Trial Outcomes & Findings for Co-Administration of Meningococcal Vaccine GSK134612 With Infanrix Hexa™ Versus Individual Administration of Each Vaccine (NCT NCT00508261)

Results Overview

The cut-off for the assay was greater than or equal to (≥) 1:8. The analysis was based only on subjects receiving Nimenrix vaccination at Day 0.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

793 participants

Primary outcome timeframe

1 month after vaccination with Nimenrix vaccine (Month 1)

Results posted on

2019-01-24

Participant Flow

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

Participant milestones

Participant milestones
Measure	Nimenrix + Infanrix-hexa Group Subjects received concomitant administration of 1 dose of Nimenrix™ and Infanrix-hexa™ vaccines at Day 0.	Nimenrix Group Subjects received a single dose of Nimenrix™ vaccine at Day 0, followed one month later by 1 dose of Infanrix-hexa™ vaccine.	Infanrix-Hexa Group Subjects received a single dose of Infanrix-Hexa™ vaccine at Day 0, followed one month later by 1 dose of Nimenrix™ vaccine.	Meningitec Group Subjects received 1 dose of Meningitec™ vaccine at Day 0 and were permitted to receive the routinely recommended Infanrix-hexa booster once the active safety follow-up of this study was completed.
Overall Study STARTED	222	220	224	127
Overall Study COMPLETED	219	212	218	126
Overall Study NOT COMPLETED	3	8	6	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Nimenrix + Infanrix-hexa Group Subjects received concomitant administration of 1 dose of Nimenrix™ and Infanrix-hexa™ vaccines at Day 0.	Nimenrix Group Subjects received a single dose of Nimenrix™ vaccine at Day 0, followed one month later by 1 dose of Infanrix-hexa™ vaccine.	Infanrix-Hexa Group Subjects received a single dose of Infanrix-Hexa™ vaccine at Day 0, followed one month later by 1 dose of Nimenrix™ vaccine.	Meningitec Group Subjects received 1 dose of Meningitec™ vaccine at Day 0 and were permitted to receive the routinely recommended Infanrix-hexa booster once the active safety follow-up of this study was completed.
Overall Study Other	0	1	1	0
Overall Study Serious Adverse Event	0	1	0	0
Overall Study Withdrawal by Subject	3	4	4	0
Overall Study Migrated/ moved from study area	0	1	0	0
Overall Study Lost to Follow-up	0	1	1	1

Baseline Characteristics

Co-Administration of Meningococcal Vaccine GSK134612 With Infanrix Hexa™ Versus Individual Administration of Each Vaccine

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nimenrix + Infanrix-hexa Group n=222 Participants Subjects received concomitant administration of 1 dose of Nimenrix™ and Infanrix-hexa™ vaccines at Day 0.	Nimenrix Group n=220 Participants Subjects received a single dose of Nimenrix™ vaccine at Day 0, followed one month later by 1 dose of Infanrix-hexa™ vaccine.	Infanrix-Hexa Group n=224 Participants Subjects received a single dose of Infanrix-Hexa™ vaccine at Day 0, followed one month later by 1 dose of Nimenrix™ vaccine.	Meningitec Group n=127 Participants Subjects received 1 dose of Meningitec™ vaccine at Day 0 and were permitted to receive the routinely recommended Infanrix-hexa booster once the active safety follow-up of this study was completed.	Total n=793 Participants Total of all reporting groups
Age, Continuous	14.6 Months STANDARD_DEVIATION 3.01 • n=5 Participants	15 Months STANDARD_DEVIATION 3.33 • n=7 Participants	14.9 Months STANDARD_DEVIATION 3.17 • n=5 Participants	14.6 Months STANDARD_DEVIATION 2.99 • n=4 Participants	14.8 Months STANDARD_DEVIATION 3.14 • n=21 Participants
Sex/Gender, Customized Female	109 Participants n=5 Participants	106 Participants n=7 Participants	119 Participants n=5 Participants	61 Participants n=4 Participants	395 Participants n=21 Participants
Sex/Gender, Customized Male	113 Participants n=5 Participants	114 Participants n=7 Participants	105 Participants n=5 Participants	66 Participants n=4 Participants	398 Participants n=21 Participants
Race/Ethnicity, Customized White - Caucasian/ European heritage, n (%)	204 Participants n=5 Participants	205 Participants n=7 Participants	212 Participants n=5 Participants	120 Participants n=4 Participants	741 Participants n=21 Participants
Race/Ethnicity, Customized African heritage / African American	3 Participants n=5 Participants	4 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	10 Participants n=21 Participants
Race/Ethnicity, Customized American Indian or Alaskan native	2 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	4 Participants n=21 Participants
Race/Ethnicity, Customized Asian - Central/ South Asian heritage	1 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	4 Participants n=21 Participants
Race/Ethnicity, Customized Asian - East Asian heritage	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Race/Ethnicity, Customized Asian - South east Asian heritage	2 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants	2 Participants n=4 Participants	8 Participants n=21 Participants
Race/Ethnicity, Customized White - Arabic / North African heritage	4 Participants n=5 Participants	7 Participants n=7 Participants	4 Participants n=5 Participants	2 Participants n=4 Participants	17 Participants n=21 Participants
Race/Ethnicity, Customized Other	4 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	7 Participants n=21 Participants

PRIMARY outcome

Timeframe: 1 month after vaccination with Nimenrix vaccine (Month 1)

Population: The analysis was performed on the According to Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

The cut-off for the assay was greater than or equal to (≥) 1:8. The analysis was based only on subjects receiving Nimenrix vaccination at Day 0.

Outcome measures

Outcome measures
Measure	Nimenrix + Infanrix-hexa Group n=193 Participants Subjects received concomitant administration of 1 dose of Nimenrix™ and Infanrix-hexa™ vaccines at Day 0.	Nimenrix Group n=186 Participants Subjects received a single dose of Nimenrix™ vaccine at Day 0, followed one month later by 1 dose of Infanrix-hexa™ vaccine.	Infanrix-Hexa Group Subjects received a single dose of Infanrix-Hexa™ vaccine at Day 0, followed one month later by 1 dose of Nimenrix™ vaccine.	Meningitec Group Subjects received 1 dose of Meningitec™ vaccine at Day 0 and were permitted to receive the routinely recommended Infanrix-hexa booster once the active safety follow-up of this study was completed.
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off. rSBA-MenA, M1	193 Participants	180 Participants	—	—
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off. rSBA-MenC, M1	191 Participants	178 Participants	—	—
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off. rSBA-MenW-135, M1	193 Participants	183 Participants	—	—
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off. rSBA-MenY, M1	192 Participants	180 Participants	—	—

PRIMARY outcome

Timeframe: 1 month after the first vaccination (Month 1)

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.The analysis for the primary outcome was based only on subjects receiving Infanrix-hexa vaccination at month 1.

The analysis was based only on subjects receiving Infanrix-hexa vaccination. The results were calculated as geometric mean expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).

Outcome measures

Outcome measures
Measure	Nimenrix + Infanrix-hexa Group n=191 Participants Subjects received concomitant administration of 1 dose of Nimenrix™ and Infanrix-hexa™ vaccines at Day 0.	Nimenrix Group n=179 Participants Subjects received a single dose of Nimenrix™ vaccine at Day 0, followed one month later by 1 dose of Infanrix-hexa™ vaccine.	Infanrix-Hexa Group Subjects received a single dose of Infanrix-Hexa™ vaccine at Day 0, followed one month later by 1 dose of Nimenrix™ vaccine.	Meningitec Group Subjects received 1 dose of Meningitec™ vaccine at Day 0 and were permitted to receive the routinely recommended Infanrix-hexa booster once the active safety follow-up of this study was completed.
Anti-PT, Anti-FHA and Anti-PRN Concentrations Anti-PT, M1	86 EL.U/mL Interval 77.0 to 95.0	85 EL.U/mL Interval 75.0 to 96.0	—	—
Anti-PT, Anti-FHA and Anti-PRN Concentrations Anti-FHA, M1	542 EL.U/mL Interval 492.0 to 597.0	544 EL.U/mL Interval 485.0 to 611.0	—	—
Anti-PT, Anti-FHA and Anti-PRN Concentrations Anti-PRN, M1	470 EL.U/mL Interval 411.0 to 537.0	450 EL.U/mL Interval 387.0 to 522.0	—	—

PRIMARY outcome

Timeframe: 1 month after vaccination with Nimenrix vaccine (Month 1)

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. The analysis for the primary outcome measure was based only on subjects receiving Infanrix-hexa vaccination at Month 1.

The cut-off for the assay was greater than or equal to (≥) 10 milli-interantional units per milliliter (mIU/mL).

Outcome measures

Outcome measures
Measure	Nimenrix + Infanrix-hexa Group n=181 Participants Subjects received concomitant administration of 1 dose of Nimenrix™ and Infanrix-hexa™ vaccines at Day 0.	Nimenrix Group n=169 Participants Subjects received a single dose of Nimenrix™ vaccine at Day 0, followed one month later by 1 dose of Infanrix-hexa™ vaccine.	Infanrix-Hexa Group Subjects received a single dose of Infanrix-Hexa™ vaccine at Day 0, followed one month later by 1 dose of Nimenrix™ vaccine.	Meningitec Group Subjects received 1 dose of Meningitec™ vaccine at Day 0 and were permitted to receive the routinely recommended Infanrix-hexa booster once the active safety follow-up of this study was completed.
Number of Subjects With Anti-HBs Concentrations ≥ the Cut-off	180 Participants	166 Participants	—	—

PRIMARY outcome

Timeframe: 1 month after vaccination with Nimenrix vaccine (Month 1)

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.The analysis for the primary outcome was based only on subjects receiving Infanrix-hexa vaccination at Day 0.

The cut-off for the assay was ≥ 1μg/mL.

Outcome measures

Outcome measures
Measure	Nimenrix + Infanrix-hexa Group n=184 Participants Subjects received concomitant administration of 1 dose of Nimenrix™ and Infanrix-hexa™ vaccines at Day 0.	Nimenrix Group n=173 Participants Subjects received a single dose of Nimenrix™ vaccine at Day 0, followed one month later by 1 dose of Infanrix-hexa™ vaccine.	Infanrix-Hexa Group Subjects received a single dose of Infanrix-Hexa™ vaccine at Day 0, followed one month later by 1 dose of Nimenrix™ vaccine.	Meningitec Group Subjects received 1 dose of Meningitec™ vaccine at Day 0 and were permitted to receive the routinely recommended Infanrix-hexa booster once the active safety follow-up of this study was completed.
Number of Subjects With Anti-PRP Concentrations ≥ the Cut-off	183 Participants	170 Participants	—	—

SECONDARY outcome

Timeframe: At month 0, month 1 and month 2

Population: ATP cohort for immunogenicity, including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. Subjects in "Nimenrix + Infanrix-hexa Group" and "Meningitec Group" only had 2 blood samples taken: prior to (M0) and 1 month after vaccination (M1).

The cut-off values for the assay were ≥ 1:8 and ≥ 1:128

Outcome measures

Outcome measures
Measure	Nimenrix + Infanrix-hexa Group n=193 Participants Subjects received concomitant administration of 1 dose of Nimenrix™ and Infanrix-hexa™ vaccines at Day 0.	Nimenrix Group n=186 Participants Subjects received a single dose of Nimenrix™ vaccine at Day 0, followed one month later by 1 dose of Infanrix-hexa™ vaccine.	Infanrix-Hexa Group n=179 Participants Subjects received a single dose of Infanrix-Hexa™ vaccine at Day 0, followed one month later by 1 dose of Nimenrix™ vaccine.	Meningitec Group n=114 Participants Subjects received 1 dose of Meningitec™ vaccine at Day 0 and were permitted to receive the routinely recommended Infanrix-hexa booster once the active safety follow-up of this study was completed.
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values rSBA-MenC [M 0], ≥1:128	5 Participants	8 Participants	5 Participants	3 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values rSBA-MenC [M 1], ≥1:128	189 Participants	172 Participants	14 Participants	102 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values rSBA-MenA [M 0], ≥1:8	30 Participants	32 Participants	34 Participants	18 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values rSBA-MenA [M 1], ≥1:8	193 Participants	180 Participants	71 Participants	43 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values rSBA-MenA [M 2], ≥1:8	—	90 Participants	178 Participants	—
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values rSBA-MenA [M 0], ≥1:128	18 Participants	21 Participants	24 Participants	11 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values rSBA-MenA [M 1], ≥1:128	193 Participants	179 Participants	57 Participants	30 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values rSBA-MenA [M 2], ≥1:128	—	90 Participants	178 Participants	—
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values rSBA-MenC [M 0], ≥1:8	20 Participants	25 Participants	13 Participants	11 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values rSBA-MenC [M 1], ≥1:8	191 Participants	178 Participants	34 Participants	112 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values rSBA-MenC [M 2], ≥1:8	—	91 Participants	178 Participants	—
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values rSBA-MenC [M 2], ≥1:128	—	85 Participants	157 Participants	—
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values rSBA-MenW-135 [M 0], ≥1:8	43 Participants	42 Participants	46 Participants	22 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values rSBA-MenW-135 [M 1], ≥1:8	193 Participants	183 Participants	86 Participants	41 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values rSBA-MenW-135 [M 2], ≥1:8	—	91 Participants	179 Participants	—
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values rSBA-MenW-135 [M 0], ≥1:128	17 Participants	11 Participants	23 Participants	10 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values rSBA-MenW-135 [M 1] ≥1:128	193 Participants	180 Participants	49 Participants	23 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values rSBA-MenW-135 [M 2], ≥1:128	—	90 Participants	178 Participants	—
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values rSBA-MenY [M 0], ≥1:8	57 Participants	53 Participants	53 Participants	30 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values rSBA-MenY [M 1], ≥1:8	192 Participants	180 Participants	103 Participants	71 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values rSBA-MenY [M 2], ≥1:8	—	91 Participants	178 Participants	—
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values rSBA-MenY [M 0], ≥1:128	38 Participants	37 Participants	34 Participants	20 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values rSBA-MenY [M 1], ≥1:128	192 Participants	178 Participants	79 Participants	38 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values rSBA-MenY [M 2], ≥1:128	—	91 Participants	178 Participants	—

SECONDARY outcome

Timeframe: At month 0, month 1 and month 2

Population: ATP cohort for immunogenicity, including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. Subjects in "Nimenrix + Infanrix-hexa Group" and "Meningitec Group" only had 2 blood samples taken: prior to (M0) and 1 month after vaccination (M1).

The results were tabulated as geometric mean expressed in titers.

Outcome measures

Outcome measures
Measure	Nimenrix + Infanrix-hexa Group n=193 Participants Subjects received concomitant administration of 1 dose of Nimenrix™ and Infanrix-hexa™ vaccines at Day 0.	Nimenrix Group n=186 Participants Subjects received a single dose of Nimenrix™ vaccine at Day 0, followed one month later by 1 dose of Infanrix-hexa™ vaccine.	Infanrix-Hexa Group n=179 Participants Subjects received a single dose of Infanrix-Hexa™ vaccine at Day 0, followed one month later by 1 dose of Nimenrix™ vaccine.	Meningitec Group n=114 Participants Subjects received 1 dose of Meningitec™ vaccine at Day 0 and were permitted to receive the routinely recommended Infanrix-hexa booster once the active safety follow-up of this study was completed.
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers rSBA-MenA [M 0]	15 Titers Interval 10.0 to 22.4	19 Titers Interval 12.2 to 29.5	24 Titers Interval 15.0 to 38.4	15.9 Titers Interval 9.2 to 27.5
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers rSBA-MenA [M 1]	3152.9 Titers Interval 2752.5 to 3611.4	3169.9 Titers Interval 2577.2 to 3898.8	24.2 Titers Interval 17.4 to 33.7	21.5 Titers Interval 14.5 to 32.1
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers rSBA-MenA [M 2]	—	2881.9 Titers Interval 2292.0 to 3623.6	1938.3 Titers Interval 1699.1 to 2211.2	—
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers rSBA-MenC [M 0]	7.4 Titers Interval 5.7 to 9.6	9.1 Titers Interval 6.7 to 12.2	6.1 Titers Interval 4.9 to 7.7	7.6 Titers Interval 5.2 to 11.2
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers rSBA-MenC [M 1]	879.7 Titers Interval 763.1 to 1014.0	828.7 Titers Interval 672.4 to 1021.4	7.5 Titers Interval 6.1 to 9.3	691.4 Titers Interval 520.8 to 917.9
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers rSBA-MenC [M 2]	—	519.6 Titers Interval 391.7 to 689.2	386 Titers Interval 333.9 to 446.2	—
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers rSBA-MenW-135 [M 0]	19 Titers Interval 13.1 to 27.6	19.2 Titers Interval 13.3 to 27.7	24.8 Titers Interval 16.7 to 36.8	15.6 Titers Interval 9.8 to 25.0
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers rSBA-MenW-135 [M 1]	4147 Titers Interval 3670.1 to 4685.8	4022.3 Titers Interval 3269.2 to 4948.8	25.2 Titers Interval 18.6 to 34.2	14.2 Titers Interval 10.2 to 19.7
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers rSBA-MenW-135 [M 2]	—	3630.1 Titers Interval 2899.1 to 4545.4	2466.4 Titers Interval 2175.4 to 2796.4	—
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers rSBA-MenY [M 0]	36.8 Titers Interval 24.7 to 54.8	45.4 Titers Interval 29.1 to 71.0	41.2 Titers Interval 26.7 to 63.4	32 Titers Interval 18.3 to 55.9
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers rSBA-MenY [M 1]	3461.8 Titers Interval 2990.1 to 4007.9	3167.7 Titers Interval 2521.9 to 3978.9	45.9 Titers Interval 33.0 to 63.9	47.2 Titers Interval 32.1 to 69.3
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers rSBA-MenY [M 2]	—	3010.4 Titers Interval 2325.3 to 3897.3	2446.9 Titers Interval 2088.5 to 2866.8	—

SECONDARY outcome

Timeframe: At month 0, month 1 and month 2

Population: ATP cohort for immunogenicity, including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. Subjects in "Nimenrix + Infanrix-hexa Group" and "Meningitec Group" only had 2 blood samples taken: prior to (M0) and 1 month after vaccination (M1).

The cut-off for the assay were ≥ 0.3 microgram per milliliter (μg/mL) and ≥ 2.0 μg/mL, respectively.

Outcome measures

Outcome measures
Measure	Nimenrix + Infanrix-hexa Group n=51 Participants Subjects received concomitant administration of 1 dose of Nimenrix™ and Infanrix-hexa™ vaccines at Day 0.	Nimenrix Group n=47 Participants Subjects received a single dose of Nimenrix™ vaccine at Day 0, followed one month later by 1 dose of Infanrix-hexa™ vaccine.	Infanrix-Hexa Group n=47 Participants Subjects received a single dose of Infanrix-Hexa™ vaccine at Day 0, followed one month later by 1 dose of Nimenrix™ vaccine.	Meningitec Group n=29 Participants Subjects received 1 dose of Meningitec™ vaccine at Day 0 and were permitted to receive the routinely recommended Infanrix-hexa booster once the active safety follow-up of this study was completed.
Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Anti-PSA [Month 2], ≥2.0	0 Participants	43 Participants	40 Participants	0 Participants
Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Anti-PSC [Month 0], ≥0.3	1 Participants	1 Participants	2 Participants	0 Participants
Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Anti-PSA [Month 0], ≥0.3	4 Participants	1 Participants	1 Participants	1 Participants
Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Anti-PSA [Month 1], ≥0.3	46 Participants	45 Participants	1 Participants	1 Participants
Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Anti-PSA [Month 2], ≥0.3	—	44 Participants	42 Participants	—
Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Anti-PSA [Month 0], ≥2.0	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Anti-PSA [Month 1], ≥2.0	46 Participants	44 Participants	1 Participants	0 Participants
Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Anti-PSC [Month 1], ≥0.3	51 Participants	41 Participants	2 Participants	28 Participants
Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Anti-PSC [Month 2], ≥0.3	—	41 Participants	47 Participants	—
Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Anti-PSC [Month 0], ≥2.0	1 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Anti-PSC [Month 1], ≥2.0	50 Participants	41 Participants	0 Participants	26 Participants
Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Anti-PSC [Month 2], ≥2.0	—	41 Participants	43 Participants	—
Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Anti-PSW-135 [Month 0], ≥0.3	1 Participants	1 Participants	2 Participants	0 Participants
Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Anti-PSW-135 [Month 1], ≥0.3	44 Participants	43 Participants	2 Participants	0 Participants
Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Anti-PSW-135 [Month 2], ≥0.3	0 Participants	43 Participants	41 Participants	0 Participants
Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Anti-PSW-135 [Month 0], ≥2.0	0 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Anti-PSW-135 [Month 1], ≥2.0	40 Participants	39 Participants	2 Participants	0 Participants
Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Anti-PSW-135 [Month 2], ≥2.0	—	36 Participants	29 Participants	—
Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Anti-PSY [Month 0], ≥0.3	1 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Anti-PSY [Month 1], ≥0.3	45 Participants	43 Participants	1 Participants	0 Participants
Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Anti-PSY [Month 2], ≥0.3	—	44 Participants	41 Participants	—
Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Anti-PSY [Month 0], ≥2.0	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Anti-PSY [Month 1], ≥2.0	40 Participants	42 Participants	1 Participants	0 Participants
Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Anti-PSY [Month 2], ≥2.0	—	40 Participants	34 Participants	—

SECONDARY outcome

Timeframe: At month 0, month 1 and month 2

Population: ATP cohort for immunogenicity, including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. Subjects in "Nimenrix + Infanrix-hexa Group" and "Meningitec Group" only had 2 blood samples taken: prior to (M0) and 1 month after vaccination (M1).

The results for the assay were tabulated as geometric mean expressed in microgram per milliliter (μg/mL).

Outcome measures

Outcome measures
Measure	Nimenrix + Infanrix-hexa Group n=51 Participants Subjects received concomitant administration of 1 dose of Nimenrix™ and Infanrix-hexa™ vaccines at Day 0.	Nimenrix Group n=47 Participants Subjects received a single dose of Nimenrix™ vaccine at Day 0, followed one month later by 1 dose of Infanrix-hexa™ vaccine.	Infanrix-Hexa Group n=47 Participants Subjects received a single dose of Infanrix-Hexa™ vaccine at Day 0, followed one month later by 1 dose of Nimenrix™ vaccine.	Meningitec Group n=29 Participants Subjects received 1 dose of Meningitec™ vaccine at Day 0 and were permitted to receive the routinely recommended Infanrix-hexa booster once the active safety follow-up of this study was completed.
Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations Anti-PSA [M 0]	0.17 μg/mL Interval 0.15 to 0.19	0.15 μg/mL Interval 0.15 to 0.16	0.16 μg/mL Interval 0.14 to 0.18	0.16 μg/mL Interval 0.14 to 0.18
Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations Anti-PSA [M 1]	31.01 μg/mL Interval 23.73 to 40.52	33.15 μg/mL Interval 21.89 to 50.18	0.17 μg/mL Interval 0.13 to 0.22	0.16 μg/mL Interval 0.14 to 0.18
Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations Anti-PSA [M 2]	—	16.93 μg/mL Interval 12.39 to 23.13	12.28 μg/mL Interval 9.38 to 16.06	—
Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations Anti-PSC [M 0]	0.16 μg/mL Interval 0.14 to 0.2	0.16 μg/mL Interval 0.14 to 0.17	0.16 μg/mL Interval 0.15 to 0.17	0.15 μg/mL Interval 0.15 to 0.15
Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations Anti-PSC [M 1]	13.74 μg/mL Interval 10.68 to 17.67	23.52 μg/mL Interval 18.91 to 29.25	0.16 μg/mL Interval 0.15 to 0.17	7.99 μg/mL Interval 5.57 to 11.46
Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations Anti-PSC [M 2]	—	9.73 μg/mL Interval 7.82 to 12.12	5.84 μg/mL Interval 4.66 to 7.32	—
Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations Anti-PSW-135 [M 0]	0.16 μg/mL Interval 0.14 to 0.17	0.15 μg/mL Interval 0.15 to 0.16	0.17 μg/mL Interval 0.14 to 0.22	0.15 μg/mL Interval 0.15 to 0.15
Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations Anti-PSW-135 [M 1]	6.43 μg/mL Interval 4.92 to 8.4	4.15 μg/mL Interval 2.82 to 6.11	0.18 μg/mL Interval 0.14 to 0.22	0.15 μg/mL Interval 0.15 to 0.15
Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations Anti-PSW-135 [M 2]	—	3.99 μg/mL Interval 2.91 to 5.48	3.4 μg/mL Interval 2.52 to 4.59	—
Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations Anti-PSY [M 0]	0.15 μg/mL Interval 0.15 to 0.16	0.15 μg/mL Interval 0.15 to 0.16	0.15 μg/mL Interval 0.15 to 0.15	0.15 μg/mL Interval 0.15 to 0.15
Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations Anti-PSY [M 1]	6.52 μg/mL Interval 4.91 to 8.65	9.42 μg/mL Interval 6.49 to 13.66	0.17 μg/mL Interval 0.13 to 0.21	0.15 μg/mL Interval 0.15 to 0.15
Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations Anti-PSY [M 2]	—	7.86 μg/mL Interval 6.04 to 10.23	4.76 μg/mL Interval 3.73 to 6.09	—

SECONDARY outcome

Timeframe: At month 0, month 1 and month 2

Population: ATP cohort for immunogenicity, including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. Subjects in "Nimenrix + Infanrix-hexa Group" and "Meningitec Group" only had 2 blood samples taken: prior to (M0) and 1 month after vaccination (M1).

The cut-off for the assay was ≥ 0.1

Outcome measures

Outcome measures
Measure	Nimenrix + Infanrix-hexa Group n=186 Participants Subjects received concomitant administration of 1 dose of Nimenrix™ and Infanrix-hexa™ vaccines at Day 0.	Nimenrix Group n=180 Participants Subjects received a single dose of Nimenrix™ vaccine at Day 0, followed one month later by 1 dose of Infanrix-hexa™ vaccine.	Infanrix-Hexa Group n=176 Participants Subjects received a single dose of Infanrix-Hexa™ vaccine at Day 0, followed one month later by 1 dose of Nimenrix™ vaccine.	Meningitec Group n=110 Participants Subjects received 1 dose of Meningitec™ vaccine at Day 0 and were permitted to receive the routinely recommended Infanrix-hexa booster once the active safety follow-up of this study was completed.
Number of Seroprotected Subjects for Anti-tetanus Toxoid (Anti-TT) anti-TT [M 0], ≥0.1	177 Participants	161 Participants	155 Participants	99 Participants
Number of Seroprotected Subjects for Anti-tetanus Toxoid (Anti-TT) anti-TT [M 1], ≥0.1	184 Participants	177 Participants	173 Participants	99 Participants
Number of Seroprotected Subjects for Anti-tetanus Toxoid (Anti-TT) anti-TT [M 2], ≥0.1	—	177 Participants	176 Participants	—

SECONDARY outcome

Timeframe: At month 0, month 1 and month 2

Population: ATP cohort for immunogenicity, including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. Subjects in "Nimenrix + Infanrix-hexa Group" and "Meningitec Group" only had 2 blood samples taken: prior to (M0) and 1 month after vaccination (M1).

The results for the assay were tabulated as geometric mean expressed in internationl units per milliliter (IU/mL).

Outcome measures

Outcome measures
Measure	Nimenrix + Infanrix-hexa Group n=186 Participants Subjects received concomitant administration of 1 dose of Nimenrix™ and Infanrix-hexa™ vaccines at Day 0.	Nimenrix Group n=180 Participants Subjects received a single dose of Nimenrix™ vaccine at Day 0, followed one month later by 1 dose of Infanrix-hexa™ vaccine.	Infanrix-Hexa Group n=176 Participants Subjects received a single dose of Infanrix-Hexa™ vaccine at Day 0, followed one month later by 1 dose of Nimenrix™ vaccine.	Meningitec Group n=110 Participants Subjects received 1 dose of Meningitec™ vaccine at Day 0 and were permitted to receive the routinely recommended Infanrix-hexa booster once the active safety follow-up of this study was completed.
Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations anti-TT [M 0]	0.481 IU/mL Interval 0.417 to 0.554	0.39 IU/mL Interval 0.332 to 0.457	0.416 IU/mL Interval 0.354 to 0.489	0.393 IU/mL Interval 0.325 to 0.475
Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations anti-TT [M 1]	10.47 IU/mL Interval 9.131 to 12.007	7.941 IU/mL Interval 6.517 to 9.677	6.189 IU/mL Interval 5.404 to 7.089	0.374 IU/mL Interval 0.306 to 0.457
Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations anti-TT [M 2]	—	13.966 IU/mL Interval 12.199 to 15.987	8.236 IU/mL Interval 7.348 to 9.231	—

SECONDARY outcome

Timeframe: At month 0, month 1 and month 2

Population: ATP cohort for immunogenicity, including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. Subjects in "Nimenrix + Infanrix-hexa Group" and "Meningitec Group" only had 2 blood samples taken: prior to (M0) and 1 month after vaccination (M1).

The cut-off for the assay was ≥ 0.1

Outcome measures

Outcome measures
Measure	Nimenrix + Infanrix-hexa Group n=185 Participants Subjects received concomitant administration of 1 dose of Nimenrix™ and Infanrix-hexa™ vaccines at Day 0.	Nimenrix Group n=178 Participants Subjects received a single dose of Nimenrix™ vaccine at Day 0, followed one month later by 1 dose of Infanrix-hexa™ vaccine.	Infanrix-Hexa Group n=176 Participants Subjects received a single dose of Infanrix-Hexa™ vaccine at Day 0, followed one month later by 1 dose of Nimenrix™ vaccine.	Meningitec Group n=110 Participants Subjects received 1 dose of Meningitec™ vaccine at Day 0 and were permitted to receive the routinely recommended Infanrix-hexa booster once the active safety follow-up of this study was completed.
Number of Subjects Seroprotected for Anti-diphtheria (Anti-D) ≥ the Cut-off anti-D [M 2], ≥0.1	—	176 Participants	176 Participants	—
Number of Subjects Seroprotected for Anti-diphtheria (Anti-D) ≥ the Cut-off anti-D [M 0], ≥0.1	169 Participants	157 Participants	154 Participants	94 Participants
Number of Subjects Seroprotected for Anti-diphtheria (Anti-D) ≥ the Cut-off anti-D [M 1], ≥0.1	184 Participants	156 Participants	173 Participants	109 Participants

SECONDARY outcome

Timeframe: At month 0, month 1 and month 2

Population: ATP cohort for immunogenicity, including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. Subjects in "Nimenrix + Infanrix-hexa Group" and "Meningitec Group" only had 2 blood samples taken: prior to (M0) and 1 month after vaccination (M1).

The results for the assay were tabulated as geometric mean expressed in internationl units per milliliter (IU/mL).

Outcome measures

Outcome measures
Measure	Nimenrix + Infanrix-hexa Group n=185 Participants Subjects received concomitant administration of 1 dose of Nimenrix™ and Infanrix-hexa™ vaccines at Day 0.	Nimenrix Group n=178 Participants Subjects received a single dose of Nimenrix™ vaccine at Day 0, followed one month later by 1 dose of Infanrix-hexa™ vaccine.	Infanrix-Hexa Group n=176 Participants Subjects received a single dose of Infanrix-Hexa™ vaccine at Day 0, followed one month later by 1 dose of Nimenrix™ vaccine.	Meningitec Group n=110 Participants Subjects received 1 dose of Meningitec™ vaccine at Day 0 and were permitted to receive the routinely recommended Infanrix-hexa booster once the active safety follow-up of this study was completed.
Anti-diphtheria (Anti-D) Antibody Concentrations anti-D [M 0]	0.477 IU/mL Interval 0.407 to 0.559	0.476 IU/mL Interval 0.397 to 0.57	0.437 IU/mL Interval 0.367 to 0.521	0.452 IU/mL Interval 0.355 to 0.574
Anti-diphtheria (Anti-D) Antibody Concentrations anti-D [M 1]	7.636 IU/mL Interval 6.889 to 8.465	0.404 IU/mL Interval 0.335 to 0.487	7.292 IU/mL Interval 6.362 to 8.358	5.201 IU/mL Interval 4.243 to 6.376
Anti-diphtheria (Anti-D) Antibody Concentrations anti-D [M 2]	—	8.561 IU/mL Interval 7.553 to 9.703	5.21 IU/mL Interval 4.623 to 5.872	—

SECONDARY outcome

Timeframe: At month 0, month 1 and month 2

Population: ATP cohort for immunogenicity, including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. Subjects in "Nimenrix + Infanrix-hexa Group" and "Meningitec Group" only had 2 blood samples taken: prior to (M0) and 1 month after vaccination (M1).

The cut-off for the assay was ≥ 1:8.

Outcome measures

Outcome measures
Measure	Nimenrix + Infanrix-hexa Group n=168 Participants Subjects received concomitant administration of 1 dose of Nimenrix™ and Infanrix-hexa™ vaccines at Day 0.	Nimenrix Group n=164 Participants Subjects received a single dose of Nimenrix™ vaccine at Day 0, followed one month later by 1 dose of Infanrix-hexa™ vaccine.	Infanrix-Hexa Group n=164 Participants Subjects received a single dose of Infanrix-Hexa™ vaccine at Day 0, followed one month later by 1 dose of Nimenrix™ vaccine.	Meningitec Group n=100 Participants Subjects received 1 dose of Meningitec™ vaccine at Day 0 and were permitted to receive the routinely recommended Infanrix-hexa booster once the active safety follow-up of this study was completed.
Number of Subjects Seroprotected for Anti-polio Type 1, 2 & 3 ≥ the Cut-off anti-p1 [M 0]	158 Participants	143 Participants	142 Participants	90 Participants
Number of Subjects Seroprotected for Anti-polio Type 1, 2 & 3 ≥ the Cut-off anti-p1 [M 1]	166 Participants	149 Participants	163 Participants	89 Participants
Number of Subjects Seroprotected for Anti-polio Type 1, 2 & 3 ≥ the Cut-off anti-p1 [M 2]	—	159 Participants	161 Participants	—
Number of Subjects Seroprotected for Anti-polio Type 1, 2 & 3 ≥ the Cut-off anti-p2 [M 0]	153 Participants	141 Participants	145 Participants	80 Participants
Number of Subjects Seroprotected for Anti-polio Type 1, 2 & 3 ≥ the Cut-off anti-p2 [M 1]	166 Participants	147 Participants	161 Participants	80 Participants
Number of Subjects Seroprotected for Anti-polio Type 1, 2 & 3 ≥ the Cut-off anti-p2 [M 2]	—	159 Participants	161 Participants	—
Number of Subjects Seroprotected for Anti-polio Type 1, 2 & 3 ≥ the Cut-off anti-p3 [M 0]	155 Participants	148 Participants	143 Participants	88 Participants
Number of Subjects Seroprotected for Anti-polio Type 1, 2 & 3 ≥ the Cut-off anti-p3 [M 1]	167 Participants	150 Participants	160 Participants	87 Participants
Number of Subjects Seroprotected for Anti-polio Type 1, 2 & 3 ≥ the Cut-off anti-p3 [M 2]	—	159 Participants	159 Participants	—

SECONDARY outcome

Timeframe: At month 0, 1 and 2

Population: ATP cohort for immunogenicity, including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. Subjects in "Nimenrix + Infanrix-hexa Group" and "Meningitec Group" only had 2 blood samples taken: prior to (M0) and 1 month after vaccination (M1).

The results for the assay were tabulated as geometric mean expressed in titers.

Outcome measures

Outcome measures
Measure	Nimenrix + Infanrix-hexa Group n=168 Participants Subjects received concomitant administration of 1 dose of Nimenrix™ and Infanrix-hexa™ vaccines at Day 0.	Nimenrix Group n=164 Participants Subjects received a single dose of Nimenrix™ vaccine at Day 0, followed one month later by 1 dose of Infanrix-hexa™ vaccine.	Infanrix-Hexa Group n=164 Participants Subjects received a single dose of Infanrix-Hexa™ vaccine at Day 0, followed one month later by 1 dose of Nimenrix™ vaccine.	Meningitec Group n=100 Participants Subjects received 1 dose of Meningitec™ vaccine at Day 0 and were permitted to receive the routinely recommended Infanrix-hexa booster once the active safety follow-up of this study was completed.
Anti-polio Type 1, 2 & 3 Titers anti-p1 [M 0]	84.2 Titers Interval 67.2 to 105.4	72.5 Titers Interval 55.6 to 94.5	83.6 Titers Interval 65.5 to 106.6	71.7 Titers Interval 51.7 to 99.6
Anti-polio Type 1, 2 & 3 Titers anti-p1 [M 1]	984.4 Titers Interval 830.4 to 1167.0	74.2 Titers Interval 56.7 to 97.3	1308.5 Titers Interval 1073.2 to 1595.5	66.3 Titers Interval 46.6 to 94.4
Anti-polio Type 1, 2 & 3 Titers anti-p1 [M 2]	—	1288.2 Titers Interval 1052.5 to 1576.6	1108.4 Titers Interval 913.5 to 1344.8	—
Anti-polio Type 1, 2 & 3 Titers anti-p2 [M 0]	76.8 Titers Interval 60.8 to 97.0	66.3 Titers Interval 50.9 to 86.5	65.6 Titers Interval 51.2 to 84.2	49.3 Titers Interval 34.9 to 69.6
Anti-polio Type 1, 2 & 3 Titers anti-p2 [M 1]	1372 Titers Interval 1153.5 to 1631.9	70.3 Titers Interval 53.4 to 92.6	1540.4 Titers Interval 1253.2 to 1893.2	49.8 Titers Interval 34.5 to 71.9
Anti-polio Type 1, 2 & 3 Titers anti-p2 [M 2]	—	1650.5 Titers Interval 1358.5 to 2005.3	1174.5 Titers Interval 961.4 to 1434.8	—
Anti-polio Type 1, 2 & 3 Titers anti-p3 [M 0]	104.4 Titers Interval 81.1 to 134.4	99.8 Titers Interval 77.5 to 128.5	113.2 Titers Interval 86.9 to 147.5	102.9 Titers Interval 72.8 to 145.4
Anti-polio Type 1, 2 & 3 Titers anti-p3 [M 1]	2295.6 Titers Interval 1952.1 to 2699.4	96.6 Titers Interval 74.2 to 125.8	2034.3 Titers Interval 1594.9 to 2594.8	85.3 Titers Interval 58.7 to 124.1
Anti-polio Type 1, 2 & 3 Titers anti-p3 [M 2]	—	2478 Titers Interval 2049.2 to 2996.4	1655.1 Titers Interval 1308.9 to 2092.9	—

SECONDARY outcome

Timeframe: At month 0, month 1 and month 2

Population: ATP cohort for immunogenicity, including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. Subjects in "Nimenrix + Infanrix-hexa Group" and "Meningitec Group" only had 2 blood samples taken: prior to (M0) and 1 month after vaccination (M1).

The cut-off for the assay was ≥ 1.0

Outcome measures

Outcome measures
Measure	Nimenrix + Infanrix-hexa Group n=185 Participants Subjects received concomitant administration of 1 dose of Nimenrix™ and Infanrix-hexa™ vaccines at Day 0.	Nimenrix Group n=179 Participants Subjects received a single dose of Nimenrix™ vaccine at Day 0, followed one month later by 1 dose of Infanrix-hexa™ vaccine.	Infanrix-Hexa Group n=176 Participants Subjects received a single dose of Infanrix-Hexa™ vaccine at Day 0, followed one month later by 1 dose of Nimenrix™ vaccine.	Meningitec Group n=110 Participants Subjects received 1 dose of Meningitec™ vaccine at Day 0 and were permitted to receive the routinely recommended Infanrix-hexa booster once the active safety follow-up of this study was completed.
Numbers of Seroprotected Subjects for Anti-PRP ≥ the Cut-off anti-PRP [M 0] ≥1.0	73 Participants	64 Participants	65 Participants	34 Participants
Numbers of Seroprotected Subjects for Anti-PRP ≥ the Cut-off anti-PRP [M 1] ≥1.0	183 Participants	70 Participants	170 Participants	34 Participants
Numbers of Seroprotected Subjects for Anti-PRP ≥ the Cut-off anti-PRP [M 2] ≥1.0	—	172 Participants	170 Participants	—

SECONDARY outcome

Timeframe: At month 0, month 1 and month 2

Population: ATP cohort for immunogenicity, including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. Subjects in "Nimenrix + Infanrix-hexa Group" and "Meningitec Group" only had 2 blood samples taken: prior to (M0) and 1 month after vaccination (M1).

The results for the assay were tabulated as geometric mean expressed in microgram per milliliter (μg/mL).

Outcome measures

Outcome measures
Measure	Nimenrix + Infanrix-hexa Group n=185 Participants Subjects received concomitant administration of 1 dose of Nimenrix™ and Infanrix-hexa™ vaccines at Day 0.	Nimenrix Group n=179 Participants Subjects received a single dose of Nimenrix™ vaccine at Day 0, followed one month later by 1 dose of Infanrix-hexa™ vaccine.	Infanrix-Hexa Group n=176 Participants Subjects received a single dose of Infanrix-Hexa™ vaccine at Day 0, followed one month later by 1 dose of Nimenrix™ vaccine.	Meningitec Group n=110 Participants Subjects received 1 dose of Meningitec™ vaccine at Day 0 and were permitted to receive the routinely recommended Infanrix-hexa booster once the active safety follow-up of this study was completed.
Anti-PRP Antibody Concentrations anti-PRP [M 0]	0.806 μg/mL Interval 0.658 to 0.987	0.665 μg/mL Interval 0.528 to 0.839	0.766 μg/mL Interval 0.596 to 0.986	0.585 μg/mL Interval 0.449 to 0.762
Anti-PRP Antibody Concentrations anti-PRP [M 1]	25.556 μg/mL Interval 21.358 to 30.579	0.711 μg/mL Interval 0.56 to 0.904	31.165 μg/mL Interval 25.142 to 38.631	0.55 μg/mL Interval 0.42 to 0.72
Anti-PRP Antibody Concentrations anti-PRP [M 2]	—	12.239 μg/mL Interval 10.392 to 14.414	21.023 μg/mL Interval 17.036 to 25.942	—

SECONDARY outcome

Timeframe: At month 0, month 1 and month 2

Population: ATP cohort for immunogenicity, including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. Subjects in "Nimenrix + Infanrix-hexa Group" and "Meningitec Group" only had 2 blood samples taken: prior to (M0) and 1 month after vaccination (M1).

The cut-offs for the assay were ≥ 10 mIU/mL and ≥ 100 mIU/mL respectively .

Outcome measures

Outcome measures
Measure	Nimenrix + Infanrix-hexa Group n=181 Participants Subjects received concomitant administration of 1 dose of Nimenrix™ and Infanrix-hexa™ vaccines at Day 0.	Nimenrix Group n=174 Participants Subjects received a single dose of Nimenrix™ vaccine at Day 0, followed one month later by 1 dose of Infanrix-hexa™ vaccine.	Infanrix-Hexa Group n=169 Participants Subjects received a single dose of Infanrix-Hexa™ vaccine at Day 0, followed one month later by 1 dose of Nimenrix™ vaccine.	Meningitec Group n=106 Participants Subjects received 1 dose of Meningitec™ vaccine at Day 0 and were permitted to receive the routinely recommended Infanrix-hexa booster once the active safety follow-up of this study was completed.
Number of Seroprotected Subjects for Anti-HBs ≥ the Cut-offs anti-HBS [M 0] ≥10	173 Participants	158 Participants	155 Participants	95 Participants
Number of Seroprotected Subjects for Anti-HBs ≥ the Cut-offs anti-HBS [M 1] ≥10	180 Participants	160 Participants	166 Participants	100 Participants
Number of Seroprotected Subjects for Anti-HBs ≥ the Cut-offs anti-HBS [M 2] ≥10	—	172 Participants	167 Participants	—
Number of Seroprotected Subjects for Anti-HBs ≥ the Cut-offs anti-HBS [M 0] ≥100	92 Participants	80 Participants	75 Participants	46 Participants
Number of Seroprotected Subjects for Anti-HBs ≥ the Cut-offs anti-HBS [M 1] ≥100	169 Participants	85 Participants	155 Participants	46 Participants
Number of Seroprotected Subjects for Anti-HBs ≥ the Cut-offs anti-HBS [M 2] ≥100	—	168 Participants	158 Participants	—

SECONDARY outcome

Timeframe: At month 0, month 1 and month 2

Population: ATP cohort for immunogenicity, including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. Subjects in "Nimenrix + Infanrix-hexa Group" and "Meningitec Group" only had 2 blood samples taken: prior to (M0) and 1 month after vaccination (M1).

The results for the assay were tabulated as geometric mean expressed in milli-international units per milliliter (mIU/mL).

Outcome measures

Outcome measures
Measure	Nimenrix + Infanrix-hexa Group n=181 Participants Subjects received concomitant administration of 1 dose of Nimenrix™ and Infanrix-hexa™ vaccines at Day 0.	Nimenrix Group n=174 Participants Subjects received a single dose of Nimenrix™ vaccine at Day 0, followed one month later by 1 dose of Infanrix-hexa™ vaccine.	Infanrix-Hexa Group n=169 Participants Subjects received a single dose of Infanrix-Hexa™ vaccine at Day 0, followed one month later by 1 dose of Nimenrix™ vaccine.	Meningitec Group n=106 Participants Subjects received 1 dose of Meningitec™ vaccine at Day 0 and were permitted to receive the routinely recommended Infanrix-hexa booster once the active safety follow-up of this study was completed.
Anti-HBs Antibody Concentrations anti-HBS [M 1]	2048.4 mIU/mL Interval 1589.3 to 2640.0	95 mIU/mL Interval 74.8 to 120.6	1711.6 mIU/mL Interval 1292.7 to 2266.3	101.6 mIU/mL Interval 75.5 to 136.7
Anti-HBs Antibody Concentrations anti-HBS [M 2]	—	2392.3 mIU/mL Interval 1841.7 to 3107.4	1241 mIU/mL Interval 976.2 to 1577.7	—
Anti-HBs Antibody Concentrations anti-HBS [M 0]	111.6 mIU/mL Interval 90.9 to 136.9	92.8 mIU/mL Interval 75.3 to 114.4	101.2 mIU/mL Interval 81.5 to 125.7	85.6 mIU/mL Interval 65.7 to 111.5

SECONDARY outcome

Timeframe: 1 month after vaccination (Month 1)

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component prior to (M0) and after vaccination (M1).

Vaccine response to these antigens is defined as appearance of antibodies in subjects who were seronegative (antibody concentration \< 5 EL.U/mL) at pre-vaccination or as at least a 2-fold increase in post-over pre-vaccination antibody concentrations in subjects seropositive at pre-vaccination. The analysis was based only on subjects receiving experimental vaccination.

Outcome measures

Outcome measures
Measure	Nimenrix + Infanrix-hexa Group n=190 Participants Subjects received concomitant administration of 1 dose of Nimenrix™ and Infanrix-hexa™ vaccines at Day 0.	Nimenrix Group n=178 Participants Subjects received a single dose of Nimenrix™ vaccine at Day 0, followed one month later by 1 dose of Infanrix-hexa™ vaccine.	Infanrix-Hexa Group n=174 Participants Subjects received a single dose of Infanrix-Hexa™ vaccine at Day 0, followed one month later by 1 dose of Nimenrix™ vaccine.	Meningitec Group Subjects received 1 dose of Meningitec™ vaccine at Day 0 and were permitted to receive the routinely recommended Infanrix-hexa booster once the active safety follow-up of this study was completed.
Number of Subjects With a Vaccine Response to PT, FHA and PRN Antigens Anti-PT	180 Participants	169 Participants	163 Participants	—
Number of Subjects With a Vaccine Response to PT, FHA and PRN Antigens Anti-FHA	184 Participants	159 Participants	158 Participants	—
Number of Subjects With a Vaccine Response to PT, FHA and PRN Antigens Anti-PRN	186 Participants	173 Participants	172 Participants	—

SECONDARY outcome

Timeframe: At month 0, month 1 and month 2

Population: ATP cohort for immunogenicity, including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. Subjects in "Nimenrix + Infanrix-hexa Group" and "Meningitec Group" only had 2 blood samples taken: prior to (M0) and 1 month after vaccination (M1).

The results were tabulated as geometric mean expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).

Outcome measures

Outcome measures
Measure	Nimenrix + Infanrix-hexa Group n=194 Participants Subjects received concomitant administration of 1 dose of Nimenrix™ and Infanrix-hexa™ vaccines at Day 0.	Nimenrix Group n=188 Participants Subjects received a single dose of Nimenrix™ vaccine at Day 0, followed one month later by 1 dose of Infanrix-hexa™ vaccine.	Infanrix-Hexa Group n=182 Participants Subjects received a single dose of Infanrix-Hexa™ vaccine at Day 0, followed one month later by 1 dose of Nimenrix™ vaccine.	Meningitec Group n=114 Participants Subjects received 1 dose of Meningitec™ vaccine at Day 0 and were permitted to receive the routinely recommended Infanrix-hexa booster once the active safety follow-up of this study was completed.
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Anti-PT [M 0]	11 EL.U/mL Interval 10.0 to 12.0	10 EL.U/mL Interval 8.0 to 11.0	10 EL.U/mL Interval 9.0 to 12.0	11 EL.U/mL Interval 9.0 to 13.0
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Anti-PT [M 1]	86 EL.U/mL Interval 77.0 to 95.0	8 EL.U/mL Interval 7.0 to 9.0	85 EL.U/mL Interval 75.0 to 96.0	9 EL.U/mL Interval 7.0 to 10.0
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Anti-PT [M 2]	—	91 EL.U/mL Interval 80.0 to 102.0	63 EL.U/mL Interval 55.0 to 71.0	—
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Anti-FHA [M 0]	51 EL.U/mL Interval 44.0 to 59.0	55 EL.U/mL Interval 46.0 to 66.0	49 EL.U/mL Interval 41.0 to 57.0	55 EL.U/mL Interval 44.0 to 68.0
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Anti-FHA [M 1]	542 EL.U/mL Interval 492.0 to 597.0	48 EL.U/mL Interval 40.0 to 58.0	544 EL.U/mL Interval 485.0 to 611.0	55 EL.U/mL Interval 42.0 to 71.0
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Anti-FHA [M 2]	—	664 EL.U/mL Interval 664.0 to 750.0	413 EL.U/mL Interval 366.0 to 465.0	—
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Anti-PRN [M 0]	26 EL.U/mL Interval 23.0 to 31.0	26 EL.U/mL Interval 22.0 to 31.0	21 EL.U/mL Interval 17.0 to 24.0	23 EL.U/mL Interval 18.0 to 28.0
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Anti-PRN [M 1]	470 EL.U/mL Interval 411.0 to 537.0	23 EL.U/mL Interval 19.0 to 27.0	450 EL.U/mL Interval 387.0 to 522.0	21 EL.U/mL Interval 16.0 to 26.0
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Anti-PRN [M 2]	—	583 EL.U/mL Interval 502.0 to 676.0	336 EL.U/mL Interval 286.0 to 395.0	—

SECONDARY outcome

Timeframe: During the 4-day (Days 0-3) follow-up period after Nimenrix or Meningitec vaccination

Population: The analysis was performed on the Total Vaccinated Cohort (TVC), which included all vaccinated subjects with the symptom sheet filled-in after meningococcal vaccination.

Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of any local symptom irrespective of intensity grade. Grade 3 Pain was defined as crying when limb was moved/ spontaneously painful.

Outcome measures

Outcome measures
Measure	Nimenrix + Infanrix-hexa Group n=220 Participants Subjects received concomitant administration of 1 dose of Nimenrix™ and Infanrix-hexa™ vaccines at Day 0.	Nimenrix Group n=217 Participants Subjects received a single dose of Nimenrix™ vaccine at Day 0, followed one month later by 1 dose of Infanrix-hexa™ vaccine.	Infanrix-Hexa Group n=219 Participants Subjects received a single dose of Infanrix-Hexa™ vaccine at Day 0, followed one month later by 1 dose of Nimenrix™ vaccine.	Meningitec Group n=126 Participants Subjects received 1 dose of Meningitec™ vaccine at Day 0 and were permitted to receive the routinely recommended Infanrix-hexa booster once the active safety follow-up of this study was completed.
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination Any Pain	49 Participants	30 Participants	35 Participants	16 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination Grade 3 Pain	3 Participants	0 Participants	1 Participants	1 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination Any Redness	70 Participants	74 Participants	56 Participants	36 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination Grade 3 Redness	3 Participants	8 Participants	8 Participants	2 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination Any Swelling	42 Participants	36 Participants	36 Participants	23 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination Grade 3 Swelling	2 Participants	3 Participants	7 Participants	0 Participants

SECONDARY outcome

Timeframe: During the 4-day (Days 0-3) follow-up period after Infanrix-hexa vaccination

Population: The analysis was performed on the Total Vaccinated Cohort (TVC), which included all vaccinated subjects with the symptom sheet filled-in after the Infanrix-hexa vaccination. Subjects in the Meningitec Group did not receive any Infanrix-hexa and hence are not included in this analysis.

The analysis was based only on subjects receiving combined-diphtheria vaccination.

Outcome measures

Outcome measures
Measure	Nimenrix + Infanrix-hexa Group n=220 Participants Subjects received concomitant administration of 1 dose of Nimenrix™ and Infanrix-hexa™ vaccines at Day 0.	Nimenrix Group n=209 Participants Subjects received a single dose of Nimenrix™ vaccine at Day 0, followed one month later by 1 dose of Infanrix-hexa™ vaccine.	Infanrix-Hexa Group n=221 Participants Subjects received a single dose of Infanrix-Hexa™ vaccine at Day 0, followed one month later by 1 dose of Nimenrix™ vaccine.	Meningitec Group Subjects received 1 dose of Meningitec™ vaccine at Day 0 and were permitted to receive the routinely recommended Infanrix-hexa booster once the active safety follow-up of this study was completed.
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Post-combined Diphtheria Vaccination Any Swelling	48 Participants	53 Participants	74 Participants	—
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Post-combined Diphtheria Vaccination Any Pain	60 Participants	65 Participants	64 Participants	—
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Post-combined Diphtheria Vaccination Grade 3 Pain	6 Participants	5 Participants	10 Participants	—
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Post-combined Diphtheria Vaccination Any Redness	70 Participants	77 Participants	99 Participants	—
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Post-combined Diphtheria Vaccination Grade 3 Redness	11 Participants	14 Participants	27 Participants	—
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Post-combined Diphtheria Vaccination Grade 3 Swelling	12 Participants	14 Participants	22 Participants	—

SECONDARY outcome

Timeframe: During the 4-day (Days 0-3) post-vaccination dose 1 (D1) and second dose (D2)

Population: The analysis was performed on the Total Vaccinated Cohort (TVC), which included all vaccinated subjects with the symptom sheet filled-in.

Solicited general symptoms assessed were drowsiness, fever, irritability and loss of appetite. Any was defined as occurrence of any general symptom irrespective of intensity grade and relationship. Subjects in the Nimenrix + Infanrix-hexa Group did not receive a second dose of vaccination.

Outcome measures

Outcome measures
Measure	Nimenrix + Infanrix-hexa Group n=220 Participants Subjects received concomitant administration of 1 dose of Nimenrix™ and Infanrix-hexa™ vaccines at Day 0.	Nimenrix Group n=218 Participants Subjects received a single dose of Nimenrix™ vaccine at Day 0, followed one month later by 1 dose of Infanrix-hexa™ vaccine.	Infanrix-Hexa Group n=221 Participants Subjects received a single dose of Infanrix-Hexa™ vaccine at Day 0, followed one month later by 1 dose of Nimenrix™ vaccine.	Meningitec Group n=126 Participants Subjects received 1 dose of Meningitec™ vaccine at Day 0 and were permitted to receive the routinely recommended Infanrix-hexa booster once the active safety follow-up of this study was completed.
Number of Subjects Reporting Any Solicited General Symptoms Following Each Dose Drowsiness, D1	85 Participants	56 Participants	80 Participants	29 Participants
Number of Subjects Reporting Any Solicited General Symptoms Following Each Dose Fever, D1	80 Participants	41 Participants	71 Participants	15 Participants
Number of Subjects Reporting Any Solicited General Symptoms Following Each Dose Irritability, D1	83 Participants	63 Participants	75 Participants	25 Participants
Number of Subjects Reporting Any Solicited General Symptoms Following Each Dose Loss of appetite, D1	51 Participants	46 Participants	51 Participants	15 Participants
Number of Subjects Reporting Any Solicited General Symptoms Following Each Dose Drowsiness, D2	0 Participants	63 Participants	56 Participants	0 Participants
Number of Subjects Reporting Any Solicited General Symptoms Following Each Dose Fever, D2	0 Participants	60 Participants	37 Participants	0 Participants
Number of Subjects Reporting Any Solicited General Symptoms Following Each Dose Irritability, D2	0 Participants	75 Participants	50 Participants	0 Participants
Number of Subjects Reporting Any Solicited General Symptoms Following Each Dose Loss of appetite, D2	0 Participants	54 Participants	38 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 0 - Month 7

Population: The analysis was performed on the Total Vaccinated Cohort (TVC), which included all vaccinated subjects.

Any was defined as occurrence of at least one symptom experienced.

Outcome measures

Outcome measures
Measure	Nimenrix + Infanrix-hexa Group n=222 Participants Subjects received concomitant administration of 1 dose of Nimenrix™ and Infanrix-hexa™ vaccines at Day 0.	Nimenrix Group n=220 Participants Subjects received a single dose of Nimenrix™ vaccine at Day 0, followed one month later by 1 dose of Infanrix-hexa™ vaccine.	Infanrix-Hexa Group n=224 Participants Subjects received a single dose of Infanrix-Hexa™ vaccine at Day 0, followed one month later by 1 dose of Nimenrix™ vaccine.	Meningitec Group n=127 Participants Subjects received 1 dose of Meningitec™ vaccine at Day 0 and were permitted to receive the routinely recommended Infanrix-hexa booster once the active safety follow-up of this study was completed.
Number of Subjects Reporting Any Rash	13 Participants	25 Participants	22 Participants	12 Participants

SECONDARY outcome

Timeframe: Day 0 - Month 7

Population: The analysis was performed on the Total Vaccinated Cohort (TVC), which included all vaccinated subjects.

Any was defined as occurrence of at least one symptom experienced.

Outcome measures

Outcome measures
Measure	Nimenrix + Infanrix-hexa Group n=222 Participants Subjects received concomitant administration of 1 dose of Nimenrix™ and Infanrix-hexa™ vaccines at Day 0.	Nimenrix Group n=220 Participants Subjects received a single dose of Nimenrix™ vaccine at Day 0, followed one month later by 1 dose of Infanrix-hexa™ vaccine.	Infanrix-Hexa Group n=224 Participants Subjects received a single dose of Infanrix-Hexa™ vaccine at Day 0, followed one month later by 1 dose of Nimenrix™ vaccine.	Meningitec Group n=127 Participants Subjects received 1 dose of Meningitec™ vaccine at Day 0 and were permitted to receive the routinely recommended Infanrix-hexa booster once the active safety follow-up of this study was completed.
Number of Subjects Reporting Any New Onset of Chronic Illnesses (NOCIs)	1 Participants	2 Participants	6 Participants	1 Participants

SECONDARY outcome

Timeframe: Day 0 - Month 7

Population: The analysis was performed on the Total Vaccinated Cohort (TVC), which included all vaccinated subjects with the symptom sheet filled-in.

Any was defined as occurrence of at least one symptom experienced.

Outcome measures

Outcome measures
Measure	Nimenrix + Infanrix-hexa Group n=222 Participants Subjects received concomitant administration of 1 dose of Nimenrix™ and Infanrix-hexa™ vaccines at Day 0.	Nimenrix Group n=220 Participants Subjects received a single dose of Nimenrix™ vaccine at Day 0, followed one month later by 1 dose of Infanrix-hexa™ vaccine.	Infanrix-Hexa Group n=224 Participants Subjects received a single dose of Infanrix-Hexa™ vaccine at Day 0, followed one month later by 1 dose of Nimenrix™ vaccine.	Meningitec Group n=127 Participants Subjects received 1 dose of Meningitec™ vaccine at Day 0 and were permitted to receive the routinely recommended Infanrix-hexa booster once the active safety follow-up of this study was completed.
Number of Subjects Reporting Any Conditions Prompting Emergency Room Visits (ER)	5 Participants	3 Participants	14 Participants	6 Participants

SECONDARY outcome

Timeframe: Occurring within Day 0-30 following vaccination

Population: The analysis was performed on the Total Vaccinated Cohort (TVC), which included all vaccinated subjects.

An AE is 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. "Any" was defined as an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.

Outcome measures

Outcome measures
Measure	Nimenrix + Infanrix-hexa Group n=222 Participants Subjects received concomitant administration of 1 dose of Nimenrix™ and Infanrix-hexa™ vaccines at Day 0.	Nimenrix Group n=220 Participants Subjects received a single dose of Nimenrix™ vaccine at Day 0, followed one month later by 1 dose of Infanrix-hexa™ vaccine.	Infanrix-Hexa Group n=224 Participants Subjects received a single dose of Infanrix-Hexa™ vaccine at Day 0, followed one month later by 1 dose of Nimenrix™ vaccine.	Meningitec Group n=127 Participants Subjects received 1 dose of Meningitec™ vaccine at Day 0 and were permitted to receive the routinely recommended Infanrix-hexa booster once the active safety follow-up of this study was completed.
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) After the First Dose	71 Participants	81 Participants	83 Participants	42 Participants

SECONDARY outcome

Timeframe: Occurring within Day 0-30 following vaccination

Population: The analysis was performed on the Total Vaccinated Cohort (TVC), which included all vaccinated subjects with the symptom sheet filled-in.

An AE is 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. "Any" was defined as an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination. The analysis was based only on subjects receiving a second dose of vaccination.

Outcome measures

Outcome measures
Measure	Nimenrix + Infanrix-hexa Group n=215 Participants Subjects received concomitant administration of 1 dose of Nimenrix™ and Infanrix-hexa™ vaccines at Day 0.	Nimenrix Group n=221 Participants Subjects received a single dose of Nimenrix™ vaccine at Day 0, followed one month later by 1 dose of Infanrix-hexa™ vaccine.	Infanrix-Hexa Group Subjects received a single dose of Infanrix-Hexa™ vaccine at Day 0, followed one month later by 1 dose of Nimenrix™ vaccine.	Meningitec Group Subjects received 1 dose of Meningitec™ vaccine at Day 0 and were permitted to receive the routinely recommended Infanrix-hexa booster once the active safety follow-up of this study was completed.
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) After the Second Dose	87 Participants	79 Participants	—	—

SECONDARY outcome

Timeframe: From dose 1 (Month 0) up to study end (Month 7)

Population: The analysis was performed on the Total Vaccinated Cohort (TVC), which included all vaccinated subjects.

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 + Infanrix-hexa Group n=222 Participants Subjects received concomitant administration of 1 dose of Nimenrix™ and Infanrix-hexa™ vaccines at Day 0.	Nimenrix Group n=220 Participants Subjects received a single dose of Nimenrix™ vaccine at Day 0, followed one month later by 1 dose of Infanrix-hexa™ vaccine.	Infanrix-Hexa Group n=224 Participants Subjects received a single dose of Infanrix-Hexa™ vaccine at Day 0, followed one month later by 1 dose of Nimenrix™ vaccine.	Meningitec Group n=127 Participants Subjects received 1 dose of Meningitec™ vaccine at Day 0 and were permitted to receive the routinely recommended Infanrix-hexa booster once the active safety follow-up of this study was completed.
Number of Subjects Reporting Any Serious Adverse Events (SAEs)	10 Participants	8 Participants	11 Participants	6 Participants

Adverse Events

Nimenrix + Infanrix-hexa Group

Serious events: 10 serious events

Other events: 166 other events

Deaths: 0 deaths

Nimenrix Group

Serious events: 8 serious events

Other events: 183 other events

Deaths: 0 deaths

Infanrix-Hexa Group

Serious events: 11 serious events

Other events: 185 other events

Deaths: 1 deaths

Meningitec Group

Serious events: 6 serious events

Other events: 75 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Nimenrix + Infanrix-hexa Group n=222 participants at risk Subjects received concomitant administration of 1 dose of Nimenrix™ and Infanrix-hexa™ vaccines at Day 0.	Nimenrix Group n=220 participants at risk Subjects received a single dose of Nimenrix™ vaccine at Day 0, followed one month later by 1 dose of Infanrix-hexa™ vaccine.	Infanrix-Hexa Group n=224 participants at risk Subjects received a single dose of Infanrix-Hexa™ vaccine at Day 0, followed one month later by 1 dose of Nimenrix™ vaccine.	Meningitec Group n=127 participants at risk Subjects received 1 dose of Meningitec™ vaccine at Day 0 and were permitted to receive the routinely recommended Infanrix-hexa booster once the active safety follow-up of this study was completed.
Infections and infestations Bronchitis	3.2% 7/222 • Number of events 7 • SAEs were reported throughout the entire study period (Day 0 - Month 7). Solicited symptoms were reported during a 4-day period (Day 0-Day 3) after any vaccine dose, while unsolicited AEs were collected within 31 days (Days 0-30) after vaccination. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	7.3% 16/220 • Number of events 18 • SAEs were reported throughout the entire study period (Day 0 - Month 7). Solicited symptoms were reported during a 4-day period (Day 0-Day 3) after any vaccine dose, while unsolicited AEs were collected within 31 days (Days 0-30) after vaccination. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	5.4% 12/224 • Number of events 13 • SAEs were reported throughout the entire study period (Day 0 - Month 7). Solicited symptoms were reported during a 4-day period (Day 0-Day 3) after any vaccine dose, while unsolicited AEs were collected within 31 days (Days 0-30) after vaccination. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	4.7% 6/127 • Number of events 7 • SAEs were reported throughout the entire study period (Day 0 - Month 7). Solicited symptoms were reported during a 4-day period (Day 0-Day 3) after any vaccine dose, while unsolicited AEs were collected within 31 days (Days 0-30) after vaccination. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
Respiratory, thoracic and mediastinal disorders Cough	3.6% 8/222 • Number of events 8 • SAEs were reported throughout the entire study period (Day 0 - Month 7). Solicited symptoms were reported during a 4-day period (Day 0-Day 3) after any vaccine dose, while unsolicited AEs were collected within 31 days (Days 0-30) after vaccination. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	5.0% 11/220 • Number of events 11 • SAEs were reported throughout the entire study period (Day 0 - Month 7). Solicited symptoms were reported during a 4-day period (Day 0-Day 3) after any vaccine dose, while unsolicited AEs were collected within 31 days (Days 0-30) after vaccination. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	2.2% 5/224 • Number of events 5 • SAEs were reported throughout the entire study period (Day 0 - Month 7). Solicited symptoms were reported during a 4-day period (Day 0-Day 3) after any vaccine dose, while unsolicited AEs were collected within 31 days (Days 0-30) after vaccination. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	2.4% 3/127 • Number of events 3 • SAEs were reported throughout the entire study period (Day 0 - Month 7). Solicited symptoms were reported during a 4-day period (Day 0-Day 3) after any vaccine dose, while unsolicited AEs were collected within 31 days (Days 0-30) after 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	23.0% 51/222 • Number of events 51 • SAEs were reported throughout the entire study period (Day 0 - Month 7). Solicited symptoms were reported during a 4-day period (Day 0-Day 3) after any vaccine dose, while unsolicited AEs were collected within 31 days (Days 0-30) after vaccination. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	35.5% 78/220 • Number of events 100 • SAEs were reported throughout the entire study period (Day 0 - Month 7). Solicited symptoms were reported during a 4-day period (Day 0-Day 3) after any vaccine dose, while unsolicited AEs were collected within 31 days (Days 0-30) after vaccination. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	30.4% 68/224 • Number of events 89 • SAEs were reported throughout the entire study period (Day 0 - Month 7). Solicited symptoms were reported during a 4-day period (Day 0-Day 3) after any vaccine dose, while unsolicited AEs were collected within 31 days (Days 0-30) after vaccination. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	11.8% 15/127 • Number of events 15 • SAEs were reported throughout the entire study period (Day 0 - Month 7). Solicited symptoms were reported during a 4-day period (Day 0-Day 3) after any vaccine dose, while unsolicited AEs were collected within 31 days (Days 0-30) after 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	41.0% 91/222 • Number of events 91 • SAEs were reported throughout the entire study period (Day 0 - Month 7). Solicited symptoms were reported during a 4-day period (Day 0-Day 3) after any vaccine dose, while unsolicited AEs were collected within 31 days (Days 0-30) after vaccination. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	46.4% 102/220 • Number of events 151 • SAEs were reported throughout the entire study period (Day 0 - Month 7). Solicited symptoms were reported during a 4-day period (Day 0-Day 3) after any vaccine dose, while unsolicited AEs were collected within 31 days (Days 0-30) after vaccination. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	46.0% 103/224 • Number of events 155 • SAEs were reported throughout the entire study period (Day 0 - Month 7). Solicited symptoms were reported during a 4-day period (Day 0-Day 3) after any vaccine dose, while unsolicited AEs were collected within 31 days (Days 0-30) after vaccination. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	28.3% 36/127 • Number of events 37 • SAEs were reported throughout the entire study period (Day 0 - Month 7). Solicited symptoms were reported during a 4-day period (Day 0-Day 3) after any vaccine dose, while unsolicited AEs were collected within 31 days (Days 0-30) after vaccination. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
Infections and infestations Gastroenteritis	2.7% 6/222 • Number of events 6 • SAEs were reported throughout the entire study period (Day 0 - Month 7). Solicited symptoms were reported during a 4-day period (Day 0-Day 3) after any vaccine dose, while unsolicited AEs were collected within 31 days (Days 0-30) after vaccination. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	8.2% 18/220 • Number of events 20 • SAEs were reported throughout the entire study period (Day 0 - Month 7). Solicited symptoms were reported during a 4-day period (Day 0-Day 3) after any vaccine dose, while unsolicited AEs were collected within 31 days (Days 0-30) after vaccination. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	8.0% 18/224 • Number of events 18 • SAEs were reported throughout the entire study period (Day 0 - Month 7). Solicited symptoms were reported during a 4-day period (Day 0-Day 3) after any vaccine dose, while unsolicited AEs were collected within 31 days (Days 0-30) after vaccination. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	3.1% 4/127 • Number of events 4 • SAEs were reported throughout the entire study period (Day 0 - Month 7). Solicited symptoms were reported during a 4-day period (Day 0-Day 3) after any vaccine dose, while unsolicited AEs were collected within 31 days (Days 0-30) after vaccination. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
Psychiatric disorders Irritability	37.4% 83/222 • Number of events 83 • SAEs were reported throughout the entire study period (Day 0 - Month 7). Solicited symptoms were reported during a 4-day period (Day 0-Day 3) after any vaccine dose, while unsolicited AEs were collected within 31 days (Days 0-30) after vaccination. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	45.5% 100/220 • Number of events 139 • SAEs were reported throughout the entire study period (Day 0 - Month 7). Solicited symptoms were reported during a 4-day period (Day 0-Day 3) after any vaccine dose, while unsolicited AEs were collected within 31 days (Days 0-30) after vaccination. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	41.5% 93/224 • Number of events 125 • SAEs were reported throughout the entire study period (Day 0 - Month 7). Solicited symptoms were reported during a 4-day period (Day 0-Day 3) after any vaccine dose, while unsolicited AEs were collected within 31 days (Days 0-30) after vaccination. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	19.7% 25/127 • Number of events 25 • SAEs were reported throughout the entire study period (Day 0 - Month 7). Solicited symptoms were reported during a 4-day period (Day 0-Day 3) after any vaccine dose, while unsolicited AEs were collected within 31 days (Days 0-30) after vaccination. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
Infections and infestations Nasopharyngitis	1.4% 3/222 • Number of events 3 • SAEs were reported throughout the entire study period (Day 0 - Month 7). Solicited symptoms were reported during a 4-day period (Day 0-Day 3) after any vaccine dose, while unsolicited AEs were collected within 31 days (Days 0-30) after vaccination. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	5.5% 12/220 • Number of events 15 • SAEs were reported throughout the entire study period (Day 0 - Month 7). Solicited symptoms were reported during a 4-day period (Day 0-Day 3) after any vaccine dose, while unsolicited AEs were collected within 31 days (Days 0-30) after vaccination. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	4.9% 11/224 • Number of events 12 • SAEs were reported throughout the entire study period (Day 0 - Month 7). Solicited symptoms were reported during a 4-day period (Day 0-Day 3) after any vaccine dose, while unsolicited AEs were collected within 31 days (Days 0-30) after vaccination. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	1.6% 2/127 • Number of events 2 • SAEs were reported throughout the entire study period (Day 0 - Month 7). Solicited symptoms were reported during a 4-day period (Day 0-Day 3) after any vaccine dose, while unsolicited AEs were collected within 31 days (Days 0-30) after vaccination. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
Infections and infestations Otitis media	1.8% 4/222 • Number of events 4 • SAEs were reported throughout the entire study period (Day 0 - Month 7). Solicited symptoms were reported during a 4-day period (Day 0-Day 3) after any vaccine dose, while unsolicited AEs were collected within 31 days (Days 0-30) after vaccination. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	5.0% 11/220 • Number of events 12 • SAEs were reported throughout the entire study period (Day 0 - Month 7). Solicited symptoms were reported during a 4-day period (Day 0-Day 3) after any vaccine dose, while unsolicited AEs were collected within 31 days (Days 0-30) after vaccination. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	3.1% 7/224 • Number of events 7 • SAEs were reported throughout the entire study period (Day 0 - Month 7). Solicited symptoms were reported during a 4-day period (Day 0-Day 3) after any vaccine dose, while unsolicited AEs were collected within 31 days (Days 0-30) after vaccination. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	3.9% 5/127 • Number of events 5 • SAEs were reported throughout the entire study period (Day 0 - Month 7). Solicited symptoms were reported during a 4-day period (Day 0-Day 3) after any vaccine dose, while unsolicited AEs were collected within 31 days (Days 0-30) after vaccination. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
General disorders Pain	30.6% 68/222 • Number of events 69 • SAEs were reported throughout the entire study period (Day 0 - Month 7). Solicited symptoms were reported during a 4-day period (Day 0-Day 3) after any vaccine dose, while unsolicited AEs were collected within 31 days (Days 0-30) after vaccination. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	34.1% 75/220 • Number of events 95 • SAEs were reported throughout the entire study period (Day 0 - Month 7). Solicited symptoms were reported during a 4-day period (Day 0-Day 3) after any vaccine dose, while unsolicited AEs were collected within 31 days (Days 0-30) after vaccination. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	30.8% 69/224 • Number of events 99 • SAEs were reported throughout the entire study period (Day 0 - Month 7). Solicited symptoms were reported during a 4-day period (Day 0-Day 3) after any vaccine dose, while unsolicited AEs were collected within 31 days (Days 0-30) after vaccination. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	12.6% 16/127 • Number of events 16 • SAEs were reported throughout the entire study period (Day 0 - Month 7). Solicited symptoms were reported during a 4-day period (Day 0-Day 3) after any vaccine dose, while unsolicited AEs were collected within 31 days (Days 0-30) after vaccination. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
General disorders Pyrexia	37.4% 83/222 • Number of events 86 • SAEs were reported throughout the entire study period (Day 0 - Month 7). Solicited symptoms were reported during a 4-day period (Day 0-Day 3) after any vaccine dose, while unsolicited AEs were collected within 31 days (Days 0-30) after vaccination. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	40.9% 90/220 • Number of events 114 • SAEs were reported throughout the entire study period (Day 0 - Month 7). Solicited symptoms were reported during a 4-day period (Day 0-Day 3) after any vaccine dose, while unsolicited AEs were collected within 31 days (Days 0-30) after vaccination. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	39.7% 89/224 • Number of events 114 • SAEs were reported throughout the entire study period (Day 0 - Month 7). Solicited symptoms were reported during a 4-day period (Day 0-Day 3) after any vaccine dose, while unsolicited AEs were collected within 31 days (Days 0-30) after vaccination. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	13.4% 17/127 • Number of events 17 • SAEs were reported throughout the entire study period (Day 0 - Month 7). Solicited symptoms were reported during a 4-day period (Day 0-Day 3) after any vaccine dose, while unsolicited AEs were collected within 31 days (Days 0-30) after vaccination. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
Infections and infestations Rhinitis	4.1% 9/222 • Number of events 11 • SAEs were reported throughout the entire study period (Day 0 - Month 7). Solicited symptoms were reported during a 4-day period (Day 0-Day 3) after any vaccine dose, while unsolicited AEs were collected within 31 days (Days 0-30) after vaccination. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	7.3% 16/220 • Number of events 17 • SAEs were reported throughout the entire study period (Day 0 - Month 7). Solicited symptoms were reported during a 4-day period (Day 0-Day 3) after any vaccine dose, while unsolicited AEs were collected within 31 days (Days 0-30) after vaccination. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	4.5% 10/224 • Number of events 10 • SAEs were reported throughout the entire study period (Day 0 - Month 7). Solicited symptoms were reported during a 4-day period (Day 0-Day 3) after any vaccine dose, while unsolicited AEs were collected within 31 days (Days 0-30) after vaccination. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	0.79% 1/127 • Number of events 1 • SAEs were reported throughout the entire study period (Day 0 - Month 7). Solicited symptoms were reported during a 4-day period (Day 0-Day 3) after any vaccine dose, while unsolicited AEs were collected within 31 days (Days 0-30) after vaccination. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
Nervous system disorders Somnolence	38.3% 85/222 • Number of events 85 • SAEs were reported throughout the entire study period (Day 0 - Month 7). Solicited symptoms were reported during a 4-day period (Day 0-Day 3) after any vaccine dose, while unsolicited AEs were collected within 31 days (Days 0-30) after vaccination. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	40.5% 89/220 • Number of events 119 • SAEs were reported throughout the entire study period (Day 0 - Month 7). Solicited symptoms were reported during a 4-day period (Day 0-Day 3) after any vaccine dose, while unsolicited AEs were collected within 31 days (Days 0-30) after vaccination. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	42.4% 95/224 • Number of events 136 • SAEs were reported throughout the entire study period (Day 0 - Month 7). Solicited symptoms were reported during a 4-day period (Day 0-Day 3) after any vaccine dose, while unsolicited AEs were collected within 31 days (Days 0-30) after vaccination. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	22.8% 29/127 • Number of events 29 • SAEs were reported throughout the entire study period (Day 0 - Month 7). Solicited symptoms were reported during a 4-day period (Day 0-Day 3) after any vaccine dose, while unsolicited AEs were collected within 31 days (Days 0-30) after vaccination. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
General disorders Swelling	28.8% 64/222 • Number of events 64 • SAEs were reported throughout the entire study period (Day 0 - Month 7). Solicited symptoms were reported during a 4-day period (Day 0-Day 3) after any vaccine dose, while unsolicited AEs were collected within 31 days (Days 0-30) after vaccination. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	30.0% 66/220 • Number of events 89 • SAEs were reported throughout the entire study period (Day 0 - Month 7). Solicited symptoms were reported during a 4-day period (Day 0-Day 3) after any vaccine dose, while unsolicited AEs were collected within 31 days (Days 0-30) after vaccination. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	37.9% 85/224 • Number of events 110 • SAEs were reported throughout the entire study period (Day 0 - Month 7). Solicited symptoms were reported during a 4-day period (Day 0-Day 3) after any vaccine dose, while unsolicited AEs were collected within 31 days (Days 0-30) after vaccination. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	18.1% 23/127 • Number of events 23 • SAEs were reported throughout the entire study period (Day 0 - Month 7). Solicited symptoms were reported during a 4-day period (Day 0-Day 3) after any vaccine dose, while unsolicited AEs were collected within 31 days (Days 0-30) after 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	5.4% 12/222 • Number of events 12 • SAEs were reported throughout the entire study period (Day 0 - Month 7). Solicited symptoms were reported during a 4-day period (Day 0-Day 3) after any vaccine dose, while unsolicited AEs were collected within 31 days (Days 0-30) after vaccination. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	12.3% 27/220 • Number of events 30 • SAEs were reported throughout the entire study period (Day 0 - Month 7). Solicited symptoms were reported during a 4-day period (Day 0-Day 3) after any vaccine dose, while unsolicited AEs were collected within 31 days (Days 0-30) after vaccination. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	10.7% 24/224 • Number of events 27 • SAEs were reported throughout the entire study period (Day 0 - Month 7). Solicited symptoms were reported during a 4-day period (Day 0-Day 3) after any vaccine dose, while unsolicited AEs were collected within 31 days (Days 0-30) after vaccination. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	6.3% 8/127 • Number of events 8 • SAEs were reported throughout the entire study period (Day 0 - Month 7). Solicited symptoms were reported during a 4-day period (Day 0-Day 3) after any vaccine dose, while unsolicited AEs were collected within 31 days (Days 0-30) after vaccination. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.

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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