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

Booster Vaccination Course With the Pneumococcal Vaccine GSK 1024850A, DTPw-HBV/Hib and OPV or IPV in Children Who Completed the Primary Vaccination Course in Study 107007

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00547248

Enrollment

756

Registered

2007-10-22

Start date

2007-10-22

Completion date

2008-10-07

Last updated

2019-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infections, Streptococcal

Keywords

Booster vaccination., Immunogenicity, Pneumococcal vaccine, Safety, Pneumococcal disease

Brief summary

The purpose of this observer blind study is to assess the safety in terms of fever \>39°C (rectal temperature) and the immunogenicity in terms of antibody response following a booster vaccination with pneumococcal vaccine GSK 1024850A at 12 to 18 months of age in children previously primed with the same vaccines including a pneumococcal conjugate vaccine co-administered with a diphtheria, tetanus, whole cell pertussis (DTPw)-combined vaccine and OPV or IPV vaccines. Subjects participating in this study should have received three doses of pneumococcal conjugate vaccine in the primary study. This protocol posting deals with objectives & outcome measures of the booster phase. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00344318)

Detailed description

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007

Interventions

BIOLOGICALSynflorix

Intramuscular injection, 1 dose

BIOLOGICALTritanrix-HepB

Intramuscular injection, 1 dose

BIOLOGICALHiberix

Reconstituted with Tritanrix-Hep B before injection

BIOLOGICALPolio Sabin

Oral, 1 dose

BIOLOGICALPoliorix

Intramuscular injection, 1 dose

BIOLOGICALPrevenar (Wyeth)

Intramuscular injection, 1 dose

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

12 Months to 18 Months

Healthy volunteers

Yes

Inclusion criteria

* Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol. * A male or female between, and including, 12-18 months of age at the time of the booster vaccination and who previously participated in study 107007 and received three doses of pneumococcal conjugate vaccine. * Written informed consent obtained from the parent or guardian of the subject. * Free of obvious health problems as established by medical history and clinical examination before entering into the study.

Exclusion criteria

* Concurrently participating in another clinical study, at any time during the study period (active phase and extended safety follow-up), in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device). * Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within one month preceding the booster dose of study vaccines, or planned use during the entire study period * Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the booster dose of study vaccines. * Planned administration/administration of a vaccine not foreseen by the study protocol, during the period starting one month before the booster dose of study vaccines and up to the follow-up visit. * Administration of any pneumococcal, diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b vaccine other than the study vaccines from study 107007. * History of, or intercurrent diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b diseases. * History of allergic disease or reactions likely to be exacerbated by any component of the vaccines. * History of seizures (this criterion does not apply to subjects who have had a single, uncomplicated febrile convulsion in the past) or progressive neurological disease. * Acute disease at the time of enrolment. * Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination * A family history of congenital or hereditary immunodeficiency. * Major congenital defects or serious chronic illness. * Administration of immunoglobulins and/or any blood products within three months preceding the booster dose of study vaccines or planned administration during the active phase of the study.

Design outcomes

Primary

Measure	Time frame	Description
Number of Subjects Reporting Rectal Temperature Greater Than (>) the Cut-off	Within the 4-day (Days 0-3) period after booster vaccination	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.

Secondary

Measure	Time frame	Description
Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Within the 4-day (Days 0-3) period after booster vaccination	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).
Number of Subjects With Any and Grade 3 Solicited General Symptoms	Within the 4-day (Days 0-3) period after booster vaccination	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.
Number of Subjects With Unsolicited Adverse Events (AEs)	Within the 31-day (Days 0-30) period after booster vaccination	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.
Number of Subjects With Serious Adverse Events (SAEs)	Throughout the active phase of the study (Month 0 to Month 1)	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.
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off	Prior to (Month 0) and one month after booster vaccination (Month 1)	The cut-off was 0.20 microgram per milliliter (μg/mL).
Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations	Prior to (Month 0) and one month after booster vaccination (Month 1)	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).
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	Prior to (Month 0) and one month after booster vaccination (Month 1)	Seropositivity status, defined as Opsonophagocytic activity against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ 8.
Antibody Concentrations to Protein D (Anti-PD)	Prior to (Month 0) and one month after booster vaccination (Month 1)	Seropositivity status, defined as anti-PD antibody concentrations ≥100 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A	Prior to (Month 0) and one month after booster vaccination (Month 1)	Seropositivity status, defined as anti-pneumococcal cross-reactive serotypes 6A and 19A antibody concentrations ≥ 0.05 microgram per milliliter (μg/mL).
Opsonophagocytic Activity (OPA) Against Pneumococcal Cross-reactive Serotypes 6A and 19A	Prior to (Month 0) and one month after booster vaccination (Month 1)	Seropositivity status, defined as Opsonophagocytic activity against pneumococcal cross-reactive serotypes 6A and 19A ≥ 8.
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	Prior to (Month 0) and one month after booster vaccination (Month 1)	The cut-off for the assay was 8.
Number of Subjects With Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A ≥ the Cut-off	Prior to (Month 0) and one month after booster vaccination (Month 1)	The cut-of for the assay was 0.05 μg/mL.
Number of Subjects With Opsonophagocytic Activity (OPA) Against Pneumococcal Cross-reactive Serotypes 6A and 19A ≥ the Cut-off	Prior to (Month 0) and one month after booster vaccination (Month 1)	The cut-off for the assay was 8.
Number of Subjects With Antibody Concentrations Against Protein D (Anti-PD) ≥ the Cut-off	Prior to (Month 0) and one month after booster vaccination (Month 1)	The cut-off for the assay was 100 ELISA units per milliliter (EL.U/mL).
Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations	Prior to (Month 0) and one month after booster vaccination (Month 1)	Seroprotection status, defined as anti-diphtheria toxoid or anti-tetanus toxoid antibody concentrations ≥ 0.1 international units per milliliter (IU/mL).
Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentrations	Prior to (Month 0) and one month after booster vaccination (Month 1)	Seroprotection status, defined as anti-PRP antibody concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL.
Anti-Bordetella Pertussis (BPT) Antibody Concentrations	Prior to (Month 0) and one month after booster vaccination (Month 1)	Seropositivity status, defined as anti-BPT antibody concentrations ≥ 15 EL.U/mL.
Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations	Prior to (Month 0) and one month after booster vaccination (Month 1)	Seroprotection status, defined as anti-HBs antibody concentrations ≥ 10 milli international units per milliliter (mIU/mL).
Anti-polio Type 1, 2 and 3 Antibody Titers	Prior to (Month 0) and one month after booster vaccination (Month 1)	Seroprotection status, defined as anti-polio type 1, anti-polio type 2 and anti-polio type 3 antibody titers ≥ 8.
Number of Subjects With Anti-Bordetella Pertussis (BPT) With Concentrations ≥ the Cut-off	Prior to (Month 0) and one month after booster vaccination (Month 1)	The cut-off for the assay was 15 EL.U/mL.
Number of Subjects With Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations ≥ the Cut-off	Prior to (Month 0) and one month after booster vaccination (Month 1)	The cut-off for the assay was 0.1 milli-international units per milliliter (mIU/mL).
Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration ≥ the Cut-off	Prior to (Month 0) and one month after booster vaccination (Month 1)	The cut-off for the assay was 0.15 μg/mL.
Number of Subjects With Anti-PRP Antibody Concentration ≥ the Cut-off	Prior to (Month 0) and one month after booster vaccination (Month 1)	The cut-off for the assay was 1.0 μg/mL.
Number of Subjects With Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations ≥ the Cut-off	Prior to (Month 0) and one month after booster vaccination (Month 1)	The cut-off for the assay was 10 mIU/mL.
Number of Subjects With Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Antibody Titers ≥ the Cut-off	Prior to (Month 0) and one month after booster vaccination (Month 1)	The cut-off for the assay was 8.
Number of Subjects With Vaccine Response to Anti-Bordetella Pertussis (BPT)	One month after booster vaccination (Month 1)	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.

Countries

Philippines, Poland

Participant flow

Pre-assignment details

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

Participants by arm

Arm	Count
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.	280
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.	93
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.	285
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.	98
Total	756

Withdrawals & dropouts

Period	Reason	FG002	FG003
Overall Study	Migrated/moved from study area	2	0
Overall Study	Protocol Violation	1	1
Overall Study	Withdrawal by Subject	7	1

Baseline characteristics

Characteristic	Synflorix + Tritanrix -HepB/ Hiberix + Polio Sabin Group	Prevenar + Tritanrix - HepB/ Hiberix + Polio Sabin Group	Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Prevenar + Tritanrix - HepB/ Hiberix + Poliorix Group	Total
Age, Continuous	16.2 Months STANDARD_DEVIATION 0.66	16.2 Months STANDARD_DEVIATION 0.59	17.2 Months STANDARD_DEVIATION 0.84	17.2 Months STANDARD_DEVIATION 0.88	16.71 Months STANDARD_DEVIATION 0.9
Race/Ethnicity, Customized Geographic ancestry Asian - south east Asian heritage	280 Participants	93 Participants	0 Participants	0 Participants	373 Participants
Race/Ethnicity, Customized Geographic ancestry White - Caucasian / European heritage	0 Participants	0 Participants	285 Participants	98 Participants	383 Participants
Sex/Gender, Customized Gender Categorical Female	133 Participants	43 Participants	134 Participants	43 Participants	353 Participants
Sex/Gender, Customized Gender Categorical Male	147 Participants	50 Participants	151 Participants	55 Participants	403 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk
deaths Total, all-cause mortality	0 / 280	1 / 93	0 / 285	0 / 98
other Total, other adverse events	237 / 280	78 / 93	276 / 285	92 / 98
serious Total, serious adverse events	6 / 280	1 / 93	14 / 285	5 / 98

Outcome results

Primary

Number of Subjects Reporting Rectal Temperature Greater Than (>) the Cut-off

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.

Time frame: 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™).

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Synflorix Pooled Group	Number of Subjects Reporting Rectal Temperature Greater Than (>) the Cut-off	64 Participants
Prevenar Pooled Group	Number of Subjects Reporting Rectal Temperature Greater Than (>) the Cut-off	20 Participants

95% CI: [-4.82, 5.59]Philips' statistical test

Secondary

Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A

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

Time frame: 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).

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Synflorix Pooled Group	Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A	Anti-6A, Month 0	0.46 μg/mL
Synflorix Pooled Group	Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A	Anti-6A, Month 1	4.07 μg/mL
Synflorix Pooled Group	Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A	Anti-19A, Month 0	0.24 μg/mL
Synflorix Pooled Group	Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A	Anti-19A, Month 1	3.22 μg/mL
Prevenar Pooled Group	Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A	Anti-6A, Month 1	4.57 μg/mL
Prevenar Pooled Group	Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A	Anti-19A, Month 0	0.08 μg/mL
Prevenar Pooled Group	Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A	Anti-19A, Month 1	0.58 μg/mL
Prevenar Pooled Group	Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A	Anti-6A, Month 0	0.24 μg/mL
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A	Anti-19A, Month 0	0.16 μg/mL
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A	Anti-6A, Month 1	0.84 μg/mL
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A	Anti-19A, Month 1	1.75 μg/mL
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A	Anti-6A, Month 0	0.12 μg/mL
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A	Anti-19A, Month 1	0.38 μg/mL
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A	Anti-6A, Month 1	2.54 μg/mL
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A	Anti-6A, Month 0	0.13 μg/mL
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A	Anti-19A, Month 0	0.06 μg/mL

Secondary

Antibody Concentrations to Protein D (Anti-PD)

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

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

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Synflorix Pooled Group	Antibody Concentrations to Protein D (Anti-PD)	Anti-PD, Month 0	573.1 EL.U/mL
Synflorix Pooled Group	Antibody Concentrations to Protein D (Anti-PD)	Anti-PD, Month 1	4973.9 EL.U/mL
Prevenar Pooled Group	Antibody Concentrations to Protein D (Anti-PD)	Anti-PD, Month 1	124.1 EL.U/mL
Prevenar Pooled Group	Antibody Concentrations to Protein D (Anti-PD)	Anti-PD, Month 0	136.8 EL.U/mL
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Antibody Concentrations to Protein D (Anti-PD)	Anti-PD, Month 0	526.8 EL.U/mL
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Antibody Concentrations to Protein D (Anti-PD)	Anti-PD, Month 1	2769.6 EL.U/mL
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Antibody Concentrations to Protein D (Anti-PD)	Anti-PD, Month 0	73.8 EL.U/mL
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Antibody Concentrations to Protein D (Anti-PD)	Anti-PD, Month 1	91.6 EL.U/mL

Secondary

Anti-Bordetella Pertussis (BPT) Antibody Concentrations

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

Time frame: 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.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Synflorix Pooled Group	Anti-Bordetella Pertussis (BPT) Antibody Concentrations	Anti-BPT, Month 0	12.88 EL.U/mL
Synflorix Pooled Group	Anti-Bordetella Pertussis (BPT) Antibody Concentrations	Anti-BPT, Month 1	139.51 EL.U/mL
Prevenar Pooled Group	Anti-Bordetella Pertussis (BPT) Antibody Concentrations	Anti-BPT, Month 1	133.45 EL.U/mL
Prevenar Pooled Group	Anti-Bordetella Pertussis (BPT) Antibody Concentrations	Anti-BPT, Month 0	12.46 EL.U/mL
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Anti-Bordetella Pertussis (BPT) Antibody Concentrations	Anti-BPT, Month 0	9.54 EL.U/mL
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Anti-Bordetella Pertussis (BPT) Antibody Concentrations	Anti-BPT, Month 1	121.73 EL.U/mL
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Anti-Bordetella Pertussis (BPT) Antibody Concentrations	Anti-BPT, Month 0	10 EL.U/mL
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Anti-Bordetella Pertussis (BPT) Antibody Concentrations	Anti-BPT, Month 1	121.76 EL.U/mL

Secondary

Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations

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

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

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Synflorix Pooled Group	Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations	Anti-DT, Month 0	0.258 IU/mL
Synflorix Pooled Group	Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations	Anti-DT, Month 1	7.829 IU/mL
Synflorix Pooled Group	Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations	Anti-TT, Month 0	0.735 IU/mL
Synflorix Pooled Group	Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations	Anti-TT, Month 1	20.979 IU/mL
Prevenar Pooled Group	Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations	Anti-DT, Month 1	4.768 IU/mL
Prevenar Pooled Group	Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations	Anti-TT, Month 0	0.455 IU/mL
Prevenar Pooled Group	Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations	Anti-TT, Month 1	9.703 IU/mL
Prevenar Pooled Group	Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations	Anti-DT, Month 0	0.17 IU/mL
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations	Anti-TT, Month 0	0.568 IU/mL
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations	Anti-DT, Month 1	8.463 IU/mL
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations	Anti-TT, Month 1	12.171 IU/mL
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations	Anti-DT, Month 0	0.188 IU/mL
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations	Anti-TT, Month 1	6.719 IU/mL
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations	Anti-DT, Month 1	4.876 IU/mL
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations	Anti-DT, Month 0	0.126 IU/mL
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations	Anti-TT, Month 0	0.525 IU/mL

Secondary

Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations

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

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

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Synflorix Pooled Group	Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations	Anti-HBs, Month 0	30 mIU/mL
Synflorix Pooled Group	Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations	Anti-HBs, Month 1	1220.5 mIU/mL
Prevenar Pooled Group	Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations	Anti-HBs, Month 1	1098.1 mIU/mL
Prevenar Pooled Group	Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations	Anti-HBs, Month 0	23.4 mIU/mL
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations	Anti-HBs, Month 0	97.9 mIU/mL
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations	Anti-HBs, Month 1	4428.7 mIU/mL
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations	Anti-HBs, Month 0	113 mIU/mL
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations	Anti-HBs, Month 1	3188.6 mIU/mL

Secondary

Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations

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).

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

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Synflorix Pooled Group	Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations	Anti-9V, Month 0	1.16 μg/mL
Synflorix Pooled Group	Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations	Anti-1, Month 1	10.8 μg/mL
Synflorix Pooled Group	Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations	Anti-7F, Month 1	12.52 μg/mL
Synflorix Pooled Group	Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations	Anti-7F, Month 0	0.9 μg/mL
Synflorix Pooled Group	Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations	Anti-6B, Month 0	0.66 μg/mL
Synflorix Pooled Group	Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations	Anti-1, Month 0	0.35 μg/mL
Synflorix Pooled Group	Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations	Anti-6B, Month 1	7.02 μg/mL
Synflorix Pooled Group	Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations	Anti-19F, Month 1	21.25 μg/mL
Synflorix Pooled Group	Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations	Anti-19F, Month 0	1.33 μg/mL
Synflorix Pooled Group	Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations	Anti-4, Month 0	0.55 μg/mL
Synflorix Pooled Group	Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations	Anti-5, Month 1	14.59 μg/mL
Synflorix Pooled Group	Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations	Anti-18C, Month 1	39.59 μg/mL
Synflorix Pooled Group	Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations	Anti-18C, Month 0	1.43 μg/mL
Synflorix Pooled Group	Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations	Anti-4, Month 1	13.16 μg/mL
Synflorix Pooled Group	Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations	Anti-23F, Month 1	13.47 μg/mL
Synflorix Pooled Group	Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations	Anti-14, Month 1	17.07 μg/mL
Synflorix Pooled Group	Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations	Anti-14, Month 0	1.32 μg/mL
Synflorix Pooled Group	Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations	Anti-5, Month 0	0.55 μg/mL
Synflorix Pooled Group	Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations	Anti-23F, Month 0	0.94 μg/mL
Synflorix Pooled Group	Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations	Anti-9V, Month 1	14.42 μg/mL
Prevenar Pooled Group	Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations	Anti-4, Month 0	0.34 μg/mL
Prevenar Pooled Group	Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations	Anti-1, Month 0	0.03 μg/mL
Prevenar Pooled Group	Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations	Anti-1, Month 1	0.04 μg/mL
Prevenar Pooled Group	Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations	Anti-4, Month 1	11.84 μg/mL
Prevenar Pooled Group	Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations	Anti-5, Month 0	0.06 μg/mL
Prevenar Pooled Group	Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations	Anti-5, Month 1	0.09 μg/mL
Prevenar Pooled Group	Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations	Anti-6B, Month 0	0.38 μg/mL
Prevenar Pooled Group	Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations	Anti-6B, Month 1	9.08 μg/mL
Prevenar Pooled Group	Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations	Anti-7F, Month 0	0.05 μg/mL
Prevenar Pooled Group	Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations	Anti-7F, Month 1	0.06 μg/mL
Prevenar Pooled Group	Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations	Anti-9V, Month 0	0.77 μg/mL
Prevenar Pooled Group	Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations	Anti-9V, Month 1	20.31 μg/mL
Prevenar Pooled Group	Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations	Anti-14, Month 0	1.83 μg/mL
Prevenar Pooled Group	Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations	Anti-14, Month 1	27.42 μg/mL
Prevenar Pooled Group	Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations	Anti-18C, Month 0	0.42 μg/mL
Prevenar Pooled Group	Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations	Anti-18C, Month 1	12.07 μg/mL
Prevenar Pooled Group	Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations	Anti-19F, Month 0	0.16 μg/mL
Prevenar Pooled Group	Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations	Anti-19F, Month 1	6.61 μg/mL
Prevenar Pooled Group	Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations	Anti-23F, Month 0	0.41 μg/mL
Prevenar Pooled Group	Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations	Anti-23F, Month 1	14.78 μg/mL
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations	Anti-18C, Month 1	10.49 μg/mL
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations	Anti-4, Month 0	0.27 μg/mL
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations	Anti-5, Month 0	0.4 μg/mL
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations	Anti-14, Month 0	0.84 μg/mL
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations	Anti-19F, Month 1	12.23 μg/mL
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations	Anti-1, Month 0	0.19 μg/mL
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations	Anti-19F, Month 0	0.99 μg/mL
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations	Anti-4, Month 1	4.21 μg/mL
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations	Anti-6B, Month 0	0.34 μg/mL
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations	Anti-23F, Month 1	3.16 μg/mL
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations	Anti-6B, Month 1	2.31 μg/mL
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations	Anti-14, Month 1	5.93 μg/mL
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations	Anti-9V, Month 1	4.63 μg/mL
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations	Anti-1, Month 1	2.14 μg/mL
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations	Anti-7F, Month 0	0.58 μg/mL
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations	Anti-9V, Month 0	0.59 μg/mL
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations	Anti-5, Month 1	2.54 μg/mL
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations	Anti-23F, Month 0	0.33 μg/mL
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations	Anti-7F, Month 1	4.14 μg/mL
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations	Anti-18C, Month 0	0.63 μg/mL
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations	Anti-7F, Month 1	0.03 μg/mL
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations	Anti-9V, Month 0	0.58 μg/mL
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations	Anti-19F, Month 1	6.01 μg/mL
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations	Anti-9V, Month 1	13.6 μg/mL
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations	Anti-4, Month 1	6.86 μg/mL
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations	Anti-1, Month 0	0.04 μg/mL
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations	Anti-14, Month 0	1.04 μg/mL
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations	Anti-14, Month 1	15.51 μg/mL
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations	Anti-4, Month 0	0.24 μg/mL
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations	Anti-18C, Month 0	0.4 μg/mL
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations	Anti-23F, Month 0	0.62 μg/mL
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations	Anti-18C, Month 1	9.92 μg/mL
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations	Anti-1, Month 1	0.04 μg/mL
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations	Anti-6B, Month 0	0.34 μg/mL
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations	Anti-19F, Month 0	0.35 μg/mL
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations	Anti-6B, Month 1	6.28 μg/mL
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations	Anti-5, Month 1	0.05 μg/mL
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations	Anti-7F, Month 0	0.03 μg/mL
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations	Anti-23F, Month 1	10.77 μg/mL
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations	Anti-5, Month 0	0.04 μg/mL

Secondary

Anti-polio Type 1, 2 and 3 Antibody Titers

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

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

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Synflorix Pooled Group	Anti-polio Type 1, 2 and 3 Antibody Titers	Anti-Polio 1, Month 0	329.1 Titers
Synflorix Pooled Group	Anti-polio Type 1, 2 and 3 Antibody Titers	Anti-Polio 1, Month 1	854.6 Titers
Synflorix Pooled Group	Anti-polio Type 1, 2 and 3 Antibody Titers	Anti-Polio 2, Month 0	222.6 Titers
Synflorix Pooled Group	Anti-polio Type 1, 2 and 3 Antibody Titers	Anti-Polio 2, Month 1	716.9 Titers
Synflorix Pooled Group	Anti-polio Type 1, 2 and 3 Antibody Titers	Anti-Polio 3, Month 0	102.2 Titers
Synflorix Pooled Group	Anti-polio Type 1, 2 and 3 Antibody Titers	Anti-Polio 3, Month 1	232.7 Titers
Prevenar Pooled Group	Anti-polio Type 1, 2 and 3 Antibody Titers	Anti-Polio 3, Month 1	190.4 Titers
Prevenar Pooled Group	Anti-polio Type 1, 2 and 3 Antibody Titers	Anti-Polio 2, Month 1	689.1 Titers
Prevenar Pooled Group	Anti-polio Type 1, 2 and 3 Antibody Titers	Anti-Polio 1, Month 0	269 Titers
Prevenar Pooled Group	Anti-polio Type 1, 2 and 3 Antibody Titers	Anti-Polio 2, Month 0	210.4 Titers
Prevenar Pooled Group	Anti-polio Type 1, 2 and 3 Antibody Titers	Anti-Polio 1, Month 1	426.9 Titers
Prevenar Pooled Group	Anti-polio Type 1, 2 and 3 Antibody Titers	Anti-Polio 3, Month 0	38.4 Titers
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Anti-polio Type 1, 2 and 3 Antibody Titers	Anti-Polio 1, Month 1	932.5 Titers
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Anti-polio Type 1, 2 and 3 Antibody Titers	Anti-Polio 2, Month 0	50.2 Titers
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Anti-polio Type 1, 2 and 3 Antibody Titers	Anti-Polio 2, Month 1	1195.7 Titers
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Anti-polio Type 1, 2 and 3 Antibody Titers	Anti-Polio 3, Month 1	1464.2 Titers
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Anti-polio Type 1, 2 and 3 Antibody Titers	Anti-Polio 3, Month 0	51.8 Titers
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Anti-polio Type 1, 2 and 3 Antibody Titers	Anti-Polio 1, Month 0	46.5 Titers
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Anti-polio Type 1, 2 and 3 Antibody Titers	Anti-Polio 3, Month 0	71.1 Titers
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Anti-polio Type 1, 2 and 3 Antibody Titers	Anti-Polio 3, Month 1	1346.2 Titers
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Anti-polio Type 1, 2 and 3 Antibody Titers	Anti-Polio 1, Month 1	727.3 Titers
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Anti-polio Type 1, 2 and 3 Antibody Titers	Anti-Polio 2, Month 1	1206.6 Titers
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Anti-polio Type 1, 2 and 3 Antibody Titers	Anti-Polio 1, Month 0	51.1 Titers
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Anti-polio Type 1, 2 and 3 Antibody Titers	Anti-Polio 2, Month 0	60.8 Titers

Secondary

Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentrations

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

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

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Synflorix Pooled Group	Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentrations	Anti-PRP, Month 0	5.335 μg/mL
Synflorix Pooled Group	Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentrations	Anti-PRP, Month 1	106.004 μg/mL
Prevenar Pooled Group	Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentrations	Anti-PRP, Month 1	89.376 μg/mL
Prevenar Pooled Group	Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentrations	Anti-PRP, Month 0	6.433 μg/mL
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentrations	Anti-PRP, Month 0	1.03 μg/mL
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentrations	Anti-PRP, Month 1	53.386 μg/mL
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentrations	Anti-PRP, Month 0	0.894 μg/mL
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentrations	Anti-PRP, Month 1	33.656 μg/mL

Secondary

Number of Subjects With Antibody Concentrations Against Protein D (Anti-PD) ≥ the Cut-off

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

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

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Synflorix Pooled Group	Number of Subjects With Antibody Concentrations Against Protein D (Anti-PD) ≥ the Cut-off	Anti-PD, Month 0	131 Participants
Synflorix Pooled Group	Number of Subjects With Antibody Concentrations Against Protein D (Anti-PD) ≥ the Cut-off	Anti-PD, Month 1	135 Participants
Prevenar Pooled Group	Number of Subjects With Antibody Concentrations Against Protein D (Anti-PD) ≥ the Cut-off	Anti-PD, Month 1	23 Participants
Prevenar Pooled Group	Number of Subjects With Antibody Concentrations Against Protein D (Anti-PD) ≥ the Cut-off	Anti-PD, Month 0	28 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Number of Subjects With Antibody Concentrations Against Protein D (Anti-PD) ≥ the Cut-off	Anti-PD, Month 0	117 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Number of Subjects With Antibody Concentrations Against Protein D (Anti-PD) ≥ the Cut-off	Anti-PD, Month 1	125 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Number of Subjects With Antibody Concentrations Against Protein D (Anti-PD) ≥ the Cut-off	Anti-PD, Month 0	11 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Number of Subjects With Antibody Concentrations Against Protein D (Anti-PD) ≥ the Cut-off	Anti-PD, Month 1	19 Participants

Secondary

Number of Subjects With Anti-Bordetella Pertussis (BPT) With Concentrations ≥ the Cut-off

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

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

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Synflorix Pooled Group	Number of Subjects With Anti-Bordetella Pertussis (BPT) With Concentrations ≥ the Cut-off	Anti-BPT, Month 0	28 Participants
Synflorix Pooled Group	Number of Subjects With Anti-Bordetella Pertussis (BPT) With Concentrations ≥ the Cut-off	Anti-BPT, Month 1	65 Participants
Prevenar Pooled Group	Number of Subjects With Anti-Bordetella Pertussis (BPT) With Concentrations ≥ the Cut-off	Anti-BPT, Month 1	25 Participants
Prevenar Pooled Group	Number of Subjects With Anti-Bordetella Pertussis (BPT) With Concentrations ≥ the Cut-off	Anti-BPT, Month 0	10 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Number of Subjects With Anti-Bordetella Pertussis (BPT) With Concentrations ≥ the Cut-off	Anti-BPT, Month 0	12 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Number of Subjects With Anti-Bordetella Pertussis (BPT) With Concentrations ≥ the Cut-off	Anti-BPT, Month 1	59 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Number of Subjects With Anti-Bordetella Pertussis (BPT) With Concentrations ≥ the Cut-off	Anti-BPT, Month 0	7 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Number of Subjects With Anti-Bordetella Pertussis (BPT) With Concentrations ≥ the Cut-off	Anti-BPT, Month 1	24 Participants

Secondary

Number of Subjects With Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations ≥ the Cut-off

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

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

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Synflorix Pooled Group	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
Synflorix Pooled Group	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
Synflorix Pooled Group	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
Synflorix Pooled Group	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
Prevenar Pooled Group	Number of Subjects With Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations ≥ the Cut-off	Anti-DT, Month 1	25 Participants
Prevenar Pooled Group	Number of Subjects With Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations ≥ the Cut-off	Anti-TT, Month 0	24 Participants
Prevenar Pooled Group	Number of Subjects With Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations ≥ the Cut-off	Anti-TT, Month 1	25 Participants
Prevenar Pooled Group	Number of Subjects With Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations ≥ the Cut-off	Anti-DT, Month 0	18 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Number of Subjects With Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations ≥ the Cut-off	Anti-TT, Month 0	60 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Number of Subjects With Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations ≥ the Cut-off	Anti-DT, Month 1	59 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Number of Subjects With Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations ≥ the Cut-off	Anti-TT, Month 1	58 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Number of Subjects With Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations ≥ the Cut-off	Anti-DT, Month 0	49 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Number of Subjects With Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations ≥ the Cut-off	Anti-TT, Month 1	24 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Number of Subjects With Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations ≥ the Cut-off	Anti-DT, Month 1	24 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Number of Subjects With Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations ≥ the Cut-off	Anti-DT, Month 0	15 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Number of Subjects With Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations ≥ the Cut-off	Anti-TT, Month 0	23 Participants

Secondary

Number of Subjects With Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations ≥ the Cut-off

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

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

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Synflorix Pooled Group	Number of Subjects With Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations ≥ the Cut-off	Anti-HBs, Month 0	53 Participants
Synflorix Pooled Group	Number of Subjects With Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations ≥ the Cut-off	Anti-HBs, Month 1	68 Participants
Prevenar Pooled Group	Number of Subjects With Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations ≥ the Cut-off	Anti-HBs, Month 1	19 Participants
Prevenar Pooled Group	Number of Subjects With Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations ≥ the Cut-off	Anti-HBs, Month 0	13 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Number of Subjects With Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations ≥ the Cut-off	Anti-HBs, Month 0	63 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Number of Subjects With Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations ≥ the Cut-off	Anti-HBs, Month 1	62 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Number of Subjects With Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations ≥ the Cut-off	Anti-HBs, Month 0	19 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Number of Subjects With Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations ≥ the Cut-off	Anti-HBs, Month 1	19 Participants

Secondary

Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off

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

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

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Synflorix Pooled Group	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
Synflorix Pooled Group	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
Synflorix Pooled Group	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
Synflorix Pooled Group	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
Synflorix Pooled Group	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
Synflorix Pooled Group	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
Synflorix Pooled Group	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
Synflorix Pooled Group	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
Synflorix Pooled Group	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
Synflorix Pooled Group	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
Synflorix Pooled Group	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
Synflorix Pooled Group	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
Synflorix Pooled Group	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
Synflorix Pooled Group	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
Synflorix Pooled Group	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
Synflorix Pooled Group	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
Synflorix Pooled Group	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
Synflorix Pooled Group	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
Synflorix Pooled Group	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
Synflorix Pooled Group	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
Prevenar Pooled Group	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	43 Participants
Prevenar Pooled Group	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	42 Participants
Prevenar Pooled Group	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	40 Participants
Prevenar Pooled Group	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	43 Participants
Prevenar Pooled Group	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	31 Participants
Prevenar Pooled Group	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	43 Participants
Prevenar Pooled Group	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	7 Participants
Prevenar Pooled Group	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	42 Participants
Prevenar Pooled Group	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	17 Participants
Prevenar Pooled Group	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	42 Participants
Prevenar Pooled Group	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	40 Participants
Prevenar Pooled Group	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	43 Participants
Prevenar Pooled Group	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	13 Participants
Prevenar Pooled Group	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	43 Participants
Prevenar Pooled Group	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	37 Participants
Prevenar Pooled Group	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	43 Participants
Prevenar Pooled Group	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	42 Participants
Prevenar Pooled Group	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	18 Participants
Prevenar Pooled Group	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	11 Participants
Prevenar Pooled Group	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	43 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	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	130 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	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	122 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	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	125 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	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	126 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	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	125 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	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	128 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	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	125 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	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	127 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	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	124 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	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	130 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	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	125 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	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	130 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	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	125 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	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	125 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	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	129 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	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	125 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	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
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	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	124 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	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	125 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	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	124 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	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	11 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	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	8 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	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	43 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	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	43 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	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	42 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	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	39 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	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	9 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	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	43 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	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	20 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	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	13 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	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	8 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	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	43 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	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	43 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	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	43 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	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	42 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	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	43 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	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	43 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	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	44 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	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	42 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	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	44 Participants

Secondary

Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off

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

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

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Synflorix Pooled Group	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
Synflorix Pooled Group	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
Synflorix Pooled Group	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
Synflorix Pooled Group	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
Synflorix Pooled Group	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
Synflorix Pooled Group	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
Synflorix Pooled Group	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
Synflorix Pooled Group	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
Synflorix Pooled Group	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
Synflorix Pooled Group	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
Synflorix Pooled Group	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
Synflorix Pooled Group	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
Synflorix Pooled Group	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
Synflorix Pooled Group	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
Synflorix Pooled Group	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
Synflorix Pooled Group	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
Synflorix Pooled Group	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
Synflorix Pooled Group	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
Synflorix Pooled Group	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
Synflorix Pooled Group	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
Prevenar Pooled Group	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	43 Participants
Prevenar Pooled Group	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	2 Participants
Prevenar Pooled Group	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	3 Participants
Prevenar Pooled Group	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	25 Participants
Prevenar Pooled Group	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	43 Participants
Prevenar Pooled Group	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	7 Participants
Prevenar Pooled Group	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	8 Participants
Prevenar Pooled Group	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	24 Participants
Prevenar Pooled Group	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	42 Participants
Prevenar Pooled Group	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	7 Participants
Prevenar Pooled Group	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	9 Participants
Prevenar Pooled Group	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	40 Participants
Prevenar Pooled Group	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	43 Participants
Prevenar Pooled Group	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	42 Participants
Prevenar Pooled Group	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	43 Participants
Prevenar Pooled Group	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	36 Participants
Prevenar Pooled Group	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	43 Participants
Prevenar Pooled Group	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	11 Participants
Prevenar Pooled Group	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	32 Participants
Prevenar Pooled Group	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	42 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	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	111 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	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	78 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	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	64 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	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	125 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	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	125 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	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	125 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	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	89 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	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	121 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	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	125 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	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	90 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	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	98 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	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	122 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	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	116 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	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	123 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	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	125 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	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	118 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	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	111 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	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	124 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	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	123 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	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	125 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	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	35 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	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	3 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	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	43 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	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	42 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	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	2 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	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	43 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	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	43 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	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	40 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	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	43 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	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	23 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	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	40 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	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	1 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	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	43 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	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	2 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	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	42 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	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	27 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	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	22 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	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	41 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	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	3 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	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	1 Participants

Secondary

Number of Subjects With Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Antibody Titers ≥ the Cut-off

The cut-off for the assay was 8.

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

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Synflorix Pooled Group	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
Synflorix Pooled Group	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
Synflorix Pooled Group	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
Synflorix Pooled Group	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
Synflorix Pooled Group	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
Synflorix Pooled Group	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
Prevenar Pooled Group	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	20 Participants
Prevenar Pooled Group	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	21 Participants
Prevenar Pooled Group	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	19 Participants
Prevenar Pooled Group	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	21 Participants
Prevenar Pooled Group	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	19 Participants
Prevenar Pooled Group	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	17 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	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	63 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	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	59 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	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	63 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	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	63 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	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	61 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	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	56 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	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	18 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	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	19 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	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	19 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	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	19 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	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	19 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	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	19 Participants

Secondary

Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration ≥ the Cut-off

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

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

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Synflorix Pooled Group	Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration ≥ the Cut-off	Anti-PRP, Month 0	65 Participants
Synflorix Pooled Group	Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration ≥ the Cut-off	Anti-PRP, Month 1	65 Participants
Prevenar Pooled Group	Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration ≥ the Cut-off	Anti-PRP, Month 1	25 Participants
Prevenar Pooled Group	Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration ≥ the Cut-off	Anti-PRP, Month 0	25 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration ≥ the Cut-off	Anti-PRP, Month 0	58 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration ≥ the Cut-off	Anti-PRP, Month 1	59 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration ≥ the Cut-off	Anti-PRP, Month 0	23 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration ≥ the Cut-off	Anti-PRP, Month 1	24 Participants

Secondary

Number of Subjects With Anti-PRP Antibody Concentration ≥ the Cut-off

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

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

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Synflorix Pooled Group	Number of Subjects With Anti-PRP Antibody Concentration ≥ the Cut-off	Anti-PRP, Month 0	56 Participants
Synflorix Pooled Group	Number of Subjects With Anti-PRP Antibody Concentration ≥ the Cut-off	Anti-PRP, Month 1	65 Participants
Prevenar Pooled Group	Number of Subjects With Anti-PRP Antibody Concentration ≥ the Cut-off	Anti-PRP, Month 1	25 Participants
Prevenar Pooled Group	Number of Subjects With Anti-PRP Antibody Concentration ≥ the Cut-off	Anti-PRP, Month 0	22 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Number of Subjects With Anti-PRP Antibody Concentration ≥ the Cut-off	Anti-PRP, Month 0	32 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Number of Subjects With Anti-PRP Antibody Concentration ≥ the Cut-off	Anti-PRP, Month 1	57 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Number of Subjects With Anti-PRP Antibody Concentration ≥ the Cut-off	Anti-PRP, Month 0	12 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Number of Subjects With Anti-PRP Antibody Concentration ≥ the Cut-off	Anti-PRP, Month 1	24 Participants

Secondary

Number of Subjects With Any and Grade 3 Solicited General Symptoms

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.

Time frame: 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.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Synflorix Pooled Group	Number of Subjects With Any and Grade 3 Solicited General Symptoms	Any Drowsiness	90 Participants
Synflorix Pooled Group	Number of Subjects With Any and Grade 3 Solicited General Symptoms	Grade 3 Drowsiness	5 Participants
Synflorix Pooled Group	Number of Subjects With Any and Grade 3 Solicited General Symptoms	Any Fever	138 Participants
Synflorix Pooled Group	Number of Subjects With Any and Grade 3 Solicited General Symptoms	Grade 3 Fever	0 Participants
Synflorix Pooled Group	Number of Subjects With Any and Grade 3 Solicited General Symptoms	Any Irritability	173 Participants
Synflorix Pooled Group	Number of Subjects With Any and Grade 3 Solicited General Symptoms	Grade 3 Irritability	12 Participants
Synflorix Pooled Group	Number of Subjects With Any and Grade 3 Solicited General Symptoms	Any Loss of appetite	97 Participants
Synflorix Pooled Group	Number of Subjects With Any and Grade 3 Solicited General Symptoms	Grade 3 Loss of appetite	8 Participants
Prevenar Pooled Group	Number of Subjects With Any and Grade 3 Solicited General Symptoms	Grade 3 Irritability	3 Participants
Prevenar Pooled Group	Number of Subjects With Any and Grade 3 Solicited General Symptoms	Any Irritability	64 Participants
Prevenar Pooled Group	Number of Subjects With Any and Grade 3 Solicited General Symptoms	Grade 3 Drowsiness	1 Participants
Prevenar Pooled Group	Number of Subjects With Any and Grade 3 Solicited General Symptoms	Grade 3 Loss of appetite	1 Participants
Prevenar Pooled Group	Number of Subjects With Any and Grade 3 Solicited General Symptoms	Any Loss of appetite	28 Participants
Prevenar Pooled Group	Number of Subjects With Any and Grade 3 Solicited General Symptoms	Grade 3 Fever	0 Participants
Prevenar Pooled Group	Number of Subjects With Any and Grade 3 Solicited General Symptoms	Any Fever	51 Participants
Prevenar Pooled Group	Number of Subjects With Any and Grade 3 Solicited General Symptoms	Any Drowsiness	32 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Number of Subjects With Any and Grade 3 Solicited General Symptoms	Any Loss of appetite	184 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Number of Subjects With Any and Grade 3 Solicited General Symptoms	Any Fever	215 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Number of Subjects With Any and Grade 3 Solicited General Symptoms	Grade 3 Fever	1 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Number of Subjects With Any and Grade 3 Solicited General Symptoms	Any Irritability	243 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Number of Subjects With Any and Grade 3 Solicited General Symptoms	Grade 3 Irritability	40 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Number of Subjects With Any and Grade 3 Solicited General Symptoms	Grade 3 Loss of appetite	13 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Number of Subjects With Any and Grade 3 Solicited General Symptoms	Any Drowsiness	190 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Number of Subjects With Any and Grade 3 Solicited General Symptoms	Grade 3 Drowsiness	7 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Number of Subjects With Any and Grade 3 Solicited General Symptoms	Any Fever	65 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Number of Subjects With Any and Grade 3 Solicited General Symptoms	Grade 3 Fever	0 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Number of Subjects With Any and Grade 3 Solicited General Symptoms	Grade 3 Drowsiness	2 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Number of Subjects With Any and Grade 3 Solicited General Symptoms	Any Drowsiness	66 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Number of Subjects With Any and Grade 3 Solicited General Symptoms	Any Irritability	79 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Number of Subjects With Any and Grade 3 Solicited General Symptoms	Grade 3 Loss of appetite	1 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Number of Subjects With Any and Grade 3 Solicited General Symptoms	Any Loss of appetite	57 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Number of Subjects With Any and Grade 3 Solicited General Symptoms	Grade 3 Irritability	5 Participants

Secondary

Number of Subjects With Any and Grade 3 Solicited Local Symptoms

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).

Time frame: 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.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Synflorix Pooled Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Pain	203 Participants
Synflorix Pooled Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Pain	40 Participants
Synflorix Pooled Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Redness	107 Participants
Synflorix Pooled Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Redness	8 Participants
Synflorix Pooled Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Swelling	92 Participants
Synflorix Pooled Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Swelling	21 Participants
Prevenar Pooled Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Swelling	9 Participants
Prevenar Pooled Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Redness	3 Participants
Prevenar Pooled Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Pain	66 Participants
Prevenar Pooled Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Redness	37 Participants
Prevenar Pooled Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Pain	20 Participants
Prevenar Pooled Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Swelling	32 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Pain	117 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Redness	197 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Redness	35 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Swelling	34 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Swelling	158 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Pain	248 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Swelling	52 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Swelling	8 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Pain	39 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Redness	11 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Pain	77 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Redness	66 Participants

Secondary

Number of Subjects With Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A ≥ the Cut-off

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

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

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Synflorix Pooled Group	Number of Subjects With Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A ≥ the Cut-off	Anti-6A, Month 0	128 Participants
Synflorix Pooled Group	Number of Subjects With Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A ≥ the Cut-off	Anti-6A, Month 1	133 Participants
Synflorix Pooled Group	Number of Subjects With Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A ≥ the Cut-off	Anti-19A, Month 0	124 Participants
Synflorix Pooled Group	Number of Subjects With Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A ≥ the Cut-off	Anti-19A, Month 1	135 Participants
Prevenar Pooled Group	Number of Subjects With Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A ≥ the Cut-off	Anti-6A, Month 1	42 Participants
Prevenar Pooled Group	Number of Subjects With Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A ≥ the Cut-off	Anti-19A, Month 0	25 Participants
Prevenar Pooled Group	Number of Subjects With Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A ≥ the Cut-off	Anti-19A, Month 1	42 Participants
Prevenar Pooled Group	Number of Subjects With Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A ≥ the Cut-off	Anti-6A, Month 0	37 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Number of Subjects With Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A ≥ the Cut-off	Anti-19A, Month 0	105 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Number of Subjects With Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A ≥ the Cut-off	Anti-6A, Month 1	125 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Number of Subjects With Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A ≥ the Cut-off	Anti-19A, Month 1	119 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Number of Subjects With Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A ≥ the Cut-off	Anti-6A, Month 0	105 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Number of Subjects With Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A ≥ the Cut-off	Anti-19A, Month 1	42 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Number of Subjects With Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A ≥ the Cut-off	Anti-6A, Month 1	42 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Number of Subjects With Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A ≥ the Cut-off	Anti-6A, Month 0	33 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Number of Subjects With Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A ≥ the Cut-off	Anti-19A, Month 0	27 Participants

Secondary

Number of Subjects With Opsonophagocytic Activity (OPA) Against Pneumococcal Cross-reactive Serotypes 6A and 19A ≥ the Cut-off

The cut-off for the assay was 8.

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

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Synflorix Pooled Group	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
Synflorix Pooled Group	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
Synflorix Pooled Group	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
Synflorix Pooled Group	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
Prevenar Pooled Group	Number of Subjects With Opsonophagocytic Activity (OPA) Against Pneumococcal Cross-reactive Serotypes 6A and 19A ≥ the Cut-off	OPA Anti-6A, Month 1	43 Participants
Prevenar Pooled Group	Number of Subjects With Opsonophagocytic Activity (OPA) Against Pneumococcal Cross-reactive Serotypes 6A and 19A ≥ the Cut-off	OPA Anti-19A, Month 0	2 Participants
Prevenar Pooled Group	Number of Subjects With Opsonophagocytic Activity (OPA) Against Pneumococcal Cross-reactive Serotypes 6A and 19A ≥ the Cut-off	OPA Anti-19A, Month 1	11 Participants
Prevenar Pooled Group	Number of Subjects With Opsonophagocytic Activity (OPA) Against Pneumococcal Cross-reactive Serotypes 6A and 19A ≥ the Cut-off	OPA Anti-6A, Month 0	30 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Number of Subjects With Opsonophagocytic Activity (OPA) Against Pneumococcal Cross-reactive Serotypes 6A and 19A ≥ the Cut-off	OPA Anti-19A, Month 0	11 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Number of Subjects With Opsonophagocytic Activity (OPA) Against Pneumococcal Cross-reactive Serotypes 6A and 19A ≥ the Cut-off	OPA Anti-6A, Month 1	97 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Number of Subjects With Opsonophagocytic Activity (OPA) Against Pneumococcal Cross-reactive Serotypes 6A and 19A ≥ the Cut-off	OPA Anti-19A, Month 1	74 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Number of Subjects With Opsonophagocytic Activity (OPA) Against Pneumococcal Cross-reactive Serotypes 6A and 19A ≥ the Cut-off	OPA Anti-6A, Month 0	63 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Number of Subjects With Opsonophagocytic Activity (OPA) Against Pneumococcal Cross-reactive Serotypes 6A and 19A ≥ the Cut-off	OPA Anti-19A, Month 1	12 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Number of Subjects With Opsonophagocytic Activity (OPA) Against Pneumococcal Cross-reactive Serotypes 6A and 19A ≥ the Cut-off	OPA Anti-6A, Month 1	32 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Number of Subjects With Opsonophagocytic Activity (OPA) Against Pneumococcal Cross-reactive Serotypes 6A and 19A ≥ the Cut-off	OPA Anti-6A, Month 0	19 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Number of Subjects With Opsonophagocytic Activity (OPA) Against Pneumococcal Cross-reactive Serotypes 6A and 19A ≥ the Cut-off	OPA Anti-19A, Month 0	1 Participants

Secondary

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

The cut-off for the assay was 8.

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

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Synflorix Pooled Group	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
Synflorix Pooled Group	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
Synflorix Pooled Group	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
Synflorix Pooled Group	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
Synflorix Pooled Group	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
Synflorix Pooled Group	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
Synflorix Pooled Group	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
Synflorix Pooled Group	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
Synflorix Pooled Group	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
Synflorix Pooled Group	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
Synflorix Pooled Group	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
Synflorix Pooled Group	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
Synflorix Pooled Group	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
Synflorix Pooled Group	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
Synflorix Pooled Group	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
Synflorix Pooled Group	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
Synflorix Pooled Group	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
Synflorix Pooled Group	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
Synflorix Pooled Group	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
Synflorix Pooled Group	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
Prevenar Pooled Group	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	42 Participants
Prevenar Pooled Group	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	42 Participants
Prevenar Pooled Group	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	37 Participants
Prevenar Pooled Group	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	3 Participants
Prevenar Pooled Group	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	4 Participants
Prevenar Pooled Group	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	42 Participants
Prevenar Pooled Group	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	3 Participants
Prevenar Pooled Group	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	42 Participants
Prevenar Pooled Group	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	36 Participants
Prevenar Pooled Group	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	39 Participants
Prevenar Pooled Group	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	21 Participants
Prevenar Pooled Group	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	42 Participants
Prevenar Pooled Group	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	28 Participants
Prevenar Pooled Group	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	43 Participants
Prevenar Pooled Group	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	7 Participants
Prevenar Pooled Group	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	20 Participants
Prevenar Pooled Group	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	43 Participants
Prevenar Pooled Group	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	1 Participants
Prevenar Pooled Group	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	5 Participants
Prevenar Pooled Group	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	39 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	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	93 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	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	45 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	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	114 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	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	39 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	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	119 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	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	56 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	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	114 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	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	34 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	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	106 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	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	109 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	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	122 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	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	121 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	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	121 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	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	120 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	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	42 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	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	114 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	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	96 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	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	118 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	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	99 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	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	120 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	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	13 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	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	15 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	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	30 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	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	36 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	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	32 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	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	14 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	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	5 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	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	12 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	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	1 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	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	2 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	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	3 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	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	36 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	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	35 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	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	29 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	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	12 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	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	36 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	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	35 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	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	36 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	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	37 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	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	4 Participants

Secondary

Number of Subjects With Serious Adverse Events (SAEs)

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.

Time frame: 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.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Synflorix Pooled Group	Number of Subjects With Serious Adverse Events (SAEs)	2 Participants
Prevenar Pooled Group	Number of Subjects With Serious Adverse Events (SAEs)	0 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Number of Subjects With Serious Adverse Events (SAEs)	5 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Number of Subjects With Serious Adverse Events (SAEs)	2 Participants

Secondary

Number of Subjects With Unsolicited Adverse Events (AEs)

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.

Time frame: 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.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Synflorix Pooled Group	Number of Subjects With Unsolicited Adverse Events (AEs)	25 Participants
Prevenar Pooled Group	Number of Subjects With Unsolicited Adverse Events (AEs)	9 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Number of Subjects With Unsolicited Adverse Events (AEs)	106 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Number of Subjects With Unsolicited Adverse Events (AEs)	35 Participants

Secondary

Number of Subjects With Vaccine Response to Anti-Bordetella Pertussis (BPT)

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.

Time frame: One month after booster vaccination (Month 1)

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Synflorix Pooled Group	Number of Subjects With Vaccine Response to Anti-Bordetella Pertussis (BPT)	Anti-BPT, S-	37 Participants
Synflorix Pooled Group	Number of Subjects With Vaccine Response to Anti-Bordetella Pertussis (BPT)	Anti-BPT, S+	27 Participants
Prevenar Pooled Group	Number of Subjects With Vaccine Response to Anti-Bordetella Pertussis (BPT)	Anti-BPT, S+	8 Participants
Prevenar Pooled Group	Number of Subjects With Vaccine Response to Anti-Bordetella Pertussis (BPT)	Anti-BPT, S-	15 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Number of Subjects With Vaccine Response to Anti-Bordetella Pertussis (BPT)	Anti-BPT, S+	11 Participants
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Number of Subjects With Vaccine Response to Anti-Bordetella Pertussis (BPT)	Anti-BPT, S-	48 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Number of Subjects With Vaccine Response to Anti-Bordetella Pertussis (BPT)	Anti-BPT, S+	7 Participants
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Number of Subjects With Vaccine Response to Anti-Bordetella Pertussis (BPT)	Anti-BPT, S-	16 Participants

Secondary

Opsonophagocytic Activity (OPA) Against Pneumococcal Cross-reactive Serotypes 6A and 19A

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

Time frame: 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.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Synflorix Pooled Group	Opsonophagocytic Activity (OPA) Against Pneumococcal Cross-reactive Serotypes 6A and 19A	OPA Anti-6A, Month 0	113.6 Titers
Synflorix Pooled Group	Opsonophagocytic Activity (OPA) Against Pneumococcal Cross-reactive Serotypes 6A and 19A	OPA Anti-6A, Month 1	882.8 Titers
Synflorix Pooled Group	Opsonophagocytic Activity (OPA) Against Pneumococcal Cross-reactive Serotypes 6A and 19A	OPA Anti-19A, Month 1	89.3 Titers
Synflorix Pooled Group	Opsonophagocytic Activity (OPA) Against Pneumococcal Cross-reactive Serotypes 6A and 19A	OPA Anti-19A, Month 0	5.3 Titers
Prevenar Pooled Group	Opsonophagocytic Activity (OPA) Against Pneumococcal Cross-reactive Serotypes 6A and 19A	OPA Anti-6A, Month 1	2563.8 Titers
Prevenar Pooled Group	Opsonophagocytic Activity (OPA) Against Pneumococcal Cross-reactive Serotypes 6A and 19A	OPA Anti-19A, Month 1	8.7 Titers
Prevenar Pooled Group	Opsonophagocytic Activity (OPA) Against Pneumococcal Cross-reactive Serotypes 6A and 19A	OPA Anti-19A, Month 0	5.1 Titers
Prevenar Pooled Group	Opsonophagocytic Activity (OPA) Against Pneumococcal Cross-reactive Serotypes 6A and 19A	OPA Anti-6A, Month 0	191.4 Titers
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Opsonophagocytic Activity (OPA) Against Pneumococcal Cross-reactive Serotypes 6A and 19A	OPA Anti-6A, Month 0	46.8 Titers
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Opsonophagocytic Activity (OPA) Against Pneumococcal Cross-reactive Serotypes 6A and 19A	OPA Anti-19A, Month 1	70.7 Titers
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Opsonophagocytic Activity (OPA) Against Pneumococcal Cross-reactive Serotypes 6A and 19A	OPA Anti-19A, Month 0	5.3 Titers
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Opsonophagocytic Activity (OPA) Against Pneumococcal Cross-reactive Serotypes 6A and 19A	OPA Anti-6A, Month 1	369.7 Titers
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Opsonophagocytic Activity (OPA) Against Pneumococcal Cross-reactive Serotypes 6A and 19A	OPA Anti-19A, Month 1	20.3 Titers
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Opsonophagocytic Activity (OPA) Against Pneumococcal Cross-reactive Serotypes 6A and 19A	OPA Anti-6A, Month 0	42.2 Titers
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Opsonophagocytic Activity (OPA) Against Pneumococcal Cross-reactive Serotypes 6A and 19A	OPA Anti-6A, Month 1	1394.5 Titers
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Opsonophagocytic Activity (OPA) Against Pneumococcal Cross-reactive Serotypes 6A and 19A	OPA Anti-19A, Month 0	4.4 Titers

Secondary

Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F

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

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

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Synflorix Pooled Group	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
Synflorix Pooled Group	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
Synflorix Pooled Group	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
Synflorix Pooled Group	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
Synflorix Pooled Group	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
Synflorix Pooled Group	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
Synflorix Pooled Group	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
Synflorix Pooled Group	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
Synflorix Pooled Group	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
Synflorix Pooled Group	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
Synflorix Pooled Group	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
Synflorix Pooled Group	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
Synflorix Pooled Group	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
Synflorix Pooled Group	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
Synflorix Pooled Group	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
Synflorix Pooled Group	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
Synflorix Pooled Group	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
Synflorix Pooled Group	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
Synflorix Pooled Group	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
Synflorix Pooled Group	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
Prevenar Pooled Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPA Anti-18C, Month 1	966.5 Titers
Prevenar Pooled Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPA Anti-9V, Month 0	666.8 Titers
Prevenar Pooled Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPA Anti-23F, Month 0	661.9 Titers
Prevenar Pooled Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPA Anti-18C, Month 0	4.5 Titers
Prevenar Pooled Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPA Anti-5, Month 1	4.9 Titers
Prevenar Pooled Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPA Anti-9V, Month 1	7387.8 Titers
Prevenar Pooled Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPA Anti-1, Month 0	4.6 Titers
Prevenar Pooled Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPA Anti-23F, Month 1	23177.9 Titers
Prevenar Pooled Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPA Anti-7F, Month 1	1407.7 Titers
Prevenar Pooled Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPA Anti-14, Month 0	337.2 Titers
Prevenar Pooled Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPA Anti-6B, Month 0	56.6 Titers
Prevenar Pooled Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPA Anti-14, Month 1	4097.3 Titers
Prevenar Pooled Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPA Anti-7F, Month 0	378.8 Titers
Prevenar Pooled Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPA Anti-4, Month 1	4783.5 Titers
Prevenar Pooled Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPA Anti-19F, Month 0	7.3 Titers
Prevenar Pooled Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPA Anti-4, Month 0	18.5 Titers
Prevenar Pooled Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPA Anti-6B, Month 1	9302.7 Titers
Prevenar Pooled Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPA Anti-5, Month 0	4.2 Titers
Prevenar Pooled Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPA Anti-1, Month 1	4.9 Titers
Prevenar Pooled Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPA Anti-19F, Month 1	473.2 Titers
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPA Anti-14, Month 0	179.6 Titers
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPA Anti-1, Month 0	8.5 Titers
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPA Anti-1, Month 1	161.4 Titers
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPA Anti-4, Month 0	12.5 Titers
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPA Anti-4, Month 1	2498.7 Titers
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPA Anti-5, Month 0	10.9 Titers
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPA Anti-5, Month 1	149.1 Titers
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPA Anti-6B, Month 0	9.9 Titers
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPA Anti-6B, Month 1	405.3 Titers
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPA Anti-7F, Month 0	796.3 Titers
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPA Anti-7F, Month 1	6436.1 Titers
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPA Anti-9V, Month 0	380.2 Titers
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPA Anti-9V, Month 1	3499.9 Titers
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPA Anti-14, Month 1	1961.3 Titers
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPA Anti-18C, Month 0	7.8 Titers
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPA Anti-18C, Month 1	694 Titers
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPA Anti-19F, Month 0	33.3 Titers
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPA Anti-19F, Month 1	1059.8 Titers
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPA Anti-23F, Month 0	301.8 Titers
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPA Anti-23F, Month 1	3427.3 Titers
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPA Anti-7F, Month 1	90.6 Titers
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPA Anti-7F, Month 0	63.6 Titers
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPA Anti-23F, Month 0	790.6 Titers
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPA Anti-18C, Month 1	612.1 Titers
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPA Anti-6B, Month 1	3547.1 Titers
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPA Anti-6B, Month 0	23.3 Titers
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPA Anti-1, Month 1	5.4 Titers
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPA Anti-19F, Month 0	11.1 Titers
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPA Anti-5, Month 1	4.3 Titers
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPA Anti-5, Month 0	4.5 Titers
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPA Anti-1, Month 0	4.7 Titers
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPA Anti-19F, Month 1	471 Titers
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPA Anti-4, Month 1	4812.5 Titers
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPA Anti-14, Month 0	236.6 Titers
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPA Anti-4, Month 0	12.4 Titers
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPA Anti-14, Month 1	2939.5 Titers
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPA Anti-9V, Month 1	6881.4 Titers
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPA Anti-9V, Month 0	247.5 Titers
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPA Anti-23F, Month 1	19943.3 Titers
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPA Anti-18C, Month 0	4.5 Titers

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

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

Conditions

Keywords

Brief summary

Detailed description

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Number of Subjects Reporting Rectal Temperature Greater Than (>) the Cut-off

Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A

Antibody Concentrations to Protein D (Anti-PD)

Anti-Bordetella Pertussis (BPT) Antibody Concentrations

Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations

Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations

Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations

Anti-polio Type 1, 2 and 3 Antibody Titers

Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentrations

Number of Subjects With Antibody Concentrations Against Protein D (Anti-PD) ≥ the Cut-off

Number of Subjects With Anti-Bordetella Pertussis (BPT) With Concentrations ≥ the Cut-off

Number of Subjects With Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations ≥ the Cut-off

Number of Subjects With Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations ≥ the Cut-off

Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off

Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off

Number of Subjects With Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Antibody Titers ≥ the Cut-off

Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration ≥ the Cut-off

Number of Subjects With Anti-PRP Antibody Concentration ≥ the Cut-off

Number of Subjects With Any and Grade 3 Solicited General Symptoms

Number of Subjects With Any and Grade 3 Solicited Local Symptoms

Number of Subjects With Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A ≥ the Cut-off

Number of Subjects With Opsonophagocytic Activity (OPA) Against Pneumococcal Cross-reactive Serotypes 6A and 19A ≥ the Cut-off

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

Number of Subjects With Serious Adverse Events (SAEs)

Number of Subjects With Unsolicited Adverse Events (AEs)

Number of Subjects With Vaccine Response to Anti-Bordetella Pertussis (BPT)

Opsonophagocytic Activity (OPA) Against Pneumococcal Cross-reactive Serotypes 6A and 19A

Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F