Study of the Booster Effect of DTaP-IPV-Hep B-PRP~T Combined Vaccine or Infanrix Hexa™ and Prevenar™ in Healthy Infants

Evaluation of Antibody Persistence Following a Primary Series at 2, 4, and 6 Months on Trial A3L24 and Booster Effect of the DTaP-IPV-Hep B-PRP~T Combined Vaccine or Infanrix Hexa™ Concomitantly Administered With Prevenar™ at 12 to 24 Months of Age in Healthy Latin American Infants

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01444781

Enrollment

1106

Registered

2011-10-03

Start date

2011-09-30

Completion date

2013-10-31

Last updated

2014-07-16

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

Conditions

Diphtheria, Hepatitis B, Poliomyelitis, Tetanus, Whooping Cough

Keywords

Diphtheria, Tetanus, Whooping Cough, Hepatitis B, Poliomyelitis, Pediatric combined vaccine, Invasive Hib infections

Brief summary

This is a follow-up of the primary series vaccination schedule in Study A3L24 (NCT01177722). The objectives are: * To describe the antibody persistence to any antigen contained in the investigational DTaP-IPV-Hep B-PRP-T vaccine and Infanrix hexa™ prior to the booster dose * To describe the safety and immunogenicity of the booster dose of either DTaP-IPV-Hep B-PRP-T or Infanrix hexa™ vaccine. * To describe the immunogenicity of a booster dose of Prevenar™ given at 12 to 24 months.

Detailed description

All participants who completed trial A3L24 (NCT01177722) will be recruited to participate in this trial. Those who received DTaP-IPV-Hep B-PRP-T combined vaccine will be randomized to receive either a booster dose of DTaP-IPV-Hep B-PRP-T or Infanrix hexa™ vaccine. Those who received Infanrix hexa™ will receive a booster dose of DTaP-IPV-Hep B-PRP-T combined vaccine. All participants will receive a booster dose of Prevenar™ concomitantly.

Interventions

BIOLOGICALDTaP-IPV-Hep B-PRP~T combined vaccine + Pneumococcal polysaccharide

0.5 mL, Intramuscular each into the right and left deltoid muscle

BIOLOGICALDTaP-Hep B-IPV // Hib Vaccine + Pneumococcal polysaccharide

0.5 mL, Intramuscular each into the right and left deltoid muscle

BIOLOGICALDTaP-IPV-Hep B-PRP~T + Pneumococcal polysaccharide vaccine

0.5 mL (each), Intramuscular each into the right and left deltoid muscle

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

12 Months to 24 Months

Healthy volunteers

Yes

Inclusion criteria

* Aged 12 to 24 months on the day of inclusion. * Informed consent form has been signed and dated by the parent(s) or other legally acceptable representative (and by an independent witness(es) if required by local regulations). * Subject and parent/guardian are able to attend all scheduled visits and to comply with all trial procedures. * Toddlers previously included in Study A3L24 who completed the three-dose primary series vaccination of either DTaP-IPV-Hep B-PRP\ T or Infanrix hexa™ at 2,4 and 6 months of age according to protocol (both concomitantly administered with Prevenar™ and Rotarix™).

Exclusion criteria

* Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the booster vaccinations. * Planned participation in another clinical trial during the present trial period. * Receipt of any vaccine in the 4 weeks preceding the booster vaccinations, except in case of pandemic influenza vaccination, which may be received at least two weeks before the study vaccines. * Planned receipt of any vaccine in the 4 weeks following the trial vaccinations. * Previous booster vaccination against pertussis, tetanus, diphtheria, poliomyelitis, Haemophilus influenzae type b, hepatitis B and pneumococcal infection(s) with either the trial vaccine or another vaccine. * Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response. * Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 3 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months). * Laboratory-confirmed or clinical suspicion of personal or maternal seropositivity for Human Immunodeficiency Virus (HIV), hepatitis B, or hepatitis C, as reported by the parent/guardian. * History of pertussis, tetanus, diphtheria, poliomyelitis, Haemophilus influenzae type b, hepatitis B and pneumococcal infection(s), confirmed either clinically, serologically, or microbiologically. * At high risk for opportunistic infection during the trial. * Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances. * History of contraindication to receipt of pertussis-containing vaccine. * Laboratory-confirmed or clinical suspicion of thrombocytopenia contraindicating Intramuscular vaccination. * Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination. * History of seizures . * Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion. * Receipt of oral or injected antibiotic therapy within 72 hours prior to the first blood draw * Febrile illness (temperature ≥ 38.0°C) or moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination.

Design outcomes

Primary

Measure	Time frame	Description
Summary of Diphtheria and Tetanus Post Primary Series Antibodies, Persistence and Booster Response Following Vaccination With Either DTaP-IPV Hep B-PRP T Vaccine or Infanrix Hexa Vaccine	Day 140 (Primary series) and Day 0 (Pre-booster)	Anti-Diphtheria (D) antibodies were measured by a toxin neutralization test. Anti-Tetanus (T) antibodies were measured by enzyme-linked immunosorbent assay (ELISA). Antibody persistence for anti-Diphtheria and anti-Tetanus antibodies was defined as titers ≥0.01 IU/mL and ≥0.1 IU/mL before the booster dose at Day 0. Booster response to Diphtheria and Tetanus was defined as antibody titers ≥0.01 IU/mL and ≥0.1 IU/mL at Day 30 post-booster vaccination. Day 140 = Primary series; Day 0 = Pre-booster; and Day 30 = Post-booster titers
Summary of Pertussis and Filamentous Haemagglutinin Post Primary Series Antibodies, Persistence and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Day 140 after primary vaccination, Day 0 (pre-vaccination), and Day 30 after final booster vaccination	Anti-Pertussis toxin (PT) and anti-Filamentous haemagglutinin (FHA) antibodies were measured by ELISA. Antibody persistence for anti-PT and anti-FHA was defined as titers ≥ lower limit of quantitation (LLOQ) before the booster dose at Day 0. Booster responses for PT and FHA at Day 30 were defined as: pre-vaccination antibody concentrations \< LLOQ and post-vaccination levels ≥ 4 x LLOQ, pre-vaccination antibody concentrations ≥ LLOQ but \< 4 x LLOQ and post/pre vaccination ≥ 4, and pre-vaccination antibody concentrations ≥ 4 x LLOQ and post/pre-vaccination ≥ 2. Day 140 = Primary series; Day 0 = Pre-booster; and Day 30 = Post-booster titers.
Summary of Polio Antibodies Post Primary Series, Persistence and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Day 140 after primary vaccination, Day 0 (pre-vaccination), and Day 30 after final booster vaccination	Anti-Poliovirus types 1, 2, and 3 antibodies were measured by neutralization assay. Antibody persistence for anti-Poliovirus 1, 2, and 3 was defined as antibody titers ≥8 (1/dil) before the booster dose at Day 0. Booster response to Poliovirus 1, 2, and 3 was defined as antibody titers ≥8 (1/dil) at Day 30. Day 140 = Primary series; Day 0 = Pre-booster; and Day 30 = Post-booster titers.
Summary of Hepatitis B and Haemophilus Influenzae Type B Post Primary Series Antibodies; Antibody Persistence, and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Day 140 after primary vaccination, Day 0 (pre-vaccination), and Day 30 after final booster vaccination	Anti-Hepatitis B antibodies were measured by the commercially available VITROS ECi/ECiQ Immunodiagnostic System. Anti-Haemophilus influenza type b capsular polyribosyl ribitol phosphate (PRP) antibodies were measured using a Farr type radioimmunoassay that used radiolabeled PRP (3H PRP) in the presence of 36Cl (volume marker). Anti-Hepatitis antibody titers ≥ 10 mIU/mL and ≥ 100 mIU/mL at Day 0 confirmed antibody persistence and booster response at Day 30. Anti-PRP antibody titers ≥ 0.15 µg/ml and ≥ 1.0 µg/ml at Day 0 confirmed antibody persistence and booster response at Day 30. Day 140 = Primary series; Day 0 = Pre-booster; and Day 30 = Post-booster titers.

Secondary

Measure	Time frame	Description
Summary of Geometric Mean Titers to Vaccine Antigens After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine by Age Strata	Day 30 after final booster vaccination	Anti-Diphtheria antibodies were measured by a toxin neutralization test. Anti-FHA antibodies were measured by ELISA. Anti-Poliovirus types 1, 2, and 3 were measured by neutralization assay.
Summary of Geometric Mean Titers to Vaccine Antibodies Post Primary Vaccination Series; Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine.	Day 140 after primary vaccination, Day 0 (pre-vaccination), and Day 30 after final booster vaccination	Anti-Diphtheria antibodies were measured by a toxin neutralization test. Anti-Tetanus, anti-PT, and anti-FHA antibodies were measured by ELISA. Anti-Poliovirus types 1, 2, and 3 were measured by neutralization assay. Anti-Hepatitis B antibodies were measured by the commercially available VITROS ECi/ECiQ Immunodiagnostic System. Anti-PRP antibodies were measured using a Farr type radioimmunoassay that used radiolabeled PRP (3H PRP) in the presence of 36Cl (volume marker). Day 140 = Primary series; Day 0 = Pre-booster; and Day 30 = Post-booster titers.
Number of Participants Reporting a Solicited Injection Site Following Booster Vaccination With Prevenar Vaccine	Day 0 up to Day 7 after final booster vaccination	Solicited injection site: Pain, Erythema, Swelling, and Extensive swelling of vaccinated limb. Grade 3 Injection site: Pain, cries if limb is moved or reduced movement; Erythema and Swelling, ≥5 cm; and Extensive swelling of limb, Severe.
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Day 0 up to Day 7 after final booster vaccination	Solicited injection site: Pain, Erythema, Swelling, and Extensive swelling of vaccinated limb; Solicited systemic reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, and Irritability. Grade 3 Injection site: Pain, Cries if limb is moved or reduced movement; Erythema and Swelling, ≥5 cm; Extensive swelling of limb, Severe. Grade 3 Systemic reactions: Pyrexia (Temperature) \>39.5˚C; Vomiting, ≥ 6 times per 24 hours or needing parenteral nutrition; Crying, \>3 hours; Somnolence, Sleeping often or difficulty waking; Anorexia, refuses ≥3 meals; and Irritability, Inconsolable.
Summary of Immune Response Against Serotypes in the Prevenar Vaccine After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Day 30 after final booster vaccination	Anti-Streptococcus pneumococcal type specific antibody (anti-Pn PS) was measured by ELISA. Booster response to pneumococcal serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F was defined as antibody titers ≥0.35 µg/mL at Day 30.
Summary of Geometric Mean Titers to Prevenar Vaccine Antibodies After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Day 30 after final booster vaccination	Anti-Streptococcus pneumococcal type specific antibody (anti-Pn PS) was measured by ELISA.
Summary of Booster Response to Vaccine Antigens Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine By Age Strata	Day 0 (pre-vaccination) and Day 30 after final booster vaccination	Anti-PT and anti-FHA antibodies were measured by ELISA.

Countries

Colombia, Costa Rica

Participant flow

Recruitment details

The study participants were enrolled from 26 September 2011 through 19 July 2012 at 2 clinic centers in Colombia and Costa Rica.

Pre-assignment details

A total of 1106 participants who met all of the inclusion and none of the exclusion criteria were randomized and vaccinated in this study.

Participants by arm

Arm	Count
DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster Group Participants who were previously primed with DTaP IPV Hep B PRP T received one dose of DTaP IPV Hep B PRP T vaccine and one dose of Prevenar (PCV7)	416
DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster Group Participants who were previously primed with DTaP IPV Hep B PRP T received one dose of Infanrix Hexa vaccine and one dose of PCV7.	415
Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster Group. Participants who were previously primed with Infanrix Hexa vaccine received one dose of DTaP IPV Hep B PRP T and one dose of PCV7	275
Total	1,106

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002
Overall Study	Lost to Follow-up	0	3	1
Overall Study	Withdrawal by Subject	3	1	2

Baseline characteristics

Characteristic	DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster Group	DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster Group	Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster Group.	Total
Age, Categorical <=18 years	416 Participants	415 Participants	275 Participants	1106 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	0 Participants	0 Participants	0 Participants	0 Participants
Age, Continuous	17.6 Months STANDARD_DEVIATION 3.25	17.6 Months STANDARD_DEVIATION 3.34	17.8 Months STANDARD_DEVIATION 3.26	17.7 Months STANDARD_DEVIATION 3.29
Region of Enrollment Colombia	266 Participants	266 Participants	172 Participants	704 Participants
Region of Enrollment Costa Rica	150 Participants	149 Participants	103 Participants	402 Participants
Sex: Female, Male Female	203 Participants	186 Participants	128 Participants	517 Participants
Sex: Female, Male Male	213 Participants	229 Participants	147 Participants	589 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —
other Total, other adverse events	253 / 416	221 / 415	168 / 275
serious Total, serious adverse events	13 / 416	15 / 415	9 / 275

Outcome results

Primary

Summary of Diphtheria and Tetanus Post Primary Series Antibodies, Persistence and Booster Response Following Vaccination With Either DTaP-IPV Hep B-PRP T Vaccine or Infanrix Hexa Vaccine

Anti-Diphtheria (D) antibodies were measured by a toxin neutralization test. Anti-Tetanus (T) antibodies were measured by enzyme-linked immunosorbent assay (ELISA). Antibody persistence for anti-Diphtheria and anti-Tetanus antibodies was defined as titers ≥0.01 IU/mL and ≥0.1 IU/mL before the booster dose at Day 0. Booster response to Diphtheria and Tetanus was defined as antibody titers ≥0.01 IU/mL and ≥0.1 IU/mL at Day 30 post-booster vaccination. Day 140 = Primary series; Day 0 = Pre-booster; and Day 30 = Post-booster titers

Time frame: Day 140 (Primary series) and Day 0 (Pre-booster)

Population: Antibody responses were assessed in the Per Protocol Analysis Set, which includes all persons who did not have any protocol deviations.

Arm	Measure	Group	Value (NUMBER)
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Diphtheria and Tetanus Post Primary Series Antibodies, Persistence and Booster Response Following Vaccination With Either DTaP-IPV Hep B-PRP T Vaccine or Infanrix Hexa Vaccine	Anti-Diphtheria Day140 ≥0.01 IU/mL (N=392,391,259)	392 Participants
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Diphtheria and Tetanus Post Primary Series Antibodies, Persistence and Booster Response Following Vaccination With Either DTaP-IPV Hep B-PRP T Vaccine or Infanrix Hexa Vaccine	Anti-Diphtheria Day 140 ≥0.1 IU/mL (N=392,391,259)	308 Participants
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Diphtheria and Tetanus Post Primary Series Antibodies, Persistence and Booster Response Following Vaccination With Either DTaP-IPV Hep B-PRP T Vaccine or Infanrix Hexa Vaccine	Anti-Diphtheria Day 0 ≥0.01 IU/mL (N=390,390,257)	382 Participants
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Diphtheria and Tetanus Post Primary Series Antibodies, Persistence and Booster Response Following Vaccination With Either DTaP-IPV Hep B-PRP T Vaccine or Infanrix Hexa Vaccine	Anti-Diphtheria Day 0 ≥0.1 IU/mL (N=390,390,257)	156 Participants
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Diphtheria and Tetanus Post Primary Series Antibodies, Persistence and Booster Response Following Vaccination With Either DTaP-IPV Hep B-PRP T Vaccine or Infanrix Hexa Vaccine	Anti-Diphtheria Day 30 ≥0.01 IU/mL (N=393,387,254)	393 Participants
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Diphtheria and Tetanus Post Primary Series Antibodies, Persistence and Booster Response Following Vaccination With Either DTaP-IPV Hep B-PRP T Vaccine or Infanrix Hexa Vaccine	Anti-Diphtheria Day 30 ≥0.1 IU/mL (N=393,387,254)	393 Participants
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Diphtheria and Tetanus Post Primary Series Antibodies, Persistence and Booster Response Following Vaccination With Either DTaP-IPV Hep B-PRP T Vaccine or Infanrix Hexa Vaccine	Anti-Tetanus Day 140 ≥0.01 IU/mL (N=392,391,258)	392 Participants
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Diphtheria and Tetanus Post Primary Series Antibodies, Persistence and Booster Response Following Vaccination With Either DTaP-IPV Hep B-PRP T Vaccine or Infanrix Hexa Vaccine	Anti-Tetanus Day 140 ≥0.1 IU/mL (N=392,391,258)	392 Participants
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Diphtheria and Tetanus Post Primary Series Antibodies, Persistence and Booster Response Following Vaccination With Either DTaP-IPV Hep B-PRP T Vaccine or Infanrix Hexa Vaccine	Anti-Tetanus Day 0 ≥0.01 IU/mL (N=389,387,255)	389 Participants
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Diphtheria and Tetanus Post Primary Series Antibodies, Persistence and Booster Response Following Vaccination With Either DTaP-IPV Hep B-PRP T Vaccine or Infanrix Hexa Vaccine	Anti-Tetanus Day 0 ≥0.1 IU/mL (N=389,387,255)	289 Participants
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Diphtheria and Tetanus Post Primary Series Antibodies, Persistence and Booster Response Following Vaccination With Either DTaP-IPV Hep B-PRP T Vaccine or Infanrix Hexa Vaccine	Anti-Tetanus Day 30 ≥0.01 IU/mL (N=392,385,254)	392 Participants
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Diphtheria and Tetanus Post Primary Series Antibodies, Persistence and Booster Response Following Vaccination With Either DTaP-IPV Hep B-PRP T Vaccine or Infanrix Hexa Vaccine	Anti-Tetanus Day 30 ≥0.1 IU/mL (N=392,385,254)	391 Participants
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Diphtheria and Tetanus Post Primary Series Antibodies, Persistence and Booster Response Following Vaccination With Either DTaP-IPV Hep B-PRP T Vaccine or Infanrix Hexa Vaccine	Anti-Tetanus Day 30 ≥0.1 IU/mL (N=392,385,254)	385 Participants
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Diphtheria and Tetanus Post Primary Series Antibodies, Persistence and Booster Response Following Vaccination With Either DTaP-IPV Hep B-PRP T Vaccine or Infanrix Hexa Vaccine	Anti-Diphtheria Day140 ≥0.01 IU/mL (N=392,391,259)	391 Participants
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Diphtheria and Tetanus Post Primary Series Antibodies, Persistence and Booster Response Following Vaccination With Either DTaP-IPV Hep B-PRP T Vaccine or Infanrix Hexa Vaccine	Anti-Tetanus Day 140 ≥0.01 IU/mL (N=392,391,258)	391 Participants
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Diphtheria and Tetanus Post Primary Series Antibodies, Persistence and Booster Response Following Vaccination With Either DTaP-IPV Hep B-PRP T Vaccine or Infanrix Hexa Vaccine	Anti-Tetanus Day 0 ≥0.01 IU/mL (N=389,387,255)	386 Participants
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Diphtheria and Tetanus Post Primary Series Antibodies, Persistence and Booster Response Following Vaccination With Either DTaP-IPV Hep B-PRP T Vaccine or Infanrix Hexa Vaccine	Anti-Diphtheria Day 140 ≥0.1 IU/mL (N=392,391,259)	290 Participants
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Diphtheria and Tetanus Post Primary Series Antibodies, Persistence and Booster Response Following Vaccination With Either DTaP-IPV Hep B-PRP T Vaccine or Infanrix Hexa Vaccine	Anti-Diphtheria Day 30 ≥0.1 IU/mL (N=393,387,254)	386 Participants
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Diphtheria and Tetanus Post Primary Series Antibodies, Persistence and Booster Response Following Vaccination With Either DTaP-IPV Hep B-PRP T Vaccine or Infanrix Hexa Vaccine	Anti-Tetanus Day 30 ≥0.01 IU/mL (N=392,385,254)	385 Participants
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Diphtheria and Tetanus Post Primary Series Antibodies, Persistence and Booster Response Following Vaccination With Either DTaP-IPV Hep B-PRP T Vaccine or Infanrix Hexa Vaccine	Anti-Diphtheria Day 0 ≥0.01 IU/mL (N=390,390,257)	378 Participants
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Diphtheria and Tetanus Post Primary Series Antibodies, Persistence and Booster Response Following Vaccination With Either DTaP-IPV Hep B-PRP T Vaccine or Infanrix Hexa Vaccine	Anti-Tetanus Day 140 ≥0.1 IU/mL (N=392,391,258)	390 Participants
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Diphtheria and Tetanus Post Primary Series Antibodies, Persistence and Booster Response Following Vaccination With Either DTaP-IPV Hep B-PRP T Vaccine or Infanrix Hexa Vaccine	Anti-Diphtheria Day 30 ≥0.01 IU/mL (N=393,387,254)	387 Participants
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Diphtheria and Tetanus Post Primary Series Antibodies, Persistence and Booster Response Following Vaccination With Either DTaP-IPV Hep B-PRP T Vaccine or Infanrix Hexa Vaccine	Anti-Diphtheria Day 0 ≥0.1 IU/mL (N=390,390,257)	153 Participants
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Diphtheria and Tetanus Post Primary Series Antibodies, Persistence and Booster Response Following Vaccination With Either DTaP-IPV Hep B-PRP T Vaccine or Infanrix Hexa Vaccine	Anti-Tetanus Day 0 ≥0.1 IU/mL (N=389,387,255)	286 Participants
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Diphtheria and Tetanus Post Primary Series Antibodies, Persistence and Booster Response Following Vaccination With Either DTaP-IPV Hep B-PRP T Vaccine or Infanrix Hexa Vaccine	Anti-Diphtheria Day 0 ≥0.1 IU/mL (N=390,390,257)	70 Participants
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Diphtheria and Tetanus Post Primary Series Antibodies, Persistence and Booster Response Following Vaccination With Either DTaP-IPV Hep B-PRP T Vaccine or Infanrix Hexa Vaccine	Anti-Diphtheria Day 30 ≥0.01 IU/mL (N=393,387,254)	254 Participants
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Diphtheria and Tetanus Post Primary Series Antibodies, Persistence and Booster Response Following Vaccination With Either DTaP-IPV Hep B-PRP T Vaccine or Infanrix Hexa Vaccine	Anti-Tetanus Day 0 ≥0.1 IU/mL (N=389,387,255)	196 Participants
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Diphtheria and Tetanus Post Primary Series Antibodies, Persistence and Booster Response Following Vaccination With Either DTaP-IPV Hep B-PRP T Vaccine or Infanrix Hexa Vaccine	Anti-Diphtheria Day 30 ≥0.1 IU/mL (N=393,387,254)	254 Participants
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Diphtheria and Tetanus Post Primary Series Antibodies, Persistence and Booster Response Following Vaccination With Either DTaP-IPV Hep B-PRP T Vaccine or Infanrix Hexa Vaccine	Anti-Tetanus Day 140 ≥0.01 IU/mL (N=392,391,258)	258 Participants
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Diphtheria and Tetanus Post Primary Series Antibodies, Persistence and Booster Response Following Vaccination With Either DTaP-IPV Hep B-PRP T Vaccine or Infanrix Hexa Vaccine	Anti-Tetanus Day 140 ≥0.1 IU/mL (N=392,391,258)	258 Participants
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Diphtheria and Tetanus Post Primary Series Antibodies, Persistence and Booster Response Following Vaccination With Either DTaP-IPV Hep B-PRP T Vaccine or Infanrix Hexa Vaccine	Anti-Tetanus Day 30 ≥0.01 IU/mL (N=392,385,254)	254 Participants
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Diphtheria and Tetanus Post Primary Series Antibodies, Persistence and Booster Response Following Vaccination With Either DTaP-IPV Hep B-PRP T Vaccine or Infanrix Hexa Vaccine	Anti-Diphtheria Day140 ≥0.01 IU/mL (N=392,391,259)	259 Participants
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Diphtheria and Tetanus Post Primary Series Antibodies, Persistence and Booster Response Following Vaccination With Either DTaP-IPV Hep B-PRP T Vaccine or Infanrix Hexa Vaccine	Anti-Diphtheria Day 140 ≥0.1 IU/mL (N=392,391,259)	197 Participants
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Diphtheria and Tetanus Post Primary Series Antibodies, Persistence and Booster Response Following Vaccination With Either DTaP-IPV Hep B-PRP T Vaccine or Infanrix Hexa Vaccine	Anti-Tetanus Day 0 ≥0.01 IU/mL (N=389,387,255)	255 Participants
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Diphtheria and Tetanus Post Primary Series Antibodies, Persistence and Booster Response Following Vaccination With Either DTaP-IPV Hep B-PRP T Vaccine or Infanrix Hexa Vaccine	Anti-Diphtheria Day 0 ≥0.01 IU/mL (N=390,390,257)	246 Participants
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Diphtheria and Tetanus Post Primary Series Antibodies, Persistence and Booster Response Following Vaccination With Either DTaP-IPV Hep B-PRP T Vaccine or Infanrix Hexa Vaccine	Anti-Tetanus Day 30 ≥0.1 IU/mL (N=392,385,254)	254 Participants

Primary

Summary of Hepatitis B and Haemophilus Influenzae Type B Post Primary Series Antibodies; Antibody Persistence, and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine

Anti-Hepatitis B antibodies were measured by the commercially available VITROS ECi/ECiQ Immunodiagnostic System. Anti-Haemophilus influenza type b capsular polyribosyl ribitol phosphate (PRP) antibodies were measured using a Farr type radioimmunoassay that used radiolabeled PRP (3H PRP) in the presence of 36Cl (volume marker). Anti-Hepatitis antibody titers ≥ 10 mIU/mL and ≥ 100 mIU/mL at Day 0 confirmed antibody persistence and booster response at Day 30. Anti-PRP antibody titers ≥ 0.15 µg/ml and ≥ 1.0 µg/ml at Day 0 confirmed antibody persistence and booster response at Day 30. Day 140 = Primary series; Day 0 = Pre-booster; and Day 30 = Post-booster titers.

Time frame: Day 140 after primary vaccination, Day 0 (pre-vaccination), and Day 30 after final booster vaccination

Population: Antibody responses were assessed in the Per Protocol Analysis Set.

Arm	Measure	Group	Value (NUMBER)
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Hepatitis B and Haemophilus Influenzae Type B Post Primary Series Antibodies; Antibody Persistence, and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-PRP Day 0 ≥0.15 µg/mL (N = 395,391,258)	290 Participants
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Hepatitis B and Haemophilus Influenzae Type B Post Primary Series Antibodies; Antibody Persistence, and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-Hep B Day 0 ≥100 mIU/mL (N = 396,391,259)	327 Participants
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Hepatitis B and Haemophilus Influenzae Type B Post Primary Series Antibodies; Antibody Persistence, and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-PRP Day 0 ≥1.0 µg/mL (N = 395,391,258)	110 Participants
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Hepatitis B and Haemophilus Influenzae Type B Post Primary Series Antibodies; Antibody Persistence, and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-PRP Day 30 ≥0.15 µg/mL (N = 396,391,258)	395 Participants
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Hepatitis B and Haemophilus Influenzae Type B Post Primary Series Antibodies; Antibody Persistence, and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-PRP Day 30 ≥1.0 µg/mL (N = 396,391,258)	391 Participants
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Hepatitis B and Haemophilus Influenzae Type B Post Primary Series Antibodies; Antibody Persistence, and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-Hep B Day 140 ≥10 mIU/mL (N = 393,392,260)	391 Participants
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Hepatitis B and Haemophilus Influenzae Type B Post Primary Series Antibodies; Antibody Persistence, and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-Hep B Day 30 ≥10 mIU/mL (N = 395,393,259)	394 Participants
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Hepatitis B and Haemophilus Influenzae Type B Post Primary Series Antibodies; Antibody Persistence, and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-Hep B Day 30 ≥100 mIU/mL (N = 395,393,259)	386 Participants
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Hepatitis B and Haemophilus Influenzae Type B Post Primary Series Antibodies; Antibody Persistence, and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-Hep B Day 0 ≥10 mIU/mL (N = 396,391,259)	386 Participants
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Hepatitis B and Haemophilus Influenzae Type B Post Primary Series Antibodies; Antibody Persistence, and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-PRP Day 140 ≥0.15 µg/mL (N = 393,392,260)	370 Participants
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Hepatitis B and Haemophilus Influenzae Type B Post Primary Series Antibodies; Antibody Persistence, and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-PRP Day 140 ≥1.0 µg/mL (N = 393,392,260)	297 Participants
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Hepatitis B and Haemophilus Influenzae Type B Post Primary Series Antibodies; Antibody Persistence, and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-Hep B Day 140 ≥100 mIU/mL (N = 393,392,260)	389 Participants
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Hepatitis B and Haemophilus Influenzae Type B Post Primary Series Antibodies; Antibody Persistence, and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-PRP Day 140 ≥0.15 µg/mL (N = 393,392,260)	375 Participants
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Hepatitis B and Haemophilus Influenzae Type B Post Primary Series Antibodies; Antibody Persistence, and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-PRP Day 0 ≥0.15 µg/mL (N = 395,391,258)	304 Participants
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Hepatitis B and Haemophilus Influenzae Type B Post Primary Series Antibodies; Antibody Persistence, and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-Hep B Day 0 ≥10 mIU/mL (N = 396,391,259)	382 Participants
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Hepatitis B and Haemophilus Influenzae Type B Post Primary Series Antibodies; Antibody Persistence, and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-Hep B Day 30 ≥10 mIU/mL (N = 395,393,259)	391 Participants
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Hepatitis B and Haemophilus Influenzae Type B Post Primary Series Antibodies; Antibody Persistence, and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-PRP Day 0 ≥1.0 µg/mL (N = 395,391,258)	129 Participants
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Hepatitis B and Haemophilus Influenzae Type B Post Primary Series Antibodies; Antibody Persistence, and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-Hep B Day 0 ≥100 mIU/mL (N = 396,391,259)	333 Participants
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Hepatitis B and Haemophilus Influenzae Type B Post Primary Series Antibodies; Antibody Persistence, and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-Hep B Day 140 ≥10 mIU/mL (N = 393,392,260)	391 Participants
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Hepatitis B and Haemophilus Influenzae Type B Post Primary Series Antibodies; Antibody Persistence, and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-PRP Day 30 ≥0.15 µg/mL (N = 396,391,258)	391 Participants
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Hepatitis B and Haemophilus Influenzae Type B Post Primary Series Antibodies; Antibody Persistence, and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-Hep B Day 140 ≥100 mIU/mL (N = 393,392,260)	387 Participants
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Hepatitis B and Haemophilus Influenzae Type B Post Primary Series Antibodies; Antibody Persistence, and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-PRP Day 140 ≥1.0 µg/mL (N = 393,392,260)	305 Participants
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Hepatitis B and Haemophilus Influenzae Type B Post Primary Series Antibodies; Antibody Persistence, and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-PRP Day 30 ≥1.0 µg/mL (N = 396,391,258)	387 Participants
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Hepatitis B and Haemophilus Influenzae Type B Post Primary Series Antibodies; Antibody Persistence, and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-Hep B Day 30 ≥100 mIU/mL (N = 395,393,259)	384 Participants
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Hepatitis B and Haemophilus Influenzae Type B Post Primary Series Antibodies; Antibody Persistence, and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-PRP Day 30 ≥1.0 µg/mL (N = 396,391,258)	258 Participants
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Hepatitis B and Haemophilus Influenzae Type B Post Primary Series Antibodies; Antibody Persistence, and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-Hep B Day 140 ≥10 mIU/mL (N = 393,392,260)	260 Participants
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Hepatitis B and Haemophilus Influenzae Type B Post Primary Series Antibodies; Antibody Persistence, and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-Hep B Day 140 ≥100 mIU/mL (N = 393,392,260)	259 Participants
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Hepatitis B and Haemophilus Influenzae Type B Post Primary Series Antibodies; Antibody Persistence, and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-Hep B Day 0 ≥10 mIU/mL (N = 396,391,259)	257 Participants
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Hepatitis B and Haemophilus Influenzae Type B Post Primary Series Antibodies; Antibody Persistence, and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-Hep B Day 0 ≥100 mIU/mL (N = 396,391,259)	213 Participants
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Hepatitis B and Haemophilus Influenzae Type B Post Primary Series Antibodies; Antibody Persistence, and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-Hep B Day 30 ≥10 mIU/mL (N = 395,393,259)	259 Participants
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Hepatitis B and Haemophilus Influenzae Type B Post Primary Series Antibodies; Antibody Persistence, and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-Hep B Day 30 ≥100 mIU/mL (N = 395,393,259)	257 Participants
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Hepatitis B and Haemophilus Influenzae Type B Post Primary Series Antibodies; Antibody Persistence, and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-PRP Day 140 ≥0.15 µg/mL (N = 393,392,260)	246 Participants
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Hepatitis B and Haemophilus Influenzae Type B Post Primary Series Antibodies; Antibody Persistence, and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-PRP Day 140 ≥1.0 µg/mL (N = 393,392,260)	188 Participants
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Hepatitis B and Haemophilus Influenzae Type B Post Primary Series Antibodies; Antibody Persistence, and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-PRP Day 0 ≥0.15 µg/mL (N = 395,391,258)	197 Participants
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Hepatitis B and Haemophilus Influenzae Type B Post Primary Series Antibodies; Antibody Persistence, and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-PRP Day 0 ≥1.0 µg/mL (N = 395,391,258)	73 Participants
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Hepatitis B and Haemophilus Influenzae Type B Post Primary Series Antibodies; Antibody Persistence, and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-PRP Day 30 ≥0.15 µg/mL (N = 396,391,258)	258 Participants

Primary

Summary of Pertussis and Filamentous Haemagglutinin Post Primary Series Antibodies, Persistence and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine

Anti-Pertussis toxin (PT) and anti-Filamentous haemagglutinin (FHA) antibodies were measured by ELISA. Antibody persistence for anti-PT and anti-FHA was defined as titers ≥ lower limit of quantitation (LLOQ) before the booster dose at Day 0. Booster responses for PT and FHA at Day 30 were defined as: pre-vaccination antibody concentrations \< LLOQ and post-vaccination levels ≥ 4 x LLOQ, pre-vaccination antibody concentrations ≥ LLOQ but \< 4 x LLOQ and post/pre vaccination ≥ 4, and pre-vaccination antibody concentrations ≥ 4 x LLOQ and post/pre-vaccination ≥ 2. Day 140 = Primary series; Day 0 = Pre-booster; and Day 30 = Post-booster titers.

Time frame: Day 140 after primary vaccination, Day 0 (pre-vaccination), and Day 30 after final booster vaccination

Population: Antibody responses were assessed in the Per-protocol Analysis Set.

Arm	Measure	Group	Value (NUMBER)
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Pertussis and Filamentous Haemagglutinin Post Primary Series Antibodies, Persistence and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-PT Day 140 ≥2 EU/mL (N=393,391,259)	393 Participants
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Pertussis and Filamentous Haemagglutinin Post Primary Series Antibodies, Persistence and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-PT Day 0 ≥2 EU/mL (N=385,382,257)	344 Participants
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Pertussis and Filamentous Haemagglutinin Post Primary Series Antibodies, Persistence and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	A-PT Day 30 ≥ 2 EU/mL (N=391,383,254)	391 Participants
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Pertussis and Filamentous Haemagglutinin Post Primary Series Antibodies, Persistence and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-PT 4-fold increase (N=380,374,252)	353 Participants
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Pertussis and Filamentous Haemagglutinin Post Primary Series Antibodies, Persistence and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-PT booster response (N=380,374,252)	375 Participants
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Pertussis and Filamentous Haemagglutinin Post Primary Series Antibodies, Persistence and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-FHA Day 140 ≥2 EU/mL (N=391,390,259)	391 Participants
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Pertussis and Filamentous Haemagglutinin Post Primary Series Antibodies, Persistence and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-FHA Day 0 ≥2 EU/mL (N=389,384,255)	389 Participants
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Pertussis and Filamentous Haemagglutinin Post Primary Series Antibodies, Persistence and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-FHA Day 30 ≥2 EU/mL (N=390,385,254)	390 Participants
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Pertussis and Filamentous Haemagglutinin Post Primary Series Antibodies, Persistence and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-FHA 4-fold increase (N=384,376,252)	336 Participants
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Pertussis and Filamentous Haemagglutinin Post Primary Series Antibodies, Persistence and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-FHA booster response (N=384,376,252)	370 Participants
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Pertussis and Filamentous Haemagglutinin Post Primary Series Antibodies, Persistence and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-FHA 4-fold increase (N=384,376,252)	334 Participants
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Pertussis and Filamentous Haemagglutinin Post Primary Series Antibodies, Persistence and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-PT Day 140 ≥2 EU/mL (N=393,391,259)	391 Participants
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Pertussis and Filamentous Haemagglutinin Post Primary Series Antibodies, Persistence and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-FHA Day 140 ≥2 EU/mL (N=391,390,259)	390 Participants
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Pertussis and Filamentous Haemagglutinin Post Primary Series Antibodies, Persistence and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-PT booster response (N=380,374,252)	365 Participants
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Pertussis and Filamentous Haemagglutinin Post Primary Series Antibodies, Persistence and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-PT Day 0 ≥2 EU/mL (N=385,382,257)	349 Participants
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Pertussis and Filamentous Haemagglutinin Post Primary Series Antibodies, Persistence and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-FHA booster response (N=384,376,252)	367 Participants
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Pertussis and Filamentous Haemagglutinin Post Primary Series Antibodies, Persistence and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-FHA Day 30 ≥2 EU/mL (N=390,385,254)	385 Participants
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Pertussis and Filamentous Haemagglutinin Post Primary Series Antibodies, Persistence and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	A-PT Day 30 ≥ 2 EU/mL (N=391,383,254)	383 Participants
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Pertussis and Filamentous Haemagglutinin Post Primary Series Antibodies, Persistence and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-FHA Day 0 ≥2 EU/mL (N=389,384,255)	384 Participants
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Pertussis and Filamentous Haemagglutinin Post Primary Series Antibodies, Persistence and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-PT 4-fold increase (N=380,374,252)	351 Participants
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Pertussis and Filamentous Haemagglutinin Post Primary Series Antibodies, Persistence and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-FHA Day 30 ≥2 EU/mL (N=390,385,254)	254 Participants
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Pertussis and Filamentous Haemagglutinin Post Primary Series Antibodies, Persistence and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-PT 4-fold increase (N=380,374,252)	234 Participants
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Pertussis and Filamentous Haemagglutinin Post Primary Series Antibodies, Persistence and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-PT booster response (N=380,374,252)	245 Participants
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Pertussis and Filamentous Haemagglutinin Post Primary Series Antibodies, Persistence and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-FHA Day 140 ≥2 EU/mL (N=391,390,259)	259 Participants
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Pertussis and Filamentous Haemagglutinin Post Primary Series Antibodies, Persistence and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-FHA 4-fold increase (N=384,376,252)	235 Participants
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Pertussis and Filamentous Haemagglutinin Post Primary Series Antibodies, Persistence and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-FHA Day 0 ≥2 EU/mL (N=389,384,255)	253 Participants
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Pertussis and Filamentous Haemagglutinin Post Primary Series Antibodies, Persistence and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-PT Day 140 ≥2 EU/mL (N=393,391,259)	259 Participants
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Pertussis and Filamentous Haemagglutinin Post Primary Series Antibodies, Persistence and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-FHA booster response (N=384,376,252)	249 Participants
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Pertussis and Filamentous Haemagglutinin Post Primary Series Antibodies, Persistence and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-PT Day 0 ≥2 EU/mL (N=385,382,257)	225 Participants
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Pertussis and Filamentous Haemagglutinin Post Primary Series Antibodies, Persistence and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	A-PT Day 30 ≥ 2 EU/mL (N=391,383,254)	254 Participants

Primary

Summary of Polio Antibodies Post Primary Series, Persistence and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine

Anti-Poliovirus types 1, 2, and 3 antibodies were measured by neutralization assay. Antibody persistence for anti-Poliovirus 1, 2, and 3 was defined as antibody titers ≥8 (1/dil) before the booster dose at Day 0. Booster response to Poliovirus 1, 2, and 3 was defined as antibody titers ≥8 (1/dil) at Day 30. Day 140 = Primary series; Day 0 = Pre-booster; and Day 30 = Post-booster titers.

Time frame: Day 140 after primary vaccination, Day 0 (pre-vaccination), and Day 30 after final booster vaccination

Population: Antibody responses were assessed in the Per Protocol Analysis Set.

Arm	Measure	Group	Value (NUMBER)
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Polio Antibodies Post Primary Series, Persistence and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-Polio 2 Day 140 (N = 338,327,214)	338 Participants
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Polio Antibodies Post Primary Series, Persistence and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-Polio 3 Day 30 (N = 340,326,212)	340 Participants
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Polio Antibodies Post Primary Series, Persistence and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-Polio 2 Day 30 (N = 340,327,212)	340 Participants
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Polio Antibodies Post Primary Series, Persistence and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-Polio 2 Day 0(N = 337,328,213)	335 Participants
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Polio Antibodies Post Primary Series, Persistence and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-Polio 1 Day 140 (N = 338,329,214)	338 Participants
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Polio Antibodies Post Primary Series, Persistence and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-Polio 3 Day 0 (N = 338,326,213)	324 Participants
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Polio Antibodies Post Primary Series, Persistence and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-Polio 1 Day 30 (N = 339,327,212)	339 Participants
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Polio Antibodies Post Primary Series, Persistence and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-Polio 1 Day 0 (N = 338,326,213)	334 Participants
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Polio Antibodies Post Primary Series, Persistence and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-Polio 3 Day 140 (N = 338,328,214)	338 Participants
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Polio Antibodies Post Primary Series, Persistence and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-Polio 2 Day 0(N = 337,328,213)	328 Participants
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Polio Antibodies Post Primary Series, Persistence and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-Polio 1 Day 140 (N = 338,329,214)	329 Participants
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Polio Antibodies Post Primary Series, Persistence and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-Polio 1 Day 0 (N = 338,326,213)	320 Participants
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Polio Antibodies Post Primary Series, Persistence and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-Polio 1 Day 30 (N = 339,327,212)	327 Participants
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Polio Antibodies Post Primary Series, Persistence and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-Polio 2 Day 140 (N = 338,327,214)	327 Participants
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Polio Antibodies Post Primary Series, Persistence and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-Polio 2 Day 30 (N = 340,327,212)	327 Participants
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Polio Antibodies Post Primary Series, Persistence and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-Polio 3 Day 140 (N = 338,328,214)	328 Participants
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Polio Antibodies Post Primary Series, Persistence and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-Polio 3 Day 0 (N = 338,326,213)	309 Participants
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Polio Antibodies Post Primary Series, Persistence and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-Polio 3 Day 30 (N = 340,326,212)	326 Participants
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Polio Antibodies Post Primary Series, Persistence and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-Polio 1 Day 30 (N = 339,327,212)	212 Participants
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Polio Antibodies Post Primary Series, Persistence and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-Polio 1 Day 140 (N = 338,329,214)	214 Participants
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Polio Antibodies Post Primary Series, Persistence and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-Polio 3 Day 140 (N = 338,328,214)	214 Participants
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Polio Antibodies Post Primary Series, Persistence and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-Polio 1 Day 0 (N = 338,326,213)	210 Participants
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Polio Antibodies Post Primary Series, Persistence and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-Polio 3 Day 30 (N = 340,326,212)	212 Participants
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Polio Antibodies Post Primary Series, Persistence and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-Polio 2 Day 0(N = 337,328,213)	213 Participants
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Polio Antibodies Post Primary Series, Persistence and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-Polio 2 Day 140 (N = 338,327,214)	214 Participants
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Polio Antibodies Post Primary Series, Persistence and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-Polio 3 Day 0 (N = 338,326,213)	211 Participants
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Polio Antibodies Post Primary Series, Persistence and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-Polio 2 Day 30 (N = 340,327,212)	212 Participants

Secondary

Number of Participants Reporting a Solicited Injection Site Following Booster Vaccination With Prevenar Vaccine

Solicited injection site: Pain, Erythema, Swelling, and Extensive swelling of vaccinated limb. Grade 3 Injection site: Pain, cries if limb is moved or reduced movement; Erythema and Swelling, ≥5 cm; and Extensive swelling of limb, Severe.

Time frame: Day 0 up to Day 7 after final booster vaccination

Population: Solicited injection site reactions were assessed in the Safety Analysis Set.

Arm	Measure	Group	Value (NUMBER)
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Number of Participants Reporting a Solicited Injection Site Following Booster Vaccination With Prevenar Vaccine	Injection site Pain (N=413,412,272)	224 Participants
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Number of Participants Reporting a Solicited Injection Site Following Booster Vaccination With Prevenar Vaccine	Grade 3 Injection site Pain (N=413,412,272)	9 Participants
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Number of Participants Reporting a Solicited Injection Site Following Booster Vaccination With Prevenar Vaccine	Injection site Erythema (N=413,412,272)	84 Participants
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Number of Participants Reporting a Solicited Injection Site Following Booster Vaccination With Prevenar Vaccine	Grade 3 Injection site Erythema (N=413,412,272)	0 Participants
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Number of Participants Reporting a Solicited Injection Site Following Booster Vaccination With Prevenar Vaccine	Injection site Swelling (N=413,412,272)	51 Participants
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Number of Participants Reporting a Solicited Injection Site Following Booster Vaccination With Prevenar Vaccine	Grade 3 Injection site Swelling (N=413,412,272)	1 Participants
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Number of Participants Reporting a Solicited Injection Site Following Booster Vaccination With Prevenar Vaccine	Grade 3 Injection site Swelling (N=413,412,272)	1 Participants
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Number of Participants Reporting a Solicited Injection Site Following Booster Vaccination With Prevenar Vaccine	Injection site Pain (N=413,412,272)	184 Participants
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Number of Participants Reporting a Solicited Injection Site Following Booster Vaccination With Prevenar Vaccine	Grade 3 Injection site Erythema (N=413,412,272)	0 Participants
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Number of Participants Reporting a Solicited Injection Site Following Booster Vaccination With Prevenar Vaccine	Injection site Swelling (N=413,412,272)	42 Participants
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Number of Participants Reporting a Solicited Injection Site Following Booster Vaccination With Prevenar Vaccine	Grade 3 Injection site Pain (N=413,412,272)	9 Participants
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Number of Participants Reporting a Solicited Injection Site Following Booster Vaccination With Prevenar Vaccine	Injection site Erythema (N=413,412,272)	77 Participants
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Number of Participants Reporting a Solicited Injection Site Following Booster Vaccination With Prevenar Vaccine	Grade 3 Injection site Pain (N=413,412,272)	5 Participants
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Number of Participants Reporting a Solicited Injection Site Following Booster Vaccination With Prevenar Vaccine	Injection site Erythema (N=413,412,272)	52 Participants
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Number of Participants Reporting a Solicited Injection Site Following Booster Vaccination With Prevenar Vaccine	Grade 3 Injection site Swelling (N=413,412,272)	1 Participants
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Number of Participants Reporting a Solicited Injection Site Following Booster Vaccination With Prevenar Vaccine	Grade 3 Injection site Erythema (N=413,412,272)	0 Participants
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Number of Participants Reporting a Solicited Injection Site Following Booster Vaccination With Prevenar Vaccine	Injection site Pain (N=413,412,272)	140 Participants
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Number of Participants Reporting a Solicited Injection Site Following Booster Vaccination With Prevenar Vaccine	Injection site Swelling (N=413,412,272)	33 Participants

Secondary

Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine

Solicited injection site: Pain, Erythema, Swelling, and Extensive swelling of vaccinated limb; Solicited systemic reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, and Irritability. Grade 3 Injection site: Pain, Cries if limb is moved or reduced movement; Erythema and Swelling, ≥5 cm; Extensive swelling of limb, Severe. Grade 3 Systemic reactions: Pyrexia (Temperature) \>39.5˚C; Vomiting, ≥ 6 times per 24 hours or needing parenteral nutrition; Crying, \>3 hours; Somnolence, Sleeping often or difficulty waking; Anorexia, refuses ≥3 meals; and Irritability, Inconsolable.

Time frame: Day 0 up to Day 7 after final booster vaccination

Population: Solicited injection site reactions and systemic reactions were assessed in the Safety Analysis Set, which includes all persons who received the study or control vaccine.

Arm	Measure	Group	Value (NUMBER)
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Crying (N=413,412,272)	148 Participants
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Grade 3 inj. site Swelling (N=412,412,272)	3 Participants
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Grade 3 Anorexia (N=413,412,272)	3 Participants
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Grade 3 Somnolence (N=413,412,272)	2 Participants
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Extensive swelling of limb (N=413,412,272)	0 Participants
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Injection site Erythema (N=413,412,272)	112 Participants
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Grade 3 Pyrexia (N=413,412,272)	2 Participants
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Grade 3 Extensive swelling of limb (N=413,412,272)	0 Participants
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Grade 3 Irritability (N=413,412,272)	1 Participants
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Pyrexia (N=413,412,272)	114 Participants
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anorexia (N=413,412,272)	118 Participants
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Grade 3 inj. site Erythema (N=413,412,272)	4 Participants
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Grade 3 inj. site Pain (N=413,412,272)	10 Participants
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Somnolence (N=413,412,272)	124 Participants
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Vomiting (N=413,412,272)	34 Participants
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Irritability (N=413,412,272)	201 Participants
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Grade 3 Crying (N=413,412,272)	1 Participants
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Grade 3 Vomiting (N=413,412,272)	1 Participants
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Injection site Swelling (N=412,412,272)	60 Participants
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Injection site Pain (N=413,412,272)	232 Participants
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Somnolence (N=413,412,272)	113 Participants
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Injection site Pain (N=413,412,272)	205 Participants
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Grade 3 inj. site Pain (N=413,412,272)	6 Participants
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Injection site Erythema (N=413,412,272)	100 Participants
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Grade 3 inj. site Erythema (N=413,412,272)	3 Participants
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Vomiting (N=413,412,272)	39 Participants
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Injection site Swelling (N=412,412,272)	56 Participants
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Grade 3 inj. site Swelling (N=412,412,272)	3 Participants
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Extensive swelling of limb (N=413,412,272)	0 Participants
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Grade 3 Extensive swelling of limb (N=413,412,272)	0 Participants
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Pyrexia (N=413,412,272)	99 Participants
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Grade 3 Pyrexia (N=413,412,272)	6 Participants
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Grade 3 Vomiting (N=413,412,272)	1 Participants
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Crying (N=413,412,272)	139 Participants
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Grade 3 Crying (N=413,412,272)	1 Participants
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Grade 3 Irritability (N=413,412,272)	3 Participants
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Grade 3 Somnolence (N=413,412,272)	1 Participants
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anorexia (N=413,412,272)	121 Participants
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Grade 3 Anorexia (N=413,412,272)	3 Participants
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Irritability (N=413,412,272)	176 Participants
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Crying (N=413,412,272)	102 Participants
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Vomiting (N=413,412,272)	19 Participants
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Irritability (N=413,412,272)	146 Participants
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Grade 3 Crying (N=413,412,272)	2 Participants
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Grade 3 inj. site Erythema (N=413,412,272)	7 Participants
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Injection site Erythema (N=413,412,272)	86 Participants
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Somnolence (N=413,412,272)	85 Participants
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Grade 3 Anorexia (N=413,412,272)	4 Participants
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Grade 3 Pyrexia (N=413,412,272)	1 Participants
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Grade 3 Somnolence (N=413,412,272)	2 Participants
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Grade 3 Extensive swelling of limb (N=413,412,272)	0 Participants
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Injection site Pain (N=413,412,272)	160 Participants
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Pyrexia (N=413,412,272)	91 Participants
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Extensive swelling of limb (N=413,412,272)	0 Participants
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anorexia (N=413,412,272)	90 Participants
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Grade 3 inj. site Swelling (N=412,412,272)	1 Participants
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Grade 3 Irritability (N=413,412,272)	2 Participants
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Grade 3 Vomiting (N=413,412,272)	0 Participants
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Injection site Swelling (N=412,412,272)	49 Participants
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Grade 3 inj. site Pain (N=413,412,272)	6 Participants

Secondary

Summary of Booster Response to Vaccine Antigens Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine By Age Strata

Anti-PT and anti-FHA antibodies were measured by ELISA.

Time frame: Day 0 (pre-vaccination) and Day 30 after final booster vaccination

Population: Booster responses to vaccine antigens were assessed in the Per Protocol Analysis Set.

Arm	Measure	Group	Value (NUMBER)
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Booster Response to Vaccine Antigens Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine By Age Strata	Anti-PT ≥15 to <19 moth Day 30 4-fold N=140,126,95	132 Participants
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Booster Response to Vaccine Antigens Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine By Age Strata	Anti-PT ≥12 to <15 moth Day 30 4-fold N=103,102,60	87 Participants
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Booster Response to Vaccine Antigens Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine By Age Strata	Anti-PT ≥12 to <15 months Booster (N=103,102,60)	100 Participants
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Booster Response to Vaccine Antigens Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine By Age Strata	Anti-PT ≥15 to <19 month Day 0 (N=142,128,96)	133 Participants
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Booster Response to Vaccine Antigens Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine By Age Strata	Anti-PT ≥12 to <15 month Day 0 (N=104,105,61)	100 Participants
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Booster Response to Vaccine Antigens Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine By Age Strata	Anti-PT ≥15 to <19 month Booster (N=140,126,95)	138 Participants
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Booster Response to Vaccine Antigens Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine By Age Strata	Anti-PT ≥19 to ≤24 months Day 0 (N=139,149,100)	111 Participants
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Booster Response to Vaccine Antigens Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine By Age Strata	AntiPT ≥19 to ≤24 month Day 30 4 fold N=137,146,97	134 Participants
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Booster Response to Vaccine Antigens Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine By Age Strata	Anti-PT ≥19 to ≤24 months Booster (N=137,146,97)	136 Participants
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Booster Response to Vaccine Antigens Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine By Age Strata	Anti-FHA ≥12 to <15 months Day 0 (N=103,105,59)	103 Participants
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Booster Response to Vaccine Antigens Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine By Age Strata	Anti-FHA ≥12 to <15 mos Day 30 4-fold N=103,101,58	76 Participants
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Booster Response to Vaccine Antigens Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine By Age Strata	Anti-FHA ≥12 to <15 months Booster (N=103,101,58)	96 Participants
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Booster Response to Vaccine Antigens Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine By Age Strata	Anti-FHA ≥15 to <19 month Day 0 (N=143,130,96)	143 Participants
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Booster Response to Vaccine Antigens Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine By Age Strata	Anti-FHA ≥15 to <19 mos Day 30 4-fold N=140,128,96	127 Participants
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Booster Response to Vaccine Antigens Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine By Age Strata	Anti-FHA ≥15 to <19 months Booster (N=140,128,96)	136 Participants
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Booster Response to Vaccine Antigens Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine By Age Strata	Anti-FHA ≥19 to ≤24 month Day 0 (N=143,149,100)	143 Participants
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Booster Response to Vaccine Antigens Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine By Age Strata	Anti-FHA ≥19 to ≤24 mos Day 30 4-fold N=141,147,98	133 Participants
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Booster Response to Vaccine Antigens Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine By Age Strata	Anti-FHA ≥19 to ≤ 24 months Booster (N=141,147,98)	138 Participants
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Booster Response to Vaccine Antigens Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine By Age Strata	Anti-FHA ≥19 to ≤ 24 months Booster (N=141,147,98)	144 Participants
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Booster Response to Vaccine Antigens Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine By Age Strata	Anti-PT ≥12 to <15 month Day 0 (N=104,105,61)	104 Participants
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Booster Response to Vaccine Antigens Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine By Age Strata	Anti-FHA ≥12 to <15 months Day 0 (N=103,105,59)	105 Participants
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Booster Response to Vaccine Antigens Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine By Age Strata	Anti-FHA ≥15 to <19 month Day 0 (N=143,130,96)	130 Participants
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Booster Response to Vaccine Antigens Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine By Age Strata	Anti-PT ≥12 to <15 moth Day 30 4-fold N=103,102,60	92 Participants
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Booster Response to Vaccine Antigens Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine By Age Strata	Anti-FHA ≥15 to <19 months Booster (N=140,128,96)	124 Participants
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Booster Response to Vaccine Antigens Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine By Age Strata	Anti-FHA ≥19 to ≤24 month Day 0 (N=143,149,100)	149 Participants
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Booster Response to Vaccine Antigens Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine By Age Strata	Anti-PT ≥12 to <15 months Booster (N=103,102,60)	99 Participants
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Booster Response to Vaccine Antigens Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine By Age Strata	Anti-FHA ≥12 to <15 mos Day 30 4-fold N=103,101,58	78 Participants
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Booster Response to Vaccine Antigens Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine By Age Strata	Anti-FHA ≥19 to ≤24 mos Day 30 4-fold N=141,147,98	138 Participants
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Booster Response to Vaccine Antigens Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine By Age Strata	Anti-PT ≥15 to <19 month Day 0 (N=142,128,96)	118 Participants
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Booster Response to Vaccine Antigens Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine By Age Strata	Anti-PT ≥19 to ≤24 months Booster (N=137,146,97)	141 Participants
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Booster Response to Vaccine Antigens Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine By Age Strata	Anti-FHA ≥15 to <19 mos Day 30 4-fold N=140,128,96	118 Participants
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Booster Response to Vaccine Antigens Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine By Age Strata	Anti-PT ≥15 to <19 moth Day 30 4-fold N=140,126,95	121 Participants
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Booster Response to Vaccine Antigens Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine By Age Strata	AntiPT ≥19 to ≤24 month Day 30 4 fold N=137,146,97	138 Participants
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Booster Response to Vaccine Antigens Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine By Age Strata	Anti-FHA ≥12 to <15 months Booster (N=103,101,58)	99 Participants
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Booster Response to Vaccine Antigens Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine By Age Strata	Anti-PT ≥15 to <19 month Booster (N=140,126,95)	125 Participants
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Booster Response to Vaccine Antigens Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine By Age Strata	Anti-PT ≥19 to ≤24 months Day 0 (N=139,149,100)	127 Participants
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Booster Response to Vaccine Antigens Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine By Age Strata	Anti-PT ≥15 to <19 month Booster (N=140,126,95)	94 Participants
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Booster Response to Vaccine Antigens Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine By Age Strata	Anti-PT ≥19 to ≤24 months Day 0 (N=139,149,100)	78 Participants
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Booster Response to Vaccine Antigens Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine By Age Strata	AntiPT ≥19 to ≤24 month Day 30 4 fold N=137,146,97	92 Participants
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Booster Response to Vaccine Antigens Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine By Age Strata	Anti-FHA ≥15 to <19 months Booster (N=140,128,96)	94 Participants
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Booster Response to Vaccine Antigens Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine By Age Strata	Anti-PT ≥19 to ≤24 months Booster (N=137,146,97)	95 Participants
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Booster Response to Vaccine Antigens Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine By Age Strata	Anti-FHA ≥19 to ≤ 24 months Booster (N=141,147,98)	97 Participants
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Booster Response to Vaccine Antigens Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine By Age Strata	Anti-FHA ≥12 to <15 months Day 0 (N=103,105,59)	59 Participants
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Booster Response to Vaccine Antigens Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine By Age Strata	Anti-FHA ≥12 to <15 mos Day 30 4-fold N=103,101,58	53 Participants
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Booster Response to Vaccine Antigens Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine By Age Strata	Anti-FHA ≥19 to ≤24 month Day 0 (N=143,149,100)	99 Participants
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Booster Response to Vaccine Antigens Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine By Age Strata	Anti-FHA ≥12 to <15 months Booster (N=103,101,58)	58 Participants
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Booster Response to Vaccine Antigens Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine By Age Strata	Anti-PT ≥12 to <15 month Day 0 (N=104,105,61)	61 Participants
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Booster Response to Vaccine Antigens Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine By Age Strata	Anti-PT ≥12 to <15 moth Day 30 4-fold N=103,102,60	53 Participants
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Booster Response to Vaccine Antigens Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine By Age Strata	Anti-FHA ≥15 to <19 month Day 0 (N=143,130,96)	95 Participants
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Booster Response to Vaccine Antigens Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine By Age Strata	Anti-PT ≥12 to <15 months Booster (N=103,102,60)	56 Participants
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Booster Response to Vaccine Antigens Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine By Age Strata	Anti-PT ≥15 to <19 month Day 0 (N=142,128,96)	86 Participants
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Booster Response to Vaccine Antigens Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine By Age Strata	Anti-PT ≥15 to <19 moth Day 30 4-fold N=140,126,95	89 Participants
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Booster Response to Vaccine Antigens Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine By Age Strata	Anti-FHA ≥15 to <19 mos Day 30 4-fold N=140,128,96	88 Participants
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Booster Response to Vaccine Antigens Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine By Age Strata	Anti-FHA ≥19 to ≤24 mos Day 30 4-fold N=141,147,98	94 Participants

Secondary

Summary of Geometric Mean Titers to Prevenar Vaccine Antibodies After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine

Anti-Streptococcus pneumococcal type specific antibody (anti-Pn PS) was measured by ELISA.

Time frame: Day 30 after final booster vaccination

Population: Geometric mean titers against Prevenar vaccine serotypes were assessed in the Per Protocol Analysis Set.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Geometric Mean Titers to Prevenar Vaccine Antibodies After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-Pneumococcal 6B (N=160,146,94)	6.87 Titers
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Geometric Mean Titers to Prevenar Vaccine Antibodies After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-Pneumococcal 18C (N=161,147,94)	2.37 Titers
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Geometric Mean Titers to Prevenar Vaccine Antibodies After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-Pneumococcal 14 (N=161,147,94)	11.6 Titers
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Geometric Mean Titers to Prevenar Vaccine Antibodies After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-Pneumococcal 4 (N=161,147,94)	2.79 Titers
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Geometric Mean Titers to Prevenar Vaccine Antibodies After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-Pneumococcal 23F (N=158,145,93)	6.98 Titers
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Geometric Mean Titers to Prevenar Vaccine Antibodies After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-Pneumococcal 19F (N=161,147,94)	3.01 Titers
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Geometric Mean Titers to Prevenar Vaccine Antibodies After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-Pneumococcal 9V (N=161,147,94)	2.51 Titers
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Geometric Mean Titers to Prevenar Vaccine Antibodies After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-Pneumococcal 14 (N=161,147,94)	13.2 Titers
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Geometric Mean Titers to Prevenar Vaccine Antibodies After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-Pneumococcal 4 (N=161,147,94)	3.03 Titers
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Geometric Mean Titers to Prevenar Vaccine Antibodies After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-Pneumococcal 6B (N=160,146,94)	8.98 Titers
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Geometric Mean Titers to Prevenar Vaccine Antibodies After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-Pneumococcal 9V (N=161,147,94)	2.86 Titers
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Geometric Mean Titers to Prevenar Vaccine Antibodies After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-Pneumococcal 18C (N=161,147,94)	2.63 Titers
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Geometric Mean Titers to Prevenar Vaccine Antibodies After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-Pneumococcal 19F (N=161,147,94)	3.74 Titers
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Geometric Mean Titers to Prevenar Vaccine Antibodies After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-Pneumococcal 23F (N=158,145,93)	7.20 Titers
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Geometric Mean Titers to Prevenar Vaccine Antibodies After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-Pneumococcal 18C (N=161,147,94)	3.40 Titers
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Geometric Mean Titers to Prevenar Vaccine Antibodies After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-Pneumococcal 6B (N=160,146,94)	9.34 Titers
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Geometric Mean Titers to Prevenar Vaccine Antibodies After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-Pneumococcal 23F (N=158,145,93)	9.30 Titers
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Geometric Mean Titers to Prevenar Vaccine Antibodies After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-Pneumococcal 19F (N=161,147,94)	3.72 Titers
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Geometric Mean Titers to Prevenar Vaccine Antibodies After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-Pneumococcal 14 (N=161,147,94)	12.3 Titers
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Geometric Mean Titers to Prevenar Vaccine Antibodies After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-Pneumococcal 9V (N=161,147,94)	2.92 Titers
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Geometric Mean Titers to Prevenar Vaccine Antibodies After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-Pneumococcal 4 (N=161,147,94)	3.58 Titers

Secondary

Summary of Geometric Mean Titers to Vaccine Antibodies Post Primary Vaccination Series; Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine.

Anti-Diphtheria antibodies were measured by a toxin neutralization test. Anti-Tetanus, anti-PT, and anti-FHA antibodies were measured by ELISA. Anti-Poliovirus types 1, 2, and 3 were measured by neutralization assay. Anti-Hepatitis B antibodies were measured by the commercially available VITROS ECi/ECiQ Immunodiagnostic System. Anti-PRP antibodies were measured using a Farr type radioimmunoassay that used radiolabeled PRP (3H PRP) in the presence of 36Cl (volume marker). Day 140 = Primary series; Day 0 = Pre-booster; and Day 30 = Post-booster titers.

Time frame: Day 140 after primary vaccination, Day 0 (pre-vaccination), and Day 30 after final booster vaccination

Population: Geometric mean titers against vaccine antibodies were assessed in the Per Protocol Analysis Set.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Geometric Mean Titers to Vaccine Antibodies Post Primary Vaccination Series; Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine.	Anti-Polio 1 Day 140 (N=338,329,214)	656 Titers
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Geometric Mean Titers to Vaccine Antibodies Post Primary Vaccination Series; Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine.	Anti-PT Day 140 (N=393,391,259)	99.6 Titers
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Geometric Mean Titers to Vaccine Antibodies Post Primary Vaccination Series; Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine.	Anti-PRP Day 30 (N=396,391,258)	42.4 Titers
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Geometric Mean Titers to Vaccine Antibodies Post Primary Vaccination Series; Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine.	Anti-Polio 1 Day 0 (N=338,326,213)	132 Titers
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Geometric Mean Titers to Vaccine Antibodies Post Primary Vaccination Series; Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine.	Anti-Hepatitis B Day 140 (N=393,392,260)	3050 Titers
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Geometric Mean Titers to Vaccine Antibodies Post Primary Vaccination Series; Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine.	Ant-PRP Day 0 (N=395,391,258)	0.482 Titers
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Geometric Mean Titers to Vaccine Antibodies Post Primary Vaccination Series; Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine.	Anti-Polio 1 Day 30 (N=339,327,212)	2140 Titers
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Geometric Mean Titers to Vaccine Antibodies Post Primary Vaccination Series; Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine.	Anti-Polio 2 Day 30 (N=340,327,212)	4232 Titers
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Geometric Mean Titers to Vaccine Antibodies Post Primary Vaccination Series; Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine.	Anti-Polio 2 Day 140 (N=338,327,214)	1152 Titers
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Geometric Mean Titers to Vaccine Antibodies Post Primary Vaccination Series; Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine.	Anti-Diphtheria Day 0 (N=390,390,257)	0.077 Titers
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Geometric Mean Titers to Vaccine Antibodies Post Primary Vaccination Series; Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine.	Anti-Polio 3 Day 140 (N=338,328,214)	1169 Titers
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Geometric Mean Titers to Vaccine Antibodies Post Primary Vaccination Series; Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine.	Anti-Polio 2 Day 0 (N=337,328,213)	251 Titers
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Geometric Mean Titers to Vaccine Antibodies Post Primary Vaccination Series; Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine.	Anti-Hepatitis B Day 0 (N=396,391,259)	386 Titers
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Geometric Mean Titers to Vaccine Antibodies Post Primary Vaccination Series; Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine.	Anti PT D30 (N=391,383,254)	154 Titers
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Geometric Mean Titers to Vaccine Antibodies Post Primary Vaccination Series; Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine.	Anti-Diphtheria Day 140 (N=392,391,259)	0.265 Titers
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Geometric Mean Titers to Vaccine Antibodies Post Primary Vaccination Series; Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine.	Anti-Hepatitis B Day 30 (N=395,393,259)	8462 Titers
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Geometric Mean Titers to Vaccine Antibodies Post Primary Vaccination Series; Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine.	Anti-Polio 3 Day 0 (N=338,326,213)	128 Titers
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Geometric Mean Titers to Vaccine Antibodies Post Primary Vaccination Series; Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine.	Anti-Tetanus Day 30 (N=392,385,254)	5.72 Titers
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Geometric Mean Titers to Vaccine Antibodies Post Primary Vaccination Series; Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine.	Anti-PRP Day 140 (N=393,392,260)	3.19 Titers
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Geometric Mean Titers to Vaccine Antibodies Post Primary Vaccination Series; Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine.	Anti-PT Day 0 (N=385,382,257)	7.43 Titers
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Geometric Mean Titers to Vaccine Antibodies Post Primary Vaccination Series; Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine.	Anti-Tetanus Day 0 (N=389,387,255)	0.208 Titers
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Geometric Mean Titers to Vaccine Antibodies Post Primary Vaccination Series; Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine.	Anti-FHA Day 0 (N=389,384,255)	21.2 Titers
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Geometric Mean Titers to Vaccine Antibodies Post Primary Vaccination Series; Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine.	Anti-Polio 3 Day 30 (N=340,326,212)	3569 Titers
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Geometric Mean Titers to Vaccine Antibodies Post Primary Vaccination Series; Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine.	Anti-Tetanus Day 140 (N=392,391,258)	1.50 Titers
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Geometric Mean Titers to Vaccine Antibodies Post Primary Vaccination Series; Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine.	Anti-FHA Day 30 (N=390,385,254)	316 Titers
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Geometric Mean Titers to Vaccine Antibodies Post Primary Vaccination Series; Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine.	Anti-FHA Day 140 (N=391,390,259)	179 Titers
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Geometric Mean Titers to Vaccine Antibodies Post Primary Vaccination Series; Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine.	Anti-Diphtheria Day 30 (N=393,387,254)	5.55 Titers
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Geometric Mean Titers to Vaccine Antibodies Post Primary Vaccination Series; Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine.	Anti-PT Day 140 (N=393,391,259)	102 Titers
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Geometric Mean Titers to Vaccine Antibodies Post Primary Vaccination Series; Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine.	Anti-Polio 3 Day 30 (N=340,326,212)	3322 Titers
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Geometric Mean Titers to Vaccine Antibodies Post Primary Vaccination Series; Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine.	Anti-Hepatitis B Day 140 (N=393,392,260)	3180 Titers
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Geometric Mean Titers to Vaccine Antibodies Post Primary Vaccination Series; Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine.	Anti-Hepatitis B Day 0 (N=396,391,259)	406 Titers
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Geometric Mean Titers to Vaccine Antibodies Post Primary Vaccination Series; Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine.	Anti-Hepatitis B Day 30 (N=395,393,259)	11218 Titers
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Geometric Mean Titers to Vaccine Antibodies Post Primary Vaccination Series; Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine.	Anti-PRP Day 140 (N=393,392,260)	3.60 Titers
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Geometric Mean Titers to Vaccine Antibodies Post Primary Vaccination Series; Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine.	Anti-FHA Day 0 (N=389,384,255)	23.4 Titers
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Geometric Mean Titers to Vaccine Antibodies Post Primary Vaccination Series; Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine.	Anti-FHA Day 30 (N=390,385,254)	418 Titers
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Geometric Mean Titers to Vaccine Antibodies Post Primary Vaccination Series; Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine.	Anti-Polio 1 Day 140 (N=338,329,214)	705 Titers
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Geometric Mean Titers to Vaccine Antibodies Post Primary Vaccination Series; Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine.	Anti-Polio 1 Day 0 (N=338,326,213)	134 Titers
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Geometric Mean Titers to Vaccine Antibodies Post Primary Vaccination Series; Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine.	Anti-Polio 1 Day 30 (N=339,327,212)	2633 Titers
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Geometric Mean Titers to Vaccine Antibodies Post Primary Vaccination Series; Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine.	Anti-Polio 2 Day 140 (N=338,327,214)	1241 Titers
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Geometric Mean Titers to Vaccine Antibodies Post Primary Vaccination Series; Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine.	Anti-Polio 2 Day 0 (N=337,328,213)	289 Titers
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Geometric Mean Titers to Vaccine Antibodies Post Primary Vaccination Series; Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine.	Anti-Polio 2 Day 30 (N=340,327,212)	4887 Titers
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Geometric Mean Titers to Vaccine Antibodies Post Primary Vaccination Series; Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine.	Anti-Polio 3 Day 140 (N=338,328,214)	1108 Titers
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Geometric Mean Titers to Vaccine Antibodies Post Primary Vaccination Series; Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine.	Anti-Polio 3 Day 0 (N=338,326,213)	126 Titers
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Geometric Mean Titers to Vaccine Antibodies Post Primary Vaccination Series; Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine.	Anti-PRP Day 30 (N=396,391,258)	41.5 Titers
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Geometric Mean Titers to Vaccine Antibodies Post Primary Vaccination Series; Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine.	Ant-PRP Day 0 (N=395,391,258)	0.556 Titers
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Geometric Mean Titers to Vaccine Antibodies Post Primary Vaccination Series; Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine.	Anti-Diphtheria Day 30 (N=393,387,254)	4.40 Titers
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Geometric Mean Titers to Vaccine Antibodies Post Primary Vaccination Series; Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine.	Anti-Tetanus Day 140 (N=392,391,258)	1.54 Titers
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Geometric Mean Titers to Vaccine Antibodies Post Primary Vaccination Series; Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine.	Anti-Tetanus Day 0 (N=389,387,255)	0.224 Titers
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Geometric Mean Titers to Vaccine Antibodies Post Primary Vaccination Series; Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine.	Anti-Diphtheria Day 140 (N=392,391,259)	0.254 Titers
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Geometric Mean Titers to Vaccine Antibodies Post Primary Vaccination Series; Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine.	Anti-Diphtheria Day 0 (N=390,390,257)	0.074 Titers
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Geometric Mean Titers to Vaccine Antibodies Post Primary Vaccination Series; Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine.	Anti-Tetanus Day 30 (N=392,385,254)	5.21 Titers
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Geometric Mean Titers to Vaccine Antibodies Post Primary Vaccination Series; Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine.	Anti-PT Day 0 (N=385,382,257)	8.47 Titers
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Geometric Mean Titers to Vaccine Antibodies Post Primary Vaccination Series; Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine.	Anti PT D30 (N=391,383,254)	191 Titers
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Geometric Mean Titers to Vaccine Antibodies Post Primary Vaccination Series; Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine.	Anti-FHA Day 140 (N=391,390,259)	187 Titers
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Geometric Mean Titers to Vaccine Antibodies Post Primary Vaccination Series; Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine.	Anti-FHA Day 0 (N=389,384,255)	14.4 Titers
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Geometric Mean Titers to Vaccine Antibodies Post Primary Vaccination Series; Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine.	Anti-Polio 2 Day 0 (N=337,328,213)	380 Titers
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Geometric Mean Titers to Vaccine Antibodies Post Primary Vaccination Series; Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine.	Anti-Tetanus Day 140 (N=392,391,258)	1.80 Titers
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Geometric Mean Titers to Vaccine Antibodies Post Primary Vaccination Series; Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine.	Anti-PRP Day 140 (N=393,392,260)	2.13 Titers
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Geometric Mean Titers to Vaccine Antibodies Post Primary Vaccination Series; Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine.	Anti-PT Day 0 (N=385,382,257)	7.41 Titers
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Geometric Mean Titers to Vaccine Antibodies Post Primary Vaccination Series; Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine.	Anti-Tetanus Day 0 (N=389,387,255)	0.201 Titers
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Geometric Mean Titers to Vaccine Antibodies Post Primary Vaccination Series; Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine.	Anti-Hepatitis B Day 30 (N=395,393,259)	9688 Titers
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Geometric Mean Titers to Vaccine Antibodies Post Primary Vaccination Series; Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine.	Anti-Hepatitis B Day 0 (N=396,391,259)	336 Titers
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Geometric Mean Titers to Vaccine Antibodies Post Primary Vaccination Series; Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine.	Anti-Polio 3 Day 140 (N=338,328,214)	1948 Titers
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Geometric Mean Titers to Vaccine Antibodies Post Primary Vaccination Series; Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine.	Anti-Diphtheria Day 140 (N=392,391,259)	0.251 Titers
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Geometric Mean Titers to Vaccine Antibodies Post Primary Vaccination Series; Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine.	Anti-Hepatitis B Day 140 (N=393,392,260)	2910 Titers
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Geometric Mean Titers to Vaccine Antibodies Post Primary Vaccination Series; Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine.	Anti-FHA Day 140 (N=391,390,259)	120 Titers
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Geometric Mean Titers to Vaccine Antibodies Post Primary Vaccination Series; Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine.	Anti-Diphtheria Day 0 (N=390,390,257)	0.059 Titers
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Geometric Mean Titers to Vaccine Antibodies Post Primary Vaccination Series; Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine.	Anti PT D30 (N=391,383,254)	140 Titers
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Geometric Mean Titers to Vaccine Antibodies Post Primary Vaccination Series; Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine.	Anti-Polio 2 Day 30 (N=340,327,212)	6369 Titers
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Geometric Mean Titers to Vaccine Antibodies Post Primary Vaccination Series; Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine.	Anti-Polio 2 Day 140 (N=338,327,214)	1945 Titers
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Geometric Mean Titers to Vaccine Antibodies Post Primary Vaccination Series; Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine.	Anti-Tetanus Day 30 (N=392,385,254)	7.52 Titers
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Geometric Mean Titers to Vaccine Antibodies Post Primary Vaccination Series; Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine.	Anti-Polio 3 Day 30 (N=340,326,212)	6015 Titers
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Geometric Mean Titers to Vaccine Antibodies Post Primary Vaccination Series; Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine.	Anti-Polio 1 Day 0 (N=338,326,213)	224 Titers
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Geometric Mean Titers to Vaccine Antibodies Post Primary Vaccination Series; Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine.	Anti-Polio 1 Day 30 (N=339,327,212)	2978 Titers
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Geometric Mean Titers to Vaccine Antibodies Post Primary Vaccination Series; Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine.	Anti-PRP Day 30 (N=396,391,258)	56.5 Titers
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Geometric Mean Titers to Vaccine Antibodies Post Primary Vaccination Series; Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine.	Anti-PT Day 140 (N=393,391,259)	97.0 Titers
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Geometric Mean Titers to Vaccine Antibodies Post Primary Vaccination Series; Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine.	Ant-PRP Day 0 (N=395,391,258)	0.455 Titers
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Geometric Mean Titers to Vaccine Antibodies Post Primary Vaccination Series; Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine.	Anti-Polio 1 Day 140 (N=338,329,214)	1276 Titers
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Geometric Mean Titers to Vaccine Antibodies Post Primary Vaccination Series; Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine.	Anti-FHA Day 30 (N=390,385,254)	260 Titers
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Geometric Mean Titers to Vaccine Antibodies Post Primary Vaccination Series; Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine.	Anti-Polio 3 Day 0 (N=338,326,213)	207 Titers
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Geometric Mean Titers to Vaccine Antibodies Post Primary Vaccination Series; Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine.	Anti-Diphtheria Day 30 (N=393,387,254)	6.05 Titers

Secondary

Summary of Geometric Mean Titers to Vaccine Antigens After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine by Age Strata

Anti-Diphtheria antibodies were measured by a toxin neutralization test. Anti-FHA antibodies were measured by ELISA. Anti-Poliovirus types 1, 2, and 3 were measured by neutralization assay.

Time frame: Day 30 after final booster vaccination

Population: Geometric mean titers to vaccine antigens were assessed in the Per Protocol Analysis Set.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Geometric Mean Titers to Vaccine Antigens After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine by Age Strata	Anti-FHA ≥12 to <15 months (N=103,105,60)	235 Titers
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Geometric Mean Titers to Vaccine Antigens After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine by Age Strata	Anti-Polio 3 ≥19 to ≤24 months (N=125,120,86)	4119 Titers
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Geometric Mean Titers to Vaccine Antigens After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine by Age Strata	Anti-FHA ≥19 to ≤24 months (N=144,150,98)	365 Titers
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Geometric Mean Titers to Vaccine Antigens After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine by Age Strata	Anti-FHA ≥15 to <19 months (N=143,130,96)	339 Titers
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Geometric Mean Titers to Vaccine Antigens After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine by Age Strata	Anti-Diphtheria ≥12 to <15 months (N=103,107,59)	3.20 Titers
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Geometric Mean Titers to Vaccine Antigens After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine by Age Strata	Anti-Polio 3 ≥15 to <19 months (N=128,114,81)	3944 Titers
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Geometric Mean Titers to Vaccine Antigens After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine by Age Strata	Anti-Diphtheria ≥19 to ≤24 months (N=146,151,100)	7.14 Titers
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Geometric Mean Titers to Vaccine Antigens After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine by Age Strata	Anti-Diphtheria ≥15 to <19 months (N=144,129,95)	6.39 Titers
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Geometric Mean Titers to Vaccine Antigens After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine by Age Strata	Anti-Polio 3 ≥12 to <15 months (N=87,92,45)	2509 Titers
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Geometric Mean Titers to Vaccine Antigens After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine by Age Strata	Anti-FHA ≥15 to <19 months (N=143,130,96)	453 Titers
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Geometric Mean Titers to Vaccine Antigens After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine by Age Strata	Anti-Diphtheria ≥12 to <15 months (N=103,107,59)	2.73 Titers
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Geometric Mean Titers to Vaccine Antigens After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine by Age Strata	Anti-Diphtheria ≥15 to <19 months (N=144,129,95)	4.77 Titers
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Geometric Mean Titers to Vaccine Antigens After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine by Age Strata	Anti-Diphtheria ≥19 to ≤24 months (N=146,151,100)	5.77 Titers
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Geometric Mean Titers to Vaccine Antigens After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine by Age Strata	Anti-FHA ≥12 to <15 months (N=103,105,60)	268 Titers
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Geometric Mean Titers to Vaccine Antigens After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine by Age Strata	Anti-FHA ≥19 to ≤24 months (N=144,150,98)	533 Titers
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Geometric Mean Titers to Vaccine Antigens After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine by Age Strata	Anti-Polio 3 ≥12 to <15 months (N=87,92,45)	2616 Titers
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Geometric Mean Titers to Vaccine Antigens After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine by Age Strata	Anti-Polio 3 ≥15 to <19 months (N=128,114,81)	3261 Titers
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Geometric Mean Titers to Vaccine Antigens After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine by Age Strata	Anti-Polio 3 ≥19 to ≤24 months (N=125,120,86)	4061 Titers
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Geometric Mean Titers to Vaccine Antigens After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine by Age Strata	Anti-Diphtheria ≥19 to ≤24 months (N=146,151,100)	7.34 Titers
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Geometric Mean Titers to Vaccine Antigens After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine by Age Strata	Anti-Diphtheria ≥12 to <15 months (N=103,107,59)	3.82 Titers
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Geometric Mean Titers to Vaccine Antigens After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine by Age Strata	Anti-Polio 3 ≥12 to <15 months (N=87,92,45)	5617 Titers
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Geometric Mean Titers to Vaccine Antigens After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine by Age Strata	Anti-Diphtheria ≥15 to <19 months (N=144,129,95)	6.56 Titers
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Geometric Mean Titers to Vaccine Antigens After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine by Age Strata	Anti-Polio 3 ≥19 to ≤24 months (N=125,120,86)	6889 Titers
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Geometric Mean Titers to Vaccine Antigens After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine by Age Strata	Anti-FHA ≥15 to <19 months (N=143,130,96)	280 Titers
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Geometric Mean Titers to Vaccine Antigens After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine by Age Strata	Anti-FHA ≥12 to <15 months (N=103,105,60)	197 Titers
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Geometric Mean Titers to Vaccine Antigens After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine by Age Strata	Anti-Polio 3 ≥15 to <19 months (N=128,114,81)	5409 Titers
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Geometric Mean Titers to Vaccine Antigens After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine by Age Strata	Anti-FHA ≥19 to ≤24 months (N=144,150,98)	287 Titers

Secondary

Summary of Immune Response Against Serotypes in the Prevenar Vaccine After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine

Anti-Streptococcus pneumococcal type specific antibody (anti-Pn PS) was measured by ELISA. Booster response to pneumococcal serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F was defined as antibody titers ≥0.35 µg/mL at Day 30.

Time frame: Day 30 after final booster vaccination

Population: Antibody responses against Prevenar vaccine serotypes were assessed in the Per-protocol Analysis Set.

Arm	Measure	Group	Value (NUMBER)
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Immune Response Against Serotypes in the Prevenar Vaccine After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-Pneumococcal 6B (N=160,146,94)	155 Participants
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Immune Response Against Serotypes in the Prevenar Vaccine After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-Pneumococcal 18C (N=161,147,94)	160 Participants
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Immune Response Against Serotypes in the Prevenar Vaccine After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-Pneumococcal 14 (N=161,147,94)	161 Participants
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Immune Response Against Serotypes in the Prevenar Vaccine After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-Pneumococcal 4 (N=161,147,94)	160 Participants
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Immune Response Against Serotypes in the Prevenar Vaccine After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-Pneumococcal 23F (N=158,145,93)	158 Participants
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Immune Response Against Serotypes in the Prevenar Vaccine After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-Pneumococcal 19F (N=161,147,94)	161 Participants
Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster	Summary of Immune Response Against Serotypes in the Prevenar Vaccine After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-Pneumococcal 9V (N=161,147,94)	161 Participants
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Immune Response Against Serotypes in the Prevenar Vaccine After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-Pneumococcal 14 (N=161,147,94)	147 Participants
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Immune Response Against Serotypes in the Prevenar Vaccine After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-Pneumococcal 4 (N=161,147,94)	146 Participants
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Immune Response Against Serotypes in the Prevenar Vaccine After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-Pneumococcal 6B (N=160,146,94)	145 Participants
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Immune Response Against Serotypes in the Prevenar Vaccine After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-Pneumococcal 9V (N=161,147,94)	147 Participants
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Immune Response Against Serotypes in the Prevenar Vaccine After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-Pneumococcal 18C (N=161,147,94)	147 Participants
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Immune Response Against Serotypes in the Prevenar Vaccine After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-Pneumococcal 19F (N=161,147,94)	144 Participants
Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster	Summary of Immune Response Against Serotypes in the Prevenar Vaccine After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-Pneumococcal 23F (N=158,145,93)	144 Participants
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Immune Response Against Serotypes in the Prevenar Vaccine After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-Pneumococcal 18C (N=161,147,94)	94 Participants
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Immune Response Against Serotypes in the Prevenar Vaccine After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-Pneumococcal 6B (N=160,146,94)	93 Participants
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Immune Response Against Serotypes in the Prevenar Vaccine After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-Pneumococcal 23F (N=158,145,93)	93 Participants
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Immune Response Against Serotypes in the Prevenar Vaccine After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-Pneumococcal 19F (N=161,147,94)	94 Participants
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Immune Response Against Serotypes in the Prevenar Vaccine After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-Pneumococcal 14 (N=161,147,94)	94 Participants
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Immune Response Against Serotypes in the Prevenar Vaccine After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-Pneumococcal 9V (N=161,147,94)	94 Participants
Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster	Summary of Immune Response Against Serotypes in the Prevenar Vaccine After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine	Anti-Pneumococcal 4 (N=161,147,94)	94 Participants

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026

Study of the Booster Effect of DTaP-IPV-Hep B-PRP~T Combined Vaccine or Infanrix Hexa™ and Prevenar™ in Healthy Infants

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Summary of Diphtheria and Tetanus Post Primary Series Antibodies, Persistence and Booster Response Following Vaccination With Either DTaP-IPV Hep B-PRP T Vaccine or Infanrix Hexa Vaccine

Summary of Hepatitis B and Haemophilus Influenzae Type B Post Primary Series Antibodies; Antibody Persistence, and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine

Summary of Pertussis and Filamentous Haemagglutinin Post Primary Series Antibodies, Persistence and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine

Summary of Polio Antibodies Post Primary Series, Persistence and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine

Number of Participants Reporting a Solicited Injection Site Following Booster Vaccination With Prevenar Vaccine

Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine

Summary of Booster Response to Vaccine Antigens Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine By Age Strata

Summary of Geometric Mean Titers to Prevenar Vaccine Antibodies After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine

Summary of Geometric Mean Titers to Vaccine Antibodies Post Primary Vaccination Series; Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine.

Summary of Geometric Mean Titers to Vaccine Antigens After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine by Age Strata

Summary of Immune Response Against Serotypes in the Prevenar Vaccine After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine