Trial Outcomes & Findings for The Long-term Antibody Persistence of GSK Biologicals' Meningococcal Vaccine GSK134612 in Healthy Toddlers (NCT NCT00718666)

NCT ID: NCT00718666

Last Updated: 2019-06-26

Results Overview

hSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off value assessed was greater than or equal to ( ≥) 1:8.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 387 participants
• Primary outcome timeframe: At Year 1 (12 months post primary vaccination)
• Results posted on: 2019-06-26

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.

Out of 387 subjects originally enrolled in the study, only 248 subjects received vaccination.

Participant milestones

Measure	Nimenrix 1 Group Subjects who received 1 dose of Nimenrix vaccine at 12 months of age.	Nimenrix 2 Group Subjects who were previously vaccinated with two doses of Nimenrix, one each at 9 and 12 months of age.	Nimenrix Naive Group Vaccine-naive subjects aged 5-6 years were enrolled to receive Nimenrix vaccine as primary vaccination at Year 5.
Persistence Phase Year 1 STARTED	118	130	0
Persistence Phase Year 1 COMPLETED	118	130	0
Persistence Phase Year 1 NOT COMPLETED	0	0	0
Persistence Phase Year 3 STARTED	98	104	0
Persistence Phase Year 3 COMPLETED	98	104	0
Persistence Phase Year 3 NOT COMPLETED	0	0	0
Persistence Phase Year 5 STARTED	70	82	0
Persistence Phase Year 5 COMPLETED	70	82	0
Persistence Phase Year 5 NOT COMPLETED	0	0	0
Booster Phase Year 5 STARTED	38	46	100
Booster Phase Year 5 COMPLETED	36	46	94
Booster Phase Year 5 NOT COMPLETED	2	0	6

Reasons for withdrawal

Measure	Nimenrix 1 Group Subjects who received 1 dose of Nimenrix vaccine at 12 months of age.	Nimenrix 2 Group Subjects who were previously vaccinated with two doses of Nimenrix, one each at 9 and 12 months of age.	Nimenrix Naive Group Vaccine-naive subjects aged 5-6 years were enrolled to receive Nimenrix vaccine as primary vaccination at Year 5.
Booster Phase Year 5 No active participation request	0	0	1
Booster Phase Year 5 Declined v-4 serology	1	0	0
Booster Phase Year 5 Withdrawal by Subject	0	0	1
Booster Phase Year 5 Lost to Follow-up	1	0	4

Baseline Characteristics

The Long-term Antibody Persistence of GSK Biologicals' Meningococcal Vaccine GSK134612 in Healthy Toddlers

Baseline characteristics by cohort

Measure	Nimenrix 1 Group Y1 n=118 Participants Subjects from Year 1 Period who received 1 dose on Nimenrix vaccine at 12 months of age.	Nimenrix 2 Group Y1 n=130 Participants Subjects from Year 1 Period who were previously vaccinated with two doses of Nimenrix, one each at 9 and 12 months of age.	Nimenrix Naive Group n=100 Participants Vaccine-naive subjects aged 5-6 years were enrolled to receive Nimenrix vaccine as primary vaccination at Year 5.	Total n=348 Participants Total of all reporting groups
Race/Ethnicity, Customized Geographic ancestry · American Indian or Alaskan Native	9 Participants n=5 Participants	16 Participants n=7 Participants	10 Participants n=5 Participants	35 Participants n=4 Participants
Race/Ethnicity, Customized Geographic ancestry · Asian-Central/South Asian heritage	3 Participants n=5 Participants	4 Participants n=7 Participants	1 Participants n=5 Participants	8 Participants n=4 Participants
Race/Ethnicity, Customized Geographic ancestry · Asian-East Asian heritage	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Race/Ethnicity, Customized Geographic ancestry · Asian-South East Asian heritage	7 Participants n=5 Participants	8 Participants n=7 Participants	3 Participants n=5 Participants	18 Participants n=4 Participants
Age, Continuous	24.5 Months STANDARD_DEVIATION 0.97 • n=5 Participants	24.6 Months STANDARD_DEVIATION 1.00 • n=7 Participants	69.2 Months STANDARD_DEVIATION 6.6 • n=5 Participants	37.38 Months STANDARD_DEVIATION 20.56 • n=4 Participants
Sex/Gender, Customized Female	56 Participants n=5 Participants	66 Participants n=7 Participants	44 Participants n=5 Participants	166 Participants n=4 Participants
Sex/Gender, Customized Male	62 Participants n=5 Participants	64 Participants n=7 Participants	56 Participants n=5 Participants	182 Participants n=4 Participants
Race/Ethnicity, Customized Geographic ancestry · African heritage/African American	7 Participants n=5 Participants	7 Participants n=7 Participants	23 Participants n=5 Participants	37 Participants n=4 Participants
Race/Ethnicity, Customized Geographic ancestry · Native Hawaiian or other Pacific Islander	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	6 Participants n=4 Participants
Race/Ethnicity, Customized Geographic ancestry · White-Arabic/North African heritage	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Race/Ethnicity, Customized Geographic ancestry · White-Caucasian/European heritage	72 Participants n=5 Participants	67 Participants n=7 Participants	46 Participants n=5 Participants	185 Participants n=4 Participants
Race/Ethnicity, Customized Geographic ancestry · Other	16 Participants n=5 Participants	26 Participants n=7 Participants	13 Participants n=5 Participants	55 Participants n=4 Participants

PRIMARY outcome

Timeframe: At Year 1 (12 months post primary vaccination)

Population: The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 1, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.

hSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off value assessed was greater than or equal to ( ≥) 1:8.

Outcome measures

Measure	Nimenrix 1 Group Y1 n=110 Participants Subjects from Year 1 Period who received 1 dose on Nimenrix vaccine at 12 months of age.	Nimenrix 2 Group Y1 n=120 Participants Subjects from Year 1 Period who were previously vaccinated with two doses of Nimenrix, one each at 9 and 12 months of age.	Nimenrix Naive Group Y5 Vaccine-naive subjects aged 5-6 years were enrolled to receive Nimenrix vaccine as primary vaccination at Year 5.
Number of Subjects With Serum Bactericidal Assay (Using Human Complement) (hSBA) Titers ≥ the Cut-off hSBA-MenA, ≥ 1:8	21 Participants	28 Participants	—
Number of Subjects With Serum Bactericidal Assay (Using Human Complement) (hSBA) Titers ≥ the Cut-off hSBA-MenC, ≥ 1:8	91 Participants	103 Participants	—
Number of Subjects With Serum Bactericidal Assay (Using Human Complement) (hSBA) Titers ≥ the Cut-off hSBA-MenW-135, ≥ 1:8	93 Participants	111 Participants	—
Number of Subjects With Serum Bactericidal Assay (Using Human Complement) (hSBA) Titers ≥ the Cut-off hSBA-MenY, ≥ 1:8	88 Participants	111 Participants	—

PRIMARY outcome

Timeframe: At Year 3 (36 months post primnary vaccination)

Population: The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 3, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.

hSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off value assessed was ≥ 1:8.

Outcome measures

Measure	Nimenrix 1 Group Y1 n=86 Participants Subjects from Year 1 Period who received 1 dose on Nimenrix vaccine at 12 months of age.	Nimenrix 2 Group Y1 n=97 Participants Subjects from Year 1 Period who were previously vaccinated with two doses of Nimenrix, one each at 9 and 12 months of age.	Nimenrix Naive Group Y5 Vaccine-naive subjects aged 5-6 years were enrolled to receive Nimenrix vaccine as primary vaccination at Year 5.
Number of Subjects With Serum Bactericidal Assay (Using Human Complement) (hSBA) Titers ≥ the Cut-off hSBA-MenA, ≥ 1:8	14 Participants	16 Participants	—
Number of Subjects With Serum Bactericidal Assay (Using Human Complement) (hSBA) Titers ≥ the Cut-off hSBA-MenC, ≥ 1:8	57 Participants	68 Participants	—
Number of Subjects With Serum Bactericidal Assay (Using Human Complement) (hSBA) Titers ≥ the Cut-off hSBA-MenW-135, ≥ 1:8	54 Participants	82 Participants	—
Number of Subjects With Serum Bactericidal Assay (Using Human Complement) (hSBA) Titers ≥ the Cut-off hSBA-MenY, ≥ 1:8	53 Participants	59 Participants	—

PRIMARY outcome

Timeframe: At Year 5 (60 months post primary vaccination)

Population: The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 5, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.

hSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off value assessed was ≥ 1:8.

Outcome measures

Measure	Nimenrix 1 Group Y1 n=63 Participants Subjects from Year 1 Period who received 1 dose on Nimenrix vaccine at 12 months of age.	Nimenrix 2 Group Y1 n=72 Participants Subjects from Year 1 Period who were previously vaccinated with two doses of Nimenrix, one each at 9 and 12 months of age.	Nimenrix Naive Group Y5 Vaccine-naive subjects aged 5-6 years were enrolled to receive Nimenrix vaccine as primary vaccination at Year 5.
Number of Subjects With Serum Bactericidal Assay (Using Human Complement) (hSBA) Titers ≥ the Cut-off Values hSBA-MenA, ≥ 1:8	20 Participants	27 Participants	—
Number of Subjects With Serum Bactericidal Assay (Using Human Complement) (hSBA) Titers ≥ the Cut-off Values hSBA-MenC, ≥ 1:8	45 Participants	53 Participants	—
Number of Subjects With Serum Bactericidal Assay (Using Human Complement) (hSBA) Titers ≥ the Cut-off Values hSBA-MenW-135, ≥ 1:8	40 Participants	62 Participants	—
Number of Subjects With Serum Bactericidal Assay (Using Human Complement) (hSBA) Titers ≥ the Cut-off Values hSBA-MenY, ≥ 1:8	32 Participants	49 Participants	—

SECONDARY outcome

Timeframe: At Year 1 (12 months post vaccination)

Population: The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 1, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.

hSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off value assessed was ≥ 1:4.

Outcome measures

Measure	Nimenrix 1 Group Y1 n=110 Participants Subjects from Year 1 Period who received 1 dose on Nimenrix vaccine at 12 months of age.	Nimenrix 2 Group Y1 n=120 Participants Subjects from Year 1 Period who were previously vaccinated with two doses of Nimenrix, one each at 9 and 12 months of age.	Nimenrix Naive Group Y5 Vaccine-naive subjects aged 5-6 years were enrolled to receive Nimenrix vaccine as primary vaccination at Year 5.
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Titers ≥ the Cut-off Values hSBA-MenA, ≥ 1:4	23 Participants	29 Participants	—
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Titers ≥ the Cut-off Values hSBA-MenC, ≥ 1:4	91 Participants	103 Participants	—
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Titers ≥ the Cut-off Values hSBA-MenW-135, ≥ 1:4	93 Participants	111 Participants	—
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Titers ≥ the Cut-off Values hSBA-MenY, ≥ 1:4	89 Participants	111 Participants	—

SECONDARY outcome

Timeframe: At Year 3 (36 months post primary vaccination)

Population: The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 3, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.

hSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off value assessed was ≥ 1:4.

Outcome measures

Measure	Nimenrix 1 Group Y1 n=86 Participants Subjects from Year 1 Period who received 1 dose on Nimenrix vaccine at 12 months of age.	Nimenrix 2 Group Y1 n=97 Participants Subjects from Year 1 Period who were previously vaccinated with two doses of Nimenrix, one each at 9 and 12 months of age.	Nimenrix Naive Group Y5 Vaccine-naive subjects aged 5-6 years were enrolled to receive Nimenrix vaccine as primary vaccination at Year 5.
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Titers ≥ the Cut-off Values hSBA-MenA, ≥ 1:4	14 Participants	19 Participants	—
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Titers ≥ the Cut-off Values hSBA-MenC, ≥ 1:4	59 Participants	69 Participants	—
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Titers ≥ the Cut-off Values hSBA-MenW-135, ≥ 1:4	54 Participants	82 Participants	—
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Titers ≥ the Cut-off Values hSBA-MenY, ≥ 1:4	53 Participants	59 Participants	—

SECONDARY outcome

Timeframe: At Year 5 (60 months post primary vaccination)

Population: The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 5, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.

hSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off value assessed was ≥ 1:4.

Outcome measures

Measure	Nimenrix 1 Group Y1 n=63 Participants Subjects from Year 1 Period who received 1 dose on Nimenrix vaccine at 12 months of age.	Nimenrix 2 Group Y1 n=72 Participants Subjects from Year 1 Period who were previously vaccinated with two doses of Nimenrix, one each at 9 and 12 months of age.	Nimenrix Naive Group Y5 Vaccine-naive subjects aged 5-6 years were enrolled to receive Nimenrix vaccine as primary vaccination at Year 5.
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Titers ≥ the Cut-off Values hSBA-MenA, ≥ 1:4	20 Participants	27 Participants	—
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Titers ≥ the Cut-off Values hSBA-MenC, ≥ 1:4	47 Participants	56 Participants	—
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Titers ≥ the Cut-off Values hSBA-MenW-135, ≥ 1:4	40 Participants	62 Participants	—
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Titers ≥ the Cut-off Values hSBA-MenY, ≥ 1:4	32 Participants	49 Participants	—

SECONDARY outcome

Timeframe: At Year 1 (12 months post primary vaccination)

Population: The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 1, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.

Titers are given as geometric mean titers (GMTs) for the serogroups hSBA-MenA, hSBA-MenC, hSBAMenW-135, and hSBA-MenY respectively, calculated on all subjects.

Outcome measures

Measure	Nimenrix 1 Group Y1 n=110 Participants Subjects from Year 1 Period who received 1 dose on Nimenrix vaccine at 12 months of age.	Nimenrix 2 Group Y1 n=120 Participants Subjects from Year 1 Period who were previously vaccinated with two doses of Nimenrix, one each at 9 and 12 months of age.	Nimenrix Naive Group Y5 Vaccine-naive subjects aged 5-6 years were enrolled to receive Nimenrix vaccine as primary vaccination at Year 5.
hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Antibody Titers hSBA-MenA	3.7 Titres Interval 2.9 to 4.8	4.1 Titres Interval 3.2 to 5.2	—
hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Antibody Titers hSBA-MenC	70.5 Titres Interval 50.4 to 98.5	72.4 Titres Interval 53.3 to 98.4	—
hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Antibody Titers hSBA-MenW-135	127.9 Titres Interval 87.3 to 187.3	204.6 Titres Interval 163.6 to 255.9	—
hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Antibody Titers hSBA-MenY	55.6 Titres Interval 38.1 to 81.1	86.2 Titres Interval 65.8 to 112.9	—

SECONDARY outcome

Timeframe: At Year 3 (36 months post primary vaccination)

Population: The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 3, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.

Titers are given as geometric mean titers (GMTs) for the serogroups hSBA-MenA, hSBA-MenC, hSBAMenW-135, and hSBA-MenY respectively, calculated on all subjects.

Outcome measures

Measure	Nimenrix 1 Group Y1 n=86 Participants Subjects from Year 1 Period who received 1 dose on Nimenrix vaccine at 12 months of age.	Nimenrix 2 Group Y1 n=97 Participants Subjects from Year 1 Period who were previously vaccinated with two doses of Nimenrix, one each at 9 and 12 months of age.	Nimenrix Naive Group Y5 Vaccine-naive subjects aged 5-6 years were enrolled to receive Nimenrix vaccine as primary vaccination at Year 5.
hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Antibody Titers hSBA-MenA	3.5 Titres Interval 2.6 to 4.6	3.4 Titres Interval 2.7 to 4.3	—
hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Antibody Titers hSBA-MenC	31.2 Titres Interval 18.9 to 51.6	29.8 Titres Interval 18.9 to 47.0	—
hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Antibody Titers hSBA-MenW-135	29 Titres Interval 18.0 to 46.9	63.9 Titres Interval 44.0 to 92.8	—
hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Antibody Titers hSBA-MenY	22 Titres Interval 14.0 to 34.5	20.5 Titres Interval 13.6 to 30.8	—

SECONDARY outcome

Timeframe: At Year 5 (60 months post primary vaccination)

Population: The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 5, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.

Titers are given as geometric mean titers (GMTs) for the serogroups hSBA-MenA, hSBA-MenC, hSBAMenW-135, and hSBA-MenY respectively, calculated on all subjects.

Outcome measures

Measure	Nimenrix 1 Group Y1 n=63 Participants Subjects from Year 1 Period who received 1 dose on Nimenrix vaccine at 12 months of age.	Nimenrix 2 Group Y1 n=72 Participants Subjects from Year 1 Period who were previously vaccinated with two doses of Nimenrix, one each at 9 and 12 months of age.	Nimenrix Naive Group Y5 Vaccine-naive subjects aged 5-6 years were enrolled to receive Nimenrix vaccine as primary vaccination at Year 5.
hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Antibody Titers hSBA-MenA	4.6 Titres Interval 3.3 to 6.3	6.6 Titres Interval 4.5 to 9.8	—
hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Antibody Titers hSBA-MenC	40.7 Titres Interval 22.7 to 73.1	38.2 Titres Interval 22.5 to 64.9	—
hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Antibody Titers hSBA-MenW-135	24.2 Titres Interval 14.4 to 40.7	53.7 Titres Interval 35.8 to 80.4	—
hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Antibody Titers hSBA-MenY	26 Titres Interval 14.1 to 47.8	37.9 Titres Interval 24.3 to 59.2	—

SECONDARY outcome

Timeframe: At Year 1 (12 months post primary vaccination)

Population: The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 1, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.

rSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off value assessed were ≥ 1:8 and 1:128. The analysis was performed by GSK Biologicals' laboratory assay.

Outcome measures

Measure	Nimenrix 1 Group Y1 n=101 Participants Subjects from Year 1 Period who received 1 dose on Nimenrix vaccine at 12 months of age.	Nimenrix 2 Group Y1 n=114 Participants Subjects from Year 1 Period who were previously vaccinated with two doses of Nimenrix, one each at 9 and 12 months of age.	Nimenrix Naive Group Y5 Vaccine-naive subjects aged 5-6 years were enrolled to receive Nimenrix vaccine as primary vaccination at Year 5.
Number of Subjects With Titers ≥ the Cut-off for Meningococcal Polysaccharides A , C, W-135 and Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay rSBA-MenA, ≥ 1:8	90 Participants	101 Participants	—
Number of Subjects With Titers ≥ the Cut-off for Meningococcal Polysaccharides A , C, W-135 and Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay rSBA-MenA, ≥ 1:128	71 Participants	80 Participants	—
Number of Subjects With Titers ≥ the Cut-off for Meningococcal Polysaccharides A , C, W-135 and Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay rSBA-MenC, ≥ 1:8	83 Participants	96 Participants	—
Number of Subjects With Titers ≥ the Cut-off for Meningococcal Polysaccharides A , C, W-135 and Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay rSBA-MenC, ≥ 1:128	46 Participants	54 Participants	—
Number of Subjects With Titers ≥ the Cut-off for Meningococcal Polysaccharides A , C, W-135 and Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay rSBA-MenW-135, ≥ 1:8	97 Participants	114 Participants	—
Number of Subjects With Titers ≥ the Cut-off for Meningococcal Polysaccharides A , C, W-135 and Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay rSBA-MenW-135, ≥ 1:128	82 Participants	89 Participants	—
Number of Subjects With Titers ≥ the Cut-off for Meningococcal Polysaccharides A , C, W-135 and Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay rSBA-MenY, ≥ 1:8	96 Participants	113 Participants	—
Number of Subjects With Titers ≥ the Cut-off for Meningococcal Polysaccharides A , C, W-135 and Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay rSBA-MenY, ≥ 1:128	85 Participants	100 Participants	—

SECONDARY outcome

Timeframe: At Year 3 (36 months post primary vaccination)

Population: The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 3, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.

rSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off value assessed were ≥ 1:8 and 1:128. The analysis was performed by GSK Biologicals' laboratory assay.

Outcome measures

Measure	Nimenrix 1 Group Y1 n=73 Participants Subjects from Year 1 Period who received 1 dose on Nimenrix vaccine at 12 months of age.	Nimenrix 2 Group Y1 n=89 Participants Subjects from Year 1 Period who were previously vaccinated with two doses of Nimenrix, one each at 9 and 12 months of age.	Nimenrix Naive Group Y5 Vaccine-naive subjects aged 5-6 years were enrolled to receive Nimenrix vaccine as primary vaccination at Year 5.
Number of Subjects With Titers ≥ the Cut-off, for MenA , MenC, MenW-135 and MenY Serum Bactericidal Antibodies, Using Baby Rabbit Complement rSBA-MenA, ≥ 1:8	65 Participants	82 Participants	—
Number of Subjects With Titers ≥ the Cut-off, for MenA , MenC, MenW-135 and MenY Serum Bactericidal Antibodies, Using Baby Rabbit Complement rSBA-MenA, ≥ 1:128	51 Participants	65 Participants	—
Number of Subjects With Titers ≥ the Cut-off, for MenA , MenC, MenW-135 and MenY Serum Bactericidal Antibodies, Using Baby Rabbit Complement rSBA-MenC, ≥ 1:8	60 Participants	75 Participants	—
Number of Subjects With Titers ≥ the Cut-off, for MenA , MenC, MenW-135 and MenY Serum Bactericidal Antibodies, Using Baby Rabbit Complement rSBA-MenC, ≥ 1:128	32 Participants	40 Participants	—
Number of Subjects With Titers ≥ the Cut-off, for MenA , MenC, MenW-135 and MenY Serum Bactericidal Antibodies, Using Baby Rabbit Complement rSBA-MenW-135, ≥ 1:8	68 Participants	88 Participants	—
Number of Subjects With Titers ≥ the Cut-off, for MenA , MenC, MenW-135 and MenY Serum Bactericidal Antibodies, Using Baby Rabbit Complement rSBA-MenW-135, ≥ 1:128	56 Participants	69 Participants	—
Number of Subjects With Titers ≥ the Cut-off, for MenA , MenC, MenW-135 and MenY Serum Bactericidal Antibodies, Using Baby Rabbit Complement rSBA-MenY, ≥ 1:8	69 Participants	89 Participants	—
Number of Subjects With Titers ≥ the Cut-off, for MenA , MenC, MenW-135 and MenY Serum Bactericidal Antibodies, Using Baby Rabbit Complement rSBA-MenY, ≥ 1:128	62 Participants	78 Participants	—

SECONDARY outcome

Timeframe: At Year 3 (36 months post primary vaccination)

Population: The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 3, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.

rSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off values assessed were ≥ 1:8 and 1:128. Titers were determined by Public Health England (PHE) laboratory assay.

Outcome measures

Measure	Nimenrix 1 Group Y1 n=83 Participants Subjects from Year 1 Period who received 1 dose on Nimenrix vaccine at 12 months of age.	Nimenrix 2 Group Y1 n=98 Participants Subjects from Year 1 Period who were previously vaccinated with two doses of Nimenrix, one each at 9 and 12 months of age.	Nimenrix Naive Group Y5 Vaccine-naive subjects aged 5-6 years were enrolled to receive Nimenrix vaccine as primary vaccination at Year 5.
Number of Subjects With Titers ≥ the Cut-off for Meningococcal Polysaccharides A , C, W-135 and Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay rSBA-MenA, ≥ 1:8	38 Participants	44 Participants	—
Number of Subjects With Titers ≥ the Cut-off for Meningococcal Polysaccharides A , C, W-135 and Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay rSBA-MenA, ≥ 1:128	23 Participants	24 Participants	—
Number of Subjects With Titers ≥ the Cut-off for Meningococcal Polysaccharides A , C, W-135 and Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay rSBA-MenC, ≥ 1:8	27 Participants	30 Participants	—
Number of Subjects With Titers ≥ the Cut-off for Meningococcal Polysaccharides A , C, W-135 and Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay rSBA-MenC, ≥ 1:128	18 Participants	15 Participants	—
Number of Subjects With Titers ≥ the Cut-off for Meningococcal Polysaccharides A , C, W-135 and Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay rSBA-MenW-135, ≥ 1:8	36 Participants	35 Participants	—
Number of Subjects With Titers ≥ the Cut-off for Meningococcal Polysaccharides A , C, W-135 and Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay rSBA-MenW-135, ≥ 1:128	24 Participants	23 Participants	—
Number of Subjects With Titers ≥ the Cut-off for Meningococcal Polysaccharides A , C, W-135 and Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay rSBA-MenY, ≥ 1:8	39 Participants	45 Participants	—
Number of Subjects With Titers ≥ the Cut-off for Meningococcal Polysaccharides A , C, W-135 and Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay rSBA-MenY, ≥ 1:128	21 Participants	24 Participants	—

SECONDARY outcome

Timeframe: At Year 5 (60 months post-primary vacccination).

Population: The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 5, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.

rSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off values assessed were ≥ 1:8 and 1:128. The analysis was performed by GSK Biologicals' laboratory assay.

Outcome measures

Measure	Nimenrix 1 Group Y1 n=53 Participants Subjects from Year 1 Period who received 1 dose on Nimenrix vaccine at 12 months of age.	Nimenrix 2 Group Y1 n=64 Participants Subjects from Year 1 Period who were previously vaccinated with two doses of Nimenrix, one each at 9 and 12 months of age.	Nimenrix Naive Group Y5 Vaccine-naive subjects aged 5-6 years were enrolled to receive Nimenrix vaccine as primary vaccination at Year 5.
Number of Subjects With Titers ≥ the Cut-off, for Meningococcal Polysaccharides A , C, W-135 and Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay rSBA-MenA, ≥ 1:8	51 Participants	57 Participants	—
Number of Subjects With Titers ≥ the Cut-off, for Meningococcal Polysaccharides A , C, W-135 and Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay rSBA-MenA, ≥ 1:128	38 Participants	49 Participants	—
Number of Subjects With Titers ≥ the Cut-off, for Meningococcal Polysaccharides A , C, W-135 and Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay rSBA-MenC, ≥ 1:8	43 Participants	53 Participants	—
Number of Subjects With Titers ≥ the Cut-off, for Meningococcal Polysaccharides A , C, W-135 and Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay rSBA-MenC, ≥ 1:128	23 Participants	31 Participants	—
Number of Subjects With Titers ≥ the Cut-off, for Meningococcal Polysaccharides A , C, W-135 and Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay rSBA-MenW-135, ≥ 1:8	51 Participants	64 Participants	—
Number of Subjects With Titers ≥ the Cut-off, for Meningococcal Polysaccharides A , C, W-135 and Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay rSBA-MenW-135,≥ 1:128	41 Participants	53 Participants	—
Number of Subjects With Titers ≥ the Cut-off, for Meningococcal Polysaccharides A , C, W-135 and Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay rSBA-MenY, ≥ 1:8	50 Participants	64 Participants	—
Number of Subjects With Titers ≥ the Cut-off, for Meningococcal Polysaccharides A , C, W-135 and Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay rSBA-MenY, ≥ 1:128	43 Participants	58 Participants	—

SECONDARY outcome

Timeframe: At Year 5 (60 months post-primary vacccination)

Population: The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 5, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.

rSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off values assessed were ≥ 1:8 and 1:128 determined by Public Health England (PHE) laboratory assay.

Outcome measures

Measure	Nimenrix 1 Group Y1 n=62 Participants Subjects from Year 1 Period who received 1 dose on Nimenrix vaccine at 12 months of age.	Nimenrix 2 Group Y1 n=72 Participants Subjects from Year 1 Period who were previously vaccinated with two doses of Nimenrix, one each at 9 and 12 months of age.	Nimenrix Naive Group Y5 Vaccine-naive subjects aged 5-6 years were enrolled to receive Nimenrix vaccine as primary vaccination at Year 5.
Number of Subjects With Titers ≥ the Cut-off for Men-A , Men-C, Men-W-135 and Men-Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay rSBA-MenA, ≥ 1:8	38 Participants	42 Participants	—
Number of Subjects With Titers ≥ the Cut-off for Men-A , Men-C, Men-W-135 and Men-Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay rSBA-MenA, ≥ 1:128	22 Participants	26 Participants	—
Number of Subjects With Titers ≥ the Cut-off for Men-A , Men-C, Men-W-135 and Men-Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay rSBA-MenC, ≥ 1:8	29 Participants	29 Participants	—
Number of Subjects With Titers ≥ the Cut-off for Men-A , Men-C, Men-W-135 and Men-Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay rSBA-MenC, ≥ 1:128	16 Participants	19 Participants	—
Number of Subjects With Titers ≥ the Cut-off for Men-A , Men-C, Men-W-135 and Men-Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay rSBA-MenW-135, ≥ 1:8	15 Participants	22 Participants	—
Number of Subjects With Titers ≥ the Cut-off for Men-A , Men-C, Men-W-135 and Men-Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay rSBA-MenW-135, ≥ 1:128	9 Participants	14 Participants	—
Number of Subjects With Titers ≥ the Cut-off for Men-A , Men-C, Men-W-135 and Men-Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay rSBA-MenY, ≥ 1:8	33 Participants	36 Participants	—
Number of Subjects With Titers ≥ the Cut-off for Men-A , Men-C, Men-W-135 and Men-Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay rSBA-MenY, ≥ 1:128	23 Participants	26 Participants	—

SECONDARY outcome

Timeframe: At Year 1 (12 months post primary vaccination)

Population: The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 1, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.

Titers were given as geometric mean titers (GMTs) for the serogroups rSBA-MenA, rSBA-MenC, rSBAMenW-135, and rSBA-MenY respectively, as performed by GSK Biologicals' laboratory assay.

Outcome measures

Measure	Nimenrix 1 Group Y1 n=101 Participants Subjects from Year 1 Period who received 1 dose on Nimenrix vaccine at 12 months of age.	Nimenrix 2 Group Y1 n=114 Participants Subjects from Year 1 Period who were previously vaccinated with two doses of Nimenrix, one each at 9 and 12 months of age.	Nimenrix Naive Group Y5 Vaccine-naive subjects aged 5-6 years were enrolled to receive Nimenrix vaccine as primary vaccination at Year 5.
rSBA Antibody Titers rSBA-MenA	259.7 Titers Interval 191.4 to 352.3	237.2 Titers Interval 187.0 to 301.0	—
rSBA Antibody Titers rSBA-MenC	94.1 Titers Interval 67.1 to 131.9	90.3 Titers Interval 65.5 to 124.4	—
rSBA Antibody Titers rSBA-MenW-135	385.2 Titers Interval 286.4 to 518.1	345.3 Titers Interval 280.1 to 425.8	—
rSBA Antibody Titers rSBA-MenY	364.5 Titers Interval 273.7 to 485.4	342.2 Titers Interval 284.5 to 411.8	—

SECONDARY outcome

Timeframe: At Year 3 (36 months post-primary vaccination)

Population: The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 3, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.

Titers are given as geometric mean titers (GMTs) for the serogroups rSBA-MenA, rSBA-MenC, rSBAMenW-135, and rSBA-MenY respectively, as performed by GSK Biologicals' laboratory assay.

Outcome measures

Measure	Nimenrix 1 Group Y1 n=73 Participants Subjects from Year 1 Period who received 1 dose on Nimenrix vaccine at 12 months of age.	Nimenrix 2 Group Y1 n=89 Participants Subjects from Year 1 Period who were previously vaccinated with two doses of Nimenrix, one each at 9 and 12 months of age.	Nimenrix Naive Group Y5 Vaccine-naive subjects aged 5-6 years were enrolled to receive Nimenrix vaccine as primary vaccination at Year 5.
rSBA Antibody Titers. rSBA-MenA	247.9 Titers Interval 173.8 to 353.7	241.8 Titers Interval 185.6 to 315.0	—
rSBA Antibody Titers. rSBA-MenC	87 Titers Interval 59.3 to 127.8	76.4 Titers Interval 53.5 to 109.0	—
rSBA Antibody Titers. rSBA-MenW-135	353.3 Titers Interval 240.0 to 520.1	358 Titers Interval 282.8 to 453.3	—
rSBA Antibody Titers. rSBA-MenY	360.5 Titers Interval 253.4 to 512.9	341.4 Titers Interval 276.9 to 421.1	—

SECONDARY outcome

Timeframe: At Year 3 (36 months following primary vaccination)

Population: The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 3, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.

Titers are given as geometric mean titers (GMTs) for the serogroups rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY respectively. Titers were determined by Public Health England (PHE) laboratory assay.

Outcome measures

Measure	Nimenrix 1 Group Y1 n=83 Participants Subjects from Year 1 Period who received 1 dose on Nimenrix vaccine at 12 months of age.	Nimenrix 2 Group Y1 n=98 Participants Subjects from Year 1 Period who were previously vaccinated with two doses of Nimenrix, one each at 9 and 12 months of age.	Nimenrix Naive Group Y5 Vaccine-naive subjects aged 5-6 years were enrolled to receive Nimenrix vaccine as primary vaccination at Year 5.
rSBA Antibody Titers rSBA-MenA	18.4 Titers Interval 12.0 to 28.3	16.6 Titers Interval 11.3 to 24.3	—
rSBA Antibody Titers rSBA-MenC	13.2 Titers Interval 8.6 to 20.2	10.6 Titers Interval 7.4 to 15.0	—
rSBA Antibody Titers rSBA-MenW-135	19.4 Titers Interval 12.3 to 30.6	14.6 Titers Interval 9.7 to 21.8	—
rSBA Antibody Titers rSBA-MenY	19.6 Titers Interval 12.7 to 30.1	16.7 Titers Interval 11.5 to 24.3	—

SECONDARY outcome

Timeframe: At Year 5 (60 months post-primary vacccination)

Population: The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 5, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.

Titers are given as geometric mean titers (GMTs), calculated on all subjects for the serogroups rSBA-MenA, rSBA-MenC, rSBAMenW-135, and rSBA-MenY respectively by GSK Biologicals' laboratory assay.

Outcome measures

Measure	Nimenrix 1 Group Y1 n=53 Participants Subjects from Year 1 Period who received 1 dose on Nimenrix vaccine at 12 months of age.	Nimenrix 2 Group Y1 n=64 Participants Subjects from Year 1 Period who were previously vaccinated with two doses of Nimenrix, one each at 9 and 12 months of age.	Nimenrix Naive Group Y5 Vaccine-naive subjects aged 5-6 years were enrolled to receive Nimenrix vaccine as primary vaccination at Year 5.
rSBA Antibody Titers rSBA-MenA	311.6 Titers Interval 221.8 to 437.6	277.5 Titers Interval 200.4 to 384.1	—
rSBA Antibody Titers rSBA-MenC	88.6 Titers Interval 54.2 to 144.8	85.5 Titers Interval 55.1 to 132.5	—
rSBA Antibody Titers rSBA-MenW-135	339.4 Titers Interval 235.2 to 489.8	404.2 Titers Interval 308.5 to 529.7	—
rSBA Antibody Titers rSBA-MenY	347.6 Titers Interval 223.9 to 539.6	367.7 Titers Interval 287.8 to 469.9	—

SECONDARY outcome

Timeframe: At Year 5 (60 months following primary vaccination)

Population: The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 5, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.

Titers are given as geometric mean titers (GMTs), calculated for all subjects for the serogroups rSBA-MenA, rSBA-MenC, rSBAMenW-135, and rSBA-MenY respectively. Titers were determined by Public Health England (PHE) laboratory assay.

Outcome measures

Measure	Nimenrix 1 Group Y1 n=62 Participants Subjects from Year 1 Period who received 1 dose on Nimenrix vaccine at 12 months of age.	Nimenrix 2 Group Y1 n=72 Participants Subjects from Year 1 Period who were previously vaccinated with two doses of Nimenrix, one each at 9 and 12 months of age.	Nimenrix Naive Group Y5 Vaccine-naive subjects aged 5-6 years were enrolled to receive Nimenrix vaccine as primary vaccination at Year 5.
rSBA Antibody Titers. rSBA-MenA	32.4 Titers Interval 18.7 to 56.0	32.3 Titers Interval 19.1 to 54.7	—
rSBA Antibody Titers. rSBA-MenC	20 Titers Interval 12.0 to 33.4	16.5 Titers Interval 10.2 to 26.6	—
rSBA Antibody Titers. rSBA-MenW-135	8.9 Titers Interval 5.9 to 13.6	11.8 Titers Interval 7.5 to 18.5	—
rSBA Antibody Titers. rSBA-MenY	32 Titers Interval 17.8 to 57.4	26.9 Titers Interval 16.2 to 44.7	—

SECONDARY outcome

Timeframe: At Year 1 (12 months post primary vaccination)

Population: The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 1, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.

Results were tabulated as geometric mean antibody concentration (GMC) calculated on all subjects, expressed in microgram per milliliter (μg/ml).

Outcome measures

Measure	Nimenrix 1 Group Y1 n=103 Participants Subjects from Year 1 Period who received 1 dose on Nimenrix vaccine at 12 months of age.	Nimenrix 2 Group Y1 n=120 Participants Subjects from Year 1 Period who were previously vaccinated with two doses of Nimenrix, one each at 9 and 12 months of age.	Nimenrix Naive Group Y5 Vaccine-naive subjects aged 5-6 years were enrolled to receive Nimenrix vaccine as primary vaccination at Year 5.
Antibody to Polysacccharide N. Meningitidis Serogroup A, C, W-135 and Y (Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY) Antibody Concentrations Anti-PSA	0.45 μg/ml Interval 0.36 to 0.58	0.33 μg/ml Interval 0.28 to 0.4	—
Antibody to Polysacccharide N. Meningitidis Serogroup A, C, W-135 and Y (Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY) Antibody Concentrations Anti-PSC	0.27 μg/ml Interval 0.22 to 0.32	0.25 μg/ml Interval 0.22 to 0.3	—
Antibody to Polysacccharide N. Meningitidis Serogroup A, C, W-135 and Y (Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY) Antibody Concentrations Anti-PSW-135	0.96 μg/ml Interval 0.74 to 1.25	1.2 μg/ml Interval 1.0 to 1.44	—
Antibody to Polysacccharide N. Meningitidis Serogroup A, C, W-135 and Y (Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY) Antibody Concentrations Anti-PSY	1.41 μg/ml Interval 1.07 to 1.85	1.7 μg/ml Interval 1.43 to 2.03	—

SECONDARY outcome

Timeframe: At Year 1 (12 months post primary vaccination)

Population: The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 1, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.

The cut-off values for the assay were ≥ 0.3 μg/ml and ≥ 2.0 μg/ml respectively.

Outcome measures

Measure	Nimenrix 1 Group Y1 n=103 Participants Subjects from Year 1 Period who received 1 dose on Nimenrix vaccine at 12 months of age.	Nimenrix 2 Group Y1 n=120 Participants Subjects from Year 1 Period who were previously vaccinated with two doses of Nimenrix, one each at 9 and 12 months of age.	Nimenrix Naive Group Y5 Vaccine-naive subjects aged 5-6 years were enrolled to receive Nimenrix vaccine as primary vaccination at Year 5.
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY ≥ the Cut-off Values Anti-PSA, ≥0.3 μg/ml	60 Participants	59 Participants	—
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY ≥ the Cut-off Values Anti-PSA, ≥2.0 μg/ml	12 Participants	6 Participants	—
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY ≥ the Cut-off Values Anti-PSC, ≥0.3 μg/ml	36 Participants	39 Participants	—
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY ≥ the Cut-off Values Anti-PSC, ≥2.0 μg/ml	3 Participants	4 Participants	—
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY ≥ the Cut-off Values Anti-PSW-135, ≥0.3 μg/ml	78 Participants	104 Participants	—
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY ≥ the Cut-off Values Anti-PSW-135, ≥2.0 μg/ml	28 Participants	29 Participants	—
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY ≥ the Cut-off Values Anti-PSY, ≥0.3 μg/ml	84 Participants	114 Participants	—
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY ≥ the Cut-off Values Row Anti-PSY, ≥2.0 μg/ml	45 Participants	50 Participants	—

SECONDARY outcome

Timeframe: At Month 60 (pre-primary vaccination with Nimenrix vaccine)

Population: The analysis was performed on the Booster 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 before the primary vaccination with Nimenrix, of the Nimenrix Naive Group.

hSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off value assessed were ≥ 1:4 or 1:8. This outcome measure only concerns the Nimenrix Naive Group.

Outcome measures

Measure	Nimenrix 1 Group Y1 n=79 Participants Subjects from Year 1 Period who received 1 dose on Nimenrix vaccine at 12 months of age.	Nimenrix 2 Group Y1 Subjects from Year 1 Period who were previously vaccinated with two doses of Nimenrix, one each at 9 and 12 months of age.	Nimenrix Naive Group Y5 Vaccine-naive subjects aged 5-6 years were enrolled to receive Nimenrix vaccine as primary vaccination at Year 5.
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ Cut-off Values hSBA-MenA, ≥1:4	16 Participants	—	—
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ Cut-off Values hSBA-MenA, ≥1:8	16 Participants	—	—
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ Cut-off Values hSBA-MenC,≥1:4	28 Participants	—	—
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ Cut-off Values hSBA-MenC, ≥1:8	24 Participants	—	—
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ Cut-off Values hSBA-MenW-135, ≥1:4	28 Participants	—	—
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ Cut-off Values hSBA-MenW-135, ≥1:8	28 Participants	—	—
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ Cut-off Values hSBA-MenY, ≥1:4	29 Participants	—	—
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ Cut-off Values hSBA-MenY, ≥1:8	29 Participants	—	—

SECONDARY outcome

Timeframe: At Month 60 (pre-vaccination with Nimenrix vaccine)

Population: The analysis was performed on the Booster 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 before the primary vaccination with Nimenrix, of the Nimenrix Naive Group.

Titers are given as geometric mean titers (GMTs) for the serogroups hSBA-MenA, hSBA-MenC, hSBAMenW-135, and hSBA-MenY respectively. This outcome measure only concerns the Nimenrix Naive Group.

Outcome measures

Measure	Nimenrix 1 Group Y1 n=79 Participants Subjects from Year 1 Period who received 1 dose on Nimenrix vaccine at 12 months of age.	Nimenrix 2 Group Y1 Subjects from Year 1 Period who were previously vaccinated with two doses of Nimenrix, one each at 9 and 12 months of age.	Nimenrix Naive Group Y5 Vaccine-naive subjects aged 5-6 years were enrolled to receive Nimenrix vaccine as primary vaccination at Year 5.
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers hSBA-MenA	3.3 Titers Interval 2.6 to 4.1	—	—
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers hSBA-MenC	5.3 Titers Interval 3.9 to 7.3	—	—
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers hSBA-MenW-135	7 Titers Interval 4.7 to 10.4	—	—
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers hSBA-MenY	9.5 Titers Interval 5.9 to 15.1	—	—

SECONDARY outcome

Timeframe: At Month 60 (pre-primary vaccination with Nimenrix vaccine)

Population: The analysis was performed on the Booster 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 before the primary vaccination with Nimenrix, of the Nimenrix Naive Group.

rSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off value assessed were ≥ 1:8 or 1:128. This outcome measure only concerns the Nimenrix Naive Group.

Outcome measures

Measure	Nimenrix 1 Group Y1 n=78 Participants Subjects from Year 1 Period who received 1 dose on Nimenrix vaccine at 12 months of age.	Nimenrix 2 Group Y1 Subjects from Year 1 Period who were previously vaccinated with two doses of Nimenrix, one each at 9 and 12 months of age.	Nimenrix Naive Group Y5 Vaccine-naive subjects aged 5-6 years were enrolled to receive Nimenrix vaccine as primary vaccination at Year 5.
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ Cut-off Values rSBA-MenA, ≥ 1:8	20 Participants	—	—
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ Cut-off Values rSBA-MenA, ≥ 1:128	9 Participants	—	—
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ Cut-off Values rSBA-MenC, ≥ 1:8	5 Participants	—	—
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ Cut-off Values rSBA-MenC, ≥ 1:128	4 Participants	—	—
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ Cut-off Values rSBA-MenW-135, ≥ 1:8	3 Participants	—	—
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ Cut-off Values rSBA-MenW-135, ≥ 1:128	3 Participants	—	—
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ Cut-off Values rSBA-MenY, ≥ 1:8	23 Participants	—	—
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ Cut-off Values rSBA-MenY, ≥ 1:128	23 Participants	—	—

SECONDARY outcome

Timeframe: At Month 60 (pre-primary vaccination with Nimenrix vaccine)

Population: The analysis was performed on the Booster 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 before the primary vaccination with Nimenrix, of the Nimenrix Naive Group.

Titers are given as geometric mean titers (GMTs) for the serogroups rSBA-MenA, rSBA-MenC, rSBAMenW-135, and rSBA-MenY respectively. This outcome measure only concerns the Nimenrix Naive Group.

Outcome measures

Measure	Nimenrix 1 Group Y1 n=78 Participants Subjects from Year 1 Period who received 1 dose on Nimenrix vaccine at 12 months of age.	Nimenrix 2 Group Y1 Subjects from Year 1 Period who were previously vaccinated with two doses of Nimenrix, one each at 9 and 12 months of age.	Nimenrix Naive Group Y5 Vaccine-naive subjects aged 5-6 years were enrolled to receive Nimenrix vaccine as primary vaccination at Year 5.
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers rSBA-MenA	8.1 Titers Interval 5.7 to 11.5	—	—
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers rSBA-MenC	5.2 Titers Interval 4.1 to 6.7	—	—
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers rSBA-MenW-135	4.7 Titers Interval 3.9 to 5.6	—	—
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers rSBA-MenY	16.6 Titers Interval 9.9 to 27.7	—	—

SECONDARY outcome

Timeframe: At Month 61, one month post-primary vaccination for Nimenrix Naive Group; one month post-booster for Nimenrix 1 and Nimenrix 2 Groups

Population: The analysis was performed on the Booster ATP cohort for immunogenicity,which included all vaccinated 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 primary (Nimenrix Naive Group) or booster vaccination (Nimenrix1 and Nimenrix 2 Group)

hSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off values assessed were ≥ 1:4 or 1:8.

Outcome measures

Measure	Nimenrix 1 Group Y1 n=32 Participants Subjects from Year 1 Period who received 1 dose on Nimenrix vaccine at 12 months of age.	Nimenrix 2 Group Y1 n=38 Participants Subjects from Year 1 Period who were previously vaccinated with two doses of Nimenrix, one each at 9 and 12 months of age.	Nimenrix Naive Group Y5 n=79 Participants Vaccine-naive subjects aged 5-6 years were enrolled to receive Nimenrix vaccine as primary vaccination at Year 5.
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ Cut-off Values hSBA-MenA, ≥ 1:4	31 Participants	38 Participants	62 Participants
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ Cut-off Values hSBA-MenA, ≥ 1:8	31 Participants	38 Participants	62 Participants
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ Cut-off Values hSBA-MenC, ≥ 1:4	32 Participants	37 Participants	68 Participants
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ Cut-off Values hSBA-MenC, ≥ 1:8	32 Participants	37 Participants	66 Participants
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ Cut-off Values hSBA-MenW-135, ≥ 1:4	32 Participants	38 Participants	70 Participants
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ Cut-off Values hSBA-MenW-135, ≥ 1:8	32 Participants	38 Participants	70 Participants
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ Cut-off Values hSBA-MenY, ≥ 1:4	32 Participants	38 Participants	66 Participants
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ Cut-off Values hSBA-MenY, ≥ 1:8	32 Participants	38 Participants	66 Participants

SECONDARY outcome

Timeframe: At Month 61, one month post-primary vaccination for Nimenrix Naive Group; one month post-booster for Nimenrix 1 and Nimenrix 2 Groups

Population: The analysis was performed on the Booster 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 primary (Nimenrix Naive Group) or booster vaccination (Nimenrix 1 and Nimenrix 2 Group)

Titers were given as geometric mean titers (GMTs) for the serogroups hSBA-MenA, hSBA-MenC,hSBAMenW-135, and hSBA-MenY respectively, calculated on all subjects.

Outcome measures

Measure	Nimenrix 1 Group Y1 n=32 Participants Subjects from Year 1 Period who received 1 dose on Nimenrix vaccine at 12 months of age.	Nimenrix 2 Group Y1 n=38 Participants Subjects from Year 1 Period who were previously vaccinated with two doses of Nimenrix, one each at 9 and 12 months of age.	Nimenrix Naive Group Y5 n=79 Participants Vaccine-naive subjects aged 5-6 years were enrolled to receive Nimenrix vaccine as primary vaccination at Year 5.
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers hSBA-MenY	8809.1 Titers Interval 6926.3 to 11203.9	10513.8 Titers Interval 7933.6 to 13933.2	198.7 Titers Interval 137.6 to 287.0
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers hSBA-MenA	1395.9 Titers Interval 926.0 to 2104.4	1590.1 Titers Interval 1157.4 to 2184.6	38.3 Titers Interval 25.4 to 57.9
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers hSBA-MenC	8185.7 Titers Interval 4736.9 to 14145.4	12881.2 Titers Interval 8549.1 to 19408.4	95.3 Titers Interval 56.5 to 160.9
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers hSBA-MenW-135	15800.9 Titers Interval 12975.8 to 19241.0	20495.9 Titers Interval 16080.2 to 26124.3	98.1 Titers Interval 65.8 to 146.0

SECONDARY outcome

Timeframe: At Month 61, one month post-primary vaccination for Nimenrix Naive Group; one month post-booster for Nimenrix 1 and Nimenrix 2 Groups

Population: The analysis was performed on the Booster 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 primary (Nimenrix Naive Group) or booster vaccination (Nimenrix 1 and Nimenrix 2 Group)

Vaccine response was defines as: for initially seronegative subjects (pre-vaccination titer < 1:4): hSBA post-vaccination antibody titers ≥ 1:8 and for seropositive subjects (pre-vaccination titers ≥ 1:4): hSBA antibody titers at least four times the pre-vaccination antibody titers.

Outcome measures

Measure	Nimenrix 1 Group Y1 n=31 Participants Subjects from Year 1 Period who received 1 dose on Nimenrix vaccine at 12 months of age.	Nimenrix 2 Group Y1 n=35 Participants Subjects from Year 1 Period who were previously vaccinated with two doses of Nimenrix, one each at 9 and 12 months of age.	Nimenrix Naive Group Y5 n=77 Participants Vaccine-naive subjects aged 5-6 years were enrolled to receive Nimenrix vaccine as primary vaccination at Year 5.
Number of Subjects With Vaccine Response for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers hSBA-MenA	31 Participants	35 Participants	56 Participants
Number of Subjects With Vaccine Response for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers hSBA-MenC	28 Participants	31 Participants	48 Participants
Number of Subjects With Vaccine Response for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers hSBA-MenW-135	31 Participants	35 Participants	48 Participants
Number of Subjects With Vaccine Response for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers hSBA-MenY	26 Participants	31 Participants	48 Participants

SECONDARY outcome

Timeframe: At Month 60 and 61 (just prior to and one month post-primary vaccination for Nimenrix Naive Group; one month post-booster vaccination for Nimenrix 1 and Nimenrix 2 Groups)

Population: The analysis was performed on the Booster 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 primary (Nimenrix Naive Group) or booster vaccination (Nimenrix 1 and Nimenrix 2 Group)

The cut-off values for the assay were ≥1:8 and ≥1:128. Titers were determined by Public Health England (PHE) laboratory assay.

Outcome measures

Measure	Nimenrix 1 Group Y1 n=31 Participants Subjects from Year 1 Period who received 1 dose on Nimenrix vaccine at 12 months of age.	Nimenrix 2 Group Y1 n=38 Participants Subjects from Year 1 Period who were previously vaccinated with two doses of Nimenrix, one each at 9 and 12 months of age.	Nimenrix Naive Group Y5 n=82 Participants Vaccine-naive subjects aged 5-6 years were enrolled to receive Nimenrix vaccine as primary vaccination at Year 5.
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBAMenW-135 and rSBA-MenY Titers ≥ the Cut-off Values rSBA-MenA, M60 ≥1:8	21 Participants	23 Participants	20 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBAMenW-135 and rSBA-MenY Titers ≥ the Cut-off Values rSBA-MenA, M60 ≥1:128	11 Participants	14 Participants	9 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBAMenW-135 and rSBA-MenY Titers ≥ the Cut-off Values rSBA-MenA, M61 ≥1:8	31 Participants	38 Participants	81 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBAMenW-135 and rSBA-MenY Titers ≥ the Cut-off Values rSBA-MenA, M61 ≥1:128	31 Participants	38 Participants	81 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBAMenW-135 and rSBA-MenY Titers ≥ the Cut-off Values rSBA-MenC, M60 ≥1:8	15 Participants	18 Participants	5 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBAMenW-135 and rSBA-MenY Titers ≥ the Cut-off Values rSBA-MenC, M60 ≥1:128	6 Participants	12 Participants	4 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBAMenW-135 and rSBA-MenY Titers ≥ the Cut-off Values rSBA-MenC, M61 ≥1:8	31 Participants	38 Participants	80 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBAMenW-135 and rSBA-MenY Titers ≥ the Cut-off Values rSBA-MenC, M61 ≥1:128	31 Participants	38 Participants	72 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBAMenW-135 and rSBA-MenY Titers ≥ the Cut-off Values rSBA-MenW-135, M60 ≥1:8	7 Participants	10 Participants	3 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBAMenW-135 and rSBA-MenY Titers ≥ the Cut-off Values rSBA-MenW-135, M60 ≥1:128	4 Participants	7 Participants	3 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBAMenW-135 and rSBA-MenY Titers ≥ the Cut-off Values rSBA-MenW-135, M61 ≥1:8	31 Participants	38 Participants	82 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBAMenW-135 and rSBA-MenY Titers ≥ the Cut-off Values rSBA-MenW-135, M61 ≥1:128	31 Participants	38 Participants	81 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBAMenW-135 and rSBA-MenY Titers ≥ the Cut-off Values rSBA-MenY, M60 ≥1:8	16 Participants	18 Participants	23 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBAMenW-135 and rSBA-MenY Titers ≥ the Cut-off Values rSBA-MenY, M60 ≥1:128	10 Participants	12 Participants	23 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBAMenW-135 and rSBA-MenY Titers ≥ the Cut-off Values rSBA-MenY, M61 ≥1:8	31 Participants	38 Participants	82 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBAMenW-135 and rSBA-MenY Titers ≥ the Cut-off Values rSBA-MenY, M61 ≥1:128	31 Participants	38 Participants	82 Participants

SECONDARY outcome

Timeframe: At Month 60 and 61 (just prior to and one month post-primary vaccination for Nimenrix Naive Group; one month post-booster for Nimenrix 1 and Nimenrix 2 Groups)

Population: The analysis was performed on the Booster 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 primary (Nimenrix Naive Group) or booster vaccination (Nimenrix 1 and Nimenrix 2 Group)

Titers are given as geometric mean titers (GMTs) for the serogroups rSBA-MenA, rSBA-MenC, rSBAMenW-135, and rSBA-MenY respectively, determined by Public Health England [PHE] laboratory assay.

Outcome measures

Measure	Nimenrix 1 Group Y1 n=31 Participants Subjects from Year 1 Period who received 1 dose on Nimenrix vaccine at 12 months of age.	Nimenrix 2 Group Y1 n=38 Participants Subjects from Year 1 Period who were previously vaccinated with two doses of Nimenrix, one each at 9 and 12 months of age.	Nimenrix Naive Group Y5 n=82 Participants Vaccine-naive subjects aged 5-6 years were enrolled to receive Nimenrix vaccine as primary vaccination at Year 5.
rSBA Antibody Titers rSBA-MenA, M61	5238.1 Titers Interval 3835.3 to 7154.1	5287.7 Titers Interval 4212.4 to 6637.4	2970.7 Titers Interval 2282.6 to 3866.1
rSBA Antibody Titers rSBA-MenA, M60	35.9 Titers Interval 16.8 to 76.8	35.8 Titers Interval 17.1 to 75.0	8.1 Titers Interval 5.7 to 11.5
rSBA Antibody Titers rSBA-MenC, M60	16 Titers Interval 8.5 to 30.0	20 Titers Interval 10.1 to 39.7	5.2 Titers Interval 4.1 to 6.7
rSBA Antibody Titers rSBA-MenC, M61	2738.9 Titers Interval 1707.8 to 4392.5	3605 Titers Interval 2401.2 to 5412.4	525.1 Titers Interval 365.2 to 755.2
rSBA Antibody Titers rSBA-MenW-135, M60	8.7 Titers Interval 4.9 to 15.5	10 Titers Interval 5.7 to 17.7	4.7 Titers Interval 3.9 to 5.6
rSBA Antibody Titers rSBA-MenW-135, M61	10713.2 Titers Interval 7632.4 to 15037.4	11585.2 Titers Interval 8901.4 to 15078.2	5792.6 Titers Interval 4591.7 to 7307.6
rSBA Antibody Titers rSBA-MenY, M60	29.2 Titers Interval 12.8 to 66.3	22 Titers Interval 10.8 to 44.9	16.6 Titers Interval 9.9 to 27.7
rSBA Antibody Titers rSBA-MenY, M61	5601.6 Titers Interval 4181.4 to 7504.0	5098.3 Titers Interval 4044.6 to 6426.5	4027.3 Titers Interval 3159.0 to 5134.4

SECONDARY outcome

Timeframe: At Month 61 (one month post-primary vaccination for Nimenrix Naive Group; one month post-booster for Nimenrix 1 and Nimenrix 2 Groups)

Population: The analysis was performed on the Booster 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 primary (Nimenrix Naive Group) or booster vaccination (Nimenrix 1 and Nimenrix 2 Group)

Vaccine response was defined as: for initially seronegative subjects: antibody titer ≥ 1:32 at post-vaccination; and for initially seropositive subjects: antibody titer at post-vaccination ≥ 4 fold the pre-vaccination antibody titer. Titers were determined by Public Health England (PHE) laboratory assay.

Outcome measures

Measure	Nimenrix 1 Group Y1 n=30 Participants Subjects from Year 1 Period who received 1 dose on Nimenrix vaccine at 12 months of age.	Nimenrix 2 Group Y1 n=37 Participants Subjects from Year 1 Period who were previously vaccinated with two doses of Nimenrix, one each at 9 and 12 months of age.	Nimenrix Naive Group Y5 n=78 Participants Vaccine-naive subjects aged 5-6 years were enrolled to receive Nimenrix vaccine as primary vaccination at Year 5.
Number of Subjects With Vaccine Response With rSBA-MenA, rSBA-MenC, hSBA-MenW-135 and rSBA-MenY Antibody Titers rSBA-MenA	28 Participants	36 Participants	75 Participants
Number of Subjects With Vaccine Response With rSBA-MenA, rSBA-MenC, hSBA-MenW-135 and rSBA-MenY Antibody Titers rSBA-MenC	26 Participants	32 Participants	70 Participants
Number of Subjects With Vaccine Response With rSBA-MenA, rSBA-MenC, hSBA-MenW-135 and rSBA-MenY Antibody Titers rSBA-MenW-135	30 Participants	37 Participants	77 Participants
Number of Subjects With Vaccine Response With rSBA-MenA, rSBA-MenC, hSBA-MenW-135 and rSBA-MenY Antibody Titers rSBA-MenY	29 Participants	36 Participants	78 Participants

SECONDARY outcome

Timeframe: During the 4-day (Days 0-3) post-primary vaccination for Nimenrix Naive Group and post-booster for Nimenrix 1 and Nimenrix 2 Groups

Population: The analysis was performed on the Booster Total Vaccinated cohort, which included all vaccinated subjects in this current study who had their symptom sheets filled in.

Assessed solicited local symptoms were pain, redness and swelling. Any was defined as occurrence of the symptom regardless of intensity grade. Grade 3 pain was defined as pain that prevented normal activity. Grade 3 redness/swelling was defined as redness/swelling spreading beyond 50 millimeters (mm) of injection site.

Outcome measures

Measure	Nimenrix 1 Group Y1 n=36 Participants Subjects from Year 1 Period who received 1 dose on Nimenrix vaccine at 12 months of age.	Nimenrix 2 Group Y1 n=45 Participants Subjects from Year 1 Period who were previously vaccinated with two doses of Nimenrix, one each at 9 and 12 months of age.	Nimenrix Naive Group Y5 n=89 Participants Vaccine-naive subjects aged 5-6 years were enrolled to receive Nimenrix vaccine as primary vaccination at Year 5.
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptom Any Pain	18 Participants	21 Participants	46 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptom Grade 3 Pain	0 Participants	1 Participants	1 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptom Any Redness	10 Participants	15 Participants	22 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptom Grade 3 Redness	1 Participants	0 Participants	1 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptom Any Swelling	8 Participants	9 Participants	21 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptom Grade 3 Swelling	1 Participants	0 Participants	2 Participants

SECONDARY outcome

Timeframe: During the 4-day (Days 0-3) post-primary vaccination for Nimenrix Naive Group and post-booster for Nimenrix 1 and Nimenrix 2 Groups

Population: The analysis was performed on the Booster Total Vaccinated cohort, which included all vaccinated subjects in this current study who had their symptom sheets filled in.

Assessed solicited general symptoms were fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], headache and gastrointestinal. Any was defined as occurrence of the symptom regardless of their intensity grade or relationship to study vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever higher than (>) 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.

Outcome measures

Measure	Nimenrix 1 Group Y1 n=36 Participants Subjects from Year 1 Period who received 1 dose on Nimenrix vaccine at 12 months of age.	Nimenrix 2 Group Y1 n=45 Participants Subjects from Year 1 Period who were previously vaccinated with two doses of Nimenrix, one each at 9 and 12 months of age.	Nimenrix Naive Group Y5 n=89 Participants Vaccine-naive subjects aged 5-6 years were enrolled to receive Nimenrix vaccine as primary vaccination at Year 5.
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptom Any Fatigue	10 Participants	7 Participants	18 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptom Grade 3 Fatigue	0 Participants	0 Participants	1 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptom Related Fatigue	8 Participants	6 Participants	15 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptom Any Gastrointestinal	4 Participants	5 Participants	7 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptom Grade 3 Gastrointestinal	1 Participants	2 Participants	0 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptom Related Gastrointestinal	3 Participants	4 Participants	5 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptom Any Headache	4 Participants	5 Participants	11 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptom Grade 3 Headache	1 Participants	1 Participants	1 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptom Related Headache	4 Participants	4 Participants	8 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptom Any Fever (Axillary)	1 Participants	2 Participants	5 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptom Fever (Axillary) >39.5°C	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptom Related Fever (Axillary)	0 Participants	1 Participants	3 Participants

SECONDARY outcome

Timeframe: During the 31-day (Days 0-30) post-primary vaccination for Nimenrix Naive Group and post-booster for Nimenrix 1 and Nimenrix 2 Groups

Population: The analysis was performed on the Booster Total Vaccinated cohort, which included all vaccinated subjects in this current study.

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

Outcome measures

Measure	Nimenrix 1 Group Y1 n=38 Participants Subjects from Year 1 Period who received 1 dose on Nimenrix vaccine at 12 months of age.	Nimenrix 2 Group Y1 n=46 Participants Subjects from Year 1 Period who were previously vaccinated with two doses of Nimenrix, one each at 9 and 12 months of age.	Nimenrix Naive Group Y5 n=100 Participants Vaccine-naive subjects aged 5-6 years were enrolled to receive Nimenrix vaccine as primary vaccination at Year 5.
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)	9 Participants	6 Participants	29 Participants

SECONDARY outcome

Timeframe: During the 181-day (Days 0-180) post primary vaccination for Nimenrix Naive Group and post booster for Nimenrix 1 and Nimenrix 2 Groups

Population: The analysis was performed on the Booster Total Vaccinated cohort, which included all vaccinated subjects in this current study.

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

Measure	Nimenrix 1 Group Y1 n=38 Participants Subjects from Year 1 Period who received 1 dose on Nimenrix vaccine at 12 months of age.	Nimenrix 2 Group Y1 n=46 Participants Subjects from Year 1 Period who were previously vaccinated with two doses of Nimenrix, one each at 9 and 12 months of age.	Nimenrix Naive Group Y5 n=100 Participants Vaccine-naive subjects aged 5-6 years were enrolled to receive Nimenrix vaccine as primary vaccination at Year 5.
Number of Subjects Reporting Any Serious Adverse Events (SAEs)	0 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: During the 181-day (Days 0-180) post primary vaccination for Nimenrix Naive Group and post booster for Nimenrix 1 and Nimenrix 2 Groups

Population: The analysis was performed on the Booster Total Vaccinated cohort, which included all vaccinated subjects in this current study.

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

Outcome measures

Measure	Nimenrix 1 Group Y1 n=38 Participants Subjects from Year 1 Period who received 1 dose on Nimenrix vaccine at 12 months of age.	Nimenrix 2 Group Y1 n=46 Participants Subjects from Year 1 Period who were previously vaccinated with two doses of Nimenrix, one each at 9 and 12 months of age.	Nimenrix Naive Group Y5 n=100 Participants Vaccine-naive subjects aged 5-6 years were enrolled to receive Nimenrix vaccine as primary vaccination at Year 5.
Number of Subjects Reporting Any New Onset of Chronic Illnesses (NOCIs)	0 Participants	0 Participants	0 Participants

Adverse Events

Nimenrix 1 Group

Serious events: 0 serious events

Other events: 31 other events

Deaths: 0 deaths

Nimenrix 2 Group

Serious events: 0 serious events

Other events: 43 other events

Deaths: 0 deaths

Nimenrix Naive Group

Serious events: 1 serious events

Other events: 67 other events

Deaths: 0 deaths

Serious adverse events

Measure	Nimenrix 1 Group n=38 participants at risk Subjects who received 1 dose of Nimenrix vaccine at 12 months of age.	Nimenrix 2 Group n=46 participants at risk Subjects who were previously vaccinated with two doses of Nimenrix, one each at 9 and 12 months of age.	Nimenrix Naive Group n=100 participants at risk Vaccine-naive subjects aged 5-6 years were enrolled to receive Nimenrix vaccine as primary vaccination at Year 5.
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/38 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-vaccination period; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 54). Unsolicitied AEs and SAEs were assessed on the Total Vaccinated Cohort. Solicited symptoms were assessed on those subjects from the Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/46 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-vaccination period; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 54). Unsolicitied AEs and SAEs were assessed on the Total Vaccinated Cohort. Solicited symptoms were assessed on those subjects from the Total Vaccinated Cohort who returned their symptom sheet.	1.0% 1/100 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-vaccination period; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 54). Unsolicitied AEs and SAEs were assessed on the Total Vaccinated Cohort. Solicited symptoms were assessed on those subjects from the Total Vaccinated Cohort who returned their symptom sheet.

Other adverse events

Measure	Nimenrix 1 Group n=38 participants at risk Subjects who received 1 dose of Nimenrix vaccine at 12 months of age.	Nimenrix 2 Group n=46 participants at risk Subjects who were previously vaccinated with two doses of Nimenrix, one each at 9 and 12 months of age.	Nimenrix Naive Group n=100 participants at risk Vaccine-naive subjects aged 5-6 years were enrolled to receive Nimenrix vaccine as primary vaccination at Year 5.
General disorders Pain	50.0% 18/36 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-vaccination period; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 54). Unsolicitied AEs and SAEs were assessed on the Total Vaccinated Cohort. Solicited symptoms were assessed on those subjects from the Total Vaccinated Cohort who returned their symptom sheet.	46.7% 21/45 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-vaccination period; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 54). Unsolicitied AEs and SAEs were assessed on the Total Vaccinated Cohort. Solicited symptoms were assessed on those subjects from the Total Vaccinated Cohort who returned their symptom sheet.	51.7% 46/89 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-vaccination period; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 54). Unsolicitied AEs and SAEs were assessed on the Total Vaccinated Cohort. Solicited symptoms were assessed on those subjects from the Total Vaccinated Cohort who returned their symptom sheet.
General disorders Redness	27.8% 10/36 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-vaccination period; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 54). Unsolicitied AEs and SAEs were assessed on the Total Vaccinated Cohort. Solicited symptoms were assessed on those subjects from the Total Vaccinated Cohort who returned their symptom sheet.	33.3% 15/45 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-vaccination period; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 54). Unsolicitied AEs and SAEs were assessed on the Total Vaccinated Cohort. Solicited symptoms were assessed on those subjects from the Total Vaccinated Cohort who returned their symptom sheet.	24.7% 22/89 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-vaccination period; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 54). Unsolicitied AEs and SAEs were assessed on the Total Vaccinated Cohort. Solicited symptoms were assessed on those subjects from the Total Vaccinated Cohort who returned their symptom sheet.
General disorders Swelling	22.2% 8/36 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-vaccination period; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 54). Unsolicitied AEs and SAEs were assessed on the Total Vaccinated Cohort. Solicited symptoms were assessed on those subjects from the Total Vaccinated Cohort who returned their symptom sheet.	20.0% 9/45 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-vaccination period; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 54). Unsolicitied AEs and SAEs were assessed on the Total Vaccinated Cohort. Solicited symptoms were assessed on those subjects from the Total Vaccinated Cohort who returned their symptom sheet.	23.6% 21/89 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-vaccination period; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 54). Unsolicitied AEs and SAEs were assessed on the Total Vaccinated Cohort. Solicited symptoms were assessed on those subjects from the Total Vaccinated Cohort who returned their symptom sheet.
General disorders Fatigue	27.8% 10/36 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-vaccination period; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 54). Unsolicitied AEs and SAEs were assessed on the Total Vaccinated Cohort. Solicited symptoms were assessed on those subjects from the Total Vaccinated Cohort who returned their symptom sheet.	15.6% 7/45 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-vaccination period; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 54). Unsolicitied AEs and SAEs were assessed on the Total Vaccinated Cohort. Solicited symptoms were assessed on those subjects from the Total Vaccinated Cohort who returned their symptom sheet.	20.2% 18/89 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-vaccination period; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 54). Unsolicitied AEs and SAEs were assessed on the Total Vaccinated Cohort. Solicited symptoms were assessed on those subjects from the Total Vaccinated Cohort who returned their symptom sheet.
General disorders Gastrointestinal symptoms	11.1% 4/36 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-vaccination period; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 54). Unsolicitied AEs and SAEs were assessed on the Total Vaccinated Cohort. Solicited symptoms were assessed on those subjects from the Total Vaccinated Cohort who returned their symptom sheet.	11.1% 5/45 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-vaccination period; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 54). Unsolicitied AEs and SAEs were assessed on the Total Vaccinated Cohort. Solicited symptoms were assessed on those subjects from the Total Vaccinated Cohort who returned their symptom sheet.	7.9% 7/89 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-vaccination period; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 54). Unsolicitied AEs and SAEs were assessed on the Total Vaccinated Cohort. Solicited symptoms were assessed on those subjects from the Total Vaccinated Cohort who returned their symptom sheet.
General disorders Headache	11.1% 4/36 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-vaccination period; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 54). Unsolicitied AEs and SAEs were assessed on the Total Vaccinated Cohort. Solicited symptoms were assessed on those subjects from the Total Vaccinated Cohort who returned their symptom sheet.	11.1% 5/45 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-vaccination period; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 54). Unsolicitied AEs and SAEs were assessed on the Total Vaccinated Cohort. Solicited symptoms were assessed on those subjects from the Total Vaccinated Cohort who returned their symptom sheet.	12.4% 11/89 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-vaccination period; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 54). Unsolicitied AEs and SAEs were assessed on the Total Vaccinated Cohort. Solicited symptoms were assessed on those subjects from the Total Vaccinated Cohort who returned their symptom sheet.
General disorders Fever	2.8% 1/36 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-vaccination period; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 54). Unsolicitied AEs and SAEs were assessed on the Total Vaccinated Cohort. Solicited symptoms were assessed on those subjects from the Total Vaccinated Cohort who returned their symptom sheet.	4.4% 2/45 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-vaccination period; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 54). Unsolicitied AEs and SAEs were assessed on the Total Vaccinated Cohort. Solicited symptoms were assessed on those subjects from the Total Vaccinated Cohort who returned their symptom sheet.	5.6% 5/89 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-vaccination period; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 54). Unsolicitied AEs and SAEs were assessed on the Total Vaccinated Cohort. Solicited symptoms were assessed on those subjects from the Total Vaccinated Cohort who returned their symptom sheet.
Injury, poisoning and procedural complications Injection site bruising	5.3% 2/38 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-vaccination period; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 54). Unsolicitied AEs and SAEs were assessed on the Total Vaccinated Cohort. Solicited symptoms were assessed on those subjects from the Total Vaccinated Cohort who returned their symptom sheet.	2.2% 1/46 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-vaccination period; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 54). Unsolicitied AEs and SAEs were assessed on the Total Vaccinated Cohort. Solicited symptoms were assessed on those subjects from the Total Vaccinated Cohort who returned their symptom sheet.	2.0% 2/100 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-vaccination period; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 54). Unsolicitied AEs and SAEs were assessed on the Total Vaccinated Cohort. Solicited symptoms were assessed on those subjects from the Total Vaccinated Cohort who returned their symptom sheet.

Additional Information

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• 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.
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