Trial Outcomes & Findings for Immunogenicity and Safety of Meningococcal Vaccine GSK 134612 Co-administered With Pneumococcal and DTPa-HBV-IPV/Hib Vaccines (NCT NCT01144663)

Last Updated: 2020-12-31

Results Overview

The cut-off value for the rSBA-MenA, rSBA-MenW-135 and rSBA-Y titers was greater than or equal to (≥) 1:8. Indication of the immunogenicity of the 2-dose and 3-dose schedules: the lower limit of the two-sided exact 95% CI for the percentage of subjects with post-primary vaccination rSBA antibody titre ≥ 1:8 is greater than or equal to the pre-defined clinical limit of 80%.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

2095 participants

Primary outcome timeframe

One month after the final primary vaccination at Month 3

Results posted on

2020-12-31

Participant Flow

Participant milestones

Participant milestones
Measure	Nimenrix 3 Group Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.	Nimenrix 2 Group Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	Menjugate Group Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	NeisVac-C Group Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
Primary Vaccination Phase STARTED	528	524	516	527
Primary Vaccination Phase COMPLETED	508	517	508	509
Primary Vaccination Phase NOT COMPLETED	20	7	8	18
Booster Vaccination Phase STARTED	497	511	503	506
Booster Vaccination Phase COMPLETED	494	509	498	505
Booster Vaccination Phase NOT COMPLETED	3	2	5	1
Extended Safety Follow-Up (ESFU) STARTED	497	511	503	506
Extended Safety Follow-Up (ESFU) COMPLETED	492	502	496	505
Extended Safety Follow-Up (ESFU) NOT COMPLETED	5	9	7	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Nimenrix 3 Group Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.	Nimenrix 2 Group Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	Menjugate Group Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	NeisVac-C Group Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
Primary Vaccination Phase Serious adverse event, fatal	2	0	1	0
Primary Vaccination Phase Adverse Event	1	0	0	1
Primary Vaccination Phase Protocol Violation	2	0	1	0
Primary Vaccination Phase Withdrawal by Subject	9	5	3	10
Primary Vaccination Phase Migrated/moved from study area	4	1	2	3
Primary Vaccination Phase Lost to Follow-up	2	0	1	2
Primary Vaccination Phase Other	0	1	0	2
Booster Vaccination Phase Withdrawal by Subject	0	0	1	1
Booster Vaccination Phase Migrated/moved from study area	1	1	1	0
Booster Vaccination Phase Lost to Follow-up	2	1	3	0
Extended Safety Follow-Up (ESFU) Withdrawal by Subject	0	0	1	1
Extended Safety Follow-Up (ESFU) Migrated/moved from study area	1	3	1	0
Extended Safety Follow-Up (ESFU) Lost to Follow-up	4	6	5	0

Baseline Characteristics

Immunogenicity and Safety of Meningococcal Vaccine GSK 134612 Co-administered With Pneumococcal and DTPa-HBV-IPV/Hib Vaccines

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nimenrix 3 Group n=528 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.	Nimenrix 2 Group n=524 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	Menjugate Group n=516 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	NeisVac-C Group n=527 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	Total n=2095 Participants Total of all reporting groups
Age, Continuous	8.7 Weeks STANDARD_DEVIATION 1.54 • n=5 Participants	8.6 Weeks STANDARD_DEVIATION 1.52 • n=7 Participants	8.7 Weeks STANDARD_DEVIATION 1.53 • n=5 Participants	8.6 Weeks STANDARD_DEVIATION 1.49 • n=4 Participants	8.65 Weeks STANDARD_DEVIATION 1.52 • n=21 Participants
Sex: Female, Male Female	255 Participants n=5 Participants	273 Participants n=7 Participants	264 Participants n=5 Participants	251 Participants n=4 Participants	1043 Participants n=21 Participants
Sex: Female, Male Male	273 Participants n=5 Participants	251 Participants n=7 Participants	252 Participants n=5 Participants	276 Participants n=4 Participants	1052 Participants n=21 Participants
Race/Ethnicity, Customized Geographic ancestry · African heritage/African American	5 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants	1 Participants n=4 Participants	16 Participants n=21 Participants
Race/Ethnicity, Customized Geographic ancestry · American Indian or Alaskan Native	1 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	2 Participants n=4 Participants	11 Participants n=21 Participants
Race/Ethnicity, Customized Geographic ancestry · Asian-Central/South Asian heritage	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Race/Ethnicity, Customized Geographic ancestry · Asian-East Asian heritage	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants
Race/Ethnicity, Customized Geographic ancestry · Asian-South East Asian heritage	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized Geographic ancestry · Native Hawaiian or other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized Geographic ancestry · White-Arabic/North African heritage	12 Participants n=5 Participants	8 Participants n=7 Participants	10 Participants n=5 Participants	21 Participants n=4 Participants	51 Participants n=21 Participants
Race/Ethnicity, Customized Geographic ancestry · White-Caucasian/European heritage	500 Participants n=5 Participants	497 Participants n=7 Participants	486 Participants n=5 Participants	495 Participants n=4 Participants	1978 Participants n=21 Participants
Race/Ethnicity, Customized Geographic ancestry · Not specified	8 Participants n=5 Participants	9 Participants n=7 Participants	8 Participants n=5 Participants	7 Participants n=4 Participants	32 Participants n=21 Participants

PRIMARY outcome

Timeframe: One month after the final primary vaccination at Month 3

Population: The analysis was performed on the Primary According-to-Protocol (ATP) cohort for immunogenicity, including all subjects who complied with the protocol, who were administered a vaccine containing rSBA-MenA, rSBA-MenW-135 and rSBA-Y components (i.e. only Group Nimenrix 3 and Nimenrix 2) and with available data for the considered assay and time point.

Outcome measures

Outcome measures
Measure	Nimenrix 3 Group n=462 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.	Nimenrix 2 Group n=456 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	Menjugate Group Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	NeisVac-C Group Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
Percentage of Subjects With Serum Bactericidal Assay Using Baby Rabbit Complement Against Meningococcal Serogroups A, W-135 and Y (rSBA-MenA, rSBA-MenW-135 and rSBA-Y) Antibody Titers Greater Than or Equal to (≥) the Cut-off Value. rSBA-MenW-135	99.1 Percentage of Participants Interval 97.8 to 99.8	99.1 Percentage of Participants Interval 97.8 to 99.8	—	—
Percentage of Subjects With Serum Bactericidal Assay Using Baby Rabbit Complement Against Meningococcal Serogroups A, W-135 and Y (rSBA-MenA, rSBA-MenW-135 and rSBA-Y) Antibody Titers Greater Than or Equal to (≥) the Cut-off Value. rSBA-MenA	99.4 Percentage of Participants Interval 98.1 to 99.9	97.4 Percentage of Participants Interval 95.4 to 98.6	—	—
Percentage of Subjects With Serum Bactericidal Assay Using Baby Rabbit Complement Against Meningococcal Serogroups A, W-135 and Y (rSBA-MenA, rSBA-MenW-135 and rSBA-Y) Antibody Titers Greater Than or Equal to (≥) the Cut-off Value. rSBA-MenY	93.1 Percentage of Participants Interval 90.3 to 95.2	98.2 Percentage of Participants Interval 96.6 to 99.2	—	—

PRIMARY outcome

Timeframe: One month after the final primary vaccination at Month 3

Population: The analysis was performed on the Primary ATP cohort for immunogenicity, which included all evaluable subjects who complied with the vaccination schedule for Visit 1, 2 and 3 (Day 0 to Month 2)and with the blood sample schedule for Visit 4 (Month 3).

The cut-off value for rSBA-MenC titers was ≥ 1:8.

Outcome measures

Outcome measures
Measure	Nimenrix 3 Group n=461 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.	Nimenrix 2 Group n=456 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	Menjugate Group n=455 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	NeisVac-C Group n=457 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
Number of Subjects With rSBA-MenC Antibody Titers ≥ the Cut-off Value	459 Participants	450 Participants	453 Participants	457 Participants

SECONDARY outcome

Timeframe: Pre-primary vaccination at Month 0

Population: The analysis was performed on the Primary ATP cohort for immunogenicity, which included all evaluable subjects who complied with the vaccination schedule for a randomized subset of 50% subjects for each of the 4 serogroups in the investigational groups, and in a randomized subset of 50% and 25% subjects for MenC, MenA, MenW, MenY in control groups.

The cut-off values for rSBA-Men antibody titers were greater than or equal to (≥) 1:8 and ≥ 1:128 at pre-vaccination

Outcome measures

Outcome measures
Measure	Nimenrix 3 Group n=223 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.	Nimenrix 2 Group n=220 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	Menjugate Group n=207 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	NeisVac-C Group n=220 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Cut-off Values rSBA-MenY ≥ 1:128	0 Participants	3 Participants	1 Participants	1 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Cut-off Values rSBA-MenA ≥ 1:8	2 Participants	4 Participants	2 Participants	2 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Cut-off Values rSBA-MenA ≥ 1:128	1 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Cut-off Values rSBA-MenC ≥ 1:8	12 Participants	10 Participants	15 Participants	14 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Cut-off Values rSBA-MenC ≥ 1:128	2 Participants	1 Participants	6 Participants	5 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Cut-off Values rSBA-MenW-135 ≥ 1:8	8 Participants	12 Participants	5 Participants	3 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Cut-off Values rSBA-MenW-135 ≥ 1:128	0 Participants	1 Participants	1 Participants	1 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Cut-off Values rSBA-MenY ≥ 1:8	6 Participants	6 Participants	8 Participants	3 Participants

SECONDARY outcome

Timeframe: Pre-primary vaccination at Month 0

Antibody titers were presented as geometric mean titers (GMTs).

Outcome measures

Outcome measures
Measure	Nimenrix 3 Group n=223 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.	Nimenrix 2 Group n=220 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	Menjugate Group n=207 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	NeisVac-C Group n=220 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers rSBA-MenA	4.1 Titers Interval 4.0 to 4.2	4.1 Titers Interval 4.0 to 4.2	4.1 Titers Interval 4.0 to 4.3	4.1 Titers Interval 3.9 to 4.3
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers rSBA-MenC	4.4 Titers Interval 4.1 to 4.8	4.3 Titers Interval 4.1 to 4.5	4.9 Titers Interval 4.4 to 5.5	4.7 Titers Interval 4.3 to 5.2
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers rSBA-MenW-135	4.3 Titers Interval 4.1 to 4.5	4.4 Titers Interval 4.1 to 4.6	4.3 Titers Interval 3.9 to 4.8	4.3 Titers Interval 3.9 to 4.7
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers rSBA-MenY	4.2 Titers Interval 4.0 to 4.4	4.2 Titers Interval 4.0 to 4.5	4.7 Titers Interval 4.2 to 5.2	4.2 Titers Interval 3.9 to 4.6

SECONDARY outcome

Timeframe: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11

Population: The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects who complied with the vaccination schedule for Visit 5 (Month 10) and with blood sample schedule for Visit 6 (Month 11).

The cut-off values for the rSBA-Men antibody titers were greater than or equal to (≥) 1:8 and ≥ 1:128.

Outcome measures

Outcome measures
Measure	Nimenrix 3 Group n=441 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.	Nimenrix 2 Group n=463 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	Menjugate Group n=446 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	NeisVac-C Group n=461 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off Values rSBA-MenW-135 ≥ 1:8, Month 10	372 Participants	417 Participants	18 Participants	27 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off Values rSBA-MenA ≥ 1:8, Month 10	300 Participants	279 Participants	26 Participants	23 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off Values rSBA-MenA ≥ 1:128, Month 10	107 Participants	99 Participants	11 Participants	3 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off Values rSBA-MenA ≥ 1:8, Month 11	437 Participants	460 Participants	21 Participants	19 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off Values rSBA-MenA ≥ 1:128, Month 11	433 Participants	456 Participants	8 Participants	12 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off Values rSBA-MenC ≥ 1:8, Month 10	324 Participants	348 Participants	229 Participants	356 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off Values rSBA-MenC ≥ 1:128, Month 10	108 Participants	183 Participants	79 Participants	195 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off Values rSBA-MenC ≥ 1:8, Month 11	437 Participants	462 Participants	439 Participants	459 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off Values rSBA-MenC ≥ 1:128, Month 11	432 Participants	454 Participants	426 Participants	457 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off Values rSBA-MenW-135 ≥ 1:128, Month 10	221 Participants	254 Participants	16 Participants	22 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off Values rSBA-MenW-135 ≥ 1:8, Month 11	433 Participants	461 Participants	34 Participants	37 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off Values rSBA-MenW-135 ≥ 1:128, Month 11	430 Participants	457 Participants	31 Participants	31 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off Values rSBA-MenY ≥ 1:8, Month 10	364 Participants	383 Participants	54 Participants	47 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off Values rSBA-MenY ≥ 1:128, Month 10	126 Participants	168 Participants	41 Participants	37 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off Values rSBA-MenY ≥ 1:8, Month 11	436 Participants	459 Participants	45 Participants	40 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off Values rSBA-MenY ≥ 1:128, Month 11	419 Participants	445 Participants	37 Participants	34 Participants

SECONDARY outcome

Timeframe: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11

Antibody titers were presented as geometric mean titers (GMTs).

Outcome measures

Outcome measures
Measure	Nimenrix 3 Group n=441 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.	Nimenrix 2 Group n=463 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	Menjugate Group n=446 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	NeisVac-C Group n=461 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers rSBA-MenA, Month 10	22.9 Titers Interval 19.8 to 26.5	19.5 Titers Interval 16.8 to 22.6	4.7 Titers Interval 4.3 to 5.0	4.4 Titers Interval 4.2 to 4.6
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers rSBA-MenA, Month 11	1417.6 Titers Interval 1281.4 to 1568.3	1561.0 Titers Interval 1412.3 to 1725.3	4.6 Titers Interval 4.3 to 4.9	4.7 Titers Interval 4.3 to 5.0
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers rSBA-MenC, Month 10	25.7 Titers Interval 22.3 to 29.6	43.7 Titers Interval 37.4 to 51.1	16.0 Titers Interval 13.8 to 18.5	49.3 Titers Interval 42.1 to 57.7
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers rSBA-MenC, Month 11	1154.6 Titers Interval 1034.1 to 1289.0	1177.0 Titers Interval 1059.1 to 1308.0	1051.4 Titers Interval 919.6 to 1202.1	1960.2 Titers Interval 1776.4 to 2163.1
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers rSBA-MenW-135, Month 10	68.7 Titers Interval 58.3 to 81.0	97.7 Titers Interval 83.3 to 114.5	4.7 Titers Interval 4.4 to 5.1	5.0 Titers Interval 4.6 to 5.5
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers rSBA-MenW-135, Month 11	1955.9 Titers Interval 1729.6 to 2211.9	2777.2 Titers Interval 2485.1 to 3103.6	5.5 Titers Interval 5.0 to 6.1	5.6 Titers Interval 5.0 to 6.2
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers rSBA-MenY, Month 10	35.4 Titers Interval 30.6 to 41.0	47.0 Titers Interval 40.3 to 54.7	6.5 Titers Interval 5.7 to 7.4	6.0 Titers Interval 5.4 to 6.8
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers rSBA-MenY, Month 11	630.6 Titers Interval 564.1 to 705.1	881.3 Titers Interval 787.5 to 986.4	6.1 Titers Interval 5.4 to 6.8	5.8 Titers Interval 5.2 to 6.6

SECONDARY outcome

Timeframe: Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3

Population: The analysis was performed on the Primary ATP cohort for immunogenicity, which included all the evaluable subjects who used hSBA complement and who complied with the vaccination schedule for Visit 1, 2 and 3 (Day 0 to Month 2) and with the blood sample schedule for Visit 4 (Month 3).

The cut-off values for hSBA antibody titers were greater than or equal to (≥) 1:4 and ≥ 1:8.

Outcome measures

Outcome measures
Measure	Nimenrix 3 Group n=214 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.	Nimenrix 2 Group n=218 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	Menjugate Group n=205 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	NeisVac-C Group n=226 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off Values hSBA-MenA ≥ 1:4, Month 0	34 Participants	31 Participants	41 Participants	34 Participants
Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off Values hSBA-MenA ≥ 1:8, Month 0	28 Participants	19 Participants	27 Participants	27 Participants
Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off Values hSBA-MenA ≥ 1:4, Month 3	197 Participants	195 Participants	21 Participants	18 Participants
Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off Values hSBA-MenA ≥ 1:8, Month 3	196 Participants	195 Participants	15 Participants	14 Participants
Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off Values hSBA-MenC ≥ 1:4, Month 0	43 Participants	35 Participants	50 Participants	44 Participants
Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off Values hSBA-MenC ≥ 1:8, Month 0	43 Participants	35 Participants	49 Participants	42 Participants
Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off Values hSBA-MenC ≥ 1:4, Month 3	213 Participants	215 Participants	202 Participants	226 Participants
Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off Values hSBA-MenC ≥ 1:8, Month 3	213 Participants	215 Participants	202 Participants	226 Participants
Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off Values hSBA-MenW-135 ≥ 1:4, Month 0	50 Participants	46 Participants	54 Participants	37 Participants
Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off Values hSBA-MenW-135 ≥ 1:8, Month 0	49 Participants	44 Participants	52 Participants	36 Participants
Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off Values hSBA-MenW-135 ≥ 1:4, Month 3	197 Participants	217 Participants	6 Participants	3 Participants
Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off Values hSBA-MenW-135 ≥ 1:8, Month 3	197 Participants	217 Participants	4 Participants	3 Participants
Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off Values hSBA-MenY ≥ 1:4, Month 0	73 Participants	73 Participants	71 Participants	78 Participants
Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off Values hSBA-MenY ≥ 1:8, Month 0	73 Participants	72 Participants	71 Participants	77 Participants
Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off Values hSBA-MenY ≥ 1:4, Month 3	187 Participants	209 Participants	11 Participants	5 Participants
Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off Values hSBA-MenY ≥ 1:8, Month 3	185 Participants	209 Participants	11 Participants	4 Participants

SECONDARY outcome

Timeframe: Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3

Antibody titers were presented as geometric mean titers (GMTs).

Outcome measures

Outcome measures
Measure	Nimenrix 3 Group n=214 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.	Nimenrix 2 Group n=218 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	Menjugate Group n=205 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	NeisVac-C Group n=226 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers hSBA-MenW-135, Month 3	190.9 Titers Interval 160.0 to 227.8	753.5 Titers Interval 643.8 to 881.8	2.1 Titers Interval 2.0 to 2.3	2.1 Titers Interval 2.0 to 2.3
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers hSBA-MenY, Month 0	8 Titers Interval 6.1 to 10.5	8 Titers Interval 6.1 to 10.5	7.1 Titers Interval 5.5 to 9.2	8.1 Titers Interval 6.3 to 10.4
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers hSBA-MenA, Month 0	2.8 Titers Interval 2.5 to 3.2	2.7 Titers Interval 2.4 to 3.0	3 Titers Interval 2.7 to 3.4	2.9 Titers Interval 2.6 to 3.3
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers hSBA-MenA, Month 3	240.9 Titers Interval 207.8 to 279.3	157.2 Titers Interval 131.4 to 188.1	2.5 Titers Interval 2.2 to 2.7	2.3 Titers Interval 2.2 to 2.5
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers hSBA-MenC, Month 0	3.9 Titers Interval 3.2 to 4.7	3.6 Titers Interval 3.0 to 4.4	4.9 Titers Interval 3.9 to 6.2	3.9 Titers Interval 3.2 to 4.7
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers hSBA-MenC, Month 3	765.6 Titers Interval 647.4 to 905.3	1308.3 Titers Interval 1051.7 to 1627.4	3188.1 Titers Interval 2645.8 to 3841.5	2626.5 Titers Interval 2218.9 to 3109.0
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers hSBA-MenW-135, Month 0	5 Titers Interval 3.9 to 6.3	4.7 Titers Interval 3.8 to 6.0	5 Titers Interval 4.0 to 6.3	3.7 Titers Interval 3.1 to 4.6
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers hSBA-MenY, Month 3	66.5 Titers Interval 53.7 to 82.2	328.1 Titers Interval 275.8 to 390.2	2.4 Titers Interval 2.1 to 2.7	2.1 Titers Interval 2.0 to 2.2

SECONDARY outcome

Timeframe: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11

Population: The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects who used hSBA complement and who complied with the vaccination schedule for Visit 5 (Month 10) and with blood sample schedule for Visit 6 (Month 11).

The cut-off values for hSBA antibody titers were greater than or equal to (≥) 1:4 and ≥ 1:8.

Outcome measures

Outcome measures
Measure	Nimenrix 3 Group n=213 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.	Nimenrix 2 Group n=221 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	Menjugate Group n=219 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	NeisVac-C Group n=219 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off Values hSBA-MenC ≥ 1:8, Month 10	184 Participants	198 Participants	160 Participants	196 Participants
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off Values hSBA-MenW-135 ≥ 1:4, Month 10	196 Participants	201 Participants	1 Participants	6 Participants
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off Values hSBA-MenW-135 ≥ 1:4, Month 11	207 Participants	218 Participants	3 Participants	6 Participants
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off Values hSBA-MenA ≥ 1:4, Month 10	142 Participants	119 Participants	28 Participants	26 Participants
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off Values hSBA-MenA ≥ 1:8, Month 10	141 Participants	119 Participants	26 Participants	26 Participants
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off Values hSBA-MenA ≥ 1:4, Month 11	210 Participants	213 Participants	50 Participants	55 Participants
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off Values hSBA-MenA ≥ 1:8, Month 11	210 Participants	213 Participants	50 Participants	55 Participants
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off Values hSBA-MenC ≥ 1:4, Month 10	184 Participants	198 Participants	160 Participants	196 Participants
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off Values hSBA-MenC ≥ 1:4, Month 11	212 Participants	220 Participants	216 Participants	219 Participants
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off Values hSBA-MenC ≥ 1:8, Month 11	212 Participants	220 Participants	216 Participants	219 Participants
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off Values hSBA-MenW-135 ≥ 1:8, Month 10	196 Participants	201 Participants	1 Participants	6 Participants
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off Values hSBA-MenW-135 ≥ 1:8, Month 11	207 Participants	218 Participants	3 Participants	6 Participants
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off Values hSBA-MenY ≥ 1:4, Month 10	185 Participants	204 Participants	6 Participants	10 Participants
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off Values hSBA-MenY ≥ 1:8, Month 10	185 Participants	204 Participants	6 Participants	10 Participants
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off Values hSBA-MenY ≥ 1:4, Month 11	206 Participants	217 Participants	7 Participants	12 Participants
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off Values hSBA-MenY ≥ 1:8, Month 11	206 Participants	217 Participants	7 Participants	12 Participants

SECONDARY outcome

Timeframe: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11

Antibody titers were presented as geometric mean titers (GMTs).

Outcome measures

Outcome measures
Measure	Nimenrix 3 Group n=213 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.	Nimenrix 2 Group n=221 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	Menjugate Group n=219 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	NeisVac-C Group n=219 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers hSBA-MenA, Month 10	32.0 Titers Interval 24.2 to 42.2	14.5 Titers Interval 11.2 to 18.7	2.7 Titers Interval 2.4 to 3.0	2.7 Titers Interval 2.4 to 3.1
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers hSBA-MenC, Month 10	116.1 Titers Interval 94.2 to 143.0	181.4 Titers Interval 147.3 to 223.4	76.8 Titers Interval 58.5 to 100.8	213.7 Titers Interval 174.6 to 261.7
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers hSBA-MenC, Month 11	4411.2 Titers Interval 3654.5 to 5324.6	4992.3 Titers Interval 4085.7 to 6100.0	5438.2 Titers Interval 4412.4 to 6702.3	5542.3 Titers Interval 4765.2 to 6446.2
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers hSBA-MenW-135, Month 10	248.1 Titers Interval 210.4 to 292.6	332.4 Titers Interval 287.3 to 384.5	2.0 Titers Interval 2.0 to 2.1	2.3 Titers Interval 2.0 to 2.6
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers hSBA-MenW-135, Month 11	3944.9 Titers Interval 3419.1 to 4551.7	5122.7 Titers Interval 4504.2 to 5826.1	2.1 Titers Interval 2.0 to 2.2	2.3 Titers Interval 2.1 to 2.7
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers hSBA-MenY, Month 11	2491.5 Titers Interval 2125.8 to 2920.1	2954.0 Titers Interval 2497.9 to 3493.3	2.3 Titers Interval 2.1 to 2.6	2.4 Titers Interval 2.2 to 2.7
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers hSBA-MenA, Month 11	1192.7 Titers Interval 978.4 to 1453.9	1007.2 Titers Interval 835.7 to 1213.8	3.9 Titers Interval 3.3 to 4.6	4.2 Titers Interval 3.5 to 5.0
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers hSBA-MenY, Month 10	99.8 Titers Interval 80.7 to 123.5	140.2 Titers Interval 116.2 to 169.2	2.2 Titers Interval 2.0 to 2.4	2.4 Titers Interval 2.1 to 2.7

SECONDARY outcome

Timeframe: Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3

Population: The analysis was performed on the Primary ATP cohort for immunogenicity, which included all the evaluable subjects who complied with the vaccination schedule for Visit 1, 2 and 3 (Day 0 to Month 2) and with the blood sample schedule for Visit 4 (Month 3), as assessed for a randomized subset of 25% of subjects.

The cut-off values for anti-1, anti-4, anti-5, anti-6B, anti-7F, anti-9V, anti-14, anti-18C, anti-19F and anti-23F concentrations were greater than or equal to (≥) 0.15 micrograms per milliliter (µg/mL) and ≥ 0.35 µg/mL

Outcome measures

Outcome measures
Measure	Nimenrix 3 Group n=98 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.	Nimenrix 2 Group n=104 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	Menjugate Group n=95 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	NeisVac-C Group n=103 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
Number of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off Values Anti-1 ≥ 0.15 µg/mL, Month 0	18 Participants	15 Participants	17 Participants	18 Participants
Number of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off Values Anti-1 ≥ 0.35 µg/mL, Month 0	3 Participants	9 Participants	8 Participants	8 Participants
Number of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off Values Anti-1 ≥ 0.15 µg/mL, Month 3	96 Participants	102 Participants	93 Participants	103 Participants
Number of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off Values Anti-1 ≥ 0.35 µg/mL, Month 3	93 Participants	95 Participants	89 Participants	91 Participants
Number of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off Values Anti-4 ≥ 0.15 µg/mL, Month 0	11 Participants	11 Participants	13 Participants	12 Participants
Number of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off Values Anti-9V ≥ 0.15 µg/mL, Month 3	94 Participants	102 Participants	90 Participants	103 Participants
Number of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off Values Anti-18C ≥ 0.15 µg/mL, Month 3	96 Participants	101 Participants	93 Participants	103 Participants
Number of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off Values Anti-23F ≥ 0.15 µg/mL, Month 3	90 Participants	99 Participants	91 Participants	98 Participants
Number of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off Values Anti-18C ≥ 0.15 µg/mL, Month 0	30 Participants	44 Participants	45 Participants	43 Participants
Number of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off Values Anti-18C ≥ 0.35 µg/mL, Month 0	14 Participants	18 Participants	20 Participants	10 Participants
Number of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off Values Anti-4 ≥ 0.35 µg/mL, Month 0	2 Participants	2 Participants	2 Participants	1 Participants
Number of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off Values Anti-4 ≥ 0.15 µg/mL, Month 3	96 Participants	102 Participants	95 Participants	103 Participants
Number of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off Values Anti-18C ≥ 0.35 µg/mL, Month 3	90 Participants	100 Participants	89 Participants	101 Participants
Number of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off Values Anti-4 ≥ 0.35 µg/mL, Month 3	94 Participants	99 Participants	93 Participants	99 Participants
Number of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off Values Anti-5 ≥ 0.15 µg/mL, Month 0	42 Participants	32 Participants	39 Participants	33 Participants
Number of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off Values Anti-5 ≥ 0.35 µg/mL, Month 0	10 Participants	5 Participants	9 Participants	14 Participants
Number of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off Values Anti-5 ≥ 0.15 µg/mL, Month 3	95 Participants	102 Participants	93 Participants	101 Participants
Number of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off Values Anti-5 ≥ 0.35 µg/mL, Month 3	84 Participants	86 Participants	80 Participants	92 Participants
Number of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off Values Anti-6B ≥ 0.15 µg/mL, Month 0	55 Participants	42 Participants	41 Participants	50 Participants
Number of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off Values Anti-6B ≥ 0.35 µg/mL, Month 0	27 Participants	19 Participants	20 Participants	26 Participants
Number of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off Values Anti-6B ≥ 0.15 µg/mL, Month 3	88 Participants	95 Participants	88 Participants	90 Participants
Number of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off Values Anti-6B ≥ 0.35 µg/mL, Month 3	71 Participants	82 Participants	75 Participants	81 Participants
Number of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off Values Anti-7F ≥ 0.15 µg/mL, Month 0	38 Participants	43 Participants	44 Participants	49 Participants
Number of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off Values Anti-19F ≥ 0.15 µg/mL, Month 0	41 Participants	61 Participants	51 Participants	53 Participants
Number of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off Values Anti-7F ≥ 0.35 µg/mL, Month 0	13 Participants	18 Participants	20 Participants	16 Participants
Number of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off Values Anti-19F ≥ 0.35 µg/mL, Month 0	21 Participants	30 Participants	27 Participants	23 Participants
Number of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off Values Anti-19F ≥ 0.15 µg/mL, Month 3	94 Participants	100 Participants	94 Participants	102 Participants
Number of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off Values Anti-19F ≥ 0.35 µg/mL, Month 3	92 Participants	94 Participants	90 Participants	99 Participants
Number of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off Values Anti-7F ≥ 0.15 µg/mL, Month 3	96 Participants	102 Participants	93 Participants	103 Participants
Number of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off Values Anti-23F ≥ 0.15 µg/mL, Month 0	37 Participants	38 Participants	29 Participants	40 Participants
Number of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off Values Anti-23F ≥ 0.35 µg/mL, Month 0	16 Participants	13 Participants	13 Participants	18 Participants
Number of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off Values Anti-23F ≥ 0.35 µg/mL, Month 3	83 Participants	83 Participants	77 Participants	86 Participants
Number of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off Values Anti-7F ≥ 0.35 µg/mL, Month 3	94 Participants	99 Participants	93 Participants	103 Participants
Number of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off Values Anti-9V ≥ 0.15 µg/mL, Month 0	38 Participants	44 Participants	35 Participants	43 Participants
Number of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off Values Anti-9V ≥ 0.35 µg/mL, Month 0	9 Participants	18 Participants	12 Participants	16 Participants
Number of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off Values Anti-9V ≥ 0.35 µg/mL, Month 3	92 Participants	99 Participants	88 Participants	99 Participants
Number of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off Values Anti-14 ≥ 0.15 µg/mL, Month 0	72 Participants	69 Participants	74 Participants	80 Participants
Number of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off Values Anti-14 ≥ 0.35 µg/mL, Month 0	53 Participants	57 Participants	57 Participants	67 Participants
Number of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off Values Anti-14 ≥ 0.15 µg/mL, Month 3	96 Participants	103 Participants	95 Participants	103 Participants
Number of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off Values Anti-14 ≥ 0.35 µg/mL, Month 3	96 Participants	103 Participants	95 Participants	103 Participants

SECONDARY outcome

Timeframe: Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3

Anti-1, anti-4, anti-5, anti-6B, anti-7F, anti-9V, anti-14, anti-18C, anti-19F and anti-23F antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in µg/mL.

Outcome measures

Outcome measures
Measure	Nimenrix 3 Group n=98 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.	Nimenrix 2 Group n=104 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	Menjugate Group n=95 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	NeisVac-C Group n=103 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
Anti-pneumococcal Serotypes Antibody Concentrations Anti-1, Month 0	0.09 µg/mL Interval 0.08 to 0.1	0.10 µg/mL Interval 0.09 to 0.12	0.10 µg/mL Interval 0.09 to 0.12	0.10 µg/mL Interval 0.09 to 0.11
Anti-pneumococcal Serotypes Antibody Concentrations Anti-1, Month 3	1.36 µg/mL Interval 1.15 to 1.62	1.13 µg/mL Interval 0.96 to 1.34	1.26 µg/mL Interval 1.06 to 1.5	1.02 µg/mL Interval 0.88 to 1.18
Anti-pneumococcal Serotypes Antibody Concentrations Anti-4, Month 0	0.09 µg/mL Interval 0.08 to 0.09	0.09 µg/mL Interval 0.08 to 0.09	0.09 µg/mL Interval 0.08 to 0.1	0.09 µg/mL Interval 0.08 to 0.09
Anti-pneumococcal Serotypes Antibody Concentrations Anti-4, Month 3	1.84 µg/mL Interval 1.58 to 2.15	1.56 µg/mL Interval 1.31 to 1.86	1.77 µg/mL Interval 1.5 to 2.1	1.60 µg/mL Interval 1.37 to 1.85
Anti-pneumococcal Serotypes Antibody Concentrations Anti-5, Month 0	0.13 µg/mL Interval 0.11 to 0.15	0.12 µg/mL Interval 0.1 to 0.13	0.13 µg/mL Interval 0.11 to 0.15	0.12 µg/mL Interval 0.11 to 0.15
Anti-pneumococcal Serotypes Antibody Concentrations Anti-5, Month 3	0.82 µg/mL Interval 0.71 to 0.95	0.70 µg/mL Interval 0.61 to 0.81	0.77 µg/mL Interval 0.66 to 0.89	0.74 µg/mL Interval 0.65 to 0.85
Anti-pneumococcal Serotypes Antibody Concentrations Anti-6B, Month 0	0.18 µg/mL Interval 0.15 to 0.21	0.15 µg/mL Interval 0.13 to 0.19	0.15 µg/mL Interval 0.13 to 0.19	0.18 µg/mL Interval 0.15 to 0.22
Anti-pneumococcal Serotypes Antibody Concentrations Anti-6B, Month 3	0.79 µg/mL Interval 0.62 to 1.0	0.90 µg/mL Interval 0.71 to 1.14	1.08 µg/mL Interval 0.84 to 1.38	0.86 µg/mL Interval 0.67 to 1.12
Anti-pneumococcal Serotypes Antibody Concentrations Anti-7F, Month 0	0.13 µg/mL Interval 0.11 to 0.16	0.17 µg/mL Interval 0.13 to 0.21	0.16 µg/mL Interval 0.13 to 0.2	0.15 µg/mL Interval 0.13 to 0.18
Anti-pneumococcal Serotypes Antibody Concentrations Anti-7F, Month 3	1.91 µg/mL Interval 1.63 to 2.23	1.84 µg/mL Interval 1.56 to 2.18	2.13 µg/mL Interval 1.82 to 2.49	1.87 µg/mL Interval 1.62 to 2.15
Anti-pneumococcal Serotypes Antibody Concentrations Anti-9V, Month 0	0.13 µg/mL Interval 0.11 to 0.15	0.15 µg/mL Interval 0.13 to 0.18	0.13 µg/mL Interval 0.11 to 0.15	0.14 µg/mL Interval 0.12 to 0.17
Anti-pneumococcal Serotypes Antibody Concentrations Anti-9V, Month 3	1.31 µg/mL Interval 1.1 to 1.56	1.12 µg/mL Interval 0.97 to 1.29	1.22 µg/mL Interval 1.02 to 1.46	1.21 µg/mL Interval 1.07 to 1.38
Anti-pneumococcal Serotypes Antibody Concentrations Anti-14, Month 0	0.50 µg/mL Interval 0.37 to 0.67	0.61 µg/mL Interval 0.44 to 0.85	0.59 µg/mL Interval 0.44 to 0.79	0.74 µg/mL Interval 0.56 to 0.99
Anti-pneumococcal Serotypes Antibody Concentrations Anti-14, Month 3	7.55 µg/mL Interval 6.4 to 8.9	7.40 µg/mL Interval 6.35 to 8.62	8.51 µg/mL Interval 7.09 to 10.22	6.04 µg/mL Interval 5.04 to 7.24
Anti-pneumococcal Serotypes Antibody Concentrations Anti-18C, Month 0	0.13 µg/mL Interval 0.11 to 0.16	0.16 µg/mL Interval 0.13 to 0.2	0.17 µg/mL Interval 0.14 to 0.21	0.14 µg/mL Interval 0.12 to 0.16
Anti-pneumococcal Serotypes Antibody Concentrations Anti-18C, Month 3	2.14 µg/mL Interval 1.74 to 2.64	1.77 µg/mL Interval 1.47 to 2.13	2.39 µg/mL Interval 1.96 to 2.93	2.80 µg/mL Interval 2.4 to 3.27
Anti-pneumococcal Serotypes Antibody Concentrations Anti-19F, Month 0	0.15 µg/mL Interval 0.13 to 0.19	0.23 µg/mL Interval 0.19 to 0.28	0.20 µg/mL Interval 0.16 to 0.25	0.19 µg/mL Interval 0.15 to 0.23
Anti-pneumococcal Serotypes Antibody Concentrations Anti-19F, Month 3	3.01 µg/mL Interval 2.37 to 3.82	2.60 µg/mL Interval 2.01 to 3.35	2.89 µg/mL Interval 2.26 to 3.69	2.85 µg/mL Interval 2.29 to 3.54
Anti-pneumococcal Serotypes Antibody Concentrations Anti-23F, Month 0	0.14 µg/mL Interval 0.11 to 0.16	0.14 µg/mL Interval 0.11 to 0.17	0.13 µg/mL Interval 0.11 to 0.15	0.15 µg/mL Interval 0.12 to 0.17
Anti-pneumococcal Serotypes Antibody Concentrations Anti-23F, Month 3	0.96 µg/mL Interval 0.78 to 1.18	0.85 µg/mL Interval 0.69 to 1.06	1.08 µg/mL Interval 0.86 to 1.36	0.94 µg/mL Interval 0.77 to 1.16

SECONDARY outcome

Timeframe: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11

Population: The analysis was performed on the Booster ATP cohort for immunogenicity, which included all the evaluable subjects who complied with the vaccination schedule for Visit 5 (Month 10) and with blood sample schedule for Visit 6 (Month 11), as assessed for a randomized subset of 25% of subjects.

The cut-off values for anti-1, anti-4, anti-5, anti-6B, anti-7F, anti-9V, anti-14, anti-18C, anti-19F and anti-23F concentrations were ≥ 0.15 µg/mL and ≥ 0.35 µg/mL

Outcome measures

Outcome measures
Measure	Nimenrix 3 Group n=104 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.	Nimenrix 2 Group n=107 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	Menjugate Group n=106 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	NeisVac-C Group n=110 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
Number of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off Values Anti-7F ≥ 0.15 µg/mL, Month 10	98 Participants	103 Participants	106 Participants	104 Participants
Number of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off Values Anti-6B ≥ 0.35 µg/mL, Month 10	71 Participants	84 Participants	83 Participants	83 Participants
Number of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off Values Anti-6B ≥ 0.15 µg/mL, Month 11	103 Participants	106 Participants	100 Participants	104 Participants
Number of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off Values Anti-6B ≥ 0.35 µg/mL, Month 11	103 Participants	105 Participants	100 Participants	104 Participants
Number of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off Values Anti-5 ≥ 0.35 µg/mL, Month 11	92 Participants	96 Participants	95 Participants	96 Participants
Number of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off Values Anti-6B ≥ 0.15 µg/mL, Month 10	96 Participants	104 Participants	104 Participants	103 Participants
Number of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off Values Anti-1 ≥ 0.15 µg/mL, Month 10	65 Participants	64 Participants	72 Participants	57 Participants
Number of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off Values Anti-1 ≥ 0.35 µg/mL, Month 10	21 Participants	20 Participants	24 Participants	10 Participants
Number of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off Values Anti-1 ≥ 0.15 µg/mL, Month 11	104 Participants	106 Participants	99 Participants	103 Participants
Number of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off Values Anti-1 ≥ 0.35 µg/mL, Month 11	102 Participants	104 Participants	97 Participants	101 Participants
Number of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off Values Anti-4 ≥ 0.15 µg/mL, Month 10	83 Participants	87 Participants	91 Participants	94 Participants
Number of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off Values Anti-4 ≥ 0.35 µg/mL, Month 10	38 Participants	35 Participants	48 Participants	30 Participants
Number of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off Values Anti-4 ≥ 0.15 µg/mL, Month 11	104 Participants	107 Participants	100 Participants	104 Participants
Number of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off Values Anti-4 ≥ 0.35 µg/mL, Month 11	104 Participants	107 Participants	99 Participants	104 Participants
Number of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off Values Anti-5 ≥ 0.15 µg/mL, Month 10	90 Participants	91 Participants	94 Participants	93 Participants
Number of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off Values Anti-5 ≥ 0.35 µg/mL, Month 10	44 Participants	43 Participants	48 Participants	43 Participants
Number of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off Values Anti-5 ≥ 0.15 µg/mL, Month 11	101 Participants	104 Participants	98 Participants	101 Participants
Number of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off Values Anti-7F ≥ 0.35 µg/mL, Month 10	76 Participants	78 Participants	75 Participants	78 Participants
Number of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off Values Anti-7F ≥ 0.15 µg/mL, Month 11	104 Participants	107 Participants	100 Participants	104 Participants
Number of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off Values Anti-7F ≥ 0.35 µg/mL, Month 11	104 Participants	107 Participants	100 Participants	104 Participants
Number of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off Values Anti-9V ≥ 0.15 µg/mL, Month 10	81 Participants	82 Participants	88 Participants	89 Participants
Number of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off Values Anti-9V ≥ 0.35 µg/mL, Month 10	42 Participants	30 Participants	43 Participants	33 Participants
Number of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off Values Anti-9V ≥ 0.15 µg/mL, Month 11	104 Participants	107 Participants	100 Participants	104 Participants
Number of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off Values Anti-9V ≥ 0.35 µg/mL, Month 11	102 Participants	105 Participants	99 Participants	102 Participants
Number of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off Values Anti-14 ≥ 0.15 µg/mL, Month 10	102 Participants	106 Participants	106 Participants	106 Participants
Number of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off Values Anti-14 ≥ 0.35 µg/mL, Month 10	100 Participants	103 Participants	99 Participants	103 Participants
Number of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off Values Anti-14 ≥ 0.15 µg/mL, Month 11	104 Participants	107 Participants	100 Participants	104 Participants
Number of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off Values Anti-14 ≥ 0.35 µg/mL, Month 11	104 Participants	107 Participants	100 Participants	104 Participants
Number of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off Values Anti-18C ≥ 0.15 µg/mL, Month 10	82 Participants	89 Participants	97 Participants	101 Participants
Number of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off Values Anti-18C ≥ 0.35 µg/mL, Month 10	45 Participants	50 Participants	54 Participants	58 Participants
Number of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off Values Anti-18C ≥ 0.15 µg/mL, Month 11	103 Participants	107 Participants	100 Participants	104 Participants
Number of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off Values Anti-18C ≥ 0.35 µg/mL, Month 11	103 Participants	106 Participants	100 Participants	104 Participants
Number of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off Values Anti-19F ≥ 0.15 µg/mL, Month 10	102 Participants	107 Participants	106 Participants	107 Participants
Number of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off Values Anti-19F ≥ 0.35 µg/mL, Month 10	96 Participants	98 Participants	103 Participants	102 Participants
Number of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off Values Anti-19F ≥ 0.15 µg/mL, Month 11	104 Participants	107 Participants	100 Participants	104 Participants
Number of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off Values Anti-19F ≥ 0.35 µg/mL, Month 11	104 Participants	107 Participants	100 Participants	104 Participants
Number of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off Values Anti-23F ≥ 0.15 µg/mL, Month 10	94 Participants	103 Participants	102 Participants	101 Participants
Number of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off Values Anti-23F ≥ 0.35 µg/mL, Month 10	58 Participants	61 Participants	63 Participants	63 Participants
Number of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off Values Anti-23F ≥ 0.15 µg/mL, Month 11	101 Participants	106 Participants	98 Participants	104 Participants
Number of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off Values Anti-23F ≥ 0.35 µg/mL, Month 11	101 Participants	106 Participants	98 Participants	104 Participants

SECONDARY outcome

Timeframe: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11

Anti-1, anti-4, anti-5, anti-6B, anti-7F, anti-9V, anti-14, anti-18C, anti-19F and anti-23F antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in µg/mL.

Outcome measures

Outcome measures
Measure	Nimenrix 3 Group n=104 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.	Nimenrix 2 Group n=107 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	Menjugate Group n=106 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	NeisVac-C Group n=110 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
Anti-pneumococcal Serotypes Antibody Concentrations Anti-7F, Month 11	2.89 µg/mL Interval 2.53 to 3.3	2.88 µg/mL Interval 2.51 to 3.31	3.38 µg/mL Interval 2.94 to 3.89	2.78 µg/mL Interval 2.43 to 3.17
Anti-pneumococcal Serotypes Antibody Concentrations Anti-1, Month 10	0.19 µg/mL Interval 0.16 to 0.22	0.17 µg/mL Interval 0.15 to 0.2	0.20 µg/mL Interval 0.17 to 0.23	0.15 µg/mL Interval 0.13 to 0.17
Anti-pneumococcal Serotypes Antibody Concentrations Anti-1, Month 11	2.03 µg/mL Interval 1.72 to 2.41	1.67 µg/mL Interval 1.39 to 2.01	2.18 µg/mL Interval 1.81 to 2.64	1.72 µg/mL Interval 1.46 to 2.03
Anti-pneumococcal Serotypes Antibody Concentrations Anti-4, Month 10	0.27 µg/mL Interval 0.23 to 0.32	0.27 µg/mL Interval 0.23 to 0.32	0.31 µg/mL Interval 0.27 to 0.37	0.25 µg/mL Interval 0.22 to 0.28
Anti-pneumococcal Serotypes Antibody Concentrations Anti-4, Month 11	2.42 µg/mL Interval 2.11 to 2.78	2.16 µg/mL Interval 1.86 to 2.51	2.86 µg/mL Interval 2.46 to 3.34	2.12 µg/mL Interval 1.87 to 2.4
Anti-pneumococcal Serotypes Antibody Concentrations Anti-5, Month 10	0.32 µg/mL Interval 0.27 to 0.37	0.28 µg/mL Interval 0.24 to 0.32	0.30 µg/mL Interval 0.26 to 0.35	0.27 µg/mL Interval 0.23 to 0.3
Anti-pneumococcal Serotypes Antibody Concentrations Anti-5, Month 11	0.89 µg/mL Interval 0.78 to 1.02	0.87 µg/mL Interval 0.76 to 1.0	0.95 µg/mL Interval 0.83 to 1.09	0.84 µg/mL Interval 0.74 to 0.97
Anti-pneumococcal Serotypes Antibody Concentrations Anti-6B, Month 10	0.62 µg/mL Interval 0.52 to 0.73	0.64 µg/mL Interval 0.54 to 0.76	0.68 µg/mL Interval 0.58 to 0.8	0.59 µg/mL Interval 0.51 to 0.69
Anti-pneumococcal Serotypes Antibody Concentrations Anti-6B, Month 11	2.91 µg/mL Interval 2.49 to 3.41	3.02 µg/mL Interval 2.57 to 3.56	3.70 µg/mL Interval 3.18 to 4.29	3.20 µg/mL Interval 2.79 to 3.68
Anti-pneumococcal Serotypes Antibody Concentrations Anti-7F, Month 10	0.50 µg/mL Interval 0.44 to 0.57	0.52 µg/mL Interval 0.45 to 0.61	0.57 µg/mL Interval 0.5 to 0.66	0.46 µg/mL Interval 0.4 to 0.52
Anti-pneumococcal Serotypes Antibody Concentrations Anti-9V, Month 10	0.27 µg/mL Interval 0.23 to 0.33	0.23 µg/mL Interval 0.2 to 0.27	0.28 µg/mL Interval 0.24 to 0.32	0.25 µg/mL Interval 0.22 to 0.28
Anti-pneumococcal Serotypes Antibody Concentrations Anti-9V, Month 11	1.49 µg/mL Interval 1.3 to 1.7	1.31 µg/mL Interval 1.15 to 1.49	1.47 µg/mL Interval 1.27 to 1.71	1.33 µg/mL Interval 1.18 to 1.49
Anti-pneumococcal Serotypes Antibody Concentrations Anti-14, Month 10	1.69 µg/mL Interval 1.39 to 2.05	1.64 µg/mL Interval 1.37 to 1.97	1.74 µg/mL Interval 1.46 to 2.09	1.42 µg/mL Interval 1.18 to 1.7
Anti-pneumococcal Serotypes Antibody Concentrations Anti-14, Month 11	8.51 µg/mL Interval 7.2 to 10.07	7.63 µg/mL Interval 6.62 to 8.79	9.75 µg/mL Interval 8.36 to 11.38	7.94 µg/mL Interval 6.85 to 9.2
Anti-pneumococcal Serotypes Antibody Concentrations Anti-18C, Month 10	0.33 µg/mL Interval 0.27 to 0.4	0.33 µg/mL Interval 0.28 to 0.39	0.39 µg/mL Interval 0.33 to 0.46	0.38 µg/mL Interval 0.33 to 0.44
Anti-pneumococcal Serotypes Antibody Concentrations Anti-18C, Month 11	2.30 µg/mL Interval 2.0 to 2.64	2.10 µg/mL Interval 1.84 to 2.39	3.08 µg/mL Interval 2.65 to 3.58	2.78 µg/mL Interval 2.44 to 3.17
Anti-pneumococcal Serotypes Antibody Concentrations Anti-19F, Month 10	1.22 µg/mL Interval 1.04 to 1.45	1.26 µg/mL Interval 1.05 to 1.52	1.34 µg/mL Interval 1.13 to 1.59	1.10 µg/mL Interval 0.94 to 1.29
Anti-pneumococcal Serotypes Antibody Concentrations Anti-19F, Month 11	9.55 µg/mL Interval 8.23 to 11.09	8.06 µg/mL Interval 6.88 to 9.46	9.74 µg/mL Interval 8.2 to 11.58	8.43 µg/mL Interval 7.35 to 9.66
Anti-pneumococcal Serotypes Antibody Concentrations Anti-23F, Month 10	0.39 µg/mL Interval 0.34 to 0.46	0.45 µg/mL Interval 0.39 to 0.53	0.47 µg/mL Interval 0.4 to 0.56	0.41 µg/mL Interval 0.35 to 0.48
Anti-pneumococcal Serotypes Antibody Concentrations Anti-23F, Month 11	3.74 µg/mL Interval 3.23 to 4.34	3.73 µg/mL Interval 3.19 to 4.35	4.24 µg/mL Interval 3.6 to 5.0	3.73 µg/mL Interval 3.3 to 4.21

SECONDARY outcome

Timeframe: Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3

The cut-off value for anti-D and anti-T concentrations was greater than or equal to (≥) 0.1 IU/mL

Outcome measures

Outcome measures
Measure	Nimenrix 3 Group n=117 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.	Nimenrix 2 Group n=113 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	Menjugate Group n=123 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	NeisVac-C Group n=115 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Concentrations ≥ the Cut-off Value Anti-D, Month 0	37 Participants	43 Participants	56 Participants	39 Participants
Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Concentrations ≥ the Cut-off Value Anti-D, Month 3	117 Participants	113 Participants	123 Participants	115 Participants
Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Concentrations ≥ the Cut-off Value Anti-T, Month 0	104 Participants	91 Participants	107 Participants	91 Participants
Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Concentrations ≥ the Cut-off Value Anti-T, Month 3	117 Participants	113 Participants	123 Participants	114 Participants

SECONDARY outcome

Timeframe: Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3

Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL).

Outcome measures

Outcome measures
Measure	Nimenrix 3 Group n=117 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.	Nimenrix 2 Group n=113 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	Menjugate Group n=123 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	NeisVac-C Group n=115 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
Anti-D and Anti-T Antibody Concentrations Anti-T, Month 3	3.137 IU/mL Interval 2.79 to 3.527	3.37 IU/mL Interval 2.98 to 3.811	2.847 IU/mL Interval 2.523 to 3.212	4.339 IU/mL Interval 3.833 to 4.912
Anti-D and Anti-T Antibody Concentrations Anti-D, Month 0	0.092 IU/mL Interval 0.077 to 0.11	0.098 IU/mL Interval 0.082 to 0.117	0.133 IU/mL Interval 0.108 to 0.165	0.093 IU/mL Interval 0.078 to 0.112
Anti-D and Anti-T Antibody Concentrations Anti-D, Month 3	2.171 IU/mL Interval 1.893 to 2.49	2.64 IU/mL Interval 2.274 to 3.065	3.005 IU/mL Interval 2.657 to 3.4	2.488 IU/mL Interval 2.169 to 2.855
Anti-D and Anti-T Antibody Concentrations Anti-T, Month 0	0.484 IU/mL Interval 0.393 to 0.596	0.496 IU/mL Interval 0.388 to 0.636	0.727 IU/mL Interval 0.581 to 0.909	0.5 IU/mL Interval 0.387 to 0.647

SECONDARY outcome

Timeframe: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11

The cut-off value for anti-D and anti-T concentrations was greater than or equal to (≥) 0.1 IU/mL

Outcome measures

Outcome measures
Measure	Nimenrix 3 Group n=116 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.	Nimenrix 2 Group n=112 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	Menjugate Group n=119 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	NeisVac-C Group n=118 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ the Cut-off Value Anti-D, Month 10	98 Participants	98 Participants	116 Participants	113 Participants
Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ the Cut-off Value Anti-T, Month 10	114 Participants	111 Participants	118 Participants	117 Participants
Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ the Cut-off Value Anti-D, Month 11	116 Participants	111 Participants	118 Participants	118 Participants
Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ the Cut-off Value Anti-T, Month 11	116 Participants	111 Participants	118 Participants	118 Participants

SECONDARY outcome

Timeframe: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11

Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL).

Outcome measures

Outcome measures
Measure	Nimenrix 3 Group n=116 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.	Nimenrix 2 Group n=112 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	Menjugate Group n=119 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	NeisVac-C Group n=118 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
Anti-D and Anti-T Antibody Concentrations Anti-T, Month 11	10.234 IU/mL Interval 9.128 to 11.475	11.004 IU/mL Interval 9.721 to 12.456	8.400 IU/mL Interval 7.285 to 9.685	13.016 IU/mL Interval 11.64 to 14.554
Anti-D and Anti-T Antibody Concentrations Anti-D, Month 10	0.292 IU/mL Interval 0.246 to 0.348	0.325 IU/mL Interval 0.272 to 0.389	0.507 IU/mL Interval 0.433 to 0.594	0.379 IU/mL Interval 0.327 to 0.44
Anti-D and Anti-T Antibody Concentrations Anti-D, Month 11	5.032 IU/mL Interval 4.337 to 5.838	5.438 IU/mL Interval 4.6 to 6.43	9.078 IU/mL Interval 7.959 to 10.354	6.437 IU/mL Interval 5.589 to 7.413
Anti-D and Anti-T Antibody Concentrations Anti-T, Month 10	0.832 IU/mL Interval 0.739 to 0.937	0.780 IU/mL Interval 0.677 to 0.898	0.684 IU/mL Interval 0.59 to 0.793	0.956 IU/mL Interval 0.835 to 1.094

SECONDARY outcome

Timeframe: Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3

The cut-off value for anti-PT, anti-FHA and anti-PRN concentrations was greater than or equal to (≥) 5 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).

Outcome measures

Outcome measures
Measure	Nimenrix 3 Group n=117 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.	Nimenrix 2 Group n=112 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	Menjugate Group n=123 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	NeisVac-C Group n=115 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Concentrations ≥ the Cut-off Value Anti-PRN, Month 0	31 Participants	39 Participants	44 Participants	32 Participants
Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Concentrations ≥ the Cut-off Value Anti-PT, Month 0	23 Participants	32 Participants	28 Participants	31 Participants
Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Concentrations ≥ the Cut-off Value Anti-PT, Month 3	117 Participants	111 Participants	122 Participants	115 Participants
Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Concentrations ≥ the Cut-off Value Anti-FHA, Month 0	83 Participants	85 Participants	93 Participants	78 Participants
Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Concentrations ≥ the Cut-off Value Anti-FHA, Month 3	117 Participants	111 Participants	123 Participants	115 Participants
Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Concentrations ≥ the Cut-off Value Anti-PRN, Month 3	117 Participants	112 Participants	122 Participants	115 Participants

SECONDARY outcome

Timeframe: Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3

Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in EL.U/mL.

Outcome measures

Outcome measures
Measure	Nimenrix 3 Group n=117 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.	Nimenrix 2 Group n=112 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	Menjugate Group n=123 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	NeisVac-C Group n=115 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Anti-PT, Month 0	3.4 EL.U/mL Interval 3.0 to 3.8	3.9 EL.U/mL Interval 3.3 to 4.5	3.6 EL.U/mL Interval 3.2 to 4.2	4.1 EL.U/mL Interval 3.5 to 4.9
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Anti-PT, Month 3	52.7 EL.U/mL Interval 46.5 to 59.8	56.3 EL.U/mL Interval 49.5 to 64.0	56.5 EL.U/mL Interval 50.5 to 63.1	56.4 EL.U/mL Interval 50.6 to 63.0
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Anti-FHA, Month 0	9.7 EL.U/mL Interval 8.0 to 11.9	13.2 EL.U/mL Interval 10.7 to 16.4	11.4 EL.U/mL Interval 9.4 to 13.9	11.9 EL.U/mL Interval 9.4 to 15.1
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Anti-FHA, Month 3	124.3 EL.U/mL Interval 109.0 to 141.8	149.2 EL.U/mL Interval 131.2 to 169.6	139.1 EL.U/mL Interval 123.2 to 157.1	132 EL.U/mL Interval 115.1 to 151.3
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Anti-PRN, Month 0	4 EL.U/mL Interval 3.4 to 4.7	5 EL.U/mL Interval 4.0 to 6.2	4.6 EL.U/mL Interval 3.9 to 5.4	4.7 EL.U/mL Interval 3.8 to 5.9
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Anti-PRN, Month 3	122 EL.U/mL Interval 104.1 to 143.1	134.9 EL.U/mL Interval 119.0 to 152.9	118.2 EL.U/mL Interval 101.5 to 137.7	132 EL.U/mL Interval 113.6 to 153.5

SECONDARY outcome

Timeframe: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11

The cut-off value for anti-PT, anti-FHA and anti-PRN concentrations was greater than or equal to (≥) 5 EL.U/mL.

Outcome measures

Outcome measures
Measure	Nimenrix 3 Group n=116 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.	Nimenrix 2 Group n=112 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	Menjugate Group n=119 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	NeisVac-C Group n=118 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations ≥ the Cut-off Value Anti-PRN, Month 10	105 Participants	98 Participants	109 Participants	105 Participants
Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations ≥ the Cut-off Value Anti-PRN, Month 11	116 Participants	110 Participants	118 Participants	118 Participants
Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations ≥ the Cut-off Value Anti-PT, Month 10	100 Participants	94 Participants	104 Participants	102 Participants
Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations ≥ the Cut-off Value Anti-PT, Month 11	110 Participants	109 Participants	116 Participants	116 Participants
Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations ≥ the Cut-off Value Anti-FHA, Month 10	112 Participants	106 Participants	118 Participants	115 Participants
Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations ≥ the Cut-off Value Anti-FHA, Month 11	113 Participants	111 Participants	116 Participants	116 Participants

SECONDARY outcome

Timeframe: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11

Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in EL.U/mL.

Outcome measures

Outcome measures
Measure	Nimenrix 3 Group n=116 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.	Nimenrix 2 Group n=112 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	Menjugate Group n=119 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	NeisVac-C Group n=118 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Anti-PT, Month 10	11.0 EL.U/mL Interval 9.4 to 12.9	11.1 EL.U/mL Interval 9.4 to 13.1	13.1 EL.U/mL Interval 11.1 to 15.4	11.4 EL.U/mL Interval 9.9 to 13.3
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Anti-PT, Month 11	82.5 EL.U/mL Interval 71.9 to 94.7	78.2 EL.U/mL Interval 67.8 to 90.2	84.7 EL.U/mL Interval 73.5 to 97.5	82.7 EL.U/mL Interval 72.5 to 94.4
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Anti-FHA, Month 10	34.5 EL.U/mL Interval 29.6 to 40.2	33.1 EL.U/mL Interval 27.5 to 39.8	37.4 EL.U/mL Interval 32.1 to 43.5	34.9 EL.U/mL Interval 29.8 to 40.9
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Anti-FHA, Month 11	285.5 EL.U/mL Interval 250.6 to 325.4	296.3 EL.U/mL Interval 258.5 to 339.7	305.9 EL.U/mL Interval 269.0 to 347.8	302.9 EL.U/mL Interval 266.8 to 343.9
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Anti-PRN, Month 10	17.9 EL.U/mL Interval 14.8 to 21.6	15.7 EL.U/mL Interval 13.1 to 18.8	19.9 EL.U/mL Interval 16.5 to 23.9	17.9 EL.U/mL Interval 14.8 to 21.6
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Anti-PRN, Month 11	283.7 EL.U/mL Interval 233.9 to 344.1	290.8 EL.U/mL Interval 242.5 to 348.7	291.7 EL.U/mL Interval 246.1 to 345.7	334.3 EL.U/mL Interval 282.9 to 395.1

SECONDARY outcome

Timeframe: Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3

The cut-off values for anti-HBs concentrations were greater than or equal to (≥) 10 milli-international units per milliliter (mIU/mL) and ≥ 100 mIU/mL.

Outcome measures

Outcome measures
Measure	Nimenrix 3 Group n=98 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.	Nimenrix 2 Group n=84 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	Menjugate Group n=97 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	NeisVac-C Group n=93 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above the Cut-off Values Anti-HBs ≥ 10 mIU/mL, Month 0	33 Participants	34 Participants	39 Participants	28 Participants
Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above the Cut-off Values Anti-HBs ≥ 10 mIU/mL, Month 3	85 Participants	84 Participants	94 Participants	79 Participants
Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above the Cut-off Values Anti-HBs ≥ 100 mIU/mL, Month 0	17 Participants	14 Participants	14 Participants	8 Participants
Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above the Cut-off Values Anti-HBs ≥ 100 mIU/mL, Month 3	74 Participants	79 Participants	89 Participants	73 Participants

SECONDARY outcome

Timeframe: Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3

Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL).

Outcome measures

Outcome measures
Measure	Nimenrix 3 Group n=98 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.	Nimenrix 2 Group n=84 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	Menjugate Group n=97 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	NeisVac-C Group n=93 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
Anti-HBs Antibody Concentrations Anti-HBs, Month 0	12.0 mIU/mL Interval 7.6 to 18.7	13.7 mIU/mL Interval 8.4 to 22.4	11.3 mIU/mL Interval 7.7 to 16.7	7.5 mIU/mL Interval 5.4 to 10.5
Anti-HBs Antibody Concentrations Anti-HBs, Month 3	692.3 mIU/mL Interval 513.2 to 934.0	732.2 mIU/mL Interval 555.1 to 965.8	848.3 mIU/mL Interval 663.7 to 1084.1	729.5 mIU/mL Interval 530.3 to 1003.5

SECONDARY outcome

Timeframe: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11

The cut-off values for anti-HBs concentrations were greater than or equal to (≥) 10 mIU/mL and ≥ 100 mIU/mL.

Outcome measures

Outcome measures
Measure	Nimenrix 3 Group n=98 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.	Nimenrix 2 Group n=97 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	Menjugate Group n=103 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	NeisVac-C Group n=100 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
Number of Subjects With Anti-HBs Antibody Concentrations Above the Cut-off Values Anti-HBs ≥ 10 mIU/mL, Month 10	91 Participants	86 Participants	96 Participants	94 Participants
Number of Subjects With Anti-HBs Antibody Concentrations Above the Cut-off Values Anti-HBs ≥ 10 mIU/mL, Month 11	95 Participants	97 Participants	103 Participants	100 Participants
Number of Subjects With Anti-HBs Antibody Concentrations Above the Cut-off Values Anti-HBs ≥ 100 mIU/mL, Month 10	67 Participants	58 Participants	75 Participants	65 Participants
Number of Subjects With Anti-HBs Antibody Concentrations Above the Cut-off Values Anti-HBs ≥ 100 mIU/mL, Month 11	93 Participants	97 Participants	102 Participants	97 Participants

SECONDARY outcome

Timeframe: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11

Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL).

Outcome measures

Outcome measures
Measure	Nimenrix 3 Group n=98 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.	Nimenrix 2 Group n=97 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	Menjugate Group n=103 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	NeisVac-C Group n=100 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
Anti-HBs Antibody Concentrations Anti-HBs, Month 10	150.5 mIU/mL Interval 111.4 to 203.3	138.2 mIU/mL Interval 99.3 to 192.3	196.6 mIU/mL Interval 141.6 to 273.1	141.9 mIU/mL Interval 106.5 to 189.0
Anti-HBs Antibody Concentrations Anti-HBs, Month 11	3624.9 mIU/mL Interval 2570.0 to 5112.8	4129.8 mIU/mL Interval 3095.4 to 5509.8	4866.4 mIU/mL Interval 3723.5 to 6360.1	3878.7 mIU/mL Interval 2861.7 to 5257.3

SECONDARY outcome

Timeframe: Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3

The cut-off values for anti-PRP antibody concentrations were greater than or equal to (≥) 0.15 micrograms per milliliter (µg/mL) and ≥ 1.0 µg/mL.

Outcome measures

Outcome measures
Measure	Nimenrix 3 Group n=119 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.	Nimenrix 2 Group n=113 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	Menjugate Group n=123 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	NeisVac-C Group n=114 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
Number of Subjects With Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Concentrations ≥ the Cut-off Values Anti-PRP ≥ 0.15 µg/mL, Month 0	46 Participants	55 Participants	46 Participants	47 Participants
Number of Subjects With Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Concentrations ≥ the Cut-off Values Anti-PRP ≥ 0.15 µg/mL, Month 3	119 Participants	113 Participants	121 Participants	113 Participants
Number of Subjects With Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Concentrations ≥ the Cut-off Values Anti-PRP ≥ 1.0 µg/mL, Month 0	9 Participants	19 Participants	10 Participants	7 Participants
Number of Subjects With Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Concentrations ≥ the Cut-off Values Anti-PRP ≥ 1.0 µg/mL, Month 3	106 Participants	101 Participants	94 Participants	106 Participants

SECONDARY outcome

Timeframe: Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3

Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL).

Outcome measures

Outcome measures
Measure	Nimenrix 3 Group n=119 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.	Nimenrix 2 Group n=113 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	Menjugate Group n=123 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	NeisVac-C Group n=114 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
Anti-PRP Antibody Concentrations Anti-PRP, Month 0	0.158 µg/mL Interval 0.131 to 0.191	0.213 µg/mL Interval 0.168 to 0.27	0.162 µg/mL Interval 0.132 to 0.198	0.162 µg/mL Interval 0.133 to 0.196
Anti-PRP Antibody Concentrations Anti-PRP, Month 3	4.011 µg/mL Interval 3.275 to 4.912	3.573 µg/mL Interval 2.946 to 4.334	2.752 µg/mL Interval 2.144 to 3.534	4.662 µg/mL Interval 3.788 to 5.739

SECONDARY outcome

Timeframe: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11

The cut-off values for anti-PRP antibody concentrations were greater than or equal to (≥) 0.15 µg/mL and ≥ 1.0 µg/mL.

Outcome measures

Outcome measures
Measure	Nimenrix 3 Group n=116 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.	Nimenrix 2 Group n=112 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	Menjugate Group n=119 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	NeisVac-C Group n=118 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
Number of Subjects With Anti-PRP Antibody Concentrations Above the Cut-off Values Anti-PRP ≥ 0.15 µg/mL, Month 10	92 Participants	91 Participants	91 Participants	100 Participants
Number of Subjects With Anti-PRP Antibody Concentrations Above the Cut-off Values Anti-PRP ≥ 0.15 µg/mL, Month 11	116 Participants	112 Participants	119 Participants	118 Participants
Number of Subjects With Anti-PRP Antibody Concentrations Above the Cut-off Values Anti-PRP ≥ 1.0 µg/mL, Month 10	23 Participants	20 Participants	40 Participants	31 Participants
Number of Subjects With Anti-PRP Antibody Concentrations Above the Cut-off Values Anti-PRP ≥ 1.0 µg/mL, Month 11	113 Participants	112 Participants	119 Participants	114 Participants

SECONDARY outcome

Timeframe: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11

Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL).

Outcome measures

Outcome measures
Measure	Nimenrix 3 Group n=116 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.	Nimenrix 2 Group n=112 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	Menjugate Group n=119 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	NeisVac-C Group n=118 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
Anti-PRP Antibody Concentrations Anti-PRP, Month 10	0.378 µg/mL Interval 0.308 to 0.464	0.400 µg/mL Interval 0.324 to 0.494	0.535 µg/mL Interval 0.404 to 0.707	0.535 µg/mL Interval 0.427 to 0.671
Anti-PRP Antibody Concentrations Anti-PRP, Month 11	17.350 µg/mL Interval 14.124 to 21.313	17.519 µg/mL Interval 14.041 to 21.859	22.879 µg/mL Interval 18.147 to 28.847	23.973 µg/mL Interval 19.194 to 29.941

SECONDARY outcome

Timeframe: Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3

The cut-off value for anti-poliovirus type 1, 2 and 3 antibody concentrations was greater than or equal to (≥) 1:8.

Outcome measures

Outcome measures
Measure	Nimenrix 3 Group n=93 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.	Nimenrix 2 Group n=83 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	Menjugate Group n=90 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	NeisVac-C Group n=86 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
Number of Subjects With Anti-poliovirus Type 1, 2 and 3 Antibody Concentrations ≥ the Cut-off Value Anti-Polio 1, Month 0	52 Participants	46 Participants	54 Participants	46 Participants
Number of Subjects With Anti-poliovirus Type 1, 2 and 3 Antibody Concentrations ≥ the Cut-off Value Anti-Polio 1, Month 3	91 Participants	83 Participants	89 Participants	84 Participants
Number of Subjects With Anti-poliovirus Type 1, 2 and 3 Antibody Concentrations ≥ the Cut-off Value Anti-Polio 2, Month 0	39 Participants	40 Participants	44 Participants	41 Participants
Number of Subjects With Anti-poliovirus Type 1, 2 and 3 Antibody Concentrations ≥ the Cut-off Value Anti-Polio 2, Month 3	81 Participants	70 Participants	81 Participants	70 Participants
Number of Subjects With Anti-poliovirus Type 1, 2 and 3 Antibody Concentrations ≥ the Cut-off Value Anti-Polio 3, Month 0	21 Participants	21 Participants	11 Participants	23 Participants
Number of Subjects With Anti-poliovirus Type 1, 2 and 3 Antibody Concentrations ≥ the Cut-off Value Anti-Polio 3, Month 3	93 Participants	79 Participants	87 Participants	77 Participants

SECONDARY outcome

Timeframe: Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3

Antibody titers were presented as geometric mean titers (GMTs).

Outcome measures

Outcome measures
Measure	Nimenrix 3 Group n=93 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.	Nimenrix 2 Group n=83 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	Menjugate Group n=90 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	NeisVac-C Group n=86 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
Anti-polio Type 1, 2 and 3 Antibody Titers Anti-Polio 2, Month 0	19.4 Titers Interval 13.2 to 28.7	28 Titers Interval 18.4 to 42.5	17.4 Titers Interval 12.7 to 23.8	22.9 Titers Interval 15.6 to 33.5
Anti-polio Type 1, 2 and 3 Antibody Titers Anti-Polio 2, Month 3	225.2 Titers Interval 173.2 to 292.6	244.8 Titers Interval 173.3 to 345.9	274.5 Titers Interval 202.1 to 372.8	232.7 Titers Interval 160.8 to 336.6
Anti-polio Type 1, 2 and 3 Antibody Titers Anti-Polio 3, Month 0	11.5 Titers Interval 7.6 to 17.5	11.7 Titers Interval 7.8 to 17.5	5.9 Titers Interval 4.7 to 7.5	14.2 Titers Interval 8.8 to 22.8
Anti-polio Type 1, 2 and 3 Antibody Titers Anti-Polio 3, Month 3	642.7 Titers Interval 478.7 to 862.8	675 Titers Interval 486.3 to 936.9	674 Titers Interval 525.5 to 864.5	494.3 Titers Interval 347.4 to 703.3
Anti-polio Type 1, 2 and 3 Antibody Titers Anti-Polio 1, Month 0	32.7 Titers Interval 22.5 to 47.5	40.2 Titers Interval 27.3 to 59.3	28.1 Titers Interval 20.1 to 39.3	30.7 Titers Interval 21.5 to 43.9
Anti-polio Type 1, 2 and 3 Antibody Titers Anti-Polio 1, Month 3	279.6 Titers Interval 222.4 to 351.5	317.9 Titers Interval 227.6 to 444.0	424.1 Titers Interval 323.1 to 556.6	277.7 Titers Interval 200.7 to 384.1

SECONDARY outcome

Timeframe: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11

The cut-off value for anti-poliovirus type 1, 2 and 3 antibody concentrations was greater than or equal to (≥) 1:8.

Outcome measures

Outcome measures
Measure	Nimenrix 3 Group n=85 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.	Nimenrix 2 Group n=85 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	Menjugate Group n=86 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	NeisVac-C Group n=87 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
Number of Subjects With Anti-polio Type 1, 2 and 3 Antibody Concentrations ≥ the Cut-off Value Anti-Polio 1, Month 10	74 Participants	63 Participants	80 Participants	81 Participants
Number of Subjects With Anti-polio Type 1, 2 and 3 Antibody Concentrations ≥ the Cut-off Value Anti-Polio 1, Month 11	85 Participants	85 Participants	81 Participants	84 Participants
Number of Subjects With Anti-polio Type 1, 2 and 3 Antibody Concentrations ≥ the Cut-off Value Anti-Polio 2, Month 10	69 Participants	66 Participants	83 Participants	72 Participants
Number of Subjects With Anti-polio Type 1, 2 and 3 Antibody Concentrations ≥ the Cut-off Value Anti-Polio 2, Month 11	70 Participants	74 Participants	71 Participants	68 Participants
Number of Subjects With Anti-polio Type 1, 2 and 3 Antibody Concentrations ≥ the Cut-off Value Anti-Polio 3, Month 10	57 Participants	62 Participants	62 Participants	64 Participants
Number of Subjects With Anti-polio Type 1, 2 and 3 Antibody Concentrations ≥ the Cut-off Value Anti-Polio 3, Month 11	79 Participants	67 Participants	74 Participants	69 Participants

SECONDARY outcome

Timeframe: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11

Antibody titers were presented as geometric mean titers (GMTs).

Outcome measures

Outcome measures
Measure	Nimenrix 3 Group n=85 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.	Nimenrix 2 Group n=85 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	Menjugate Group n=86 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	NeisVac-C Group n=87 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
Anti-polio Type 1, 2 and 3 Antibody Titers Anti-polio 3, Month 10	115.0 Titers Interval 80.1 to 165.2	104.6 Titers Interval 77.9 to 140.3	155.2 Titers Interval 118.3 to 203.7	108.6 Titers Interval 77.6 to 152.1
Anti-polio Type 1, 2 and 3 Antibody Titers Anti-polio 1, Month 10	74.9 Titers Interval 56.3 to 99.6	84.7 Titers Interval 60.0 to 119.7	120.8 Titers Interval 92.5 to 157.8	90.0 Titers Interval 65.8 to 123.0
Anti-polio Type 1, 2 and 3 Antibody Titers Anti-polio 1, Month 11	909.8 Titers Interval 694.1 to 1192.6	1070.9 Titers Interval 812.5 to 1411.4	1524.5 Titers Interval 1214.9 to 1913.0	1217.7 Titers Interval 956.5 to 1550.2
Anti-polio Type 1, 2 and 3 Antibody Titers Anti-polio 2, Month 10	93.7 Titers Interval 71.1 to 123.5	80.1 Titers Interval 57.6 to 111.5	112.5 Titers Interval 86.7 to 146.1	78.1 Titers Interval 57.6 to 105.9
Anti-polio Type 1, 2 and 3 Antibody Titers Anti-polio 2, Month 11	1205.7 Titers Interval 902.2 to 1611.3	1306.3 Titers Interval 985.1 to 1732.2	2068.0 Titers Interval 1602.7 to 2668.5	1419.0 Titers Interval 1088.4 to 1849.9
Anti-polio Type 1, 2 and 3 Antibody Titers Anti-polio 3, Month 11	1681.0 Titers Interval 1285.1 to 2198.9	2167.8 Titers Interval 1645.7 to 2855.6	2136.2 Titers Interval 1688.1 to 2703.4	1852.2 Titers Interval 1425.6 to 2406.4

SECONDARY outcome

Timeframe: During the 8-day (Days 0-7) post-vaccination period following each dose and across doses from Day 0 to Month 3 (Primary Vaccination)

Population: The analysis was performed on the Primary Total Vaccinated cohort, which included all vaccinated subjects during the primary phase, who had filled in their symptom sheets. For the considered assay and time point data was reported only for the Primary Vaccination doses.

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site. For the Nimenrix 2, Menjugate and NeisVac-C groups, results corresponding to Dose 2 are for Infanrix hexa and Synflorix vaccination at Visit 2 (Month 1), while results corresponding to Dose 3 refer to the vaccination at Visit 3 (Month 2).

Outcome measures

Outcome measures
Measure	Nimenrix 3 Group n=518 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.	Nimenrix 2 Group n=523 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	Menjugate Group n=509 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	NeisVac-C Group n=518 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness, Dose 1	241 Participants	229 Participants	236 Participants	230 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling, Dose 1	188 Participants	182 Participants	179 Participants	188 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Dose 2	23 Participants	37 Participants	23 Participants	29 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness, Dose 2	261 Participants	271 Participants	283 Participants	284 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness, Dose 2	3 Participants	5 Participants	10 Participants	2 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling, Dose 2	211 Participants	206 Participants	225 Participants	210 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling, Dose 2	3 Participants	6 Participants	14 Participants	10 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain, Dose 3	168 Participants	180 Participants	180 Participants	193 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness, Dose 3	9 Participants	6 Participants	13 Participants	9 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling, Dose 3	210 Participants	216 Participants	252 Participants	218 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling, Dose 3	8 Participants	6 Participants	11 Participants	13 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Across doses	54 Participants	67 Participants	48 Participants	69 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness, Across doses	18 Participants	15 Participants	24 Participants	15 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling, Across doses	326 Participants	318 Participants	343 Participants	317 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling, Across doses	15 Participants	11 Participants	27 Participants	24 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness, Dose 1	9 Participants	5 Participants	9 Participants	5 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling, Dose 1	6 Participants	4 Participants	14 Participants	6 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain, Dose 2	212 Participants	210 Participants	230 Participants	214 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain, Dose 1	247 Participants	243 Participants	243 Participants	233 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness, Across doses	363 Participants	369 Participants	391 Participants	371 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Dose 1	32 Participants	33 Participants	28 Participants	34 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Dose 3	13 Participants	18 Participants	15 Participants	22 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness, Dose 3	247 Participants	265 Participants	308 Participants	274 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain, Across doses	319 Participants	332 Participants	344 Participants	327 Participants

SECONDARY outcome

Timeframe: During the 8-day (Days 0-7) post-meningococcal vaccination period following each dose and across doses from Day 0 to Month 3 (Primary Vaccination)

Population: The analysis was performed on the Primary Total Vaccinated cohort, which included all vaccinated subjects during the primary phase, who had filled in their symptom sheets. No data was applicable for the Nimenrix 2 Group, Menjugate Group and NeisVac-C Group since meningococcal vaccine was not given in Dose 2.

Outcome measures

Outcome measures
Measure	Nimenrix 3 Group n=518 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.	Nimenrix 2 Group n=523 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	Menjugate Group n=509 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	NeisVac-C Group n=518 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination Any Pain, Dose 1	161 Participants	155 Participants	158 Participants	157 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination Grade 3 Swelling, Dose 3	0 Participants	1 Participants	0 Participants	4 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination Grade 3 Pain, Dose 1	18 Participants	17 Participants	12 Participants	24 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination Grade 3 Redness, Dose 1	2 Participants	1 Participants	2 Participants	1 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination Any Pain, Across doses	229 Participants	202 Participants	213 Participants	212 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination Any Pain, Dose 2	125 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination Any Pain, Dose 3	106 Participants	124 Participants	130 Participants	142 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination Grade 3 Pain, Dose 3	7 Participants	11 Participants	9 Participants	12 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination Grade 3 Redness, Dose 3	0 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination Grade 3 Pain, Across doses	29 Participants	26 Participants	19 Participants	33 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination Grade 3 Redness, Across doses	2 Participants	1 Participants	2 Participants	2 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination Grade 3 Swelling, Across doses	1 Participants	1 Participants	3 Participants	4 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination Any Redness, Dose 1	132 Participants	128 Participants	138 Participants	140 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination Any Swelling, Dose 1	68 Participants	62 Participants	87 Participants	82 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination Grade 3 Swelling, Dose 1	1 Participants	0 Participants	3 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination Grade 3 Pain, Dose 2	9 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination Any Redness, Dose 2	131 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination Grade 3 Redness, Dose 2	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination Any Swelling, Dose 2	77 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination Grade 3 Swelling, Dose 2	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination Any Redness, Dose 3	162 Participants	169 Participants	214 Participants	197 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination Any Swelling, Dose 3	104 Participants	115 Participants	137 Participants	130 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination Any Redness, Across doses	233 Participants	206 Participants	255 Participants	233 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination Any Swelling, Across doses	154 Participants	136 Participants	175 Participants	164 Participants

SECONDARY outcome

Timeframe: During the 8-day (Days 0-7) post-Infanrix hexa vaccination period following each dose and across doses from Day 0 to Month 3 (Primary Vaccination)

Outcome measures

Outcome measures
Measure	Nimenrix 3 Group n=518 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.	Nimenrix 2 Group n=523 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	Menjugate Group n=509 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	NeisVac-C Group n=518 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa Vaccination Any Pain, Dose 1	212 Participants	202 Participants	208 Participants	210 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa Vaccination Any Redness, Dose 1	201 Participants	190 Participants	191 Participants	192 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa Vaccination Grade 3 Redness, Dose 1	7 Participants	3 Participants	6 Participants	2 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa Vaccination Any Swelling, Dose 1	148 Participants	148 Participants	128 Participants	147 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa Vaccination Grade 3 Swelling, Dose 1	6 Participants	4 Participants	13 Participants	4 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa Vaccination Any Pain, Dose 2	184 Participants	200 Participants	219 Participants	198 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa Vaccination Grade 3 Pain, Dose 2	18 Participants	34 Participants	22 Participants	27 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa Vaccination Any Redness, Dose 2	232 Participants	250 Participants	264 Participants	265 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa Vaccination Grade 3 Redness, Dose 2	1 Participants	5 Participants	10 Participants	2 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa Vaccination Any Swelling, Dose 2	182 Participants	185 Participants	208 Participants	195 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa Vaccination Grade 3 Swelling, Dose 2	1 Participants	3 Participants	13 Participants	10 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa Vaccination Any Pain, Dose 3	144 Participants	159 Participants	153 Participants	175 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa Vaccination Grade 3 Pain, Dose 3	9 Participants	14 Participants	11 Participants	19 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa Vaccination Grade 3 Pain, Dose 1	28 Participants	28 Participants	25 Participants	32 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa Vaccination Any Redness, Dose 3	228 Participants	243 Participants	272 Participants	247 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa Vaccination Grade 3 Redness, Dose 3	5 Participants	4 Participants	11 Participants	7 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa Vaccination Any Swelling, Dose 3	191 Participants	200 Participants	227 Participants	197 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa Vaccination Grade 3 Swelling, Dose 3	6 Participants	4 Participants	11 Participants	11 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa Vaccination Any Pain, Across doses	289 Participants	311 Participants	314 Participants	310 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa Vaccination Grade 3 Pain, Across doses	44 Participants	58 Participants	43 Participants	63 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa Vaccination Any Redness, Across doses	336 Participants	344 Participants	358 Participants	349 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa Vaccination Grade 3 Redness, Across doses	13 Participants	11 Participants	19 Participants	10 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa Vaccination Any Swelling, Across doses	297 Participants	292 Participants	308 Participants	294 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa Vaccination Grade 3 Swelling, Across doses	12 Participants	7 Participants	25 Participants	21 Participants

SECONDARY outcome

Timeframe: During the 8-day (Days 0-7) post-Synflorix vaccination period following each dose and across doses from Day 0 to Month 3 (Primary Vaccination)

Outcome measures

Outcome measures
Measure	Nimenrix 3 Group n=518 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.	Nimenrix 2 Group n=523 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	Menjugate Group n=509 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	NeisVac-C Group n=518 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix Vaccination Grade 3 Redness, Dose 1	4 Participants	2 Participants	5 Participants	4 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix Vaccination Grade 3 Swelling, Dose 1	4 Participants	1 Participants	10 Participants	4 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix Vaccination Any Pain, Dose 2	179 Participants	186 Participants	203 Participants	189 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix Vaccination Any Redness, Dose 2	197 Participants	216 Participants	225 Participants	235 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix Vaccination Grade 3 Redness, Dose 2	2 Participants	1 Participants	5 Participants	1 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix Vaccination Any Swelling, Dose 2	154 Participants	162 Participants	156 Participants	155 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix Vaccination Grade 3 Swelling, Dose 2	3 Participants	4 Participants	8 Participants	5 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix Vaccination Any Pain, Dose 3	129 Participants	152 Participants	132 Participants	150 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix Vaccination Grade 3 Pain, Dose 3	10 Participants	13 Participants	10 Participants	18 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix Vaccination Any Redness, Dose 3	173 Participants	213 Participants	227 Participants	209 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix Vaccination Grade 3 Redness, Dose 3	4 Participants	4 Participants	6 Participants	2 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix Vaccination Any Redness, Across doses	297 Participants	322 Participants	331 Participants	316 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix Vaccination Grade 3 Redness, Across doses	8 Participants	7 Participants	12 Participants	7 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix Vaccination Any Swelling, Across doses	247 Participants	259 Participants	262 Participants	237 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix Vaccination Any Swelling, Dose 1	135 Participants	136 Participants	130 Participants	120 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix Vaccination Any Pain, Dose 1	218 Participants	201 Participants	217 Participants	195 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix Vaccination Grade 3 Pain, Dose 1	29 Participants	26 Participants	26 Participants	32 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix Vaccination Any Redness, Dose 1	209 Participants	184 Participants	196 Participants	183 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix Vaccination Grade 3 Pain, Dose 2	20 Participants	31 Participants	19 Participants	25 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix Vaccination Any Swelling, Dose 3	136 Participants	152 Participants	164 Participants	146 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix Vaccination Grade 3 Swelling, Dose 3	3 Participants	4 Participants	6 Participants	5 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix Vaccination Any Pain, Across doses	285 Participants	304 Participants	312 Participants	291 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix Vaccination Grade 3 Pain, Across doses	46 Participants	54 Participants	41 Participants	61 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix Vaccination Grade 3 Swelling, Across doses	9 Participants	7 Participants	16 Participants	13 Participants

SECONDARY outcome

Timeframe: During the 8-day (Days 0-7) post-meningococcal booster vaccination period

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

Outcome measures

Outcome measures
Measure	Nimenrix 3 Group n=491 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.	Nimenrix 2 Group n=510 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	Menjugate Group n=496 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	NeisVac-C Group n=503 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination Grade 3 Redness	3 Participants	6 Participants	5 Participants	4 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination Any Pain	191 Participants	203 Participants	203 Participants	181 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination Grade 3 Pain	24 Participants	23 Participants	31 Participants	18 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination Any Redness	186 Participants	221 Participants	213 Participants	228 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination Any Swelling	133 Participants	152 Participants	158 Participants	165 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination Grade 3 Swelling	1 Participants	2 Participants	2 Participants	5 Participants

SECONDARY outcome

Timeframe: During the 8-day (Days 0-7) post-Infanrix™ hexa booster vaccination period

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

Outcome measures

Outcome measures
Measure	Nimenrix 3 Group n=491 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.	Nimenrix 2 Group n=510 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	Menjugate Group n=495 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	NeisVac-C Group n=504 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa Vaccination Any Pain	240 Participants	241 Participants	242 Participants	221 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa Vaccination Grade Pain	35 Participants	33 Participants	39 Participants	23 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa Vaccination Any Redness	259 Participants	286 Participants	282 Participants	280 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa Vaccination Any Swelling	212 Participants	226 Participants	244 Participants	240 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa Vaccination Grade 3 Swelling	20 Participants	18 Participants	17 Participants	14 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa Vaccination Grade 3 Redness	29 Participants	24 Participants	32 Participants	22 Participants

SECONDARY outcome

Timeframe: Within 31-days (Days 0-30) post-each primary vaccination dose

Population: The analysis was performed on the Primary Total Vaccinated cohort, which included all vaccinated subjects during the primary phase, who had filled in their symptom sheets.

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

Outcome measures

Outcome measures
Measure	Nimenrix 3 Group n=528 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.	Nimenrix 2 Group n=524 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	Menjugate Group n=516 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	NeisVac-C Group n=527 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
Number of Subjects With Any Unsolicited Adverse Events (AEs)	293 Participants	273 Participants	291 Participants	280 Participants

SECONDARY outcome

Timeframe: During the 8-day (Days 0-7) post-Synflorix™ booster vaccination period

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

Outcome measures

Outcome measures
Measure	Nimenrix 3 Group n=491 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.	Nimenrix 2 Group n=510 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	Menjugate Group n=495 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	NeisVac-C Group n=504 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix™ Vaccination Grade 3 Pain	36 Participants	33 Participants	33 Participants	26 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix™ Vaccination Any Redness	219 Participants	243 Participants	242 Participants	250 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix™ Vaccination Any Swelling	173 Participants	174 Participants	189 Participants	193 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix™ Vaccination Any Pain	212 Participants	215 Participants	227 Participants	205 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix™ Vaccination Grade 3 Redness	14 Participants	9 Participants	20 Participants	9 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix™ Vaccination Grade 3 Swelling	5 Participants	5 Participants	4 Participants	10 Participants

SECONDARY outcome

Timeframe: During the 8-day (Days 0-7) post-vaccination period following each dose and across doses from Day 0 to Month 3 (Primary Vaccination)

Population: The analysis was performed on the Primary Total Vaccinated cohort, which included all vaccinated subjects during the primary phase, who had filled in their symptom sheets.

Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature \[defined as rectal temperature greater than or equal to (≥) 38 degrees Celsius (°C)\]. Any = occurrence of any general symptoms, regardless of their intensity grade or relationship to study vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Irritability = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Not eating at all. Grade 3 Temperature= temperature above 40.0 (°C). Related = symptom assessed by the investigator as related to the vaccination. For the Nimenrix 2, Menjugate and NeisVac-C groups, results corresponding to Dose 2 are for Infanrix™ hexa and Synflorix™ vaccination at Visit 2 (Month 1), while results corresponding to Dose 3 refer to the vaccination at Visit 3 (Month 2).

Outcome measures

Outcome measures
Measure	Nimenrix 3 Group n=518 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.	Nimenrix 2 Group n=523 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	Menjugate Group n=509 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	NeisVac-C Group n=518 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Drowsiness, Dose 1	163 Participants	167 Participants	163 Participants	178 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Drowsiness, Dose 1	298 Participants	282 Participants	285 Participants	297 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Irritability, Dose 2	208 Participants	198 Participants	194 Participants	212 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Loss of appetite, Dose 2	164 Participants	185 Participants	183 Participants	179 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Loss of appetite, Dose 2	10 Participants	6 Participants	6 Participants	7 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Temperature, Dose 2	1 Participants	0 Participants	1 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Irritability, Dose 3	37 Participants	30 Participants	32 Participants	39 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Irritability, Dose 3	165 Participants	178 Participants	164 Participants	174 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Loss of appetite, Dose 3	149 Participants	176 Participants	159 Participants	154 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Loss of appetite, Dose 3	14 Participants	11 Participants	10 Participants	9 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Loss of appetite, Dose 3	88 Participants	94 Participants	83 Participants	90 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Temperature, Across doses	272 Participants	274 Participants	277 Participants	275 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Irritability, Dose 1	199 Participants	206 Participants	213 Participants	235 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Irritability, Dose 1	329 Participants	337 Participants	355 Participants	364 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Irritability, Dose 1	54 Participants	41 Participants	45 Participants	54 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Drowsiness, Dose 1	22 Participants	22 Participants	17 Participants	34 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Loss of appetite, Dose 1	188 Participants	208 Participants	196 Participants	219 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Loss of appetite, Dose 1	95 Participants	106 Participants	111 Participants	117 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Temperature, Dose 1	166 Participants	162 Participants	170 Participants	183 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Temperature, Dose 1	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Temperature, Dose 1	128 Participants	119 Participants	122 Participants	144 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Drowsiness, Dose 2	232 Participants	210 Participants	231 Participants	211 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Drowsiness, Dose 2	20 Participants	20 Participants	17 Participants	12 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Drowsiness, Dose 2	133 Participants	123 Participants	137 Participants	132 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Irritability, Dose 2	328 Participants	312 Participants	319 Participants	320 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Irritability, Dose 2	52 Participants	35 Participants	44 Participants	48 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Loss of appetite, Dose 1	12 Participants	11 Participants	9 Participants	8 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Loss of appetite, Dose 2	95 Participants	103 Participants	93 Participants	106 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Temperature, Dose 2	146 Participants	145 Participants	158 Participants	144 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Temperature, Dose 2	107 Participants	105 Participants	116 Participants	110 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Drowsiness, Dose 3	181 Participants	194 Participants	197 Participants	193 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Drowsiness, Dose 3	21 Participants	7 Participants	13 Participants	14 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Drowsiness, Dose 3	112 Participants	115 Participants	109 Participants	112 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Irritability, Dose 3	259 Participants	279 Participants	271 Participants	262 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Drowsiness, Across doses	45 Participants	41 Participants	40 Participants	47 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Temperature, Dose 3	106 Participants	127 Participants	112 Participants	114 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Temperature, Dose 3	0 Participants	2 Participants	2 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Temperature, Dose 3	71 Participants	88 Participants	79 Participants	89 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Drowsiness, Across doses	376 Participants	365 Participants	370 Participants	377 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Drowsiness, Across doses	235 Participants	231 Participants	235 Participants	237 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Irritability, Across doses	419 Participants	436 Participants	439 Participants	441 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Irritability, Across doses	109 Participants	83 Participants	86 Participants	104 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Irritability, Across doses	302 Participants	304 Participants	311 Participants	325 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Temperature, Across doses	203 Participants	208 Participants	208 Participants	220 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Loss of appetite, Across doses	295 Participants	325 Participants	307 Participants	312 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Loss of appetite, Across doses	28 Participants	23 Participants	22 Participants	22 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Loss of appetite, Across doses	180 Participants	194 Participants	186 Participants	182 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Temperature, Across doses	1 Participants	2 Participants	3 Participants	2 Participants

SECONDARY outcome

Timeframe: During the 8-day (Days 0-7) post-booster vaccination period

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

Outcome measures

Outcome measures
Measure	Nimenrix 3 Group n=491 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.	Nimenrix 2 Group n=510 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	Menjugate Group n=496 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	NeisVac-C Group n=504 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Irritability	180 Participants	197 Participants	181 Participants	186 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Loss of appetite	189 Participants	193 Participants	198 Participants	195 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Loss of appetite	12 Participants	21 Participants	23 Participants	27 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Drowsiness	198 Participants	206 Participants	208 Participants	202 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Drowsiness	14 Participants	13 Participants	21 Participants	18 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Loss of appetite	118 Participants	114 Participants	114 Participants	121 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Drowsiness	125 Participants	129 Participants	119 Participants	125 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Temperature (Rectally)	187 Participants	180 Participants	186 Participants	170 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Temperature (Rectally)	2 Participants	2 Participants	3 Participants	7 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Irritability	284 Participants	296 Participants	284 Participants	297 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Irritability	41 Participants	37 Participants	37 Participants	45 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Temperature (Rectally)	133 Participants	132 Participants	122 Participants	125 Participants

SECONDARY outcome

Timeframe: Within 31-days (Days 0-30) post-booster vaccination period

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

Outcome measures

Outcome measures
Measure	Nimenrix 3 Group n=497 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.	Nimenrix 2 Group n=511 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	Menjugate Group n=503 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	NeisVac-C Group n=506 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
Number of Subjects With Any Unsolicited Adverse Events (AEs)	179 Participants	185 Participants	164 Participants	167 Participants

SECONDARY outcome

Timeframe: Throughout the entire study (from Day 0 to Month 16)

Population: The analysis was performed on the Primary Total Vaccinated cohort, which included all vaccinated subjects during the primary phase, who had filled in their symptom sheets.

Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Outcome measures

Outcome measures
Measure	Nimenrix 3 Group n=528 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.	Nimenrix 2 Group n=524 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	Menjugate Group n=516 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	NeisVac-C Group n=527 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
Number of Subjects With Serious Adverse Events (SAEs) From Day 0 up to Month 1 post-primary vaccination	1 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Serious Adverse Events (SAEs) From primary vaccination up to ESFU contact	54 Participants	56 Participants	45 Participants	52 Participants

SECONDARY outcome

Timeframe: From Booster vaccination (Month 10) up to Extended Safety Follow-Up (ESFU) (Month 16)

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

Outcome measures

Outcome measures
Measure	Nimenrix 3 Group n=497 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.	Nimenrix 2 Group n=511 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	Menjugate Group n=503 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	NeisVac-C Group n=506 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
Number of Subjects With Serious Adverse Events (SAEs)	14 Participants	18 Participants	14 Participants	17 Participants

SECONDARY outcome

Timeframe: During 31-days (Days 0-30) post-each primary vaccination dose (Day 0 to Month 3) and from primary vaccination up to ESFU (Month 16)

Population: The analysis was performed on the Primary Total Vaccinated cohort, which included all vaccinated subjects during the primary phase, who had filled in their symptom sheets.

NOCIs assessed included asthma, autoimmune disorders, type 1 diabetes and allergies.

Outcome measures

Outcome measures
Measure	Nimenrix 3 Group n=528 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.	Nimenrix 2 Group n=524 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	Menjugate Group n=516 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	NeisVac-C Group n=527 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
Number of Subjects With New Onset of Chronic Illnesses (NOCIs) From primary vaccination up to ESFU contact	14 Participants	11 Participants	15 Participants	11 Participants
Number of Subjects With New Onset of Chronic Illnesses (NOCIs) Day 0 - Day 30 after each primary dose	11 Participants	6 Participants	5 Participants	5 Participants

SECONDARY outcome

Timeframe: From Booster vaccination (Month 10 to Month 11) up to ESFU (Month 16)

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

NOCIs assessed included asthma, autoimmune disorders, type 1 diabetes and allergies.

Outcome measures

Outcome measures
Measure	Nimenrix 3 Group n=497 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.	Nimenrix 2 Group n=511 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	Menjugate Group n=503 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.	NeisVac-C Group n=506 Participants Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
Number of Subjects With New Onset of Chronic Illnesses (NOCIs)	2 Participants	2 Participants	5 Participants	3 Participants

Adverse Events

Nimenrix 3 Group

Serious events: 54 serious events

Other events: 512 other events

Deaths: 0 deaths

Nimenrix 2 Group

Serious events: 56 serious events

Other events: 516 other events

Deaths: 0 deaths

Menjugate Group

Serious events: 45 serious events

Other events: 506 other events

Deaths: 0 deaths

NeisVac-C Group

Serious events: 52 serious events

Other events: 513 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: [email protected]

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