Trial Outcomes & Findings for Primary and Booster Vaccination Study With Pneumococcal Vaccine GSK1024850A in Healthy Japanese Children (NCT NCT01027845)

Last Updated: 2019-11-29

Results Overview

Concentrations were expressed as geometric mean concentrations (GMCs). 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). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 microgram per milliliter (µg/mL).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

360 participants

Primary outcome timeframe

1 month following primary immunization (at Month 3)

Results posted on

2019-11-29

Participant Flow

A total of 360 subjects were enrolled in the study. All subjects received at least one vaccination dose.

Participant milestones

Participant milestones
Measure	10Pn Group Healthy male or female subjects, between 90 and 118 days of age who received, during primary vaccination phase, 3 doses of Synflorix (10Pn) vaccine, administered intramuscularly on alternating (left/right) sides of the anterolateral thigh and DPT "KAKETSUKEN" Syringe (DTPa) vaccine administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm. Both vaccines were administered at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase).	DTPa Group Healthy male or female subjects, between 90 and 118 days of age, who received, during the primary vaccination phase, 3 doses of the DPT "KAKETSUKEN" Syringe (DTPa) vaccine, administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase). Subjects from this group who also received at least one dose of Prevenar (PCV7): Pfizer's (formerly Wyeth Lederle) 7-valent pneumococcal conjugate vaccine, given before pre-booster blood sample (as optional treatment considered as standard of care), were assigned to the DTPa + Prevenar Group in the booster phase, and subjects who did not receive any dose of Prevenar before pre-booster blood sample were assigned to the DTPa-no Prevenar Group in the booster phase. Some booster phase analyses were only performed on subjects of both pooled sub-groups, renamed as DTPa booster Group, at the time of the analysis..	DTPa + Prevenar Group Healthy male or female subjects, between 90 and 118 days of age, who received, during the primary vaccination phase, 3 doses of the DPT "KAKETSUKEN" Syringe (DTPa) vaccine, administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase). Those subjects received at least one dose of Prevenar (PCV7): Pfizer's (formerly Wyeth Lederle) 7-valent pneumococcal conjugate vaccine, given before pre-booster blood sample and considered optional treatment as standard of care.	DTPa - no Prevenar Group Healthy male or female subjects, between 90 and 118 days of age, who received, during the primary vaccination phase, 3 doses of the DPT "KAKETSUKEN" Syringe (DTPa) vaccine, administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase). Those subjects did not receive any dose of Prevenar vaccination before pre-booster blood sample.
Primary Vaccination Phase STARTED	237	123	0	0
Primary Vaccination Phase COMPLETED	233	122	0	0
Primary Vaccination Phase NOT COMPLETED	4	1	0	0
Booster Vaccination Phase STARTED	228	0	119	1
Booster Vaccination Phase COMPLETED	226	0	119	1
Booster Vaccination Phase NOT COMPLETED	2	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	10Pn Group Healthy male or female subjects, between 90 and 118 days of age who received, during primary vaccination phase, 3 doses of Synflorix (10Pn) vaccine, administered intramuscularly on alternating (left/right) sides of the anterolateral thigh and DPT "KAKETSUKEN" Syringe (DTPa) vaccine administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm. Both vaccines were administered at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase).	DTPa Group Healthy male or female subjects, between 90 and 118 days of age, who received, during the primary vaccination phase, 3 doses of the DPT "KAKETSUKEN" Syringe (DTPa) vaccine, administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase). Subjects from this group who also received at least one dose of Prevenar (PCV7): Pfizer's (formerly Wyeth Lederle) 7-valent pneumococcal conjugate vaccine, given before pre-booster blood sample (as optional treatment considered as standard of care), were assigned to the DTPa + Prevenar Group in the booster phase, and subjects who did not receive any dose of Prevenar before pre-booster blood sample were assigned to the DTPa-no Prevenar Group in the booster phase. Some booster phase analyses were only performed on subjects of both pooled sub-groups, renamed as DTPa booster Group, at the time of the analysis..
Primary Vaccination Phase Serious Adverse Event	2	0
Primary Vaccination Phase Adverse Event	1	0
Primary Vaccination Phase Protocol Violation	1	0
Primary Vaccination Phase Migrated/moved from study area	0	1
Booster Vaccination Phase Withdrawal by Subject	1	0
Booster Vaccination Phase Migrated/moved from study area	1	0

Baseline Characteristics

Primary and Booster Vaccination Study With Pneumococcal Vaccine GSK1024850A in Healthy Japanese Children

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	10Pn Group n=237 Participants Healthy male or female subjects, between 90 and 118 days of age who received, during primary vaccination phase, 3 doses of Synflorix (10Pn) vaccine, administered intramuscularly on alternating (left/right) sides of the anterolateral thigh and DPT "KAKETSUKEN" Syringe (DTPa) vaccine administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm. Both vaccines were administered at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase).	DTPa Group n=123 Participants Healthy male or female subjects, between 90 and 118 days of age, who received, during the primary vaccination phase, 3 doses of the DPT "KAKETSUKEN" Syringe (DTPa) vaccine, administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase). Subjects from this group who also received at least one dose of Prevenar (PCV7): Pfizer's (formerly Wyeth Lederle) 7-valent pneumococcal conjugate vaccine, given before pre-booster blood sample (as optional treatment considered as standard of care), were assigned to the DTPa + Prevenar Group in the booster phase, and subjects who did not receive any dose of Prevenar before pre-booster blood sample were assigned to the DTPa-no Prevenar Group in the booster phase. Some booster phase analyses were only performed on subjects of both pooled sub-groups, renamed as DTPa booster Group, at the time of the analysis..	Total n=360 Participants Total of all reporting groups
Age, Continuous	13.6 Weeks STANDARD_DEVIATION 1.02 • n=5 Participants	13.5 Weeks STANDARD_DEVIATION 1.1 • n=7 Participants	13.57 Weeks STANDARD_DEVIATION 1.05 • n=5 Participants
Sex: Female, Male Female	117 Participants n=5 Participants	59 Participants n=7 Participants	176 Participants n=5 Participants
Sex: Female, Male Male	120 Participants n=5 Participants	64 Participants n=7 Participants	184 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 month following primary immunization (at Month 3)

Population: The analysis was performed on the ATP cohort for immunogenicity for primary epoch, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after primary vaccination.

Outcome measures

Outcome measures
Measure	10Pn Group n=231 Participants Healthy male or female subjects, between 90 and 118 days of age who received, during primary vaccination phase, 3 doses of Synflorix (10Pn) vaccine, administered intramuscularly on alternating (left/right) sides of the anterolateral thigh and DPT "KAKETSUKEN" Syringe (DTPa) vaccine administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm. Both vaccines were administered at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase).	DTPa Group n=121 Participants Healthy male or female subjects, between 90 and 118 days of age, who received, during the primary vaccination phase, 3 doses of the DPT "KAKETSUKEN" Syringe (DTPa) vaccine, administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase). Subjects from this group who also received at least one dose of Prevenar (PCV7): Pfizer's (formerly Wyeth Lederle) 7-valent pneumococcal conjugate vaccine, given before pre-booster blood sample (as optional treatment considered as standard of care), were assigned to the DTPa + Prevenar Group in the booster phase, and subjects who did not receive any dose of Prevenar before pre-booster blood sample were assigned to the DTPa-no Prevenar Group in the booster phase. Some booster phase analyses were only performed on subjects of both pooled sub-groups, renamed as DTPa booster Group, at the time of the analysis..	DTPa - no Prevenar Group Healthy male or female subjects, between 90 and 118 days of age, who received, during the primary vaccination phase, 3 doses of the DPT "KAKETSUKEN" Syringe (DTPa) vaccine, administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase). Those subjects did not receive any dose of Prevenar vaccination before pre-booster blood sample.
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Primary Immunization) Anti-19F	17.39 μg/mL Interval 15.53 to 19.48	0.06 μg/mL Interval 0.05 to 0.07	—
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Primary Immunization) Anti-1	6.52 μg/mL Interval 5.85 to 7.26	0.04 μg/mL Interval 0.03 to 0.04	—
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Primary Immunization) Anti-4	6.54 μg/mL Interval 5.86 to 7.3	0.03 μg/mL Interval 0.03 to 0.03	—
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Primary Immunization) Anti-5	6.54 μg/mL Interval 5.94 to 7.21	0.05 μg/mL Interval 0.04 to 0.06	—
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Primary Immunization) Anti-6B	1.71 μg/mL Interval 1.43 to 2.05	0.03 μg/mL Interval 0.03 to 0.03	—
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Primary Immunization) Anti-7F	6.11 μg/mL Interval 5.5 to 6.78	0.03 μg/mL Interval 0.03 to 0.04	—
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Primary Immunization) Anti-9V	5.42 μg/mL Interval 4.81 to 6.1	0.03 μg/mL Interval 0.03 to 0.03	—
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Primary Immunization) Anti-14	10.03 μg/mL Interval 8.8 to 11.43	0.07 μg/mL Interval 0.06 to 0.09	—
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Primary Immunization) Anti-18C	16.59 μg/mL Interval 14.4 to 19.13	0.04 μg/mL Interval 0.03 to 0.04	—
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Primary Immunization) Anti-23F	2.17 μg/mL Interval 1.83 to 2.57	0.04 μg/mL Interval 0.03 to 0.04	—

SECONDARY outcome

Timeframe: Prior to (PRE, at Month 14-16 ) and one month after booster (POST, at Month 15-17) immunization

Population: The analysis was performed on the ATP cohort for immunogenicity for booster epoch, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component before and after booster vaccination.

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 ELISA, expressed as GMCs, in μg/mL. The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL. Antibody concentrations \< 0.05 μg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation. Administration of catch-up pneumococcal vaccination with a licensed product other than Synflorix was allowed in the DTPa Group at least 7 days before DTPa vaccine booster dose. Thus, for this booster phase analysis, the DTPa Group was further split in DTPa + Prevenar Group and DTPa - no Prevenar Group.

Outcome measures

Outcome measures
Measure	10Pn Group n=216 Participants Healthy male or female subjects, between 90 and 118 days of age who received, during primary vaccination phase, 3 doses of Synflorix (10Pn) vaccine, administered intramuscularly on alternating (left/right) sides of the anterolateral thigh and DPT "KAKETSUKEN" Syringe (DTPa) vaccine administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm. Both vaccines were administered at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase).	DTPa Group n=114 Participants Healthy male or female subjects, between 90 and 118 days of age, who received, during the primary vaccination phase, 3 doses of the DPT "KAKETSUKEN" Syringe (DTPa) vaccine, administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase). Subjects from this group who also received at least one dose of Prevenar (PCV7): Pfizer's (formerly Wyeth Lederle) 7-valent pneumococcal conjugate vaccine, given before pre-booster blood sample (as optional treatment considered as standard of care), were assigned to the DTPa + Prevenar Group in the booster phase, and subjects who did not receive any dose of Prevenar before pre-booster blood sample were assigned to the DTPa-no Prevenar Group in the booster phase. Some booster phase analyses were only performed on subjects of both pooled sub-groups, renamed as DTPa booster Group, at the time of the analysis..	DTPa - no Prevenar Group n=1 Participants Healthy male or female subjects, between 90 and 118 days of age, who received, during the primary vaccination phase, 3 doses of the DPT "KAKETSUKEN" Syringe (DTPa) vaccine, administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase). Those subjects did not receive any dose of Prevenar vaccination before pre-booster blood sample.
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Booster Immunization) Anti-1 PRE	0.8 μg/mL Interval 0.69 to 0.92	0.04 μg/mL Interval 0.03 to 0.04	0.03 μg/mL The lower limit (LL) and upper limit (UL) of the 95% confidence interval could not be determined in this group (not applicable because number of subjects with concentrations within the specified range = 0)
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Booster Immunization) Anti-1 POST	7.81 μg/mL Interval 6.91 to 8.82	0.04 μg/mL Interval 0.04 to 0.05	0.24 μg/mL The lower limit (LL) and upper limit (UL) of the 95% confidence interval could not be determined in this group (not applicable because number of subjects with concentrations within the specified range = 0)
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Booster Immunization) Anti-4 PRE	0.81 μg/mL Interval 0.7 to 0.93	0.85 μg/mL Interval 0.71 to 1.02	0.03 μg/mL The lower limit (LL) and upper limit (UL) of the 95% confidence interval could not be determined in this group (not applicable because number of subjects with concentrations within the specified range = 0)
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Booster Immunization) Anti-4 POST	12.89 μg/mL Interval 11.41 to 14.56	0.78 μg/mL Interval 0.64 to 0.94	0.03 μg/mL The lower limit (LL) and upper limit (UL) of the 95% confidence interval could not be determined in this group (not applicable because number of subjects with concentrations within the specified range = 0)
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Booster Immunization) Anti-5 PRE	1.22 μg/mL Interval 1.05 to 1.41	0.08 μg/mL Interval 0.07 to 0.1	0.05 μg/mL The lower limit (LL) and upper limit (UL) of the 95% confidence interval could not be determined in this group (not applicable because number of subjects with concentrations within the specified range = 0)
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Booster Immunization) Anti-5 POST	8.81 μg/mL Interval 7.87 to 9.86	0.15 μg/mL Interval 0.12 to 0.17	0.03 μg/mL The lower limit (LL) and upper limit (UL) of the 95% confidence interval could not be determined in this group (not applicable because number of subjects with concentrations within the specified range = 0)
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Booster Immunization) Anti-6B PRE	0.93 μg/mL Interval 0.79 to 1.1	0.34 μg/mL Interval 0.27 to 0.44	0.03 μg/mL The lower limit (LL) and upper limit (UL) of the 95% confidence interval could not be determined in this group (not applicable because number of subjects with concentrations within the specified range = 0)
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Booster Immunization) Anti-6B POST	3.66 μg/mL Interval 3.14 to 4.27	0.33 μg/mL Interval 0.25 to 0.42	0.03 μg/mL The lower limit (LL) and upper limit (UL) of the 95% confidence interval could not be determined in this group (not applicable because number of subjects with concentrations within the specified range = 0)
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Booster Immunization) Anti-7F PRE	1.48 μg/mL Interval 1.32 to 1.65	0.05 μg/mL Interval 0.04 to 0.05	0.03 μg/mL The lower limit (LL) and upper limit (UL) of the 95% confidence interval could not be determined in this group (not applicable because number of subjects with concentrations within the specified range = 0)
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Booster Immunization) Anti-7F POST	10.68 μg/mL Interval 9.66 to 11.81	0.09 μg/mL Interval 0.08 to 0.11	0.03 μg/mL The lower limit (LL) and upper limit (UL) of the 95% confidence interval could not be determined in this group (not applicable because number of subjects with concentrations within the specified range = 0)
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Booster Immunization) Anti-9V PRE	1.81 μg/mL Interval 1.61 to 2.03	1.01 μg/mL Interval 0.83 to 1.25	0.03 μg/mL The lower limit (LL) and upper limit (UL) of the 95% confidence interval could not be determined in this group (not applicable because number of subjects with concentrations within the specified range = 0)
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Booster Immunization) Anti-9V POST	12.79 μg/mL Interval 11.49 to 14.23	0.96 μg/mL Interval 0.79 to 1.17	0.03 μg/mL The lower limit (LL) and upper limit (UL) of the 95% confidence interval could not be determined in this group (not applicable because number of subjects with concentrations within the specified range = 0)
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Booster Immunization) Anti-14 PRE	2.37 μg/mL Interval 2.04 to 2.74	3.17 μg/mL Interval 2.74 to 3.67	0.09 μg/mL The lower limit (LL) and upper limit (UL) of the 95% confidence interval could not be determined in this group (not applicable because number of subjects with concentrations within the specified range = 0)
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Booster Immunization) Anti-14 POST	15.72 μg/mL Interval 13.97 to 17.69	2.92 μg/mL Interval 2.53 to 3.38	0.16 μg/mL The lower limit (LL) and upper limit (UL) of the 95% confidence interval could not be determined in this group (not applicable because number of subjects with concentrations within the specified range = 0)
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Booster Immunization) Anti-18C PRE	2.18 μg/mL Interval 1.89 to 2.51	0.94 μg/mL Interval 0.79 to 1.11	0.03 μg/mL The lower limit (LL) and upper limit (UL) of the 95% confidence interval could not be determined in this group (not applicable because number of subjects with concentrations within the specified range = 0)
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Booster Immunization) Anti-18C POST	34.9 μg/mL Interval 31.05 to 39.23	0.77 μg/mL Interval 0.65 to 0.92	0.03 μg/mL The lower limit (LL) and upper limit (UL) of the 95% confidence interval could not be determined in this group (not applicable because number of subjects with concentrations within the specified range = 0)
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Booster Immunization) Anti-19F PRE	2.92 μg/mL Interval 2.5 to 3.41	0.51 μg/mL Interval 0.38 to 0.68	0.03 μg/mL The lower limit (LL) and upper limit (UL) of the 95% confidence interval could not be determined in this group (not applicable because number of subjects with concentrations within the specified range = 0)
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Booster Immunization) Anti-19F POST	28.72 μg/mL Interval 25.29 to 32.63	0.68 μg/mL Interval 0.51 to 0.91	0.03 μg/mL The lower limit (LL) and upper limit (UL) of the 95% confidence interval could not be determined in this group (not applicable because number of subjects with concentrations within the specified range = 0)
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Booster Immunization) Anti-23F PRE	1.14 μg/mL Interval 0.93 to 1.39	0.55 μg/mL Interval 0.42 to 0.73	0.03 μg/mL The lower limit (LL) and upper limit (UL) of the 95% confidence interval could not be determined in this group (not applicable because number of subjects with concentrations within the specified range = 0)
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Booster Immunization) Anti-23F POST	7.68 μg/mL Interval 6.68 to 8.83	0.88 μg/mL Interval 0.7 to 1.12	0.03 μg/mL The lower limit (LL) and upper limit (UL) of the 95% confidence interval could not be determined in this group (not applicable because number of subjects with concentrations within the specified range = 0)

SECONDARY outcome

Timeframe: 1 month following primary immunization (at Month 3)

Outcome measures

Outcome measures
Measure	10Pn Group n=224 Participants Healthy male or female subjects, between 90 and 118 days of age who received, during primary vaccination phase, 3 doses of Synflorix (10Pn) vaccine, administered intramuscularly on alternating (left/right) sides of the anterolateral thigh and DPT "KAKETSUKEN" Syringe (DTPa) vaccine administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm. Both vaccines were administered at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase).	DTPa Group n=116 Participants Healthy male or female subjects, between 90 and 118 days of age, who received, during the primary vaccination phase, 3 doses of the DPT "KAKETSUKEN" Syringe (DTPa) vaccine, administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase). Subjects from this group who also received at least one dose of Prevenar (PCV7): Pfizer's (formerly Wyeth Lederle) 7-valent pneumococcal conjugate vaccine, given before pre-booster blood sample (as optional treatment considered as standard of care), were assigned to the DTPa + Prevenar Group in the booster phase, and subjects who did not receive any dose of Prevenar before pre-booster blood sample were assigned to the DTPa-no Prevenar Group in the booster phase. Some booster phase analyses were only performed on subjects of both pooled sub-groups, renamed as DTPa booster Group, at the time of the analysis..	DTPa - no Prevenar Group Healthy male or female subjects, between 90 and 118 days of age, who received, during the primary vaccination phase, 3 doses of the DPT "KAKETSUKEN" Syringe (DTPa) vaccine, administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase). Those subjects did not receive any dose of Prevenar vaccination before pre-booster blood sample.
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Primary Immunization) OPSONO-23F	4312.1 Titers Interval 3401.5 to 5466.5	6 Titers Interval 4.5 to 8.0	—
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Primary Immunization) OPSONO-1	619.8 Titers Interval 511.9 to 750.6	4.8 Titers Interval 4.2 to 5.5	—
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Primary Immunization) OPSONO-4	1184.6 Titers Interval 1043.7 to 1344.5	4.1 Titers Interval 3.9 to 4.3	—
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Primary Immunization) OPSONO-5	335.1 Titers Interval 286.4 to 392.1	4.2 Titers Interval 4.0 to 4.5	—
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Primary Immunization) OPSONO-6B	1926.6 Titers Interval 1559.6 to 2380.0	5 Titers Interval 4.2 to 5.9	—
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Primary Immunization) OPSONO-7F	7905.9 Titers Interval 6854.5 to 9118.6	69.5 Titers Interval 43.2 to 111.9	—
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Primary Immunization) OPSONO-9V	4063.4 Titers Interval 3565.8 to 4630.4	4.9 Titers Interval 4.2 to 5.6	—
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Primary Immunization) OPSONO-14	3392.4 Titers Interval 2962.5 to 3884.8	6.5 Titers Interval 5.0 to 8.5	—
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Primary Immunization) OPSONO-18C	893.2 Titers Interval 727.7 to 1096.2	4.8 Titers Interval 4.0 to 5.7	—
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Primary Immunization) OPSONO-19F	1254.6 Titers Interval 1031.1 to 1526.5	4.4 Titers Interval 4.0 to 4.9	—

SECONDARY outcome

Timeframe: Prior to (PRE, at Month 14-16) and one month after booster (POST, at Month 15-17) immunization

Pneumococcal vaccine serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F and were calculated, expressed as geometric mean titers (GMTs). The seropositivity cut-off for the assay was ≥ 8. Antibody titers \< 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation. Administration of catch-up pneumococcal vaccination with a licensed product other than Synflorix was allowed in the DTPa Group at least 7 days before DTPa vaccine booster dose. Thus, for this booster phase analysis, the DTPa Group was further split in DTPa + Prevenar Group and DTPa - no Prevenar Group.

Outcome measures

Outcome measures
Measure	10Pn Group n=214 Participants Healthy male or female subjects, between 90 and 118 days of age who received, during primary vaccination phase, 3 doses of Synflorix (10Pn) vaccine, administered intramuscularly on alternating (left/right) sides of the anterolateral thigh and DPT "KAKETSUKEN" Syringe (DTPa) vaccine administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm. Both vaccines were administered at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase).	DTPa Group n=113 Participants Healthy male or female subjects, between 90 and 118 days of age, who received, during the primary vaccination phase, 3 doses of the DPT "KAKETSUKEN" Syringe (DTPa) vaccine, administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase). Subjects from this group who also received at least one dose of Prevenar (PCV7): Pfizer's (formerly Wyeth Lederle) 7-valent pneumococcal conjugate vaccine, given before pre-booster blood sample (as optional treatment considered as standard of care), were assigned to the DTPa + Prevenar Group in the booster phase, and subjects who did not receive any dose of Prevenar before pre-booster blood sample were assigned to the DTPa-no Prevenar Group in the booster phase. Some booster phase analyses were only performed on subjects of both pooled sub-groups, renamed as DTPa booster Group, at the time of the analysis..	DTPa - no Prevenar Group n=1 Participants Healthy male or female subjects, between 90 and 118 days of age, who received, during the primary vaccination phase, 3 doses of the DPT "KAKETSUKEN" Syringe (DTPa) vaccine, administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase). Those subjects did not receive any dose of Prevenar vaccination before pre-booster blood sample.
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Booster Immunization) OPSONO-1 PRE	45.9 Titers Interval 34.9 to 60.4	4.5 Titers Interval 4.0 to 5.1	4 Titers The lower limit (LL) and upper limit (UL) of the 95% confidence interval could not be determined in this group (not applicable because number of subjects with concentrations within the specified range = 0)
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Booster Immunization) OPSONO-1 POST	2320.7 Titers Interval 1941.8 to 2773.6	4.7 Titers Interval 4.1 to 5.5	4 Titers The lower limit (LL) and upper limit (UL) of the 95% confidence interval could not be determined in this group (not applicable because number of subjects with concentrations within the specified range = 0)
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Booster Immunization) OPSONO-4 PRE	58.3 Titers Interval 43.6 to 77.9	79 Titers Interval 49.3 to 126.7	371 Titers The lower limit (LL) and upper limit (UL) of the 95% confidence interval could not be determined in this group (not applicable because number of subjects with concentrations within the specified range = 0)
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Booster Immunization) OPSONO-4 POST	3863.1 Titers Interval 3319.7 to 4495.5	69.3 Titers Interval 43.1 to 111.5	493 Titers The lower limit (LL) and upper limit (UL) of the 95% confidence interval could not be determined in this group (not applicable because number of subjects with concentrations within the specified range = 0)
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Booster Immunization) OPSONO-5 PRE	22.9 Titers Interval 19.1 to 27.6	4.2 Titers Interval 3.9 to 4.5	4 Titers The lower limit (LL) and upper limit (UL) of the 95% confidence interval could not be determined in this group (not applicable because number of subjects with concentrations within the specified range = 0)
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Booster Immunization) OPSONO-5 POST	686.7 Titers Interval 583.8 to 807.9	4.7 Titers Interval 4.1 to 5.3	4 Titers The lower limit (LL) and upper limit (UL) of the 95% confidence interval could not be determined in this group (not applicable because number of subjects with concentrations within the specified range = 0)
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Booster Immunization) OPSONO-6B PRE	191.2 Titers Interval 141.9 to 257.5	118.5 Titers Interval 66.3 to 211.7	4 Titers The lower limit (LL) and upper limit (UL) of the 95% confidence interval could not be determined in this group (not applicable because number of subjects with concentrations within the specified range = 0)
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Booster Immunization) OPSONO-6B POST	1682.9 Titers Interval 1379.1 to 2053.7	119 Titers Interval 68.5 to 206.9	4 Titers The lower limit (LL) and upper limit (UL) of the 95% confidence interval could not be determined in this group (not applicable because number of subjects with concentrations within the specified range = 0)
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Booster Immunization) OPSONO-7F PRE	2244.8 Titers Interval 1921.9 to 2621.9	1014.7 Titers Interval 743.8 to 1384.1	588 Titers The lower limit (LL) and upper limit (UL) of the 95% confidence interval could not be determined in this group (not applicable because number of subjects with concentrations within the specified range = 0)
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Booster Immunization) OPSONO-7F POST	14144.3 Titers Interval 12109.3 to 16521.4	1165.6 Titers Interval 855.7 to 1587.8	1278 Titers The lower limit (LL) and upper limit (UL) of the 95% confidence interval could not be determined in this group (not applicable because number of subjects with concentrations within the specified range = 0)
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Booster Immunization) OPSONO-9V PRE	520 Titers Interval 437.3 to 618.5	1081.6 Titers Interval 803.3 to 1456.4	4595 Titers The lower limit (LL) and upper limit (UL) of the 95% confidence interval could not be determined in this group (not applicable because number of subjects with concentrations within the specified range = 0)
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Booster Immunization) OPSONO-9V POST	4693.7 Titers Interval 4099.0 to 5374.6	958.8 Titers Interval 680.0 to 1351.8	367 Titers The lower limit (LL) and upper limit (UL) of the 95% confidence interval could not be determined in this group (not applicable because number of subjects with concentrations within the specified range = 0)
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Booster Immunization) OPSONO-14 PRE	673.1 Titers Interval 573.1 to 790.6	826.7 Titers Interval 669.3 to 1021.0	4 Titers The lower limit (LL) and upper limit (UL) of the 95% confidence interval could not be determined in this group (not applicable because number of subjects with concentrations within the specified range = 0)
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Booster Immunization) OPSONO-14 POST	6209 Titers Interval 5299.3 to 7274.8	819.1 Titers Interval 651.4 to 1030.1	4 Titers The lower limit (LL) and upper limit (UL) of the 95% confidence interval could not be determined in this group (not applicable because number of subjects with concentrations within the specified range = 0)
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Booster Immunization) OPSONO-18C PRE	26.3 Titers Interval 21.1 to 32.6	11.5 Titers Interval 8.2 to 16.0	4 Titers The lower limit (LL) and upper limit (UL) of the 95% confidence interval could not be determined in this group (not applicable because number of subjects with concentrations within the specified range = 0)
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Booster Immunization) OPSONO-18C POST	2181 Titers Interval 1900.1 to 2503.4	12.7 Titers Interval 9.1 to 17.7	4 Titers The lower limit (LL) and upper limit (UL) of the 95% confidence interval could not be determined in this group (not applicable because number of subjects with concentrations within the specified range = 0)
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Booster Immunization) OPSONO-19F PRE	83.4 Titers Interval 64.7 to 107.6	21.1 Titers Interval 13.5 to 32.9	4 Titers The lower limit (LL) and upper limit (UL) of the 95% confidence interval could not be determined in this group (not applicable because number of subjects with concentrations within the specified range = 0)
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Booster Immunization) OPSONO-19F POST	3496.3 Titers Interval 2938.8 to 4159.6	20.9 Titers Interval 13.7 to 31.8	191 Titers The lower limit (LL) and upper limit (UL) of the 95% confidence interval could not be determined in this group (not applicable because number of subjects with concentrations within the specified range = 0)
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Booster Immunization) OPSONO-23F PRE	600.5 Titers Interval 417.6 to 863.4	1048 Titers Interval 561.5 to 1956.1	4 Titers The lower limit (LL) and upper limit (UL) of the 95% confidence interval could not be determined in this group (not applicable because number of subjects with concentrations within the specified range = 0)
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Booster Immunization) OPSONO-23F POST	7057.2 Titers Interval 5896.6 to 8446.1	1758.3 Titers Interval 949.4 to 3256.5	4 Titers The lower limit (LL) and upper limit (UL) of the 95% confidence interval could not be determined in this group (not applicable because number of subjects with concentrations within the specified range = 0)

SECONDARY outcome

Timeframe: 1 month following primary immunization (at Month 3)

Outcome measures

Outcome measures
Measure	10Pn Group n=231 Participants Healthy male or female subjects, between 90 and 118 days of age who received, during primary vaccination phase, 3 doses of Synflorix (10Pn) vaccine, administered intramuscularly on alternating (left/right) sides of the anterolateral thigh and DPT "KAKETSUKEN" Syringe (DTPa) vaccine administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm. Both vaccines were administered at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase).	DTPa Group n=121 Participants Healthy male or female subjects, between 90 and 118 days of age, who received, during the primary vaccination phase, 3 doses of the DPT "KAKETSUKEN" Syringe (DTPa) vaccine, administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase). Subjects from this group who also received at least one dose of Prevenar (PCV7): Pfizer's (formerly Wyeth Lederle) 7-valent pneumococcal conjugate vaccine, given before pre-booster blood sample (as optional treatment considered as standard of care), were assigned to the DTPa + Prevenar Group in the booster phase, and subjects who did not receive any dose of Prevenar before pre-booster blood sample were assigned to the DTPa-no Prevenar Group in the booster phase. Some booster phase analyses were only performed on subjects of both pooled sub-groups, renamed as DTPa booster Group, at the time of the analysis..	DTPa - no Prevenar Group Healthy male or female subjects, between 90 and 118 days of age, who received, during the primary vaccination phase, 3 doses of the DPT "KAKETSUKEN" Syringe (DTPa) vaccine, administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase). Those subjects did not receive any dose of Prevenar vaccination before pre-booster blood sample.
Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Primary Immunization) Anti-6A	0.41 μg/mL Interval 0.34 to 0.49	0.04 μg/mL Interval 0.03 to 0.04	—
Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Primary Immunization) Anti-19A	0.48 μg/mL Interval 0.4 to 0.57	0.04 μg/mL Interval 0.04 to 0.05	—

SECONDARY outcome

Timeframe: Prior to (PRE, at Month 14-16) and one month after booster (POST, at Month 15-17) immunization

Concentrations were given in microgram per millilitre (µg/mL) and were expressed in geometric mean antibody concentrations. Cross-reactive pneumococcal vaccine serotypes assessed were 6A and 19A. The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 µg/mL. Antibody concentrations \< 0.05 g/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation. Administration of catch-up pneumococcal vaccination with a licensed product other than Synflorix was allowed in the DTPa Group at least 7 days before DTPa vaccine booster dose. Thus, for this booster phase analysis, the DTPa Group was further split in DTPa + Prevenar Group and DTPa - no Prevenar Group.

Outcome measures

Outcome measures
Measure	10Pn Group n=214 Participants Healthy male or female subjects, between 90 and 118 days of age who received, during primary vaccination phase, 3 doses of Synflorix (10Pn) vaccine, administered intramuscularly on alternating (left/right) sides of the anterolateral thigh and DPT "KAKETSUKEN" Syringe (DTPa) vaccine administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm. Both vaccines were administered at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase).	DTPa Group n=114 Participants Healthy male or female subjects, between 90 and 118 days of age, who received, during the primary vaccination phase, 3 doses of the DPT "KAKETSUKEN" Syringe (DTPa) vaccine, administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase). Subjects from this group who also received at least one dose of Prevenar (PCV7): Pfizer's (formerly Wyeth Lederle) 7-valent pneumococcal conjugate vaccine, given before pre-booster blood sample (as optional treatment considered as standard of care), were assigned to the DTPa + Prevenar Group in the booster phase, and subjects who did not receive any dose of Prevenar before pre-booster blood sample were assigned to the DTPa-no Prevenar Group in the booster phase. Some booster phase analyses were only performed on subjects of both pooled sub-groups, renamed as DTPa booster Group, at the time of the analysis..	DTPa - no Prevenar Group n=1 Participants Healthy male or female subjects, between 90 and 118 days of age, who received, during the primary vaccination phase, 3 doses of the DPT "KAKETSUKEN" Syringe (DTPa) vaccine, administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase). Those subjects did not receive any dose of Prevenar vaccination before pre-booster blood sample.
Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Booster Immunization) Anti-6A PRE	0.61 μg/mL Interval 0.5 to 0.75	0.19 μg/mL Interval 0.14 to 0.26	0.03 μg/mL The lower limit (LL) and upper limit (UL) of the 95% confidence interval could not be determined in this group (not applicable because number of subjects with concentrations within the specified range = 0)
Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Booster Immunization) Anti-6A POST	2.72 μg/mL Interval 2.24 to 3.3	0.21 μg/mL Interval 0.16 to 0.27	0.03 μg/mL The lower limit (LL) and upper limit (UL) of the 95% confidence interval could not be determined in this group (not applicable because number of subjects with concentrations within the specified range = 0)
Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Booster Immunization) Anti-19A PRE	0.57 μg/mL Interval 0.45 to 0.71	0.12 μg/mL Interval 0.09 to 0.16	0.03 μg/mL The lower limit (LL) and upper limit (UL) of the 95% confidence interval could not be determined in this group (not applicable because number of subjects with concentrations within the specified range = 0)
Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Booster Immunization) Anti-19A POST	5.16 μg/mL Interval 4.18 to 6.37	0.15 μg/mL Interval 0.11 to 0.2	0.03 μg/mL The lower limit (LL) and upper limit (UL) of the 95% confidence interval could not be determined in this group (not applicable because number of subjects with concentrations within the specified range = 0)

SECONDARY outcome

Timeframe: 1 month following primary immunization (at Month 3)

Outcome measures

Outcome measures
Measure	10Pn Group n=213 Participants Healthy male or female subjects, between 90 and 118 days of age who received, during primary vaccination phase, 3 doses of Synflorix (10Pn) vaccine, administered intramuscularly on alternating (left/right) sides of the anterolateral thigh and DPT "KAKETSUKEN" Syringe (DTPa) vaccine administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm. Both vaccines were administered at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase).	DTPa Group n=115 Participants Healthy male or female subjects, between 90 and 118 days of age, who received, during the primary vaccination phase, 3 doses of the DPT "KAKETSUKEN" Syringe (DTPa) vaccine, administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase). Subjects from this group who also received at least one dose of Prevenar (PCV7): Pfizer's (formerly Wyeth Lederle) 7-valent pneumococcal conjugate vaccine, given before pre-booster blood sample (as optional treatment considered as standard of care), were assigned to the DTPa + Prevenar Group in the booster phase, and subjects who did not receive any dose of Prevenar before pre-booster blood sample were assigned to the DTPa-no Prevenar Group in the booster phase. Some booster phase analyses were only performed on subjects of both pooled sub-groups, renamed as DTPa booster Group, at the time of the analysis..	DTPa - no Prevenar Group Healthy male or female subjects, between 90 and 118 days of age, who received, during the primary vaccination phase, 3 doses of the DPT "KAKETSUKEN" Syringe (DTPa) vaccine, administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase). Those subjects did not receive any dose of Prevenar vaccination before pre-booster blood sample.
Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Primary Immunization) Opsono-6A	339.6 Titers Interval 253.8 to 454.4	4.6 Titers Interval 4.1 to 5.1	—
Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Primary Immunization) Opsono-19A	34.3 Titers Interval 26.2 to 44.9	4.3 Titers Interval 4.0 to 4.6	—

SECONDARY outcome

Timeframe: Prior to (PRE, at Month 14-16) and one month after booster (POST, at Month 15-17) immunization

Cross-reactive pneumococcal vaccine serotypes assessed were 6A and 19A and were calculated, expressed as geometric mean titers (GMTs). The seropositivity cut-off for the assay was ≥ 8. Antibody titers \< 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation. Administration of catch-up pneumococcal vaccination with a licensed product other than Synflorix was allowed in the DTPa Group at least 7 days before DTPa vaccine booster dose. Thus, for this booster phase analysis, the DTPa Group was further split in DTPa + Prevenar Group and DTPa - no Prevenar Group.

Outcome measures

Outcome measures
Measure	10Pn Group n=213 Participants Healthy male or female subjects, between 90 and 118 days of age who received, during primary vaccination phase, 3 doses of Synflorix (10Pn) vaccine, administered intramuscularly on alternating (left/right) sides of the anterolateral thigh and DPT "KAKETSUKEN" Syringe (DTPa) vaccine administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm. Both vaccines were administered at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase).	DTPa Group n=111 Participants Healthy male or female subjects, between 90 and 118 days of age, who received, during the primary vaccination phase, 3 doses of the DPT "KAKETSUKEN" Syringe (DTPa) vaccine, administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase). Subjects from this group who also received at least one dose of Prevenar (PCV7): Pfizer's (formerly Wyeth Lederle) 7-valent pneumococcal conjugate vaccine, given before pre-booster blood sample (as optional treatment considered as standard of care), were assigned to the DTPa + Prevenar Group in the booster phase, and subjects who did not receive any dose of Prevenar before pre-booster blood sample were assigned to the DTPa-no Prevenar Group in the booster phase. Some booster phase analyses were only performed on subjects of both pooled sub-groups, renamed as DTPa booster Group, at the time of the analysis..	DTPa - no Prevenar Group n=1 Participants Healthy male or female subjects, between 90 and 118 days of age, who received, during the primary vaccination phase, 3 doses of the DPT "KAKETSUKEN" Syringe (DTPa) vaccine, administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase). Those subjects did not receive any dose of Prevenar vaccination before pre-booster blood sample.
Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Booster Immunization) OPSONO-6A PRE	138.5 Titers Interval 103.3 to 185.7	60.4 Titers Interval 35.2 to 103.7	4 Titers The lower limit (LL) and upper limit (UL) of the 95% confidence interval could not be determined in this group (not applicable because number of subjects with concentrations within the specified range = 0)
Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Booster Immunization) OPSONO-6A POST	767.9 Titers Interval 593.1 to 994.1	103.3 Titers Interval 60.4 to 176.6	4 Titers The lower limit (LL) and upper limit (UL) of the 95% confidence interval could not be determined in this group (not applicable because number of subjects with concentrations within the specified range = 0)
Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Booster Immunization) OPSONO-19A PRE	13.1 Titers Interval 10.1 to 16.9	7.7 Titers Interval 5.5 to 10.6	4 Titers The lower limit (LL) and upper limit (UL) of the 95% confidence interval could not be determined in this group (not applicable because number of subjects with concentrations within the specified range = 0)
Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Booster Immunization) OPSONO-19A POST	431.4 Titers Interval 330.9 to 562.4	8.6 Titers Interval 6.0 to 12.2	4 Titers The lower limit (LL) and upper limit (UL) of the 95% confidence interval could not be determined in this group (not applicable because number of subjects with concentrations within the specified range = 0)

SECONDARY outcome

Timeframe: 1 month following primary immunization (at Month 3)

Anti-protein D (Anti-PD) antibody concentrations by Enzyme-Linked Immunosorbent Assay (ELISA) were calculated, expressed as geometric mean concentrations (GMCs) in ELISA unit per milli-liter (EL.U/mL) and tabulated. The seropositivity cut-off for the assay was ≥ 100 EL.U/mL. Antibody concentrations \< 100 EL.U/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.

Outcome measures

Outcome measures
Measure	10Pn Group n=229 Participants Healthy male or female subjects, between 90 and 118 days of age who received, during primary vaccination phase, 3 doses of Synflorix (10Pn) vaccine, administered intramuscularly on alternating (left/right) sides of the anterolateral thigh and DPT "KAKETSUKEN" Syringe (DTPa) vaccine administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm. Both vaccines were administered at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase).	DTPa Group n=119 Participants Healthy male or female subjects, between 90 and 118 days of age, who received, during the primary vaccination phase, 3 doses of the DPT "KAKETSUKEN" Syringe (DTPa) vaccine, administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase). Subjects from this group who also received at least one dose of Prevenar (PCV7): Pfizer's (formerly Wyeth Lederle) 7-valent pneumococcal conjugate vaccine, given before pre-booster blood sample (as optional treatment considered as standard of care), were assigned to the DTPa + Prevenar Group in the booster phase, and subjects who did not receive any dose of Prevenar before pre-booster blood sample were assigned to the DTPa-no Prevenar Group in the booster phase. Some booster phase analyses were only performed on subjects of both pooled sub-groups, renamed as DTPa booster Group, at the time of the analysis..	DTPa - no Prevenar Group Healthy male or female subjects, between 90 and 118 days of age, who received, during the primary vaccination phase, 3 doses of the DPT "KAKETSUKEN" Syringe (DTPa) vaccine, administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase). Those subjects did not receive any dose of Prevenar vaccination before pre-booster blood sample.
Concentrations of Antibodies Against Protein D (PD) (Primary Immunization)	2548.6 EL.U/mL Interval 2315.1 to 2805.7	87.9 EL.U/mL Interval 75.8 to 102.0	—

SECONDARY outcome

Timeframe: Prior to (PRE, at Month 14-16) and one month after booster (POST, at Month 15-17) immunization

Population: Analysis was performed on the ATP cohort for immunogenicity for booster epoch, which included all evaluable subjects with assay results available for antibodies against Protein D before and after booster vaccination. Analysis was performed on the 10Pn Group and only on the pooled DTPa booster Group, i.e subjects with or without Prevenar vaccination

Outcome measures

Outcome measures
Measure	10Pn Group n=214 Participants Healthy male or female subjects, between 90 and 118 days of age who received, during primary vaccination phase, 3 doses of Synflorix (10Pn) vaccine, administered intramuscularly on alternating (left/right) sides of the anterolateral thigh and DPT "KAKETSUKEN" Syringe (DTPa) vaccine administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm. Both vaccines were administered at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase).	DTPa Group n=113 Participants Healthy male or female subjects, between 90 and 118 days of age, who received, during the primary vaccination phase, 3 doses of the DPT "KAKETSUKEN" Syringe (DTPa) vaccine, administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase). Subjects from this group who also received at least one dose of Prevenar (PCV7): Pfizer's (formerly Wyeth Lederle) 7-valent pneumococcal conjugate vaccine, given before pre-booster blood sample (as optional treatment considered as standard of care), were assigned to the DTPa + Prevenar Group in the booster phase, and subjects who did not receive any dose of Prevenar before pre-booster blood sample were assigned to the DTPa-no Prevenar Group in the booster phase. Some booster phase analyses were only performed on subjects of both pooled sub-groups, renamed as DTPa booster Group, at the time of the analysis..	DTPa - no Prevenar Group Healthy male or female subjects, between 90 and 118 days of age, who received, during the primary vaccination phase, 3 doses of the DPT "KAKETSUKEN" Syringe (DTPa) vaccine, administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase). Those subjects did not receive any dose of Prevenar vaccination before pre-booster blood sample.
Concentrations of Antibodies Against Protein D (PD) (Booster Immunization) Anti-PD PRE	702.6 EL.U/mL Interval 601.0 to 821.5	82.3 EL.U/mL Interval 71.7 to 94.5	—
Concentrations of Antibodies Against Protein D (PD) (Booster Immunization) Anti-PD POST	2916.9 EL.U/mL Interval 2552.9 to 3332.7	86.9 EL.U/mL Interval 75.1 to 100.4	—

SECONDARY outcome

Timeframe: 1 month following primary immunization (at Month 3)

Population: The analysis was performed on the ATP cohort for immunogenicity for primary epoch, which included all evaluable subjects for whom assay results were available for antibodies against Diphtheria Toxoid or Tetanus Toxoid after primary vaccination.

Concentrations of antibodies are presented as geometric mean concentrations expressed as International units per millilitre (IU/mL). Seroprotection status, defined as Anti-DT or Anti-TT antibody concentration equal to or greater than 0.1 IU/mL.

Outcome measures

Outcome measures
Measure	10Pn Group n=230 Participants Healthy male or female subjects, between 90 and 118 days of age who received, during primary vaccination phase, 3 doses of Synflorix (10Pn) vaccine, administered intramuscularly on alternating (left/right) sides of the anterolateral thigh and DPT "KAKETSUKEN" Syringe (DTPa) vaccine administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm. Both vaccines were administered at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase).	DTPa Group n=120 Participants Healthy male or female subjects, between 90 and 118 days of age, who received, during the primary vaccination phase, 3 doses of the DPT "KAKETSUKEN" Syringe (DTPa) vaccine, administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase). Subjects from this group who also received at least one dose of Prevenar (PCV7): Pfizer's (formerly Wyeth Lederle) 7-valent pneumococcal conjugate vaccine, given before pre-booster blood sample (as optional treatment considered as standard of care), were assigned to the DTPa + Prevenar Group in the booster phase, and subjects who did not receive any dose of Prevenar before pre-booster blood sample were assigned to the DTPa-no Prevenar Group in the booster phase. Some booster phase analyses were only performed on subjects of both pooled sub-groups, renamed as DTPa booster Group, at the time of the analysis..	DTPa - no Prevenar Group Healthy male or female subjects, between 90 and 118 days of age, who received, during the primary vaccination phase, 3 doses of the DPT "KAKETSUKEN" Syringe (DTPa) vaccine, administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase). Those subjects did not receive any dose of Prevenar vaccination before pre-booster blood sample.
Concentrations of Antibodies Against Diphtheria Toxoid (DT) and Tetanus Toxoid (TT)(Primary Immunization) Anti-DT	5.363 IU/mL Interval 5.002 to 5.749	3.829 IU/mL Interval 3.464 to 4.233	—
Concentrations of Antibodies Against Diphtheria Toxoid (DT) and Tetanus Toxoid (TT)(Primary Immunization) Anti-TT	5.427 IU/mL Interval 4.94 to 5.962	3.626 IU/mL Interval 3.174 to 4.143	—

SECONDARY outcome

Timeframe: Prior to (PRE, at Month 14-16) and one month after booster (POST, at Month 15-17) immunization

Population: Analysis was performed on the ATP cohort for immunogenicity for booster epoch, which included all evaluable subjects with assay results available for antibodies against DT or TT before and after booster vaccination. Analysis was performed on the 10Pn Group and only on the pooled DTPa booster Group, i.e subjects with or without Prevenar vaccination.

Outcome measures

Outcome measures
Measure	10Pn Group n=214 Participants Healthy male or female subjects, between 90 and 118 days of age who received, during primary vaccination phase, 3 doses of Synflorix (10Pn) vaccine, administered intramuscularly on alternating (left/right) sides of the anterolateral thigh and DPT "KAKETSUKEN" Syringe (DTPa) vaccine administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm. Both vaccines were administered at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase).	DTPa Group n=113 Participants Healthy male or female subjects, between 90 and 118 days of age, who received, during the primary vaccination phase, 3 doses of the DPT "KAKETSUKEN" Syringe (DTPa) vaccine, administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase). Subjects from this group who also received at least one dose of Prevenar (PCV7): Pfizer's (formerly Wyeth Lederle) 7-valent pneumococcal conjugate vaccine, given before pre-booster blood sample (as optional treatment considered as standard of care), were assigned to the DTPa + Prevenar Group in the booster phase, and subjects who did not receive any dose of Prevenar before pre-booster blood sample were assigned to the DTPa-no Prevenar Group in the booster phase. Some booster phase analyses were only performed on subjects of both pooled sub-groups, renamed as DTPa booster Group, at the time of the analysis..	DTPa - no Prevenar Group Healthy male or female subjects, between 90 and 118 days of age, who received, during the primary vaccination phase, 3 doses of the DPT "KAKETSUKEN" Syringe (DTPa) vaccine, administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase). Those subjects did not receive any dose of Prevenar vaccination before pre-booster blood sample.
Concentrations of Antibodies Against Diphtheria Toxoid (DT) and Tetanus Toxoid (TT)(Booster Immunization) Anti-DT PRE	0.615 IU/mL Interval 0.556 to 0.679	0.717 IU/mL Interval 0.618 to 0.833	—
Concentrations of Antibodies Against Diphtheria Toxoid (DT) and Tetanus Toxoid (TT)(Booster Immunization) Anti-DT POST	15.977 IU/mL Interval 14.573 to 17.515	10.814 IU/mL Interval 9.684 to 12.075	—
Concentrations of Antibodies Against Diphtheria Toxoid (DT) and Tetanus Toxoid (TT)(Booster Immunization) Anti-TT PRE	2.043 IU/mL Interval 1.677 to 2.489	1.352 IU/mL Interval 1.038 to 1.762	—
Concentrations of Antibodies Against Diphtheria Toxoid (DT) and Tetanus Toxoid (TT)(Booster Immunization) Anti-TT POST	11.057 IU/mL Interval 9.949 to 12.287	6.278 IU/mL Interval 5.334 to 7.389	—

SECONDARY outcome

Timeframe: 1 month following primary immunization (at Month 3)

Population: The analysis was performed on the ATP cohort for immunogenicity for primary epoch, which included all evaluable subjects for whom assay results were available for antibodies against Pertussis or Filamentous haemagglutinin after primary vaccination.

Concentrations of antibodies are presented as geometric mean concentrations expressed as Enzyme-Linked Immuno-Sorbent Assay (ELISA) units per millilitre (EL.U/mL). Seropositivity was defined as an antibody concentration equal to or greater than 5 EL.U/mL

Outcome measures

Outcome measures
Measure	10Pn Group n=231 Participants Healthy male or female subjects, between 90 and 118 days of age who received, during primary vaccination phase, 3 doses of Synflorix (10Pn) vaccine, administered intramuscularly on alternating (left/right) sides of the anterolateral thigh and DPT "KAKETSUKEN" Syringe (DTPa) vaccine administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm. Both vaccines were administered at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase).	DTPa Group n=121 Participants Healthy male or female subjects, between 90 and 118 days of age, who received, during the primary vaccination phase, 3 doses of the DPT "KAKETSUKEN" Syringe (DTPa) vaccine, administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase). Subjects from this group who also received at least one dose of Prevenar (PCV7): Pfizer's (formerly Wyeth Lederle) 7-valent pneumococcal conjugate vaccine, given before pre-booster blood sample (as optional treatment considered as standard of care), were assigned to the DTPa + Prevenar Group in the booster phase, and subjects who did not receive any dose of Prevenar before pre-booster blood sample were assigned to the DTPa-no Prevenar Group in the booster phase. Some booster phase analyses were only performed on subjects of both pooled sub-groups, renamed as DTPa booster Group, at the time of the analysis..	DTPa - no Prevenar Group Healthy male or female subjects, between 90 and 118 days of age, who received, during the primary vaccination phase, 3 doses of the DPT "KAKETSUKEN" Syringe (DTPa) vaccine, administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase). Those subjects did not receive any dose of Prevenar vaccination before pre-booster blood sample.
Concentrations of Antibodies Against Pertussis (PT) and Filamentous Haemagglutinin (FHA)(Primary Immunization) Anti-PT	123.2 EL.U/mL Interval 115.2 to 131.7	133.1 EL.U/mL Interval 119.5 to 148.3	—
Concentrations of Antibodies Against Pertussis (PT) and Filamentous Haemagglutinin (FHA)(Primary Immunization) Anti-FHA	308.6 EL.U/mL Interval 284.8 to 334.3	365 EL.U/mL Interval 327.9 to 406.2	—

SECONDARY outcome

Timeframe: Prior to (PRE, at Month 14-16) and one month after booster (POST, at Month 15-17) immunization

Population: Analysis was performed on the ATPcohort for immunogenicity for booster epoch, which included all evaluable subjects with assay results available for antibodies against PT or FHA before and after booster vaccination. Analysis was performed on the 10Pn Group and only on the pooled DTPa booster Group, i.e. subjects with or without Prevenar vaccination

Outcome measures

Outcome measures
Measure	10Pn Group n=214 Participants Healthy male or female subjects, between 90 and 118 days of age who received, during primary vaccination phase, 3 doses of Synflorix (10Pn) vaccine, administered intramuscularly on alternating (left/right) sides of the anterolateral thigh and DPT "KAKETSUKEN" Syringe (DTPa) vaccine administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm. Both vaccines were administered at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase).	DTPa Group n=114 Participants Healthy male or female subjects, between 90 and 118 days of age, who received, during the primary vaccination phase, 3 doses of the DPT "KAKETSUKEN" Syringe (DTPa) vaccine, administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase). Subjects from this group who also received at least one dose of Prevenar (PCV7): Pfizer's (formerly Wyeth Lederle) 7-valent pneumococcal conjugate vaccine, given before pre-booster blood sample (as optional treatment considered as standard of care), were assigned to the DTPa + Prevenar Group in the booster phase, and subjects who did not receive any dose of Prevenar before pre-booster blood sample were assigned to the DTPa-no Prevenar Group in the booster phase. Some booster phase analyses were only performed on subjects of both pooled sub-groups, renamed as DTPa booster Group, at the time of the analysis..	DTPa - no Prevenar Group Healthy male or female subjects, between 90 and 118 days of age, who received, during the primary vaccination phase, 3 doses of the DPT "KAKETSUKEN" Syringe (DTPa) vaccine, administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase). Those subjects did not receive any dose of Prevenar vaccination before pre-booster blood sample.
Concentrations of Antibodies Against Pertussis (PT) and Filamentous Haemagglutinin (FHA)(Booster Immunization) Anti-PT PRE	14.9 EL.U/mL Interval 13.2 to 16.8	18.1 EL.U/mL Interval 15.1 to 21.7	—
Concentrations of Antibodies Against Pertussis (PT) and Filamentous Haemagglutinin (FHA)(Booster Immunization) Anti-PT POST	158.4 EL.U/mL Interval 143.7 to 174.7	204 EL.U/mL Interval 176.7 to 235.6	—
Concentrations of Antibodies Against Pertussis (PT) and Filamentous Haemagglutinin (FHA)(Booster Immunization) Anti-FHA PRE	37.9 EL.U/mL Interval 33.3 to 43.1	48.4 EL.U/mL Interval 40.6 to 57.8	—
Concentrations of Antibodies Against Pertussis (PT) and Filamentous Haemagglutinin (FHA)(Booster Immunization) Anti-FHA POST	460.6 EL.U/mL Interval 421.2 to 503.7	584.5 EL.U/mL Interval 512.6 to 666.6	—

SECONDARY outcome

Timeframe: During the 8-day (Days 0-7) after each primary vaccine dose

Population: The analysis was performed on the Total Vaccinated cohort for primary epoch, which included all subjects having received at least one of the 3 primary vaccination doses and who had their symptoms sheet filled in.

Solicited local AEs assessed were pain, redness and swelling. Any = incidence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling above 30 millimetre.

Outcome measures

Outcome measures
Measure	10Pn Group n=237 Participants Healthy male or female subjects, between 90 and 118 days of age who received, during primary vaccination phase, 3 doses of Synflorix (10Pn) vaccine, administered intramuscularly on alternating (left/right) sides of the anterolateral thigh and DPT "KAKETSUKEN" Syringe (DTPa) vaccine administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm. Both vaccines were administered at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase).	DTPa Group n=123 Participants Healthy male or female subjects, between 90 and 118 days of age, who received, during the primary vaccination phase, 3 doses of the DPT "KAKETSUKEN" Syringe (DTPa) vaccine, administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase). Subjects from this group who also received at least one dose of Prevenar (PCV7): Pfizer's (formerly Wyeth Lederle) 7-valent pneumococcal conjugate vaccine, given before pre-booster blood sample (as optional treatment considered as standard of care), were assigned to the DTPa + Prevenar Group in the booster phase, and subjects who did not receive any dose of Prevenar before pre-booster blood sample were assigned to the DTPa-no Prevenar Group in the booster phase. Some booster phase analyses were only performed on subjects of both pooled sub-groups, renamed as DTPa booster Group, at the time of the analysis..	DTPa - no Prevenar Group Healthy male or female subjects, between 90 and 118 days of age, who received, during the primary vaccination phase, 3 doses of the DPT "KAKETSUKEN" Syringe (DTPa) vaccine, administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase). Those subjects did not receive any dose of Prevenar vaccination before pre-booster blood sample.
Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Primary Vaccination Any pain Dose 1	83 Participants	19 Participants	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Primary Vaccination Grade 3 pain Dose 1	1 Participants	0 Participants	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Primary Vaccination Any redness Dose 1	182 Participants	71 Participants	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Primary Vaccination Grade 3 Redness Dose 1	10 Participants	0 Participants	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Primary Vaccination Any swelling Dose 1	126 Participants	33 Participants	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Primary Vaccination Grade 3 Swelling Dose 1	16 Participants	0 Participants	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Primary Vaccination Any pain Dose 2	74 Participants	26 Participants	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Primary Vaccination Grade 3 pain Dose 2	0 Participants	0 Participants	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Primary Vaccination Any redness Dose 2	200 Participants	96 Participants	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Primary Vaccination Grade 3 Redness Dose 2	25 Participants	4 Participants	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Primary Vaccination Any swelling Dose 2	160 Participants	75 Participants	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Primary Vaccination Grade 3 Swelling Dose 2	26 Participants	4 Participants	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Primary Vaccination Any pain Dose 3	63 Participants	23 Participants	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Primary Vaccination Grade 3 pain Dose 3	1 Participants	0 Participants	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Primary Vaccination Any redness Dose 3	178 Participants	84 Participants	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Primary Vaccination Grade 3 Redness Dose 3	24 Participants	0 Participants	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Primary Vaccination Any swelling Dose 3	142 Participants	65 Participants	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Primary Vaccination Grade 3 Swelling Dose 3	27 Participants	1 Participants	—

SECONDARY outcome

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

Population: The analysis was performed on the Total Vaccinated cohort for booster epoch, which included all subjects having received the booster dose and who had their symptoms sheet filled in. Analysis was performed on the 10Pn Group and only on the pooled DTPa booster Group, i.e subjects with or without Prevenar vaccination.

Outcome measures

Outcome measures
Measure	10Pn Group n=228 Participants Healthy male or female subjects, between 90 and 118 days of age who received, during primary vaccination phase, 3 doses of Synflorix (10Pn) vaccine, administered intramuscularly on alternating (left/right) sides of the anterolateral thigh and DPT "KAKETSUKEN" Syringe (DTPa) vaccine administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm. Both vaccines were administered at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase).	DTPa Group n=120 Participants Healthy male or female subjects, between 90 and 118 days of age, who received, during the primary vaccination phase, 3 doses of the DPT "KAKETSUKEN" Syringe (DTPa) vaccine, administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase). Subjects from this group who also received at least one dose of Prevenar (PCV7): Pfizer's (formerly Wyeth Lederle) 7-valent pneumococcal conjugate vaccine, given before pre-booster blood sample (as optional treatment considered as standard of care), were assigned to the DTPa + Prevenar Group in the booster phase, and subjects who did not receive any dose of Prevenar before pre-booster blood sample were assigned to the DTPa-no Prevenar Group in the booster phase. Some booster phase analyses were only performed on subjects of both pooled sub-groups, renamed as DTPa booster Group, at the time of the analysis..	DTPa - no Prevenar Group Healthy male or female subjects, between 90 and 118 days of age, who received, during the primary vaccination phase, 3 doses of the DPT "KAKETSUKEN" Syringe (DTPa) vaccine, administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase). Those subjects did not receive any dose of Prevenar vaccination before pre-booster blood sample.
Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Booster Vaccination Any pain	134 Subjects	47 Subjects	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Booster Vaccination Grade 3 pain	12 Subjects	0 Subjects	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Booster Vaccination Any redness	197 Subjects	102 Subjects	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Booster Vaccination Redness > 30 mm	72 Subjects	20 Subjects	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Booster Vaccination Any swelling	180 Subjects	90 Subjects	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Booster Vaccination Swelling > 30 mm	65 Subjects	18 Subjects	—

SECONDARY outcome

Timeframe: During the 8-day (Days 0-7) after each primary vaccine dose

General AEs = drowsiness, fever (axillary ≥ 37.5 degrees Celsius), irritabilityand loss of appetite, vomiting. Any= Incidence of any symptom regardless of intensity grade or relationship to vaccination. Grade 3 drowsiness = prevented normal activity. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 fever = \> 39.5°C Related = symptom assessed by the investigator as related to the vaccination.

Outcome measures

Outcome measures
Measure	10Pn Group n=237 Participants Healthy male or female subjects, between 90 and 118 days of age who received, during primary vaccination phase, 3 doses of Synflorix (10Pn) vaccine, administered intramuscularly on alternating (left/right) sides of the anterolateral thigh and DPT "KAKETSUKEN" Syringe (DTPa) vaccine administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm. Both vaccines were administered at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase).	DTPa Group n=123 Participants Healthy male or female subjects, between 90 and 118 days of age, who received, during the primary vaccination phase, 3 doses of the DPT "KAKETSUKEN" Syringe (DTPa) vaccine, administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase). Subjects from this group who also received at least one dose of Prevenar (PCV7): Pfizer's (formerly Wyeth Lederle) 7-valent pneumococcal conjugate vaccine, given before pre-booster blood sample (as optional treatment considered as standard of care), were assigned to the DTPa + Prevenar Group in the booster phase, and subjects who did not receive any dose of Prevenar before pre-booster blood sample were assigned to the DTPa-no Prevenar Group in the booster phase. Some booster phase analyses were only performed on subjects of both pooled sub-groups, renamed as DTPa booster Group, at the time of the analysis..	DTPa - no Prevenar Group Healthy male or female subjects, between 90 and 118 days of age, who received, during the primary vaccination phase, 3 doses of the DPT "KAKETSUKEN" Syringe (DTPa) vaccine, administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase). Those subjects did not receive any dose of Prevenar vaccination before pre-booster blood sample.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination Any Fever Dose 1	61 Participants	20 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination Grade 3 Fever Dose 1	1 Participants	0 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination Related fever Dose 1	20 Participants	5 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination Any irritability Dose 1	100 Participants	43 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination Grade 3 irritability Dose 1	6 Participants	3 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination Related irritability Dose 1	40 Participants	12 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination Any loss of appetite Dose 1	32 Participants	12 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination Grade 3 loss of appetite Dose 1	0 Participants	0 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination Related loss of appetite Dose 1	4 Participants	1 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination Any drowsiness Dose 2	67 Participants	34 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination Grade 3 drowsiness Dose 2	2 Participants	0 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination Related drowsiness Dose 2	26 Participants	9 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination Any Fever Dose 2	65 Participants	22 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination Grade 3 Fever Dose 2	0 Participants	0 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination Related fever Dose 2	31 Participants	7 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination Any irritability Dose 2	88 Participants	45 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination Grade 3 irritability Dose 2	4 Participants	0 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination Related irritability Dose 2	30 Participants	12 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination Any loss of appetite Dose 2	27 Participants	7 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination Grade 3 loss of appetite Dose 2	0 Participants	0 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination Related loss of appetite Dose 2	7 Participants	2 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination Any drowsiness Dose 3	41 Participants	25 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination Grade 3 drowsiness Dose 3	0 Participants	0 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination Related drowsiness Dose 3	15 Participants	10 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination Any Fever Dose 3	51 Participants	21 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination Grade 3 Fever Dose 3	2 Participants	0 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination Related fever Dose 3	21 Participants	2 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination Any irritability Dose 3	80 Participants	31 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination Grade 3 irritability Dose 3	3 Participants	0 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination Related irritability Dose 3	31 Participants	10 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination Any loss of appetite Dose 3	25 Participants	7 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination Grade 3 loss of appetite Dose 3	0 Participants	0 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination Related loss of appetite Dose 3	5 Participants	0 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination Any drowsiness Dose 1	67 Participants	24 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination Grade 3 drowsiness Dose 1	3 Participants	0 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination Related drowsiness Dose 1	24 Participants	6 Participants	—

SECONDARY outcome

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

Solicited general AEs = drowsiness, irritability, loss of appetite and fever (axillary ≥ 37.5 degrees Celsius). Any= Incidence of any symptom regardless of intensity grade or relationship to vaccination. Grade 3: drowsiness = prevented normal activity. irritability = crying that could not be comforted/ prevented normal activity. loss of appetite = not eating at all. Fever = temperature \> 39.5°C Related = symptom assessed by the investigator as related to the vaccination.

Outcome measures

Outcome measures
Measure	10Pn Group n=228 Participants Healthy male or female subjects, between 90 and 118 days of age who received, during primary vaccination phase, 3 doses of Synflorix (10Pn) vaccine, administered intramuscularly on alternating (left/right) sides of the anterolateral thigh and DPT "KAKETSUKEN" Syringe (DTPa) vaccine administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm. Both vaccines were administered at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase).	DTPa Group n=120 Participants Healthy male or female subjects, between 90 and 118 days of age, who received, during the primary vaccination phase, 3 doses of the DPT "KAKETSUKEN" Syringe (DTPa) vaccine, administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase). Subjects from this group who also received at least one dose of Prevenar (PCV7): Pfizer's (formerly Wyeth Lederle) 7-valent pneumococcal conjugate vaccine, given before pre-booster blood sample (as optional treatment considered as standard of care), were assigned to the DTPa + Prevenar Group in the booster phase, and subjects who did not receive any dose of Prevenar before pre-booster blood sample were assigned to the DTPa-no Prevenar Group in the booster phase. Some booster phase analyses were only performed on subjects of both pooled sub-groups, renamed as DTPa booster Group, at the time of the analysis..	DTPa - no Prevenar Group Healthy male or female subjects, between 90 and 118 days of age, who received, during the primary vaccination phase, 3 doses of the DPT "KAKETSUKEN" Syringe (DTPa) vaccine, administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase). Those subjects did not receive any dose of Prevenar vaccination before pre-booster blood sample.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Booster Vaccination Any drowsiness	69 Subjects	30 Subjects	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Booster Vaccination Grade 3 drowsiness	3 Subjects	3 Subjects	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Booster Vaccination Related drowsiness	19 Subjects	7 Subjects	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Booster Vaccination Fever >= 37.5°C	90 Subjects	24 Subjects	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Booster Vaccination Fever > 39.5°C	6 Subjects	0 Subjects	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Booster Vaccination Related fever	41 Subjects	11 Subjects	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Booster Vaccination Any irritability	90 Subjects	35 Subjects	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Booster Vaccination Grade 3 irritability	8 Subjects	2 Subjects	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Booster Vaccination Related irritability	36 Subjects	10 Subjects	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Booster Vaccination Any loss of appetite	48 Subjects	17 Subjects	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Booster Vaccination Grade 3 loss of appetite	4 Subjects	1 Subjects	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Booster Vaccination Related loss of appetite	12 Subjects	2 Subjects	—

SECONDARY outcome

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

Population: The analysis was performed on the Total Vaccinated cohort for primary epoch, which included all subjects having received at least one of the 3 primary vaccination doses.

An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.

Outcome measures

Outcome measures
Measure	10Pn Group n=237 Participants Healthy male or female subjects, between 90 and 118 days of age who received, during primary vaccination phase, 3 doses of Synflorix (10Pn) vaccine, administered intramuscularly on alternating (left/right) sides of the anterolateral thigh and DPT "KAKETSUKEN" Syringe (DTPa) vaccine administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm. Both vaccines were administered at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase).	DTPa Group n=123 Participants Healthy male or female subjects, between 90 and 118 days of age, who received, during the primary vaccination phase, 3 doses of the DPT "KAKETSUKEN" Syringe (DTPa) vaccine, administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase). Subjects from this group who also received at least one dose of Prevenar (PCV7): Pfizer's (formerly Wyeth Lederle) 7-valent pneumococcal conjugate vaccine, given before pre-booster blood sample (as optional treatment considered as standard of care), were assigned to the DTPa + Prevenar Group in the booster phase, and subjects who did not receive any dose of Prevenar before pre-booster blood sample were assigned to the DTPa-no Prevenar Group in the booster phase. Some booster phase analyses were only performed on subjects of both pooled sub-groups, renamed as DTPa booster Group, at the time of the analysis..	DTPa - no Prevenar Group Healthy male or female subjects, between 90 and 118 days of age, who received, during the primary vaccination phase, 3 doses of the DPT "KAKETSUKEN" Syringe (DTPa) vaccine, administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase). Those subjects did not receive any dose of Prevenar vaccination before pre-booster blood sample.
Number of Subjects With Unsolicited AEs After Primary Vaccination	193 Subjects	97 Subjects	—

SECONDARY outcome

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

Population: The analysis was performed on the Total Vaccinated cohort for booster epoch, which included all subjects having received the booster dose. Analysis was performed on the 10Pn Group and only on the pooled DTPa booster Group, i.e subjects with or without Prevenar vaccination.

Outcome measures

Outcome measures
Measure	10Pn Group n=228 Participants Healthy male or female subjects, between 90 and 118 days of age who received, during primary vaccination phase, 3 doses of Synflorix (10Pn) vaccine, administered intramuscularly on alternating (left/right) sides of the anterolateral thigh and DPT "KAKETSUKEN" Syringe (DTPa) vaccine administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm. Both vaccines were administered at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase).	DTPa Group n=120 Participants Healthy male or female subjects, between 90 and 118 days of age, who received, during the primary vaccination phase, 3 doses of the DPT "KAKETSUKEN" Syringe (DTPa) vaccine, administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase). Subjects from this group who also received at least one dose of Prevenar (PCV7): Pfizer's (formerly Wyeth Lederle) 7-valent pneumococcal conjugate vaccine, given before pre-booster blood sample (as optional treatment considered as standard of care), were assigned to the DTPa + Prevenar Group in the booster phase, and subjects who did not receive any dose of Prevenar before pre-booster blood sample were assigned to the DTPa-no Prevenar Group in the booster phase. Some booster phase analyses were only performed on subjects of both pooled sub-groups, renamed as DTPa booster Group, at the time of the analysis..	DTPa - no Prevenar Group Healthy male or female subjects, between 90 and 118 days of age, who received, during the primary vaccination phase, 3 doses of the DPT "KAKETSUKEN" Syringe (DTPa) vaccine, administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase). Those subjects did not receive any dose of Prevenar vaccination before pre-booster blood sample.
Number of Subjects With Unsolicited AEs After Booster Vaccination	132 Subjects	66 Subjects	—

SECONDARY outcome

Timeframe: From study start at Month 0 up to study end at Month 15-17

Population: The analysis was performed on the Total Vaccinated cohort for primary epoch, which included all subjects having received at least one of the 3 primary vaccination doses.

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

Outcome measures

Outcome measures
Measure	10Pn Group n=237 Participants Healthy male or female subjects, between 90 and 118 days of age who received, during primary vaccination phase, 3 doses of Synflorix (10Pn) vaccine, administered intramuscularly on alternating (left/right) sides of the anterolateral thigh and DPT "KAKETSUKEN" Syringe (DTPa) vaccine administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm. Both vaccines were administered at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase).	DTPa Group n=123 Participants Healthy male or female subjects, between 90 and 118 days of age, who received, during the primary vaccination phase, 3 doses of the DPT "KAKETSUKEN" Syringe (DTPa) vaccine, administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase). Subjects from this group who also received at least one dose of Prevenar (PCV7): Pfizer's (formerly Wyeth Lederle) 7-valent pneumococcal conjugate vaccine, given before pre-booster blood sample (as optional treatment considered as standard of care), were assigned to the DTPa + Prevenar Group in the booster phase, and subjects who did not receive any dose of Prevenar before pre-booster blood sample were assigned to the DTPa-no Prevenar Group in the booster phase. Some booster phase analyses were only performed on subjects of both pooled sub-groups, renamed as DTPa booster Group, at the time of the analysis..	DTPa - no Prevenar Group Healthy male or female subjects, between 90 and 118 days of age, who received, during the primary vaccination phase, 3 doses of the DPT "KAKETSUKEN" Syringe (DTPa) vaccine, administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase). Those subjects did not receive any dose of Prevenar vaccination before pre-booster blood sample.
Number of Subjects With Serious Adverse Events (SAEs)	28 Participants	19 Participants	—

Adverse Events

10Pn Group

Serious events: 28 serious events

Other events: 236 other events

Deaths: 1 deaths

DTPa Group

Serious events: 19 serious events

Other events: 122 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

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

Restriction type: OTHER

Measure	10Pn Group n=237 participants at risk Healthy male or female subjects, between 90 and 118 days of age who received, during primary vaccination phase, 3 doses of Synflorix (10Pn) vaccine, administered intramuscularly on alternating (left/right) sides of the anterolateral thigh and DPT "KAKETSUKEN" Syringe (DTPa) vaccine administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm. Both vaccines were administered at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase).	DTPa Group n=123 participants at risk Healthy male or female subjects, between 90 and 118 days of age, who received, during the primary vaccination phase, 3 doses of the DPT "KAKETSUKEN" Syringe (DTPa) vaccine, administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase). Subjects from this group who also received at least one dose of Prevenar (PCV7): Pfizer's (formerly Wyeth Lederle) 7-valent pneumococcal conjugate vaccine, given before pre-booster blood sample (as optional treatment considered as standard of care), were assigned to the DTPa + Prevenar Group in the booster phase, and subjects who did not receive any dose of Prevenar before pre-booster blood sample were assigned to the DTPa-no Prevenar Group in the booster phase. Some booster phase analyses were only performed on subjects of both pooled sub-groups, renamed as DTPa booster Group, at the time of the analysis..
Infections and infestations Bronchitis	7.2% 17/237 • Number of events 21 • Solicited AEs: within 8 days (Day 0 - Day 7) after any vaccine dose; Unsolicited AEs: within 31 days (Day 0 - Day 30) after any vaccine dose. SAEs: from Dose 1 up to Study End (Day 0 to Month 15-17) All-causes mortality, SAEs and other AEs collection was made for primary vaccination phase groups, including all vaccinated subjects in the study.	12.2% 15/123 • Number of events 18 • Solicited AEs: within 8 days (Day 0 - Day 7) after any vaccine dose; Unsolicited AEs: within 31 days (Day 0 - Day 30) after any vaccine dose. SAEs: from Dose 1 up to Study End (Day 0 to Month 15-17) All-causes mortality, SAEs and other AEs collection was made for primary vaccination phase groups, including all vaccinated subjects in the study.
Eye disorders Conjunctivitis	7.6% 18/237 • Number of events 22 • Solicited AEs: within 8 days (Day 0 - Day 7) after any vaccine dose; Unsolicited AEs: within 31 days (Day 0 - Day 30) after any vaccine dose. SAEs: from Dose 1 up to Study End (Day 0 to Month 15-17) All-causes mortality, SAEs and other AEs collection was made for primary vaccination phase groups, including all vaccinated subjects in the study.	7.3% 9/123 • Number of events 13 • Solicited AEs: within 8 days (Day 0 - Day 7) after any vaccine dose; Unsolicited AEs: within 31 days (Day 0 - Day 30) after any vaccine dose. SAEs: from Dose 1 up to Study End (Day 0 to Month 15-17) All-causes mortality, SAEs and other AEs collection was made for primary vaccination phase groups, including all vaccinated subjects in the study.
Metabolism and nutrition disorders Decreased appetite	38.4% 91/237 • Number of events 133 • Solicited AEs: within 8 days (Day 0 - Day 7) after any vaccine dose; Unsolicited AEs: within 31 days (Day 0 - Day 30) after any vaccine dose. SAEs: from Dose 1 up to Study End (Day 0 to Month 15-17) All-causes mortality, SAEs and other AEs collection was made for primary vaccination phase groups, including all vaccinated subjects in the study.	30.1% 37/123 • Number of events 43 • Solicited AEs: within 8 days (Day 0 - Day 7) after any vaccine dose; Unsolicited AEs: within 31 days (Day 0 - Day 30) after any vaccine dose. SAEs: from Dose 1 up to Study End (Day 0 to Month 15-17) All-causes mortality, SAEs and other AEs collection was made for primary vaccination phase groups, including all vaccinated subjects in the study.
Skin and subcutaneous tissue disorders Dermatitis diaper	6.3% 15/237 • Number of events 19 • Solicited AEs: within 8 days (Day 0 - Day 7) after any vaccine dose; Unsolicited AEs: within 31 days (Day 0 - Day 30) after any vaccine dose. SAEs: from Dose 1 up to Study End (Day 0 to Month 15-17) All-causes mortality, SAEs and other AEs collection was made for primary vaccination phase groups, including all vaccinated subjects in the study.	7.3% 9/123 • Number of events 9 • Solicited AEs: within 8 days (Day 0 - Day 7) after any vaccine dose; Unsolicited AEs: within 31 days (Day 0 - Day 30) after any vaccine dose. SAEs: from Dose 1 up to Study End (Day 0 to Month 15-17) All-causes mortality, SAEs and other AEs collection was made for primary vaccination phase groups, including all vaccinated subjects in the study.
Gastrointestinal disorders Diarrhoea	12.2% 29/237 • Number of events 32 • Solicited AEs: within 8 days (Day 0 - Day 7) after any vaccine dose; Unsolicited AEs: within 31 days (Day 0 - Day 30) after any vaccine dose. SAEs: from Dose 1 up to Study End (Day 0 to Month 15-17) All-causes mortality, SAEs and other AEs collection was made for primary vaccination phase groups, including all vaccinated subjects in the study.	11.4% 14/123 • Number of events 14 • Solicited AEs: within 8 days (Day 0 - Day 7) after any vaccine dose; Unsolicited AEs: within 31 days (Day 0 - Day 30) after any vaccine dose. SAEs: from Dose 1 up to Study End (Day 0 to Month 15-17) All-causes mortality, SAEs and other AEs collection was made for primary vaccination phase groups, including all vaccinated subjects in the study.
Skin and subcutaneous tissue disorders Eczema	20.7% 49/237 • Number of events 65 • Solicited AEs: within 8 days (Day 0 - Day 7) after any vaccine dose; Unsolicited AEs: within 31 days (Day 0 - Day 30) after any vaccine dose. SAEs: from Dose 1 up to Study End (Day 0 to Month 15-17) All-causes mortality, SAEs and other AEs collection was made for primary vaccination phase groups, including all vaccinated subjects in the study.	20.3% 25/123 • Number of events 28 • Solicited AEs: within 8 days (Day 0 - Day 7) after any vaccine dose; Unsolicited AEs: within 31 days (Day 0 - Day 30) after any vaccine dose. SAEs: from Dose 1 up to Study End (Day 0 to Month 15-17) All-causes mortality, SAEs and other AEs collection was made for primary vaccination phase groups, including all vaccinated subjects in the study.
Skin and subcutaneous tissue disorders Erythema	97.0% 230/237 • Number of events 768 • Solicited AEs: within 8 days (Day 0 - Day 7) after any vaccine dose; Unsolicited AEs: within 31 days (Day 0 - Day 30) after any vaccine dose. SAEs: from Dose 1 up to Study End (Day 0 to Month 15-17) All-causes mortality, SAEs and other AEs collection was made for primary vaccination phase groups, including all vaccinated subjects in the study.	92.7% 114/123 • Number of events 368 • Solicited AEs: within 8 days (Day 0 - Day 7) after any vaccine dose; Unsolicited AEs: within 31 days (Day 0 - Day 30) after any vaccine dose. SAEs: from Dose 1 up to Study End (Day 0 to Month 15-17) All-causes mortality, SAEs and other AEs collection was made for primary vaccination phase groups, including all vaccinated subjects in the study.
Infections and infestations Gastroenteritis	7.6% 18/237 • Number of events 19 • Solicited AEs: within 8 days (Day 0 - Day 7) after any vaccine dose; Unsolicited AEs: within 31 days (Day 0 - Day 30) after any vaccine dose. SAEs: from Dose 1 up to Study End (Day 0 to Month 15-17) All-causes mortality, SAEs and other AEs collection was made for primary vaccination phase groups, including all vaccinated subjects in the study.	4.1% 5/123 • Number of events 5 • Solicited AEs: within 8 days (Day 0 - Day 7) after any vaccine dose; Unsolicited AEs: within 31 days (Day 0 - Day 30) after any vaccine dose. SAEs: from Dose 1 up to Study End (Day 0 to Month 15-17) All-causes mortality, SAEs and other AEs collection was made for primary vaccination phase groups, including all vaccinated subjects in the study.
Infections and infestations Impetigo	2.1% 5/237 • Number of events 5 • Solicited AEs: within 8 days (Day 0 - Day 7) after any vaccine dose; Unsolicited AEs: within 31 days (Day 0 - Day 30) after any vaccine dose. SAEs: from Dose 1 up to Study End (Day 0 to Month 15-17) All-causes mortality, SAEs and other AEs collection was made for primary vaccination phase groups, including all vaccinated subjects in the study.	6.5% 8/123 • Number of events 9 • Solicited AEs: within 8 days (Day 0 - Day 7) after any vaccine dose; Unsolicited AEs: within 31 days (Day 0 - Day 30) after any vaccine dose. SAEs: from Dose 1 up to Study End (Day 0 to Month 15-17) All-causes mortality, SAEs and other AEs collection was made for primary vaccination phase groups, including all vaccinated subjects in the study.
General disorders Injection site induration	23.6% 56/237 • Number of events 86 • Solicited AEs: within 8 days (Day 0 - Day 7) after any vaccine dose; Unsolicited AEs: within 31 days (Day 0 - Day 30) after any vaccine dose. SAEs: from Dose 1 up to Study End (Day 0 to Month 15-17) All-causes mortality, SAEs and other AEs collection was made for primary vaccination phase groups, including all vaccinated subjects in the study.	18.7% 23/123 • Number of events 34 • Solicited AEs: within 8 days (Day 0 - Day 7) after any vaccine dose; Unsolicited AEs: within 31 days (Day 0 - Day 30) after any vaccine dose. SAEs: from Dose 1 up to Study End (Day 0 to Month 15-17) All-causes mortality, SAEs and other AEs collection was made for primary vaccination phase groups, including all vaccinated subjects in the study.
Psychiatric disorders Irritability	74.7% 177/237 • Number of events 358 • Solicited AEs: within 8 days (Day 0 - Day 7) after any vaccine dose; Unsolicited AEs: within 31 days (Day 0 - Day 30) after any vaccine dose. SAEs: from Dose 1 up to Study End (Day 0 to Month 15-17) All-causes mortality, SAEs and other AEs collection was made for primary vaccination phase groups, including all vaccinated subjects in the study.	65.9% 81/123 • Number of events 154 • Solicited AEs: within 8 days (Day 0 - Day 7) after any vaccine dose; Unsolicited AEs: within 31 days (Day 0 - Day 30) after any vaccine dose. SAEs: from Dose 1 up to Study End (Day 0 to Month 15-17) All-causes mortality, SAEs and other AEs collection was made for primary vaccination phase groups, including all vaccinated subjects in the study.
Infections and infestations Nasopharyngitis	17.3% 41/237 • Number of events 60 • Solicited AEs: within 8 days (Day 0 - Day 7) after any vaccine dose; Unsolicited AEs: within 31 days (Day 0 - Day 30) after any vaccine dose. SAEs: from Dose 1 up to Study End (Day 0 to Month 15-17) All-causes mortality, SAEs and other AEs collection was made for primary vaccination phase groups, including all vaccinated subjects in the study.	19.5% 24/123 • Number of events 41 • Solicited AEs: within 8 days (Day 0 - Day 7) after any vaccine dose; Unsolicited AEs: within 31 days (Day 0 - Day 30) after any vaccine dose. SAEs: from Dose 1 up to Study End (Day 0 to Month 15-17) All-causes mortality, SAEs and other AEs collection was made for primary vaccination phase groups, including all vaccinated subjects in the study.
Infections and infestations Otitis media	3.8% 9/237 • Number of events 10 • Solicited AEs: within 8 days (Day 0 - Day 7) after any vaccine dose; Unsolicited AEs: within 31 days (Day 0 - Day 30) after any vaccine dose. SAEs: from Dose 1 up to Study End (Day 0 to Month 15-17) All-causes mortality, SAEs and other AEs collection was made for primary vaccination phase groups, including all vaccinated subjects in the study.	5.7% 7/123 • Number of events 7 • Solicited AEs: within 8 days (Day 0 - Day 7) after any vaccine dose; Unsolicited AEs: within 31 days (Day 0 - Day 30) after any vaccine dose. SAEs: from Dose 1 up to Study End (Day 0 to Month 15-17) All-causes mortality, SAEs and other AEs collection was made for primary vaccination phase groups, including all vaccinated subjects in the study.
General disorders Pain	70.5% 167/237 • Number of events 354 • Solicited AEs: within 8 days (Day 0 - Day 7) after any vaccine dose; Unsolicited AEs: within 31 days (Day 0 - Day 30) after any vaccine dose. SAEs: from Dose 1 up to Study End (Day 0 to Month 15-17) All-causes mortality, SAEs and other AEs collection was made for primary vaccination phase groups, including all vaccinated subjects in the study.	50.4% 62/123 • Number of events 115 • Solicited AEs: within 8 days (Day 0 - Day 7) after any vaccine dose; Unsolicited AEs: within 31 days (Day 0 - Day 30) after any vaccine dose. SAEs: from Dose 1 up to Study End (Day 0 to Month 15-17) All-causes mortality, SAEs and other AEs collection was made for primary vaccination phase groups, including all vaccinated subjects in the study.
General disorders Pyrexia	65.8% 156/237 • Number of events 284 • Solicited AEs: within 8 days (Day 0 - Day 7) after any vaccine dose; Unsolicited AEs: within 31 days (Day 0 - Day 30) after any vaccine dose. SAEs: from Dose 1 up to Study End (Day 0 to Month 15-17) All-causes mortality, SAEs and other AEs collection was made for primary vaccination phase groups, including all vaccinated subjects in the study.	52.0% 64/123 • Number of events 92 • Solicited AEs: within 8 days (Day 0 - Day 7) after any vaccine dose; Unsolicited AEs: within 31 days (Day 0 - Day 30) after any vaccine dose. SAEs: from Dose 1 up to Study End (Day 0 to Month 15-17) All-causes mortality, SAEs and other AEs collection was made for primary vaccination phase groups, including all vaccinated subjects in the study.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	5.9% 14/237 • Number of events 16 • Solicited AEs: within 8 days (Day 0 - Day 7) after any vaccine dose; Unsolicited AEs: within 31 days (Day 0 - Day 30) after any vaccine dose. SAEs: from Dose 1 up to Study End (Day 0 to Month 15-17) All-causes mortality, SAEs and other AEs collection was made for primary vaccination phase groups, including all vaccinated subjects in the study.	3.3% 4/123 • Number of events 4 • Solicited AEs: within 8 days (Day 0 - Day 7) after any vaccine dose; Unsolicited AEs: within 31 days (Day 0 - Day 30) after any vaccine dose. SAEs: from Dose 1 up to Study End (Day 0 to Month 15-17) All-causes mortality, SAEs and other AEs collection was made for primary vaccination phase groups, including all vaccinated subjects in the study.
Nervous system disorders Somnolence	55.3% 131/237 • Number of events 244 • Solicited AEs: within 8 days (Day 0 - Day 7) after any vaccine dose; Unsolicited AEs: within 31 days (Day 0 - Day 30) after any vaccine dose. SAEs: from Dose 1 up to Study End (Day 0 to Month 15-17) All-causes mortality, SAEs and other AEs collection was made for primary vaccination phase groups, including all vaccinated subjects in the study.	51.2% 63/123 • Number of events 113 • Solicited AEs: within 8 days (Day 0 - Day 7) after any vaccine dose; Unsolicited AEs: within 31 days (Day 0 - Day 30) after any vaccine dose. SAEs: from Dose 1 up to Study End (Day 0 to Month 15-17) All-causes mortality, SAEs and other AEs collection was made for primary vaccination phase groups, including all vaccinated subjects in the study.
General disorders Swelling	90.3% 214/237 • Number of events 610 • Solicited AEs: within 8 days (Day 0 - Day 7) after any vaccine dose; Unsolicited AEs: within 31 days (Day 0 - Day 30) after any vaccine dose. SAEs: from Dose 1 up to Study End (Day 0 to Month 15-17) All-causes mortality, SAEs and other AEs collection was made for primary vaccination phase groups, including all vaccinated subjects in the study.	91.9% 113/123 • Number of events 265 • Solicited AEs: within 8 days (Day 0 - Day 7) after any vaccine dose; Unsolicited AEs: within 31 days (Day 0 - Day 30) after any vaccine dose. SAEs: from Dose 1 up to Study End (Day 0 to Month 15-17) All-causes mortality, SAEs and other AEs collection was made for primary vaccination phase groups, including all vaccinated subjects in the study.
Infections and infestations Upper respiratory tract infection	35.9% 85/237 • Number of events 131 • Solicited AEs: within 8 days (Day 0 - Day 7) after any vaccine dose; Unsolicited AEs: within 31 days (Day 0 - Day 30) after any vaccine dose. SAEs: from Dose 1 up to Study End (Day 0 to Month 15-17) All-causes mortality, SAEs and other AEs collection was made for primary vaccination phase groups, including all vaccinated subjects in the study.	35.0% 43/123 • Number of events 69 • Solicited AEs: within 8 days (Day 0 - Day 7) after any vaccine dose; Unsolicited AEs: within 31 days (Day 0 - Day 30) after any vaccine dose. SAEs: from Dose 1 up to Study End (Day 0 to Month 15-17) All-causes mortality, SAEs and other AEs collection was made for primary vaccination phase groups, including all vaccinated subjects in the study.
Respiratory, thoracic and mediastinal disorders Upper respiratory tract inflammation	8.0% 19/237 • Number of events 20 • Solicited AEs: within 8 days (Day 0 - Day 7) after any vaccine dose; Unsolicited AEs: within 31 days (Day 0 - Day 30) after any vaccine dose. SAEs: from Dose 1 up to Study End (Day 0 to Month 15-17) All-causes mortality, SAEs and other AEs collection was made for primary vaccination phase groups, including all vaccinated subjects in the study.	5.7% 7/123 • Number of events 9 • Solicited AEs: within 8 days (Day 0 - Day 7) after any vaccine dose; Unsolicited AEs: within 31 days (Day 0 - Day 30) after any vaccine dose. SAEs: from Dose 1 up to Study End (Day 0 to Month 15-17) All-causes mortality, SAEs and other AEs collection was made for primary vaccination phase groups, including all vaccinated subjects in the study.