Events (SAEs)	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From month 48 to month 49 (post booster follow up period)

Population: The analysis was performed on the Booster Total Vaccinated cohort, which included all vaccinated subjects in the primary study (109670) \[NCT00474266\], with a booster vaccine administration documented.

Serious adverse events (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 Group Y2 n=245 Participants Subjects from Year 2 Period vaccinated with Nimenrix vaccine in the primary study 109670 \[NCT00474266\] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study.	Meningitec Group Y2 n=48 Participants Subjects from Year 2 Period who received Meningitec vaccine in the primary vaccination study 109670 \[NCT00474266\] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study.
Number of Subjects Reporting Any Serious Adverse Events (SAEs)	2 Participants	0 Participants

SECONDARY outcome

Timeframe: From month 49 to month 60

Population: The analysis was performed on the Total cohort for each persistence time point, which included all vaccinated subjects in the primary study (109670) \[NCT00474266\], who came back to the visit at the considered time point.

Serious adverse events (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 Group Y2 n=239 Participants Subjects from Year 2 Period vaccinated with Nimenrix vaccine in the primary study 109670 \[NCT00474266\] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study.	Meningitec Group Y2 n=47 Participants Subjects from Year 2 Period who received Meningitec vaccine in the primary vaccination study 109670 \[NCT00474266\] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study.
Number of Subjects Reporting Any Serious Adverse Events (SAEs)	0 Participants	0 Participants

Adverse Events

Nimenrix Group

Serious events: 2 serious events

Other events: 190 other events

Deaths: 0 deaths

Meningitec Group

Serious events: 0 serious events

Other events: 39 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Nimenrix Group n=245 participants at risk Subjects vaccinated with Nimenrix vaccine in the primary study 109670 \[NCT00474266\] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study.	Meningitec Group n=48 participants at risk Subjects who received Meningitec vaccine in the primary vaccination study 109670 \[NCT00474266\] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study.
Immune system disorders Hypersensitivity	0.41% 1/245 • Number of events 1 • Solicited local and general symptoms: during the 8-day period (Days 0-7) after booster vaccination. Unsolicited symptoms: during the 31-day period (Days 0-30) after booster vaccination. SAEs: during the 31-day period (Days 0-30) following booster vaccination. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	0.00% 0/48 • Solicited local and general symptoms: during the 8-day period (Days 0-7) after booster vaccination. Unsolicited symptoms: during the 31-day period (Days 0-30) after booster vaccination. SAEs: during the 31-day period (Days 0-30) following booster vaccination. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
Injury, poisoning and procedural complications Limb injury	0.41% 1/245 • Number of events 1 • Solicited local and general symptoms: during the 8-day period (Days 0-7) after booster vaccination. Unsolicited symptoms: during the 31-day period (Days 0-30) after booster vaccination. SAEs: during the 31-day period (Days 0-30) following booster vaccination. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	0.00% 0/48 • Solicited local and general symptoms: during the 8-day period (Days 0-7) after booster vaccination. Unsolicited symptoms: during the 31-day period (Days 0-30) after booster vaccination. SAEs: during the 31-day period (Days 0-30) following booster vaccination. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.

Other adverse events

Other adverse events
Measure	Nimenrix Group n=245 participants at risk Subjects vaccinated with Nimenrix vaccine in the primary study 109670 \[NCT00474266\] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study.	Meningitec Group n=48 participants at risk Subjects who received Meningitec vaccine in the primary vaccination study 109670 \[NCT00474266\] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study.
Respiratory, thoracic and mediastinal disorders Cough	6.1% 15/245 • Number of events 16 • Solicited local and general symptoms: during the 8-day period (Days 0-7) after booster vaccination. Unsolicited symptoms: during the 31-day period (Days 0-30) after booster vaccination. SAEs: during the 31-day period (Days 0-30) following booster vaccination. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	4.2% 2/48 • Number of events 2 • Solicited local and general symptoms: during the 8-day period (Days 0-7) after booster vaccination. Unsolicited symptoms: during the 31-day period (Days 0-30) after booster vaccination. SAEs: during the 31-day period (Days 0-30) following booster vaccination. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
Metabolism and nutrition disorders Decreased appetite	12.7% 31/245 • Number of events 31 • Solicited local and general symptoms: during the 8-day period (Days 0-7) after booster vaccination. Unsolicited symptoms: during the 31-day period (Days 0-30) after booster vaccination. SAEs: during the 31-day period (Days 0-30) following booster vaccination. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	16.7% 8/48 • Number of events 8 • Solicited local and general symptoms: during the 8-day period (Days 0-7) after booster vaccination. Unsolicited symptoms: during the 31-day period (Days 0-30) after booster vaccination. SAEs: during the 31-day period (Days 0-30) following booster vaccination. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
Skin and subcutaneous tissue disorders Erythema	36.7% 90/245 • Number of events 90 • Solicited local and general symptoms: during the 8-day period (Days 0-7) after booster vaccination. Unsolicited symptoms: during the 31-day period (Days 0-30) after booster vaccination. SAEs: during the 31-day period (Days 0-30) following booster vaccination. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	35.4% 17/48 • Number of events 17 • Solicited local and general symptoms: during the 8-day period (Days 0-7) after booster vaccination. Unsolicited symptoms: during the 31-day period (Days 0-30) after booster vaccination. SAEs: during the 31-day period (Days 0-30) following booster vaccination. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
Nervous system disorders Headache	2.0% 5/245 • Number of events 6 • Solicited local and general symptoms: during the 8-day period (Days 0-7) after booster vaccination. Unsolicited symptoms: during the 31-day period (Days 0-30) after booster vaccination. SAEs: during the 31-day period (Days 0-30) following booster vaccination. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	6.2% 3/48 • Number of events 4 • Solicited local and general symptoms: during the 8-day period (Days 0-7) after booster vaccination. Unsolicited symptoms: during the 31-day period (Days 0-30) after booster vaccination. SAEs: during the 31-day period (Days 0-30) following booster vaccination. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
Psychiatric disorders Irritability	16.3% 40/245 • Number of events 40 • Solicited local and general symptoms: during the 8-day period (Days 0-7) after booster vaccination. Unsolicited symptoms: during the 31-day period (Days 0-30) after booster vaccination. SAEs: during the 31-day period (Days 0-30) following booster vaccination. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	22.9% 11/48 • Number of events 11 • Solicited local and general symptoms: during the 8-day period (Days 0-7) after booster vaccination. Unsolicited symptoms: during the 31-day period (Days 0-30) after booster vaccination. SAEs: during the 31-day period (Days 0-30) following booster vaccination. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
Infections and infestations Nasopharyngitis	5.3% 13/245 • Number of events 14 • Solicited local and general symptoms: during the 8-day period (Days 0-7) after booster vaccination. Unsolicited symptoms: during the 31-day period (Days 0-30) after booster vaccination. SAEs: during the 31-day period (Days 0-30) following booster vaccination. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	2.1% 1/48 • Number of events 1 • Solicited local and general symptoms: during the 8-day period (Days 0-7) after booster vaccination. Unsolicited symptoms: during the 31-day period (Days 0-30) after booster vaccination. SAEs: during the 31-day period (Days 0-30) following booster vaccination. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
General disorders Pain	60.8% 149/245 • Number of events 149 • Solicited local and general symptoms: during the 8-day period (Days 0-7) after booster vaccination. Unsolicited symptoms: during the 31-day period (Days 0-30) after booster vaccination. SAEs: during the 31-day period (Days 0-30) following booster vaccination. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	47.9% 23/48 • Number of events 23 • Solicited local and general symptoms: during the 8-day period (Days 0-7) after booster vaccination. Unsolicited symptoms: during the 31-day period (Days 0-30) after booster vaccination. SAEs: during the 31-day period (Days 0-30) following booster vaccination. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
General disorders Pyrexia	9.4% 23/245 • Number of events 23 • Solicited local and general symptoms: during the 8-day period (Days 0-7) after booster vaccination. Unsolicited symptoms: during the 31-day period (Days 0-30) after booster vaccination. SAEs: during the 31-day period (Days 0-30) following booster vaccination. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	8.3% 4/48 • Number of events 4 • Solicited local and general symptoms: during the 8-day period (Days 0-7) after booster vaccination. Unsolicited symptoms: during the 31-day period (Days 0-30) after booster vaccination. SAEs: during the 31-day period (Days 0-30) following booster vaccination. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
Nervous system disorders Somnolence	16.7% 41/245 • Number of events 41 • Solicited local and general symptoms: during the 8-day period (Days 0-7) after booster vaccination. Unsolicited symptoms: during the 31-day period (Days 0-30) after booster vaccination. SAEs: during the 31-day period (Days 0-30) following booster vaccination. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	20.8% 10/48 • Number of events 10 • Solicited local and general symptoms: during the 8-day period (Days 0-7) after booster vaccination. Unsolicited symptoms: during the 31-day period (Days 0-30) after booster vaccination. SAEs: during the 31-day period (Days 0-30) following booster vaccination. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
General disorders Swelling	28.6% 70/245 • Number of events 70 • Solicited local and general symptoms: during the 8-day period (Days 0-7) after booster vaccination. Unsolicited symptoms: during the 31-day period (Days 0-30) after booster vaccination. SAEs: during the 31-day period (Days 0-30) following booster vaccination. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	22.9% 11/48 • Number of events 11 • Solicited local and general symptoms: during the 8-day period (Days 0-7) after booster vaccination. Unsolicited symptoms: during the 31-day period (Days 0-30) after booster vaccination. SAEs: during the 31-day period (Days 0-30) following booster vaccination. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
Infections and infestations Upper respiratory tract infection	6.1% 15/245 • Number of events 15 • Solicited local and general symptoms: during the 8-day period (Days 0-7) after booster vaccination. Unsolicited symptoms: during the 31-day period (Days 0-30) after booster vaccination. SAEs: during the 31-day period (Days 0-30) following booster vaccination. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	4.2% 2/48 • Number of events 2 • Solicited local and general symptoms: during the 8-day period (Days 0-7) after booster vaccination. Unsolicited symptoms: during the 31-day period (Days 0-30) after booster vaccination. SAEs: during the 31-day period (Days 0-30) following booster vaccination. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.

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

Measure	Nimenrix Group (Y2 - Y 5) n=1256 Participants Subjects from Year 2, 3, 4, Month 49 and Year 5 period, vaccinated with Nimenrix vaccine in the primary study 109670 \[NCT00474266\] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study.	Meningitec Group (Y 2- Y 5) n=232 Participants Subjects from Year 2, 3, 4, Month 49 and Year 5 period, who received Meningitec vaccine in the primary vaccination study 109670 \[NCT00474266\] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study.	Total n=1488 Participants Total of all reporting groups
Age, Continuous Year 2 Period	40.7 Months STANDARD_DEVIATION 1.87 • n=253 Participants • Note: The numbers analyzed in rows represent the number of subjects at the respective study periods.	41.1 Months STANDARD_DEVIATION 1.74 • n=42 Participants • Note: The numbers analyzed in rows represent the number of subjects at the respective study periods.	40.76 Months STANDARD_DEVIATION 1.85 • n=295 Participants • Note: The numbers analyzed in rows represent the number of subjects at the respective study periods.
Age, Continuous Year 3 Period	49.0 Months STANDARD_DEVIATION 1.77 • n=273 Participants • Note: The numbers analyzed in rows represent the number of subjects at the respective study periods.	49.3 Months STANDARD_DEVIATION 2.09 • n=47 Participants • Note: The numbers analyzed in rows represent the number of subjects at the respective study periods.	49.04 Months STANDARD_DEVIATION 1.82 • n=320 Participants • Note: The numbers analyzed in rows represent the number of subjects at the respective study periods.
Age, Continuous Year 4 Period	63.7 Months STANDARD_DEVIATION 1.81 • n=246 Participants • Note: The numbers analyzed in rows represent the number of subjects at the respective study periods.	63.9 Months STANDARD_DEVIATION 1.97 • n=48 Participants • Note: The numbers analyzed in rows represent the number of subjects at the respective study periods.	63.73 Months STANDARD_DEVIATION 1.84 • n=294 Participants • Note: The numbers analyzed in rows represent the number of subjects at the respective study periods.
Age, Continuous Booster Period Month 49	63.7 Months STANDARD_DEVIATION 1.81 • n=245 Participants • Note: The numbers analyzed in rows represent the number of subjects at the respective study periods.	63.9 Months STANDARD_DEVIATION 1.97 • n=48 Participants • Note: The numbers analyzed in rows represent the number of subjects at the respective study periods.	63.73 Months STANDARD_DEVIATION 1.84 • n=293 Participants • Note: The numbers analyzed in rows represent the number of subjects at the respective study periods.
Age, Continuous Year 5 Period	72.9 Months STANDARD_DEVIATION 1.68 • n=239 Participants • Note: The numbers analyzed in rows represent the number of subjects at the respective study periods.	72.9 Months STANDARD_DEVIATION 1.83 • n=47 Participants • Note: The numbers analyzed in rows represent the number of subjects at the respective study periods.	72.9 Months STANDARD_DEVIATION 1.70 • n=286 Participants • Note: The numbers analyzed in rows represent the number of subjects at the respective study periods.
Sex: Female, Male Year 2 Period · Female	120 Participants n=253 Participants • Note: The numbers analyzed in rows represent the number of subjects at the respective study periods.	20 Participants n=42 Participants • Note: The numbers analyzed in rows represent the number of subjects at the respective study periods.	140 Participants n=295 Participants • Note: The numbers analyzed in rows represent the number of subjects at the respective study periods.
Sex: Female, Male Year 2 Period · Male	133 Participants n=253 Participants • Note: The numbers analyzed in rows represent the number of subjects at the respective study periods.	22 Participants n=42 Participants • Note: The numbers analyzed in rows represent the number of subjects at the respective study periods.	155 Participants n=295 Participants • Note: The numbers analyzed in rows represent the number of subjects at the respective study periods.
Sex: Female, Male Year 3 Period · Female	129 Participants n=273 Participants • Note: The numbers analyzed in rows represent the number of subjects at the respective study periods.	22 Participants n=47 Participants • Note: The numbers analyzed in rows represent the number of subjects at the respective study periods.	151 Participants n=320 Participants • Note: The numbers analyzed in rows represent the number of subjects at the respective study periods.
Sex: Female, Male Year 3 Period · Male	144 Participants n=273 Participants • Note: The numbers analyzed in rows represent the number of subjects at the respective study periods.	25 Participants n=47 Participants • Note: The numbers analyzed in rows represent the number of subjects at the respective study periods.	169 Participants n=320 Participants • Note: The numbers analyzed in rows represent the number of subjects at the respective study periods.
Sex: Female, Male Year 4 Period · Female	120 Participants n=246 Participants • Note: The numbers analyzed in rows represent the number of subjects at the respective study periods.	22 Participants n=48 Participants • Note: The numbers analyzed in rows represent the number of subjects at the respective study periods.	142 Participants n=294 Participants • Note: The numbers analyzed in rows represent the number of subjects at the respective study periods.
Sex: Female, Male Year 4 Period · Male	126 Participants n=246 Participants • Note: The numbers analyzed in rows represent the number of subjects at the respective study periods.	26 Participants n=48 Participants • Note: The numbers analyzed in rows represent the number of subjects at the respective study periods.	152 Participants n=294 Participants • Note: The numbers analyzed in rows represent the number of subjects at the respective study periods.
Sex: Female, Male Booster Period Month 49 · Female	119 Participants n=245 Participants • Note: The numbers analyzed in rows represent the number of subjects at the respective study periods.	22 Participants n=48 Participants • Note: The numbers analyzed in rows represent the number of subjects at the respective study periods.	141 Participants n=293 Participants • Note: The numbers analyzed in rows represent the number of subjects at the respective study periods.
Sex: Female, Male Booster Period Month 49 · Male	126 Participants n=245 Participants • Note: The numbers analyzed in rows represent the number of subjects at the respective study periods.	26 Participants n=48 Participants • Note: The numbers analyzed in rows represent the number of subjects at the respective study periods.	152 Participants n=293 Participants • Note: The numbers analyzed in rows represent the number of subjects at the respective study periods.
Sex: Female, Male Year 5 Period · Female	116 Participants n=239 Participants • Note: The numbers analyzed in rows represent the number of subjects at the respective study periods.	22 Participants n=47 Participants • Note: The numbers analyzed in rows represent the number of subjects at the respective study periods.	138 Participants n=286 Participants • Note: The numbers analyzed in rows represent the number of subjects at the respective study periods.
Sex: Female, Male Year 5 Period · Male	123 Participants n=239 Participants • Note: The numbers analyzed in rows represent the number of subjects at the respective study periods.	25 Participants n=47 Participants • Note: The numbers analyzed in rows represent the number of subjects at the respective study periods.	148 Participants n=286 Participants • Note: The numbers analyzed in rows represent the number of subjects at the respective study periods.
Race/Ethnicity, Customized Year 2 Period · White - Caucasian / European heritage, n (%)	252 Participants n=253 Participants • Note: The numbers analyzed in rows represent the number of subjects at the respective study periods.	42 Participants n=42 Participants • Note: The numbers analyzed in rows represent the number of subjects at the respective study periods.	294 Participants n=295 Participants • Note: The numbers analyzed in rows represent the number of subjects at the respective study periods.
Race/Ethnicity, Customized Year 2 Period · Other	1 Participants n=253 Participants • Note: The numbers analyzed in rows represent the number of subjects at the respective study periods.	0 Participants n=42 Participants • Note: The numbers analyzed in rows represent the number of subjects at the respective study periods.	1 Participants n=295 Participants • Note: The numbers analyzed in rows represent the number of subjects at the respective study periods.
Race/Ethnicity, Customized Year 3 Period · White - Caucasian / European heritage, n (%)	271 Participants n=273 Participants • Note: The numbers analyzed in rows represent the number of subjects at the respective study periods.	47 Participants n=47 Participants • Note: The numbers analyzed in rows represent the number of subjects at the respective study periods.	318 Participants n=320 Participants • Note: The numbers analyzed in rows represent the number of subjects at the respective study periods.
Race/Ethnicity, Customized Year 3 Period · Other	2 Participants n=273 Participants • Note: The numbers analyzed in rows represent the number of subjects at the respective study periods.	0 Participants n=47 Participants • Note: The numbers analyzed in rows represent the number of subjects at the respective study periods.	2 Participants n=320 Participants • Note: The numbers analyzed in rows represent the number of subjects at the respective study periods.
Race/Ethnicity, Customized Year 4 Period · White - Caucasian / European heritage, n (%)	245 Participants n=246 Participants • Note: The numbers analyzed in rows represent the number of subjects at the respective study periods.	47 Participants n=48 Participants • Note: The numbers analyzed in rows represent the number of subjects at the respective study periods.	292 Participants n=294 Participants • Note: The numbers analyzed in rows represent the number of subjects at the respective study periods.
Race/Ethnicity, Customized Year 4 Period · Other	1 Participants n=246 Participants • Note: The numbers analyzed in rows represent the number of subjects at the respective study periods.	1 Participants n=48 Participants • Note: The numbers analyzed in rows represent the number of subjects at the respective study periods.	2 Participants n=294 Participants • Note: The numbers analyzed in rows represent the number of subjects at the respective study periods.
Race/Ethnicity, Customized Booster Period Month 49 · White - Caucasian / European heritage, n (%)	244 Participants n=245 Participants • Note: The numbers analyzed in rows represent the number of subjects at the respective study periods.	47 Participants n=48 Participants • Note: The numbers analyzed in rows represent the number of subjects at the respective study periods.	291 Participants n=293 Participants • Note: The numbers analyzed in rows represent the number of subjects at the respective study periods.
Race/Ethnicity, Customized Booster Period Month 49 · Other	1 Participants n=245 Participants • Note: The numbers analyzed in rows represent the number of subjects at the respective study periods.	1 Participants n=48 Participants • Note: The numbers analyzed in rows represent the number of subjects at the respective study periods.	2 Participants n=293 Participants • Note: The numbers analyzed in rows represent the number of subjects at the respective study periods.
Race/Ethnicity, Customized Year 5 Period · White - Caucasian / European heritage, n (%)	238 Participants n=239 Participants • Note: The numbers analyzed in rows represent the number of subjects at the respective study periods.	46 Participants n=47 Participants • Note: The numbers analyzed in rows represent the number of subjects at the respective study periods.	284 Participants n=286 Participants • Note: The numbers analyzed in rows represent the number of subjects at the respective study periods.
Race/Ethnicity, Customized Year 5 Period · Other	1 Participants n=239 Participants • Note: The numbers analyzed in rows represent the number of subjects at the respective study periods.	1 Participants n=47 Participants • Note: The numbers analyzed in rows represent the number of subjects at the respective study periods.	2 Participants n=286 Participants • Note: The numbers analyzed in rows represent the number of subjects at the respective study periods.