Trial Outcomes & Findings for Pneumococcal Vaccine Booster Study in Healthy Children 12-18 Mths Old Previously Primed With the Same Vaccines (NCT NCT00547248)

NCT ID: NCT00547248

Last Updated: 2019-01-14

Results Overview

Fever was measured as rectal temperature. The cut-off was 39.0 degree Celsius (°C). Assessment of occurrences of fever \> 39.0 (°C) was performed after booster vaccination with Synflorix™ or Prevenar™ vaccines.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 756 participants
• Primary outcome timeframe: Within the 4-day (Days 0-3) period after booster vaccination
• Results posted on: 2019-01-14

Participant Flow

During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.

Participant milestones

Measure	Synflorix + Tritanrix -HepB/ Hiberix + Polio Sabin Group Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of Synflorix™ vaccine, co-administered with Tritanrix™-HepB/ Hiberix™ and Polio Sabin™ vaccines at 12-18 months of age.	Prevenar + Tritanrix - HepB/ Hiberix + Polio Sabin Group Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/ Hiberix™ and Polio Sabin™ at 12-18 months of age.	Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of Synflorix™ vaccine co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines at 12-18 months of age.	Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of the Prevenar™ vaccine, co-administered with Tritanrix -HepB/ Hiberix and Poliorix at 12-18 months of age.
Overall Study STARTED	280	93	285	98
Overall Study COMPLETED	280	93	275	96
Overall Study NOT COMPLETED	0	0	10	2

Reasons for withdrawal

Measure	Synflorix + Tritanrix -HepB/ Hiberix + Polio Sabin Group Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of Synflorix™ vaccine, co-administered with Tritanrix™-HepB/ Hiberix™ and Polio Sabin™ vaccines at 12-18 months of age.	Prevenar + Tritanrix - HepB/ Hiberix + Polio Sabin Group Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/ Hiberix™ and Polio Sabin™ at 12-18 months of age.	Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of Synflorix™ vaccine co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines at 12-18 months of age.	Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of the Prevenar™ vaccine, co-administered with Tritanrix -HepB/ Hiberix and Poliorix at 12-18 months of age.
Overall Study Protocol Violation	0	0	1	1
Overall Study Migrated/moved from study area	0	0	2	0
Overall Study Withdrawal by Subject	0	0	7	1

Baseline Characteristics

Pneumococcal Vaccine Booster Study in Healthy Children 12-18 Mths Old Previously Primed With the Same Vaccines

Baseline characteristics by cohort

Measure	Synflorix + Tritanrix -HepB/ Hiberix + Polio Sabin Group n=280 Participants Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of Synflorix™ vaccine, co-administered with Tritanrix™-HepB/ Hiberix™ and Polio Sabin™ vaccines at 12-18 months of age.	Prevenar + Tritanrix - HepB/ Hiberix + Polio Sabin Group n=93 Participants Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/ Hiberix™ and Polio Sabin™ at 12-18 months of age.	Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group n=285 Participants Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of Synflorix™ vaccine co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines at 12-18 months of age.	Prevenar + Tritanrix - HepB/ Hiberix + Poliorix Group n=98 Participants Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of the Prevenar™ vaccine, co-administered with Tritanrix -HepB/ Hiberix™ and Poliorix™ at 12-18 months of age.	Total n=756 Participants Total of all reporting groups
Age, Continuous	16.2 Months STANDARD_DEVIATION 0.66 • n=5 Participants	16.2 Months STANDARD_DEVIATION 0.59 • n=7 Participants	17.2 Months STANDARD_DEVIATION 0.84 • n=5 Participants	17.2 Months STANDARD_DEVIATION 0.88 • n=4 Participants	16.71 Months STANDARD_DEVIATION 0.90 • n=21 Participants
Sex/Gender, Customized Gender Categorical · Female	133 Participants n=5 Participants	43 Participants n=7 Participants	134 Participants n=5 Participants	43 Participants n=4 Participants	353 Participants n=21 Participants
Sex/Gender, Customized Gender Categorical · Male	147 Participants n=5 Participants	50 Participants n=7 Participants	151 Participants n=5 Participants	55 Participants n=4 Participants	403 Participants n=21 Participants
Race/Ethnicity, Customized Geographic ancestry · White - Caucasian / European heritage	0 Participants n=5 Participants	0 Participants n=7 Participants	285 Participants n=5 Participants	98 Participants n=4 Participants	383 Participants n=21 Participants
Race/Ethnicity, Customized Geographic ancestry · Asian - south east Asian heritage	280 Participants n=5 Participants	93 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	373 Participants n=21 Participants

PRIMARY outcome

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

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with the symptom sheets filled in. For the purpose of the analysis, subjects were pooled into two groups, according to the booster vaccine they have received (Synflorix™ or Prevenar™).

Fever was measured as rectal temperature. The cut-off was 39.0 degree Celsius (°C). Assessment of occurrences of fever > 39.0 (°C) was performed after booster vaccination with Synflorix™ or Prevenar™ vaccines.

Outcome measures

Measure	Synflorix Pooled Group n=558 Participants Subjects primary vaccinated at 6-10-14 weeks of age, receiving a booster dose of Synflorix™ vaccine, either co-administered with Tritanrix™-HepB/ Hiberix™ and Polio Sabin™ vaccines in the Philippines or co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines in Poland, at 12-18 months of age.	Prevenar Pooled Group n=189 Participants Subjects primary vaccinated at 6-10-14 weeks of age, receiving a booster dose of the Prevenar™ vaccine, either co-administered with Tritanrix™-HepB/ Hiberix™ and Polio Sabin™ vaccines in the Philippines or co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines in Poland, at 12-18 months of age.	Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of Synflorix™ vaccine co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines at 12-18 months of age.	Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of the Prevenar™ vaccine, co-administered with Tritanrix -HepB/ Hiberix™ and Poliorix™ at 12-18 months of age.
Number of Subjects Reporting Rectal Temperature Greater Than (>) the Cut-off	64 Participants	20 Participants	—	—

SECONDARY outcome

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

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with the symptom sheet filled-in.

Solicited local symptoms assessed included pain, redness and swelling. "Any" was defined as incidence of the specified symptom regardless of intensity. Grade 3 pain was defined as crying when limb was moved/ spontaneously painful. Grade 3 swelling/ redness was defined as swelling/ redness greater than (>) 30 millimeters (mm).

Outcome measures

Measure	Synflorix Pooled Group n=280 Participants Subjects primary vaccinated at 6-10-14 weeks of age, receiving a booster dose of Synflorix™ vaccine, either co-administered with Tritanrix™-HepB/ Hiberix™ and Polio Sabin™ vaccines in the Philippines or co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines in Poland, at 12-18 months of age.	Prevenar Pooled Group n=93 Participants Subjects primary vaccinated at 6-10-14 weeks of age, receiving a booster dose of the Prevenar™ vaccine, either co-administered with Tritanrix™-HepB/ Hiberix™ and Polio Sabin™ vaccines in the Philippines or co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines in Poland, at 12-18 months of age.	Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group n=278 Participants Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of Synflorix™ vaccine co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines at 12-18 months of age.	Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group n=96 Participants Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of the Prevenar™ vaccine, co-administered with Tritanrix -HepB/ Hiberix™ and Poliorix™ at 12-18 months of age.
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling	21 Participants	9 Participants	34 Participants	8 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain	203 Participants	66 Participants	248 Participants	77 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain	40 Participants	20 Participants	117 Participants	39 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness	107 Participants	37 Participants	197 Participants	66 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness	8 Participants	3 Participants	35 Participants	11 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling	92 Participants	32 Participants	158 Participants	52 Participants

SECONDARY outcome

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

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with the symptom sheet filled-in.

Solicited general symptoms assessed include drowsiness, fever (defined as rectal temperature greater than or equal to (≥) 38.0°C), irritability, and loss of appetite."Any" was defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination. Grade 3 drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (rectal temperature) >40.0 degree Celsius (°C). Grade 3 irritability was defined as crying that could not be comforted/ preventing normal activity. Grade 3 loss of appetite was defined as the subject not eating at all.

Outcome measures

Measure	Synflorix Pooled Group n=280 Participants Subjects primary vaccinated at 6-10-14 weeks of age, receiving a booster dose of Synflorix™ vaccine, either co-administered with Tritanrix™-HepB/ Hiberix™ and Polio Sabin™ vaccines in the Philippines or co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines in Poland, at 12-18 months of age.	Prevenar Pooled Group n=93 Participants Subjects primary vaccinated at 6-10-14 weeks of age, receiving a booster dose of the Prevenar™ vaccine, either co-administered with Tritanrix™-HepB/ Hiberix™ and Polio Sabin™ vaccines in the Philippines or co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines in Poland, at 12-18 months of age.	Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group n=278 Participants Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of Synflorix™ vaccine co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines at 12-18 months of age.	Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group n=96 Participants Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of the Prevenar™ vaccine, co-administered with Tritanrix -HepB/ Hiberix™ and Poliorix™ at 12-18 months of age.
Number of Subjects With Any and Grade 3 Solicited General Symptoms Any Fever	138 Participants	51 Participants	215 Participants	65 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms Any Drowsiness	90 Participants	32 Participants	190 Participants	66 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms Grade 3 Drowsiness	5 Participants	1 Participants	7 Participants	2 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms Grade 3 Fever	0 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms Any Irritability	173 Participants	64 Participants	243 Participants	79 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms Grade 3 Irritability	12 Participants	3 Participants	40 Participants	5 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms Any Loss of appetite	97 Participants	28 Participants	184 Participants	57 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms Grade 3 Loss of appetite	8 Participants	1 Participants	13 Participants	1 Participants

SECONDARY outcome

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

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.

An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. "Any" was defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.

Outcome measures

Measure	Synflorix Pooled Group n=280 Participants Subjects primary vaccinated at 6-10-14 weeks of age, receiving a booster dose of Synflorix™ vaccine, either co-administered with Tritanrix™-HepB/ Hiberix™ and Polio Sabin™ vaccines in the Philippines or co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines in Poland, at 12-18 months of age.	Prevenar Pooled Group n=93 Participants Subjects primary vaccinated at 6-10-14 weeks of age, receiving a booster dose of the Prevenar™ vaccine, either co-administered with Tritanrix™-HepB/ Hiberix™ and Polio Sabin™ vaccines in the Philippines or co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines in Poland, at 12-18 months of age.	Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group n=285 Participants Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of Synflorix™ vaccine co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines at 12-18 months of age.	Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group n=98 Participants Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of the Prevenar™ vaccine, co-administered with Tritanrix -HepB/ Hiberix™ and Poliorix™ at 12-18 months of age.
Number of Subjects With Unsolicited Adverse Events (AEs)	25 Participants	9 Participants	106 Participants	35 Participants

SECONDARY outcome

Timeframe: Throughout the active phase of the study (Month 0 to Month 1)

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.

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

Outcome measures

Measure	Synflorix Pooled Group n=280 Participants Subjects primary vaccinated at 6-10-14 weeks of age, receiving a booster dose of Synflorix™ vaccine, either co-administered with Tritanrix™-HepB/ Hiberix™ and Polio Sabin™ vaccines in the Philippines or co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines in Poland, at 12-18 months of age.	Prevenar Pooled Group n=93 Participants Subjects primary vaccinated at 6-10-14 weeks of age, receiving a booster dose of the Prevenar™ vaccine, either co-administered with Tritanrix™-HepB/ Hiberix™ and Polio Sabin™ vaccines in the Philippines or co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines in Poland, at 12-18 months of age.	Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group n=285 Participants Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of Synflorix™ vaccine co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines at 12-18 months of age.	Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group n=98 Participants Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of the Prevenar™ vaccine, co-administered with Tritanrix -HepB/ Hiberix™ and Poliorix™ at 12-18 months of age.
Number of Subjects With Serious Adverse Events (SAEs)	2 Participants	0 Participants	5 Participants	2 Participants

SECONDARY outcome

Timeframe: Prior to (Month 0) and one month after booster vaccination (Month 1)

Population: The analysis was performed on the According-To-Protocol (ATP) cohort for persistence, which included all subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sampling taken before the administration of the study booster dose (pre-booster blood sampling).

The cut-off was 0.20 microgram per milliliter (μg/mL).

Outcome measures

Measure	Synflorix Pooled Group n=136 Participants Subjects primary vaccinated at 6-10-14 weeks of age, receiving a booster dose of Synflorix™ vaccine, either co-administered with Tritanrix™-HepB/ Hiberix™ and Polio Sabin™ vaccines in the Philippines or co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines in Poland, at 12-18 months of age.	Prevenar Pooled Group n=43 Participants Subjects primary vaccinated at 6-10-14 weeks of age, receiving a booster dose of the Prevenar™ vaccine, either co-administered with Tritanrix™-HepB/ Hiberix™ and Polio Sabin™ vaccines in the Philippines or co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines in Poland, at 12-18 months of age.	Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group n=130 Participants Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of Synflorix™ vaccine co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines at 12-18 months of age.	Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group n=44 Participants Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of the Prevenar™ vaccine, co-administered with Tritanrix -HepB/ Hiberix™ and Poliorix™ at 12-18 months of age.
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off Anti-19F, Month 1	136 Participants	43 Participants	123 Participants	43 Participants
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off Anti-1, Month 0	100 Participants	2 Participants	64 Participants	2 Participants
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off Anti-1, Month 1	136 Participants	3 Participants	125 Participants	2 Participants
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off Anti-4, Month 0	113 Participants	25 Participants	78 Participants	23 Participants
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off Anti-4, Month 1	136 Participants	43 Participants	125 Participants	43 Participants
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off Anti-5, Month 0	118 Participants	7 Participants	98 Participants	3 Participants
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off Anti-5, Month 1	136 Participants	8 Participants	124 Participants	3 Participants
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off Anti-6B, Month 0	113 Participants	24 Participants	90 Participants	27 Participants
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off Anti-6B, Month 1	134 Participants	42 Participants	122 Participants	41 Participants
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off Anti-7F, Month 0	128 Participants	7 Participants	118 Participants	1 Participants
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off Anti-7F, Month 1	136 Participants	9 Participants	125 Participants	1 Participants
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off Anti-9V, Month 0	132 Participants	40 Participants	116 Participants	42 Participants
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off Anti-9V, Month 1	136 Participants	43 Participants	125 Participants	43 Participants
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off Anti-14, Month 0	126 Participants	42 Participants	111 Participants	40 Participants
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off Anti-14, Month 1	135 Participants	43 Participants	125 Participants	43 Participants
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off Anti-18C, Month 0	130 Participants	36 Participants	111 Participants	35 Participants
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off Anti-18C, Month 1	136 Participants	43 Participants	125 Participants	43 Participants
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off Anti-19F, Month 0	129 Participants	11 Participants	121 Participants	22 Participants
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off Anti-23F, Month 0	123 Participants	32 Participants	89 Participants	40 Participants
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off Anti-23F, Month 1	135 Participants	42 Participants	123 Participants	42 Participants

SECONDARY outcome

Timeframe: Prior to (Month 0) and one month after booster vaccination (Month 1)

Population: The analysis was performed on the According-To-Protocol (ATP) cohort for persistence, which included all subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sampling taken before the administration of the study booster dose (pre-booster blood sampling.

Seropositivity status, defined as anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations ≥ 0.05 microgram per milliliter (μg/mL).

Outcome measures

Measure	Synflorix Pooled Group n=136 Participants Subjects primary vaccinated at 6-10-14 weeks of age, receiving a booster dose of Synflorix™ vaccine, either co-administered with Tritanrix™-HepB/ Hiberix™ and Polio Sabin™ vaccines in the Philippines or co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines in Poland, at 12-18 months of age.	Prevenar Pooled Group n=43 Participants Subjects primary vaccinated at 6-10-14 weeks of age, receiving a booster dose of the Prevenar™ vaccine, either co-administered with Tritanrix™-HepB/ Hiberix™ and Polio Sabin™ vaccines in the Philippines or co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines in Poland, at 12-18 months of age.	Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group n=130 Participants Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of Synflorix™ vaccine co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines at 12-18 months of age.	Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group n=44 Participants Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of the Prevenar™ vaccine, co-administered with Tritanrix -HepB/ Hiberix™ and Poliorix™ at 12-18 months of age.
Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Anti-1, Month 0	0.35 μg/mL Interval 0.29 to 0.42	0.03 μg/mL Interval 0.03 to 0.04	0.19 μg/mL Interval 0.16 to 0.22	0.04 μg/mL Interval 0.03 to 0.05
Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Anti-1, Month 1	10.8 μg/mL Interval 9.22 to 12.66	0.04 μg/mL Interval 0.03 to 0.05	2.14 μg/mL Interval 1.8 to 2.55	0.04 μg/mL Interval 0.03 to 0.05
Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Anti-4, Month 0	0.55 μg/mL Interval 0.45 to 0.67	0.34 μg/mL Interval 0.25 to 0.45	0.27 μg/mL Interval 0.22 to 0.33	0.24 μg/mL Interval 0.19 to 0.3
Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Anti-4, Month 1	13.16 μg/mL Interval 11.43 to 15.14	11.84 μg/mL Interval 8.74 to 16.04	4.21 μg/mL Interval 3.61 to 4.91	6.86 μg/mL Interval 5.39 to 8.73
Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Anti-5, Month 0	0.55 μg/mL Interval 0.47 to 0.64	0.06 μg/mL Interval 0.04 to 0.09	0.4 μg/mL Interval 0.34 to 0.47	0.04 μg/mL Interval 0.03 to 0.05
Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Anti-5, Month 1	14.59 μg/mL Interval 12.53 to 16.99	0.09 μg/mL Interval 0.06 to 0.13	2.54 μg/mL Interval 2.11 to 3.06	0.05 μg/mL Interval 0.04 to 0.06
Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Anti-6B, Month 0	0.66 μg/mL Interval 0.54 to 0.8	0.38 μg/mL Interval 0.22 to 0.65	0.34 μg/mL Interval 0.28 to 0.41	0.34 μg/mL Interval 0.2 to 0.59
Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Anti-6B, Month 1	7.02 μg/mL Interval 5.83 to 8.45	9.08 μg/mL Interval 6.5 to 12.7	2.31 μg/mL Interval 1.93 to 2.75	6.28 μg/mL Interval 4.18 to 9.44
Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Anti-7F, Month 0	0.9 μg/mL Interval 0.77 to 1.04	0.05 μg/mL Interval 0.03 to 0.07	0.58 μg/mL Interval 0.51 to 0.67	0.03 μg/mL Interval 0.03 to 0.04
Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Anti-7F, Month 1	12.52 μg/mL Interval 11.09 to 14.13	0.06 μg/mL Interval 0.04 to 0.1	4.14 μg/mL Interval 3.61 to 4.74	0.03 μg/mL Interval 0.03 to 0.04
Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Anti-9V, Month 0	1.16 μg/mL Interval 0.98 to 1.37	0.77 μg/mL Interval 0.59 to 0.99	0.59 μg/mL Interval 0.5 to 0.7	0.58 μg/mL Interval 0.47 to 0.71
Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Anti-9V, Month 1	14.42 μg/mL Interval 12.44 to 16.7	20.31 μg/mL Interval 15.44 to 26.71	4.63 μg/mL Interval 4.0 to 5.36	13.6 μg/mL Interval 11.12 to 16.62
Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Anti-14, Month 0	1.32 μg/mL Interval 1.07 to 1.63	1.83 μg/mL Interval 1.26 to 2.66	0.84 μg/mL Interval 0.66 to 1.07	1.04 μg/mL Interval 0.75 to 1.43
Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Anti-14, Month 1	17.07 μg/mL Interval 14.12 to 20.64	27.42 μg/mL Interval 20.96 to 35.86	5.93 μg/mL Interval 4.97 to 7.09	15.51 μg/mL Interval 12.14 to 19.82
Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Anti-18C, Month 0	1.43 μg/mL Interval 1.2 to 1.71	0.42 μg/mL Interval 0.32 to 0.55	0.63 μg/mL Interval 0.52 to 0.77	0.4 μg/mL Interval 0.3 to 53.0
Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Anti-18C, Month 1	39.59 μg/mL Interval 34.04 to 46.05	12.07 μg/mL Interval 9.23 to 15.79	10.49 μg/mL Interval 8.81 to 12.49	9.92 μg/mL Interval 7.74 to 12.71
Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Anti-19F, Month 0	1.33 μg/mL Interval 1.08 to 1.64	0.16 μg/mL Interval 0.1 to 0.26	0.99 μg/mL Interval 0.81 to 1.22	0.35 μg/mL Interval 0.2 to 0.61
Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Anti-19F, Month 1	21.25 μg/mL Interval 18.07 to 24.98	6.61 μg/mL Interval 4.9 to 8.92	12.23 μg/mL Interval 9.89 to 15.13	6.01 μg/mL Interval 4.75 to 7.6
Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Anti-23F, Month 0	0.94 μg/mL Interval 0.76 to 1.16	0.41 μg/mL Interval 0.26 to 0.64	0.33 μg/mL Interval 0.27 to 0.4	0.62 μg/mL Interval 0.43 to 0.91
Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Anti-23F, Month 1	13.47 μg/mL Interval 11.38 to 15.94	14.78 μg/mL Interval 9.45 to 23.11	3.16 μg/mL Interval 2.61 to 3.83	10.77 μg/mL Interval 7.19 to 16.12

SECONDARY outcome

Timeframe: Prior to (Month 0) and one month after booster vaccination (Month 1)

Population: The analysis was performed on the According-To-Protocol (ATP) cohort for persistence, which included all subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sampling taken before the administration of the study booster dose (pre-booster blood sampling).

Seropositivity status, defined as Opsonophagocytic activity against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ 8.

Outcome measures

Measure	Synflorix Pooled Group n=136 Participants Subjects primary vaccinated at 6-10-14 weeks of age, receiving a booster dose of Synflorix™ vaccine, either co-administered with Tritanrix™-HepB/ Hiberix™ and Polio Sabin™ vaccines in the Philippines or co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines in Poland, at 12-18 months of age.	Prevenar Pooled Group n=43 Participants Subjects primary vaccinated at 6-10-14 weeks of age, receiving a booster dose of the Prevenar™ vaccine, either co-administered with Tritanrix™-HepB/ Hiberix™ and Polio Sabin™ vaccines in the Philippines or co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines in Poland, at 12-18 months of age.	Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group n=125 Participants Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of Synflorix™ vaccine co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines at 12-18 months of age.	Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group n=37 Participants Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of the Prevenar™ vaccine, co-administered with Tritanrix -HepB/ Hiberix™ and Poliorix™ at 12-18 months of age.
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F OPA Anti-1, Month 0	13.2 Titers Interval 10.2 to 16.9	4.6 Titers Interval 3.9 to 5.4	8.5 Titers Interval 7.0 to 10.5	4.7 Titers Interval 3.8 to 5.8
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F OPA Anti-1, Month 1	1571.6 Titers Interval 1210.7 to 2040.0	4.9 Titers Interval 4.1 to 5.8	161.4 Titers Interval 120.7 to 215.9	5.4 Titers Interval 4.0 to 7.4
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F OPA Anti-4, Month 0	40.5 Titers Interval 27.6 to 59.2	18.5 Titers Interval 10.0 to 34.2	12.5 Titers Interval 8.9 to 17.4	12.4 Titers Interval 6.7 to 22.8
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F OPA Anti-4, Month 1	5035.8 Titers Interval 4214.0 to 6017.8	4783.5 Titers Interval 3432.0 to 6667.2	2498.7 Titers Interval 2103.3 to 2968.4	4812.5 Titers Interval 3167.8 to 7311.3
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F OPA Anti-5, Month 0	19.8 Titers Interval 16.0 to 24.7	4.2 Titers Interval 3.8 to 4.6	10.9 Titers Interval 8.8 to 13.6	4.5 Titers Interval 3.7 to 5.5
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F OPA Anti-5, Month 1	1135.8 Titers Interval 928.5 to 1389.6	4.9 Titers Interval 3.9 to 6.0	149.1 Titers Interval 115.4 to 192.5	4.3 Titers Interval 3.8 to 4.8
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F OPA Anti-6B, Month 0	97.8 Titers Interval 61.5 to 155.5	56.6 Titers Interval 21.3 to 150.1	9.9 Titers Interval 7.2 to 13.5	23.3 Titers Interval 9.1 to 60.1
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F OPA Anti-6B, Month 1	2896.8 Titers Interval 2247.5 to 3733.8	9302.7 Titers Interval 7187.3 to 12040.8	405.3 Titers Interval 267.4 to 614.3	3547.1 Titers Interval 1500.7 to 8384.5
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F OPA Anti-7F, Month 0	2278.4 Titers Interval 1803.1 to 2879.0	378.8 Titers Interval 136.9 to 1048.0	796.3 Titers Interval 582.2 to 1089.1	63.6 Titers Interval 21.3 to 190.1
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F OPA Anti-7F, Month 1	12484 Titers Interval 10750.7 to 14496.8	1407.7 Titers Interval 694.6 to 2852.9	6436.1 Titers Interval 5507.6 to 7521.0	90.6 Titers Interval 25.2 to 325.5
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F OPA Anti-9V, Month 0	788 Titers Interval 655.1 to 947.8	666.8 Titers Interval 482.1 to 922.2	380.2 Titers Interval 313.1 to 461.7	247.5 Titers Interval 164.9 to 371.3
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F OPA Anti-9V, Month 1	4842 Titers Interval 4122.7 to 5686.9	7387.8 Titers Interval 5429.2 to 10052.9	3499.9 Titers Interval 2950.8 to 4151.3	6881.4 Titers Interval 4883.6 to 9696.4
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F OPA Anti-14, Month 0	298.4 Titers Interval 220.1 to 404.7	337.2 Titers Interval 207.0 to 549.2	179.6 Titers Interval 127.4 to 253.2	236.6 Titers Interval 132.6 to 422.2
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F OPA Anti-14, Month 1	3579.7 Titers Interval 2966.3 to 4319.9	4097.3 Titers Interval 3019.2 to 5560.2	1961.3 Titers Interval 1630.0 to 2359.8	2939.5 Titers Interval 2022.3 to 4272.7
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F OPA Anti-18C, Month 0	19.8 Titers Interval 15.2 to 25.9	4.5 Titers Interval 3.9 to 5.2	7.8 Titers Interval 6.5 to 9.4	4.5 Titers Interval 4.0 to 5.2
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F OPA Anti-18C, Month 1	2417.2 Titers Interval 1989.9 to 2936.2	966.5 Titers Interval 607.1 to 1538.6	694 Titers Interval 532.9 to 903.7	612.1 Titers Interval 338.4 to 1107.0
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F OPA Anti-19F, Month 0	58.6 Titers Interval 45.2 to 76.0	7.3 Titers Interval 4.5 to 11.8	33.3 Titers Interval 25.7 to 43.2	11.1 Titers Interval 6.0 to 20.6
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F OPA Anti-19F, Month 1	2016 Titers Interval 1609.0 to 2526.0	473.2 Titers Interval 263.5 to 849.9	1059.8 Titers Interval 808.2 to 1389.7	471 Titers Interval 270.0 to 821.8
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F OPA Anti-23F, Month 0	948.9 Titers Interval 688.4 to 1308.2	661.9 Titers Interval 312.5 to 1402.0	301.8 Titers Interval 198.4 to 459.0	790.6 Titers Interval 326.8 to 1912.6
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F OPA Anti-23F, Month 1	7456.2 Titers Interval 6301.9 to 8822.0	23177.9 Titers Interval 13235.9 to 40587.7	3427.3 Titers Interval 2727.7 to 4306.3	19943.3 Titers Interval 13473.1 to 29520.5

SECONDARY outcome

Timeframe: Prior to (Month 0) and one month after booster vaccination (Month 1)

Population: The analysis was performed on the According-To-Protocol (ATP) cohort for persistence, which included all subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sampling taken before the administration of the study booster dose (pre-booster blood sampling).

Seropositivity status, defined as anti-PD antibody concentrations ≥100 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).

Outcome measures

Measure	Synflorix Pooled Group n=135 Participants Subjects primary vaccinated at 6-10-14 weeks of age, receiving a booster dose of Synflorix™ vaccine, either co-administered with Tritanrix™-HepB/ Hiberix™ and Polio Sabin™ vaccines in the Philippines or co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines in Poland, at 12-18 months of age.	Prevenar Pooled Group n=43 Participants Subjects primary vaccinated at 6-10-14 weeks of age, receiving a booster dose of the Prevenar™ vaccine, either co-administered with Tritanrix™-HepB/ Hiberix™ and Polio Sabin™ vaccines in the Philippines or co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines in Poland, at 12-18 months of age.	Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group n=128 Participants Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of Synflorix™ vaccine co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines at 12-18 months of age.	Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group n=43 Participants Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of the Prevenar™ vaccine, co-administered with Tritanrix -HepB/ Hiberix™ and Poliorix™ at 12-18 months of age.
Antibody Concentrations to Protein D (Anti-PD) Anti-PD, Month 0	573.1 EL.U/mL Interval 495.7 to 662.6	136.8 EL.U/mL Interval 102.0 to 183.3	526.8 EL.U/mL Interval 427.4 to 649.3	73.8 EL.U/mL Interval 58.4 to 93.2
Antibody Concentrations to Protein D (Anti-PD) Anti-PD, Month 1	4973.9 EL.U/mL Interval 4280.2 to 5780.0	124.1 EL.U/mL Interval 92.8 to 166.0	2769.6 EL.U/mL Interval 2308.5 to 3322.7	91.6 EL.U/mL Interval 72.0 to 116.7

SECONDARY outcome

Timeframe: Prior to (Month 0) and one month after booster vaccination (Month 1)

Population: The analysis was performed on the According-To-Protocol (ATP) cohort for persistence, which included all subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sampling taken before the administration of the study booster dose (pre-booster blood sampling).

Seropositivity status, defined as anti-pneumococcal cross-reactive serotypes 6A and 19A antibody concentrations ≥ 0.05 microgram per milliliter (μg/mL).

Outcome measures

Measure	Synflorix Pooled Group n=136 Participants Subjects primary vaccinated at 6-10-14 weeks of age, receiving a booster dose of Synflorix™ vaccine, either co-administered with Tritanrix™-HepB/ Hiberix™ and Polio Sabin™ vaccines in the Philippines or co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines in Poland, at 12-18 months of age.	Prevenar Pooled Group n=43 Participants Subjects primary vaccinated at 6-10-14 weeks of age, receiving a booster dose of the Prevenar™ vaccine, either co-administered with Tritanrix™-HepB/ Hiberix™ and Polio Sabin™ vaccines in the Philippines or co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines in Poland, at 12-18 months of age.	Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group n=130 Participants Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of Synflorix™ vaccine co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines at 12-18 months of age.	Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group n=44 Participants Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of the Prevenar™ vaccine, co-administered with Tritanrix -HepB/ Hiberix™ and Poliorix™ at 12-18 months of age.
Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A Anti-6A, Month 0	0.46 μg/mL Interval 0.36 to 0.6	0.24 μg/mL Interval 0.14 to 0.4	0.12 μg/mL Interval 0.1 to 0.14	0.13 μg/mL Interval 0.08 to 0.2
Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A Anti-6A, Month 1	4.07 μg/mL Interval 3.09 to 5.36	4.57 μg/mL Interval 2.92 to 7.17	0.84 μg/mL Interval 0.65 to 1.08	2.54 μg/mL Interval 1.65 to 3.93
Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A Anti-19A, Month 0	0.24 μg/mL Interval 0.19 to 0.3	0.08 μg/mL Interval 0.05 to 0.12	0.16 μg/mL Interval 0.12 to 0.2	0.06 μg/mL Interval 0.04 to 0.08
Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A Anti-19A, Month 1	3.22 μg/mL Interval 2.46 to 4.21	0.58 μg/mL Interval 0.37 to 0.91	1.75 μg/mL Interval 1.27 to 2.43	0.38 μg/mL Interval 0.25 to 0.58

SECONDARY outcome

Timeframe: Prior to (Month 0) and one month after booster vaccination (Month 1)

Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.

Seropositivity status, defined as Opsonophagocytic activity against pneumococcal cross-reactive serotypes 6A and 19A ≥ 8.

Outcome measures

Measure	Synflorix Pooled Group n=134 Participants Subjects primary vaccinated at 6-10-14 weeks of age, receiving a booster dose of Synflorix™ vaccine, either co-administered with Tritanrix™-HepB/ Hiberix™ and Polio Sabin™ vaccines in the Philippines or co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines in Poland, at 12-18 months of age.	Prevenar Pooled Group n=43 Participants Subjects primary vaccinated at 6-10-14 weeks of age, receiving a booster dose of the Prevenar™ vaccine, either co-administered with Tritanrix™-HepB/ Hiberix™ and Polio Sabin™ vaccines in the Philippines or co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines in Poland, at 12-18 months of age.	Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group n=123 Participants Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of Synflorix™ vaccine co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines at 12-18 months of age.	Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group n=36 Participants Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of the Prevenar™ vaccine, co-administered with Tritanrix -HepB/ Hiberix™ and Poliorix™ at 12-18 months of age.
Opsonophagocytic Activity (OPA) Against Pneumococcal Cross-reactive Serotypes 6A and 19A OPA Anti-6A, Month 0	113.6 Titers Interval 73.6 to 175.4	191.4 Titers Interval 89.7 to 408.2	46.8 Titers Interval 30.8 to 71.1	42.2 Titers Interval 19.3 to 92.1
Opsonophagocytic Activity (OPA) Against Pneumococcal Cross-reactive Serotypes 6A and 19A OPA Anti-6A, Month 1	882.8 Titers Interval 665.9 to 1170.3	2563.8 Titers Interval 1689.9 to 3889.4	369.7 Titers Interval 258.5 to 528.8	1394.5 Titers Interval 827.9 to 2348.9
Opsonophagocytic Activity (OPA) Against Pneumococcal Cross-reactive Serotypes 6A and 19A OPA Anti-19A, Month 0	5.3 Titers Interval 4.5 to 6.3	5.1 Titers Interval 3.6 to 7.3	5.3 Titers Interval 4.5 to 6.2	4.4 Titers Interval 3.6 to 5.3
Opsonophagocytic Activity (OPA) Against Pneumococcal Cross-reactive Serotypes 6A and 19A OPA Anti-19A, Month 1	89.3 Titers Interval 58.9 to 135.4	8.7 Titers Interval 5.4 to 14.2	70.7 Titers Interval 45.3 to 110.4	20.3 Titers Interval 8.8 to 46.8

SECONDARY outcome

Timeframe: Prior to (Month 0) and one month after booster vaccination (Month 1)

Population: The analysis was performed on the According-To-Protocol (ATP) cohort for persistence, which included all subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sampling taken before the administration of the study booster dose (pre-booster blood sampling).

The cut-off of the assay was 0.05 μg/mL.

Outcome measures

Measure	Synflorix Pooled Group n=136 Participants Subjects primary vaccinated at 6-10-14 weeks of age, receiving a booster dose of Synflorix™ vaccine, either co-administered with Tritanrix™-HepB/ Hiberix™ and Polio Sabin™ vaccines in the Philippines or co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines in Poland, at 12-18 months of age.	Prevenar Pooled Group n=43 Participants Subjects primary vaccinated at 6-10-14 weeks of age, receiving a booster dose of the Prevenar™ vaccine, either co-administered with Tritanrix™-HepB/ Hiberix™ and Polio Sabin™ vaccines in the Philippines or co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines in Poland, at 12-18 months of age.	Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group n=130 Participants Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of Synflorix™ vaccine co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines at 12-18 months of age.	Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group n=44 Participants Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of the Prevenar™ vaccine, co-administered with Tritanrix -HepB/ Hiberix™ and Poliorix™ at 12-18 months of age.
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off Anti-1, Month 0	135 Participants	7 Participants	122 Participants	8 Participants
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off Anti-1, Month 1	136 Participants	11 Participants	125 Participants	9 Participants
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off Anti-4, Month 0	134 Participants	43 Participants	126 Participants	42 Participants
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off Anti-4, Month 1	136 Participants	43 Participants	125 Participants	43 Participants
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off Anti-5, Month 0	135 Participants	18 Participants	128 Participants	13 Participants
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off Anti-5, Month 1	136 Participants	31 Participants	125 Participants	20 Participants
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off Anti-6B, Month 0	132 Participants	40 Participants	127 Participants	39 Participants
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off Anti-6B, Month 1	135 Participants	42 Participants	124 Participants	42 Participants
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off Anti-7F, Month 0	135 Participants	13 Participants	130 Participants	8 Participants
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off Anti-7F, Month 1	136 Participants	17 Participants	125 Participants	11 Participants
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off Anti-9V, Month 0	135 Participants	42 Participants	130 Participants	44 Participants
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off Anti-9V, Month 1	136 Participants	43 Participants	125 Participants	43 Participants
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off Anti-14, Month 0	134 Participants	42 Participants	130 Participants	43 Participants
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off Anti-14, Month 1	136 Participants	43 Participants	125 Participants	43 Participants
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off Anti-18C, Month 0	135 Participants	43 Participants	129 Participants	44 Participants
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off Anti-18C, Month 1	136 Participants	43 Participants	125 Participants	43 Participants
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off Anti-19F, Month 0	134 Participants	37 Participants	129 Participants	43 Participants
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off Anti-19F, Month 1	136 Participants	43 Participants	124 Participants	43 Participants
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off Anti-23F, Month 0	132 Participants	40 Participants	125 Participants	43 Participants
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off Anti-23F, Month 1	136 Participants	42 Participants	124 Participants	42 Participants

SECONDARY outcome

Timeframe: Prior to (Month 0) and one month after booster vaccination (Month 1)

Population: The analysis was performed on the According-To-Protocol (ATP) cohort for persistence, which included all subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sampling taken before the administration of the study booster dose (pre-booster blood sampling).

The cut-off for the assay was 8.

Outcome measures

Measure	Synflorix Pooled Group n=136 Participants Subjects primary vaccinated at 6-10-14 weeks of age, receiving a booster dose of Synflorix™ vaccine, either co-administered with Tritanrix™-HepB/ Hiberix™ and Polio Sabin™ vaccines in the Philippines or co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines in Poland, at 12-18 months of age.	Prevenar Pooled Group n=43 Participants Subjects primary vaccinated at 6-10-14 weeks of age, receiving a booster dose of the Prevenar™ vaccine, either co-administered with Tritanrix™-HepB/ Hiberix™ and Polio Sabin™ vaccines in the Philippines or co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines in Poland, at 12-18 months of age.	Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group n=125 Participants Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of Synflorix™ vaccine co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines at 12-18 months of age.	Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group n=37 Participants Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of the Prevenar™ vaccine, co-administered with Tritanrix -HepB/ Hiberix™ and Poliorix™ at 12-18 months of age.
Number of Subjects With Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off OPA Anti-1, Month 0	61 Participants	3 Participants	45 Participants	3 Participants
Number of Subjects With Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off OPA Anti-1, Month 1	134 Participants	5 Participants	114 Participants	5 Participants
Number of Subjects With Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off OPA Anti-4, Month 0	83 Participants	20 Participants	39 Participants	12 Participants
Number of Subjects With Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off OPA Anti-4, Month 1	134 Participants	43 Participants	119 Participants	35 Participants
Number of Subjects With Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off OPA Anti-5, Month 0	94 Participants	1 Participants	56 Participants	2 Participants
Number of Subjects With Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off OPA Anti-5, Month 1	130 Participants	4 Participants	114 Participants	1 Participants
Number of Subjects With Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off OPA Anti-6B, Month 0	93 Participants	21 Participants	34 Participants	14 Participants
Number of Subjects With Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off OPA Anti-6B, Month 1	134 Participants	43 Participants	106 Participants	32 Participants
Number of Subjects With Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off OPA Anti-7F, Month 0	133 Participants	28 Participants	109 Participants	15 Participants
Number of Subjects With Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off OPA Anti-7F, Month 1	136 Participants	36 Participants	122 Participants	13 Participants
Number of Subjects With Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off OPA Anti-9V, Month 0	135 Participants	42 Participants	121 Participants	36 Participants
Number of Subjects With Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off OPA Anti-9V, Month 1	134 Participants	42 Participants	121 Participants	35 Participants
Number of Subjects With Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off OPA Anti-14, Month 0	119 Participants	39 Participants	93 Participants	29 Participants
Number of Subjects With Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off OPA Anti-14, Month 1	132 Participants	42 Participants	120 Participants	36 Participants
Number of Subjects With Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off OPA Anti-18C, Month 0	84 Participants	3 Participants	42 Participants	4 Participants
Number of Subjects With Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off OPA Anti-18C, Month 1	133 Participants	42 Participants	114 Participants	36 Participants
Number of Subjects With Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off OPA Anti-19F, Month 0	117 Participants	7 Participants	96 Participants	12 Participants
Number of Subjects With Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off OPA Anti-19F, Month 1	135 Participants	39 Participants	118 Participants	36 Participants
Number of Subjects With Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off OPA Anti-23F, Month 0	130 Participants	37 Participants	99 Participants	30 Participants
Number of Subjects With Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off OPA Anti-23F, Month 1	136 Participants	42 Participants	120 Participants	37 Participants

SECONDARY outcome

Timeframe: Prior to (Month 0) and one month after booster vaccination (Month 1)

Population: The analysis was performed on the According-To-Protocol (ATP) cohort for persistence, which included all subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sampling taken before the administration of the study booster dose (pre-booster blood sampling).

The cut-of for the assay was 0.05 μg/mL.

Outcome measures

Measure	Synflorix Pooled Group n=136 Participants Subjects primary vaccinated at 6-10-14 weeks of age, receiving a booster dose of Synflorix™ vaccine, either co-administered with Tritanrix™-HepB/ Hiberix™ and Polio Sabin™ vaccines in the Philippines or co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines in Poland, at 12-18 months of age.	Prevenar Pooled Group n=43 Participants Subjects primary vaccinated at 6-10-14 weeks of age, receiving a booster dose of the Prevenar™ vaccine, either co-administered with Tritanrix™-HepB/ Hiberix™ and Polio Sabin™ vaccines in the Philippines or co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines in Poland, at 12-18 months of age.	Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group n=130 Participants Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of Synflorix™ vaccine co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines at 12-18 months of age.	Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group n=44 Participants Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of the Prevenar™ vaccine, co-administered with Tritanrix -HepB/ Hiberix™ and Poliorix™ at 12-18 months of age.
Number of Subjects With Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A ≥ the Cut-off Anti-6A, Month 0	128 Participants	37 Participants	105 Participants	33 Participants
Number of Subjects With Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A ≥ the Cut-off Anti-6A, Month 1	133 Participants	42 Participants	125 Participants	42 Participants
Number of Subjects With Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A ≥ the Cut-off Anti-19A, Month 0	124 Participants	25 Participants	105 Participants	27 Participants
Number of Subjects With Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A ≥ the Cut-off Anti-19A, Month 1	135 Participants	42 Participants	119 Participants	42 Participants

SECONDARY outcome

Timeframe: Prior to (Month 0) and one month after booster vaccination (Month 1)

Population: The analysis was performed on the According-To-Protocol (ATP) cohort for persistence, which included all subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sampling taken before the administration of the study booster dose (pre-booster blood sampling).

The cut-off for the assay was 8.

Outcome measures

Measure	Synflorix Pooled Group n=134 Participants Subjects primary vaccinated at 6-10-14 weeks of age, receiving a booster dose of Synflorix™ vaccine, either co-administered with Tritanrix™-HepB/ Hiberix™ and Polio Sabin™ vaccines in the Philippines or co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines in Poland, at 12-18 months of age.	Prevenar Pooled Group n=43 Participants Subjects primary vaccinated at 6-10-14 weeks of age, receiving a booster dose of the Prevenar™ vaccine, either co-administered with Tritanrix™-HepB/ Hiberix™ and Polio Sabin™ vaccines in the Philippines or co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines in Poland, at 12-18 months of age.	Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group n=123 Participants Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of Synflorix™ vaccine co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines at 12-18 months of age.	Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group n=36 Participants Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of the Prevenar™ vaccine, co-administered with Tritanrix -HepB/ Hiberix™ and Poliorix™ at 12-18 months of age.
Number of Subjects With Opsonophagocytic Activity (OPA) Against Pneumococcal Cross-reactive Serotypes 6A and 19A ≥ the Cut-off OPA Anti-6A, Month 0	82 Participants	30 Participants	63 Participants	19 Participants
Number of Subjects With Opsonophagocytic Activity (OPA) Against Pneumococcal Cross-reactive Serotypes 6A and 19A ≥ the Cut-off OPA Anti-6A, Month 1	127 Participants	43 Participants	97 Participants	32 Participants
Number of Subjects With Opsonophagocytic Activity (OPA) Against Pneumococcal Cross-reactive Serotypes 6A and 19A ≥ the Cut-off OPA Anti-19A, Month 0	14 Participants	2 Participants	11 Participants	1 Participants
Number of Subjects With Opsonophagocytic Activity (OPA) Against Pneumococcal Cross-reactive Serotypes 6A and 19A ≥ the Cut-off OPA Anti-19A, Month 1	92 Participants	11 Participants	74 Participants	12 Participants

SECONDARY outcome

Timeframe: Prior to (Month 0) and one month after booster vaccination (Month 1)

Population: The analysis was performed on the According-To-Protocol (ATP) cohort for persistence, which included all subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sampling taken before the administration of the study booster dose (pre-booster blood sampling).

The cut-off for the assay was 100 ELISA units per milliliter (EL.U/mL).

Outcome measures

Measure	Synflorix Pooled Group n=135 Participants Subjects primary vaccinated at 6-10-14 weeks of age, receiving a booster dose of Synflorix™ vaccine, either co-administered with Tritanrix™-HepB/ Hiberix™ and Polio Sabin™ vaccines in the Philippines or co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines in Poland, at 12-18 months of age.	Prevenar Pooled Group n=43 Participants Subjects primary vaccinated at 6-10-14 weeks of age, receiving a booster dose of the Prevenar™ vaccine, either co-administered with Tritanrix™-HepB/ Hiberix™ and Polio Sabin™ vaccines in the Philippines or co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines in Poland, at 12-18 months of age.	Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group n=128 Participants Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of Synflorix™ vaccine co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines at 12-18 months of age.	Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group n=43 Participants Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of the Prevenar™ vaccine, co-administered with Tritanrix -HepB/ Hiberix™ and Poliorix™ at 12-18 months of age.
Number of Subjects With Antibody Concentrations Against Protein D (Anti-PD) ≥ the Cut-off Anti-PD, Month 0	131 Participants	28 Participants	117 Participants	11 Participants
Number of Subjects With Antibody Concentrations Against Protein D (Anti-PD) ≥ the Cut-off Anti-PD, Month 1	135 Participants	23 Participants	125 Participants	19 Participants

SECONDARY outcome

Timeframe: Prior to (Month 0) and one month after booster vaccination (Month 1)

Population: The analysis was performed on the According-To-Protocol (ATP) cohort for persistence, which included all subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sampling taken before the administration of the study booster dose (pre-booster blood sampling).

Seroprotection status, defined as anti-diphtheria toxoid or anti-tetanus toxoid antibody concentrations ≥ 0.1 international units per milliliter (IU/mL).

Outcome measures

Measure	Synflorix Pooled Group n=65 Participants Subjects primary vaccinated at 6-10-14 weeks of age, receiving a booster dose of Synflorix™ vaccine, either co-administered with Tritanrix™-HepB/ Hiberix™ and Polio Sabin™ vaccines in the Philippines or co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines in Poland, at 12-18 months of age.	Prevenar Pooled Group n=25 Participants Subjects primary vaccinated at 6-10-14 weeks of age, receiving a booster dose of the Prevenar™ vaccine, either co-administered with Tritanrix™-HepB/ Hiberix™ and Polio Sabin™ vaccines in the Philippines or co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines in Poland, at 12-18 months of age.	Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group n=62 Participants Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of Synflorix™ vaccine co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines at 12-18 months of age.	Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group n=24 Participants Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of the Prevenar™ vaccine, co-administered with Tritanrix -HepB/ Hiberix™ and Poliorix™ at 12-18 months of age.
Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations Anti-DT, Month 0	0.258 IU/mL Interval 0.209 to 0.319	0.17 IU/mL Interval 0.118 to 0.243	0.188 IU/mL Interval 0.153 to 0.231	0.126 IU/mL Interval 0.088 to 0.179
Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations Anti-DT, Month 1	7.829 IU/mL Interval 6.339 to 9.671	4.768 IU/mL Interval 3.699 to 6.145	8.463 IU/mL Interval 7.11 to 10.074	4.876 IU/mL Interval 3.503 to 6.787
Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations Anti-TT, Month 0	0.735 IU/mL Interval 0.629 to 0.858	0.455 IU/mL Interval 0.314 to 0.66	0.568 IU/mL Interval 0.432 to 0.748	0.525 IU/mL Interval 0.29 to 0.951
Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations Anti-TT, Month 1	20.979 IU/mL Interval 18.359 to 23.972	9.703 IU/mL Interval 8.173 to 11.518	12.171 IU/mL Interval 9.772 to 15.16	6.719 IU/mL Interval 4.598 to 9.819

SECONDARY outcome

Timeframe: Prior to (Month 0) and one month after booster vaccination (Month 1)

Population: The analysis was performed on the According-To-Protocol (ATP) cohort for persistence, which included all subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sampling taken before the administration of the study booster dose (pre-booster blood sampling).

Seroprotection status, defined as anti-PRP antibody concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL.

Outcome measures

Measure	Synflorix Pooled Group n=65 Participants Subjects primary vaccinated at 6-10-14 weeks of age, receiving a booster dose of Synflorix™ vaccine, either co-administered with Tritanrix™-HepB/ Hiberix™ and Polio Sabin™ vaccines in the Philippines or co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines in Poland, at 12-18 months of age.	Prevenar Pooled Group n=25 Participants Subjects primary vaccinated at 6-10-14 weeks of age, receiving a booster dose of the Prevenar™ vaccine, either co-administered with Tritanrix™-HepB/ Hiberix™ and Polio Sabin™ vaccines in the Philippines or co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines in Poland, at 12-18 months of age.	Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group n=62 Participants Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of Synflorix™ vaccine co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines at 12-18 months of age.	Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group n=24 Participants Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of the Prevenar™ vaccine, co-administered with Tritanrix -HepB/ Hiberix™ and Poliorix™ at 12-18 months of age.
Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentrations Anti-PRP, Month 0	5.335 μg/mL Interval 3.578 to 7.953	6.433 μg/mL Interval 2.93 to 14.124	1.03 μg/mL Interval 0.745 to 1.423	0.894 μg/mL Interval 0.57 to 1.401
Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentrations Anti-PRP, Month 1	106.004 μg/mL Interval 79.937 to 140.572	89.376 μg/mL Interval 55.131 to 144.891	53.386 μg/mL Interval 34.817 to 81.858	33.656 μg/mL Interval 19.464 to 58.198

SECONDARY outcome

Timeframe: Prior to (Month 0) and one month after booster vaccination (Month 1)

Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.

Seropositivity status, defined as anti-BPT antibody concentrations ≥ 15 EL.U/mL.

Outcome measures

Measure	Synflorix Pooled Group n=65 Participants Subjects primary vaccinated at 6-10-14 weeks of age, receiving a booster dose of Synflorix™ vaccine, either co-administered with Tritanrix™-HepB/ Hiberix™ and Polio Sabin™ vaccines in the Philippines or co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines in Poland, at 12-18 months of age.	Prevenar Pooled Group n=25 Participants Subjects primary vaccinated at 6-10-14 weeks of age, receiving a booster dose of the Prevenar™ vaccine, either co-administered with Tritanrix™-HepB/ Hiberix™ and Polio Sabin™ vaccines in the Philippines or co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines in Poland, at 12-18 months of age.	Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group n=62 Participants Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of Synflorix™ vaccine co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines at 12-18 months of age.	Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group n=24 Participants Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of the Prevenar™ vaccine, co-administered with Tritanrix -HepB/ Hiberix™ and Poliorix™ at 12-18 months of age.
Anti-Bordetella Pertussis (BPT) Antibody Concentrations Anti-BPT, Month 0	12.88 EL.U/mL Interval 10.86 to 15.28	12.46 EL.U/mL Interval 9.32 to 16.65	9.54 EL.U/mL Interval 8.34 to 10.91	10 EL.U/mL Interval 8.21 to 12.19
Anti-Bordetella Pertussis (BPT) Antibody Concentrations Anti-BPT, Month 1	139.51 EL.U/mL Interval 123.26 to 157.89	133.45 EL.U/mL Interval 110.33 to 161.4	121.73 EL.U/mL Interval 103.16 to 143.64	121.76 EL.U/mL Interval 91.81 to 161.47

SECONDARY outcome

Timeframe: Prior to (Month 0) and one month after booster vaccination (Month 1)

Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.

Seroprotection status, defined as anti-HBs antibody concentrations ≥ 10 milli international units per milliliter (mIU/mL).

Outcome measures

Measure	Synflorix Pooled Group n=69 Participants Subjects primary vaccinated at 6-10-14 weeks of age, receiving a booster dose of Synflorix™ vaccine, either co-administered with Tritanrix™-HepB/ Hiberix™ and Polio Sabin™ vaccines in the Philippines or co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines in Poland, at 12-18 months of age.	Prevenar Pooled Group n=21 Participants Subjects primary vaccinated at 6-10-14 weeks of age, receiving a booster dose of the Prevenar™ vaccine, either co-administered with Tritanrix™-HepB/ Hiberix™ and Polio Sabin™ vaccines in the Philippines or co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines in Poland, at 12-18 months of age.	Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group n=64 Participants Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of Synflorix™ vaccine co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines at 12-18 months of age.	Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group n=19 Participants Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of the Prevenar™ vaccine, co-administered with Tritanrix -HepB/ Hiberix™ and Poliorix™ at 12-18 months of age.
Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations Anti-HBs, Month 0	30 mIU/mL Interval 21.1 to 42.8	23.4 mIU/mL Interval 11.5 to 47.7	97.9 mIU/mL Interval 77.0 to 124.5	113 mIU/mL Interval 55.1 to 231.7
Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations Anti-HBs, Month 1	1220.5 mIU/mL Interval 790.6 to 1884.0	1098.1 mIU/mL Interval 358.4 to 3364.9	4428.7 mIU/mL Interval 2980.3 to 6581.0	3188.6 mIU/mL Interval 1171.7 to 8677.1

SECONDARY outcome

Timeframe: Prior to (Month 0) and one month after booster vaccination (Month 1)

Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.

Seroprotection status, defined as anti-polio type 1, anti-polio type 2 and anti-polio type 3 antibody titers ≥ 8.

Outcome measures

Measure	Synflorix Pooled Group n=69 Participants Subjects primary vaccinated at 6-10-14 weeks of age, receiving a booster dose of Synflorix™ vaccine, either co-administered with Tritanrix™-HepB/ Hiberix™ and Polio Sabin™ vaccines in the Philippines or co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines in Poland, at 12-18 months of age.	Prevenar Pooled Group n=21 Participants Subjects primary vaccinated at 6-10-14 weeks of age, receiving a booster dose of the Prevenar™ vaccine, either co-administered with Tritanrix™-HepB/ Hiberix™ and Polio Sabin™ vaccines in the Philippines or co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines in Poland, at 12-18 months of age.	Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group n=64 Participants Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of Synflorix™ vaccine co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines at 12-18 months of age.	Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group n=20 Participants Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of the Prevenar™ vaccine, co-administered with Tritanrix -HepB/ Hiberix™ and Poliorix™ at 12-18 months of age.
Anti-polio Type 1, 2 and 3 Antibody Titers Anti-Polio 1, Month 0	329.1 Titers Interval 214.9 to 504.1	269 Titers Interval 114.8 to 630.3	46.5 Titers Interval 33.6 to 64.4	51.1 Titers Interval 28.4 to 91.9
Anti-polio Type 1, 2 and 3 Antibody Titers Anti-Polio 1, Month 1	854.6 Titers Interval 573.5 to 1273.5	426.9 Titers Interval 166.2 to 1096.7	932.5 Titers Interval 770.5 to 1128.6	727.3 Titers Interval 512.9 to 1059.9
Anti-polio Type 1, 2 and 3 Antibody Titers Anti-Polio 2, Month 0	222.6 Titers Interval 171.8 to 288.3	210.4 Titers Interval 115.4 to 383.6	50.2 Titers Interval 36.9 to 68.2	60.8 Titers Interval 33.4 to 110.8
Anti-polio Type 1, 2 and 3 Antibody Titers Anti-Polio 2, Month 1	716.9 Titers Interval 487.6 to 1054.1	689.1 Titers Interval 304.8 to 1557.9	1195.7 Titers Interval 977.8 to 1462.2	1206.6 Titers Interval 737.0 to 1975.4
Anti-polio Type 1, 2 and 3 Antibody Titers Anti-Polio 3, Month 0	102.2 Titers Interval 73.9 to 141.5	38.4 Titers Interval 20.3 to 72.9	51.8 Titers Interval 37.4 to 71.7	71.1 Titers Interval 36.2 to 139.5
Anti-polio Type 1, 2 and 3 Antibody Titers Anti-Polio 3, Month 1	232.7 Titers Interval 159.6 to 339.4	190.4 Titers Interval 78.2 to 463.6	1464.2 Titers Interval 1128.0 to 1900.6	1346.2 Titers Interval 857.6 to 2113.2

SECONDARY outcome

Timeframe: Prior to (Month 0) and one month after booster vaccination (Month 1)

Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.

The cut-off for the assay was 15 EL.U/mL.

Outcome measures

Measure	Synflorix Pooled Group n=65 Participants Subjects primary vaccinated at 6-10-14 weeks of age, receiving a booster dose of Synflorix™ vaccine, either co-administered with Tritanrix™-HepB/ Hiberix™ and Polio Sabin™ vaccines in the Philippines or co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines in Poland, at 12-18 months of age.	Prevenar Pooled Group n=25 Participants Subjects primary vaccinated at 6-10-14 weeks of age, receiving a booster dose of the Prevenar™ vaccine, either co-administered with Tritanrix™-HepB/ Hiberix™ and Polio Sabin™ vaccines in the Philippines or co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines in Poland, at 12-18 months of age.	Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group n=62 Participants Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of Synflorix™ vaccine co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines at 12-18 months of age.	Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group n=24 Participants Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of the Prevenar™ vaccine, co-administered with Tritanrix -HepB/ Hiberix™ and Poliorix™ at 12-18 months of age.
Number of Subjects With Anti-Bordetella Pertussis (BPT) With Concentrations ≥ the Cut-off Anti-BPT, Month 0	28 Participants	10 Participants	12 Participants	7 Participants
Number of Subjects With Anti-Bordetella Pertussis (BPT) With Concentrations ≥ the Cut-off Anti-BPT, Month 1	65 Participants	25 Participants	59 Participants	24 Participants

SECONDARY outcome

Timeframe: Prior to (Month 0) and one month after booster vaccination (Month 1)

Population: The analysis was performed on the According-To-Protocol (ATP) cohort for persistence, which included all subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sampling taken before the administration of the study booster dose (pre-booster blood sampling).

The cut-off for the assay was 0.1 milli-international units per milliliter (mIU/mL).

Outcome measures

Measure	Synflorix Pooled Group n=65 Participants Subjects primary vaccinated at 6-10-14 weeks of age, receiving a booster dose of Synflorix™ vaccine, either co-administered with Tritanrix™-HepB/ Hiberix™ and Polio Sabin™ vaccines in the Philippines or co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines in Poland, at 12-18 months of age.	Prevenar Pooled Group n=25 Participants Subjects primary vaccinated at 6-10-14 weeks of age, receiving a booster dose of the Prevenar™ vaccine, either co-administered with Tritanrix™-HepB/ Hiberix™ and Polio Sabin™ vaccines in the Philippines or co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines in Poland, at 12-18 months of age.	Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group n=62 Participants Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of Synflorix™ vaccine co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines at 12-18 months of age.	Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group n=24 Participants Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of the Prevenar™ vaccine, co-administered with Tritanrix -HepB/ Hiberix™ and Poliorix™ at 12-18 months of age.
Number of Subjects With Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations ≥ the Cut-off Anti-DT, Month 0	56 Participants	18 Participants	49 Participants	15 Participants
Number of Subjects With Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations ≥ the Cut-off Anti-DT, Month 1	65 Participants	25 Participants	59 Participants	24 Participants
Number of Subjects With Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations ≥ the Cut-off Anti-TT, Month 0	65 Participants	24 Participants	60 Participants	23 Participants
Number of Subjects With Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations ≥ the Cut-off Anti-TT, Month 1	65 Participants	25 Participants	58 Participants	24 Participants

SECONDARY outcome

Timeframe: Prior to (Month 0) and one month after booster vaccination (Month 1)

Population: The analysis was performed on the According-To-Protocol (ATP) cohort for persistence, which included all subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sampling taken before the administration of the study booster dose (pre-booster blood sampling).

The cut-off for the assay was 0.15 μg/mL.

Outcome measures

Measure	Synflorix Pooled Group n=65 Participants Subjects primary vaccinated at 6-10-14 weeks of age, receiving a booster dose of Synflorix™ vaccine, either co-administered with Tritanrix™-HepB/ Hiberix™ and Polio Sabin™ vaccines in the Philippines or co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines in Poland, at 12-18 months of age.	Prevenar Pooled Group n=25 Participants Subjects primary vaccinated at 6-10-14 weeks of age, receiving a booster dose of the Prevenar™ vaccine, either co-administered with Tritanrix™-HepB/ Hiberix™ and Polio Sabin™ vaccines in the Philippines or co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines in Poland, at 12-18 months of age.	Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group n=62 Participants Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of Synflorix™ vaccine co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines at 12-18 months of age.	Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group n=24 Participants Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of the Prevenar™ vaccine, co-administered with Tritanrix -HepB/ Hiberix™ and Poliorix™ at 12-18 months of age.
Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration ≥ the Cut-off Anti-PRP, Month 0	65 Participants	25 Participants	58 Participants	23 Participants
Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration ≥ the Cut-off Anti-PRP, Month 1	65 Participants	25 Participants	59 Participants	24 Participants

SECONDARY outcome

Timeframe: Prior to (Month 0) and one month after booster vaccination (Month 1)

Population: The analysis was performed on the According-To-Protocol (ATP) cohort for persistence, which included all subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sampling taken before the administration of the study booster dose (pre-booster blood sampling).

The cut-off for the assay was 1.0 μg/mL.

Outcome measures

Measure	Synflorix Pooled Group n=65 Participants Subjects primary vaccinated at 6-10-14 weeks of age, receiving a booster dose of Synflorix™ vaccine, either co-administered with Tritanrix™-HepB/ Hiberix™ and Polio Sabin™ vaccines in the Philippines or co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines in Poland, at 12-18 months of age.	Prevenar Pooled Group n=25 Participants Subjects primary vaccinated at 6-10-14 weeks of age, receiving a booster dose of the Prevenar™ vaccine, either co-administered with Tritanrix™-HepB/ Hiberix™ and Polio Sabin™ vaccines in the Philippines or co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines in Poland, at 12-18 months of age.	Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group n=62 Participants Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of Synflorix™ vaccine co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines at 12-18 months of age.	Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group n=24 Participants Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of the Prevenar™ vaccine, co-administered with Tritanrix -HepB/ Hiberix™ and Poliorix™ at 12-18 months of age.
Number of Subjects With Anti-PRP Antibody Concentration ≥ the Cut-off Anti-PRP, Month 0	56 Participants	22 Participants	32 Participants	12 Participants
Number of Subjects With Anti-PRP Antibody Concentration ≥ the Cut-off Anti-PRP, Month 1	65 Participants	25 Participants	57 Participants	24 Participants

SECONDARY outcome

Timeframe: Prior to (Month 0) and one month after booster vaccination (Month 1)

Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.

The cut-off for the assay was 10 mIU/mL.

Outcome measures

Measure	Synflorix Pooled Group n=69 Participants Subjects primary vaccinated at 6-10-14 weeks of age, receiving a booster dose of Synflorix™ vaccine, either co-administered with Tritanrix™-HepB/ Hiberix™ and Polio Sabin™ vaccines in the Philippines or co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines in Poland, at 12-18 months of age.	Prevenar Pooled Group n=21 Participants Subjects primary vaccinated at 6-10-14 weeks of age, receiving a booster dose of the Prevenar™ vaccine, either co-administered with Tritanrix™-HepB/ Hiberix™ and Polio Sabin™ vaccines in the Philippines or co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines in Poland, at 12-18 months of age.	Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group n=64 Participants Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of Synflorix™ vaccine co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines at 12-18 months of age.	Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group n=19 Participants Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of the Prevenar™ vaccine, co-administered with Tritanrix -HepB/ Hiberix™ and Poliorix™ at 12-18 months of age.
Number of Subjects With Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations ≥ the Cut-off Anti-HBs, Month 0	53 Participants	13 Participants	63 Participants	19 Participants
Number of Subjects With Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations ≥ the Cut-off Anti-HBs, Month 1	68 Participants	19 Participants	62 Participants	19 Participants

SECONDARY outcome

Timeframe: Prior to (Month 0) and one month after booster vaccination (Month 1)

Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.

The cut-off for the assay was 8.

Outcome measures

Measure	Synflorix Pooled Group n=69 Participants Subjects primary vaccinated at 6-10-14 weeks of age, receiving a booster dose of Synflorix™ vaccine, either co-administered with Tritanrix™-HepB/ Hiberix™ and Polio Sabin™ vaccines in the Philippines or co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines in Poland, at 12-18 months of age.	Prevenar Pooled Group n=21 Participants Subjects primary vaccinated at 6-10-14 weeks of age, receiving a booster dose of the Prevenar™ vaccine, either co-administered with Tritanrix™-HepB/ Hiberix™ and Polio Sabin™ vaccines in the Philippines or co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines in Poland, at 12-18 months of age.	Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group n=64 Participants Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of Synflorix™ vaccine co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines at 12-18 months of age.	Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group n=20 Participants Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of the Prevenar™ vaccine, co-administered with Tritanrix -HepB/ Hiberix™ and Poliorix™ at 12-18 months of age.
Number of Subjects With Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Antibody Titers ≥ the Cut-off Anti-Polio 1, Month 0	64 Participants	19 Participants	56 Participants	19 Participants
Number of Subjects With Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Antibody Titers ≥ the Cut-off Anti-Polio 1, Month 1	68 Participants	19 Participants	63 Participants	19 Participants
Number of Subjects With Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Antibody Titers ≥ the Cut-off Anti-Polio 2, Month 0	69 Participants	21 Participants	59 Participants	19 Participants
Number of Subjects With Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Antibody Titers ≥ the Cut-off Anti-Polio 2, Month 1	69 Participants	21 Participants	63 Participants	19 Participants
Number of Subjects With Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Antibody Titers ≥ the Cut-off Anti-Polio 3, Month 0	65 Participants	17 Participants	61 Participants	18 Participants
Number of Subjects With Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Antibody Titers ≥ the Cut-off Anti-Polio 3, Month 1	66 Participants	20 Participants	63 Participants	19 Participants

SECONDARY outcome

Timeframe: One month after booster vaccination (Month 1)

Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.

Vaccine response for anti-BPT, defined as the appearance of antibodies in subjects seronegative at pre-vaccination, or at least 2-fold increase of pre-vaccination antibody concentrations in those who were initially seropositive at pre-vaccination.

Outcome measures

Measure	Synflorix Pooled Group n=37 Participants Subjects primary vaccinated at 6-10-14 weeks of age, receiving a booster dose of Synflorix™ vaccine, either co-administered with Tritanrix™-HepB/ Hiberix™ and Polio Sabin™ vaccines in the Philippines or co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines in Poland, at 12-18 months of age.	Prevenar Pooled Group n=15 Participants Subjects primary vaccinated at 6-10-14 weeks of age, receiving a booster dose of the Prevenar™ vaccine, either co-administered with Tritanrix™-HepB/ Hiberix™ and Polio Sabin™ vaccines in the Philippines or co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines in Poland, at 12-18 months of age.	Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group n=48 Participants Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of Synflorix™ vaccine co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines at 12-18 months of age.	Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group n=16 Participants Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of the Prevenar™ vaccine, co-administered with Tritanrix -HepB/ Hiberix™ and Poliorix™ at 12-18 months of age.
Number of Subjects With Vaccine Response to Anti-Bordetella Pertussis (BPT) Anti-BPT, S-	37 Participants	15 Participants	48 Participants	16 Participants
Number of Subjects With Vaccine Response to Anti-Bordetella Pertussis (BPT) Anti-BPT, S+	27 Participants	8 Participants	11 Participants	7 Participants

Adverse Events

Synflorix + Tritanrix -HepB/ Hiberix + Polio Sabin Group

Serious events: 6 serious events

Other events: 237 other events

Deaths: 0 deaths

Prevenar + Tritanrix - HepB/ Hiberix + Polio Sabin Group

Serious events: 1 serious events

Other events: 78 other events

Deaths: 1 deaths

Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group

Serious events: 14 serious events

Other events: 276 other events

Deaths: 0 deaths

Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group

Serious events: 5 serious events

Other events: 92 other events

Deaths: 0 deaths

Serious adverse events

Measure	Synflorix + Tritanrix -HepB/ Hiberix + Polio Sabin Group n=280 participants at risk Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of Synflorix™ vaccine, co-administered with Tritanrix™-HepB/ Hiberix™ and Polio Sabin™ vaccines at 12-18 months of age.	Prevenar + Tritanrix - HepB/ Hiberix + Polio Sabin Group n=93 participants at risk Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/ Hiberix™ and Polio Sabin™ at 12-18 months of age.	Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group n=285 participants at risk Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of Synflorix™ vaccine co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines at 12-18 months of age.	Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group n=98 participants at risk Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of the Prevenar™ vaccine, co-administered with Tritanrix -HepB/ Hiberix™ and Poliorix™ at 12-18 months of age.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.00% 0/280 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	1.1% 1/93 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	0.00% 0/285 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	0.00% 0/98 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.
Injury, poisoning and procedural complications Internal injury	0.00% 0/280 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	1.1% 1/93 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	0.00% 0/285 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	0.00% 0/98 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.
Injury, poisoning and procedural complications Thermal burn	0.00% 0/280 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	0.00% 0/93 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	0.35% 1/285 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	0.00% 0/98 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain neoplasm	0.00% 0/280 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	1.1% 1/93 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	0.00% 0/285 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	0.00% 0/98 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatoblastoma	0.00% 0/280 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	0.00% 0/93 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	0.35% 1/285 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	0.00% 0/98 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.
Blood and lymphatic system disorders Anaemia	0.00% 0/280 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	0.00% 0/93 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	0.00% 0/285 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	1.0% 1/98 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.
Blood and lymphatic system disorders Hypoglobulinaemia	0.00% 0/280 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	0.00% 0/93 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	0.00% 0/285 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	1.0% 1/98 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.
Blood and lymphatic system disorders Lymphadenitis	0.00% 0/280 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	0.00% 0/93 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	0.00% 0/285 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	1.0% 1/98 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.
Nervous system disorders Febrile convulsion	1.1% 3/280 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	0.00% 0/93 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	0.35% 1/285 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	0.00% 0/98 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.
General disorders Pyrexia	0.00% 0/280 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	0.00% 0/93 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	0.35% 1/285 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	0.00% 0/98 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.
Gastrointestinal disorders Diarrhoea	0.00% 0/280 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	0.00% 0/93 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	0.35% 1/285 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	1.0% 1/98 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.
Gastrointestinal disorders Enterocolitis haemorrhagic	0.00% 0/280 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	0.00% 0/93 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	0.00% 0/285 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	1.0% 1/98 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.
Gastrointestinal disorders Intussusception	0.00% 0/280 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	0.00% 0/93 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	0.00% 0/285 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	1.0% 1/98 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.
Metabolism and nutrition disorders Dehydration	0.36% 1/280 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	0.00% 0/93 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	0.00% 0/285 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	0.00% 0/98 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.
Infections and infestations Gastroenteritis	0.36% 1/280 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	0.00% 0/93 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	1.8% 5/285 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	2.0% 2/98 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.
Infections and infestations Pneumonia	0.36% 1/280 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	0.00% 0/93 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	1.1% 3/285 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	1.0% 1/98 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.
Infections and infestations Bronchitis	0.36% 1/280 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	0.00% 0/93 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	0.70% 2/285 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	0.00% 0/98 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.
Infections and infestations Pharyngitis	0.00% 0/280 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	0.00% 0/93 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	1.1% 3/285 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	0.00% 0/98 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.
Infections and infestations Gastroenteritis rotavirus	0.00% 0/280 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	0.00% 0/93 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	0.70% 2/285 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	0.00% 0/98 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.
Infections and infestations Amoebiasis	0.36% 1/280 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	0.00% 0/93 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	0.00% 0/285 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	0.00% 0/98 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.
Infections and infestations Clostridium difficile colitis	0.00% 0/280 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	0.00% 0/93 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	0.00% 0/285 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	1.0% 1/98 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.
Infections and infestations Infectious mononucleosis	0.00% 0/280 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	0.00% 0/93 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	0.35% 1/285 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	0.00% 0/98 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.
Infections and infestations Infestation	0.00% 0/280 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	0.00% 0/93 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	0.00% 0/285 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	1.0% 1/98 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.
Infections and infestations Nasopharyngitis	0.00% 0/280 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	0.00% 0/93 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	0.35% 1/285 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	0.00% 0/98 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.
Infections and infestations Otitis media	0.00% 0/280 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	0.00% 0/93 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	0.35% 1/285 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	0.00% 0/98 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.
Infections and infestations Pneumonia mycoplasmal	0.00% 0/280 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	0.00% 0/93 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	0.35% 1/285 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	0.00% 0/98 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.
Infections and infestations Rotavirus infection	0.00% 0/280 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	0.00% 0/93 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	0.35% 1/285 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	0.00% 0/98 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.
Infections and infestations Tonsillitis	0.00% 0/280 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	0.00% 0/93 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	0.35% 1/285 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	0.00% 0/98 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.
Infections and infestations Urinary tract infection	0.36% 1/280 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	0.00% 0/93 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	0.00% 0/285 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	0.00% 0/98 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.
Infections and infestations Wound	0.36% 1/280 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	0.00% 0/93 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	0.00% 0/285 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	0.00% 0/98 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.

Other adverse events

Measure	Synflorix + Tritanrix -HepB/ Hiberix + Polio Sabin Group n=280 participants at risk Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of Synflorix™ vaccine, co-administered with Tritanrix™-HepB/ Hiberix™ and Polio Sabin™ vaccines at 12-18 months of age.	Prevenar + Tritanrix - HepB/ Hiberix + Polio Sabin Group n=93 participants at risk Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/ Hiberix™ and Polio Sabin™ at 12-18 months of age.	Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group n=285 participants at risk Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of Synflorix™ vaccine co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines at 12-18 months of age.	Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group n=98 participants at risk Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of the Prevenar™ vaccine, co-administered with Tritanrix -HepB/ Hiberix™ and Poliorix™ at 12-18 months of age.
Metabolism and nutrition disorders Decreased appetite	34.6% 97/280 • Number of events 97 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	30.1% 28/93 • Number of events 28 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	64.6% 184/285 • Number of events 184 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	58.2% 57/98 • Number of events 57 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.
Skin and subcutaneous tissue disorders Erythema	38.2% 107/280 • Number of events 107 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	39.8% 37/93 • Number of events 37 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	69.1% 197/285 • Number of events 197 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	67.3% 66/98 • Number of events 66 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.
Psychiatric disorders Irritability	61.8% 173/280 • Number of events 173 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	68.8% 64/93 • Number of events 64 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	85.6% 244/285 • Number of events 244 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	80.6% 79/98 • Number of events 79 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.
Infections and infestations Nasopharyngitis	0.00% 0/280 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	0.00% 0/93 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	4.9% 14/285 • Number of events 15 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	5.1% 5/98 • Number of events 5 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.
General disorders Pain	72.5% 203/280 • Number of events 203 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	71.0% 66/93 • Number of events 66 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	87.0% 248/285 • Number of events 249 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	78.6% 77/98 • Number of events 77 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.
Infections and infestations Pharyngitis	0.00% 0/280 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	0.00% 0/93 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	1.4% 4/285 • Number of events 4 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	6.1% 6/98 • Number of events 8 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.
General disorders Pyrexia	49.3% 138/280 • Number of events 138 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	54.8% 51/93 • Number of events 51 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	75.4% 215/285 • Number of events 219 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	66.3% 65/98 • Number of events 65 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.
Infections and infestations Rhinitis	1.1% 3/280 • Number of events 3 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	2.2% 2/93 • Number of events 2 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	3.9% 11/285 • Number of events 11 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	5.1% 5/98 • Number of events 5 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.
Nervous system disorders Somnolence	32.1% 90/280 • Number of events 90 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	34.4% 32/93 • Number of events 32 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	66.7% 190/285 • Number of events 190 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	67.3% 66/98 • Number of events 66 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.
General disorders Swelling	32.9% 92/280 • Number of events 92 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	34.4% 32/93 • Number of events 32 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	55.4% 158/285 • Number of events 158 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	53.1% 52/98 • Number of events 52 • Solicited local and general symptoms during the 4-day and unsolicited AEs during the 31- day after booster vaccination; serious adverse events (SAEs): throughout the entire study period from Month 0 to Month 6 The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.

Additional Information

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