Trial Outcomes & Findings for A Study to Compare the Immunogenicity of GSK Biologicals' 10Pn-PD-DiT 4-dose Presentation to the Licensed 1-dose Synflorix™ (10Pn-PD-DiT) Vaccine When Co-administered With DTPw-combination Vaccine in Healthy Infants (NCT NCT02447432)

Last Updated: 2018-08-02

Results Overview

Antibodies assessed for this outcome measure were those against the vaccine/cross-reactive pneumococcal serotypes 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (ANTI-1, -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 the 10 vaccine serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

320 participants

Primary outcome timeframe

At study Month 4, e. g. at one month post-Dose 3 of pneumococcal vaccine

Results posted on

2018-08-02

Participant Flow

Two epochs were defined in the study. The duration of the study was for Epoch 001: Primary starting at Month 0 and ending at Month 4 and for Epoch 002: Booster starting at Month 8 and ending at Month 9. 5 subjects did not participate to the Epoch 002 (none due to an serious adverse event)

Participant milestones

Participant milestones
Measure	10Pn_4d Group Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the investigational 4-dose presentation 10Pn-PD-DiT vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination - Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 4-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).	Synflorix Group Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the licensed 1-dose presentation 10Pn-PD-DiT (Synflorix™) vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination - Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 1-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
Epoch 001 STARTED	160	160
Epoch 001 COMPLETED	155	147
Epoch 001 NOT COMPLETED	5	13
Epoch 002 STARTED	152	145
Epoch 002 COMPLETED	152	145
Epoch 002 NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	10Pn_4d Group Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the investigational 4-dose presentation 10Pn-PD-DiT vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination - Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 4-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).	Synflorix Group Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the licensed 1-dose presentation 10Pn-PD-DiT (Synflorix™) vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination - Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 1-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
Epoch 001 Adverse Event	1	1
Epoch 001 Withdrawal by Subject	0	4
Epoch 001 Migrated/moved from study area	3	5
Epoch 001 Lost to Follow-up	1	3

Baseline Characteristics

A Study to Compare the Immunogenicity of GSK Biologicals' 10Pn-PD-DiT 4-dose Presentation to the Licensed 1-dose Synflorix™ (10Pn-PD-DiT) Vaccine When Co-administered With DTPw-combination Vaccine in Healthy Infants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	10Pn_4d Group n=160 Participants Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the investigational 4-dose presentation 10Pn-PD-DiT vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination - Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 4-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch 002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine : right thigh; DTPw-HBV/Hibvaccine : left thigh).	Synflorix Group n=160 Participants Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the licensed 1-dose presentation 10Pn-PD-DiT (Synflorix™) vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination - Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of Synflorix™ vaccine at approximatively 9 months of age (Epoch 002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine : right thigh; DTPw-HBV/Hibvaccine : left thigh).	Total n=320 Participants Total of all reporting groups
Age, Continuous	6.9 Weeks STANDARD_DEVIATION 1.3 • n=5 Participants	6.8 Weeks STANDARD_DEVIATION 1.2 • n=7 Participants	6.8 Weeks STANDARD_DEVIATION 1.3 • n=5 Participants
Sex: Female, Male Female	80 Participants n=5 Participants	73 Participants n=7 Participants	153 Participants n=5 Participants
Sex: Female, Male Male	80 Participants n=5 Participants	87 Participants n=7 Participants	167 Participants n=5 Participants
Race/Ethnicity, Customized Asian-South East Asian heritage	160 Participants n=5 Participants	160 Participants n=7 Participants	320 Participants n=5 Participants

PRIMARY outcome

Timeframe: At study Month 4, 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 Epoch 001 which included all evaluable subjects (i.e., those meeting eligibility criteria, complied with procedures and intervals defined in protocol, with no elimination criteria) for whom data concerning primary immunogenicity outcomes measures were available.

Outcome measures

Outcome measures
Measure	10Pn_4d Group n=154 Participants Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the investigational 4-dose presentation 10Pn-PD-DiT vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination - Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 4-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).	Synflorix Group n=146 Participants Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the licensed 1-dose presentation 10Pn-PD-DiT (Synflorix™) vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination - Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 1-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
Antibody Concentrations Against Pneumococcal Serotypes (Epoch 001) ANTI-1	2.78 µg/mL Interval 2.43 to 3.18	3.03 µg/mL Interval 2.6 to 3.54
Antibody Concentrations Against Pneumococcal Serotypes (Epoch 001) ANTI-4	4.23 µg/mL Interval 3.69 to 4.84	3.87 µg/mL Interval 3.33 to 4.51
Antibody Concentrations Against Pneumococcal Serotypes (Epoch 001) ANTI-5	5.12 µg/mL Interval 4.46 to 5.88	5.30 µg/mL Interval 4.59 to 6.12
Antibody Concentrations Against Pneumococcal Serotypes (Epoch 001) ANTI-6B	1.23 µg/mL Interval 0.95 to 1.57	1.37 µg/mL Interval 1.05 to 1.79
Antibody Concentrations Against Pneumococcal Serotypes (Epoch 001) ANTI-7F	5.52 µg/mL Interval 4.9 to 6.22	5.79 µg/mL Interval 5.06 to 6.62
Antibody Concentrations Against Pneumococcal Serotypes (Epoch 001) ANTI-9V	4.60 µg/mL Interval 3.98 to 5.32	4.07 µg/mL Interval 3.34 to 4.95
Antibody Concentrations Against Pneumococcal Serotypes (Epoch 001) ANTI-14	4.97 µg/mL Interval 4.05 to 6.1	4.84 µg/mL Interval 3.91 to 5.99
Antibody Concentrations Against Pneumococcal Serotypes (Epoch 001) ANTI-18C	19.58 µg/mL Interval 16.65 to 23.03	21.18 µg/mL Interval 17.9 to 25.06
Antibody Concentrations Against Pneumococcal Serotypes (Epoch 001) ANTI-19F	13.24 µg/mL Interval 11.17 to 15.68	13.11 µg/mL Interval 11.16 to 15.41
Antibody Concentrations Against Pneumococcal Serotypes (Epoch 001) ANTI-23F	1.59 µg/mL Interval 1.25 to 2.01	2.04 µg/mL Interval 1.61 to 2.58
Antibody Concentrations Against Pneumococcal Serotypes (Epoch 001) ANTI-6A	0.31 µg/mL Interval 0.25 to 0.38	0.29 µg/mL Interval 0.23 to 0.36
Antibody Concentrations Against Pneumococcal Serotypes (Epoch 001) ANTI-19A	0.76 µg/mL Interval 0.6 to 0.96	0.68 µg/mL Interval 0.54 to 0.86

SECONDARY outcome

Timeframe: At Month 8 and Month 9, 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 Epoch 002 which included all evaluable subjects (i.e., those meeting eligibility criteria, complied with procedures and intervals defined in protocol, with no elimination criteria) for whom data concerning booster immunogenicity outcomes measures were available.

Outcome measures

Outcome measures
Measure	10Pn_4d Group n=151 Participants Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the investigational 4-dose presentation 10Pn-PD-DiT vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination - Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 4-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).	Synflorix Group n=144 Participants Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the licensed 1-dose presentation 10Pn-PD-DiT (Synflorix™) vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination - Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 1-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
Antibody Concentrations Against Pneumococcal Serotypes (Epoch 002) ANTI-6B Month 9	3.76 µg/mL Interval 3.01 to 4.69	4.11 µg/mL Interval 3.21 to 5.25
Antibody Concentrations Against Pneumococcal Serotypes (Epoch 002) ANTI-7F Month 8	2.86 µg/mL Interval 2.5 to 3.27	2.75 µg/mL Interval 2.4 to 3.16
Antibody Concentrations Against Pneumococcal Serotypes (Epoch 002) ANTI-7F Month 9	12.84 µg/mL Interval 11.38 to 14.48	13.71 µg/mL Interval 12.01 to 15.65
Antibody Concentrations Against Pneumococcal Serotypes (Epoch 002) ANTI-9V Month 8	2.32 µg/mL Interval 1.96 to 2.75	2.25 µg/mL Interval 1.83 to 2.76
Antibody Concentrations Against Pneumococcal Serotypes (Epoch 002) ANTI-9V Month 9	12.07 µg/mL Interval 10.42 to 13.98	12.43 µg/mL Interval 10.22 to 15.13
Antibody Concentrations Against Pneumococcal Serotypes (Epoch 002) ANTI-14 Month 8	2.98 µg/mL Interval 2.39 to 3.72	2.4 µg/mL Interval 1.9 to 3.04
Antibody Concentrations Against Pneumococcal Serotypes (Epoch 002) ANTI-14 Month 9	9.84 µg/mL Interval 8.02 to 12.08	9.72 µg/mL Interval 7.92 to 11.93
Antibody Concentrations Against Pneumococcal Serotypes (Epoch 002) ANTI-18C Month 8	8.37 µg/mL Interval 7.14 to 9.82	9.23 µg/mL Interval 7.82 to 10.9
Antibody Concentrations Against Pneumococcal Serotypes (Epoch 002) ANTI-18C Month 9	41.64 µg/mL Interval 36.87 to 47.02	47.06 µg/mL Interval 41.88 to 52.88
Antibody Concentrations Against Pneumococcal Serotypes (Epoch 002) ANTI-1 Month 8	0.93 µg/mL Interval 0.79 to 1.1	0.99 µg/mL Interval 0.81 to 1.19
Antibody Concentrations Against Pneumococcal Serotypes (Epoch 002) ANTI-1 Month 9	6.37 µg/mL Interval 5.48 to 7.41	7.5 µg/mL Interval 6.28 to 8.97
Antibody Concentrations Against Pneumococcal Serotypes (Epoch 002) ANTI-4 Month 8	1.9 µg/mL Interval 1.65 to 2.19	1.71 µg/mL Interval 1.45 to 2.01
Antibody Concentrations Against Pneumococcal Serotypes (Epoch 002) ANTI-4 Month 9	9.68 µg/mL Interval 8.47 to 11.06	9.41 µg/mL Interval 8.16 to 10.86
Antibody Concentrations Against Pneumococcal Serotypes (Epoch 002) ANTI-5 Month 8	1.75 µg/mL Interval 1.5 to 2.05	1.75 µg/mL Interval 1.48 to 2.08
Antibody Concentrations Against Pneumococcal Serotypes (Epoch 002) ANTI-5 Month 9	11.53 µg/mL Interval 10.14 to 13.12	12.24 µg/mL Interval 10.65 to 14.05
Antibody Concentrations Against Pneumococcal Serotypes (Epoch 002) ANTI-6B Month 8	1.14 µg/mL Interval 0.93 to 1.4	1.06 µg/mL Interval 0.84 to 1.32
Antibody Concentrations Against Pneumococcal Serotypes (Epoch 002) ANTI-19F Month 8	6.36 µg/mL Interval 5.36 to 7.55	6.45 µg/mL Interval 5.5 to 7.57
Antibody Concentrations Against Pneumococcal Serotypes (Epoch 002) ANTI-19F Month 9	23.43 µg/mL Interval 19.48 to 28.19	24.96 µg/mL Interval 21.07 to 29.57
Antibody Concentrations Against Pneumococcal Serotypes (Epoch 002) ANTI-23F Month 8	1.09 µg/mL Interval 0.89 to 1.33	1.21 µg/mL Interval 0.96 to 1.53
Antibody Concentrations Against Pneumococcal Serotypes (Epoch 002) ANTI-23F Month 9	6.69 µg/mL Interval 5.66 to 7.9	6.69 µg/mL Interval 5.33 to 8.41
Antibody Concentrations Against Pneumococcal Serotypes (Epoch 002) ANTI-6A Month 8	0.31 µg/mL Interval 0.24 to 0.39	0.3 µg/mL Interval 0.24 to 0.38
Antibody Concentrations Against Pneumococcal Serotypes (Epoch 002) ANTI-6A Month 9	0.97 µg/mL Interval 0.74 to 1.26	1.11 µg/mL Interval 0.83 to 1.49
Antibody Concentrations Against Pneumococcal Serotypes (Epoch 002) ANTI-19A Month 8	0.7 µg/mL Interval 0.55 to 0.89	0.69 µg/mL Interval 0.54 to 0.88
Antibody Concentrations Against Pneumococcal Serotypes (Epoch 002) ANTI-19A Month 9	3.03 µg/mL Interval 2.26 to 4.05	3.63 µg/mL Interval 2.73 to 4.82

SECONDARY outcome

Timeframe: At study Month 4, 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, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (OPA-1, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, 19 A ,-19F and -23F). The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8.

Outcome measures

Outcome measures
Measure	10Pn_4d Group n=75 Participants Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the investigational 4-dose presentation 10Pn-PD-DiT vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination - Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 4-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).	Synflorix Group n=74 Participants Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the licensed 1-dose presentation 10Pn-PD-DiT (Synflorix™) vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination - Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 1-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 001) OPA-1	48.3 Titers Interval 34.9 to 67.0	52.8 Titers Interval 36.0 to 77.5
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 001) OPA-4	823.1 Titers Interval 670.9 to 1009.8	836.8 Titers Interval 644.5 to 1086.6
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 001) OPA-5	179.0 Titers Interval 140.7 to 227.8	211.0 Titers Interval 162.9 to 273.2
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 001) OPA-6B	560.6 Titers Interval 336.9 to 932.8	759.6 Titers Interval 470.2 to 1227.3
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 001) OPA-7F	2044.0 Titers Interval 1669.3 to 2502.9	2076.8 Titers Interval 1627.0 to 2650.9
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 001) OPA-9V	613.3 Titers Interval 444.9 to 845.4	821.1 Titers Interval 602.5 to 1119.2
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 001) OPA-14	1563.9 Titers Interval 1105.1 to 2213.2	1655.8 Titers Interval 1141.1 to 2402.7
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 001) OPA-18C	3965.4 Titers Interval 3288.6 to 4781.5	3809.7 Titers Interval 3067.0 to 4732.3
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 001) OPA-19F	2151.3 Titers Interval 1573.5 to 2941.4	2879.2 Titers Interval 2348.4 to 3529.9
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 001) OPA-23F	524.8 Titers Interval 338.5 to 813.9	730.2 Titers Interval 495.6 to 1075.7
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 001) OPA-6A	50.3 Titers Interval 26.9 to 94.0	68.5 Titers Interval 36.8 to 127.7
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 001) OPA-19A	98.6 Titers Interval 60.9 to 159.6	117.1 Titers Interval 71.9 to 190.6

SECONDARY outcome

Timeframe: At study Month 8 and Month 9, e.g.: prior to and 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 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (OPA-1, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8.

Outcome measures

Outcome measures
Measure	10Pn_4d Group n=76 Participants Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the investigational 4-dose presentation 10Pn-PD-DiT vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination - Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 4-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).	Synflorix Group n=73 Participants Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the licensed 1-dose presentation 10Pn-PD-DiT (Synflorix™) vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination - Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 1-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 002) OPA-1 Month 8	11.5 Titers Interval 8.2 to 16.1	12.8 Titers Interval 9.1 to 17.9
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 002) OPA-1 Month 9	227.7 Titers Interval 170.6 to 303.9	326.7 Titers Interval 238.7 to 447.0
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 002) OPA-4 Month 8	248.1 Titers Interval 178.6 to 344.7	280.5 Titers Interval 193.4 to 406.6
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 002) OPA-4 Month 9	2025.4 Titers Interval 1641.6 to 2498.8	2888.7 Titers Interval 2221.6 to 3756.1
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 002) OPA-5 Month 8	51.3 Titers Interval 37.0 to 71.3	62.7 Titers Interval 44.4 to 88.7
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 002) OPA-5 Month 9	550.6 Titers Interval 437.8 to 692.4	801.2 Titers Interval 633.2 to 1013.6
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 002) OPA-6B Month 8	290.3 Titers Interval 177.1 to 475.7	286.8 Titers Interval 183.5 to 448.0
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 002) OPA-6B Month 9	851.3 Titers Interval 533.4 to 1358.6	1352 Titers Interval 913.9 to 1999.9
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 002) OPA-7F Month 8	1112.8 Titers Interval 864.8 to 1431.8	1181.7 Titers Interval 933.4 to 1495.9
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 002) OPA-7F Month 9	4574.7 Titers Interval 3756.1 to 5571.6	5635.8 Titers Interval 4561.7 to 6962.9
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 002) OPA-9V Month 8	415.8 Titers Interval 280.6 to 616.3	570.6 Titers Interval 408.4 to 797.3
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 002) OPA-9V Month 9	2308.4 Titers Interval 1903.3 to 2799.7	3181.9 Titers Interval 2376.9 to 4259.6
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 002) OPA-14 Month 8	660.1 Titers Interval 432.4 to 1007.6	745 Titers Interval 513.9 to 1080.0
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 002) OPA-14 Month 9	3345.6 Titers Interval 2585.0 to 4330.1	3649.1 Titers Interval 2808.6 to 4741.2
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 002) OPA-18C Month 8	1505.4 Titers Interval 1196.4 to 1894.1	1735.2 Titers Interval 1373.8 to 2191.7
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 002) OPA-18C Month 9	7316.1 Titers Interval 6137.6 to 8720.8	7181.6 Titers Interval 6003.6 to 8590.7
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 002) OPA-19F Month 8	770.1 Titers Interval 536.6 to 1105.3	1254.3 Titers Interval 990.8 to 1587.9
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 002) OPA-19F Month 9	3197.3 Titers Interval 2271.1 to 4501.2	4757.7 Titers Interval 3772.3 to 6000.4
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 002) OPA-23F Month 8	267.7 Titers Interval 168.7 to 424.9	252.7 Titers Interval 154.8 to 412.4
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 002) OPA-23F Month 9	1250.8 Titers Interval 931.3 to 1679.8	1465.6 Titers Interval 1002.9 to 2141.7
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 002) OPA-6A Month 8	52.4 Titers Interval 27.4 to 100.1	45.5 Titers Interval 24.0 to 86.5
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 002) OPA-6A Month 9	192 Titers Interval 102.9 to 358.4	284.4 Titers Interval 158.4 to 510.6
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 002) OPA-19A Month 8	42.7 Titers Interval 25.1 to 72.7	43.6 Titers Interval 26.6 to 71.3
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 002) OPA-19A Month 9	410.4 Titers Interval 246.7 to 682.8	591.7 Titers Interval 356.9 to 980.9

SECONDARY outcome

Timeframe: At study Month 4, 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 (≥) 153 EL.U/mL.

Outcome measures

Outcome measures
Measure	10Pn_4d Group n=78 Participants Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the investigational 4-dose presentation 10Pn-PD-DiT vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination - Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 4-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).	Synflorix Group n=75 Participants Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the licensed 1-dose presentation 10Pn-PD-DiT (Synflorix™) vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination - Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 1-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
Concentrations of Antibodies Against Protein D (Anti-PD) (Epoch 001)	2410.5 EL.U/mL Interval 2029.2 to 2863.5	2495.4 EL.U/mL Interval 2055.7 to 3029.1

SECONDARY outcome

Timeframe: At study Month 9, e.g.: at one month post booster vaccination with pneumococcal vaccine

Outcome measures

Outcome measures
Measure	10Pn_4d Group n=76 Participants Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the investigational 4-dose presentation 10Pn-PD-DiT vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination - Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 4-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).	Synflorix Group n=73 Participants Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the licensed 1-dose presentation 10Pn-PD-DiT (Synflorix™) vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination - Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 1-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
Concentrations of Antibodies Against Protein D (Anti-PD) (Epoch 002)	2672.4 EL.U/mL Interval 2285.5 to 3124.8	2944 EL.U/mL Interval 2486.2 to 3486.0

SECONDARY outcome

Timeframe: Within the 4-day (Days 0-3) post-vaccination period following each primary dose of 10Pn-PD-DiTvaccine

Population: The analysis was performed on the Total vaccinated cohort of Epoch 001 included all subjects who had received at least one dose of primary vaccination, 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). Dose 1 = 10Pn-PD-DIT+DTPw-HBV/Hib at 6 weeks of age. Dose 2 = 10Pn-PD-DIT+DTPw-HBV/Hib at 10 weeks of age. Dose 4 = 10Pn-PD-DIT at 18 weeks of age.

Outcome measures

Outcome measures
Measure	10Pn_4d Group n=159 Participants Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the investigational 4-dose presentation 10Pn-PD-DiT vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination - Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 4-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).	Synflorix Group n=156 Participants Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the licensed 1-dose presentation 10Pn-PD-DiT (Synflorix™) vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination - Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 1-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
Number of Subjects With Any and Grade 3 Solicited Local Symptoms (Epoch 001) Any Pain, post Dose 1	82 Participants	90 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms (Epoch 001) Grade 3 Pain, post Dose 1	4 Participants	5 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms (Epoch 001) Any Redness, post Dose 1	24 Participants	26 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms (Epoch 001) Grade 3 Redness, post Dose 1	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms (Epoch 001) Any Swelling, post Dose 1	63 Participants	64 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms (Epoch 001) Grade 3 Swelling, post Dose 1	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms (Epoch 001) Any Pain, post Dose 2	56 Participants	56 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms (Epoch 001) Grade 3 Pain, post Dose 2	1 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms (Epoch 001) Any Redness, post Dose 2	22 Participants	26 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms (Epoch 001) Grade 3 Redness, post Dose 2	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms (Epoch 001) Any Swelling, post Dose 2	31 Participants	37 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms (Epoch 001) Grade 3 Swelling, post Dose 2	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms (Epoch 001) Any Pain, post Dose 4	13 Participants	15 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms (Epoch 001) Grade 3 Pain, post Dose 4	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms (Epoch 001) Any Redness, post Dose 4	9 Participants	8 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms (Epoch 001) Grade 3 Redness, post Dose 4	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms (Epoch 001) Any Swelling, post Dose 4	11 Participants	9 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms (Epoch 001) Grade 3 Swelling, post Dose 4	0 Participants	0 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 of Epoch 002 included all subjects who had received the booster vaccination, with analysis done solely on subjects for whom post-vaccination results about solicited or unsolicited symptoms were available.

Outcome measures

Outcome measures
Measure	10Pn_4d Group n=152 Participants Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the investigational 4-dose presentation 10Pn-PD-DiT vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination - Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 4-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).	Synflorix Group n=145 Participants Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the licensed 1-dose presentation 10Pn-PD-DiT (Synflorix™) vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination - Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 1-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
Number of Subjects With Any and Grade 3 Solicited Local Symptoms (Epoch 002) Any Pain	9 Participants	2 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms (Epoch 002) Grade 3 Pain	1 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms (Epoch 002) Any Redness	14 Participants	5 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms (Epoch 002) Grade 3 Redness	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms (Epoch 002) Any Swelling	16 Participants	8 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms (Epoch 002) Grade 3 Swelling	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Within the 4-day (Days 0-3) post-vaccination period following each primary dose of 10Pn-PD-DiTvaccine

Assessed solicited general symptoms were Drowsiness, Irritability/Fussiness, Loss of appetite and Fever (axillary route - temperature equal or higher than \[≥\] 37.5 degrees Celsius \[°C\]). Any = Occurrence of the specified solicited general symptom, regardless of intensity or relationship to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Irritability/Fussiness = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. Grade 3 Fever = (axillary) temperature higher than (\>) 39.5°C. Related = Occurrence of the specified symptom assessed by the investigator as causally related to vaccination. Dose 1 = 10Pn-PD-DIT+DTPw-HBV/Hib at 6 weeks of age. Dose 2 = 10Pn-PD-DIT+DTPw-HBV/Hib at 10 weeks of age. Dose 4 = 10Pn-PD-DIT at 18 weeks of age.

Outcome measures

Outcome measures
Measure	10Pn_4d Group n=159 Participants Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the investigational 4-dose presentation 10Pn-PD-DiT vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination - Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 4-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).	Synflorix Group n=156 Participants Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the licensed 1-dose presentation 10Pn-PD-DiT (Synflorix™) vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination - Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 1-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) Any Drowsiness, post Dose 2	15 Participants	23 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) Grade 3 Drowsiness, post Dose 2	1 Participants	1 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) Any Drowsiness, post Dose 1	26 Participants	31 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) Grade 3 Drowsiness, post Dose 1	1 Participants	5 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) Related Drowsiness, post Dose 1	26 Participants	29 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) Any Irritability/Fussiness, post Dose 1	61 Participants	62 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) Grade 3 Irritability/Fussiness, post Dose 1	14 Participants	8 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) Related Irritability/Fussiness, post Dose 1	61 Participants	62 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) Any Loss Appetite, post Dose 1	43 Participants	46 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) Grade 3 Loss Appetite, post Dose 1	4 Participants	3 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) Related Loss Appetite, post Dose 1	43 Participants	46 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) Any Fever, post Dose 1	28 Participants	30 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) Grade 3 Fever, post Dose 1	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) Related Drowsiness, post Dose 2	15 Participants	23 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) Any Irritability/Fussiness, post Dose 2	39 Participants	47 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) Grade 3 Irritability/Fussiness, post D2	4 Participants	5 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) Related Fever, post Dose 1	28 Participants	30 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) Related Irritability/Fussiness, post Dose 2	39 Participants	47 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) Any Loss Appetite, post Dose 2	24 Participants	20 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) Grade 3 Loss Appetite, post Dose 2	3 Participants	2 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) Related Loss Appetite, post Dose 2	23 Participants	20 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) Any Fever, post Dose 2	23 Participants	18 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) Grade 3 Fever, post Dose 2	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) Related Fever, post Dose 2	22 Participants	18 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) Any Drowsiness, post Dose 4	6 Participants	8 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) Grade 3 Drowsiness, post Dose 4	0 Participants	1 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) Related Drowsiness, post Dose 4	6 Participants	8 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) Any Irritability/Fussiness, post Dose 4	10 Participants	12 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) Grade 3 Irritability/Fussiness, post Dose 4	0 Participants	1 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) Related Irritability/Fussiness, post Dose 4	10 Participants	12 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) Any Loss Appetite, post Dose 4	5 Participants	5 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) Grade 3 Loss Appetite, post Dose 4	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) Related Loss Appetite, post Dose 4	5 Participants	5 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) Any Fever, post Dose 4	2 Participants	6 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) Grade 3 Fever, post Dose 4	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) Related Fever, post Dose 4	2 Participants	6 Participants

SECONDARY outcome

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

Assessed solicited general symptoms were Drowsiness, Irritability/Fussiness, Loss of appetite and Fever (axillary route - temperature equal or higher than \[≥\] 37.5 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 Irritability/Fussiness = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. Grade 3 Fever = (Axillary) temperature higher than (\>) 39.5°C.

Outcome measures

Outcome measures
Measure	10Pn_4d Group n=152 Participants Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the investigational 4-dose presentation 10Pn-PD-DiT vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination - Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 4-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).	Synflorix Group n=145 Participants Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the licensed 1-dose presentation 10Pn-PD-DiT (Synflorix™) vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination - Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 1-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination (Epoch 002) Any Drowsiness	8 Participants	4 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination (Epoch 002) Grade 3 Drowsiness	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination (Epoch 002) Related Drowsiness	8 Participants	4 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination (Epoch 002) Any Irritability/Fussiness	11 Participants	5 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination (Epoch 002) Grade 3 Irritability/Fusiness	1 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination (Epoch 002) Related Irritability/Fussiness	11 Participants	5 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination (Epoch 002) Any Loss Appetite	8 Participants	4 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination (Epoch 002) Grade 3 Loss Appetite	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination (Epoch 002) Related Loss Appetite	8 Participants	4 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination (Epoch 002) Any Fever	4 Participants	3 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination (Epoch 002) Grade 3 Fever	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination (Epoch 002) Related Fever	4 Participants	3 Participants

SECONDARY outcome

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

Population: The analysis was performed on the Total vaccinated cohort of Epoch 001 which included all subjects who had received at least one dose of primary vaccination.

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	10Pn_4d Group n=160 Participants Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the investigational 4-dose presentation 10Pn-PD-DiT vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination - Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 4-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).	Synflorix Group n=160 Participants Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the licensed 1-dose presentation 10Pn-PD-DiT (Synflorix™) vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination - Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 1-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
Number of Subjects With Any Unsolicited Adverse Events (AEs) (Epoch 001)	10 Participants	16 Participants

SECONDARY outcome

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

Outcome measures

Outcome measures
Measure	10Pn_4d Group n=152 Participants Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the investigational 4-dose presentation 10Pn-PD-DiT vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination - Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 4-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).	Synflorix Group n=145 Participants Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the licensed 1-dose presentation 10Pn-PD-DiT (Synflorix™) vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination - Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 1-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
Number of Subjects With Any Unsolicited Adverse Events (AEs) (Epoch 002)	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From Month 0 to Month 4

Population: The analysis was performed on the Total vaccinated cohort of Epoch 001 which included all subjects who had received at least one dose of primary vaccination.

An 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 hospitalization, as per the medical or scientific judgement of the physician. Any = Occurrence of an SAE, regardless of relationship to vaccination.

Outcome measures

Outcome measures
Measure	10Pn_4d Group n=160 Participants Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the investigational 4-dose presentation 10Pn-PD-DiT vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination - Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 4-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).	Synflorix Group n=160 Participants Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the licensed 1-dose presentation 10Pn-PD-DiT (Synflorix™) vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination - Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 1-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
Number of Subjects With Any Serious Adverse Events (SAEs) (Epoch 001)	4 Participants	9 Participants

SECONDARY outcome

Timeframe: From Day 0 to Month 9

Population: The analysis was performed on the Total vaccinated cohort of Epoch 001 which included all subjects who had received at least one dose of primary vaccination.

Outcome measures

Outcome measures
Measure	10Pn_4d Group n=160 Participants Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the investigational 4-dose presentation 10Pn-PD-DiT vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination - Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 4-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).	Synflorix Group n=160 Participants Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the licensed 1-dose presentation 10Pn-PD-DiT (Synflorix™) vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination - Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 1-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
Number of Subjects With Any Serious Adverse Events (SAEs) During the Entire Duration of the Study	4 Participants	9 Participants

Adverse Events

10Pn_4d Group

Serious events: 4 serious events

Other events: 120 other events

Deaths: 1 deaths

Synflorix Group

Serious events: 9 serious events

Other events: 126 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	10Pn_4d Group n=160 participants at risk Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the investigational 4-dose presentation 10Pn-PD-DiT vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination - Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 4-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).	Synflorix Group n=160 participants at risk Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the licensed 1-dose presentation 10Pn-PD-DiT (Synflorix™) vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination - Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 1-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
Injury, poisoning and procedural complications Chemical poisoning	0.00% 0/160 • Solicited symptoms and Unsolicited AEs: during 31 days post vaccination period. SAEs: during the whole study period (from Day 0 to Month 9).	0.62% 1/160 • Number of events 1 • Solicited symptoms and Unsolicited AEs: during 31 days post vaccination period. SAEs: during the whole study period (from Day 0 to Month 9).
Nervous system disorders Febrile convulsion	0.00% 0/160 • Solicited symptoms and Unsolicited AEs: during 31 days post vaccination period. SAEs: during the whole study period (from Day 0 to Month 9).	0.62% 1/160 • Number of events 1 • Solicited symptoms and Unsolicited AEs: during 31 days post vaccination period. SAEs: during the whole study period (from Day 0 to Month 9).
Infections and infestations Sepsis	1.2% 2/160 • Number of events 2 • Solicited symptoms and Unsolicited AEs: during 31 days post vaccination period. SAEs: during the whole study period (from Day 0 to Month 9).	0.00% 0/160 • Solicited symptoms and Unsolicited AEs: during 31 days post vaccination period. SAEs: during the whole study period (from Day 0 to Month 9).
Infections and infestations Septic shock	0.00% 0/160 • Solicited symptoms and Unsolicited AEs: during 31 days post vaccination period. SAEs: during the whole study period (from Day 0 to Month 9).	0.62% 1/160 • Number of events 1 • Solicited symptoms and Unsolicited AEs: during 31 days post vaccination period. SAEs: during the whole study period (from Day 0 to Month 9).
Congenital, familial and genetic disorders Cerebral palsy	0.00% 0/160 • Solicited symptoms and Unsolicited AEs: during 31 days post vaccination period. SAEs: during the whole study period (from Day 0 to Month 9).	0.62% 1/160 • Number of events 1 • Solicited symptoms and Unsolicited AEs: during 31 days post vaccination period. SAEs: during the whole study period (from Day 0 to Month 9).
Congenital, familial and genetic disorders Laryngomalacia	0.00% 0/160 • Solicited symptoms and Unsolicited AEs: during 31 days post vaccination period. SAEs: during the whole study period (from Day 0 to Month 9).	0.62% 1/160 • Number of events 1 • Solicited symptoms and Unsolicited AEs: during 31 days post vaccination period. SAEs: during the whole study period (from Day 0 to Month 9).
Gastrointestinal disorders Diarrhoea	0.00% 0/160 • Solicited symptoms and Unsolicited AEs: during 31 days post vaccination period. SAEs: during the whole study period (from Day 0 to Month 9).	1.2% 2/160 • Number of events 3 • Solicited symptoms and Unsolicited AEs: during 31 days post vaccination period. SAEs: during the whole study period (from Day 0 to Month 9).
Infections and infestations Bronchiolitis	0.00% 0/160 • Solicited symptoms and Unsolicited AEs: during 31 days post vaccination period. SAEs: during the whole study period (from Day 0 to Month 9).	1.2% 2/160 • Number of events 2 • Solicited symptoms and Unsolicited AEs: during 31 days post vaccination period. SAEs: during the whole study period (from Day 0 to Month 9).
Infections and infestations Gastroenteritis	0.62% 1/160 • Number of events 1 • Solicited symptoms and Unsolicited AEs: during 31 days post vaccination period. SAEs: during the whole study period (from Day 0 to Month 9).	0.62% 1/160 • Number of events 1 • Solicited symptoms and Unsolicited AEs: during 31 days post vaccination period. SAEs: during the whole study period (from Day 0 to Month 9).
Infections and infestations Pneumonia	0.62% 1/160 • Number of events 1 • Solicited symptoms and Unsolicited AEs: during 31 days post vaccination period. SAEs: during the whole study period (from Day 0 to Month 9).	2.5% 4/160 • Number of events 4 • Solicited symptoms and Unsolicited AEs: during 31 days post vaccination period. SAEs: during the whole study period (from Day 0 to Month 9).
Infections and infestations Respiratory syncytial virus bronchiolitis	0.62% 1/160 • Number of events 1 • Solicited symptoms and Unsolicited AEs: during 31 days post vaccination period. SAEs: during the whole study period (from Day 0 to Month 9).	0.00% 0/160 • Solicited symptoms and Unsolicited AEs: during 31 days post vaccination period. SAEs: during the whole study period (from Day 0 to Month 9).
Infections and infestations Respiratory tract infection	0.62% 1/160 • Number of events 1 • Solicited symptoms and Unsolicited AEs: during 31 days post vaccination period. SAEs: during the whole study period (from Day 0 to Month 9).	0.00% 0/160 • Solicited symptoms and Unsolicited AEs: during 31 days post vaccination period. SAEs: during the whole study period (from Day 0 to Month 9).

Other adverse events

Other adverse events
Measure	10Pn_4d Group n=160 participants at risk Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the investigational 4-dose presentation 10Pn-PD-DiT vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination - Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 4-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).	Synflorix Group n=160 participants at risk Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the licensed 1-dose presentation 10Pn-PD-DiT (Synflorix™) vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination - Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 1-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
General disorders Pain	63.1% 101/160 • Number of events 160 • Solicited symptoms and Unsolicited AEs: during 31 days post vaccination period. SAEs: during the whole study period (from Day 0 to Month 9).	63.7% 102/160 • Number of events 163 • Solicited symptoms and Unsolicited AEs: during 31 days post vaccination period. SAEs: during the whole study period (from Day 0 to Month 9).
General disorders Pyrexia	31.9% 51/160 • Number of events 59 • Solicited symptoms and Unsolicited AEs: during 31 days post vaccination period. SAEs: during the whole study period (from Day 0 to Month 9).	29.4% 47/160 • Number of events 57 • Solicited symptoms and Unsolicited AEs: during 31 days post vaccination period. SAEs: during the whole study period (from Day 0 to Month 9).
General disorders Swelling	51.9% 83/160 • Number of events 121 • Solicited symptoms and Unsolicited AEs: during 31 days post vaccination period. SAEs: during the whole study period (from Day 0 to Month 9).	50.6% 81/160 • Number of events 118 • Solicited symptoms and Unsolicited AEs: during 31 days post vaccination period. SAEs: during the whole study period (from Day 0 to Month 9).
Metabolism and nutrition disorders Decreased appetite	36.2% 58/160 • Number of events 80 • Solicited symptoms and Unsolicited AEs: during 31 days post vaccination period. SAEs: during the whole study period (from Day 0 to Month 9).	33.1% 53/160 • Number of events 75 • Solicited symptoms and Unsolicited AEs: during 31 days post vaccination period. SAEs: during the whole study period (from Day 0 to Month 9).
Nervous system disorders Somnolence	23.8% 38/160 • Number of events 55 • Solicited symptoms and Unsolicited AEs: during 31 days post vaccination period. SAEs: during the whole study period (from Day 0 to Month 9).	26.2% 42/160 • Number of events 66 • Solicited symptoms and Unsolicited AEs: during 31 days post vaccination period. SAEs: during the whole study period (from Day 0 to Month 9).
Psychiatric disorders Irritability	48.1% 77/160 • Number of events 121 • Solicited symptoms and Unsolicited AEs: during 31 days post vaccination period. SAEs: during the whole study period (from Day 0 to Month 9).	52.5% 84/160 • Number of events 126 • Solicited symptoms and Unsolicited AEs: during 31 days post vaccination period. SAEs: during the whole study period (from Day 0 to Month 9).
Skin and subcutaneous tissue disorders Erythema	23.1% 37/160 • Number of events 69 • Solicited symptoms and Unsolicited AEs: during 31 days post vaccination period. SAEs: during the whole study period (from Day 0 to Month 9).	25.0% 40/160 • Number of events 65 • Solicited symptoms and Unsolicited AEs: during 31 days post vaccination period. SAEs: during the whole study period (from Day 0 to Month 9).

Additional Information

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