Trial Outcomes & Findings for Immunogenicity and Safety of Two Formulations of GSK Biologicals' Pneumococcal Vaccine (2830929A and 2830930A) When Administered in Healthy Infants (NCT NCT01616459)

Last Updated: 2019-07-16

Results Overview

Antibodies assessed for this outcome measure were those against the vaccine/cross-reactive pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (ANTI-1, -3, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). Antibody concentrations were measured by 22F-Inhibition enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. Primary outcome results correspond to antibody concentrations for all serotypes presented at the exception of those for the antibodies against the cross-reactive pneumococcal serotype 3 (ANTI-3).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

953 participants

Primary outcome timeframe

At study Month 3, e. g. at one month post-Dose 3 of pneumococcal vaccine

Results posted on

2019-07-16

Participant Flow

953 subjects were enrolled in the study, among whom 951 received at least one dose of study vaccine, while 2 were allocated a subject number but did not receive any study vaccine dose.

Study vaccines were administered as a 3-dose primary vaccination in healthy infants between 6-12 weeks (42-90 days) of age at the time of the first vaccination (Primary Phase), and then as an additional booster dose when subjects reached 12-15 months of age (Booster Phase).

Participant milestones

Participant milestones
Measure	11Pn Group Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).	12Pn Group Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).	Synflorix Group Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).	Prevnar13 Group Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
Overall Study STARTED	240	240	230	241
Overall Study COMPLETED	236	223	220	233
Overall Study NOT COMPLETED	4	17	10	8

Reasons for withdrawal

Reasons for withdrawal
Measure	11Pn Group Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).	12Pn Group Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).	Synflorix Group Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).	Prevnar13 Group Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
Overall Study Adverse Event	1	1	2	0
Overall Study Lost to Follow-up	1	11	3	2
Overall Study Protocol Violation	0	0	0	2
Overall Study Withdrawal by Subject	2	4	4	4
Overall Study Other reason	0	1	1	0

Baseline Characteristics

Immunogenicity and Safety of Two Formulations of GSK Biologicals' Pneumococcal Vaccine (2830929A and 2830930A) When Administered in Healthy Infants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	11Pn Group n=240 Participants Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).	12Pn Group n=240 Participants Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).	Synflorix Group n=230 Participants Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).	Prevnar13 Group n=241 Participants Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate ).	Total n=951 Participants Total of all reporting groups
Age, Continuous	8.6 Weeks STANDARD_DEVIATION 1.49 • n=5 Participants	8.7 Weeks STANDARD_DEVIATION 1.61 • n=7 Participants	8.7 Weeks STANDARD_DEVIATION 1.62 • n=5 Participants	8.6 Weeks STANDARD_DEVIATION 1.54 • n=4 Participants	8.6 Weeks STANDARD_DEVIATION 1.56 • n=21 Participants
Sex: Female, Male Female	113 Participants n=5 Participants	120 Participants n=7 Participants	113 Participants n=5 Participants	121 Participants n=4 Participants	467 Participants n=21 Participants
Sex: Female, Male Male	127 Participants n=5 Participants	120 Participants n=7 Participants	117 Participants n=5 Participants	120 Participants n=4 Participants	484 Participants n=21 Participants

PRIMARY outcome

Timeframe: At study Month 3, e. g. at one month post-Dose 3 of pneumococcal vaccine

Population: The analysis was performed on the According-to-Protocol cohort for immunogenicity of the Primary Phase which included all evaluable subjects for whom data concerning primary immunogenicity outcome measures were available for antibodies against at least one vaccine antigen component after primary vaccination against pneumococcal diseases.

Outcome measures

Outcome measures
Measure	11Pn Group n=223 Participants Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).	12Pn Group n=214 Participants Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).	Synflorix Group n=210 Participants Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).	Prevnar13 Group n=219 Participants Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate ).
Antibody Concentrations Against Pneumococcal Serotypes During the Primary Phase of the Study ANTI-1	1.54 µg/mL Interval 1.37 to 1.74	1.59 µg/mL Interval 1.41 to 1.79	1.37 µg/mL Interval 1.21 to 1.54	2.18 µg/mL Interval 1.97 to 2.42
Antibody Concentrations Against Pneumococcal Serotypes During the Primary Phase of the Study ANTI-3	0.06 µg/mL Interval 0.05 to 0.06	0.06 µg/mL Interval 0.05 to 0.07	0.05 µg/mL Interval 0.05 to 0.06	2.27 µg/mL Interval 2.06 to 2.49
Antibody Concentrations Against Pneumococcal Serotypes During the Primary Phase of the Study ANTI-4	1.78 µg/mL Interval 1.56 to 2.02	1.99 µg/mL Interval 1.73 to 2.28	1.68 µg/mL Interval 1.47 to 1.93	2.83 µg/mL Interval 2.6 to 3.09
Antibody Concentrations Against Pneumococcal Serotypes During the Primary Phase of the Study ANTI-5	2.48 µg/mL Interval 2.24 to 2.74	2.37 µg/mL Interval 2.13 to 2.64	2.19 µg/mL Interval 1.97 to 2.44	2.81 µg/mL Interval 2.52 to 3.13
Antibody Concentrations Against Pneumococcal Serotypes During the Primary Phase of the Study ANTI-6A	0.14 µg/mL Interval 0.12 to 0.17	1.12 µg/mL Interval 0.93 to 1.34	0.12 µg/mL Interval 0.1 to 0.14	2.05 µg/mL Interval 1.81 to 2.32
Antibody Concentrations Against Pneumococcal Serotypes During the Primary Phase of the Study ANTI-6B	0.51 µg/mL Interval 0.42 to 0.61	0.58 µg/mL Interval 0.48 to 0.69	0.48 µg/mL Interval 0.4 to 0.58	0.49 µg/mL Interval 0.42 to 0.58
Antibody Concentrations Against Pneumococcal Serotypes During the Primary Phase of the Study ANTI-7F	2.30 µg/mL Interval 2.1 to 2.52	2.44 µg/mL Interval 2.18 to 2.72	2.20 µg/mL Interval 1.97 to 2.47	3.16 µg/mL Interval 2.91 to 3.43
Antibody Concentrations Against Pneumococcal Serotypes During the Primary Phase of the Study ANTI-9V	1.57 µg/mL Interval 1.4 to 1.76	1.77 µg/mL Interval 1.58 to 1.97	1.42 µg/mL Interval 1.27 to 1.59	2.27 µg/mL Interval 2.05 to 2.51
Antibody Concentrations Against Pneumococcal Serotypes During the Primary Phase of the Study ANTI-14	4.19 µg/mL Interval 3.72 to 4.71	4.45 µg/mL Interval 3.95 to 5.0	4.21 µg/mL Interval 3.72 to 4.77	4.20 µg/mL Interval 3.68 to 4.8
Antibody Concentrations Against Pneumococcal Serotypes During the Primary Phase of the Study ANTI-18C	2.84 µg/mL Interval 2.45 to 3.28	2.56 µg/mL Interval 2.21 to 2.96	2.56 µg/mL Interval 2.19 to 2.98	3.17 µg/mL Interval 2.87 to 3.51
Antibody Concentrations Against Pneumococcal Serotypes During the Primary Phase of the Study ANTI-19A	1.63 µg/mL Interval 1.43 to 1.86	1.18 µg/mL Interval 1.03 to 1.36	0.18 µg/mL Interval 0.15 to 0.22	2.67 µg/mL Interval 2.39 to 3.0
Antibody Concentrations Against Pneumococcal Serotypes During the Primary Phase of the Study ANTI-19F	3.65 µg/mL Interval 3.2 to 4.16	3.31 µg/mL Interval 2.91 to 3.76	3.68 µg/mL Interval 3.15 to 4.3	3.07 µg/mL Interval 2.83 to 3.34
Antibody Concentrations Against Pneumococcal Serotypes During the Primary Phase of the Study ANTI-23F	0.62 µg/mL Interval 0.52 to 0.73	0.69 µg/mL Interval 0.57 to 0.83	0.72 µg/mL Interval 0.61 to 0.86	1.59 µg/mL Interval 1.38 to 1.84

PRIMARY outcome

Timeframe: 1 month post-dose 3 (primary phase)

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity of the Primary Phase which included all evaluable subjects for whom data concerning primary immunogenicity outcome measures were available for antibodies against at least one vaccine antigen component after primary vaccination against pneumococcal diseases.

N = number of subjects with post primary vaccination results available. % = percentage of subjects with ELISA pneumococcal antibody concentrations ≥ 0.2 μg/mL. Antibodies assessed for this outcome measure were those against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (ANTI-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). Antibody concentrations were measured by 22F-Inhibition enzyme-linked immunosorbent assay (ELISA).

Outcome measures

Outcome measures
Measure	11Pn Group n=223 Participants Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).	12Pn Group n=210 Participants Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).	Synflorix Group Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).	Prevnar13 Group Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate ).
Percentage (%) of Subjects (Synflorix and 11Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Pneumococcal Serotypes ANTI-1	99.5 Percentage of participants	98.6 Percentage of participants	—	—
Percentage (%) of Subjects (Synflorix and 11Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Pneumococcal Serotypes ANTI-4	97.7 Percentage of participants	96.7 Percentage of participants	—	—
Percentage (%) of Subjects (Synflorix and 11Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Pneumococcal Serotypes ANTI-5	100 Percentage of participants	99.5 Percentage of participants	—	—
Percentage (%) of Subjects (Synflorix and 11Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Pneumococcal Serotypes ANTI-6B	77.5 Percentage of participants	75.2 Percentage of participants	—	—
Percentage (%) of Subjects (Synflorix and 11Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Pneumococcal Serotypes ANTI-7F	99.6 Percentage of participants	99.5 Percentage of participants	—	—
Percentage (%) of Subjects (Synflorix and 11Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Pneumococcal Serotypes ANTI-9V	98.6 Percentage of participants	99.0 Percentage of participants	—	—
Percentage (%) of Subjects (Synflorix and 11Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Pneumococcal Serotypes ANTI-14	99.5 Percentage of participants	100 Percentage of participants	—	—
Percentage (%) of Subjects (Synflorix and 11Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Pneumococcal Serotypes ANTI-18C	99.1 Percentage of participants	98.1 Percentage of participants	—	—
Percentage (%) of Subjects (Synflorix and 11Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Pneumococcal Serotypes ANTI-19F	100 Percentage of participants	97.6 Percentage of participants	—	—
Percentage (%) of Subjects (Synflorix and 11Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Pneumococcal Serotypes ANTI-23F	81.1 Percentage of participants	83.8 Percentage of participants	—	—

PRIMARY outcome

Timeframe: 1 month post-dose 3 (primary phase)

Population: The analysis was performed on the ATP cohort for immunogenicity of the Primary Phase which included all evaluable subjects for whom data concerning primary immunogenicity outcome measures were available for antibodies against at least one vaccine antigen component after primary vaccination against pneumococcal diseases.

N = number of subjects with post primary vaccination results available. % = percentage of subjects with ELISA pneumococcal antibody concentrations ≥ 0.2 μg/mL. Antibodies assessed for this outcome measure were those against the vaccine pneumococcal serotype 19A (ANTI-19A). Antibody concentrations were measured by 22F-Inhibition enzyme-linked immunosorbent assay (ELISA).

Outcome measures

Outcome measures
Measure	11Pn Group n=222 Participants Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).	12Pn Group n=219 Participants Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).	Synflorix Group Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).	Prevnar13 Group Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate ).
Percentage (%) of Subjects (Prevnar13 and 11Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Anti-19A Pneumococcal Serotype	98.6 Percentage of participants	99.5 Percentage of participants	—	—

PRIMARY outcome

Timeframe: 1 month post-dose 3 (primary phase)

Outcome measures

Outcome measures
Measure	11Pn Group n=214 Participants Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).	12Pn Group n=210 Participants Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).	Synflorix Group Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).	Prevnar13 Group Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate ).
Percentage (%) of Subjects (Synflorix and 12Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Pneumococcal Serotypes ANTI-1	99.1 Percentage of participants	98.6 Percentage of participants	—	—
Percentage (%) of Subjects (Synflorix and 12Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Pneumococcal Serotypes ANTI-4	96.7 Percentage of participants	96.7 Percentage of participants	—	—
Percentage (%) of Subjects (Synflorix and 12Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Pneumococcal Serotypes ANTI-5	99.5 Percentage of participants	99.5 Percentage of participants	—	—
Percentage (%) of Subjects (Synflorix and 12Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Pneumococcal Serotypes ANTI-6B	79.9 Percentage of participants	75.2 Percentage of participants	—	—
Percentage (%) of Subjects (Synflorix and 12Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Pneumococcal Serotypes ANTI-7F	99.1 Percentage of participants	99.5 Percentage of participants	—	—
Percentage (%) of Subjects (Synflorix and 12Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Pneumococcal Serotypes ANTI-9V	99.1 Percentage of participants	99.0 Percentage of participants	—	—
Percentage (%) of Subjects (Synflorix and 12Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Pneumococcal Serotypes ANTI-14	100 Percentage of participants	100 Percentage of participants	—	—
Percentage (%) of Subjects (Synflorix and 12Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Pneumococcal Serotypes ANTI-18C	98.6 Percentage of participants	98.1 Percentage of participants	—	—
Percentage (%) of Subjects (Synflorix and 12Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Pneumococcal Serotypes ANTI-19F	98.6 Percentage of participants	97.6 Percentage of participants	—	—
Percentage (%) of Subjects (Synflorix and 12Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Pneumococcal Serotypes ANTI-23F	81.3 Percentage of participants	83.8 Percentage of participants	—	—

PRIMARY outcome

Timeframe: 1 month post-dose 3 (primary phase)

N = number of subjects with post primary vaccination results available. % = percentage of subjects with ELISA pneumococcal antibody concentrations ≥ 0.2 μg/mL. Antibodies assessed for this outcome measure were those against the vaccine pneumococcal serotype 6A and 19A (ANTI-6A and 19A). Antibody concentrations were measured by 22F-Inhibition enzyme-linked immunosorbent assay (ELISA).

Outcome measures

Outcome measures
Measure	11Pn Group n=214 Participants Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).	12Pn Group n=219 Participants Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).	Synflorix Group Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).	Prevnar13 Group Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate ).
Percentage (%) of Subjects (Prevnar13 and 12Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Anti-6A and 19A Pneumococcal Serotypes ANTI-6A	88.3 Percentage of participants	99.5 Percentage of participants	—	—
Percentage (%) of Subjects (Prevnar13 and 12Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Anti-6A and 19A Pneumococcal Serotypes ANTI-19A	95.8 Percentage of participants	99.5 Percentage of participants	—	—

SECONDARY outcome

Timeframe: At study Month 10 (M10) and Month 11 (M11), e.g.: prior to and at one month post booster vaccination with pneumococcal vaccine

Population: The analysis was performed on the ATP cohort for immunogenicity of the Booster Phase which included all evaluable subjects for whom data concerning booster immunogenicity outcome measures were available for antibodies against at least one vaccine antigen component before or after booster vaccination against pneumococcal diseases.

Antibodies assessed for this outcome measure were those against the vaccine/cross-reactive pneumococcal serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (ANTI-1, -3, -4, -5, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). Antibody concentrations were measured by 22F-Inhibition enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. Analysis of concentrations of antibodies against the cross-reactive pneumococcal serotype 6C (ANTI-6C) will not be performed due to unavailability of a specific qualified assay.

Outcome measures

Outcome measures
Measure	11Pn Group n=216 Participants Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).	12Pn Group n=206 Participants Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).	Synflorix Group n=203 Participants Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).	Prevnar13 Group n=210 Participants Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate ).
Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study ANTI-1 (M10)	0.26 µg/mL Interval 0.24 to 0.3	0.26 µg/mL Interval 0.24 to 0.3	0.26 µg/mL Interval 0.23 to 0.29	0.44 µg/mL Interval 0.4 to 0.48
Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study ANTI-1 (M11)	2.49 µg/mL Interval 2.21 to 2.82	2.18 µg/mL Interval 1.94 to 2.46	2.25 µg/mL Interval 2.01 to 2.53	3.84 µg/mL Interval 3.5 to 4.22
Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study ANTI-3 (M10)	0.06 µg/mL Interval 0.05 to 0.07	0.06 µg/mL Interval 0.05 to 0.06	0.06 µg/mL Interval 0.05 to 0.07	0.25 µg/mL Interval 0.22 to 0.29
Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study ANTI-3 (M11)	0.07 µg/mL Interval 0.06 to 0.08	0.07 µg/mL Interval 0.06 to 0.08	0.07 µg/mL Interval 0.06 to 0.09	1.68 µg/mL Interval 1.53 to 1.85
Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study ANTI-4 (M10)	0.49 µg/mL Interval 0.44 to 0.54	0.48 µg/mL Interval 0.43 to 0.54	0.50 µg/mL Interval 0.45 to 0.56	0.41 µg/mL Interval 0.37 to 0.46
Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study ANTI-4 (M11)	3.89 µg/mL Interval 3.49 to 4.34	4.18 µg/mL Interval 3.77 to 4.63	4.06 µg/mL Interval 3.7 to 4.45	3.86 µg/mL Interval 3.43 to 4.35
Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study ANTI-5 (M11)	3.23 µg/mL Interval 2.88 to 3.64	3.31 µg/mL Interval 2.98 to 3.68	3.05 µg/mL Interval 2.75 to 3.38	6.84 µg/mL Interval 6.12 to 7.66
Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study ANTI-5 (M10)	0.51 µg/mL Interval 0.46 to 0.57	0.51 µg/mL Interval 0.45 to 0.57	0.48 µg/mL Interval 0.43 to 0.53	0.77 µg/mL Interval 0.69 to 0.85
Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study ANTI-6B (M10)	0.57 µg/mL Interval 0.49 to 0.65	0.64 µg/mL Interval 0.56 to 0.74	0.59 µg/mL Interval 0.51 to 0.69	0.22 µg/mL Interval 0.19 to 0.25
Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study ANTI-6B (M11)	2.66 µg/mL Interval 2.34 to 3.03	4.09 µg/mL Interval 3.6 to 4.66	2.53 µg/mL Interval 2.24 to 2.86	3.80 µg/mL Interval 3.34 to 4.33
Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study ANTI-7F (M10)	1.04 µg/mL Interval 0.94 to 1.16	0.99 µg/mL Interval 0.89 to 1.1	0.94 µg/mL Interval 0.84 to 1.05	1.21 µg/mL Interval 1.11 to 1.32
Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study ANTI-7F (M11)	4.88 µg/mL Interval 4.4 to 5.4	4.57 µg/mL Interval 4.14 to 5.04	4.31 µg/mL Interval 3.91 to 4.75	6.34 µg/mL Interval 5.8 to 6.95
Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study ANTI-9V (M10)	0.76 µg/mL Interval 0.68 to 0.85	0.77 µg/mL Interval 0.69 to 0.87	0.70 µg/mL Interval 0.63 to 0.77	0.53 µg/mL Interval 0.48 to 0.58
Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study ANTI-9V (M11)	4.14 µg/mL Interval 3.7 to 4.62	4.36 µg/mL Interval 3.93 to 4.84	3.68 µg/mL Interval 3.32 to 4.09	5.83 µg/mL Interval 5.26 to 6.46
Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study ANTI-14 (M10)	1.30 µg/mL Interval 1.11 to 1.53	1.45 µg/mL Interval 1.28 to 1.64	1.12 µg/mL Interval 0.97 to 1.3	1.66 µg/mL Interval 1.44 to 1.93
Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study ANTI-14 (M11)	6.17 µg/mL Interval 5.45 to 6.98	6.52 µg/mL Interval 5.8 to 7.33	5.75 µg/mL Interval 5.07 to 6.51	10.05 µg/mL Interval 8.97 to 11.25
Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study ANTI-18C (M10)	0.76 µg/mL Interval 0.67 to 0.86	0.68 µg/mL Interval 0.6 to 0.77	0.74 µg/mL Interval 0.65 to 0.84	0.59 µg/mL Interval 0.54 to 0.65
Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study ANTI-18C (M11)	7.65 µg/mL Interval 6.79 to 8.61	7.20 µg/mL Interval 6.39 to 8.11	8.00 µg/mL Interval 7.06 to 9.06	6.01 µg/mL Interval 5.45 to 6.63
Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study ANTI-19A (M10)	0.46 µg/mL Interval 0.39 to 0.54	0.36 µg/mL Interval 0.31 to 0.42	0.18 µg/mL Interval 0.15 to 0.21	0.42 µg/mL Interval 0.35 to 0.49
Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study ANTI-19A (M11)	5.35 µg/mL Interval 4.67 to 6.13	4.46 µg/mL Interval 3.83 to 5.2	1.11 µg/mL Interval 0.91 to 1.35	7.06 µg/mL Interval 6.25 to 7.98
Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study ANTI-19F (M10)	1.11 µg/mL Interval 0.97 to 1.28	1.11 µg/mL Interval 0.96 to 1.29	1.10 µg/mL Interval 0.95 to 1.29	0.50 µg/mL Interval 0.44 to 0.57
Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study ANTI-19F (M11)	8.67 µg/mL Interval 7.72 to 9.73	8.50 µg/mL Interval 7.55 to 9.59	8.22 µg/mL Interval 7.4 to 9.13	6.40 µg/mL Interval 5.77 to 7.11
Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study ANTI-23F (M10)	0.51 µg/mL Interval 0.44 to 0.58	0.54 µg/mL Interval 0.47 to 0.62	0.49 µg/mL Interval 0.43 to 0.56	0.34 µg/mL Interval 0.29 to 0.39
Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study ANTI-23F (M11)	3.09 µg/mL Interval 2.73 to 3.49	3.31 µg/mL Interval 2.93 to 3.73	2.98 µg/mL Interval 2.65 to 3.35	6.49 µg/mL Interval 5.69 to 7.39

SECONDARY outcome

Timeframe: At study Month 3, e. g. at one month post-Dose 3 of pneumococcal vaccine

Titers for opsonophagocytic activity assessed for this outcome measure were those for opsonophagocytic activity against the vaccine/cross-reactive pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19F and 23F (OPA-1, -3, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19F and -23F). The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8. Testing for opsonophagocytic activity against the cross-reactive pneumococcal serotype 6C will not be performed due to unavailability of a specific qualified assay.

Outcome measures

Outcome measures
Measure	11Pn Group n=105 Participants Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).	12Pn Group n=105 Participants Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).	Synflorix Group n=99 Participants Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).	Prevnar13 Group n=105 Participants Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate ).
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Primary Phase of the Study OPA-1	13.2 Titers Interval 9.6 to 18.2	15.6 Titers Interval 11.4 to 21.1	13.6 Titers Interval 9.9 to 18.6	26.4 Titers Interval 19.3 to 36.0
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Primary Phase of the Study OPA-3	4.8 Titers Interval 4.2 to 5.5	5.2 Titers Interval 4.4 to 6.0	5.0 Titers Interval 4.3 to 5.7	97.2 Titers Interval 81.6 to 116.0
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Primary Phase of the Study OPA-4	527.3 Titers Interval 401.5 to 692.4	609.0 Titers Interval 492.8 to 752.5	616.7 Titers Interval 503.2 to 756.0	540.1 Titers Interval 444.7 to 656.1
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Primary Phase of the Study OPA-5	43.0 Titers Interval 32.6 to 56.9	46.7 Titers Interval 36.8 to 59.3	40.5 Titers Interval 30.4 to 54.0	57.2 Titers Interval 44.3 to 74.0
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Primary Phase of the Study OPA-6A	37.4 Titers Interval 22.9 to 60.9	1292.6 Titers Interval 940.3 to 1777.0	36.5 Titers Interval 22.6 to 59.0	2832.0 Titers Interval 2212.8 to 3624.4
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Primary Phase of the Study OPA-6B	478.3 Titers Interval 345.2 to 662.7	603.2 Titers Interval 436.9 to 832.8	622.6 Titers Interval 444.2 to 872.7	742.3 Titers Interval 533.9 to 1031.8
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Primary Phase of the Study OPA-7F	3515.0 Titers Interval 2787.1 to 4433.0	4472.3 Titers Interval 3463.6 to 5774.9	3424.1 Titers Interval 2631.9 to 4454.8	9737.9 Titers Interval 7540.5 to 12575.8
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Primary Phase of the Study OPA-9V	1212.9 Titers Interval 953.6 to 1542.6	1629.0 Titers Interval 1293.0 to 2052.4	1469.9 Titers Interval 1178.3 to 1833.6	1614.5 Titers Interval 1283.9 to 2030.2
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Primary Phase of the Study OPA-14	1000.8 Titers Interval 743.1 to 1347.9	1699.1 Titers Interval 1313.8 to 2197.3	1417.4 Titers Interval 1059.6 to 1896.0	2034.4 Titers Interval 1513.4 to 2734.8
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Primary Phase of the Study OPA-18C	100.9 Titers Interval 67.7 to 150.4	131.5 Titers Interval 86.9 to 198.8	72.0 Titers Interval 47.0 to 110.4	145.7 Titers Interval 102.6 to 206.8
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Primary Phase of the Study OPA-19F	144.2 Titers Interval 101.8 to 204.3	201.4 Titers Interval 147.2 to 275.4	210.4 Titers Interval 143.6 to 308.2	66.0 Titers Interval 49.8 to 87.5
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Primary Phase of the Study OPA-23F	989.6 Titers Interval 652.9 to 1499.8	1377.9 Titers Interval 951.5 to 1995.3	1097.3 Titers Interval 742.1 to 1622.4	5136.4 Titers Interval 3829.2 to 6889.8

SECONDARY outcome

Timeframe: At study Month 11, e.g.: at one month post booster vaccination with pneumococcal vaccine

Outcome measures

Outcome measures
Measure	11Pn Group n=99 Participants Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).	12Pn Group n=97 Participants Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).	Synflorix Group n=96 Participants Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).	Prevnar13 Group n=101 Participants Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate ).
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Booster Phase of the Study OPA-1	192.4 Titers Interval 129.0 to 287.1	192.4 Titers Interval 133.3 to 277.5	216.8 Titers Interval 148.3 to 316.9	207.6 Titers Interval 145.8 to 295.6
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Booster Phase of the Study OPA-3	9.7 Titers Interval 7.5 to 12.7	10.5 Titers Interval 8.0 to 13.7	10.9 Titers Interval 7.6 to 15.5	317.2 Titers Interval 275.4 to 365.4
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Booster Phase of the Study OPA-4	1455.3 Titers Interval 1208.9 to 1751.9	1650.5 Titers Interval 1360.9 to 2001.9	1550.5 Titers Interval 1230.2 to 1954.1	1972.2 Titers Interval 1586.3 to 2451.9
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Booster Phase of the Study OPA-5	134.5 Titers Interval 100.3 to 180.4	133.3 Titers Interval 105.2 to 168.8	133.4 Titers Interval 100.5 to 177.1	269.9 Titers Interval 216.2 to 337.0
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Booster Phase of the Study OPA-6A	116.8 Titers Interval 67.9 to 201.0	3436.7 Titers Interval 2716.0 to 4348.5	146.4 Titers Interval 87.6 to 244.6	5200.7 Titers Interval 4134.9 to 6541.3
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Booster Phase of the Study OPA-6B	681.4 Titers Interval 520.3 to 892.5	1246.4 Titers Interval 963.1 to 1613.0	694.6 Titers Interval 546.5 to 882.6	1727.9 Titers Interval 1406.2 to 2123.4
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Booster Phase of the Study OPA-7F	8362.9 Titers Interval 6977.1 to 10023.9	7516.4 Titers Interval 6223.0 to 9078.7	7880.8 Titers Interval 6408.6 to 9691.3	16592.6 Titers Interval 13909.7 to 19792.9
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Booster Phase of the Study OPA-9V	3406.9 Titers Interval 2758.2 to 4208.1	3616.1 Titers Interval 2838.1 to 4607.5	3260.6 Titers Interval 2620.1 to 4057.6	8470.4 Titers Interval 6692.4 to 10720.8
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Booster Phase of the Study OPA-14	2038.4 Titers Interval 1594.3 to 2606.2	2519.9 Titers Interval 1960.2 to 3239.6	2285.1 Titers Interval 1845.9 to 2828.9	2772.6 Titers Interval 2218.6 to 3464.9
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Booster Phase of the Study OPA-18C	914.8 Titers Interval 621.8 to 1345.9	781.2 Titers Interval 536.3 to 1137.8	912.0 Titers Interval 605.4 to 1374.1	610.7 Titers Interval 421.3 to 885.1
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Booster Phase of the Study OPA-19F	523.9 Titers Interval 382.9 to 716.8	565.3 Titers Interval 406.4 to 786.6	759.6 Titers Interval 554.3 to 1040.8	438.0 Titers Interval 312.7 to 613.7
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Booster Phase of the Study OPA-23F	2562.9 Titers Interval 2016.3 to 3257.6	2923.6 Titers Interval 2248.9 to 3800.9	2600.0 Titers Interval 1896.8 to 3563.9	24350.4 Titers Interval 18303.2 to 32395.5

SECONDARY outcome

Timeframe: At study Month 3, e. g. at one month post-Dose 3 of pneumococcal vaccine

Anti-PD antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). The cut-off of the assay was an anti-PD antibody concentration higher than or equal to (≥) 100 EL.U/mL.

Outcome measures

Outcome measures
Measure	11Pn Group n=112 Participants Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).	12Pn Group n=106 Participants Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).	Synflorix Group n=103 Participants Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).	Prevnar13 Group n=106 Participants Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate ).
Concentrations of Antibodies Against Protein D (Anti-PD) During the Primary Phase of the Study	1430.1 EL.U/mL Interval 1194.2 to 1712.7	1194.2 EL.U/mL Interval 1017.7 to 1401.3	1344.8 EL.U/mL Interval 1116.4 to 1619.9	64.4 EL.U/mL Interval 57.7 to 71.9

SECONDARY outcome

Timeframe: At study Month 10 (M10) and Month 11 (M11), e.g.: prior to and at one month post booster vaccination with pneumococcal vaccine

Outcome measures

Outcome measures
Measure	11Pn Group n=108 Participants Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).	12Pn Group n=102 Participants Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).	Synflorix Group n=101 Participants Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).	Prevnar13 Group n=106 Participants Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate ).
Concentrations of Antibodies Against Protein D (Anti-PD) During the Booster Phase of the Study Anti-PD (M10)	445.9 EL.U/mL Interval 365.0 to 544.7	447.6 EL.U/mL Interval 363.4 to 551.2	460.0 EL.U/mL Interval 376.2 to 562.4	70.9 EL.U/mL Interval 61.8 to 81.3
Concentrations of Antibodies Against Protein D (Anti-PD) During the Booster Phase of the Study Anti-PD (M11)	1866.0 EL.U/mL Interval 1535.7 to 2267.4	1835.5 EL.U/mL Interval 1511.5 to 2229.0	2128.4 EL.U/mL Interval 1777.1 to 2549.2	77.8 EL.U/mL Interval 67.1 to 90.1

SECONDARY outcome

Timeframe: Within the 4-day (Days 0-3) post-vaccination period following each primary dose (D).

Population: The analysis was performed on the Total Vaccinated cohort for the Primary Phase, which included all subjects who received at least one of the 3 vaccine doses priming against pneumococcal diseases, with analysis done solely on subjects for whom post-vaccination results about solicited symptoms were available.

Assessed local symptoms were pain, redness and swelling. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (\>) 30 millimeters (mm).

Outcome measures

Outcome measures
Measure	11Pn Group n=240 Participants Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).	12Pn Group n=236 Participants Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).	Synflorix Group n=228 Participants Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).	Prevnar13 Group n=238 Participants Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate ).
Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Phase Any Pain, post D1	104 Participants	105 Participants	94 Participants	85 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Phase Grade 3 Pain, post D1	16 Participants	5 Participants	12 Participants	6 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Phase Any Redness, post D1	82 Participants	90 Participants	72 Participants	75 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Phase Grade 3 Redness, post D1	0 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Phase Any Swelling, post D1	51 Participants	57 Participants	46 Participants	47 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Phase Grade 3 Swelling, post D1	1 Participants	4 Participants	7 Participants	1 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Phase Any Pain, post D2	89 Participants	100 Participants	88 Participants	90 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Phase Grade 3 Pain, post D2	12 Participants	12 Participants	10 Participants	6 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Phase Any Redness, post D2	86 Participants	95 Participants	78 Participants	79 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Phase Grade 3 Redness, post D2	2 Participants	1 Participants	1 Participants	1 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Phase Any Swelling, post D2	61 Participants	72 Participants	54 Participants	49 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Phase Grade 3 Swelling, post D2	2 Participants	3 Participants	5 Participants	2 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Phase Any Pain, post D3	76 Participants	75 Participants	76 Participants	75 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Phase Grade 3 Pain, post D3	4 Participants	4 Participants	6 Participants	3 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Phase Any Redness, post D3	93 Participants	85 Participants	91 Participants	85 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Phase Grade 3 Redness, post D3	3 Participants	2 Participants	2 Participants	1 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Phase Any Swelling, post D3	72 Participants	76 Participants	58 Participants	61 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Phase Grade 3 Swelling, post D3	2 Participants	5 Participants	2 Participants	3 Participants

SECONDARY outcome

Timeframe: Within the 4-day (Days 0-3) period after booster vaccination

Population: The analysis was performed on the Total Vaccinated cohort for the Booster Phase, which included all subjects who received the booster dose against pneumococcal diseases, with analysis done solely on subjects for whom post-vaccination results about solicited symptoms were available.

Outcome measures

Outcome measures
Measure	11Pn Group n=235 Participants Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).	12Pn Group n=224 Participants Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).	Synflorix Group n=219 Participants Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).	Prevnar13 Group n=231 Participants Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate ).
Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Booster Phase of the Study Any Swelling	84 Participants	88 Participants	89 Participants	85 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Booster Phase of the Study Any Pain	112 Participants	123 Participants	119 Participants	110 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Booster Phase of the Study Grade 3 Pain	13 Participants	16 Participants	18 Participants	8 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Booster Phase of the Study Any Redness	109 Participants	117 Participants	108 Participants	107 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Booster Phase of the Study Grade 3 Redness	5 Participants	10 Participants	7 Participants	5 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Booster Phase of the Study Grade 3 Swelling	8 Participants	7 Participants	5 Participants	7 Participants

SECONDARY outcome

Timeframe: Within the 4-day (Days 0-3) post-vaccination period following each primary dose (D).

Assessed solicited general symptoms were Drowsiness, Irritability/Fussiness (Irr./Fuss.), Loss of appetite (Loss Appet.) and Fever (rectal temperature higher than \[≥\] 38.0 degrees Celsius \[°C\]),. Any = Occurrence of the specified solicited general symptom, regardless of intensity or relationship to vaccination. Related = Occurrence of the specified symptom assessed by the investigators as causally related to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Irr./Fuss. = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. Grade 3 Fever = Rectal temperature higher than (\>) 40.0°C.

Outcome measures

Outcome measures
Measure	11Pn Group n=240 Participants Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).	12Pn Group n=236 Participants Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).	Synflorix Group n=227 Participants Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).	Prevnar13 Group n=238 Participants Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate ).
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study Any Drowsiness, post D1	148 Participants	144 Participants	129 Participants	129 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study Grade 3 Drowsiness, post D1	7 Participants	6 Participants	10 Participants	10 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study Related Drowsiness, post D1	124 Participants	104 Participants	95 Participants	103 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study Any Irr./Fuss., post D1	151 Participants	156 Participants	134 Participants	138 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study Grade 3 Irr./Fuss., post D1	16 Participants	15 Participants	17 Participants	10 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study Related Irr./Fuss., post D1	119 Participants	122 Participants	98 Participants	103 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study Any Loss Appet., post D1	85 Participants	89 Participants	81 Participants	73 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study Grade 3 Loss Appet., post D1	2 Participants	2 Participants	3 Participants	2 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study Related Loss Appet., post D1	59 Participants	65 Participants	56 Participants	57 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study Any Fever, post D1	108 Participants	104 Participants	107 Participants	87 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study Grade 3 Fever, post D1	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study Related Fever, post D1	94 Participants	91 Participants	92 Participants	76 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study Any Drowsiness, post D2	125 Participants	115 Participants	105 Participants	111 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study Grade 3 Drowsiness, post D2	6 Participants	7 Participants	6 Participants	8 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study Related Drowsiness, post D2	96 Participants	89 Participants	81 Participants	97 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study Any Irr./Fuss., post D2	151 Participants	151 Participants	141 Participants	128 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study Grade 3 Irr./Fuss., post D2	18 Participants	12 Participants	17 Participants	10 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study Related Irr./Fuss., post D2	123 Participants	113 Participants	114 Participants	106 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study Any Loss Appet., post D2	69 Participants	78 Participants	71 Participants	72 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study Grade 3 Loss Appet., post D2	2 Participants	3 Participants	1 Participants	3 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study Related Loss Appet., post D2	52 Participants	58 Participants	48 Participants	56 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study Any Fever, post D2	97 Participants	84 Participants	90 Participants	90 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study Grade 3 Fever, post D2	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study Related Fever, post D2	87 Participants	75 Participants	82 Participants	82 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study Any Drowsiness, post D3	99 Participants	92 Participants	88 Participants	87 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study Grade 3 Drowsiness, post D3	4 Participants	2 Participants	3 Participants	5 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study Related Drowsiness, post D3	80 Participants	67 Participants	70 Participants	71 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study Any Irr./Fuss., post D3	117 Participants	123 Participants	118 Participants	112 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study Grade 3 Irr./Fuss., post D3	6 Participants	7 Participants	8 Participants	7 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study Related Irr./Fuss., post D3	95 Participants	92 Participants	96 Participants	87 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study Any Loss Appet., post D3	63 Participants	62 Participants	67 Participants	54 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study Grade 3 Loss Appet., post D3	0 Participants	3 Participants	3 Participants	5 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study Related Loss Appet., post D3	49 Participants	42 Participants	54 Participants	41 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study Any Fever, post D3	51 Participants	53 Participants	61 Participants	58 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study Grade 3 Fever, post D3	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study Related Fever, post D3	50 Participants	51 Participants	56 Participants	49 Participants

SECONDARY outcome

Timeframe: Within the 4-day (Days 0-3) period after booster vaccination

Assessed solicited general symptoms were Drowsiness, Irritability/Fussiness (Irr./Fuss.), Loss of appetite (Loss Appet.) and Fever (rectal temperature higher than \[≥\] 38.0 degrees Celsius \[°C\]). Any = Occurrence of the specified solicited general symptom, regardless of intensity or relationship to vaccination. Related = Occurrence of the specified symptom assessed by the investigators as causally related to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Irr./Fuss. = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. Grade 3 Fever = Rectal temperature higher than (\>) 40.0°C.

Outcome measures

Outcome measures
Measure	11Pn Group n=235 Participants Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).	12Pn Group n=224 Participants Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).	Synflorix Group n=219 Participants Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).	Prevnar13 Group n=231 Participants Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate ).
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Booster Phase of the Study Any Drowsiness	109 Participants	100 Participants	84 Participants	96 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Booster Phase of the Study Grade 3 Drowsiness	9 Participants	6 Participants	4 Participants	2 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Booster Phase of the Study Related Drowsiness	93 Participants	79 Participants	68 Participants	81 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Booster Phase of the Study Any Irr./Fuss.	140 Participants	136 Participants	137 Participants	129 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Booster Phase of the Study Grade 3 Irr./Fuss.	14 Participants	14 Participants	12 Participants	9 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Booster Phase of the Study Related Irr./Fuss.	107 Participants	117 Participants	109 Participants	107 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Booster Phase of the Study Any Loss Appet.	80 Participants	85 Participants	83 Participants	61 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Booster Phase of the Study Grade 3 Loss Appet.	6 Participants	3 Participants	9 Participants	7 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Booster Phase of the Study Related Loss Appet.	66 Participants	64 Participants	65 Participants	45 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Booster Phase of the Study Any Fever.	80 Participants	72 Participants	68 Participants	75 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Booster Phase of the Study Grade 3 Fever	2 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Booster Phase of the Study Related Fever	72 Participants	66 Participants	60 Participants	67 Participants

SECONDARY outcome

Timeframe: Within the 31-day (Days 0-30) period post primary vaccination, across doses

An unsolicited AE was defined as 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. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For the marketed products administered in the study, this also included failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse of the product. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination.

Outcome measures

Outcome measures
Measure	11Pn Group n=240 Participants Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).	12Pn Group n=240 Participants Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).	Synflorix Group n=230 Participants Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).	Prevnar13 Group n=241 Participants Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate ).
Number of Subjects With Any Unsolicited Adverse Events (AEs) During the Primary Phase of the Study	110 Participants	108 Participants	123 Participants	124 Participants

SECONDARY outcome

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

Population: The analysis was performed on the Total Vaccinated cohort for the Booster Phase, which included all subjects who received the booster dose against pneumococcal diseases.

Outcome measures

Outcome measures
Measure	11Pn Group n=237 Participants Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).	12Pn Group n=226 Participants Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).	Synflorix Group n=222 Participants Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).	Prevnar13 Group n=234 Participants Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate ).
Number of Subjects With Any Unsolicited Adverse Events (AEs) During the Booster Phase of the Study	69 Participants	68 Participants	74 Participants	53 Participants

SECONDARY outcome

Timeframe: From Month 0 to Month 3

A SAE was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalisation, as per the medical or scientific judgement of the physician. Any = Occurrence of a SAE, regardless of relationship to vaccination.

Outcome measures

Outcome measures
Measure	11Pn Group n=240 Participants Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).	12Pn Group n=240 Participants Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).	Synflorix Group n=230 Participants Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).	Prevnar13 Group n=241 Participants Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate ).
Number of Subjects With Any Serious Adverse Events (SAEs)During the Primary Phase of the Study	12 Participants	11 Participants	17 Participants	12 Participants

SECONDARY outcome

Timeframe: From Day 0 to Month 11

Population: The analysis was performed on the Total Vaccinated cohort for the Booster Phase, which included all subjects who received the booster dose against pneumococcal diseases.

A SAE was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalisation, as per the medical or scientific judgement of the the physician. Any = Occurrence of a SAE, regardless of relationship to vaccination.

Outcome measures

Outcome measures
Measure	11Pn Group n=240 Participants Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).	12Pn Group n=240 Participants Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).	Synflorix Group n=230 Participants Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).	Prevnar13 Group n=241 Participants Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate ).
Number of Subjects With Any Serious Adverse Events (SAEs) During the Entire Duration of the Study	29 Participants	26 Participants	38 Participants	24 Participants

SECONDARY outcome

Timeframe: At study Month 10 (M10) and Month 11 (M11), e.g.: prior to and at one month post booster vaccination with pneumococcal vaccine

Population: The analysis was performed on the According-to-Protocol cohort for immunogenicity of the Booster Phase which included all evaluable subjects for whom data concerning booster immunogenicity outcome measures were available for antibodies against at least one vaccine antigen component before or after booster vaccination against pneumococcal diseases.

Antibodies assessed for this outcome measure was that against the cross-reactive pneumococcal serotype 6A (ANTI-6A). Antibody concentrations were measured by 22F-Inhibition enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL.

Outcome measures

Outcome measures
Measure	11Pn Group n=212 Participants Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).	12Pn Group n=203 Participants Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).	Synflorix Group n=200 Participants Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).	Prevnar13 Group n=209 Participants Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate ).
Antibody Concentrations Against Pneumococcal Serotype 6A During the Booster Phase of the Study ANTI-6A (M10)	0.23 µg/mL Interval 0.19 to 0.27	0.89 µg/mL Interval 0.78 to 1.01	0.22 µg/mL Interval 0.18 to 0.26	0.64 µg/mL Interval 0.56 to 0.73
Antibody Concentrations Against Pneumococcal Serotype 6A During the Booster Phase of the Study ANTI-6A (M11)	1.07 µg/mL Interval 0.9 to 1.27	7.94 µg/mL Interval 6.99 to 9.02	0.91 µg/mL Interval 0.76 to 1.09	9.31 µg/mL Interval 8.41 to 10.3

SECONDARY outcome

Timeframe: At study Month 3, e. g. at one month post-Dose 3 of pneumococcal vaccine

Titers for opsonophagocytic activity assessed for this outcome measure were those for opsonophagocytic activity against the vaccine/cross-reactive pneumococcal serotypes 19A (OPA-19A). The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) serotype-specific Lower Limit of Quantification (143).

Outcome measures

Outcome measures
Measure	11Pn Group n=87 Participants Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).	12Pn Group n=88 Participants Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).	Synflorix Group n=76 Participants Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).	Prevnar13 Group n=92 Participants Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate ).
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes 19A During the Primary Phase of the Study	1813.0 Titers Interval 1524.4 to 2156.1	1523.9 Titers Interval 1215.3 to 1910.9	759.6 Titers Interval 559.2 to 1032.0	2056.6 Titers Interval 1748.9 to 2418.4

SECONDARY outcome

Timeframe: At study Month 11, e. g. at one month post-Booster vaccination with pneumococcal vaccine

Titers for opsonophagocytic activity assessed for this outcome measure were those for opsonophagocytic activity against the vaccine/cross-reactive pneumococcal serotypes 19A (OPA-19A). The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) serotype-specific Lower Limit of Quantification (143).

Outcome measures

Outcome measures
Measure	11Pn Group n=74 Participants Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).	12Pn Group n=67 Participants Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).	Synflorix Group n=69 Participants Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).	Prevnar13 Group n=75 Participants Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate ).
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes 19A During the Booster Phase of the Study	4866.4 Titers Interval 4184.6 to 5659.4	3896.4 Titers Interval 3263.2 to 4652.4	2191.0 Titers Interval 1720.0 to 2791.0	5720.1 Titers Interval 4883.9 to 6699.4

SECONDARY outcome

Timeframe: At study Month 3, e. g. at one month post-Dose 3 of pneumococcal vaccine

Population: The analysis was to be performed on the According-to-Protocol cohort for immunogenicity of the Primary Phase. But no analysis was performed on Enzyme-Linked ImmunoSorbent Assay (ELISA) testing for antibody concentrations against vaccine serotype 6C as no specific qualified/validated assay was available

No analysis was performed on Enzyme-Linked ImmunoSorbent Assay (ELISA) testing for antibody concentrations against vaccine serotype 6C as no specific qualified/validated assay was available.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At study Month 10 (M10) and Month 11 (M11), e.g.: prior to and at one month post booster vaccination with pneumococcal vaccine

Population: The analysis was to be performed on the According-to-Protocol cohort for immunogenicity of the Booster Phase but no analysis was performed on Enzyme-Linked ImmunoSorbent Assay (ELISA) testing for antibody concentrations against vaccine serotype 6C as no specific qualified/validated assay was available.

No analysis was performed on Enzyme-Linked ImmunoSorbent Assay (ELISA) testing for antibody concentrations against vaccine serotype 6C as no specific qualified/validated assay was available.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At study Month 3, e. g. at one month post-Dose 3 of pneumococcal vaccine

Population: The analysis was to be performed on the According-to-Protocol cohort for immunogenicity of the Primary Phase but no analysis was performed on opsonophagocytic activity for antibody titers against vaccine serotype 6C as no specific qualified/validated assay was available.

No analysis was performed on opsonophagocytic activity for antibody titers against vaccine serotype 6C as no specific qualified/validated assay was available.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At study Month 11, e. g. at one month post-Booster vaccination with pneumococcal vaccine

Population: The analysis was to be performed on the According-to-Protocol cohort for immunogenicity of the Booster Phase but no analysis was performed on opsonophagocytic activity for antibody titers against vaccine serotype 6C as no specific qualified/validated assay was available.

No analysis was performed on opsonophagocytic activity for antibody titers against vaccine serotype 6C as no specific qualified/validated assay was available.

Outcome measures

Outcome data not reported

Adverse Events

11Pn Group

Serious events: 29 serious events

Other events: 234 other events

Deaths: 0 deaths

12Pn Group

Serious events: 26 serious events

Other events: 229 other events

Deaths: 0 deaths

Synflorix Group

Serious events: 38 serious events

Other events: 221 other events

Deaths: 0 deaths

Prevnar13 Group

Serious events: 24 serious events

Other events: 235 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	11Pn Group n=240 participants at risk Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).	12Pn Group n=240 participants at risk Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).	Synflorix Group n=230 participants at risk Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).	Prevnar13 Group n=241 participants at risk Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate ).
General disorders Pain	47.7% 112/235 • Solicited symptoms: during the 4 days post-primary and post-booster vaccination. Unsolicited AEs: during 31 days post-primary and post-booster vaccination. SAEs: during the whole study period (from Day 0 to Month 11). Analysis of AEs and SAEs was performed on all subjects who received at least one primary vaccination dose or at least the booster vaccination. Analysis of solicited symptoms was performed on subjects who received at least one primary vaccination or at least the booster vaccination and for whom results were available.	54.9% 123/224 • Solicited symptoms: during the 4 days post-primary and post-booster vaccination. Unsolicited AEs: during 31 days post-primary and post-booster vaccination. SAEs: during the whole study period (from Day 0 to Month 11). Analysis of AEs and SAEs was performed on all subjects who received at least one primary vaccination dose or at least the booster vaccination. Analysis of solicited symptoms was performed on subjects who received at least one primary vaccination or at least the booster vaccination and for whom results were available.	54.3% 119/219 • Solicited symptoms: during the 4 days post-primary and post-booster vaccination. Unsolicited AEs: during 31 days post-primary and post-booster vaccination. SAEs: during the whole study period (from Day 0 to Month 11). Analysis of AEs and SAEs was performed on all subjects who received at least one primary vaccination dose or at least the booster vaccination. Analysis of solicited symptoms was performed on subjects who received at least one primary vaccination or at least the booster vaccination and for whom results were available.	47.6% 110/231 • Solicited symptoms: during the 4 days post-primary and post-booster vaccination. Unsolicited AEs: during 31 days post-primary and post-booster vaccination. SAEs: during the whole study period (from Day 0 to Month 11). Analysis of AEs and SAEs was performed on all subjects who received at least one primary vaccination dose or at least the booster vaccination. Analysis of solicited symptoms was performed on subjects who received at least one primary vaccination or at least the booster vaccination and for whom results were available.
General disorders Redness	46.4% 109/235 • Solicited symptoms: during the 4 days post-primary and post-booster vaccination. Unsolicited AEs: during 31 days post-primary and post-booster vaccination. SAEs: during the whole study period (from Day 0 to Month 11). Analysis of AEs and SAEs was performed on all subjects who received at least one primary vaccination dose or at least the booster vaccination. Analysis of solicited symptoms was performed on subjects who received at least one primary vaccination or at least the booster vaccination and for whom results were available.	52.2% 117/224 • Solicited symptoms: during the 4 days post-primary and post-booster vaccination. Unsolicited AEs: during 31 days post-primary and post-booster vaccination. SAEs: during the whole study period (from Day 0 to Month 11). Analysis of AEs and SAEs was performed on all subjects who received at least one primary vaccination dose or at least the booster vaccination. Analysis of solicited symptoms was performed on subjects who received at least one primary vaccination or at least the booster vaccination and for whom results were available.	49.3% 108/219 • Solicited symptoms: during the 4 days post-primary and post-booster vaccination. Unsolicited AEs: during 31 days post-primary and post-booster vaccination. SAEs: during the whole study period (from Day 0 to Month 11). Analysis of AEs and SAEs was performed on all subjects who received at least one primary vaccination dose or at least the booster vaccination. Analysis of solicited symptoms was performed on subjects who received at least one primary vaccination or at least the booster vaccination and for whom results were available.	46.3% 107/231 • Solicited symptoms: during the 4 days post-primary and post-booster vaccination. Unsolicited AEs: during 31 days post-primary and post-booster vaccination. SAEs: during the whole study period (from Day 0 to Month 11). Analysis of AEs and SAEs was performed on all subjects who received at least one primary vaccination dose or at least the booster vaccination. Analysis of solicited symptoms was performed on subjects who received at least one primary vaccination or at least the booster vaccination and for whom results were available.
General disorders Swelling	35.7% 84/235 • Solicited symptoms: during the 4 days post-primary and post-booster vaccination. Unsolicited AEs: during 31 days post-primary and post-booster vaccination. SAEs: during the whole study period (from Day 0 to Month 11). Analysis of AEs and SAEs was performed on all subjects who received at least one primary vaccination dose or at least the booster vaccination. Analysis of solicited symptoms was performed on subjects who received at least one primary vaccination or at least the booster vaccination and for whom results were available.	39.3% 88/224 • Solicited symptoms: during the 4 days post-primary and post-booster vaccination. Unsolicited AEs: during 31 days post-primary and post-booster vaccination. SAEs: during the whole study period (from Day 0 to Month 11). Analysis of AEs and SAEs was performed on all subjects who received at least one primary vaccination dose or at least the booster vaccination. Analysis of solicited symptoms was performed on subjects who received at least one primary vaccination or at least the booster vaccination and for whom results were available.	40.6% 89/219 • Solicited symptoms: during the 4 days post-primary and post-booster vaccination. Unsolicited AEs: during 31 days post-primary and post-booster vaccination. SAEs: during the whole study period (from Day 0 to Month 11). Analysis of AEs and SAEs was performed on all subjects who received at least one primary vaccination dose or at least the booster vaccination. Analysis of solicited symptoms was performed on subjects who received at least one primary vaccination or at least the booster vaccination and for whom results were available.	36.8% 85/231 • Solicited symptoms: during the 4 days post-primary and post-booster vaccination. Unsolicited AEs: during 31 days post-primary and post-booster vaccination. SAEs: during the whole study period (from Day 0 to Month 11). Analysis of AEs and SAEs was performed on all subjects who received at least one primary vaccination dose or at least the booster vaccination. Analysis of solicited symptoms was performed on subjects who received at least one primary vaccination or at least the booster vaccination and for whom results were available.
General disorders Drowsiness	46.4% 109/235 • Solicited symptoms: during the 4 days post-primary and post-booster vaccination. Unsolicited AEs: during 31 days post-primary and post-booster vaccination. SAEs: during the whole study period (from Day 0 to Month 11). Analysis of AEs and SAEs was performed on all subjects who received at least one primary vaccination dose or at least the booster vaccination. Analysis of solicited symptoms was performed on subjects who received at least one primary vaccination or at least the booster vaccination and for whom results were available.	44.6% 100/224 • Solicited symptoms: during the 4 days post-primary and post-booster vaccination. Unsolicited AEs: during 31 days post-primary and post-booster vaccination. SAEs: during the whole study period (from Day 0 to Month 11). Analysis of AEs and SAEs was performed on all subjects who received at least one primary vaccination dose or at least the booster vaccination. Analysis of solicited symptoms was performed on subjects who received at least one primary vaccination or at least the booster vaccination and for whom results were available.	38.4% 84/219 • Solicited symptoms: during the 4 days post-primary and post-booster vaccination. Unsolicited AEs: during 31 days post-primary and post-booster vaccination. SAEs: during the whole study period (from Day 0 to Month 11). Analysis of AEs and SAEs was performed on all subjects who received at least one primary vaccination dose or at least the booster vaccination. Analysis of solicited symptoms was performed on subjects who received at least one primary vaccination or at least the booster vaccination and for whom results were available.	41.6% 96/231 • Solicited symptoms: during the 4 days post-primary and post-booster vaccination. Unsolicited AEs: during 31 days post-primary and post-booster vaccination. SAEs: during the whole study period (from Day 0 to Month 11). Analysis of AEs and SAEs was performed on all subjects who received at least one primary vaccination dose or at least the booster vaccination. Analysis of solicited symptoms was performed on subjects who received at least one primary vaccination or at least the booster vaccination and for whom results were available.
General disorders Irritability/Fussiness	84.2% 202/240 • Solicited symptoms: during the 4 days post-primary and post-booster vaccination. Unsolicited AEs: during 31 days post-primary and post-booster vaccination. SAEs: during the whole study period (from Day 0 to Month 11). Analysis of AEs and SAEs was performed on all subjects who received at least one primary vaccination dose or at least the booster vaccination. Analysis of solicited symptoms was performed on subjects who received at least one primary vaccination or at least the booster vaccination and for whom results were available.	86.0% 203/236 • Solicited symptoms: during the 4 days post-primary and post-booster vaccination. Unsolicited AEs: during 31 days post-primary and post-booster vaccination. SAEs: during the whole study period (from Day 0 to Month 11). Analysis of AEs and SAEs was performed on all subjects who received at least one primary vaccination dose or at least the booster vaccination. Analysis of solicited symptoms was performed on subjects who received at least one primary vaccination or at least the booster vaccination and for whom results were available.	81.1% 185/228 • Solicited symptoms: during the 4 days post-primary and post-booster vaccination. Unsolicited AEs: during 31 days post-primary and post-booster vaccination. SAEs: during the whole study period (from Day 0 to Month 11). Analysis of AEs and SAEs was performed on all subjects who received at least one primary vaccination dose or at least the booster vaccination. Analysis of solicited symptoms was performed on subjects who received at least one primary vaccination or at least the booster vaccination and for whom results were available.	78.2% 186/238 • Solicited symptoms: during the 4 days post-primary and post-booster vaccination. Unsolicited AEs: during 31 days post-primary and post-booster vaccination. SAEs: during the whole study period (from Day 0 to Month 11). Analysis of AEs and SAEs was performed on all subjects who received at least one primary vaccination dose or at least the booster vaccination. Analysis of solicited symptoms was performed on subjects who received at least one primary vaccination or at least the booster vaccination and for whom results were available.
General disorders Loss of appetite	34.0% 80/235 • Solicited symptoms: during the 4 days post-primary and post-booster vaccination. Unsolicited AEs: during 31 days post-primary and post-booster vaccination. SAEs: during the whole study period (from Day 0 to Month 11). Analysis of AEs and SAEs was performed on all subjects who received at least one primary vaccination dose or at least the booster vaccination. Analysis of solicited symptoms was performed on subjects who received at least one primary vaccination or at least the booster vaccination and for whom results were available.	37.9% 85/224 • Solicited symptoms: during the 4 days post-primary and post-booster vaccination. Unsolicited AEs: during 31 days post-primary and post-booster vaccination. SAEs: during the whole study period (from Day 0 to Month 11). Analysis of AEs and SAEs was performed on all subjects who received at least one primary vaccination dose or at least the booster vaccination. Analysis of solicited symptoms was performed on subjects who received at least one primary vaccination or at least the booster vaccination and for whom results were available.	37.9% 83/219 • Solicited symptoms: during the 4 days post-primary and post-booster vaccination. Unsolicited AEs: during 31 days post-primary and post-booster vaccination. SAEs: during the whole study period (from Day 0 to Month 11). Analysis of AEs and SAEs was performed on all subjects who received at least one primary vaccination dose or at least the booster vaccination. Analysis of solicited symptoms was performed on subjects who received at least one primary vaccination or at least the booster vaccination and for whom results were available.	26.4% 61/231 • Solicited symptoms: during the 4 days post-primary and post-booster vaccination. Unsolicited AEs: during 31 days post-primary and post-booster vaccination. SAEs: during the whole study period (from Day 0 to Month 11). Analysis of AEs and SAEs was performed on all subjects who received at least one primary vaccination dose or at least the booster vaccination. Analysis of solicited symptoms was performed on subjects who received at least one primary vaccination or at least the booster vaccination and for whom results were available.
General disorders Fever (rectal temperature ≥ 38°C)	34.0% 80/235 • Solicited symptoms: during the 4 days post-primary and post-booster vaccination. Unsolicited AEs: during 31 days post-primary and post-booster vaccination. SAEs: during the whole study period (from Day 0 to Month 11). Analysis of AEs and SAEs was performed on all subjects who received at least one primary vaccination dose or at least the booster vaccination. Analysis of solicited symptoms was performed on subjects who received at least one primary vaccination or at least the booster vaccination and for whom results were available.	32.1% 72/224 • Solicited symptoms: during the 4 days post-primary and post-booster vaccination. Unsolicited AEs: during 31 days post-primary and post-booster vaccination. SAEs: during the whole study period (from Day 0 to Month 11). Analysis of AEs and SAEs was performed on all subjects who received at least one primary vaccination dose or at least the booster vaccination. Analysis of solicited symptoms was performed on subjects who received at least one primary vaccination or at least the booster vaccination and for whom results were available.	31.1% 68/219 • Solicited symptoms: during the 4 days post-primary and post-booster vaccination. Unsolicited AEs: during 31 days post-primary and post-booster vaccination. SAEs: during the whole study period (from Day 0 to Month 11). Analysis of AEs and SAEs was performed on all subjects who received at least one primary vaccination dose or at least the booster vaccination. Analysis of solicited symptoms was performed on subjects who received at least one primary vaccination or at least the booster vaccination and for whom results were available.	32.5% 75/231 • Solicited symptoms: during the 4 days post-primary and post-booster vaccination. Unsolicited AEs: during 31 days post-primary and post-booster vaccination. SAEs: during the whole study period (from Day 0 to Month 11). Analysis of AEs and SAEs was performed on all subjects who received at least one primary vaccination dose or at least the booster vaccination. Analysis of solicited symptoms was performed on subjects who received at least one primary vaccination or at least the booster vaccination and for whom results were available.
Infections and infestations Upper respiratory tract infection	4.6% 11/237 • Solicited symptoms: during the 4 days post-primary and post-booster vaccination. Unsolicited AEs: during 31 days post-primary and post-booster vaccination. SAEs: during the whole study period (from Day 0 to Month 11). Analysis of AEs and SAEs was performed on all subjects who received at least one primary vaccination dose or at least the booster vaccination. Analysis of solicited symptoms was performed on subjects who received at least one primary vaccination or at least the booster vaccination and for whom results were available.	7.1% 16/226 • Solicited symptoms: during the 4 days post-primary and post-booster vaccination. Unsolicited AEs: during 31 days post-primary and post-booster vaccination. SAEs: during the whole study period (from Day 0 to Month 11). Analysis of AEs and SAEs was performed on all subjects who received at least one primary vaccination dose or at least the booster vaccination. Analysis of solicited symptoms was performed on subjects who received at least one primary vaccination or at least the booster vaccination and for whom results were available.	9.0% 20/222 • Solicited symptoms: during the 4 days post-primary and post-booster vaccination. Unsolicited AEs: during 31 days post-primary and post-booster vaccination. SAEs: during the whole study period (from Day 0 to Month 11). Analysis of AEs and SAEs was performed on all subjects who received at least one primary vaccination dose or at least the booster vaccination. Analysis of solicited symptoms was performed on subjects who received at least one primary vaccination or at least the booster vaccination and for whom results were available.	5.6% 13/234 • Solicited symptoms: during the 4 days post-primary and post-booster vaccination. Unsolicited AEs: during 31 days post-primary and post-booster vaccination. SAEs: during the whole study period (from Day 0 to Month 11). Analysis of AEs and SAEs was performed on all subjects who received at least one primary vaccination dose or at least the booster vaccination. Analysis of solicited symptoms was performed on subjects who received at least one primary vaccination or at least the booster vaccination and for whom results were available.
Infections and infestations Rhinitis	7.5% 18/240 • Solicited symptoms: during the 4 days post-primary and post-booster vaccination. Unsolicited AEs: during 31 days post-primary and post-booster vaccination. SAEs: during the whole study period (from Day 0 to Month 11). Analysis of AEs and SAEs was performed on all subjects who received at least one primary vaccination dose or at least the booster vaccination. Analysis of solicited symptoms was performed on subjects who received at least one primary vaccination or at least the booster vaccination and for whom results were available.	6.2% 15/240 • Solicited symptoms: during the 4 days post-primary and post-booster vaccination. Unsolicited AEs: during 31 days post-primary and post-booster vaccination. SAEs: during the whole study period (from Day 0 to Month 11). Analysis of AEs and SAEs was performed on all subjects who received at least one primary vaccination dose or at least the booster vaccination. Analysis of solicited symptoms was performed on subjects who received at least one primary vaccination or at least the booster vaccination and for whom results were available.	5.2% 12/230 • Solicited symptoms: during the 4 days post-primary and post-booster vaccination. Unsolicited AEs: during 31 days post-primary and post-booster vaccination. SAEs: during the whole study period (from Day 0 to Month 11). Analysis of AEs and SAEs was performed on all subjects who received at least one primary vaccination dose or at least the booster vaccination. Analysis of solicited symptoms was performed on subjects who received at least one primary vaccination or at least the booster vaccination and for whom results were available.	6.6% 16/241 • Solicited symptoms: during the 4 days post-primary and post-booster vaccination. Unsolicited AEs: during 31 days post-primary and post-booster vaccination. SAEs: during the whole study period (from Day 0 to Month 11). Analysis of AEs and SAEs was performed on all subjects who received at least one primary vaccination dose or at least the booster vaccination. Analysis of solicited symptoms was performed on subjects who received at least one primary vaccination or at least the booster vaccination and for whom results were available.
Infections and infestations Bronchiolitis	5.0% 12/240 • Solicited symptoms: during the 4 days post-primary and post-booster vaccination. Unsolicited AEs: during 31 days post-primary and post-booster vaccination. SAEs: during the whole study period (from Day 0 to Month 11). Analysis of AEs and SAEs was performed on all subjects who received at least one primary vaccination dose or at least the booster vaccination. Analysis of solicited symptoms was performed on subjects who received at least one primary vaccination or at least the booster vaccination and for whom results were available.	4.2% 10/240 • Solicited symptoms: during the 4 days post-primary and post-booster vaccination. Unsolicited AEs: during 31 days post-primary and post-booster vaccination. SAEs: during the whole study period (from Day 0 to Month 11). Analysis of AEs and SAEs was performed on all subjects who received at least one primary vaccination dose or at least the booster vaccination. Analysis of solicited symptoms was performed on subjects who received at least one primary vaccination or at least the booster vaccination and for whom results were available.	5.7% 13/230 • Solicited symptoms: during the 4 days post-primary and post-booster vaccination. Unsolicited AEs: during 31 days post-primary and post-booster vaccination. SAEs: during the whole study period (from Day 0 to Month 11). Analysis of AEs and SAEs was performed on all subjects who received at least one primary vaccination dose or at least the booster vaccination. Analysis of solicited symptoms was performed on subjects who received at least one primary vaccination or at least the booster vaccination and for whom results were available.	4.6% 11/241 • Solicited symptoms: during the 4 days post-primary and post-booster vaccination. Unsolicited AEs: during 31 days post-primary and post-booster vaccination. SAEs: during the whole study period (from Day 0 to Month 11). Analysis of AEs and SAEs was performed on all subjects who received at least one primary vaccination dose or at least the booster vaccination. Analysis of solicited symptoms was performed on subjects who received at least one primary vaccination or at least the booster vaccination and for whom results were available.
Infections and infestations Bronchitis	4.2% 10/240 • Solicited symptoms: during the 4 days post-primary and post-booster vaccination. Unsolicited AEs: during 31 days post-primary and post-booster vaccination. SAEs: during the whole study period (from Day 0 to Month 11). Analysis of AEs and SAEs was performed on all subjects who received at least one primary vaccination dose or at least the booster vaccination. Analysis of solicited symptoms was performed on subjects who received at least one primary vaccination or at least the booster vaccination and for whom results were available.	2.9% 7/240 • Solicited symptoms: during the 4 days post-primary and post-booster vaccination. Unsolicited AEs: during 31 days post-primary and post-booster vaccination. SAEs: during the whole study period (from Day 0 to Month 11). Analysis of AEs and SAEs was performed on all subjects who received at least one primary vaccination dose or at least the booster vaccination. Analysis of solicited symptoms was performed on subjects who received at least one primary vaccination or at least the booster vaccination and for whom results were available.	7.8% 18/230 • Solicited symptoms: during the 4 days post-primary and post-booster vaccination. Unsolicited AEs: during 31 days post-primary and post-booster vaccination. SAEs: during the whole study period (from Day 0 to Month 11). Analysis of AEs and SAEs was performed on all subjects who received at least one primary vaccination dose or at least the booster vaccination. Analysis of solicited symptoms was performed on subjects who received at least one primary vaccination or at least the booster vaccination and for whom results were available.	6.6% 16/241 • Solicited symptoms: during the 4 days post-primary and post-booster vaccination. Unsolicited AEs: during 31 days post-primary and post-booster vaccination. SAEs: during the whole study period (from Day 0 to Month 11). Analysis of AEs and SAEs was performed on all subjects who received at least one primary vaccination dose or at least the booster vaccination. Analysis of solicited symptoms was performed on subjects who received at least one primary vaccination or at least the booster vaccination and for whom results were available.
Infections and infestations Nasopharyngitis	4.2% 10/240 • Solicited symptoms: during the 4 days post-primary and post-booster vaccination. Unsolicited AEs: during 31 days post-primary and post-booster vaccination. SAEs: during the whole study period (from Day 0 to Month 11). Analysis of AEs and SAEs was performed on all subjects who received at least one primary vaccination dose or at least the booster vaccination. Analysis of solicited symptoms was performed on subjects who received at least one primary vaccination or at least the booster vaccination and for whom results were available.	5.8% 14/240 • Solicited symptoms: during the 4 days post-primary and post-booster vaccination. Unsolicited AEs: during 31 days post-primary and post-booster vaccination. SAEs: during the whole study period (from Day 0 to Month 11). Analysis of AEs and SAEs was performed on all subjects who received at least one primary vaccination dose or at least the booster vaccination. Analysis of solicited symptoms was performed on subjects who received at least one primary vaccination or at least the booster vaccination and for whom results were available.	3.5% 8/230 • Solicited symptoms: during the 4 days post-primary and post-booster vaccination. Unsolicited AEs: during 31 days post-primary and post-booster vaccination. SAEs: during the whole study period (from Day 0 to Month 11). Analysis of AEs and SAEs was performed on all subjects who received at least one primary vaccination dose or at least the booster vaccination. Analysis of solicited symptoms was performed on subjects who received at least one primary vaccination or at least the booster vaccination and for whom results were available.	4.6% 11/241 • Solicited symptoms: during the 4 days post-primary and post-booster vaccination. Unsolicited AEs: during 31 days post-primary and post-booster vaccination. SAEs: during the whole study period (from Day 0 to Month 11). Analysis of AEs and SAEs was performed on all subjects who received at least one primary vaccination dose or at least the booster vaccination. Analysis of solicited symptoms was performed on subjects who received at least one primary vaccination or at least the booster vaccination and for whom results were available.
General disorders Irritability/Fusiness	59.6% 140/235 • Solicited symptoms: during the 4 days post-primary and post-booster vaccination. Unsolicited AEs: during 31 days post-primary and post-booster vaccination. SAEs: during the whole study period (from Day 0 to Month 11). Analysis of AEs and SAEs was performed on all subjects who received at least one primary vaccination dose or at least the booster vaccination. Analysis of solicited symptoms was performed on subjects who received at least one primary vaccination or at least the booster vaccination and for whom results were available.	60.7% 136/224 • Solicited symptoms: during the 4 days post-primary and post-booster vaccination. Unsolicited AEs: during 31 days post-primary and post-booster vaccination. SAEs: during the whole study period (from Day 0 to Month 11). Analysis of AEs and SAEs was performed on all subjects who received at least one primary vaccination dose or at least the booster vaccination. Analysis of solicited symptoms was performed on subjects who received at least one primary vaccination or at least the booster vaccination and for whom results were available.	62.6% 137/219 • Solicited symptoms: during the 4 days post-primary and post-booster vaccination. Unsolicited AEs: during 31 days post-primary and post-booster vaccination. SAEs: during the whole study period (from Day 0 to Month 11). Analysis of AEs and SAEs was performed on all subjects who received at least one primary vaccination dose or at least the booster vaccination. Analysis of solicited symptoms was performed on subjects who received at least one primary vaccination or at least the booster vaccination and for whom results were available.	55.8% 129/231 • Solicited symptoms: during the 4 days post-primary and post-booster vaccination. Unsolicited AEs: during 31 days post-primary and post-booster vaccination. SAEs: during the whole study period (from Day 0 to Month 11). Analysis of AEs and SAEs was performed on all subjects who received at least one primary vaccination dose or at least the booster vaccination. Analysis of solicited symptoms was performed on subjects who received at least one primary vaccination or at least the booster vaccination and for whom results were available.

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