Trial Outcomes & Findings for Comparison of GSKBiologicals' Hib-MenCY-TT Vaccine vs Licensed Hib Conjugate or Meningococcal Vaccine (NCT NCT00129129)

Results Overview

The anti-PRP antibody cut-off value used for this outcome was 1.0 microgram per milliliter (µg/mL). This Outcome Measure only concerns the MenHibrix and ActHIB groups .

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

756 participants

Primary outcome timeframe

One month after the 3-dose primary vaccination course (at Month 5)

Results posted on

2018-08-24

Participant Flow

In a Primary Phase (study 101858), 3 groups, MenHibrix, ActiHIB and Menomune, were followed from Day 0 to either Month (M) 7 or 10, depending on vaccination. Then, in a Fourth-Dose Phase (study 102015), 3 groups (MenHibrix, ActiHIB/ActHIB and ActiHIB/MenHibrix) were followed from M10-13 to study end (M16-19). Treatment allocation: primary phase:

MenHibrix Group was followed during the entire study period, from Day 0 to M16-19). ActiHIB Group was followed as ActiHIB Group up to M10-13, when it was split into the ActHIB/ActHIB and ActHIB/MenHibrix groups, these latter being followed from M10-13 to study end. Menomune Group was followed up to M7.

Participant milestones

Participant milestones
Measure	MenHibrix Group Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	ActHIB Group During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.	Menomune Group Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.	ActHIB/MenHibrix Group Subjects primed with ActHIB vaccine who received a fourth dose of Menhibrix vaccine and a concomitant fourth dose of Prevnar vaccine during the fourth dose vaccination phase. In the fourth dose phase, Menhibrix and Prevnar vaccines were administered intramuscularly in the right and left upper thigh, respectively.	ActHIB/ActHIB Group Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
Primary Phase STARTED	287	319	150	0	0
Primary Phase COMPLETED	262	294	150	0	0
Primary Phase NOT COMPLETED	25	25	0	0	0
Fourth Dose Phase STARTED	236	0	0	132	130
Fourth Dose Phase COMPLETED	232	0	0	128	124
Fourth Dose Phase NOT COMPLETED	4	0	0	4	6

Reasons for withdrawal

Reasons for withdrawal
Measure	MenHibrix Group Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	ActHIB Group During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.	ActHIB/MenHibrix Group Subjects primed with ActHIB vaccine who received a fourth dose of Menhibrix vaccine and a concomitant fourth dose of Prevnar vaccine during the fourth dose vaccination phase. In the fourth dose phase, Menhibrix and Prevnar vaccines were administered intramuscularly in the right and left upper thigh, respectively.	ActHIB/ActHIB Group Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
Primary Phase Adverse Event	2	1	0	0
Primary Phase Withdrawal by Subject	12	10	0	0
Primary Phase Migration from study area	1	3	0	0
Primary Phase Lost to Follow-up	8	6	0	0
Primary Phase Other	2	5	0	0
Fourth Dose Phase Lost to Follow-up	4	0	2	2
Fourth Dose Phase Withdrawal by Subject	0	0	0	1
Fourth Dose Phase Migration from study area	0	0	0	2
Fourth Dose Phase Other	0	0	1	1
Fourth Dose Phase Protocol Violation	0	0	1	0

Baseline Characteristics

Comparison of GSKBiologicals' Hib-MenCY-TT Vaccine vs Licensed Hib Conjugate or Meningococcal Vaccine

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MenHibrix Group n=287 Participants Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh..	ActHIB Group n=319 Participants During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.	Menomune Group n=150 Participants Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.	Total n=756 Participants Total of all reporting groups
Age, Continuous	64.2 Days STANDARD_DEVIATION 8.05 • n=5 Participants	64.0 Days STANDARD_DEVIATION 7.52 • n=7 Participants	1554.1 Days STANDARD_DEVIATION 338.4 • n=5 Participants	560.8 Days STANDARD_DEVIATION 118.0 • n=4 Participants
Sex: Female, Male Female	141 Participants n=5 Participants	166 Participants n=7 Participants	70 Participants n=5 Participants	377 Participants n=4 Participants
Sex: Female, Male Male	146 Participants n=5 Participants	153 Participants n=7 Participants	80 Participants n=5 Participants	379 Participants n=4 Participants

PRIMARY outcome

Timeframe: One month after the 3-dose primary vaccination course (at Month 5)

Population: The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures, with no elimination criteria) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase

The anti-PRP antibody cut-off value used for this outcome was 1.0 microgram per milliliter (µg/mL). This Outcome Measure only concerns the MenHibrix and ActHIB groups .

Outcome measures

Outcome measures
Measure	MenHibrix Group n=199 Participants Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	ActHIB Group n=211 Participants During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.	Menomune Group Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
Number of Subjects With Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentration Equal to or Above (≥) Cut-off Value.	186 Participants	181 Participants	—

PRIMARY outcome

Timeframe: One month after the 3-dose primary vaccination course (at Month 5)

Population: The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.

Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL). Vaccine pneumococcal serotypes included serotypes 4, 6B, 9V, 14, 18C, 19F, 23F. This Outcome Measure only concerns the MenHibrix and ActHIB groups .

Outcome measures

Outcome measures
Measure	MenHibrix Group n=174 Participants Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	ActHIB Group n=180 Participants During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.	Menomune Group Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
Concentration of Antibodies Against Streptococcus Pneumoniae Serotypes Anti-4 (N=173;177)	1.72 µg/mL Interval 1.53 to 1.94	1.9 µg/mL Interval 1.7 to 2.14	—
Concentration of Antibodies Against Streptococcus Pneumoniae Serotypes Anti-6B (N=166;162)	1.31 µg/mL Interval 1.08 to 1.58	1.59 µg/mL Interval 1.35 to 1.87	—
Concentration of Antibodies Against Streptococcus Pneumoniae Serotypes Anti-9V (N=174;180)	2.17 µg/mL Interval 1.93 to 2.44	2.32 µg/mL Interval 2.09 to 2.59	—
Concentration of Antibodies Against Streptococcus Pneumoniae Serotypes Anti-14 (N=167;172)	4.79 µg/mL Interval 4.23 to 5.43	4.64 µg/mL Interval 4.06 to 5.31	—
Concentration of Antibodies Against Streptococcus Pneumoniae Serotypes Anti-18C (N=172;169)	2.5 µg/mL Interval 2.22 to 2.83	2.56 µg/mL Interval 2.27 to 2.88	—
Concentration of Antibodies Against Streptococcus Pneumoniae Serotypes Anti-19F (N=167;169)	1.62 µg/mL Interval 1.45 to 1.82	1.74 µg/mL Interval 1.57 to 1.94	—
Concentration of Antibodies Against Streptococcus Pneumoniae Serotypes Anti-23F (N=174;177)	2.25 µg/mL Interval 1.92 to 2.63	2.46 µg/mL Interval 2.12 to 2.86	—

PRIMARY outcome

Timeframe: One month after the 3-dose primary vaccination course (at Month 5)

Population: The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.

Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed in Enzyme-Linked Immunosorbent Assay (ELISA) units per milliliter (EL.U/mL). This Outcome Measure only concerns the MenHibrix and ActHIB groups .

Outcome measures

Outcome measures
Measure	MenHibrix Group n=200 Participants Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	ActHIB Group n=217 Participants During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.	Menomune Group Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations Anti-PT (N=198;215)	57.1 EL.U/mL Interval 51.7 to 63.0	66.4 EL.U/mL Interval 61.0 to 72.3	—
Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations Anti-FHA (N=200;213)	208.9 EL.U/mL Interval 189.7 to 230.1	252.2 EL.U/mL Interval 228.8 to 277.9	—
Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations Anti-PRN (N=200;217)	86.3 EL.U/mL Interval 75.7 to 98.4	93.8 EL.U/mL Interval 83.1 to 105.8	—

PRIMARY outcome

Timeframe: During the 4-day follow-up period after each primary vaccine dose

Population: The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase.

"Symptoms" were defined as solicited local and general symptoms and unsolicited adverse events (AEs). A "Grade 3" symptom was defined as any symptom that prevented normal everyday activity. "Any" was defined as an occurrence of any specified symptom regardless of intensity grade. This Outcome Measure only concerns the MenHibrix and ActHIB groups .

Outcome measures

Outcome measures
Measure	MenHibrix Group n=287 Participants Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	ActHIB Group n=319 Participants During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.	Menomune Group Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
Number of Subjects Reporting Any Grade 3 Symptoms	33 Participants	79 Participants	—

PRIMARY outcome

Timeframe: One month after the fourth dose (at Month 11-14)

Population: The Fourth Dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies 1 month (31 to 48 days) after the administration of the fourth dose.

The anti-PRP antibody cut-off value used for this outcome was 1.0 microgram per milliliter (µg/mL). This Outcome Measure only concerns the MenHibrix and ActHIB/ActHIB groups .

Outcome measures

Outcome measures
Measure	MenHibrix Group n=176 Participants Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	ActHIB Group n=93 Participants During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.	Menomune Group Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
Number of Subjects With Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentration Equal to or Above (≥) Cut-off Value	174 Participants	92 Participants	—

SECONDARY outcome

Timeframe: Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)

Population: The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.

rSBA-MenC antibody cut-off values for this outcome were 1:8 and 1:128.

Outcome measures

Outcome measures
Measure	MenHibrix Group n=177 Participants Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	ActHIB Group n=194 Participants During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.	Menomune Group n=136 Participants Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
Number of Subjects With Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC) Antibody Titers ≥ the Cut-off Values ≥1:8 [Prior to vaccination] (N=153;183;133)	10 Participants	13 Participants	27 Participants
Number of Subjects With Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC) Antibody Titers ≥ the Cut-off Values ≥1:128 [Prior to vaccination] (N=153;183;133)	3 Participants	5 Participants	20 Participants
Number of Subjects With Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC) Antibody Titers ≥ the Cut-off Values ≥1:8 [1 month post-vaccination] (N=177;194;136)	173 Participants	7 Participants	126 Participants
Number of Subjects With Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC) Antibody Titers ≥ the Cut-off Values ≥1:128 [1 month post-vaccination] (N=177;194;136)	171 Participants	2 Participants	105 Participants

SECONDARY outcome

Timeframe: Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)

Population: The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.

Titers are presented as geometric mean titers (GMTs).

Outcome measures

Outcome measures
Measure	MenHibrix Group n=177 Participants Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	ActHIB Group n=194 Participants During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.	Menomune Group n=136 Participants Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC) Antibody Titers [Prior to vaccination] (N=153;183;133)	4.8 Titers Interval 4.2 to 5.5	5.1 Titers Interval 4.4 to 5.8	9 Titers Interval 6.8 to 12.1
Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC) Antibody Titers [1 month post-vaccination] (N=177;194;136)	1096.5 Titers Interval 896.5 to 1341.1	4.4 Titers Interval 4.1 to 4.8	284.2 Titers Interval 210.1 to 384.3

SECONDARY outcome

Timeframe: Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)

Population: The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.

rSBA-MenY antibody cut-off values for this outcome measure were 1:8 and 1:128.

Outcome measures

Outcome measures
Measure	MenHibrix Group n=174 Participants Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	ActHIB Group n=186 Participants During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.	Menomune Group n=140 Participants Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
Number of Subjects With Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenY) Antibody Titers ≥ the Cut-off Values ≥1:8 [Prior to vaccination] (N=156;186;140)	29 Participants	28 Participants	92 Participants
Number of Subjects With Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenY) Antibody Titers ≥ the Cut-off Values ≥1:128 [Prior to vaccination] (N=156;186;140)	4 Participants	3 Participants	61 Participants
Number of Subjects With Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenY) Antibody Titers ≥ the Cut-off Values ≥1:8 [1 month post-vaccination] (N=174;186;139)	171 Participants	35 Participants	134 Participants
Number of Subjects With Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenY) Antibody Titers ≥ the Cut-off Values ≥1:128 [1 month post-vaccination] (N=174;186;139)	154 Participants	6 Participants	131 Participants

SECONDARY outcome

Timeframe: Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)

Population: The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.

Titers are presented as geometric mean titers (GMTs).

Outcome measures

Outcome measures
Measure	MenHibrix Group n=174 Participants Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	ActHIB Group n=186 Participants During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.	Menomune Group n=140 Participants Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenY) Antibody Titers [prior to vaccination] (N=156;186;140)	6.1 Titers Interval 5.2 to 7.2	5.7 Titers Interval 5.0 to 6.6	54.9 Titers Interval 38.9 to 77.5
Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenY) Antibody Titers [1 month post-vaccination] (N=174;186;139)	495.3 Titers Interval 409.2 to 599.6	6.8 Titers Interval 5.8 to 8.1	685.1 Titers Interval 540.3 to 868.7

SECONDARY outcome

Timeframe: One month after the primary vaccination course (at Month 5 for the MenHibrix and ActHIB groups)/one month after vaccination (at Month 1 for the Menomune Group)

Population: The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.

A composite outcome variable was formulated as follows for this immunogenicity analysis outcome: hSBA-Men titers ≥ 1:4 for subjects with post-vaccination rSBA-Men antibody titers ≥ 1:8 and lower than (\<) 1:128.

Outcome measures

Outcome measures
Measure	MenHibrix Group n=177 Participants Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	ActHIB Group n=22 Participants During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.	Menomune Group n=136 Participants Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
Number of Subjects With Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Human Complement (hSBA-MenC) Antibody Titers ≥ 1:4	2 Participants	1 Participants	3 Participants

SECONDARY outcome

Timeframe: One month after the primary vaccination course (at Month 5 for the MenHibrix and ActHIB groups)/one month after vaccination (at Month 1 for the Menomune Group)

Population: The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.

A composite outcome variable was formulated as follows for this immunogenicity analysis outcome: hSBA-Men titers ≥ 1:4 for subjects with post-vaccination rSBA-Men antibody titers ≥ 1:8 and lower than (\<) 1:128.

Outcome measures

Outcome measures
Measure	MenHibrix Group n=174 Participants Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	ActHIB Group n=22 Participants During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.	Menomune Group n=139 Participants Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
Number of Subjects With Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Human Complement (hSBA-MenC) Antibody Titers ≥ 1:4	13 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)

Population: The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.

Anti-PSC antibody cut-off values for this outcome were 0.3 µg/mL and 2.0 µg/mL.

Outcome measures

Outcome measures
Measure	MenHibrix Group n=197 Participants Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	ActHIB Group n=207 Participants During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.	Menomune Group n=138 Participants Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentrations Above ≥ the Cut-off Values ≥0.3 µg/mL [prior to vaccination] (N=161;185;138)	24 Participants	16 Participants	10 Participants
Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentrations Above ≥ the Cut-off Values ≥0.3 µg/mL [after vaccination] (N=197;207;136)	196 Participants	8 Participants	134 Participants
Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentrations Above ≥ the Cut-off Values ≥2.0 µg/mL [prior to vaccination] (N=161;185;138)	1 Participants	6 Participants	3 Participants
Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentrations Above ≥ the Cut-off Values ≥2.0 µg/mL [after vaccination] (N=197;207;136)	172 Participants	0 Participants	122 Participants

SECONDARY outcome

Timeframe: Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)

Population: The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.

Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL).

Outcome measures

Outcome measures
Measure	MenHibrix Group n=197 Participants Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	ActHIB Group n=207 Participants During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.	Menomune Group n=138 Participants Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
Anti-polysaccharide C (Anti-PSC) Antibody Concentrations [prior to vaccination] (N=161;185;138)	0.19 µg/mL Interval 0.17 to 0.21	0.18 µg/mL Interval 0.16 to 0.2	0.17 µg/mL Interval 0.16 to 0.19
Anti-polysaccharide C (Anti-PSC) Antibody Concentrations [1 month post-vaccination] (N=197;207;136)	4.41 µg/mL Interval 3.96 to 4.92	0.16 µg/mL Interval 0.15 to 0.17	7.37 µg/mL Interval 6.1 to 8.91

SECONDARY outcome

Timeframe: Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)

Population: The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.

Anti-PSY antibody cut-off values for this outcome were 0.3 µg/mL and 2.0 µg/mL.

Outcome measures

Outcome measures
Measure	MenHibrix Group n=189 Participants Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	ActHIB Group n=187 Participants During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.	Menomune Group n=137 Participants Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
Number of Subjects With Anti-polysaccharide Y (Anti-PSY) Antibody Concentrations Equal to or Above ≥ the Cut-off Values ≥0.3 µg/mL [prior to vaccination] (N=157;187;137)	23 Participants	28 Participants	6 Participants
Number of Subjects With Anti-polysaccharide Y (Anti-PSY) Antibody Concentrations Equal to or Above ≥ the Cut-off Values ≥0.3 µg/mL [after vaccination] (N=189;181;129)	188 Participants	5 Participants	125 Participants
Number of Subjects With Anti-polysaccharide Y (Anti-PSY) Antibody Concentrations Equal to or Above ≥ the Cut-off Values ≥2.0 µg/mL [prior to vaccination] (N=157;187;137)	5 Participants	6 Participants	2 Participants
Number of Subjects With Anti-polysaccharide Y (Anti-PSY) Antibody Concentrations Equal to or Above ≥ the Cut-off Values ≥2.0 µg/mL [after vaccination] (N=189;181;129)	186 Participants	0 Participants	108 Participants

SECONDARY outcome

Timeframe: Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)

Population: The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.

Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL)

Outcome measures

Outcome measures
Measure	MenHibrix Group n=189 Participants Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	ActHIB Group n=187 Participants During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.	Menomune Group n=137 Participants Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
Anti-polysaccharide Y (Anti-PSY) Antibody Concentrations [prior to vaccination] (N=157;187;137)	0.20 µg/mL Interval 0.18 to 0.22	0.20 µg/mL Interval 0.18 to 0.22	0.17 µg/mL Interval 0.15 to 0.18
Anti-polysaccharide Y (Anti-PSY) Antibody Concentrations [1 month post-vaccination] (N=189;181;129)	19.82 µg/mL Interval 17.4 to 22.57	0.15 µg/mL Interval 0.15 to 0.16	7.21 µg/mL Interval 5.57 to 9.34

SECONDARY outcome

Timeframe: During the 31-day follow-up period after vaccination with Menomune vaccine at Day 0

Population: The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase.

A medically attended visit was defined as an hospitalization, an emergency room visit or a visit to or from medical personnel. This Outcome Measure only concerns subjects in the Menomune Group.

Outcome measures

Outcome measures
Measure	MenHibrix Group n=150 Participants Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	ActHIB Group During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.	Menomune Group Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
Number of Subjects Reporting Medically Attended Visits Emergency room visit	1 Participants	—	—
Number of Subjects Reporting Medically Attended Visits Physician's office visit	18 Participants	—	—

SECONDARY outcome

Timeframe: During the 31-day follow-up period after vaccination with Menomune vaccine at Day 0

Population: The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase.

An episode of rash was defined as an episode of hives, idiopathic thrombocytopenic purpura, petechiae. This Outcome Measure only concerns subjects in the Menomune Group.

Outcome measures

Outcome measures
Measure	MenHibrix Group n=150 Participants Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	ActHIB Group During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.	Menomune Group Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
Number of Subjects Reporting Rash	1 Participants	—	—

SECONDARY outcome

Timeframe: During the 31-day follow-up period after vaccination with Menomune vaccine at Day 0

Population: The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase.

SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject . This Outcome Measure only concerns subjects in the Menomune Group.

Outcome measures

Outcome measures
Measure	MenHibrix Group n=150 Participants Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	ActHIB Group During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.	Menomune Group Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
Number of Subjects Reporting Serious Adverse Events (SAEs)	0 Participants	—	—

SECONDARY outcome

Timeframe: Prior to and one month after the primary vaccination course (at Day 0 and Month 5)

Population: The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.

Anti-PRP antibody cut-off values for this outcome were 0.15 µg/mL and 1.0 µg/mL. This Outcome Measure only concerns the MenHibrix and ActHIB groups .

Outcome measures

Outcome measures
Measure	MenHibrix Group n=199 Participants Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	ActHIB Group n=211 Participants During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.	Menomune Group Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
Number of Subjects With Anti-PRP Antibody Concentrations ≥ the Cut-off Values ≥0.15 µg/mL [prior to vaccination] (N=112;132)	43 Participants	42 Participants	—
Number of Subjects With Anti-PRP Antibody Concentrations ≥ the Cut-off Values ≥0.15 µg/mL [after vaccination] (N=199;211)	196 Participants	202 Participants	—
Number of Subjects With Anti-PRP Antibody Concentrations ≥ the Cut-off Values ≥1.0 µg/mL [prior to vaccination] (N=112;132)	9 Participants	10 Participants	—
Number of Subjects With Anti-PRP Antibody Concentrations ≥ the Cut-off Values ≥1.0 µg/mL [after vaccination] (N=199;211)	186 Participants	181 Participants	—

SECONDARY outcome

Timeframe: Prior to and one month after the primary vaccination course (at Day 0 and Month 5)

Population: The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.

Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL). This Outcome Measure only concerns the MenHibrix and ActHIB groups .

Outcome measures

Outcome measures
Measure	MenHibrix Group n=199 Participants Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	ActHIB Group n=211 Participants During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.	Menomune Group Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
Anti-PRP Antibody Concentrations [prior to vaccination] (N=112;132)	0.155 µg/mL Interval 0.126 to 0.189	0.142 µg/mL Interval 0.117 to 0.171	—
Anti-PRP Antibody Concentrations [1 month post-vaccination] (N=199;211)	7.992 µg/mL Interval 6.756 to 9.455	4.392 µg/mL Interval 3.556 to 5.425	—

SECONDARY outcome

Timeframe: Prior to and one month after the primary vaccination course (at Day 0 and Month 5)

Population: The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.

The Streptococcus pneumoniae antibody cut-off value for this outcome was 0.05 µg/mL for the 7 serotypes in Prevnar vaccine. Prevnar vaccine pneumococcal serotypes included the serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F. This Outcome Measure only concerns the MenHibrix and ActHIB groups .

Outcome measures

Outcome measures
Measure	MenHibrix Group n=174 Participants Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	ActHIB Group n=180 Participants During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.	Menomune Group Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off Anti-4 [prior to vaccination] (N=87;100)	23 Participants	18 Participants	—
Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off Anti-4 [after vaccination] (N=173;177)	173 Participants	177 Participants	—
Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off Anti-6B [prior to vaccination] (N=84;96)	40 Participants	41 Participants	—
Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off Anti-6B [after vaccination] (N=166;162)	163 Participants	162 Participants	—
Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off Anti-9V [prior to vaccination] (N=88;100)	45 Participants	54 Participants	—
Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off Anti-9V [after vaccination] (N=174;180)	174 Participants	180 Participants	—
Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off Anti-14 [prior to vaccination] (N=75;90)	70 Participants	80 Participants	—
Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off Anti-14 [after vaccination] (N=167;172)	167 Participants	172 Participants	—
Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off Anti-18C [prior to vaccination] (N=85;97)	41 Participants	55 Participants	—
Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off Anti-18C [after vaccination] (N=172;169)	172 Participants	169 Participants	—
Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off Anti-19F [prior to vaccination] (N=88;99)	76 Participants	82 Participants	—
Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off Anti-19F [after vaccination] (N=167;169)	167 Participants	169 Participants	—
Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off Anti-23F [prior to vaccination] (N=86;103)	44 Participants	47 Participants	—
Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off Anti-23F [after vaccination] (N=174;177)	173 Participants	176 Participants	—

SECONDARY outcome

Timeframe: Prior to and one month after the primary vaccination course (at Day 0 and Month 5)

Population: The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.

The Streptococcus pneumoniae antibody cut-off value for this outcome was 0.2 µg/mL for the 7 serotypes in Prevnar vaccine. Prevnar vaccine pneumococcal serotypes included the serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F. This Outcome Measure only concerns the MenHibrix and ActHIB groups

Outcome measures

Outcome measures
Measure	MenHibrix Group n=174 Participants Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	ActHIB Group n=180 Participants During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.	Menomune Group Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off Anti-4 [prior to vaccination] (N=87;100)	9 Participants	3 Participants	—
Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off Anti-4 [after vaccination] (N=173;177)	173 Participants	177 Participants	—
Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off Anti-6B [prior to vaccination] (N=84;96)	12 Participants	15 Participants	—
Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off Anti-6B [after vaccination] (N=166;162)	155 Participants	155 Participants	—
Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off Anti-9V [prior to vaccination] (N=88;100)	19 Participants	19 Participants	—
Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off Anti-9V [after vaccination] (N=174;180)	173 Participants	180 Participants	—
Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off Anti-14 [prior to vaccination] (N=75;90)	46 Participants	62 Participants	—
Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off Anti-14 [after vaccination] (N=167;172)	166 Participants	171 Participants	—
Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off Anti-18C [prior to vaccination] (N=85;97)	19 Participants	24 Participants	—
Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off Anti-18C [after vaccination] (N=172;169)	172 Participants	167 Participants	—
Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off Anti-19F [prior to vaccination] (N=88;99)	47 Participants	52 Participants	—
Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off Anti-19F [after vaccination] (N=167;169)	166 Participants	169 Participants	—
Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off Anti-23F [prior to vaccination] (N=86;103)	13 Participants	15 Participants	—
Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off Anti-23F [after vaccination] (N=174;177)	171 Participants	174 Participants	—

SECONDARY outcome

Timeframe: Prior to and one month after the primary vaccination course (at Day 0 and Month 5)

Population: The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.

The Streptococcus pneumoniae antibody cut-off value for this outcome was 0.5 µg/mL for the 7 serotypes in Prevnar vaccine. Prevnar vaccine pneumococcal serotypes included the serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F. This Outcome Measure only concerns the MenHibrix and ActHIB groups .

Outcome measures

Outcome measures
Measure	MenHibrix Group n=174 Participants Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	ActHIB Group n=180 Participants During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.	Menomune Group Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off Anti-4 [prior to vaccination] (N=87;100)	1 Participants	0 Participants	—
Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off Anti-4 [after vaccination] (N=173;177)	162 Participants	168 Participants	—
Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off Anti-6B [prior to vaccination] (N=84;96)	10 Participants	8 Participants	—
Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off Anti-6B [after vaccination] (N=166;162)	130 Participants	139 Participants	—
Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off Anti-9V [prior to vaccination] (N=88;100)	5 Participants	9 Participants	—
Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off Anti-9V [after vaccination] (N=174;180)	169 Participants	175 Participants	—
Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off Anti-14 [prior to vaccination] (N=75;90)	32 Participants	33 Participants	—
Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off Anti-14 [after vaccination] (N=167;172)	164 Participants	167 Participants	—
Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off Anti-18C [prior to vaccination] (N=85;97)	5 Participants	8 Participants	—
Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off Anti-18C [after vaccination] (N=172;169)	168 Participants	166 Participants	—
Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off Anti-19F [prior to vaccination] (N=88;99)	27 Participants	20 Participants	—
Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off Anti-19F [after vaccination] (N=167;169)	156 Participants	160 Participants	—
Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off Anti-23F [prior to vaccination] (N=86;103)	7 Participants	8 Participants	—
Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off Anti-23F [after vaccination] (N=174;177)	155 Participants	167 Participants	—

SECONDARY outcome

Timeframe: Prior to and one month after the primary vaccination course (at Day 0 and Month 5)

Population: The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.

The anti-diphtheria and anti-tetanus antibody cut-off value for this outcome was ≥ 0.1 IU/mL. This Outcome Measure only concerns the MenHibrix and ActHIB groups.

Outcome measures

Outcome measures
Measure	MenHibrix Group n=201 Participants Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	ActHIB Group n=220 Participants During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.	Menomune Group Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
Number of Subjects With Anti-diphtheria and Anti-tetanus Antibody Concentration ≥ 0.1 International Units Per Milliliter (IU/mL) Anti-diphtheria [prior to vaccination] (N=118;140)	81 Participants	89 Participants	—
Number of Subjects With Anti-diphtheria and Anti-tetanus Antibody Concentration ≥ 0.1 International Units Per Milliliter (IU/mL) Anti-diphtheria [after vaccination] (N=201;220)	201 Participants	219 Participants	—
Number of Subjects With Anti-diphtheria and Anti-tetanus Antibody Concentration ≥ 0.1 International Units Per Milliliter (IU/mL) Anti-tetanus [prior to vaccination] (N=118;139)	109 Participants	130 Participants	—
Number of Subjects With Anti-diphtheria and Anti-tetanus Antibody Concentration ≥ 0.1 International Units Per Milliliter (IU/mL) Anti-tetanus [after vaccination] (N=199;216)	198 Participants	216 Participants	—

SECONDARY outcome

Timeframe: Prior to and one month after the primary vaccination course (at Day 0 and Month 5)

Population: The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.

Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as international units per milliliter (IU/mL). This Outcome Measure only concerns the MenHibrix and ActHIB groups .

Outcome measures

Outcome measures
Measure	MenHibrix Group n=201 Participants Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	ActHIB Group n=220 Participants During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.	Menomune Group Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
Anti-diphtheria and Anti-tetanus Antibody Concentrations Anti-diphtheria [prior to vaccination] (N=118;140)	0.173 IU/mL Interval 0.142 to 0.21	0.155 IU/mL Interval 0.13 to 0.185	—
Anti-diphtheria and Anti-tetanus Antibody Concentrations Anti-diphtheria [after vaccination] (N=201;220)	2.060 IU/mL Interval 1.845 to 2.301	2.277 IU/mL Interval 2.043 to 2.537	—
Anti-diphtheria and Anti-tetanus Antibody Concentrations Anti-tetanus [prior to vaccination] (N=118;139)	0.565 IU/mL Interval 0.465 to 0.685	0.497 IU/mL Interval 0.422 to 0.585	—
Anti-diphtheria and Anti-tetanus Antibody Concentrations Anti-tetanus [after vaccination] (N=199;216)	3.618 IU/mL Interval 3.272 to 4.001	1.986 IU/mL Interval 1.773 to 2.225	—

SECONDARY outcome

Timeframe: Prior to and one month after the primary vaccination course (at Day 0 and Month 5)

Population: The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.

This Outcome Measure only concerns the MenHibrix and ActHIB groups .

Outcome measures

Outcome measures
Measure	MenHibrix Group n=171 Participants Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	ActHIB Group n=169 Participants During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.	Menomune Group Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
Number of Subjects With Anti-hepatitis-B Surface Antigen (Anti-HBs) Antibody Concentration ≥ 10.0 Milli-international Units Per Milliliter (mIU/mL) [prior to vaccination] (N=91;108)	28 Participants	27 Participants	—
Number of Subjects With Anti-hepatitis-B Surface Antigen (Anti-HBs) Antibody Concentration ≥ 10.0 Milli-international Units Per Milliliter (mIU/mL) [after vaccination] (N=171;169)	167 Participants	166 Participants	—

SECONDARY outcome

Timeframe: Prior to and one month after the primary vaccination course (at Day 0 and Month 5)

Population: The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.

Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as milli-international units per milliliter (mIU/mL). This Outcome Measure only concerns the MenHibrix and ActHIB groups .

Outcome measures

Outcome measures
Measure	MenHibrix Group n=171 Participants Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	ActHIB Group n=169 Participants During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.	Menomune Group Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
Anti-hepatitis-B Surface Antigen (Anti-HBs) Antibody Concentrations [prior to vaccination] (N=91;108)	13.5 mIU/mL Interval 9.1 to 20.1	11.3 mIU/mL Interval 8.3 to 15.4	—
Anti-hepatitis-B Surface Antigen (Anti-HBs) Antibody Concentrations [after vaccination] (N=171;169)	1567.5 mIU/mL Interval 1231.7 to 1994.9	1555.1 mIU/mL Interval 1228.0 to 1969.4	—

SECONDARY outcome

Timeframe: Prior to and one month after the primary vaccination course (at Day 0 and Month 5)

Population: The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.

This Outcome Measure only concerns the MenHibrix and ActHIB groups .

Outcome measures

Outcome measures
Measure	MenHibrix Group n=200 Participants Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	ActHIB Group n=217 Participants During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.	Menomune Group Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentration ≥ 5.0 EL.U/mL Anti-PT [prior to vaccination] (N=116;140)	21 Participants	37 Participants	—
Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentration ≥ 5.0 EL.U/mL Anti-PT [after vaccination] (N=198;215)	196 Participants	214 Participants	—
Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentration ≥ 5.0 EL.U/mL Anti-FHA [prior to vaccination] (N=118;140)	91 Participants	103 Participants	—
Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentration ≥ 5.0 EL.U/mL Anti-FHA [after vaccination] (N=200;213)	200 Participants	213 Participants	—
Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentration ≥ 5.0 EL.U/mL Anti-PRN [prior to vaccination] (N=117;139)	40 Participants	56 Participants	—
Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentration ≥ 5.0 EL.U/mL Anti-PRN [after vaccination] (N=200;217)	199 Participants	215 Participants	—

SECONDARY outcome

Timeframe: Prior to the primary vaccination course (at Day 0)

Population: The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.

Concentrations of antibodies are presented as GMCs expressed as EL.U/mL. Results for one month after the 3-dose primary vaccination course (at Month 5) are presented under the Primary Outcome Measures section. This Outcome Measure only concerns the MenHibrix and ActHIB groups .

Outcome measures

Outcome measures
Measure	MenHibrix Group n=118 Participants Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	ActHIB Group n=140 Participants During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.	Menomune Group Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
Anti PT, Anti-FHA and Anti-PRN Antibody Concentrations Anti-PT [prior to vaccination] (N=116;140)	3.4 EL.U/mL Interval 3.0 to 3.8	3.9 EL.U/mL Interval 3.4 to 4.4	—
Anti PT, Anti-FHA and Anti-PRN Antibody Concentrations Anti-FHA [prior to vaccination] (N=118;140)	10.0 EL.U/mL Interval 8.2 to 12.2	10.5 EL.U/mL Interval 8.7 to 12.8	—
Anti PT, Anti-FHA and Anti-PRN Antibody Concentrations Anti-PRN [prior to vaccination] (N=117;139)	4.8 EL.U/mL Interval 3.9 to 5.8	5.1 EL.U/mL Interval 4.3 to 6.1	—

SECONDARY outcome

Timeframe: Prior to and one month after the primary vaccination course (at Day 0 and Month 5)

Population: The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.

This Outcome Measure only concerns the MenHibrix and ActHIB groups .

Outcome measures

Outcome measures
Measure	MenHibrix Group n=91 Participants Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	ActHIB Group n=83 Participants During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.	Menomune Group Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
Number of Subjects With Anti-poliovirus Types 1, 2 and 3 Antibody Titer ≥ 1:8 Anti-polio 1 [prior to vaccination] (N=61;60)	34 Participants	41 Participants	—
Number of Subjects With Anti-poliovirus Types 1, 2 and 3 Antibody Titer ≥ 1:8 Anti-polio 1 [after vaccination] (N=87;82)	86 Participants	82 Participants	—
Number of Subjects With Anti-poliovirus Types 1, 2 and 3 Antibody Titer ≥ 1:8 Anti-polio 2 [prior to vaccination] (N=60;63)	31 Participants	39 Participants	—
Number of Subjects With Anti-poliovirus Types 1, 2 and 3 Antibody Titer ≥ 1:8 Anti-polio 2 [after vaccination] (N=91;83)	91 Participants	82 Participants	—
Number of Subjects With Anti-poliovirus Types 1, 2 and 3 Antibody Titer ≥ 1:8 Anti-polio 3 [prior to vaccination] (N=61;64)	7 Participants	13 Participants	—
Number of Subjects With Anti-poliovirus Types 1, 2 and 3 Antibody Titer ≥ 1:8 Anti-polio 3 [after vaccination] (N=84;79)	84 Participants	79 Participants	—

SECONDARY outcome

Timeframe: Prior to and one month after the primary vaccination course (at Day 0 and Month 5)

Population: The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.

Titers are presented as geometric mean titers (GMTs). This Outcome Measure only concerns the MenHibrix and ActHIB groups .

Outcome measures

Outcome measures
Measure	MenHibrix Group n=91 Participants Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	ActHIB Group n=83 Participants During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.	Menomune Group Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
Anti-poliovirus Types 1, 2 and 3 Antibody Titers Anti-polio 1 [prior to vaccination] (N=61;60)	12.3 Titers Interval 8.8 to 17.2	17.3 Titers Interval 12.4 to 24.2	—
Anti-poliovirus Types 1, 2 and 3 Antibody Titers Anti-polio 1 [after vaccination] (N=87;82)	530.7 Titers Interval 409.7 to 687.5	651.5 Titers Interval 501.7 to 846.0	—
Anti-poliovirus Types 1, 2 and 3 Antibody Titers Anti-polio 2 [prior to vaccination] (N=60;63)	9.4 Titers Interval 7.1 to 12.3	13.5 Titers Interval 9.9 to 18.5	—
Anti-poliovirus Types 1, 2 and 3 Antibody Titers Anti-polio 2 [after vaccination] (N=91;83)	398.2 Titers Interval 304.7 to 520.3	330.4 Titers Interval 242.8 to 449.6	—
Anti-poliovirus Types 1, 2 and 3 Antibody Titers Anti-polio 3 [prior to vaccination] (N=61;64)	4.7 Titers Interval 4.1 to 5.2	6.2 Titers Interval 4.7 to 8.2	—
Anti-poliovirus Types 1, 2 and 3 Antibody Titers Anti-polio 3 [after vaccination] (N=84;79)	923.7 Titers Interval 696.1 to 1225.8	1055.8 Titers Interval 813.4 to 1370.5	—

SECONDARY outcome

Timeframe: One month after the 3-dose primary vaccination course (at Month 5)

Population: The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.

Vaccine response to PT/FHA/PRN was defined as, for initially seronegative subjects, antibody concentration ≥ 5 EL.U/mL one month post-primary vaccination course, and, for initially seropositive subjects, antibody concentration one month post-primary vaccination course ≥ 1-fold the pre-vaccination antibody concentration. A seronegative/seronegative subject was defined as a subject with antibody concentration \</≥ 5 EL.U/mL for anti-PT/FHA/PRN prior to vaccination. This Outcome Measure only concerns the MenHibrix and ActHIB groups .

Outcome measures

Outcome measures
Measure	MenHibrix Group n=116 Participants Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	ActHIB Group n=135 Participants During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.	Menomune Group Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
Number of Subjects With Vaccine Response to PT, FHA and PRN Anti-PT (N=111;135)	109 Participants	132 Participants	—
Number of Subjects With Vaccine Response to PT, FHA and PRN Anti-FHA (N=116;132)	113 Participants	128 Participants	—
Number of Subjects With Vaccine Response to PT, FHA and PRN Anti-PRN (N=115;133)	103 Participants	126 Participants	—

SECONDARY outcome

Timeframe: Within 4 days (Day 0-3) after the 3-dose primary vaccination

Population: The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase.

Solicited local symptoms were pain, redness and swelling at injection site. "Any" = any report of the specified symptom irrespective of intensity grade; "Grade 2 pain" = cried/protested on touch; "Grade 3 pain" = cried when limb was moved/spontaneously painful; "Grade 2 or 3" redness/swelling = redness/swelling larger than (\>) 10 millimeters (mm); "Grade 3" redness/swelling = redness/swelling \> 30 mm. This Outcome Measure only concerns the MenHibrix and ActHIB groups .

Outcome measures

Outcome measures
Measure	MenHibrix Group n=286 Participants Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	ActHIB Group n=317 Participants During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.	Menomune Group Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms Swelling >30 mm	1 Participants	11 Participants	—
Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms Any pain	129 Participants	171 Participants	—
Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms Grade 2 or 3 pain	62 Participants	90 Participants	—
Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms Grade 3 pain	13 Participants	31 Participants	—
Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms Any redness	112 Participants	148 Participants	—
Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms Redness >10 mm	22 Participants	31 Participants	—
Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms Redness >30 mm	1 Participants	11 Participants	—
Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms Any swelling	90 Participants	110 Participants	—
Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms Swelling >10 mm	27 Participants	27 Participants	—

SECONDARY outcome

Timeframe: Within 8 days (Day 0-7) after the 3-dose primary vaccination

Population: The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase.

Solicited local symptoms were pain, redness and swelling at injection site. "Any" = any report of the specified symptom irrespective of intensity grade; "Grade 2 pain" = cried/protested on touch; "Grade 3 pain" = cried when limb was moved/spontaneously painful; "Grade 2 or 3" redness/swelling = redness/swelling larger than (\>) 10 millimeters (mm); "Grade 3" redness/swelling = redness/swelling \> 30 mm. This Outcome Measure only concerns the MenHibrix and ActHIB groups .

Outcome measures

Outcome measures
Measure	MenHibrix Group n=286 Participants Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	ActHIB Group n=317 Participants During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.	Menomune Group Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms Any pain	129 Participants	171 Participants	—
Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms Grade 2 or 3 pain	63 Participants	90 Participants	—
Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms Grade 3 pain	13 Participants	31 Participants	—
Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms Any redness	113 Participants	148 Participants	—
Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms Redness >10 mm	22 Participants	31 Participants	—
Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms Redness >30 mm	1 Participants	11 Participants	—
Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms Any swelling	90 Participants	111 Participants	—
Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms Swelling >10 mm	27 Participants	27 Participants	—
Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms Swelling >30 mm	1 Participants	11 Participants	—

SECONDARY outcome

Timeframe: Within 4 days (Day 0-3) after the 3-dose primary vaccination

Population: The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase.

Solicited general symptoms were fever, irritability/fussiness, drowsiness, and loss of appetite. "Any" = any report of the specified symptom irrespective of intensity grade and relationship to vaccination. "Grade 2" for Drowsiness, Irritability/Fussiness and Loss of appetite = symptom that interfered with normal activity; "Grade 3" for Drowsiness and Irritability/Fussiness = symptom that prevented normal activity; "Grade 3" Loss of appetite = not eating at all. Fever = rectal temperature ≥ 38.0 degrees Celsius (°C); "Grade 2 or 3" fever = rectal temperature higher than (\>) 39°C; "Grade 3" fever = rectal temperature \> 40°C. This Outcome Measure only concerns the MenHibrix and ActHIB groups .

Outcome measures

Outcome measures
Measure	MenHibrix Group n=286 Participants Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	ActHIB Group n=317 Participants During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.	Menomune Group Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms Any drowsiness	185 Participants	224 Participants	—
Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms Grade 2 or 3 drowsiness	84 Participants	112 Participants	—
Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms Grade 3 drowsiness	9 Participants	20 Participants	—
Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms Fever ≥38.0°C	110 Participants	150 Participants	—
Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms Fever >39.0°C	14 Participants	13 Participants	—
Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms Fever >40.0°C	0 Participants	0 Participants	—
Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms Any irritability	217 Participants	268 Participants	—
Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms Grade 2 or 3 irritability	125 Participants	161 Participants	—
Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms Grade 3 irritability	22 Participants	48 Participants	—
Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms Any loss of appetite	123 Participants	159 Participants	—
Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms Grade 2 or 3 loss of appetite	32 Participants	51 Participants	—
Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms Grade 3 loss of appetite	3 Participants	4 Participants	—

SECONDARY outcome

Timeframe: Within 8 days (Day 0-7) after the 3-dose primary vaccination

Population: The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase.

Solicited general symptoms were fever, irritability/fussiness, drowsiness, and loss of appetite. "Any" = any report of the specified symptom irrespective of intensity grade and relationship to vaccination. "Grade 2" for Drowsiness, Irritability/Fussiness and Loss of appetite = symptom that interfered with normal activity; "Grade 3" for Drowsiness and Irritability/Fussiness = symptom that prevented normal activity; "Grade 3" Loss of appetite = not eating at all. Fever = rectal temperature ≥ 38.0 degrees Celsius (°C); "Grade 2 or 3" fever = rectal temperature higher than (\>) 39°C; "Grade 3" fever = rectal temperature \> 40°C. This Outcome Measure only concerns the MenHibrix and ActHIB groups

Outcome measures

Outcome measures
Measure	MenHibrix Group n=286 Participants Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	ActHIB Group n=317 Participants During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.	Menomune Group Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms Grade 3 drowsiness	10 Participants	21 Participants	—
Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms Grade 2 or 3 irritability	127 Participants	168 Participants	—
Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms Fever ≥38.0°C	115 Participants	158 Participants	—
Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms Fever >39.0°C	19 Participants	19 Participants	—
Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms Fever >40.0°C	0 Participants	0 Participants	—
Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms Any irritability	222 Participants	272 Participants	—
Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms Grade 3 irritability	25 Participants	51 Participants	—
Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms Any loss of appetite	127 Participants	164 Participants	—
Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms Grade 2 or 3 loss of appetite	35 Participants	56 Participants	—
Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms Grade 3 loss of appetite	4 Participants	5 Participants	—
Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms Any drowsiness	187 Participants	227 Participants	—
Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms Grade 2 or 3 drowsiness	85 Participants	116 Participants	—

SECONDARY outcome

Timeframe: From Dose 1 (at Day 0) through Day 30 following the last vaccine dose administered (Day 30 post Month 4 vaccination for MenHibrix and ActHIB groups, Day 30 post Month 1 for Menomune Group).

Population: The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase.

An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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	MenHibrix Group n=287 Participants Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	ActHIB Group n=319 Participants During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.	Menomune Group n=150 Participants Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
Number of Subjects Reporting Unsolicited Adverse Events (AEs)	213 Participants	230 Participants	37 Participants

SECONDARY outcome

Timeframe: During the entire Primary Phase of the study, from Day 0 up to the end of Primary Phase safety follow-up period (6 months after the last vaccination).

Population: The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase.

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

Outcome measures

Outcome measures
Measure	MenHibrix Group n=287 Participants Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	ActHIB Group n=319 Participants During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.	Menomune Group n=150 Participants Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
Number of Subjects Reporting Serious Adverse Events (SAEs)	16 Participants	20 Participants	0 Participants

SECONDARY outcome

Timeframe: From Day 0 following Dose 1 throughout the study up to the day preceding the administration of the fourth dose of vaccine.

Population: The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase.

SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. This Outcome Measure only concerns the MenHibrix and ActHIB groups .

Outcome measures

Outcome measures
Measure	MenHibrix Group n=287 Participants Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	ActHIB Group n=319 Participants During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.	Menomune Group Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
Number of Subjects Reporting Serious Adverse Events (SAEs)	16 Participants	20 Participants	—

SECONDARY outcome

Timeframe: From Day 0 following Dose 1 throughout the study up to the day preceding the administration of the fourth dose of vaccine

Population: The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase.

NOCIs include autoimmune disorders, asthma, type I diabetes, allergies. This Outcome Measure only concerns the MenHibrix and ActHIB groups .

Outcome measures

Outcome measures
Measure	MenHibrix Group n=287 Participants Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	ActHIB Group n=319 Participants During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.	Menomune Group Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
Number of Subjects Reporting New Onset of Chronic Illness(es) (NOCIs)	2 Participants	5 Participants	—

SECONDARY outcome

Timeframe: From Day 0 following Dose 1 throughout the study up to the day preceding the administration of the fourth dose of vaccine.

Population: The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase.

An episode of rash was defined as an episode of hives, idiopathic thrombocytopenic purpura, petechiae. This Outcome Measure only concerns the MenHibrix and ActHIB groups .

Outcome measures

Outcome measures
Measure	MenHibrix Group n=287 Participants Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	ActHIB Group n=319 Participants During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.	Menomune Group Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
Number of Subjects Reporting Rash	50 Participants	55 Participants	—

SECONDARY outcome

Timeframe: From Day 0 following Dose 1 throughout the study up to the day preceding the administration of the fourth dose of vaccine.

Population: The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase.

Emergency room (ER) visits or physicians office visits assessed were those unrelated to well-child care, vaccination, injury or common acute illnesses such as upper respiratory tract infections, otitis media, pharyngitis, gastroenteritis. This Outcome Measure only concerns the MenHibrix and ActHIB groups.

Outcome measures

Outcome measures
Measure	MenHibrix Group n=287 Participants Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	ActHIB Group n=319 Participants During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.	Menomune Group Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
Number of Subjects Reporting Emergency Room (ER) Visits or Visits to Physicians' Office, Related or Not to Common Illnesses Emergency room visit	25 Participants	31 Participants	—
Number of Subjects Reporting Emergency Room (ER) Visits or Visits to Physicians' Office, Related or Not to Common Illnesses Physician's office visit	181 Participants	190 Participants	—
Number of Subjects Reporting Emergency Room (ER) Visits or Visits to Physicians' Office, Related or Not to Common Illnesses Physician's o. v. not related to common illnesses	51 Participants	46 Participants	—

SECONDARY outcome

Timeframe: One month post fourth dose vaccination (at Month 11-14)

Population: The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.

Fourth dose responses to rSBA-MenC and rSBA-MenY were defined as follows (Definition 1): * Initially seronegative subjects (pre-fourth dose antibody titer below cut-off: \< 1:8) should have an antibody titer at least four-fold higher than the cut-off, one month after fourth dose (post-fourth dose antibody titer ≥1:32), * Initially seropositive subjects (pre-fourth dose antibody titer above cut-off: ≥1:8) should have an antibody titer at least four-fold higher than the pre-fourth dose antibody titer, one month after fourth dose.

Outcome measures

Outcome measures
Measure	MenHibrix Group n=149 Participants Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	ActHIB Group n=72 Participants During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.	Menomune Group n=79 Participants Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
Number of Subjects With Fourth Dose Response for Neisseria Meningitidis Serogroup C and Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC and Y) rSBA-MenC (N=149;72;77)	131 Participants	2 Participants	71 Participants
Number of Subjects With Fourth Dose Response for Neisseria Meningitidis Serogroup C and Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC and Y) rSBA-MenY (N=147;67;79)	119 Participants	10 Participants	76 Participants

SECONDARY outcome

Timeframe: One month post fourth dose vaccination (at Month 11-14)

Population: The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.

Fourth dose responses to rSBA-MenC and rSBA-MenY were also assessed using a second definition (Definition 2): * Post-fourth dose rSBA antibody titers ≥1:32 in subjects seronegative at the pre-fourth dose time point (rSBA antibody titers \< 1:8), * At least (i.e., greater than or equal to) a 4-fold rise in rSBA antibody titers in subjects with pre-fourth dose antibody titers ≥1:8 but \< 1:128, * At least (i.e., greater than or equal to) a 2-fold rise in rSBA antibody titers in subjects with pre-fourth dose antibody titers ≥1:128.

Outcome measures

Outcome measures
Measure	MenHibrix Group n=149 Participants Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	ActHIB Group n=72 Participants During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.	Menomune Group n=79 Participants Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
Number of Subjects With Fourth Dose Response for Neisseria Meningitidis Serogroup C and Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC and Y) rSBA-MenC (N=149;72;77)	140 Participants	2 Participants	71 Participants
Number of Subjects With Fourth Dose Response for Neisseria Meningitidis Serogroup C and Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC and Y) rSBA-MenY (N=147;67;79)	134 Participants	11 Participants	78 Participants

SECONDARY outcome

Timeframe: One month post fourth dose vaccination (at Month 11-14)

Population: The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.

Fourth dose responses to hSBA-MenC and hSBA-MenY were defined as follows (Definition 1): * Initially seronegative subjects (pre-fourth dose antibody titer below cut-off: \< 1:8) should have an antibody titer at least four-fold higher than the cut-off, one month after the fourth dose (post-fourth dose antibody titer ≥1:16), * Initially seropositive subjects (pre-fourth dose antibody titer above cut-off: ≥1:8) should have an antibody titer at least four-fold higher than the pre-fourth dose antibody titer, one month after the fourth dose.

Outcome measures

Outcome measures
Measure	MenHibrix Group n=61 Participants Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	ActHIB Group n=36 Participants During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.	Menomune Group n=33 Participants Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
Number of Subjects With Fourth Dose Response for Neisseria Meningitidis Serogroup C and Y Serum Bacterial Assay Using Human Complement (hSBA-MenC and Y) hSBA-MenC (N=58;36;33)	44 Participants	0 Participants	29 Participants
Number of Subjects With Fourth Dose Response for Neisseria Meningitidis Serogroup C and Y Serum Bacterial Assay Using Human Complement (hSBA-MenC and Y) hSBA-MenY (N=61;36;33)	52 Participants	1 Participants	15 Participants

SECONDARY outcome

Timeframe: One month post fourth dose vaccination (at Month 11-14)

Population: The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.

Fourth dose responses to hSBA-MenC and hSBA-MenY were also assessed using a second definition (Definition 2): * Post-fourth dose hSBA antibody titers ≥1:16 in subjects seronegative at the pre-fourth dose time point (hSBA antibody titers \< 1:8), * At least (i.e., greater than or equal to) a 4-fold rise in hSBA antibody titers in subjects with pre-fourth dose antibody titers ≥1:4 but \< 1: 8, * At least (i.e., greater than or equal to) a 2-fold rise in hSBA antibody titers in subjects with pre-fourth dose antibody titers ≥1:8.

Outcome measures

Outcome measures
Measure	MenHibrix Group n=61 Participants Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	ActHIB Group n=36 Participants During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.	Menomune Group n=33 Participants Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
Number of Subjects With Fourth Dose Response for Neisseria Meningitidis Serogroup C and Y Serum Bacterial Assay Using Human Complement (hSBA-MenC and Y) hSBA-MenC (N=58;36;33)	52 Participants	0 Participants	29 Participants
Number of Subjects With Fourth Dose Response for Neisseria Meningitidis Serogroup C and Y Serum Bacterial Assay Using Human Complement (hSBA-MenC and Y) hSBA-MenY (N=61;36;33)	56 Participants	1 Participants	15 Participants

SECONDARY outcome

Timeframe: One month after fourth dose vaccination (at Month 11-14)

Population: The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.

Streptococcus pneumoniae antibody cut-off values assessed was ≥0.05 µg/mL for the 7 serotypes in Prevnar vaccine. Vaccine pneumococcal serotypes included serotypes 4, 6B, 9V, 14, 18C, 19F, 23F.

Outcome measures

Outcome measures
Measure	MenHibrix Group n=176 Participants Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	ActHIB Group n=90 Participants During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.	Menomune Group n=102 Participants Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.05 Microgram Per Milliliter (µg/mL) Anti-4 (N=174;89;102)	174 Participants	89 Participants	102 Participants
Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.05 Microgram Per Milliliter (µg/mL) Anti-6B (N=174;89;101)	174 Participants	89 Participants	101 Participants
Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.05 Microgram Per Milliliter (µg/mL) Anti-9V (N=175;90;102)	175 Participants	90 Participants	102 Participants
Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.05 Microgram Per Milliliter (µg/mL) Anti-14 (N=174;87;100)	174 Participants	87 Participants	100 Participants
Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.05 Microgram Per Milliliter (µg/mL) Anti-18C (N=175;88;102)	175 Participants	88 Participants	102 Participants
Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.05 Microgram Per Milliliter (µg/mL) Anti-19F (N=173;89;96)	173 Participants	89 Participants	96 Participants
Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.05 Microgram Per Milliliter (µg/mL) Anti-23F (N=176;90;102)	175 Participants	90 Participants	101 Participants

SECONDARY outcome

Timeframe: One month after fourth dose vaccination (at Month 11-14)

Population: The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.

Streptococcus pneumoniae antibody cut-off values assessed was ≥0.2 µg/mL for the 7 serotypes in Prevnar vaccine. Vaccine pneumococcal serotypes included serotypes 4, 6B, 9V, 14, 18C, 19F, 23F.

Outcome measures

Outcome measures
Measure	MenHibrix Group n=176 Participants Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	ActHIB Group n=90 Participants During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.	Menomune Group n=102 Participants Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.2 Microgram Per Milliliter (µg/mL) Anti-4 (N=174;89;102)	174 Participants	89 Participants	102 Participants
Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.2 Microgram Per Milliliter (µg/mL) Anti-6B (N=174;89;101)	174 Participants	89 Participants	101 Participants
Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.2 Microgram Per Milliliter (µg/mL) Anti-9V (N=175;90;102)	175 Participants	90 Participants	102 Participants
Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.2 Microgram Per Milliliter (µg/mL) Anti-14 (N=174;87;100)	174 Participants	87 Participants	100 Participants
Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.2 Microgram Per Milliliter (µg/mL) Anti-18C (N=175;88;102)	175 Participants	88 Participants	102 Participants
Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.2 Microgram Per Milliliter (µg/mL) Anti-19F (N=173;89;96)	171 Participants	89 Participants	96 Participants
Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.2 Microgram Per Milliliter (µg/mL) Anti-23F (N=176;90;102)	175 Participants	90 Participants	101 Participants

SECONDARY outcome

Timeframe: One month after fourth dose vaccination (at Month 11-14)

Population: The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.

Streptococcus pneumoniae antibody cut-off values assessed was ≥0.5 µg/mL for the 7 serotypes in Prevnar vaccine. Vaccine pneumococcal serotypes included serotypes 4, 6B, 9V, 14, 18C, 19F, 23F.

Outcome measures

Outcome measures
Measure	MenHibrix Group n=176 Participants Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	ActHIB Group n=90 Participants During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.	Menomune Group n=102 Participants Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.5 Microgram Per Milliliter (µg/mL) Anti-4 (N=174;89;102)	165 Participants	86 Participants	99 Participants
Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.5 Microgram Per Milliliter (µg/mL) Anti-6B (N=174;89;101)	171 Participants	89 Participants	100 Participants
Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.5 Microgram Per Milliliter (µg/mL) Anti-9V (N=175;90;102)	174 Participants	90 Participants	102 Participants
Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.5 Microgram Per Milliliter (µg/mL) Anti-14 (N=174;87;100)	172 Participants	87 Participants	100 Participants
Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.5 Microgram Per Milliliter (µg/mL) Anti-18C (N=175;88;102)	174 Participants	88 Participants	102 Participants
Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.5 Microgram Per Milliliter (µg/mL) Anti-19F (N=173;89;96)	157 Participants	83 Participants	91 Participants
Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.5 Microgram Per Milliliter (µg/mL) Anti-23F (N=176;90;102)	175 Participants	90 Participants	101 Participants

SECONDARY outcome

Timeframe: One month post fourth dose vaccination (at Month 11-14)

Population: The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.

Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL). Vaccine pneumococcal serotypes included serotypes 4, 6B, 9V, 14, 18C, 19F, 23F.