Trial Outcomes & Findings for Safety & Immunogenicity Study of Meningococcal Vaccine GSK134612 Given With Priorix-Tetra™ to 12-23 Month-Old Children (NCT NCT00474266)

Results Overview

The cut-off values for the rSBA titers were ≥ 1:8. The analysis was performed only on subjects receiving meningitis vaccination (Nimenrix) at Day 0.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1000 participants

Primary outcome timeframe

42 days after the first vaccine dose (Day 42)

Results posted on

2019-11-18

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 + Priorix-Tetra Group Subjects received 1 dose of Nimenrix™ vaccine and 1 dose of Priorix-Tetra™ vaccine on Day 0 and a second dose of Priorix-Tetra™ vaccine on Day 84.	Nimenrix Group Subjects received 1 dose of Nimenrix™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.	Priorix-Tetra Group Subjects received 1 dose of Priorix-Tetra™ vaccine on Day 0, 1 dose of Meningitec™ vaccine on Day 42 and a second dose of Priorix-Tetra™ vaccine on Day 84.	Meningitec Group Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.
Overall Study STARTED	375	374	126	125
Overall Study COMPLETED	368	354	122	118
Overall Study NOT COMPLETED	7	20	4	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Nimenrix + Priorix-Tetra Group Subjects received 1 dose of Nimenrix™ vaccine and 1 dose of Priorix-Tetra™ vaccine on Day 0 and a second dose of Priorix-Tetra™ vaccine on Day 84.	Nimenrix Group Subjects received 1 dose of Nimenrix™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.	Priorix-Tetra Group Subjects received 1 dose of Priorix-Tetra™ vaccine on Day 0, 1 dose of Meningitec™ vaccine on Day 42 and a second dose of Priorix-Tetra™ vaccine on Day 84.	Meningitec Group Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.
Overall Study Withdrawal by Subject	7	20	4	7

Baseline Characteristics

Safety & Immunogenicity Study of Meningococcal Vaccine GSK134612 Given With Priorix-Tetra™ to 12-23 Month-Old Children

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nimenrix + Priorix-Tetra Group n=375 Participants Subjects received 1 dose of Nimenrix™ vaccine and 1 dose of Priorix-Tetra™ vaccine on Day 0 and a second dose of Priorix-Tetra™ vaccine on Day 84.	Nimenrix Group n=374 Participants Subjects received 1 dose of Nimenrix™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.	Priorix-Tetra Group n=126 Participants Subjects received 1 dose of Priorix-Tetra™ vaccine on Day 0, 1 dose of Meningitec™ vaccine on Day 42 and a second dose of Priorix-Tetra™ vaccine on Day 84.	Meningitec Group n=125 Participants Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.	Total n=1000 Participants Total of all reporting groups
Age, Continuous	14.7 Months STANDARD_DEVIATION 1.5 • n=5 Participants	14.6 Months STANDARD_DEVIATION 1.49 • n=7 Participants	14.6 Months STANDARD_DEVIATION 1.41 • n=5 Participants	14.4 Months STANDARD_DEVIATION 1.47 • n=4 Participants	14.61 Months STANDARD_DEVIATION 1.48 • n=21 Participants
Sex/Gender, Customized Female	180 Participants n=5 Participants	174 Participants n=7 Participants	68 Participants n=5 Participants	60 Participants n=4 Participants	482 Participants n=21 Participants
Sex/Gender, Customized Male	195 Participants n=5 Participants	200 Participants n=7 Participants	58 Participants n=5 Participants	65 Participants n=4 Participants	518 Participants n=21 Participants
Race/Ethnicity, Customized White-Caucasian/ European heritage, n (%)	369 Participants n=5 Participants	372 Participants n=7 Participants	123 Participants n=5 Participants	123 Participants n=4 Participants	987 Participants n=21 Participants
Race/Ethnicity, Customized Other	4 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	10 Participants n=21 Participants
Race/Ethnicity, Customized White - Arabic / North African heritage	2 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants

PRIMARY outcome

Timeframe: 42 days after the first vaccine dose (Day 42)

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

The cut-off values for the rSBA titers were ≥ 1:8. The analysis was performed only on subjects receiving meningitis vaccination (Nimenrix) at Day 0.

Outcome measures

Outcome measures
Measure	Nimenrix + Priorix-Tetra Group n=360 Participants Subjects received 1 dose of Nimenrix™ vaccine and 1 dose of Priorix-Tetra™ vaccine on Day 0 and a second dose of Priorix-Tetra™ vaccine on Day 84.	Nimenrix Group n=354 Participants Subjects received 1 dose of Nimenrix™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.	Meningitec Group n=121 Participants Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.	Meningitec Group Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.
Number of Subjects With rSBA-MenC, rSBA-MenA, rSBA-MenW-135, rSBA-MenY Titers Greater Than or Equal to (≥) the Cut-off Values rSBA-MenA, D42	360 Participants	353 Participants	23 Participants	—
Number of Subjects With rSBA-MenC, rSBA-MenA, rSBA-MenW-135, rSBA-MenY Titers Greater Than or Equal to (≥) the Cut-off Values rSBA-MenC, D42	357 Participants	353 Participants	118 Participants	—
Number of Subjects With rSBA-MenC, rSBA-MenA, rSBA-MenW-135, rSBA-MenY Titers Greater Than or Equal to (≥) the Cut-off Values rSBA-MenW-135, D42	360 Participants	354 Participants	29 Participants	—
Number of Subjects With rSBA-MenC, rSBA-MenA, rSBA-MenW-135, rSBA-MenY Titers Greater Than or Equal to (≥) the Cut-off Values rSBA-MenY, D42	359 Participants	354 Participants	32 Participants	—

PRIMARY outcome

Timeframe: 42 days after the first vaccine dose (Day 42)

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

The cut-off values for anti-measles antibody concentrations were ≥ 150 milli-international units per milliliter (mIU/mL).

Outcome measures

Outcome measures
Measure	Nimenrix + Priorix-Tetra Group n=361 Participants Subjects received 1 dose of Nimenrix™ vaccine and 1 dose of Priorix-Tetra™ vaccine on Day 0 and a second dose of Priorix-Tetra™ vaccine on Day 84.	Nimenrix Group n=354 Participants Subjects received 1 dose of Nimenrix™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.	Meningitec Group n=118 Participants Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.	Meningitec Group n=120 Participants Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.
Number of Subjects With Anti-measles Antibody Concentrations ≥ the Cut-off Values	361 Participants	0 Participants	118 Participants	0 Participants

PRIMARY outcome

Timeframe: 42 days after the first vaccine dose (Day 42)

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

The cut-off values for anti-mumps antibody concentrations were ≥ 231 units per milliliter (U/mL).

Outcome measures

Outcome measures
Measure	Nimenrix + Priorix-Tetra Group n=349 Participants Subjects received 1 dose of Nimenrix™ vaccine and 1 dose of Priorix-Tetra™ vaccine on Day 0 and a second dose of Priorix-Tetra™ vaccine on Day 84.	Nimenrix Group n=354 Participants Subjects received 1 dose of Nimenrix™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.	Meningitec Group n=116 Participants Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.	Meningitec Group n=120 Participants Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.
Number of Subjects With Anti-mumps Antibody Concentrations ≥ the Cut-off Values	306 Participants	0 Participants	97 Participants	0 Participants

PRIMARY outcome

Timeframe: 42 days after the first vaccine dose (Day 42)

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

The cut-off values for anti-rubella antibody concentrations were ≥ 4 international units per milliliter (IU/mL).

Outcome measures

Outcome measures
Measure	Nimenrix + Priorix-Tetra Group n=361 Participants Subjects received 1 dose of Nimenrix™ vaccine and 1 dose of Priorix-Tetra™ vaccine on Day 0 and a second dose of Priorix-Tetra™ vaccine on Day 84.	Nimenrix Group n=354 Participants Subjects received 1 dose of Nimenrix™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.	Meningitec Group n=118 Participants Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.	Meningitec Group n=120 Participants Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.
Number of Subjects With Anti-rubella Antibody Concentrations ≥ the Cut-off Values.	361 Participants	1 Participants	118 Participants	1 Participants

PRIMARY outcome

Timeframe: 42 days after the first vaccine dose (Day 42)

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

The cut-off values for anti-varicella antibody concentrations were ≥ 1:4.

Outcome measures

Outcome measures
Measure	Nimenrix + Priorix-Tetra Group n=333 Participants Subjects received 1 dose of Nimenrix™ vaccine and 1 dose of Priorix-Tetra™ vaccine on Day 0 and a second dose of Priorix-Tetra™ vaccine on Day 84.	Nimenrix Group n=335 Participants Subjects received 1 dose of Nimenrix™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.	Meningitec Group n=111 Participants Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.	Meningitec Group n=116 Participants Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.
Number of Subjects With Anti-varicella Antibody Concentrations ≥ the Cut-off Values	326 Participants	6 Participants	105 Participants	2 Participants

SECONDARY outcome

Timeframe: Prior to vaccination (Day 0) and after the first vaccination dose (Day 42)

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

The cut-off values for the rSBA titers were ≥ 1:8 and ≥ 1:128 respectively. At pre-vaccination for all groups, half of the subjects were sera tested for rSBA-MenC while the other half was tested for rSBA-MenA, rSBA-MenW-135 and rSBA-MenY. At Post vaccination I (Day 42), all subjects from Nimenrix + Priorix-Tetra and Nimenrix groups were sera tested for each rSBA. For Meningitec and Priorix-Tetra groups, all subjects were tested for rSBA-MenC while half of subjects were tested for rSBA-MenA, rSBA-MenW-135 and rSBA-MenY.

Outcome measures

Outcome measures
Measure	Nimenrix + Priorix-Tetra Group n=360 Participants Subjects received 1 dose of Nimenrix™ vaccine and 1 dose of Priorix-Tetra™ vaccine on Day 0 and a second dose of Priorix-Tetra™ vaccine on Day 84.	Nimenrix Group n=354 Participants Subjects received 1 dose of Nimenrix™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.	Meningitec Group n=117 Participants Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.	Meningitec Group n=121 Participants Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values rSBA-MenA ≥ 1:128, D0	32 Participants	50 Participants	18 Participants	10 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values rSBA-MenC ≥ 1:8, D0	48 Participants	47 Participants	16 Participants	13 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values rSBA-MenW-135 ≥ 1:128, D42	360 Participants	352 Participants	16 Participants	15 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values rSBA-MenY ≥ 1:128, D0	75 Participants	79 Participants	30 Participants	23 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values rSBA-MenA ≥ 1:8, D0	57 Participants	77 Participants	24 Participants	18 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values rSBA-MenA ≥ 1:128, D42	359 Participants	353 Participants	22 Participants	17 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values rSBA-MenC ≥ 1:128, D0	19 Participants	22 Participants	4 Participants	4 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values rSBA-MenC ≥ 1:128, D42	337 Participants	339 Participants	13 Participants	85 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values rSBA-MenW-135 ≥ 1:8, D0	76 Participants	81 Participants	29 Participants	30 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values rSBA-MenW-135 ≥ 1:128, D0	30 Participants	28 Participants	14 Participants	12 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values rSBA-MenY ≥ 1:8, D0	103 Participants	112 Participants	41 Participants	34 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values rSBA-MenY ≥ 1:128, D42	358 Participants	353 Participants	30 Participants	21 Participants

SECONDARY outcome

Timeframe: Prior to first vaccine dose (Day 0) and 42 days after the first vaccine dose (Day 42)

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

Antibody titers were expressed as geometric mean titers (GMTs). At pre-vaccination for all groups, half of the subjects were sera tested for rSBA-MenC while the other half were tested for rSBA-MenA, rSBA-MenW-135 and rSBA-MenY. At Post vaccination I (Day 42), all subjects from Nimenrix + Priorix-Tetra and Nimenrix groups were sera tested for each rSBA. For Meningitec and Priorix-Tetra groups, all subjects were tested for rSBA-MenC while half of subjects were tested for rSBA-MenA, rSBA-MenW-135 and rSBA-MenY.

Outcome measures

Outcome measures
Measure	Nimenrix + Priorix-Tetra Group n=360 Participants Subjects received 1 dose of Nimenrix™ vaccine and 1 dose of Priorix-Tetra™ vaccine on Day 0 and a second dose of Priorix-Tetra™ vaccine on Day 84.	Nimenrix Group n=354 Participants Subjects received 1 dose of Nimenrix™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.	Meningitec Group n=117 Participants Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.	Meningitec Group n=121 Participants Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers rSBA-MenA, D42	2085.9 Titer Interval 1905.3 to 2283.6	2205 Titer Interval 2007.8 to 2421.6	33.1 Titer Interval 19.1 to 57.4	24.3 Titer Interval 13.4 to 44.1
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers rSBA-MenY, D0	41.4 Titer Interval 30.2 to 56.6	50.1 Titer Interval 36.7 to 68.2	71 Titer Interval 40.9 to 123.2	31.7 Titer Interval 18.9 to 53.2
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers rSBA-MenY, D42	2282.4 Titer Interval 2051.3 to 2539.5	2729.4 Titer Interval 2472.7 to 3012.8	70 Titer Interval 39.3 to 124.7	31.4 Titer Interval 18.4 to 53.6
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers rSBA-MenC, D0	9.2 Titer Interval 7.4 to 11.4	10 Titer Interval 7.8 to 12.6	8.5 Titer Interval 6.0 to 12.2	7.6 Titer Interval 5.5 to 10.6
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers rSBA-MenA, D0	14.6 Titer Interval 10.9 to 19.4	22.8 Titer Interval 16.8 to 31.0	24.4 Titer Interval 13.7 to 43.4	14.3 Titer Interval 8.5 to 24.0
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers rSBA-MenC, D42	519 Titer Interval 470.9 to 571.9	477.6 Titer Interval 437.3 to 521.6	11.2 Titer Interval 8.3 to 15.2	212.3 Titer Interval 170.0 to 265.2
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers rSBA-MenW-135, D0	16.2 Titer Interval 12.6 to 20.7	16.7 Titer Interval 13.1 to 21.4	21.9 Titer Interval 13.5 to 35.4	20.8 Titer Interval 13.1 to 33.2
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers rSBA-MenW-135, D42	2055.8 Titer Interval 1871.0 to 2258.9	2681.7 Titer Interval 2453.1 to 2931.6	25.6 Titer Interval 15.6 to 42.1	25.1 Titer Interval 14.6 to 43.1

SECONDARY outcome

Timeframe: Prior to the first vaccine dose (Day 0) and 42 days after the first vaccine dose (Day 42)

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

Anti-PS antibody concentrations were given as geometric mean concentrations (GMCs) and expressed as microgram per milliliter (μg/mL). At pre-vaccination (Day 0) and Post-vaccination I (Day 42), a quarter of the subjects were tested for anti-PSC and another quarter for anti-PSA, anti-PSW-135 and anti-PSY.

Outcome measures

Outcome measures
Measure	Nimenrix + Priorix-Tetra Group n=90 Participants Subjects received 1 dose of Nimenrix™ vaccine and 1 dose of Priorix-Tetra™ vaccine on Day 0 and a second dose of Priorix-Tetra™ vaccine on Day 84.	Nimenrix Group n=93 Participants Subjects received 1 dose of Nimenrix™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.	Meningitec Group n=30 Participants Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.	Meningitec Group n=31 Participants Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.
Anti-PSA (Anti-polysaccharide A), Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values Anti-PSC, D0	0.15 μg/mL Interval 0.15 to 0.15	0.15 μg/mL Interval 0.15 to 0.15	0.15 μg/mL Interval 0.15 to 0.15	0.15 μg/mL Interval 0.15 to 0.15
Anti-PSA (Anti-polysaccharide A), Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values Anti-PSW-135, D0	0.16 μg/mL Interval 0.15 to 0.17	0.15 μg/mL Interval 0.15 to 0.16	0.16 μg/mL Interval 0.14 to 0.18	0.15 μg/mL Interval 0.15 to 0.15
Anti-PSA (Anti-polysaccharide A), Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values Anti-PSY, D0	0.15 μg/mL Interval 0.15 to 0.15	0.16 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-PSA (Anti-polysaccharide A), Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values Anti-PSA, D0	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 0.17
Anti-PSA (Anti-polysaccharide A), Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values Anti-PSA, D42	28.74 μg/mL Interval 24.01 to 34.4	15.71 μg/mL Interval 12.91 to 19.12	0.16 μg/mL Interval 0.15 to 0.17	0.15 μg/mL Interval 0.15 to 0.17
Anti-PSA (Anti-polysaccharide A), Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values Anti-PSC, D42	9.26 μg/mL Interval 7.73 to 11.1	7.44 μg/mL Interval 6.43 to 8.6	0.15 μg/mL Interval 0.15 to 0.15	4.89 μg/mL Interval 3.69 to 6.47
Anti-PSA (Anti-polysaccharide A), Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values Anti-PSW-135, D42	6.5 μg/mL Interval 5.52 to 7.65	4.5 μg/mL Interval 3.77 to 5.37	0.16 μg/mL Interval 0.14 to 0.17	0.15 μg/mL Interval 0.15 to 0.15
Anti-PSA (Anti-polysaccharide A), Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values Anti-PSY, D42	8.56 μg/mL Interval 7.26 to 10.11	6.37 μg/mL Interval 5.13 to 7.92	0.16 μg/mL Interval 0.14 to 0.17	0.15 μg/mL Interval 0.15 to 0.15

SECONDARY outcome

Timeframe: Prior to first vaccine dose (Day 0) and 42 days after the first vaccine dose (Day 42)

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

The cut-off values for anti-PS antibody concentrations were ≥ 0.3 μg/mL and ≥ 2.0 μg/mL respectively. At pre-vaccination (Day 0) and Post-vaccination I (Day 42), a quarter of the subjects were tested for anti-PSC and another quarter for anti-PSA, anti-PSW-135 and anti-PSY.

Outcome measures

Outcome measures
Measure	Nimenrix + Priorix-Tetra Group n=90 Participants Subjects received 1 dose of Nimenrix™ vaccine and 1 dose of Priorix-Tetra™ vaccine on Day 0 and a second dose of Priorix-Tetra™ vaccine on Day 84.	Nimenrix Group n=93 Participants Subjects received 1 dose of Nimenrix™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.	Meningitec Group n=30 Participants Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.	Meningitec Group n=31 Participants Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values Anti-PSA ≥ 2 μg/mL, D0	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values Anti-PSA ≥ 2 μg/mL, D42	90 Participants	88 Participants	0 Participants	0 Participants
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values Anti-PSA ≥ 0.3 μg/mL, D0	6 Participants	1 Participants	1 Participants	1 Participants
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values Anti-PSA ≥ 0.3 μg/mL, D42	90 Participants	89 Participants	2 Participants	1 Participants
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values Anti-PSC ≥ 0.3 μg/mL, D0	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values Anti-PSC ≥ 0.3 μg/mL, D42	89 Participants	87 Participants	0 Participants	29 Participants
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values Anti-PSC ≥ 2 μg/mL, D0	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values Anti-PSC ≥ 2 μg/mL, D42	85 Participants	85 Participants	0 Participants	26 Participants
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values Anti-PSW-135 ≥ 0.3 μg/mL, D0	4 Participants	2 Participants	1 Participants	0 Participants
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values Anti-PSW-135 ≥ 0.3 μg/mL, D42	90 Participants	89 Participants	1 Participants	0 Participants
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values Anti-PSW-135 ≥ 2 μg/mL, D0	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values Anti-PSW-135 ≥ 2 μg/mL, D42	82 Participants	80 Participants	0 Participants	0 Participants
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values Anti-PSY ≥ 0.3 μg/mL, D0	0 Participants	4 Participants	0 Participants	0 Participants
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values Anti-PSY ≥ 0.3 μg/mL, D42	90 Participants	89 Participants	1 Participants	0 Participants
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values Anti-PSY ≥ 2 μg/mL, D0	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values Anti-PSY ≥ 2 μg/mL, D42	87 Participants	79 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Prior to first vaccine dose (Day 0) and 42 days after the first vaccine dose (Day 42)

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

The cut-off values for hSBA antibody titers were ≥ 1:4 and ≥ 1:8 for Nimenrix + Priorix-Tetra group, Nimenrix group, Meningitec group and Pooled group (Nimenrix + Priorix-Tetra and Nimenrix groups), respectively. The analysis was performed only on subjects receiving meningitis vaccination (Nimenrix) at Day 0.

Outcome measures

Outcome measures
Measure	Nimenrix + Priorix-Tetra Group n=359 Participants Subjects received 1 dose of Nimenrix™ vaccine and 1 dose of Priorix-Tetra™ vaccine on Day 0 and a second dose of Priorix-Tetra™ vaccine on Day 84.	Nimenrix Group n=363 Participants Subjects received 1 dose of Nimenrix™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.	Meningitec Group n=123 Participants Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.	Meningitec Group n=722 Participants Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.
Number of Subjects With hSBA-MenA (Meningococcal Polysaccharide A Serum Bactericidal Antibodies Using Human Complement), hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ the Cut-off Values hSBA-MenA ≥1:4, D0	14 Participants	8 Participants	2 Participants	22 Participants
Number of Subjects With hSBA-MenA (Meningococcal Polysaccharide A Serum Bactericidal Antibodies Using Human Complement), hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ the Cut-off Values hSBA-MenA ≥1:4, D42	305 Participants	273 Participants	1 Participants	578 Participants
Number of Subjects With hSBA-MenA (Meningococcal Polysaccharide A Serum Bactericidal Antibodies Using Human Complement), hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ the Cut-off Values hSBA-MenA ≥1:8, D0	7 Participants	7 Participants	1 Participants	14 Participants
Number of Subjects With hSBA-MenA (Meningococcal Polysaccharide A Serum Bactericidal Antibodies Using Human Complement), hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ the Cut-off Values hSBA-MenA ≥1:8, D42	292 Participants	261 Participants	1 Participants	553 Participants
Number of Subjects With hSBA-MenA (Meningococcal Polysaccharide A Serum Bactericidal Antibodies Using Human Complement), hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ the Cut-off Values hSBA-MenC ≥1:4, D0	1 Participants	3 Participants	1 Participants	4 Participants
Number of Subjects With hSBA-MenA (Meningococcal Polysaccharide A Serum Bactericidal Antibodies Using Human Complement), hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ the Cut-off Values hSBA-MenC ≥1:4, D42	339 Participants	339 Participants	95 Participants	677 Participants
Number of Subjects With hSBA-MenA (Meningococcal Polysaccharide A Serum Bactericidal Antibodies Using Human Complement), hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ the Cut-off Values hSBA-MenC ≥1:8, D0	1 Participants	3 Participants	1 Participants	4 Participants
Number of Subjects With hSBA-MenA (Meningococcal Polysaccharide A Serum Bactericidal Antibodies Using Human Complement), hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ the Cut-off Values hSBA-MenC ≥1:8, D42	339 Participants	336 Participants	95 Participants	675 Participants
Number of Subjects With hSBA-MenA (Meningococcal Polysaccharide A Serum Bactericidal Antibodies Using Human Complement), hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ the Cut-off Values hSBA-MenW-135 ≥1:4, D0	4 Participants	3 Participants	0 Participants	7 Participants
Number of Subjects With hSBA-MenA (Meningococcal Polysaccharide A Serum Bactericidal Antibodies Using Human Complement), hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ the Cut-off Values hSBA-MenW-135 ≥1:4, D42	280 Participants	295 Participants	1 Participants	575 Participants
Number of Subjects With hSBA-MenA (Meningococcal Polysaccharide A Serum Bactericidal Antibodies Using Human Complement), hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ the Cut-off Values hSBA-MenW-135 ≥1:8, D0	4 Participants	2 Participants	0 Participants	6 Participants
Number of Subjects With hSBA-MenA (Meningococcal Polysaccharide A Serum Bactericidal Antibodies Using Human Complement), hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ the Cut-off Values hSBA-MenW-135 ≥1:8, D42	279 Participants	294 Participants	1 Participants	573 Participants
Number of Subjects With hSBA-MenA (Meningococcal Polysaccharide A Serum Bactericidal Antibodies Using Human Complement), hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ the Cut-off Values hSBA-MenY ≥1:4, D0	4 Participants	5 Participants	1 Participants	9 Participants
Number of Subjects With hSBA-MenA (Meningococcal Polysaccharide A Serum Bactericidal Antibodies Using Human Complement), hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ the Cut-off Values hSBA-MenY ≥1:4, D42	273 Participants	261 Participants	2 Participants	534 Participants
Number of Subjects With hSBA-MenA (Meningococcal Polysaccharide A Serum Bactericidal Antibodies Using Human Complement), hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ the Cut-off Values hSBA-MenY ≥1:8, D0	4 Participants	5 Participants	1 Participants	9 Participants
Number of Subjects With hSBA-MenA (Meningococcal Polysaccharide A Serum Bactericidal Antibodies Using Human Complement), hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ the Cut-off Values hSBA-MenY ≥1:8, D42	271 Participants	261 Participants	2 Participants	532 Participants

SECONDARY outcome

Timeframe: Prior to first vaccine dose (Day 0) and 42 days after the first vaccine dose (Day 42)

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

Anti-hSBA antibody titers were expressed as geometric mean titers (GMTs) for Nimenrix + Priorix-Tetra group, Nimenrix group, Meningitec group and Pooled group (Nimenrix + Priorix-Tetra and Nimenrix groups), respectively. The analysis was performed only on subjects receiving meningitis vaccination (Nimenrix) at Day 0.

Outcome measures

Outcome measures
Measure	Nimenrix + Priorix-Tetra Group n=359 Participants Subjects received 1 dose of Nimenrix™ vaccine and 1 dose of Priorix-Tetra™ vaccine on Day 0 and a second dose of Priorix-Tetra™ vaccine on Day 84.	Nimenrix Group n=363 Participants Subjects received 1 dose of Nimenrix™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.	Meningitec Group n=123 Participants Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.	Meningitec Group n=722 Participants Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers hSBA-MenC, D42	209.1 Titer Interval 183.8 to 238.0	196 Titer Interval 175.4 to 219.0	40.3 Titer Interval 29.5 to 55.1	202.5 Titer Interval 186.0 to 220.5
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers hSBA-MenW-135, D0	2.1 Titer Interval 2.0 to 2.1	2.1 Titer Interval 2.0 to 2.1	2 Titer Interval 2.0 to 2.0	2.1 Titer Interval 2.0 to 2.1
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers hSBA-MenW-135, D42	57.3 Titer Interval 47.0 to 69.9	48.9 Titer Interval 41.2 to 58.0	2 Titer Interval 2.0 to 2.2	52.9 Titer Interval 46.4 to 60.3
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers hSBA-MenY, D0	2.1 Titer Interval 2.0 to 2.1	2.1 Titer Interval 2.0 to 2.1	2.1 Titer Interval 1.9 to 2.2	2.1 Titer Interval 2.0 to 2.1
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers hSBA-MenY, D42	38.7 Titer Interval 32.2 to 46.7	30.9 Titer Interval 25.8 to 37.1	2.1 Titer Interval 1.9 to 2.3	34.6 Titer Interval 30.4 to 39.4
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers hSBA- MenA, D0	2.1 Titer Interval 2.1 to 2.2	2.1 Titer Interval 2.0 to 2.1	2 Titer Interval 2.0 to 2.1	2.1 Titer Interval 2.1 to 2.2
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers hSBA- MenA, D42	33.7 Titer Interval 28.9 to 39.2	19 Titer Interval 16.4 to 22.1	2 Titer Interval 2.0 to 2.1	25.4 Titer Interval 22.8 to 28.4
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers hSBA-MenC, D0	2 Titer Interval 2.0 to 2.0	2 Titer Interval 2.0 to 2.1	2 Titer Interval 2.0 to 2.1	2 Titer Interval 2.0 to 2.1

SECONDARY outcome

Timeframe: 42 days after the first vaccine dose (Day 42)

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

Anti-measles antibody concentrations were given as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL) in all groups.

Outcome measures

Outcome measures
Measure	Nimenrix + Priorix-Tetra Group n=361 Participants Subjects received 1 dose of Nimenrix™ vaccine and 1 dose of Priorix-Tetra™ vaccine on Day 0 and a second dose of Priorix-Tetra™ vaccine on Day 84.	Nimenrix Group n=354 Participants Subjects received 1 dose of Nimenrix™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.	Meningitec Group n=118 Participants Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.	Meningitec Group n=120 Participants Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.
Anti-measles Antibody Concentrations	4273.4 mIU/mL Interval 4018.4 to 4544.6	75 mIU/mL Interval 75.0 to 75.0	4457.3 mIU/mL Interval 3976.3 to 4996.6	75 mIU/mL Interval 75.0 to 75.0

SECONDARY outcome

Timeframe: 42 days after the second Priorix-Tetra vaccine dose (Day 126)

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

Anti-measles antibody concentrations were given as geometric mean concentrations (GMCs) and expressed in mIU/mL in a subset (30%) of the Nimenrix + Priorix-Tetra and Priorix-Tetra groups only. The analysis was performed only on subjects receiving varicella vaccination (Priorix-Tetra) at Day 0.

Outcome measures

Outcome measures
Measure	Nimenrix + Priorix-Tetra Group n=37 Participants Subjects received 1 dose of Nimenrix™ vaccine and 1 dose of Priorix-Tetra™ vaccine on Day 0 and a second dose of Priorix-Tetra™ vaccine on Day 84.	Nimenrix Group n=7 Participants Subjects received 1 dose of Nimenrix™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.	Meningitec Group Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.	Meningitec Group Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.
Anti-measles Antibody Concentrations	7113.8 mIU/mL Interval 5335.6 to 9484.7	8699.8 mIU/mL Interval 4865.3 to 15556.2	—	—

SECONDARY outcome

Timeframe: 42 days after the first vaccine dose (Day 42)

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

Anti-mumps antibody concentrations were given as geometric mean concentrations (GMCs) and expressed in units per milliliter (U/mL) in all groups.

Outcome measures

Outcome measures
Measure	Nimenrix + Priorix-Tetra Group n=349 Participants Subjects received 1 dose of Nimenrix™ vaccine and 1 dose of Priorix-Tetra™ vaccine on Day 0 and a second dose of Priorix-Tetra™ vaccine on Day 84.	Nimenrix Group n=354 Participants Subjects received 1 dose of Nimenrix™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.	Meningitec Group n=116 Participants Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.	Meningitec Group n=120 Participants Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.
Anti-mumps Antibody Concentrations	662.9 U/mL Interval 598.4 to 734.4	115.5 U/mL Interval 115.5 to 115.5	710.1 U/mL Interval 583.8 to 863.8	115.5 U/mL Interval 115.5 to 115.5

SECONDARY outcome

Timeframe: 42 days after the second Priorix-Tetra vaccine dose (Day 126)

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

Anti-mumps antibody concentrations were given as geometric mean concentrations (GMCs) and expressed in U/mL in a subset (30%) of the Nimenrix + Priorix-Tetra and Priorix-Tetra groups only. The analysis was performed only on subjects receiving varicella vaccination ( Priorix-Tetra) at Day 0.

Outcome measures

Outcome measures
Measure	Nimenrix + Priorix-Tetra Group n=37 Participants Subjects received 1 dose of Nimenrix™ vaccine and 1 dose of Priorix-Tetra™ vaccine on Day 0 and a second dose of Priorix-Tetra™ vaccine on Day 84.	Nimenrix Group n=7 Participants Subjects received 1 dose of Nimenrix™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.	Meningitec Group Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.	Meningitec Group Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.
Anti-mumps Antibody Concentrations	3351.2 U/mL Interval 2658.2 to 4224.7	3334.1 U/mL Interval 1933.1 to 5750.5	—	—

SECONDARY outcome

Timeframe: 42 days after the first vaccine dose (Day 42)

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

Anti-rubella antibody concentrations were given as geometric mean concentrations (GMCs) and expressed in international units per millilier (IU/mL) in all groups.

Outcome measures

Outcome measures
Measure	Nimenrix + Priorix-Tetra Group n=361 Participants Subjects received 1 dose of Nimenrix™ vaccine and 1 dose of Priorix-Tetra™ vaccine on Day 0 and a second dose of Priorix-Tetra™ vaccine on Day 84.	Nimenrix Group n=354 Participants Subjects received 1 dose of Nimenrix™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.	Meningitec Group n=118 Participants Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.	Meningitec Group n=120 Participants Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.
Anti-rubella Antibody Concentrations	43.1 IU/mL Interval 40.0 to 46.5	2 IU/mL Interval 2.0 to 2.0	53.2 IU/mL Interval 46.6 to 60.7	2 IU/mL Interval 2.0 to 2.1

SECONDARY outcome

Timeframe: 42 days after the second Priorix-Tetra vaccine dose (Day 126)

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

Anti-rubella antibody concentrations were given as geometric mean concentrations (GMCs) and expressed in IU/mL in a subset (30%) of the Nimenrix + Priorix-Tetra and Priorix-Tetra groups only. The analysis was performed only on subjects receiving varicella vaccination (Priorix-Tetra) at Day 0.

Outcome measures

Outcome measures
Measure	Nimenrix + Priorix-Tetra Group n=37 Participants Subjects received 1 dose of Nimenrix™ vaccine and 1 dose of Priorix-Tetra™ vaccine on Day 0 and a second dose of Priorix-Tetra™ vaccine on Day 84.	Nimenrix Group n=7 Participants Subjects received 1 dose of Nimenrix™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.	Meningitec Group Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.	Meningitec Group Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.
Anti-rubella Antibody Concentrations	87.2 IU/mL Interval 74.8 to 101.6	117 IU/mL Interval 73.8 to 185.5	—	—

SECONDARY outcome

Timeframe: 42 days after the first vaccine dose (Day 42)

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

Anti-varicella antibody titers were given as geometric mean titers (GMTs) for all groups.

Outcome measures

Outcome measures
Measure	Nimenrix + Priorix-Tetra Group n=333 Participants Subjects received 1 dose of Nimenrix™ vaccine and 1 dose of Priorix-Tetra™ vaccine on Day 0 and a second dose of Priorix-Tetra™ vaccine on Day 84.	Nimenrix Group n=335 Participants Subjects received 1 dose of Nimenrix™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.	Meningitec Group n=111 Participants Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.	Meningitec Group n=116 Participants Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.
Anti-varicella Antibody Titers	152.8 Titers Interval 133.5 to 174.8	2.2 Titers Interval 2.0 to 2.3	128.8 Titers Interval 99.1 to 167.4	2.2 Titers Interval 1.9 to 2.5

SECONDARY outcome

Timeframe: 42 days after the second Priorix-Tetra vaccine dose (Day 126)

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

Anti-varicella antibody titers were given as geometric mean titers (GMTs) in a subset (30%) of the Nimenrix + Priorix-Tetra and Priorix-Tetra groups only. The analysis was performed only on subjects receiving varicella vaccination ( Priorix-Tetra) at Day 0.

Outcome measures

Outcome measures
Measure	Nimenrix + Priorix-Tetra Group n=36 Participants Subjects received 1 dose of Nimenrix™ vaccine and 1 dose of Priorix-Tetra™ vaccine on Day 0 and a second dose of Priorix-Tetra™ vaccine on Day 84.	Nimenrix Group n=7 Participants Subjects received 1 dose of Nimenrix™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.	Meningitec Group Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.	Meningitec Group Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.
Anti-varicella Antibody Titers	4175.6 Titers Interval 3064.0 to 5690.6	3360.1 Titers Interval 1646.5 to 6857.0	—	—

SECONDARY outcome

Timeframe: During the 4-day (Days 0-3) after vaccination with first dose of Priorix-Tetra vaccine at Day 0

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

Solicited local symptoms assessed were pain, redness and swelling for the Nimenrix + Priorix-Tetra Group and Priorix-Tetra Group, respectively. The analysis was performed only on subjects receiving varicella vaccination (Priorix-Tetra) at Day 0.

Outcome measures

Outcome measures
Measure	Nimenrix + Priorix-Tetra Group n=375 Participants Subjects received 1 dose of Nimenrix™ vaccine and 1 dose of Priorix-Tetra™ vaccine on Day 0 and a second dose of Priorix-Tetra™ vaccine on Day 84.	Nimenrix Group n=124 Participants Subjects received 1 dose of Nimenrix™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.	Meningitec Group Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.	Meningitec Group Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.
Number of Subjects Reporting Solicited Local Symptoms Specific for Priorix-Tetra Vaccination Pain	75 Participants	22 Participants	—	—
Number of Subjects Reporting Solicited Local Symptoms Specific for Priorix-Tetra Vaccination Redness	126 Participants	48 Participants	—	—
Number of Subjects Reporting Solicited Local Symptoms Specific for Priorix-Tetra Vaccination Swelling	28 Participants	7 Participants	—	—

SECONDARY outcome

Timeframe: During the 4-day (Days 0-3) after vaccination with Nimenrix or Meningitec at Day 0

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

Solicited local symptoms assessed were pain, redness and swelling for the Nimenrix + Priorix-Tetra Group, Nimenrix Group and Meningitec Group, respectively. The analysis was performed only on subjects receiving meningitis vaccination (Priorix-Tetra) at Day 0.

Outcome measures

Outcome measures
Measure	Nimenrix + Priorix-Tetra Group n=375 Participants Subjects received 1 dose of Nimenrix™ vaccine and 1 dose of Priorix-Tetra™ vaccine on Day 0 and a second dose of Priorix-Tetra™ vaccine on Day 84.	Nimenrix Group n=367 Participants Subjects received 1 dose of Nimenrix™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.	Meningitec Group n=123 Participants Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.	Meningitec Group Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.
Number of Subjects Reporting Solicited Local Symptoms After Nimenrix or Meningitec Vaccination at Day 0 Pain	91 Participants	107 Participants	31 Participants	—
Number of Subjects Reporting Solicited Local Symptoms After Nimenrix or Meningitec Vaccination at Day 0 Redness	133 Participants	136 Participants	39 Participants	—
Number of Subjects Reporting Solicited Local Symptoms After Nimenrix or Meningitec Vaccination at Day 0 Swelling	52 Participants	69 Participants	10 Participants	—

SECONDARY outcome

Timeframe: During the 4-day (Days 0-3) follow-up period after first vaccination dose in all groups

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 (measured rectally and temperature ≥ 38.0°C ), irritability and loss of appetite, Meningismus, Parotiditis and Rash.

Outcome measures

Outcome measures
Measure	Nimenrix + Priorix-Tetra Group n=375 Participants Subjects received 1 dose of Nimenrix™ vaccine and 1 dose of Priorix-Tetra™ vaccine on Day 0 and a second dose of Priorix-Tetra™ vaccine on Day 84.	Nimenrix Group n=367 Participants Subjects received 1 dose of Nimenrix™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.	Meningitec Group n=124 Participants Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.	Meningitec Group n=124 Participants Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.
Number of Subjects Reporting Solicited General Symptoms Loss of appetite	107 Participants	84 Participants	29 Participants	33 Participants
Number of Subjects Reporting Solicited General Symptoms Irritability	190 Participants	150 Participants	48 Participants	54 Participants
Number of Subjects Reporting Solicited General Symptoms Drowsiness	122 Participants	103 Participants	29 Participants	40 Participants
Number of Subjects Reporting Solicited General Symptoms Fever≥38.0˚C	56 Participants	34 Participants	14 Participants	16 Participants
Number of Subjects Reporting Solicited General Symptoms Meningismus	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Solicited General Symptoms Parotiditis	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Solicited General Symptoms Rash	22 Participants	23 Participants	10 Participants	6 Participants

SECONDARY outcome

Timeframe: During the 43-day (Days 0-42) after first vaccination dose

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 fever (measured rectally and temperature ≥ 38.0°C ), Meningismus, Parotiditis and Rash.

Outcome measures

Outcome measures
Measure	Nimenrix + Priorix-Tetra Group n=375 Participants Subjects received 1 dose of Nimenrix™ vaccine and 1 dose of Priorix-Tetra™ vaccine on Day 0 and a second dose of Priorix-Tetra™ vaccine on Day 84.	Nimenrix Group n=367 Participants Subjects received 1 dose of Nimenrix™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.	Meningitec Group n=124 Participants Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.	Meningitec Group n=124 Participants Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.
Number of Subjects With Priorix-Tetra - Specific Solicited General Symptoms Fever ≥ 38.0˚C	295 Participants	164 Participants	99 Participants	56 Participants
Number of Subjects With Priorix-Tetra - Specific Solicited General Symptoms Meningismus	1 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Priorix-Tetra - Specific Solicited General Symptoms Parotiditis	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Priorix-Tetra - Specific Solicited General Symptoms Rash	119 Participants	66 Participants	36 Participants	24 Participants

SECONDARY outcome

Timeframe: From Day 0 up to Month 6 after first vaccine dose

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

Specific AEs include: rash, New Onset of Chronic Illness(es) (NOCI), and/or conditions prompting emergency room (ER) visits or non-routine physician office visits.

Outcome measures

Outcome measures
Measure	Nimenrix + Priorix-Tetra Group n=375 Participants Subjects received 1 dose of Nimenrix™ vaccine and 1 dose of Priorix-Tetra™ vaccine on Day 0 and a second dose of Priorix-Tetra™ vaccine on Day 84.	Nimenrix Group n=374 Participants Subjects received 1 dose of Nimenrix™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.	Meningitec Group n=126 Participants Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.	Meningitec Group n=125 Participants Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.
Number of Subjects Reporting Specific Adverse Events (AEs) Rash (es)	13 Participants	10 Participants	2 Participants	6 Participants
Number of Subjects Reporting Specific Adverse Events (AEs) NOCI (s)	6 Participants	3 Participants	1 Participants	1 Participants
Number of Subjects Reporting Specific Adverse Events (AEs) ER visit (s)	28 Participants	29 Participants	3 Participants	7 Participants

SECONDARY outcome

Timeframe: During the 43-day (Days 0-42) post Dose 1 vaccination period

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

Unsolicited symptom covers any symptom reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.

Outcome measures

Outcome measures
Measure	Nimenrix + Priorix-Tetra Group n=375 Participants Subjects received 1 dose of Nimenrix™ vaccine and 1 dose of Priorix-Tetra™ vaccine on Day 0 and a second dose of Priorix-Tetra™ vaccine on Day 84.	Nimenrix Group n=374 Participants Subjects received 1 dose of Nimenrix™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.	Meningitec Group n=126 Participants Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.	Meningitec Group n=125 Participants Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.
Number of Subjects Reporting Unsolicited Symptoms	243 Participants	225 Participants	86 Participants	68 Participants

SECONDARY outcome

Timeframe: During the 43-day (Days 0-42) follow-up period after each vaccination

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

Unsolicited symptom covers any symptom reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.

Outcome measures

Outcome measures
Measure	Nimenrix + Priorix-Tetra Group n=375 Participants Subjects received 1 dose of Nimenrix™ vaccine and 1 dose of Priorix-Tetra™ vaccine on Day 0 and a second dose of Priorix-Tetra™ vaccine on Day 84.	Nimenrix Group n=374 Participants Subjects received 1 dose of Nimenrix™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.	Meningitec Group n=126 Participants Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.	Meningitec Group n=125 Participants Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.
Number of Subjects Reporting Unsolicited Symptoms	252 Participants	233 Participants	90 Participants	75 Participants

SECONDARY outcome

Timeframe: From Day 0 up to Month 6 after vaccination

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

SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization, result in disability/ incapacity or are a congenital anomaly/ birth defect in the offspring of a study subject.

Outcome measures

Outcome measures
Measure	Nimenrix + Priorix-Tetra Group n=375 Participants Subjects received 1 dose of Nimenrix™ vaccine and 1 dose of Priorix-Tetra™ vaccine on Day 0 and a second dose of Priorix-Tetra™ vaccine on Day 84.	Nimenrix Group n=374 Participants Subjects received 1 dose of Nimenrix™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.	Meningitec Group n=126 Participants Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.	Meningitec Group n=125 Participants Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.
Number of Subjects Reporting Serious Adverse Events (SAEs)	13 Participants	10 Participants	3 Participants	2 Participants

Adverse Events

Nimenrix + Priorix-Tetra Group

Serious events: 13 serious events

Other events: 340 other events

Deaths: 0 deaths

Meningitec Group

Serious events: 2 serious events

Other events: 103 other events

Deaths: 0 deaths

Nimenrix Group

Serious events: 10 serious events

Other events: 313 other events

Deaths: 0 deaths

Priorix-Tetra Group

Serious events: 3 serious events

Other events: 108 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Nimenrix + Priorix-Tetra Group n=375 participants at risk Subjects received 1 dose of Nimenrix™ vaccine and 1 dose of Priorix-Tetra™ vaccine on Day 0 and a second dose of Priorix-Tetra™ vaccine on Day 84.	Meningitec Group n=125 participants at risk Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.	Nimenrix Group n=374 participants at risk Subjects received 1 dose of Nimenrix™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.	Priorix-Tetra Group n=126 participants at risk Subjects received 1 dose of Priorix-Tetra™ vaccine on Day 0, one dose of Meningitec™ vaccine on Day 42 and a second dose of Priorix-Tetra™ vaccine on Day 84.
Nervous system disorders Somnolence	34.1% 128/375 • SAEs: Day 0 up to Month 6. Solicited local and general symptoms: 4-day after vaccination (Day 0-Day 3). Unsolicited symptoms: 43-day after vaccination (Days 0-42). The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	32.0% 40/125 • SAEs: Day 0 up to Month 6. Solicited local and general symptoms: 4-day after vaccination (Day 0-Day 3). Unsolicited symptoms: 43-day after vaccination (Days 0-42). The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	27.8% 104/374 • SAEs: Day 0 up to Month 6. Solicited local and general symptoms: 4-day after vaccination (Day 0-Day 3). Unsolicited symptoms: 43-day after vaccination (Days 0-42). The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	23.8% 30/126 • SAEs: Day 0 up to Month 6. Solicited local and general symptoms: 4-day after vaccination (Day 0-Day 3). Unsolicited symptoms: 43-day after vaccination (Days 0-42). The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
Psychiatric disorders Irritability	56.0% 210/375 • SAEs: Day 0 up to Month 6. Solicited local and general symptoms: 4-day after vaccination (Day 0-Day 3). Unsolicited symptoms: 43-day after vaccination (Days 0-42). The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	44.8% 56/125 • SAEs: Day 0 up to Month 6. Solicited local and general symptoms: 4-day after vaccination (Day 0-Day 3). Unsolicited symptoms: 43-day after vaccination (Days 0-42). The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	43.0% 161/374 • SAEs: Day 0 up to Month 6. Solicited local and general symptoms: 4-day after vaccination (Day 0-Day 3). Unsolicited symptoms: 43-day after vaccination (Days 0-42). The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	46.0% 58/126 • SAEs: Day 0 up to Month 6. Solicited local and general symptoms: 4-day after vaccination (Day 0-Day 3). Unsolicited symptoms: 43-day after vaccination (Days 0-42). The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
Gastrointestinal disorders Diarrhoea	14.1% 53/375 • SAEs: Day 0 up to Month 6. Solicited local and general symptoms: 4-day after vaccination (Day 0-Day 3). Unsolicited symptoms: 43-day after vaccination (Days 0-42). The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	12.8% 16/125 • SAEs: Day 0 up to Month 6. Solicited local and general symptoms: 4-day after vaccination (Day 0-Day 3). Unsolicited symptoms: 43-day after vaccination (Days 0-42). The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	10.7% 40/374 • SAEs: Day 0 up to Month 6. Solicited local and general symptoms: 4-day after vaccination (Day 0-Day 3). Unsolicited symptoms: 43-day after vaccination (Days 0-42). The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	11.1% 14/126 • SAEs: Day 0 up to Month 6. Solicited local and general symptoms: 4-day after vaccination (Day 0-Day 3). Unsolicited symptoms: 43-day after vaccination (Days 0-42). The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
Gastrointestinal disorders Teething	10.4% 39/375 • SAEs: Day 0 up to Month 6. Solicited local and general symptoms: 4-day after vaccination (Day 0-Day 3). Unsolicited symptoms: 43-day after vaccination (Days 0-42). The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	10.4% 13/125 • SAEs: Day 0 up to Month 6. Solicited local and general symptoms: 4-day after vaccination (Day 0-Day 3). Unsolicited symptoms: 43-day after vaccination (Days 0-42). The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	10.2% 38/374 • SAEs: Day 0 up to Month 6. Solicited local and general symptoms: 4-day after vaccination (Day 0-Day 3). Unsolicited symptoms: 43-day after vaccination (Days 0-42). The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	11.1% 14/126 • SAEs: Day 0 up to Month 6. Solicited local and general symptoms: 4-day after vaccination (Day 0-Day 3). Unsolicited symptoms: 43-day after vaccination (Days 0-42). The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
Infections and infestations Rhinitis	14.4% 54/375 • SAEs: Day 0 up to Month 6. Solicited local and general symptoms: 4-day after vaccination (Day 0-Day 3). Unsolicited symptoms: 43-day after vaccination (Days 0-42). The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	18.4% 23/125 • SAEs: Day 0 up to Month 6. Solicited local and general symptoms: 4-day after vaccination (Day 0-Day 3). Unsolicited symptoms: 43-day after vaccination (Days 0-42). The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	17.6% 66/374 • SAEs: Day 0 up to Month 6. Solicited local and general symptoms: 4-day after vaccination (Day 0-Day 3). Unsolicited symptoms: 43-day after vaccination (Days 0-42). The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	16.7% 21/126 • SAEs: Day 0 up to Month 6. Solicited local and general symptoms: 4-day after vaccination (Day 0-Day 3). Unsolicited symptoms: 43-day after vaccination (Days 0-42). 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	10.1% 38/375 • SAEs: Day 0 up to Month 6. Solicited local and general symptoms: 4-day after vaccination (Day 0-Day 3). Unsolicited symptoms: 43-day after vaccination (Days 0-42). The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	8.8% 11/125 • SAEs: Day 0 up to Month 6. Solicited local and general symptoms: 4-day after vaccination (Day 0-Day 3). Unsolicited symptoms: 43-day after vaccination (Days 0-42). The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	9.6% 36/374 • SAEs: Day 0 up to Month 6. Solicited local and general symptoms: 4-day after vaccination (Day 0-Day 3). Unsolicited symptoms: 43-day after vaccination (Days 0-42). The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	12.7% 16/126 • SAEs: Day 0 up to Month 6. Solicited local and general symptoms: 4-day after vaccination (Day 0-Day 3). Unsolicited symptoms: 43-day after vaccination (Days 0-42). The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
Infections and infestations Otitis media	6.9% 26/375 • SAEs: Day 0 up to Month 6. Solicited local and general symptoms: 4-day after vaccination (Day 0-Day 3). Unsolicited symptoms: 43-day after vaccination (Days 0-42). The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	6.4% 8/125 • SAEs: Day 0 up to Month 6. Solicited local and general symptoms: 4-day after vaccination (Day 0-Day 3). Unsolicited symptoms: 43-day after vaccination (Days 0-42). The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	7.8% 29/374 • SAEs: Day 0 up to Month 6. Solicited local and general symptoms: 4-day after vaccination (Day 0-Day 3). Unsolicited symptoms: 43-day after vaccination (Days 0-42). The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	7.1% 9/126 • SAEs: Day 0 up to Month 6. Solicited local and general symptoms: 4-day after vaccination (Day 0-Day 3). Unsolicited symptoms: 43-day after vaccination (Days 0-42). The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
Respiratory, thoracic and mediastinal disorders Cough	5.6% 21/375 • SAEs: Day 0 up to Month 6. Solicited local and general symptoms: 4-day after vaccination (Day 0-Day 3). Unsolicited symptoms: 43-day after vaccination (Days 0-42). The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	4.8% 6/125 • SAEs: Day 0 up to Month 6. Solicited local and general symptoms: 4-day after vaccination (Day 0-Day 3). Unsolicited symptoms: 43-day after vaccination (Days 0-42). The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	6.1% 23/374 • SAEs: Day 0 up to Month 6. Solicited local and general symptoms: 4-day after vaccination (Day 0-Day 3). Unsolicited symptoms: 43-day after vaccination (Days 0-42). The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	5.6% 7/126 • SAEs: Day 0 up to Month 6. Solicited local and general symptoms: 4-day after vaccination (Day 0-Day 3). Unsolicited symptoms: 43-day after vaccination (Days 0-42). The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
Metabolism and nutrition disorders Decrease appetite	32.3% 121/375 • SAEs: Day 0 up to Month 6. Solicited local and general symptoms: 4-day after vaccination (Day 0-Day 3). Unsolicited symptoms: 43-day after vaccination (Days 0-42). The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	27.2% 34/125 • SAEs: Day 0 up to Month 6. Solicited local and general symptoms: 4-day after vaccination (Day 0-Day 3). Unsolicited symptoms: 43-day after vaccination (Days 0-42). The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	22.7% 85/374 • SAEs: Day 0 up to Month 6. Solicited local and general symptoms: 4-day after vaccination (Day 0-Day 3). Unsolicited symptoms: 43-day after vaccination (Days 0-42). The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	28.6% 36/126 • SAEs: Day 0 up to Month 6. Solicited local and general symptoms: 4-day after vaccination (Day 0-Day 3). Unsolicited symptoms: 43-day after vaccination (Days 0-42). The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
Skin and subcutaneous tissue disorders Erythema	45.6% 171/375 • SAEs: Day 0 up to Month 6. Solicited local and general symptoms: 4-day after vaccination (Day 0-Day 3). Unsolicited symptoms: 43-day after vaccination (Days 0-42). The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	31.2% 39/125 • SAEs: Day 0 up to Month 6. Solicited local and general symptoms: 4-day after vaccination (Day 0-Day 3). Unsolicited symptoms: 43-day after vaccination (Days 0-42). The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	36.4% 136/374 • SAEs: Day 0 up to Month 6. Solicited local and general symptoms: 4-day after vaccination (Day 0-Day 3). Unsolicited symptoms: 43-day after vaccination (Days 0-42). The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	38.1% 48/126 • SAEs: Day 0 up to Month 6. Solicited local and general symptoms: 4-day after vaccination (Day 0-Day 3). Unsolicited symptoms: 43-day after vaccination (Days 0-42). The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
General disorders Pain	29.9% 112/375 • SAEs: Day 0 up to Month 6. Solicited local and general symptoms: 4-day after vaccination (Day 0-Day 3). Unsolicited symptoms: 43-day after vaccination (Days 0-42). The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	24.8% 31/125 • SAEs: Day 0 up to Month 6. Solicited local and general symptoms: 4-day after vaccination (Day 0-Day 3). Unsolicited symptoms: 43-day after vaccination (Days 0-42). The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	29.7% 111/374 • SAEs: Day 0 up to Month 6. Solicited local and general symptoms: 4-day after vaccination (Day 0-Day 3). Unsolicited symptoms: 43-day after vaccination (Days 0-42). The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	17.5% 22/126 • SAEs: Day 0 up to Month 6. Solicited local and general symptoms: 4-day after vaccination (Day 0-Day 3). Unsolicited symptoms: 43-day after vaccination (Days 0-42). The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
General disorders Swelling	17.6% 66/375 • SAEs: Day 0 up to Month 6. Solicited local and general symptoms: 4-day after vaccination (Day 0-Day 3). Unsolicited symptoms: 43-day after vaccination (Days 0-42). The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	8.0% 10/125 • SAEs: Day 0 up to Month 6. Solicited local and general symptoms: 4-day after vaccination (Day 0-Day 3). Unsolicited symptoms: 43-day after vaccination (Days 0-42). The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	18.7% 70/374 • SAEs: Day 0 up to Month 6. Solicited local and general symptoms: 4-day after vaccination (Day 0-Day 3). Unsolicited symptoms: 43-day after vaccination (Days 0-42). The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	5.6% 7/126 • SAEs: Day 0 up to Month 6. Solicited local and general symptoms: 4-day after vaccination (Day 0-Day 3). Unsolicited symptoms: 43-day after vaccination (Days 0-42). The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
Gastrointestinal disorders Vomiting	5.3% 20/375 • SAEs: Day 0 up to Month 6. Solicited local and general symptoms: 4-day after vaccination (Day 0-Day 3). Unsolicited symptoms: 43-day after vaccination (Days 0-42). The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	1.6% 2/125 • SAEs: Day 0 up to Month 6. Solicited local and general symptoms: 4-day after vaccination (Day 0-Day 3). Unsolicited symptoms: 43-day after vaccination (Days 0-42). The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	3.7% 14/374 • SAEs: Day 0 up to Month 6. Solicited local and general symptoms: 4-day after vaccination (Day 0-Day 3). Unsolicited symptoms: 43-day after vaccination (Days 0-42). The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	2.4% 3/126 • SAEs: Day 0 up to Month 6. Solicited local and general symptoms: 4-day after vaccination (Day 0-Day 3). Unsolicited symptoms: 43-day after vaccination (Days 0-42). The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

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

Restriction type: OTHER