Trial Outcomes & Findings for 3 Formulations of Hib-MenCY-TT Vaccine & 1 Formulation of Hib-MenC-TT Vaccine Compared to Licensed Meningococcal Serogroup C Conjugate Vaccine, Each Administered at 2,3,4 Mths of Age (NCT NCT00129116)

Results Overview

Anti-PRP antibody concentration cut-off value assessed was equal to or above (≥) 1 microgram per millilitre (µg/mL)

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

388 participants

Primary outcome timeframe

One month after dose 3 (at study Month 3 - primary phase)

Results posted on

2018-08-27

Participant Flow

The study is divided in two phases: * Primary phase: 3-dose primary vaccination at 2, 3 and 4 months of age = study Months 0, 1, 2. Data were collected up to 1 month after the 3rd dose (study Month 3) * Booster phase: booster dose at 12-18 months of age = study Month 0. Data were collected up to 1 month after the booster dose (study Month 1)

Participant milestones

Participant milestones
Measure	Menhibrix F1/Infanrix-penta Group Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F2/Infanrix-penta Group Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F3/Infanrix-penta Group Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menitorix/Infanrix-penta Group Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menjugate/Infanrix-hexa Group Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
Primary Phase STARTED	78	77	78	78	77
Primary Phase COMPLETED	76	73	77	77	76
Primary Phase NOT COMPLETED	2	4	1	1	1
Booster Phase STARTED	47	42	44	44	44
Booster Phase COMPLETED	45	42	44	44	43
Booster Phase NOT COMPLETED	2	0	0	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Menhibrix F1/Infanrix-penta Group Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F2/Infanrix-penta Group Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F3/Infanrix-penta Group Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menitorix/Infanrix-penta Group Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menjugate/Infanrix-hexa Group Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
Primary Phase Lost to Follow-up	1	1	0	1	1
Primary Phase Protocol Violation	0	1	0	0	0
Primary Phase Adverse Event	1	1	0	0	0
Primary Phase Withdrawal by Subject	0	1	0	0	0
Primary Phase Other	0	0	1	0	0
Booster Phase Lost to Follow-up	2	0	0	0	1

Baseline Characteristics

3 Formulations of Hib-MenCY-TT Vaccine & 1 Formulation of Hib-MenC-TT Vaccine Compared to Licensed Meningococcal Serogroup C Conjugate Vaccine, Each Administered at 2,3,4 Mths of Age

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Menhibrix F1/Infanrix-penta Group n=78 Participants Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F2/Infanrix-penta Group n=77 Participants Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F3/Infanrix-penta Group n=78 Participants Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menitorix/Infanrix-penta Group n=78 Participants Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menjugate/Infanrix-hexa Group n=77 Participants Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Total n=388 Participants Total of all reporting groups
Age, Continuous	8.5 Weeks STANDARD_DEVIATION 1.69 • n=5 Participants	8.8 Weeks STANDARD_DEVIATION 1.72 • n=7 Participants	8.7 Weeks STANDARD_DEVIATION 1.55 • n=5 Participants	8.3 Weeks STANDARD_DEVIATION 1.63 • n=4 Participants	9.0 Weeks STANDARD_DEVIATION 1.65 • n=21 Participants	8.7 Weeks STANDARD_DEVIATION 1.65 • n=10 Participants
Sex: Female, Male Female	31 Participants n=5 Participants	37 Participants n=7 Participants	44 Participants n=5 Participants	33 Participants n=4 Participants	40 Participants n=21 Participants	185 Participants n=10 Participants
Sex: Female, Male Male	47 Participants n=5 Participants	40 Participants n=7 Participants	34 Participants n=5 Participants	45 Participants n=4 Participants	37 Participants n=21 Participants	203 Participants n=10 Participants

PRIMARY outcome

Timeframe: One month after dose 3 (at study Month 3 - primary phase)

Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.

Anti-PRP antibody concentration cut-off value assessed was equal to or above (≥) 1 microgram per millilitre (µg/mL)

Outcome measures

Outcome measures
Measure	Menhibrix F1/Infanrix-penta Group n=67 Participants Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F2/Infanrix-penta Group n=67 Participants Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F3/Infanrix-penta Group n=70 Participants Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menitorix/Infanrix-penta Group n=74 Participants Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menjugate/Infanrix-hexa Group n=71 Participants Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1 Microgram Per Millilitre (µg/mL).	66 Subjects	66 Subjects	69 Subjects	73 Subjects	57 Subjects

PRIMARY outcome

Timeframe: One month after dose 3 (at study Month 3 - primary phase)

Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.

rSBA-MenC antibody titre cut-off value assessed was ≥1:8

Outcome measures

Outcome measures
Measure	Menhibrix F1/Infanrix-penta Group n=70 Participants Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F2/Infanrix-penta Group n=67 Participants Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F3/Infanrix-penta Group n=71 Participants Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menitorix/Infanrix-penta Group n=74 Participants Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menjugate/Infanrix-hexa Group n=71 Participants Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:8	70 Subjects	67 Subjects	71 Subjects	74 Subjects	71 Subjects

PRIMARY outcome

Timeframe: One month after dose 3 (at study Month 3 - primary phase)

Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.

rSBA-MenY antibody titre cut-off value assessed was ≥1:8

Outcome measures

Outcome measures
Measure	Menhibrix F1/Infanrix-penta Group n=69 Participants Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F2/Infanrix-penta Group n=66 Participants Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F3/Infanrix-penta Group n=71 Participants Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menitorix/Infanrix-penta Group n=74 Participants Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menjugate/Infanrix-hexa Group n=71 Participants Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:8	67 Subjects	64 Subjects	70 Subjects	16 Subjects	14 Subjects

PRIMARY outcome

Timeframe: One month after the booster vaccination (at study Month 1 - booster phase)

Population: The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.

Anti-PRP antibody concentration cut-off value assessed was equal to or above (≥) 1 microgram per millilitre (µg/mL)

Outcome measures

Outcome measures
Measure	Menhibrix F1/Infanrix-penta Group n=39 Participants Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F2/Infanrix-penta Group n=39 Participants Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F3/Infanrix-penta Group n=39 Participants Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menitorix/Infanrix-penta Group n=40 Participants Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menjugate/Infanrix-hexa Group n=39 Participants Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1 Microgram Per Millilitre (µg/mL).	39 Subjects	39 Subjects	39 Subjects	40 Subjects	39 Subjects

PRIMARY outcome

Timeframe: One month after the booster vaccination (at study Month 1 - booster phase)

Population: The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.

rSBA-MenC antibody titre cut-off value assessed was ≥1:8

Outcome measures

Outcome measures
Measure	Menhibrix F1/Infanrix-penta Group n=40 Participants Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F2/Infanrix-penta Group n=39 Participants Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F3/Infanrix-penta Group n=42 Participants Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menitorix/Infanrix-penta Group n=41 Participants Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menjugate/Infanrix-hexa Group n=39 Participants Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:8	40 Subjects	39 Subjects	42 Subjects	41 Subjects	39 Subjects

PRIMARY outcome

Timeframe: One month after the booster vaccination (at study Month 1 - booster phase)

Population: The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.

rSBA-MenY antibody titre cut-off value assessed was ≥1:8

Outcome measures

Outcome measures
Measure	Menhibrix F1/Infanrix-penta Group n=40 Participants Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F2/Infanrix-penta Group n=39 Participants Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F3/Infanrix-penta Group n=42 Participants Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menitorix/Infanrix-penta Group n=40 Participants Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menjugate/Infanrix-hexa Group n=39 Participants Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:8	40 Subjects	39 Subjects	42 Subjects	13 Subjects	14 Subjects

SECONDARY outcome

Timeframe: Before the administration of the first dose (at pre-vaccination = study Month 0 - primary phase)

Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.

rSBA-MenC antibody titre cut-off value assessed was ≥1:8

Outcome measures

Outcome measures
Measure	Menhibrix F1/Infanrix-penta Group n=69 Participants Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F2/Infanrix-penta Group n=64 Participants Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F3/Infanrix-penta Group n=70 Participants Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menitorix/Infanrix-penta Group n=73 Participants Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menjugate/Infanrix-hexa Group n=71 Participants Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:8	4 Subjects	6 Subjects	4 Subjects	6 Subjects	3 Subjects

SECONDARY outcome

Timeframe: Before the administration of the first dose (at pre-vaccination = study Month 0 - primary phase)

Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.

rSBA-MenY antibody titre cut-off value assessed was ≥1:8

Outcome measures

Outcome measures
Measure	Menhibrix F1/Infanrix-penta Group n=70 Participants Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F2/Infanrix-penta Group n=63 Participants Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F3/Infanrix-penta Group n=71 Participants Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menitorix/Infanrix-penta Group n=73 Participants Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menjugate/Infanrix-hexa Group n=71 Participants Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:8	11 Subjects	10 Subjects	16 Subjects	10 Subjects	17 Subjects

SECONDARY outcome

Timeframe: Before the administration of the first dose (at pre-vaccination = study Month 0 - primary phase)

Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.

Anti-PRP antibody concentration cut-off value assessed was equal to or above (≥) 1 microgram per millilitre (µg/mL)

Outcome measures

Outcome measures
Measure	Menhibrix F1/Infanrix-penta Group n=69 Participants Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F2/Infanrix-penta Group n=63 Participants Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F3/Infanrix-penta Group n=71 Participants Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menitorix/Infanrix-penta Group n=73 Participants Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menjugate/Infanrix-hexa Group n=71 Participants Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1 Microgram Per Millilitre (µg/mL).	13 Subjects	8 Subjects	8 Subjects	9 Subjects	3 Subjects

SECONDARY outcome

Timeframe: Prior to the booster vaccination (at study Month 0 - booster phase)

Population: The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.

Anti-PRP antibody concentration cut-off value assessed was equal to or above (≥) 1 microgram per millilitre (µg/mL)

Outcome measures

Outcome measures
Measure	Menhibrix F1/Infanrix-penta Group n=41 Participants Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F2/Infanrix-penta Group n=39 Participants Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F3/Infanrix-penta Group n=42 Participants Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menitorix/Infanrix-penta Group n=42 Participants Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menjugate/Infanrix-hexa Group n=36 Participants Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1 Microgram Per Millilitre (µg/mL).	26 Subjects	28 Subjects	27 Subjects	32 Subjects	11 Subjects

SECONDARY outcome

Timeframe: Prior to the booster vaccination (at study Month 0 - booster phase)

Population: The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.

rSBA-MenC antibody titre cut-off value assessed was ≥1:8

Outcome measures

Outcome measures
Measure	Menhibrix F1/Infanrix-penta Group n=42 Participants Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F2/Infanrix-penta Group n=39 Participants Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F3/Infanrix-penta Group n=41 Participants Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menitorix/Infanrix-penta Group n=41 Participants Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menjugate/Infanrix-hexa Group n=38 Participants Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:8	38 Subjects	38 Subjects	38 Subjects	39 Subjects	36 Subjects

SECONDARY outcome

Timeframe: Prior to the booster vaccination (at study Month 0 - booster phase)

Population: The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.

rSBA-MenY antibody titre cut-off value assessed was ≥1:8

Outcome measures

Outcome measures
Measure	Menhibrix F1/Infanrix-penta Group n=41 Participants Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F2/Infanrix-penta Group n=39 Participants Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F3/Infanrix-penta Group n=42 Participants Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menitorix/Infanrix-penta Group n=42 Participants Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menjugate/Infanrix-hexa Group n=37 Participants Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:8	35 Subjects	31 Subjects	36 Subjects	11 Subjects	15 Subjects

SECONDARY outcome

Timeframe: Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)

Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.

Titres are expressed as geometric mean titres (GMTs)

Outcome measures

Outcome measures
Measure	Menhibrix F1/Infanrix-penta Group n=70 Participants Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F2/Infanrix-penta Group n=67 Participants Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F3/Infanrix-penta Group n=71 Participants Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menitorix/Infanrix-penta Group n=74 Participants Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menjugate/Infanrix-hexa Group n=71 Participants Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
rSBA-MenC Antibody Titres rSBA-MenC [Month 3] (N=70,67,71,74,71)	1005.8 Titers Interval 773.5 to 1308.0	1029.8 Titers Interval 799.7 to 1326.0	906.9 Titers Interval 691.3 to 1189.8	871.0 Titers Interval 677.3 to 1120.0	3557.6 Titers Interval 2978.8 to 4248.8
rSBA-MenC Antibody Titres rSBA-MenC [Month 0] (N=69,64,70,73,71)	4.7 Titers Interval 3.9 to 5.7	4.8 Titers Interval 4.1 to 5.6	4.6 Titers Interval 4.0 to 5.4	4.7 Titers Interval 4.0 to 5.7	4.5 Titers Interval 3.9 to 5.2

SECONDARY outcome

Timeframe: Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)

Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.

Titres are expressed as geometric mean titres (GMTs)

Outcome measures

Outcome measures
Measure	Menhibrix F1/Infanrix-penta Group n=70 Participants Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F2/Infanrix-penta Group n=66 Participants Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F3/Infanrix-penta Group n=71 Participants Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menitorix/Infanrix-penta Group n=74 Participants Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menjugate/Infanrix-hexa Group n=71 Participants Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
rSBA-MenY Antibody Titres rSBA-MenY [Month 3] (N=69,66,71,74,71)	470.7 Titers Interval 351.1 to 631.2	437.1 Titers Interval 322.0 to 593.4	635.3 Titers Interval 501.5 to 804.8	9.3 Titers Interval 6.3 to 13.7	7.5 Titers Interval 5.4 to 10.4
rSBA-MenY Antibody Titres rSBA-MenY [Month 0] (N=70,63,71,73,71)	5.9 Titers Interval 4.7 to 7.5	5.9 Titers Interval 4.6 to 7.6	7.4 Titers Interval 5.6 to 9.9	5.9 Titers Interval 4.6 to 7.4	7.7 Titers Interval 5.7 to 10.3

SECONDARY outcome

Timeframe: Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)

Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.

Anti-PRP antibody concentration cut-off value assessed was equal to or above (≥) 0.15 microgram per millilitre (µg/mL)

Outcome measures

Outcome measures
Measure	Menhibrix F1/Infanrix-penta Group n=69 Participants Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F2/Infanrix-penta Group n=67 Participants Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F3/Infanrix-penta Group n=71 Participants Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menitorix/Infanrix-penta Group n=74 Participants Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menjugate/Infanrix-hexa Group n=71 Participants Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 0.15 Microgram Per Millilitre (µg/mL). Anti-PRP >= 0.15 µg/mL [Mth 0] (N=69,63,71,73,71)	51 Subjects	42 Subjects	50 Subjects	50 Subjects	50 Subjects
Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 0.15 Microgram Per Millilitre (µg/mL). Anti-PRP >= 0.15 µg/mL [Mth 3] (N=67,67,70,74,71)	67 Subjects	67 Subjects	70 Subjects	74 Subjects	71 Subjects

SECONDARY outcome

Timeframe: Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)

Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.

Antibody concentrations are expressed as geometric mean concentrations (GMCs) in µg/mL.

Outcome measures

Outcome measures
Measure	Menhibrix F1/Infanrix-penta Group n=69 Participants Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F2/Infanrix-penta Group n=67 Participants Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F3/Infanrix-penta Group n=71 Participants Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menitorix/Infanrix-penta Group n=74 Participants Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menjugate/Infanrix-hexa Group n=71 Participants Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
Anti-PRP Antibody Concentrations Anti-PRP [Month 0] (N=69,63,71,73,71)	0.289 µg/mL Interval 0.217 to 0.385	0.243 µg/mL Interval 0.185 to 0.318	0.255 µg/mL Interval 0.197 to 0.331	0.243 µg/mL Interval 0.184 to 0.319	0.217 µg/mL Interval 0.177 to 0.267
Anti-PRP Antibody Concentrations Anti-PRP [Month 3] (N=67,67,70,74,71)	9.014 µg/mL Interval 7.248 to 11.209	9.485 µg/mL Interval 7.721 to 11.651	8.075 µg/mL Interval 6.532 to 9.982	10.435 µg/mL Interval 8.487 to 12.83	2.595 µg/mL Interval 1.965 to 3.428

SECONDARY outcome

Timeframe: Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)

Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.

Anti-PSC antibody concentration cut-off value assessed was ≥0.30 µg/mL

Outcome measures

Outcome measures
Measure	Menhibrix F1/Infanrix-penta Group n=69 Participants Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F2/Infanrix-penta Group n=66 Participants Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F3/Infanrix-penta Group n=71 Participants Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menitorix/Infanrix-penta Group n=74 Participants Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menjugate/Infanrix-hexa Group n=71 Participants Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Equal to or Above 0.30 Microgram Per Millilitre (µg/mL) Anti-PSC [Month 0] (N=69,63,71,74,71)	7 Subjects	12 Subjects	7 Subjects	7 Subjects	10 Subjects
Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Equal to or Above 0.30 Microgram Per Millilitre (µg/mL) Anti-PSC [Month 3] (N=69,66,70,74,71)	69 Subjects	66 Subjects	70 Subjects	74 Subjects	71 Subjects

SECONDARY outcome

Timeframe: Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)

Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.

Anti-PSY antibody concentration cut-off value assessed was ≥0.30 µg/mL

Outcome measures

Outcome measures
Measure	Menhibrix F1/Infanrix-penta Group n=69 Participants Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F2/Infanrix-penta Group n=66 Participants Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F3/Infanrix-penta Group n=71 Participants Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menitorix/Infanrix-penta Group n=74 Participants Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menjugate/Infanrix-hexa Group n=71 Participants Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
Number of Subjects With Anti-polysaccharide Y (Anti-PSY) Antibody Concentration Equal to or Above 0.30 Microgram Per Millilitre (µg/mL) Anti-PSY [Month 0] (N=69,64,71,73,71)	7 Subjects	6 Subjects	12 Subjects	15 Subjects	12 Subjects
Number of Subjects With Anti-polysaccharide Y (Anti-PSY) Antibody Concentration Equal to or Above 0.30 Microgram Per Millilitre (µg/mL) Anti-PSY [Month 3] (N=69,66,70,74,71)	69 Subjects	66 Subjects	70 Subjects	6 Subjects	4 Subjects

SECONDARY outcome

Timeframe: Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)

Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.

Antibody concentrations are expressed as geometric mean concentrations (GMCs) in µg/mL.

Outcome measures

Outcome measures
Measure	Menhibrix F1/Infanrix-penta Group n=69 Participants Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F2/Infanrix-penta Group n=66 Participants Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F3/Infanrix-penta Group n=71 Participants Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menitorix/Infanrix-penta Group n=74 Participants Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menjugate/Infanrix-hexa Group n=71 Participants Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
Anti-PSC Antibody Concentrations Anti-PSC [Month 0] (N=69,63,71,74,71)	0.18 µg/mL Interval 0.16 to 0.2	0.20 µg/mL Interval 0.17 to 0.24	0.18 µg/mL Interval 0.16 to 0.21	0.18 µg/mL Interval 0.15 to 0.22	0.18 µg/mL Interval 0.16 to 0.21
Anti-PSC Antibody Concentrations Anti-PSC [Month 3] (N=69,66,70,74,71)	21.70 µg/mL Interval 18.36 to 25.65	27.26 µg/mL Interval 23.26 to 31.95	19.02 µg/mL Interval 16.49 to 21.93	21.08 µg/mL Interval 18.24 to 24.35	38.49 µg/mL Interval 33.64 to 44.05

SECONDARY outcome

Timeframe: Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)

Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.

Antibody concentrations are expressed as geometric mean concentrations (GMCs) in µg/mL.

Outcome measures

Outcome measures
Measure	Menhibrix F1/Infanrix-penta Group n=69 Participants Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F2/Infanrix-penta Group n=66 Participants Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F3/Infanrix-penta Group n=71 Participants Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menitorix/Infanrix-penta Group n=74 Participants Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menjugate/Infanrix-hexa Group n=71 Participants Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
Anti-PSY Antibody Concentrations Anti-PSY [Month 0] (N=69,64,71,73,71)	0.19 µg/mL Interval 0.16 to 0.23	0.18 µg/mL Interval 0.15 to 0.2	0.20 µg/mL Interval 0.17 to 0.25	0.22 µg/mL Interval 0.18 to 0.27	0.20 µg/mL Interval 0.17 to 0.23
Anti-PSY Antibody Concentrations Anti-PSY [Month 3] (N=69,66,70,74,71)	26.86 µg/mL Interval 22.86 to 31.56	37.02 µg/mL Interval 31.84 to 43.04	23.57 µg/mL Interval 19.94 to 27.86	0.19 µg/mL Interval 0.15 to 0.25	0.17 µg/mL Interval 0.15 to 0.19

SECONDARY outcome

Timeframe: Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)

Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.

Antibody concentrations are expressed as geometric mean concentrations (GMCs) in International Units per millilitre (IU/mL).

Outcome measures

Outcome measures
Measure	Menhibrix F1/Infanrix-penta Group n=69 Participants Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F2/Infanrix-penta Group n=67 Participants Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F3/Infanrix-penta Group n=71 Participants Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menitorix/Infanrix-penta Group n=74 Participants Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menjugate/Infanrix-hexa Group n=71 Participants Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
Anti-tetanus Antibody Concentrations Anti-tetanus [Month 0] (N=69,63,71,73,71)	0.433 IU/mL Interval 0.32 to 0.586	0.485 IU/mL Interval 0.373 to 0.63	0.523 IU/mL Interval 0.388 to 0.705	0.436 IU/mL Interval 0.323 to 0.589	0.379 IU/mL Interval 0.285 to 0.503
Anti-tetanus Antibody Concentrations Anti-tetanus [Month 3] (N=68,67,70,74,71)	3.057 IU/mL Interval 2.629 to 3.554	3.254 IU/mL Interval 2.879 to 3.677	2.972 IU/mL Interval 2.591 to 3.409	3.151 IU/mL Interval 2.726 to 3.641	1.656 IU/mL Interval 1.394 to 1.967

SECONDARY outcome

Timeframe: Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)

Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.

Antibody concentrations are expressed as geometric mean concentrations (GMCs) in Enzyme-Linked Immunosorbent Assay (ELISA) Units per millilitre.

Outcome measures

Outcome measures
Measure	Menhibrix F1/Infanrix-penta Group n=69 Participants Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F2/Infanrix-penta Group n=67 Participants Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F3/Infanrix-penta Group n=71 Participants Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menitorix/Infanrix-penta Group n=74 Participants Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menjugate/Infanrix-hexa Group n=71 Participants Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN), Anti-pertussis Toxoid (Anti-PT) Antibody Concentrations Anti-PT [Month 0] (N=67,62,68,70,69)	3.4 EL.U/mL Interval 2.9 to 4.0	3.1 EL.U/mL Interval 2.7 to 3.5	3.7 EL.U/mL Interval 3.0 to 4.6	3.3 EL.U/mL Interval 2.8 to 4.0	3.1 EL.U/mL Interval 2.7 to 3.5
Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN), Anti-pertussis Toxoid (Anti-PT) Antibody Concentrations Anti-PT [Month 3] (N=67,63,69,74,69)	53.9 EL.U/mL Interval 46.3 to 62.7	52.9 EL.U/mL Interval 45.3 to 61.8	50.8 EL.U/mL Interval 44.1 to 58.5	55.4 EL.U/mL Interval 48.1 to 63.7	41.3 EL.U/mL Interval 35.1 to 48.5
Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN), Anti-pertussis Toxoid (Anti-PT) Antibody Concentrations Anti-FHA [Month 0] (N=69,63,69,72,70)	6.5 EL.U/mL Interval 5.2 to 8.1	6.0 EL.U/mL Interval 4.8 to 7.5	7.3 EL.U/mL Interval 5.7 to 9.3	9.9 EL.U/mL Interval 7.8 to 12.6	7.0 EL.U/mL Interval 5.6 to 8.7
Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN), Anti-pertussis Toxoid (Anti-PT) Antibody Concentrations Anti-FHA [Month 3] (N=67,63,69,74,71)	83.7 EL.U/mL Interval 72.9 to 96.0	91.5 EL.U/mL Interval 78.7 to 106.3	89.3 EL.U/mL Interval 78.4 to 101.6	92.4 EL.U/mL Interval 79.8 to 106.9	74.0 EL.U/mL Interval 64.9 to 84.5
Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN), Anti-pertussis Toxoid (Anti-PT) Antibody Concentrations Anti-PRN [Month 0] (N=68,62,71,72,70)	6.3 EL.U/mL Interval 4.9 to 8.2	4.5 EL.U/mL Interval 3.6 to 5.7	5.5 EL.U/mL Interval 4.5 to 6.8	6.4 EL.U/mL Interval 4.9 to 8.3	6.5 EL.U/mL Interval 5.0 to 8.4
Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN), Anti-pertussis Toxoid (Anti-PT) Antibody Concentrations Anti-PRN [Month 3] (N=68,67,70,74,71)	94.2 EL.U/mL Interval 77.6 to 114.5	97.1 EL.U/mL Interval 79.8 to 118.2	96.2 EL.U/mL Interval 80.2 to 115.5	99.1 EL.U/mL Interval 79.0 to 124.3	80.2 EL.U/mL Interval 66.1 to 97.2

SECONDARY outcome

Timeframe: Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)

Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.

Seroprotection status is defined as anti-tetanus toxoid antibody concentration ≥ 0.1 International Units per millilitre (IU/mL)

Outcome measures

Outcome measures
Measure	Menhibrix F1/Infanrix-penta Group n=69 Participants Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F2/Infanrix-penta Group n=67 Participants Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F3/Infanrix-penta Group n=71 Participants Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menitorix/Infanrix-penta Group n=74 Participants Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menjugate/Infanrix-hexa Group n=71 Participants Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
Number of Seroprotected Subjects for Anti-tetanus Antibodies Anti-tetanus [Month 0] (N=69,63,71,73,71)	58 Subjects	57 Subjects	60 Subjects	63 Subjects	61 Subjects
Number of Seroprotected Subjects for Anti-tetanus Antibodies Anti-tetanus [Month 3] (N=68,67,70,74,71)	68 Subjects	67 Subjects	70 Subjects	74 Subjects	71 Subjects

SECONDARY outcome

Timeframe: Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)

Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.

Anti-FHA, anti-PRN and anti-PT antibody concentration cut-off value assessed was ≥ 5 ELISA units per millilitre.

Outcome measures

Outcome measures
Measure	Menhibrix F1/Infanrix-penta Group n=69 Participants Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F2/Infanrix-penta Group n=67 Participants Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F3/Infanrix-penta Group n=71 Participants Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menitorix/Infanrix-penta Group n=74 Participants Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menjugate/Infanrix-hexa Group n=71 Participants Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
Number of Subjects With Anti-FHA, Anti-PRN and Anti-PT Antibody Concentration Equal to or Above 5 Enzyme-Linked Immunosorbent Assay (ELISA) Units Per Millilitre (EL.U/mL) Anti-PRN [Month 3] (N=68,67,70,74,71)	68 Subjects	67 Subjects	70 Subjects	74 Subjects	71 Subjects
Number of Subjects With Anti-FHA, Anti-PRN and Anti-PT Antibody Concentration Equal to or Above 5 Enzyme-Linked Immunosorbent Assay (ELISA) Units Per Millilitre (EL.U/mL) Anti-FHA [Month 0] (N=69,63,69,72,70)	42 Subjects	37 Subjects	42 Subjects	55 Subjects	45 Subjects
Number of Subjects With Anti-FHA, Anti-PRN and Anti-PT Antibody Concentration Equal to or Above 5 Enzyme-Linked Immunosorbent Assay (ELISA) Units Per Millilitre (EL.U/mL) Anti-PT [Month 0] (N=67,62,68,70,69)	15 Subjects	11 Subjects	18 Subjects	12 Subjects	9 Subjects
Number of Subjects With Anti-FHA, Anti-PRN and Anti-PT Antibody Concentration Equal to or Above 5 Enzyme-Linked Immunosorbent Assay (ELISA) Units Per Millilitre (EL.U/mL) Anti-PT [Month 3] (N=67,63,69,74,69)	67 Subjects	63 Subjects	69 Subjects	74 Subjects	69 Subjects
Number of Subjects With Anti-FHA, Anti-PRN and Anti-PT Antibody Concentration Equal to or Above 5 Enzyme-Linked Immunosorbent Assay (ELISA) Units Per Millilitre (EL.U/mL) Anti-FHA [Month 3] (N=67,63,69,74,71)	67 Subjects	63 Subjects	69 Subjects	74 Subjects	71 Subjects
Number of Subjects With Anti-FHA, Anti-PRN and Anti-PT Antibody Concentration Equal to or Above 5 Enzyme-Linked Immunosorbent Assay (ELISA) Units Per Millilitre (EL.U/mL) Anti-PRN [Month 0] (N=68,62,71,72,70)	36 Subjects	25 Subjects	37 Subjects	37 Subjects	37 Subjects

SECONDARY outcome

Timeframe: Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)

Population: The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.

Anti-PRP antibody concentration cut-off value assessed was equal to or above (≥) 0.15 microgram per millilitre (µg/mL)

Outcome measures

Outcome measures
Measure	Menhibrix F1/Infanrix-penta Group n=41 Participants Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F2/Infanrix-penta Group n=39 Participants Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F3/Infanrix-penta Group n=42 Participants Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menitorix/Infanrix-penta Group n=42 Participants Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menjugate/Infanrix-hexa Group n=39 Participants Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 0.15 Microgram Per Millilitre (µg/mL). Anti-PRP >= 0.15 µg/mL Month 0 (N=41,39,42,42,36)	39 Subjects	38 Subjects	42 Subjects	42 Subjects	36 Subjects
Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 0.15 Microgram Per Millilitre (µg/mL). Anti-PRP >= 0.15 µg/mL Month 1 (N=39,39,39,40,39)	39 Subjects	39 Subjects	39 Subjects	40 Subjects	39 Subjects

SECONDARY outcome

Timeframe: Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)

Population: The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.

Antibody concentrations are expressed as geometric mean concentrations (GMCs) in µg/mL.

Outcome measures

Outcome measures
Measure	Menhibrix F1/Infanrix-penta Group n=41 Participants Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F2/Infanrix-penta Group n=39 Participants Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F3/Infanrix-penta Group n=42 Participants Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menitorix/Infanrix-penta Group n=42 Participants Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menjugate/Infanrix-hexa Group n=39 Participants Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
Anti-PRP Antibody Concentrations Anti-PRP [Month 0] (N=41,39,42,42,36)	1.306 µg/mL Interval 0.947 to 1.801	1.591 µg/mL Interval 1.185 to 2.135	1.414 µg/mL Interval 1.068 to 1.871	1.764 µg/mL Interval 1.301 to 2.391	0.607 µg/mL Interval 0.459 to 0.802
Anti-PRP Antibody Concentrations Anti-PRP [Month 1] (N=39,39,39,40,39)	36.280 µg/mL Interval 27.856 to 47.252	32.930 µg/mL Interval 22.797 to 47.567	34.107 µg/mL Interval 24.902 to 46.715	47.742 µg/mL Interval 34.631 to 65.817	24.345 µg/mL Interval 17.445 to 33.974

SECONDARY outcome

Timeframe: Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)

Population: The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.

rSBA-MenC antibody titre cut-off value assessed was ≥1:128

Outcome measures

Outcome measures
Measure	Menhibrix F1/Infanrix-penta Group n=42 Participants Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F2/Infanrix-penta Group n=39 Participants Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F3/Infanrix-penta Group n=42 Participants Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menitorix/Infanrix-penta Group n=41 Participants Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menjugate/Infanrix-hexa Group n=39 Participants Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:128 rSBA-Menc [Month 0] (N=42,39,41,41,38)	25 Subjects	24 Subjects	22 Subjects	27 Subjects	26 Subjects
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:128 rSBA-Menc [Month 1] (N=40,39,42,41,39)	40 Subjects	36 Subjects	42 Subjects	40 Subjects	39 Subjects

SECONDARY outcome

Timeframe: Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)

Population: The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.

rSBA-MenY antibody titre cut-off value assessed was ≥1:128

Outcome measures

Outcome measures
Measure	Menhibrix F1/Infanrix-penta Group n=41 Participants Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F2/Infanrix-penta Group n=39 Participants Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F3/Infanrix-penta Group n=42 Participants Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menitorix/Infanrix-penta Group n=42 Participants Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menjugate/Infanrix-hexa Group n=39 Participants Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:128 rSBA-MenY [Month 0] (N=41,39,42,42,37)	24 Subjects	18 Subjects	23 Subjects	6 Subjects	7 Subjects
Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:128 rSBA-MenY [Month 1] (N=40,39,42,40,39)	40 Subjects	39 Subjects	42 Subjects	6 Subjects	10 Subjects

SECONDARY outcome

Timeframe: Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)

Population: The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.

Titres are expressed as geometric mean titres (GMTs)

Outcome measures

Outcome measures
Measure	Menhibrix F1/Infanrix-penta Group n=42 Participants Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F2/Infanrix-penta Group n=39 Participants Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F3/Infanrix-penta Group n=42 Participants Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menitorix/Infanrix-penta Group n=41 Participants Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menjugate/Infanrix-hexa Group n=39 Participants Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
rSBA-MenC Antibody Titres rSBA-MenC [Month 1] (N=40,39,42,41,39)	4762.6 Titers Interval 3427.5 to 6617.7	2897.7 Titers Interval 1793.1 to 4682.7	2626.4 Titers Interval 1893.9 to 3642.3	3226.2 Titers Interval 2294.7 to 4535.8	11819.3 Titers Interval 8458.6 to 16515.2
rSBA-MenC Antibody Titres rSBA-MenC [Month 0] (N=42,39,41,41,38)	128.0 Titers Interval 74.9 to 218.5	144.2 Titers Interval 92.8 to 224.1	125.8 Titers Interval 81.0 to 195.3	150.6 Titers Interval 96.7 to 234.5	195.5 Titers Interval 122.4 to 312.2

SECONDARY outcome

Timeframe: Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)

Population: The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.

Titres are expressed as geometric mean titres (GMTs)

Outcome measures

Outcome measures
Measure	Menhibrix F1/Infanrix-penta Group n=41 Participants Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F2/Infanrix-penta Group n=39 Participants Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F3/Infanrix-penta Group n=42 Participants Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menitorix/Infanrix-penta Group n=42 Participants Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menjugate/Infanrix-hexa Group n=39 Participants Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
rSBA-MenY Antibody Titres rSBA-MenY [Month 0] (N=41,39,42,42,37)	97.2 Titres Interval 58.4 to 161.8	64.0 Titres Interval 37.6 to 108.9	100.9 Titres Interval 62.3 to 163.5	11.0 Titres Interval 6.3 to 19.1	16.1 Titres Interval 8.8 to 29.5
rSBA-MenY Antibody Titres rSBA-MenY [Month 1] (N=40,39,42,40,39)	1708.1 Titres Interval 1313.3 to 2221.4	1313.8 Titres Interval 1004.4 to 1718.6	1566.0 Titres Interval 1172.8 to 2091.1	11.7 Titres Interval 6.8 to 20.2	16.5 Titres Interval 8.7 to 31.3

SECONDARY outcome

Timeframe: Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)

Population: The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.

Anti-PSC antibody concentration cut-off value assessed was ≥0.30 µg/mL

Outcome measures

Outcome measures
Measure	Menhibrix F1/Infanrix-penta Group n=38 Participants Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F2/Infanrix-penta Group n=38 Participants Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F3/Infanrix-penta Group n=40 Participants Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menitorix/Infanrix-penta Group n=40 Participants Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menjugate/Infanrix-hexa Group n=39 Participants Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Equal to or Above 0.30 Microgram Per Millilitre (µg/mL) Anti-PSC [Month 1] (N=33,33,39,37,39)	33 Subjects	33 Subjects	39 Subjects	37 Subjects	39 Subjects
Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Equal to or Above 0.30 Microgram Per Millilitre (µg/mL) Anti-PSC [Month 0] (N=38,38,40,40,38)	38 Subjects	38 Subjects	40 Subjects	40 Subjects	38 Subjects

SECONDARY outcome

Timeframe: Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)

Population: The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.

Anti-PSC antibody concentration cut-off value assessed was ≥2.0 µg/mL

Outcome measures

Outcome measures
Measure	Menhibrix F1/Infanrix-penta Group n=38 Participants Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F2/Infanrix-penta Group n=38 Participants Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F3/Infanrix-penta Group n=40 Participants Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menitorix/Infanrix-penta Group n=40 Participants Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menjugate/Infanrix-hexa Group n=39 Participants Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Equal to or Above 2.0 Microgram Per Millilitre (µg/mL) Anti-PSC [Month 1] (N=33,33,39,37,39)	33 Subjects	33 Subjects	39 Subjects	37 Subjects	39 Subjects
Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Equal to or Above 2.0 Microgram Per Millilitre (µg/mL) Anti-PSC [Month 0] (N=38,38,40,40,38)	24 Subjects	30 Subjects	28 Subjects	26 Subjects	27 Subjects

SECONDARY outcome

Timeframe: Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)

Population: The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.

Antibody concentrations are expressed as geometric mean concentrations (GMCs) in µg/mL.

Outcome measures

Outcome measures
Measure	Menhibrix F1/Infanrix-penta Group n=38 Participants Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F2/Infanrix-penta Group n=38 Participants Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F3/Infanrix-penta Group n=40 Participants Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menitorix/Infanrix-penta Group n=40 Participants Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menjugate/Infanrix-hexa Group n=39 Participants Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
Anti-PSC Antibody Concentrations Anti-PSC [Month 0] (N=38,38,40,40,38)	2.57 µg/mL Interval 1.88 to 3.51	3.23 µg/mL Interval 2.55 to 4.08	2.53 µg/mL Interval 2.06 to 3.12	3.08 µg/mL Interval 2.33 to 4.08	3.17 µg/mL Interval 2.46 to 4.08
Anti-PSC Antibody Concentrations Anti-PSC [Month 1] (N=33,33,39,37,39)	32.04 µg/mL Interval 22.99 to 44.65	28.00 µg/mL Interval 19.4 to 40.42	19.75 µg/mL Interval 15.23 to 25.6	27.71 µg/mL Interval 22.23 to 34.54	64.41 µg/mL Interval 50.72 to 81.79

SECONDARY outcome

Timeframe: Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)

Population: The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.

Antibody concentrations are expressed as geometric mean concentrations (GMCs) in µg/mL.

Outcome measures

Outcome measures
Measure	Menhibrix F1/Infanrix-penta Group n=42 Participants Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F2/Infanrix-penta Group n=39 Participants Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F3/Infanrix-penta Group n=42 Participants Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menitorix/Infanrix-penta Group n=42 Participants Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menjugate/Infanrix-hexa Group n=38 Participants Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
Anti-PSY Antibody Concentrations Anti-PSY [Month 0] (N=39,39,42,42,38)	3.72 µg/mL Interval 2.76 to 5.03	5.25 µg/mL Interval 3.95 to 6.96	3.96 µg/mL Interval 3.02 to 5.19	0.16 µg/mL Interval 0.14 to 0.19	NA µg/mL Values were below the assay cut-off value of 0.3 µg/mL.
Anti-PSY Antibody Concentrations Anti-PSY [Month 1] (N=42,39,41,40,38)	26.15 µg/mL Interval 17.8 to 38.42	35.90 µg/mL Interval 25.33 to 50.88	32.18 µg/mL Interval 25.26 to 40.99	0.17 µg/mL Interval 0.13 to 0.21	NA µg/mL Values were below the assay cut-off value of 0.3 µg/mL.

SECONDARY outcome

Timeframe: Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)

Population: The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.

Anti-tetanus toxoid antibody concentration cut-off value assessed was ≥ 0.1 IU/mL

Outcome measures

Outcome measures
Measure	Menhibrix F1/Infanrix-penta Group n=41 Participants Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F2/Infanrix-penta Group n=39 Participants Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F3/Infanrix-penta Group n=42 Participants Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menitorix/Infanrix-penta Group n=42 Participants Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menjugate/Infanrix-hexa Group n=39 Participants Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
Number of Subjects With Anti-tetanus Toxoid (Anti-T) Antibody Concentration Equal to or Above 0.1 International Units Per Millilitre (IU/mL). Anti-tetanus [Month 0] (N=41,39,42,42,38)	41 Subjects	39 Subjects	42 Subjects	42 Subjects	37 Subjects
Number of Subjects With Anti-tetanus Toxoid (Anti-T) Antibody Concentration Equal to or Above 0.1 International Units Per Millilitre (IU/mL). Anti-tetanus [Month 1] (N=39,39,39,40,39)	39 Subjects	39 Subjects	39 Subjects	40 Subjects	39 Subjects

SECONDARY outcome

Timeframe: Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)

Population: The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.

Antibody concentrations are expressed as geometric mean concentrations (GMCs) in International Units per millilitre (IU/mL).

Outcome measures

Outcome measures
Measure	Menhibrix F1/Infanrix-penta Group n=41 Participants Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F2/Infanrix-penta Group n=39 Participants Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F3/Infanrix-penta Group n=42 Participants Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menitorix/Infanrix-penta Group n=42 Participants Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menjugate/Infanrix-hexa Group n=39 Participants Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
Anti-T Antibody Concentrations Anti-tetanus [Month 0] (N=41,39,42,42,38)	0.836 IU/mL Interval 0.655 to 1.067	0.986 IU/mL Interval 0.81 to 1.202	0.894 IU/mL Interval 0.748 to 1.069	0.839 IU/mL Interval 0.693 to 1.016	0.322 IU/mL Interval 0.257 to 0.402
Anti-T Antibody Concentrations Anti-tetanus [Month 1] (N=39,39,39,40,39)	12.609 IU/mL Interval 10.769 to 14.762	10.175 IU/mL Interval 8.269 to 12.52	9.893 IU/mL Interval 8.255 to 11.856	11.674 IU/mL Interval 9.538 to 14.288	5.474 IU/mL Interval 4.331 to 6.918

SECONDARY outcome

Timeframe: One month after the third dose (at study Month 3 - primary phase)

Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.

Antibody concentrations are expressed as geometric mean concentrations (GMCs) in IU/mL.

Outcome measures

Outcome measures
Measure	Menhibrix F1/Infanrix-penta Group n=68 Participants Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F2/Infanrix-penta Group n=64 Participants Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F3/Infanrix-penta Group n=69 Participants Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menitorix/Infanrix-penta Group n=74 Participants Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menjugate/Infanrix-hexa Group n=69 Participants Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
Anti-diphtheria Antibody Concentrations	1.016 IU/mL Interval 0.796 to 1.297	0.927 IU/mL Interval 0.759 to 1.132	0.980 IU/mL Interval 0.788 to 1.219	1.012 IU/mL Interval 0.827 to 1.238	1.904 IU/mL Interval 1.606 to 2.258

SECONDARY outcome

Timeframe: One month after the third dose (at study Month 3 - primary phase)

Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.

Antibody concentrations are expressed as geometric mean concentrations (GMCs) in milli-International Units per millilitre (mIU/mL).

Outcome measures

Outcome measures
Measure	Menhibrix F1/Infanrix-penta Group n=62 Participants Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F2/Infanrix-penta Group n=61 Participants Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F3/Infanrix-penta Group n=67 Participants Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menitorix/Infanrix-penta Group n=72 Participants Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menjugate/Infanrix-hexa Group n=65 Participants Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations	377.9 mIU/mL Interval 261.7 to 545.8	397.0 mIU/mL Interval 271.5 to 580.4	408.9 mIU/mL Interval 305.9 to 546.6	520.5 mIU/mL Interval 374.1 to 724.3	287.3 mIU/mL Interval 194.3 to 424.7

SECONDARY outcome

Timeframe: One month after the third dose (at study Month 3 - primary phase)

Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.

Titres are expressed as geometric mean titres (GMTs)

Outcome measures

Outcome measures
Measure	Menhibrix F1/Infanrix-penta Group n=57 Participants Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F2/Infanrix-penta Group n=55 Participants Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F3/Infanrix-penta Group n=58 Participants Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menitorix/Infanrix-penta Group n=61 Participants Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menjugate/Infanrix-hexa Group n=56 Participants Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
Anti-poliovirus Types 1, 2, 3 Antibody Titres Anti-poliovirus type 1 (N=57,55,56,61,56)	275.5 Titers Interval 206.9 to 366.8	242.0 Titers Interval 181.2 to 323.4	216.8 Titers Interval 162.6 to 288.9	305.2 Titers Interval 229.2 to 406.4	282.6 Titers Interval 204.4 to 390.7
Anti-poliovirus Types 1, 2, 3 Antibody Titres Anti-poliovirus type 2 (N=55,55,58,61,56)	155.8 Titers Interval 110.4 to 220.0	149.9 Titers Interval 108.3 to 207.7	133.7 Titers Interval 95.5 to 187.2	123.1 Titers Interval 86.3 to 175.6	171.3 Titers Interval 123.2 to 238.1
Anti-poliovirus Types 1, 2, 3 Antibody Titres Anti-poliovirus type 3 (N=57,55,58,61,56)	649.0 Titers Interval 492.3 to 855.7	577.2 Titers Interval 418.7 to 795.8	451.7 Titers Interval 320.9 to 635.9	603.6 Titers Interval 452.7 to 804.6	505.7 Titers Interval 375.5 to 681.0

SECONDARY outcome

Timeframe: One month after the third dose (at study Month 3 - primary phase)

Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.

Seroprotection status is defined as anti-diphtheria antibody concentrations ≥ 0.1 IU/mL

Outcome measures

Outcome measures
Measure	Menhibrix F1/Infanrix-penta Group n=68 Participants Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F2/Infanrix-penta Group n=64 Participants Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F3/Infanrix-penta Group n=69 Participants Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menitorix/Infanrix-penta Group n=74 Participants Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menjugate/Infanrix-hexa Group n=69 Participants Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
Number of Seroprotected Subjects for Anti-diphtheria Antibodies	66 Subjects	64 Subjects	69 Subjects	74 Subjects	69 Subjects

SECONDARY outcome

Timeframe: One month after the third dose (at study Month 3 - primary phase)

Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.

Seroprotection status is defined as anti-HBs antibody concentrations ≥ 10 mIU/mL

Outcome measures

Outcome measures
Measure	Menhibrix F1/Infanrix-penta Group n=62 Participants Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F2/Infanrix-penta Group n=61 Participants Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F3/Infanrix-penta Group n=67 Participants Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menitorix/Infanrix-penta Group n=72 Participants Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menjugate/Infanrix-hexa Group n=65 Participants Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
Number of Seroprotected Subjects for Anti-hepatitis B Antibodies	60 Subjects	60 Subjects	66 Subjects	70 Subjects	61 Subjects

SECONDARY outcome

Timeframe: One month after the third dose (at study Month 3 - primary phase)

Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.

Seroprotection status is defined as anti-polio 1, 2 and 3 antibody titres ≥ 1:8

Outcome measures

Outcome measures
Measure	Menhibrix F1/Infanrix-penta Group n=57 Participants Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F2/Infanrix-penta Group n=55 Participants Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F3/Infanrix-penta Group n=58 Participants Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menitorix/Infanrix-penta Group n=61 Participants Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menjugate/Infanrix-hexa Group n=56 Participants Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
Number of Seroprotected Subjects for Anti-poliovirus Types 1, 2 and 3 Antibodies Anti-poliovirus type 1 (N=57,55,56,61,56)	57 Subjects	55 Subjects	56 Subjects	61 Subjects	55 Subjects
Number of Seroprotected Subjects for Anti-poliovirus Types 1, 2 and 3 Antibodies Anti-poliovirus type 2 (N=55,55,58,61,56)	55 Subjects	55 Subjects	58 Subjects	59 Subjects	56 Subjects
Number of Seroprotected Subjects for Anti-poliovirus Types 1, 2 and 3 Antibodies Anti-poliovirus type 3 (N=57,55,58,61,56)	57 Subjects	55 Subjects	58 Subjects	61 Subjects	56 Subjects

SECONDARY outcome

Timeframe: One month after the third dose (at study Month 3 - primary phase)

Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.

Vaccine response rates are defined as appearance of antibodies in subjects who were initially seronegative (i.e., with concentrations \< cut-off value) or at least maintenance of pre-vaccination antibody concentrations in subjects who were initially seropositive (i.e., with concentrations ≥ cut-off value), taking into consideration the decreasing maternal antibodies.

Outcome measures

Outcome measures
Measure	Menhibrix F1/Infanrix-penta Group n=66 Participants Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F2/Infanrix-penta Group n=62 Participants Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F3/Infanrix-penta Group n=70 Participants Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menitorix/Infanrix-penta Group n=72 Participants Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menjugate/Infanrix-hexa Group n=70 Participants Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
Number of Subjects With Vaccine Response to PT, FHA and PRN Anti-PT (N=64,58,66,70,68)	63 Subjects	58 Subjects	64 Subjects	66 Subjects	68 Subjects
Number of Subjects With Vaccine Response to PT, FHA and PRN Anti-FHA (N=66,59,67,72,70)	65 Subjects	58 Subjects	65 Subjects	68 Subjects	70 Subjects
Number of Subjects With Vaccine Response to PT, FHA and PRN Anti-PRN (N=66,62,70,72,70)	61 Subjects	59 Subjects	68 Subjects	63 Subjects	65 Subjects

SECONDARY outcome

Timeframe: During the 8-day (Day 0-7) follow-up period (during the primary phase)

Population: The Total Vaccinated Cohort included all subjects with study vaccine administered for whom data were available.

Solicited local symptoms assessed were pain, redness and swelling.

Outcome measures

Outcome measures
Measure	Menhibrix F1/Infanrix-penta Group n=78 Participants Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F2/Infanrix-penta Group n=77 Participants Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F3/Infanrix-penta Group n=78 Participants Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menitorix/Infanrix-penta Group n=78 Participants Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menjugate/Infanrix-hexa Group n=77 Participants Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
Number of Subjects With Solicited Local Symptoms Pain	21 Subjects	20 Subjects	22 Subjects	19 Subjects	19 Subjects
Number of Subjects With Solicited Local Symptoms Redness	35 Subjects	38 Subjects	50 Subjects	32 Subjects	46 Subjects
Number of Subjects With Solicited Local Symptoms Swelling	31 Subjects	35 Subjects	30 Subjects	27 Subjects	35 Subjects

SECONDARY outcome

Timeframe: During the 8-day (Day 0-7) follow-up period (during the primary phase)

Population: The Total Vaccinated Cohort included all subjects with study vaccine administered for whom data were available.

Solicited general symptoms assessed were drowsiness, irritability, loss of appetite and fever (fever is defined as rectal temperature ≥ 38.0 degrees Celsius (°C)).

Outcome measures

Outcome measures
Measure	Menhibrix F1/Infanrix-penta Group n=78 Participants Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F2/Infanrix-penta Group n=77 Participants Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F3/Infanrix-penta Group n=78 Participants Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menitorix/Infanrix-penta Group n=78 Participants Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menjugate/Infanrix-hexa Group n=77 Participants Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
Number of Subjects With Solicited General Symptoms Drowsiness	39 Subjects	53 Subjects	43 Subjects	37 Subjects	46 Subjects
Number of Subjects With Solicited General Symptoms Loss of appetite	24 Subjects	34 Subjects	29 Subjects	33 Subjects	30 Subjects
Number of Subjects With Solicited General Symptoms Fever (rectal) >= 38.0°C	25 Subjects	28 Subjects	26 Subjects	28 Subjects	28 Subjects
Number of Subjects With Solicited General Symptoms Irritability	44 Subjects	42 Subjects	51 Subjects	47 Subjects	44 Subjects

SECONDARY outcome

Timeframe: During the 31-day (Day 0-30) follow-up period (during the primary phase)

Population: The Total Vaccinated Cohort included all subjects with study vaccine administered for whom data were available.

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 F1/Infanrix-penta Group n=78 Participants Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F2/Infanrix-penta Group n=77 Participants Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F3/Infanrix-penta Group n=78 Participants Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menitorix/Infanrix-penta Group n=78 Participants Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menjugate/Infanrix-hexa Group n=77 Participants Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
Number of Subjects With Unsolicited Adverse Events (AEs)	39 Subjects	33 Subjects	35 Subjects	31 Subjects	26 Subjects

SECONDARY outcome

Timeframe: Over the full course of the primary phase (up to study Month 3 - primary phase)

Population: The Total Vaccinated Cohort included all subjects with study vaccine administered for whom data were available.

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 F1/Infanrix-penta Group n=78 Participants Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F2/Infanrix-penta Group n=77 Participants Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F3/Infanrix-penta Group n=78 Participants Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menitorix/Infanrix-penta Group n=78 Participants Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menjugate/Infanrix-hexa Group n=77 Participants Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
Number of Subjects Reporting Serious Adverse Events (SAEs)	0 Subjects	1 Subjects	2 Subjects	1 Subjects	3 Subjects

SECONDARY outcome

Timeframe: During the 8-day (Day 0-7) follow-up period (during the booster phase)

Population: The Booster Total Vaccinated Cohort included all subjects who received the booster dose.

Solicited local symptoms assessed were pain, redness and swelling.

Outcome measures

Outcome measures
Measure	Menhibrix F1/Infanrix-penta Group n=47 Participants Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F2/Infanrix-penta Group n=42 Participants Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F3/Infanrix-penta Group n=44 Participants Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menitorix/Infanrix-penta Group n=44 Participants Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menjugate/Infanrix-hexa Group n=44 Participants Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
Number of Subjects With Solicited Local Symptoms Pain	5 Subjects	10 Subjects	8 Subjects	8 Subjects	9 Subjects
Number of Subjects With Solicited Local Symptoms Redness	20 Subjects	18 Subjects	22 Subjects	16 Subjects	16 Subjects
Number of Subjects With Solicited Local Symptoms Swelling	15 Subjects	12 Subjects	12 Subjects	9 Subjects	10 Subjects

SECONDARY outcome

Timeframe: During the 8-day (Day 0-7) follow-up period (during the booster phase)

Population: The Booster Total Vaccinated Cohort included all subjects who received the booster dose.

Solicited general symptoms assessed were drowsiness, irritability, loss of appetite and fever (fever is defined as rectal temperature ≥ 38.0 degrees Celsius (°C)).

Outcome measures

Outcome measures
Measure	Menhibrix F1/Infanrix-penta Group n=47 Participants Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F2/Infanrix-penta Group n=42 Participants Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F3/Infanrix-penta Group n=44 Participants Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menitorix/Infanrix-penta Group n=44 Participants Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menjugate/Infanrix-hexa Group n=44 Participants Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
Number of Subjects With Solicited General Symptoms Drowsiness	14 Subjects	18 Subjects	18 Subjects	17 Subjects	18 Subjects
Number of Subjects With Solicited General Symptoms Loss of appetite	11 Subjects	16 Subjects	12 Subjects	10 Subjects	14 Subjects
Number of Subjects With Solicited General Symptoms Irritability	16 Subjects	18 Subjects	19 Subjects	14 Subjects	17 Subjects
Number of Subjects With Solicited General Symptoms Fever (rectal) >= 38.0°C	13 Subjects	10 Subjects	16 Subjects	18 Subjects	16 Subjects

SECONDARY outcome

Timeframe: During the 31-day (Day 0-30) follow-up period (during the booster phase)

Population: The Booster Total Vaccinated Cohort included all subjects who received the booster dose.

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 F1/Infanrix-penta Group n=47 Participants Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F2/Infanrix-penta Group n=42 Participants Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F3/Infanrix-penta Group n=44 Participants Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menitorix/Infanrix-penta Group n=44 Participants Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menjugate/Infanrix-hexa Group n=44 Participants Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
Number of Subjects With Unsolicited Adverse Events (AEs)	7 Subjects	12 Subjects	13 Subjects	12 Subjects	11 Subjects

SECONDARY outcome

Timeframe: Over the full course of the booster phase (up to study Month 1 - booster phase)

Population: The Booster Total Vaccinated Cohort included all subjects who received the booster dose.

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 F1/Infanrix-penta Group n=47 Participants Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F2/Infanrix-penta Group n=42 Participants Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F3/Infanrix-penta Group n=44 Participants Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menitorix/Infanrix-penta Group n=44 Participants Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menjugate/Infanrix-hexa Group n=44 Participants Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
Number of Subjects Reporting Serious Adverse Events (SAEs)	1 Subjects	1 Subjects	0 Subjects	1 Subjects	0 Subjects

Adverse Events

Menhibrix F1/Infanrix-penta Group

Serious events: 1 serious events

Other events: 70 other events

Deaths: 0 deaths

Menhibrix F2/Infanrix-penta Group

Serious events: 1 serious events

Other events: 71 other events

Deaths: 0 deaths

Menhibrix F3/Infanrix-penta Group

Serious events: 2 serious events

Other events: 73 other events

Deaths: 0 deaths

Menitorix/Infanrix-penta Group

Serious events: 1 serious events

Other events: 71 other events

Deaths: 0 deaths

Menjugate/Infanrix-hexa Group

Serious events: 3 serious events

Other events: 70 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Menhibrix F1/Infanrix-penta Group n=78 participants at risk Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F2/Infanrix-penta Group n=77 participants at risk Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F3/Infanrix-penta Group n=78 participants at risk Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menitorix/Infanrix-penta Group n=78 participants at risk Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menjugate/Infanrix-hexa Group n=77 participants at risk Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
Respiratory, thoracic and mediastinal disorders Apnoea	0.00% 0/78 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	0.00% 0/77 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	0.00% 0/78 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	0.00% 0/78 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	1.3% 1/77 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period
Infections and infestations Bronchitis	0.00% 0/78 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	0.00% 0/77 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	0.00% 0/78 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	0.00% 0/78 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	1.3% 1/77 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period
Gastrointestinal disorders Constipation	0.00% 0/78 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	0.00% 0/77 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	1.3% 1/78 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	0.00% 0/78 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	0.00% 0/77 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period
Metabolism and nutrition disorders Dehydration	0.00% 0/78 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	0.00% 0/77 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	0.00% 0/78 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	0.00% 0/78 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	1.3% 1/77 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period
Infections and infestations Gastroenteritis	2.1% 1/47 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	0.00% 0/42 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	0.00% 0/44 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	0.00% 0/44 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	0.00% 0/44 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period
Infections and infestations Laryngotracheo bronchitis	0.00% 0/78 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	0.00% 0/77 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	0.00% 0/78 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	0.00% 0/78 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	1.3% 1/77 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period
Infections and infestations Upper respiratory tract infection	0.00% 0/47 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	2.4% 1/42 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	0.00% 0/44 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	0.00% 0/44 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	0.00% 0/44 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period
Infections and infestations Urinary tract infection	0.00% 0/78 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	1.3% 1/77 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	0.00% 0/78 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	0.00% 0/78 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	0.00% 0/77 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period
Gastrointestinal disorders Vomiting	0.00% 0/78 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	0.00% 0/77 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	1.3% 1/78 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	0.00% 0/78 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	0.00% 0/77 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period
Nervous system disorders Febrile convulsion	0.00% 0/47 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	2.4% 1/42 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	0.00% 0/44 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	0.00% 0/44 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	0.00% 0/44 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period
Infections and infestations Otitis media	0.00% 0/47 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	0.00% 0/42 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	0.00% 0/44 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	2.3% 1/44 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	0.00% 0/44 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period

Other adverse events

Other adverse events
Measure	Menhibrix F1/Infanrix-penta Group n=78 participants at risk Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F2/Infanrix-penta Group n=77 participants at risk Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menhibrix F3/Infanrix-penta Group n=78 participants at risk Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menitorix/Infanrix-penta Group n=78 participants at risk Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.	Menjugate/Infanrix-hexa Group n=77 participants at risk Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/78 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	5.2% 4/77 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	0.00% 0/78 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	1.3% 1/78 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	2.6% 2/77 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period
General disorders Pain	26.9% 21/78 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	26.0% 20/77 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	28.2% 22/78 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	24.4% 19/78 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	24.7% 19/77 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period
General disorders Redness	44.9% 35/78 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	49.4% 38/77 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	64.1% 50/78 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	41.0% 32/78 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	59.7% 46/77 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period
General disorders Swelling	39.7% 31/78 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	45.5% 35/77 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	38.5% 30/78 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	34.6% 27/78 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	45.5% 35/77 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period
General disorders Drowsiness	50.0% 39/78 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	68.8% 53/77 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	55.1% 43/78 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	47.4% 37/78 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	59.7% 46/77 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period
General disorders Irritability	56.4% 44/78 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	54.5% 42/77 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	65.4% 51/78 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	60.3% 47/78 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	57.1% 44/77 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period
General disorders Loss of appetite	30.8% 24/78 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	44.2% 34/77 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	37.2% 29/78 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	42.3% 33/78 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	39.0% 30/77 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period
General disorders Fever	32.1% 25/78 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	36.4% 28/77 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	33.3% 26/78 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	35.9% 28/78 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	36.4% 28/77 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period
Gastrointestinal disorders Diarrhoea	3.8% 3/78 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	1.3% 1/77 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	2.6% 2/78 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	5.1% 4/78 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	2.6% 2/77 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period
General disorders Pyrexia	1.3% 1/78 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	0.00% 0/77 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	5.1% 4/78 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	3.8% 3/78 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	2.6% 2/77 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period
Gastrointestinal disorders Constipation	2.6% 2/78 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	0.00% 0/77 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	2.6% 2/78 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	1.3% 1/78 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	5.2% 4/77 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period
Infections and infestations Upper respiratory tract infection	10.6% 5/47 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	14.3% 6/42 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	9.1% 4/44 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	4.5% 2/44 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	9.1% 4/44 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period
Infections and infestations Bronchitis	7.7% 6/78 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	5.2% 4/77 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	2.6% 2/78 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	3.8% 3/78 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	3.9% 3/77 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period
Infections and infestations Candidiasis	7.7% 6/78 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	3.9% 3/77 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	5.1% 4/78 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	2.6% 2/78 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	3.9% 3/77 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period
Respiratory, thoracic and mediastinal disorders Rhinitis	3.8% 3/78 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	5.2% 4/77 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	3.8% 3/78 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	5.1% 4/78 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	5.2% 4/77 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period
Skin and subcutaneous tissue disorders Eczema	3.8% 3/78 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	1.3% 1/77 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	6.4% 5/78 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	1.3% 1/78 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period	5.2% 4/77 • SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

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

Restriction type: OTHER