Trial Outcomes & Findings for Safety and Immunogenicity Study of GlaxoSmithKline (GSK) Biologicals' 10-valent Pneumococcal Conjugate Vaccine (NCT NCT00344318)

Last Updated: 2018-12-07

Results Overview

Fever was measured as rectal temperature. Assessment of occurrences of fever \> 39.0 °C was performed post doses 1, 2 and 3 and across doses of Synflorix™ or Prevenar™ vaccine.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

806 participants

Primary outcome timeframe

Within 4 day (Days 0-3) after each dose and across doses

Results posted on

2018-12-07

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

Participant milestones
Measure	Synflorix 1 Group Subjects aged 6-12 weeks from the Philippines receiving Synflorix™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ vaccines at 6, 10, 14 weeks of age.	Synflorix 2 Group Subjects aged 6-12 weeks from Poland receiving Synflorix™ vaccine co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines at 2, 4, 6 months of age.	Prevenar 1 Group Subjects aged 6-12 weeks from the Philippines receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ at 6, 10, 14 weeks of age.	Prevenar 2 Group Subjects aged 6-12 weeks from Poland receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ at 2, 4, 6 months of age.
Overall Study STARTED	300	303	100	103
Overall Study COMPLETED	296	298	99	100
Overall Study NOT COMPLETED	4	5	1	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Synflorix 1 Group Subjects aged 6-12 weeks from the Philippines receiving Synflorix™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ vaccines at 6, 10, 14 weeks of age.	Synflorix 2 Group Subjects aged 6-12 weeks from Poland receiving Synflorix™ vaccine co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines at 2, 4, 6 months of age.	Prevenar 1 Group Subjects aged 6-12 weeks from the Philippines receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ at 6, 10, 14 weeks of age.	Prevenar 2 Group Subjects aged 6-12 weeks from Poland receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ at 2, 4, 6 months of age.
Overall Study Adverse Event	0	3	0	1
Overall Study Withdrawal by Subject	2	2	0	2
Overall Study Lost to Follow-up	2	0	1	0

Baseline Characteristics

Safety and Immunogenicity Study of GlaxoSmithKline (GSK) Biologicals' 10-valent Pneumococcal Conjugate Vaccine

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Synflorix 1 Group n=300 Participants Subjects aged 6-12 weeks from the Philippines receiving Synflorix™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ vaccines at 6, 10, 14 weeks of age.	Synflorix 2 Group n=303 Participants Subjects aged 6-12 weeks from Poland receiving Synflorix™ vaccine co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines at 2, 4, 6 months of age.	Prevenar 1 Group n=100 Participants Subjects aged 6-12 weeks from the Philippines receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ at 6, 10, 14 weeks of age.	Prevenar 2 Group n=103 Participants Subjects aged 6-12 weeks from Poland receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ at 2, 4, 6 months of age.	Total n=806 Participants Total of all reporting groups
Age, Continuous	7.5 Weeks STANDARD_DEVIATION 1.64 • n=5 Participants	7.4 Weeks STANDARD_DEVIATION 1.5 • n=7 Participants	7.4 Weeks STANDARD_DEVIATION 1.53 • n=5 Participants	7.5 Weeks STANDARD_DEVIATION 1.55 • n=4 Participants	7.45 Weeks STANDARD_DEVIATION 1.56 • n=21 Participants
Sex: Female, Male Female	146 Participants n=5 Participants	141 Participants n=7 Participants	48 Participants n=5 Participants	46 Participants n=4 Participants	381 Participants n=21 Participants
Sex: Female, Male Male	154 Participants n=5 Participants	162 Participants n=7 Participants	52 Participants n=5 Participants	57 Participants n=4 Participants	425 Participants n=21 Participants

PRIMARY outcome

Timeframe: Within 4 day (Days 0-3) after each dose and across doses

Population: The analysis was performed on the Total vaccinated cohort, which included all subjects with at least one vaccine administration documented and who had their symptom sheets filled in. For reasons of safety analysis related to rectal temperature, subjects were pooled to form the Synflorix Pooled Group and Prevenar Group.

Fever was measured as rectal temperature. Assessment of occurrences of fever \> 39.0 °C was performed post doses 1, 2 and 3 and across doses of Synflorix™ or Prevenar™ vaccine.

Outcome measures

Outcome measures
Measure	Synflorix Pooled Group n=599 Participants Synflorix 1 Group and Synflorix 2 Group pooled together	Prevenar Pooled Group n=199 Participants Prevenar 1 Group and Prevenar 2 Group pooled together	Prevenar 1 Group Subjects aged 6-12 weeks from the Philippines receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ at 6, 10, 14 weeks of age.	Prevenar 2 Group Subjects aged 6-12 weeks from Poland receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ at 2, 4, 6 months of age.
Number of Subjects Reporting Rectal Temperature Above (>) 39.0 Degrees Celsius (°C) Fever > 39.0°C, post Dose 1	31 Participants	6 Participants	—	—
Number of Subjects Reporting Rectal Temperature Above (>) 39.0 Degrees Celsius (°C) Fever > 39.0°C, post Dose 2	30 Participants	13 Participants	—	—
Number of Subjects Reporting Rectal Temperature Above (>) 39.0 Degrees Celsius (°C) Fever > 39.0°C, post Dose 3	42 Participants	8 Participants	—	—
Number of Subjects Reporting Rectal Temperature Above (>) 39.0 Degrees Celsius (°C) Fever > 39.0°C, across doses	88 Participants	23 Participants	—	—

SECONDARY outcome

Timeframe: Within 4 day (Days 0-3) after each dose and across doses

Population: The analysis was performed on the Total vaccinated cohort, which included all subjects with at least one vaccine administration documented and who had their symptom sheets filled in.

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

Outcome measures

Outcome measures
Measure	Synflorix Pooled Group n=299 Participants Synflorix 1 Group and Synflorix 2 Group pooled together	Prevenar Pooled Group n=300 Participants Prevenar 1 Group and Prevenar 2 Group pooled together	Prevenar 1 Group n=99 Participants Subjects aged 6-12 weeks from the Philippines receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ at 6, 10, 14 weeks of age.	Prevenar 2 Group n=100 Participants Subjects aged 6-12 weeks from Poland receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ at 2, 4, 6 months of age.
Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms Grade 3 Swelling, Post Dose 1	41 Participants	43 Participants	15 Participants	9 Participants
Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms Any Pain, Post Dose 2	191 Participants	186 Participants	55 Participants	61 Participants
Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms Grade 3 Redness, Post Dose 2	8 Participants	9 Participants	1 Participants	2 Participants
Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms Any Redness, Post Dose 3	158 Participants	209 Participants	45 Participants	70 Participants
Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms Grade 3 Pain, Across Doses	64 Participants	83 Participants	22 Participants	25 Participants
Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms Any Swelling, Across Doses	174 Participants	226 Participants	42 Participants	75 Participants
Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms Any Pain, Post Dose 1	240 Participants	206 Participants	76 Participants	65 Participants
Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms Grade 3 Pain, Post Dose 1	52 Participants	59 Participants	19 Participants	17 Participants
Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms Any Redness, Post Dose 1	126 Participants	199 Participants	35 Participants	65 Participants
Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms Grade 3 Redness, Post Dose 1	10 Participants	30 Participants	6 Participants	8 Participants
Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms Any Swelling, Post Dose 1	142 Participants	153 Participants	39 Participants	56 Participants
Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms Grade 3 Pain, Post Dose 2	18 Participants	31 Participants	8 Participants	12 Participants
Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms Any Redness, Post Dose 2	135 Participants	204 Participants	44 Participants	59 Participants
Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms Any Swelling, Post Dose 2	98 Participants	163 Participants	29 Participants	51 Participants
Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms Grade 3 Swelling, Post Dose 2	27 Participants	19 Participants	5 Participants	5 Participants
Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms Any Pain, Post Dose 3	168 Participants	173 Participants	44 Participants	56 Participants
Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms Grade 3 Pain, Post Dose 3	14 Participants	23 Participants	1 Participants	8 Participants
Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms Grade 3 Redness, Post Dose 3	3 Participants	8 Participants	0 Participants	4 Participants
Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms Any Swelling, Post Dose 3	84 Participants	151 Participants	25 Participants	53 Participants
Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms Grade 3 Swelling, Post Dose 3	15 Participants	19 Participants	4 Participants	10 Participants
Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms Any Pain, Across Doses	258 Participants	255 Participants	82 Participants	89 Participants
Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms Any Redness, Across Doses	221 Participants	265 Participants	67 Participants	90 Participants
Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms Grade 3 Redness, Across Doses	18 Participants	42 Participants	6 Participants	12 Participants
Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms Grade 3 Swelling, Across Doses	57 Participants	65 Participants	16 Participants	16 Participants

SECONDARY outcome

Timeframe: Within 4-day (Days 0-3) after each dose and across doses

Population: The analysis was performed on the Total vaccinated cohort, which included all subjects with at least one vaccine administration documented and who had their symptom sheets filled in.

Solicited general symptoms assessed include drowsiness, fever (defined as rectal temperature ≥ 38.0°C), irritability, and loss of appetite. Grade 3 (G3) drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 (G3) fever was defined as fever (rectal temperature) above (\>) 40.0 degree Celsius (°C). Grade 3 (G3) irritability was defined as crying that could not be comforted/preventing normal activity. Grade 3 (G3) loss of appetite was defined as the subject not eating at all. "Any" is defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination. Related (REL) = Symptom assessed by the investigator as causally related to vaccination.

Outcome measures

Outcome measures
Measure	Synflorix Pooled Group n=299 Participants Synflorix 1 Group and Synflorix 2 Group pooled together	Prevenar Pooled Group n=300 Participants Prevenar 1 Group and Prevenar 2 Group pooled together	Prevenar 1 Group n=99 Participants Subjects aged 6-12 weeks from the Philippines receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ at 6, 10, 14 weeks of age.	Prevenar 2 Group n=100 Participants Subjects aged 6-12 weeks from Poland receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ at 2, 4, 6 months of age.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms G3 Fever, Dose 1	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms REL Drowsiness Dose 1	154 Participants	222 Participants	45 Participants	75 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fever, Dose 3	147 Participants	163 Participants	50 Participants	49 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fever, Dose 1	214 Participants	190 Participants	74 Participants	54 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms REL Fever, Dose 1	214 Participants	190 Participants	74 Participants	54 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Irritability, Dose 1	236 Participants	269 Participants	78 Participants	83 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms G3 Irritability, Dose 1	11 Participants	60 Participants	3 Participants	17 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms REL Irritability, Dose 1	236 Participants	266 Participants	78 Participants	83 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Loss of appetite, Dose 1	104 Participants	166 Participants	26 Participants	52 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms G3 Loss of appetite, Dose 1	1 Participants	1 Participants	1 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms REL Loss of appetite, Dose 1	104 Participants	165 Participants	26 Participants	51 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms G3 Fever, Dose 3	0 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Drowsiness, Dose 2	102 Participants	172 Participants	25 Participants	57 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms G3 Drowsiness, Dose 2	1 Participants	9 Participants	1 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms REL Drowsiness, Dose 2	102 Participants	172 Participants	24 Participants	56 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fever, Dose 2	182 Participants	184 Participants	63 Participants	51 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms G3 Fever, Dose 2	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms REL Fever, Dose 2	182 Participants	184 Participants	63 Participants	50 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Irritability, Dose 2	185 Participants	238 Participants	49 Participants	73 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms G3 Irritability, Dose 2	8 Participants	37 Participants	3 Participants	9 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms G3 Drowsiness, Dose 1	6 Participants	10 Participants	3 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms REL Loss of appetite, Dose 2	66 Participants	116 Participants	19 Participants	27 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Irritability, Dose 3	169 Participants	225 Participants	43 Participants	64 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms REL Irritability, Dose 3	169 Participants	223 Participants	43 Participants	64 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Loss of appetite, Dose 3	61 Participants	113 Participants	19 Participants	19 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms REL Loss of appetite, Dose 3	61 Participants	113 Participants	19 Participants	19 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Drowsiness, Across Doses	184 Participants	256 Participants	56 Participants	85 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms REL Irritability, Dose 2	185 Participants	237 Participants	48 Participants	72 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Loss of appetite, Dose 2	66 Participants	117 Participants	20 Participants	28 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms REL Fever, Dose 3	147 Participants	162 Participants	50 Participants	49 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms G3 Loss of appetite, Dose 2	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Drowsiness, Dose 3	90 Participants	152 Participants	25 Participants	41 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms G3 Drowsiness, Dose 3	2 Participants	5 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms REL Drowsiness, Dose 3	90 Participants	151 Participants	25 Participants	40 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Drowsiness, Dose 1	154 Participants	223 Participants	45 Participants	75 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms G3 Irritability, Dose 3	7 Participants	22 Participants	1 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms G3 Loss of appetite, Dose 3	1 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms G3 Drowsiness, Across Doses	9 Participants	17 Participants	3 Participants	3 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms REL Drowsiness, Across Doses	184 Participants	256 Participants	56 Participants	85 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fever, Across Doses	255 Participants	261 Participants	88 Participants	77 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms G3 Fever, Across Doses	0 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms REL Fever, Across Doses	255 Participants	261 Participants	88 Participants	77 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Irritability, Across Doses	258 Participants	289 Participants	82 Participants	93 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms G3 Irritability, Across Doses	22 Participants	89 Participants	6 Participants	24 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms REL Irritability, Across Doses	258 Participants	289 Participants	82 Participants	93 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Loss of appetite, Across	140 Participants	221 Participants	39 Participants	64 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms G3 Loss of appetite, Across	1 Participants	2 Participants	1 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms REL Loss of appetite, Across	140 Participants	220 Participants	39 Participants	63 Participants

SECONDARY outcome

Timeframe: Within 31 days (Days 0-30) after each vaccination

Population: The analysis was performed on the Total vaccinated cohort, which included all subjects with at least one vaccine administration documented.

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" is defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.

Outcome measures

Outcome measures
Measure	Synflorix Pooled Group n=300 Participants Synflorix 1 Group and Synflorix 2 Group pooled together	Prevenar Pooled Group n=303 Participants Prevenar 1 Group and Prevenar 2 Group pooled together	Prevenar 1 Group n=100 Participants Subjects aged 6-12 weeks from the Philippines receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ at 6, 10, 14 weeks of age.	Prevenar 2 Group n=103 Participants Subjects aged 6-12 weeks from Poland receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ at 2, 4, 6 months of age.
Number of Subjects With Unsolicited Adverse Events (AEs)	168 Participants	166 Participants	46 Participants	61 Participants

SECONDARY outcome

Timeframe: During the Active Phase: From Month 0 to Month 3 for Synflorix 1 Group and Prevenar 1 Group and from Month 0 to Month 5 for the Synflorix 2 Group and Prevenar 2 Group

Population: The analysis was performed on the Total vaccinated cohort, which included all subjects with at least one vaccine administration documented.

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

Outcome measures

Outcome measures
Measure	Synflorix Pooled Group n=300 Participants Synflorix 1 Group and Synflorix 2 Group pooled together	Prevenar Pooled Group n=303 Participants Prevenar 1 Group and Prevenar 2 Group pooled together	Prevenar 1 Group n=100 Participants Subjects aged 6-12 weeks from the Philippines receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ at 6, 10, 14 weeks of age.	Prevenar 2 Group n=103 Participants Subjects aged 6-12 weeks from Poland receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ at 2, 4, 6 months of age.
Number of Subjects With Serious Adverse Events (SAEs)	6 Participants	34 Participants	1 Participants	9 Participants

SECONDARY outcome

Timeframe: During the Extended Safety Follow-Up Phase: At Month 8 for Synflorix 1 Group and Prevenar 1 Group and at Month 10 for the Synflorix 2 Group and Prevenar 2 Group

Population: The analysis was performed on the Total vaccinated cohort, which included all subjects with at least one vaccine administration documented.

Outcome measures

Outcome measures
Measure	Synflorix Pooled Group n=300 Participants Synflorix 1 Group and Synflorix 2 Group pooled together	Prevenar Pooled Group n=303 Participants Prevenar 1 Group and Prevenar 2 Group pooled together	Prevenar 1 Group n=100 Participants Subjects aged 6-12 weeks from the Philippines receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ at 6, 10, 14 weeks of age.	Prevenar 2 Group n=103 Participants Subjects aged 6-12 weeks from Poland receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ at 2, 4, 6 months of age.
Number of Subjects With Serious Adverse (SAEs)	16 Participants	52 Participants	4 Participants	19 Participants

SECONDARY outcome

Timeframe: One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™

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

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

Outcome measures
Measure	Synflorix Pooled Group n=285 Participants Synflorix 1 Group and Synflorix 2 Group pooled together	Prevenar Pooled Group n=285 Participants Prevenar 1 Group and Prevenar 2 Group pooled together	Prevenar 1 Group n=95 Participants Subjects aged 6-12 weeks from the Philippines receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ at 6, 10, 14 weeks of age.	Prevenar 2 Group n=96 Participants Subjects aged 6-12 weeks from Poland receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ at 2, 4, 6 months of age.
Concentrations of Antibodies Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Anti-1 POST	3.23 μg/mL Interval 2.94 to 3.54	1.04 μg/mL Interval 0.94 to 1.15	0.03 μg/mL Interval 0.03 to 0.4	0.03 μg/mL Interval 0.03 to 0.03
Concentrations of Antibodies Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Anti-4 POST	4.96 μg/mL Interval 4.46 to 5.51	1.64 μg/mL Interval 1.49 to 1.8	5.68 μg/mL Interval 4.94 to 6.53	2.14 μg/mL Interval 1.88 to 2.44
Concentrations of Antibodies Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Anti-5 POST	4.87 μg/mL Interval 4.5 to 5.26	1.62 μg/mL Interval 1.48 to 1.78	0.03 μg/mL Interval 0.03 to 0.04	0.03 μg/mL Interval 0.03 to 0.03
Concentrations of Antibodies Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Anti-6B POST	1.19 μg/mL Interval 1.02 to 1.38	0.73 μg/mL Interval 0.64 to 0.84	1.06 μg/mL Interval 0.8 to 1.4	1.23 μg/mL Interval 0.96 to 1.58
Concentrations of Antibodies Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Anti-7F POST	4.84 μg/mL Interval 4.45 to 5.27	2.25 μg/mL Interval 2.07 to 2.45	0.05 μg/mL Interval 0.04 to 0.06	0.04 μg/mL Interval 0.03 to 0.04
Concentrations of Antibodies Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Anti-9V POST	4.04 μg/mL Interval 3.66 to 4.46	1.51 μg/mL Interval 1.37 to 1.66	5.07 μg/mL Interval 4.32 to 5.96	2.7 μg/mL Interval 2.32 to 3.14
Concentrations of Antibodies Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Anti-14 POST	6.45 μg/mL Interval 5.65 to 7.38	3.31 μg/mL Interval 2.98 to 3.68	5.88 μg/mL Interval 4.71 to 7.34	5.23 μg/mL Interval 4.39 to 6.24
Concentrations of Antibodies Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Anti-18C POST	11.56 μg/mL Interval 10.22 to 13.08	3.74 μg/mL Interval 3.28 to 4.28	3.71 μg/mL Interval 3.14 to 4.38	2.64 μg/mL Interval 2.25 to 3.11
Concentrations of Antibodies Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Anti-19F POST	10.46 μg/mL Interval 9.32 to 11.74	5.3 μg/mL Interval 4.77 to 5.89	4.68 μg/mL Interval 4.02 to 5.45	2.38 μg/mL Interval 2.04 to 2.78
Concentrations of Antibodies Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Anti-23F POST	2.23 μg/mL Interval 1.98 to 2.5	1.11 μg/mL Interval 0.98 to 1.26	2.28 μg/mL Interval 1.7 to 3.06	2.2 μg/mL Interval 1.83 to 2.65

SECONDARY outcome

Timeframe: One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™

Cut-off values assessed were greater than or equal to 0.2 microgram per milliliter (µg/mL) in the sera of subjects.

Outcome measures

Outcome measures
Measure	Synflorix Pooled Group n=285 Participants Synflorix 1 Group and Synflorix 2 Group pooled together	Prevenar Pooled Group n=285 Participants Prevenar 1 Group and Prevenar 2 Group pooled together	Prevenar 1 Group n=95 Participants Subjects aged 6-12 weeks from the Philippines receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ at 6, 10, 14 weeks of age.	Prevenar 2 Group n=96 Participants Subjects aged 6-12 weeks from Poland receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ at 2, 4, 6 months of age.
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.2 Microgram Per Milliliter (µg/mL) Anti-1 POST	285 Participants	280 Participants	3 Participants	3 Participants
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.2 Microgram Per Milliliter (µg/mL) Anti-4 POST	283 Participants	282 Participants	95 Participants	96 Participants
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.2 Microgram Per Milliliter (µg/mL) Anti-5 POST	285 Participants	282 Participants	3 Participants	2 Participants
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.2 Microgram Per Milliliter (µg/mL) Anti-6B POST	260 Participants	244 Participants	82 Participants	91 Participants
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.2 Microgram Per Milliliter (µg/mL) Anti-7F POST	284 Participants	285 Participants	9 Participants	5 Participants
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.2 Microgram Per Milliliter (µg/mL) Anti-9V POST	284 Participants	285 Participants	95 Participants	96 Participants
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.2 Microgram Per Milliliter (µg/mL) Anti-14 POST	285 Participants	285 Participants	95 Participants	96 Participants
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.2 Microgram Per Milliliter (µg/mL) Anti-18C POST	284 Participants	281 Participants	95 Participants	95 Participants
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.2 Microgram Per Milliliter (µg/mL) Anti-19F POST	285 Participants	282 Participants	94 Participants	95 Participants
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.2 Microgram Per Milliliter (µg/mL) Anti-23F POST	277 Participants	269 Participants	90 Participants	95 Participants

SECONDARY outcome

Timeframe: One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™

Cut-off values assessed were greater than or equal to 0.05 microgram per liter (µg/mL) in the sera of subjects.

Outcome measures

Outcome measures
Measure	Synflorix Pooled Group n=285 Participants Synflorix 1 Group and Synflorix 2 Group pooled together	Prevenar Pooled Group n=285 Participants Prevenar 1 Group and Prevenar 2 Group pooled together	Prevenar 1 Group n=95 Participants Subjects aged 6-12 weeks from the Philippines receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ at 6, 10, 14 weeks of age.	Prevenar 2 Group n=96 Participants Subjects aged 6-12 weeks from Poland receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ at 2, 4, 6 months of age.
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.05 Microgram Per Liter (µg/mL) Anti-4 POST	285 Participants	285 Participants	95 Participants	96 Participants
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.05 Microgram Per Liter (µg/mL) Anti-6B POST	279 Participants	274 Participants	92 Participants	91 Participants
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.05 Microgram Per Liter (µg/mL) Anti-23F POST	285 Participants	279 Participants	91 Participants	96 Participants
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.05 Microgram Per Liter (µg/mL) Anti-1 POST	285 Participants	285 Participants	20 Participants	13 Participants
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.05 Microgram Per Liter (µg/mL) Anti-5 POST	285 Participants	285 Participants	19 Participants	13 Participants
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.05 Microgram Per Liter (µg/mL) Anti-7F POST	285 Participants	285 Participants	37 Participants	22 Participants
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.05 Microgram Per Liter (µg/mL) Anti-9V POST	285 Participants	285 Participants	95 Participants	96 Participants
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.05 Microgram Per Liter (µg/mL) Anti-14 POST	285 Participants	285 Participants	95 Participants	96 Participants
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.05 Microgram Per Liter (µg/mL) Anti-18C POST	284 Participants	285 Participants	95 Participants	95 Participants
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.05 Microgram Per Liter (µg/mL) Anti-19F POST	285 Participants	285 Participants	95 Participants	95 Participants

SECONDARY outcome

Timeframe: One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™

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

Outcome measures

Outcome measures
Measure	Synflorix Pooled Group n=142 Participants Synflorix 1 Group and Synflorix 2 Group pooled together	Prevenar Pooled Group n=145 Participants Prevenar 1 Group and Prevenar 2 Group pooled together	Prevenar 1 Group n=46 Participants Subjects aged 6-12 weeks from the Philippines receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ at 6, 10, 14 weeks of age.	Prevenar 2 Group n=49 Participants Subjects aged 6-12 weeks from Poland receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ at 2, 4, 6 months of age.
Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F OPA Anti-5	209.3 Titers Interval 176.6 to 248.0	67.2 Titers Interval 52.2 to 86.6	4 Titers Interval 4.0 to 4.0	4 Titers Interval 4.0 to 4.0
Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F OPA Anti-9V	1631.9 Titers Interval 1343.8 to 1981.9	1171.7 Titers Interval 966.1 to 1421.1	1713.3 Titers Interval 1294.6 to 2267.5	1166 Titers Interval 782.6 to 1737.2
Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F OPA Anti-1	93.7 Titers Interval 68.2 to 128.7	14.8 Titers Interval 11.2 to 19.6	4.2 Titers Interval 3.8 to 4.5	4 Titers Interval 4.0 to 4.0
Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F OPA Anti-4	1008.7 Titers Interval 849.1 to 1198.4	602.9 Titers Interval 494.8 to 734.6	1229.9 Titers Interval 975.5 to 1550.7	513 Titers Interval 388.2 to 677.9
Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F OPA Anti-6B	963.5 Titers Interval 714.7 to 1299.0	361.9 Titers Interval 255.0 to 513.7	1762.2 Titers Interval 975.3 to 3184.0	805 Titers Interval 436.9 to 1483.4
Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F OPA Anti-7F	5196.4 Titers Interval 4349.2 to 6208.6	2002.2 Titers Interval 1543.1 to 2597.9	14.2 Titers Interval 6.9 to 29.4	6.9 Titers Interval 4.3 to 11.1
Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F OPA Anti-14	1669.1 Titers Interval 1267.7 to 2197.6	640 Titers Interval 520.2 to 787.5	2117.4 Titers Interval 1210.9 to 3702.6	947.6 Titers Interval 658.6 to 1363.4
Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F OPA Anti-18C	673.3 Titers Interval 569.7 to 795.8	174.9 Titers Interval 137.1 to 223.1	283.7 Titers Interval 209.6 to 384.1	127 Titers Interval 86.4 to 186.5
Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F OPA Anti-19F	1121.7 Titers Interval 931.5 to 1350.6	337.8 Titers Interval 262.9 to 434.1	81.6 Titers Interval 53.0 to 125.5	35.9 Titers Interval 25.7 to 50.1
Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F OPA Anti-23F	2186.6 Titers Interval 1845.4 to 2590.9	920.6 Titers Interval 678.0 to 1249.9	4126.6 Titers Interval 2609.0 to 6526.8	3895.4 Titers Interval 2842.8 to 5337.8

SECONDARY outcome

Timeframe: One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™

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

Outcome measures

Outcome measures
Measure	Synflorix Pooled Group n=142 Participants Synflorix 1 Group and Synflorix 2 Group pooled together	Prevenar Pooled Group n=145 Participants Prevenar 1 Group and Prevenar 2 Group pooled together	Prevenar 1 Group n=46 Participants Subjects aged 6-12 weeks from the Philippines receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ at 6, 10, 14 weeks of age.	Prevenar 2 Group n=49 Participants Subjects aged 6-12 weeks from Poland receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ at 2, 4, 6 months of age.
Number of Subjects With Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Equal to or Above (≥) 8 OPA Anti-1	117 Participants	62 Participants	1 Participants	0 Participants
Number of Subjects With Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Equal to or Above (≥) 8 OPA Anti-4	137 Participants	143 Participants	43 Participants	49 Participants
Number of Subjects With Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Equal to or Above (≥) 8 OPA Anti-5	139 Participants	127 Participants	0 Participants	0 Participants
Number of Subjects With Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Equal to or Above (≥) 8 OPA Anti-6B	132 Participants	122 Participants	40 Participants	44 Participants
Number of Subjects With Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Equal to or Above (≥) 8 OPA Anti-7F	137 Participants	141 Participants	10 Participants	5 Participants
Number of Subjects With Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Equal to or Above (≥) 8 OPA Anti-9V	130 Participants	144 Participants	43 Participants	49 Participants
Number of Subjects With Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Equal to or Above (≥) 8 OPA Anti-14	138 Participants	142 Participants	43 Participants	48 Participants
Number of Subjects With Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Equal to or Above (≥) 8 OPA Anti-18C	138 Participants	137 Participants	45 Participants	48 Participants
Number of Subjects With Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Equal to or Above (≥) 8 OPA Anti-19F	137 Participants	142 Participants	42 Participants	45 Participants
Number of Subjects With Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Equal to or Above (≥) 8 OPA Anti-23F	141 Participants	132 Participants	42 Participants	49 Participants

SECONDARY outcome

Timeframe: One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™

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

Outcome measures

Outcome measures
Measure	Synflorix Pooled Group n=285 Participants Synflorix 1 Group and Synflorix 2 Group pooled together	Prevenar Pooled Group n=285 Participants Prevenar 1 Group and Prevenar 2 Group pooled together	Prevenar 1 Group n=95 Participants Subjects aged 6-12 weeks from the Philippines receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ at 6, 10, 14 weeks of age.	Prevenar 2 Group n=96 Participants Subjects aged 6-12 weeks from Poland receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ at 2, 4, 6 months of age.
Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A Anti-6A	0.3 μg/mL Interval 0.26 to 0.35	0.17 μg/mL Interval 0.15 to 0.2	0.23 μg/mL Interval 0.18 to 0.3	0.26 μg/mL Interval 0.2 to 0.33
Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A Anti-19A	0.36 μg/mL Interval 0.31 to 0.41	0.29 μg/mL Interval 0.25 to 0.34	0.18 μg/mL Interval 0.15 to 0.22	0.12 μg/mL Interval 0.1 to 0.15

SECONDARY outcome

Timeframe: One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™

Cut-off values assessed were greater than or equal to 0.05 microgram per milliliter (μg/mL) in the sera of subjects seronegative before vaccination.

Outcome measures

Outcome measures
Measure	Synflorix Pooled Group n=285 Participants Synflorix 1 Group and Synflorix 2 Group pooled together	Prevenar Pooled Group n=285 Participants Prevenar 1 Group and Prevenar 2 Group pooled together	Prevenar 1 Group n=95 Participants Subjects aged 6-12 weeks from the Philippines receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ at 6, 10, 14 weeks of age.	Prevenar 2 Group n=96 Participants Subjects aged 6-12 weeks from Poland receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ at 2, 4, 6 months of age.
Number of Subjects With Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A Equal to or Above (≥) 0.05 Microgram Per Milliliter (μg/mL) Anti-6A	261 Participants	230 Participants	84 Participants	84 Participants
Number of Subjects With Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A Equal to or Above (≥) 0.05 Microgram Per Milliliter (μg/mL) Anti-19A	169 Participants	164 Participants	90 Participants	83 Participants

SECONDARY outcome

Timeframe: One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™

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

Outcome measures

Outcome measures
Measure	Synflorix Pooled Group n=137 Participants Synflorix 1 Group and Synflorix 2 Group pooled together	Prevenar Pooled Group n=143 Participants Prevenar 1 Group and Prevenar 2 Group pooled together	Prevenar 1 Group n=44 Participants Subjects aged 6-12 weeks from the Philippines receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ at 6, 10, 14 weeks of age.	Prevenar 2 Group n=49 Participants Subjects aged 6-12 weeks from Poland receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ at 2, 4, 6 months of age.
Opsonophagocytic Activity (OPA) Against Cross-reactive Pneumococcal Serotypes 6A and 19A OPA Anti-6A	93.1 Titers Interval 64.1 to 135.2	60.5 Titers Interval 40.7 to 89.9	137.3 Titers Interval 69.7 to 270.3	175.1 Titers Interval 87.2 to 351.6
Opsonophagocytic Activity (OPA) Against Cross-reactive Pneumococcal Serotypes 6A and 19A OPA Anti-19A	10.6 Titers Interval 7.9 to 14.2	10.1 Titers Interval 7.8 to 13.1	4.2 Titers Interval 3.8 to 4.7	4 Titers Interval 4.0 to 4.0

SECONDARY outcome

Timeframe: One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™

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

Outcome measures

Outcome measures
Measure	Synflorix Pooled Group n=137 Participants Synflorix 1 Group and Synflorix 2 Group pooled together	Prevenar Pooled Group n=143 Participants Prevenar 1 Group and Prevenar 2 Group pooled together	Prevenar 1 Group n=44 Participants Subjects aged 6-12 weeks from the Philippines receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ at 6, 10, 14 weeks of age.	Prevenar 2 Group n=49 Participants Subjects aged 6-12 weeks from Poland receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ at 2, 4, 6 months of age.
Number of Subjects With Opsonophagocytic Activity (OPA) Against Cross-reactive Pneumococcal Serotypes 6A and 19A Equal to or Above (≥) 8 OPA Anti-6A	91 Participants	83 Participants	34 Participants	36 Participants
Number of Subjects With Opsonophagocytic Activity (OPA) Against Cross-reactive Pneumococcal Serotypes 6A and 19A Equal to or Above (≥) 8 OPA Anti-19A	35 Participants	41 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™

Seropositivity status, defined as Anti-PD antibody concentrations ≥ 100 ELISA units per milliliter ( EL.U/mL)

Outcome measures

Outcome measures
Measure	Synflorix Pooled Group n=284 Participants Synflorix 1 Group and Synflorix 2 Group pooled together	Prevenar Pooled Group n=285 Participants Prevenar 1 Group and Prevenar 2 Group pooled together	Prevenar 1 Group n=95 Participants Subjects aged 6-12 weeks from the Philippines receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ at 6, 10, 14 weeks of age.	Prevenar 2 Group n=96 Participants Subjects aged 6-12 weeks from Poland receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ at 2, 4, 6 months of age.
Concentrations of Antibodies Against Protein D (Anti-PD)	3800 EL.U/mL Interval 3481.2 to 4148.0	2002 EL.U/mL Interval 1780.0 to 2251.6	105.2 EL.U/mL Interval 85.3 to 129.6	66.6 EL.U/mL Interval 58.5 to 75.8

SECONDARY outcome

Timeframe: One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™

Cut-off values assessed were greater than or equal to 100 ELISA units per milliliter (EL.U/mL) in the sera of subjects.