Trial Outcomes & Findings for Study of the Booster Effect of DTaP-IPV-Hep B-PRP~T Combined Vaccine or Infanrix Hexa™ and Prevenar™ in Healthy Infants (NCT NCT01444781)

Last Updated: 2014-07-16

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1106 participants

Primary outcome timeframe

Day 140 (Primary series) and Day 0 (Pre-booster)

Results posted on

2014-07-16

Participant Flow

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

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

Participant milestones

Participant milestones
Measure	Group 1: DTaP-IPV-Hep B-PRP~T + Prevenar™ Primary and Booster 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)	Group2: DTaPIPV-Hep B-PRP~T Primary/Infanrix Hexa+PCV7 Booster Participants who were previously primed with DTaP-IPV-Hep B-PRP\~T received one dose of Infanrix Hexa vaccine and one dose of PCV7.	Group3: Infanrix Hexa Primary/DTaPIPV-Hep B PRP~T+PCV7 Booster Participants who were previously primed with Infanrix Hexa vaccine received one dose of DTaP-IPV-Hep B-PRP\~T and one dose of PCV7
Overall Study STARTED	416	415	275
Overall Study COMPLETED	413	411	272
Overall Study NOT COMPLETED	3	4	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Group 1: DTaP-IPV-Hep B-PRP~T + Prevenar™ Primary and Booster 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)	Group2: DTaPIPV-Hep B-PRP~T Primary/Infanrix Hexa+PCV7 Booster Participants who were previously primed with DTaP-IPV-Hep B-PRP\~T received one dose of Infanrix Hexa vaccine and one dose of PCV7.	Group3: Infanrix Hexa Primary/DTaPIPV-Hep B PRP~T+PCV7 Booster Participants who were previously primed with Infanrix Hexa vaccine received one dose of DTaP-IPV-Hep B-PRP\~T and one dose of PCV7
Overall Study Lost to Follow-up	0	3	1
Overall Study Withdrawal by Subject	3	1	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster Group n=416 Participants 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)	DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster Group n=415 Participants Participants who were previously primed with DTaP IPV Hep B PRP T received one dose of Infanrix Hexa vaccine and one dose of PCV7.	Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster Group. n=275 Participants Participants who were previously primed with Infanrix Hexa vaccine received one dose of DTaP IPV Hep B PRP T and one dose of PCV7	Total n=1106 Participants Total of all reporting groups
Age, Categorical <=18 years	416 Participants n=5 Participants	415 Participants n=7 Participants	275 Participants n=5 Participants	1106 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	17.6 Months STANDARD_DEVIATION 3.25 • n=5 Participants	17.6 Months STANDARD_DEVIATION 3.34 • n=7 Participants	17.8 Months STANDARD_DEVIATION 3.26 • n=5 Participants	17.7 Months STANDARD_DEVIATION 3.29 • n=4 Participants
Sex: Female, Male Female	203 Participants n=5 Participants	186 Participants n=7 Participants	128 Participants n=5 Participants	517 Participants n=4 Participants
Sex: Female, Male Male	213 Participants n=5 Participants	229 Participants n=7 Participants	147 Participants n=5 Participants	589 Participants n=4 Participants
Region of Enrollment Colombia	266 Participants n=5 Participants	266 Participants n=7 Participants	172 Participants n=5 Participants	704 Participants n=4 Participants
Region of Enrollment Costa Rica	150 Participants n=5 Participants	149 Participants n=7 Participants	103 Participants n=5 Participants	402 Participants n=4 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster n=396 Participants 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)	Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster n=393 Participants Participants who were previously primed with DTaP IPV Hep B PRP T received one dose of Infanrix Hexa vaccine and one dose of PCV7.	Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster n=260 Participants Participants who were previously primed with Infanrix Hexa vaccine received one dose of DTaP IPV Hep B PRP T and one dose of PCV7
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	391 Participants Interval 0.0 to 0.0	259 Participants Interval 0.0 to 0.0
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	290 Participants Interval 0.0 to 0.0	197 Participants Interval 0.0 to 0.0
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	378 Participants Interval 0.0 to 0.0	246 Participants Interval 0.0 to 0.0
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	153 Participants Interval 0.0 to 0.0	70 Participants Interval 0.0 to 0.0
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	387 Participants Interval 0.0 to 0.0	254 Participants Interval 0.0 to 0.0
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	386 Participants Interval 0.0 to 0.0	254 Participants Interval 0.0 to 0.0
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	391 Participants Interval 0.0 to 0.0	258 Participants Interval 0.0 to 0.0
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	390 Participants Interval 0.0 to 0.0	258 Participants Interval 0.0 to 0.0
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	386 Participants Interval 0.0 to 0.0	255 Participants Interval 0.0 to 0.0
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	286 Participants Interval 0.0 to 0.0	196 Participants Interval 0.0 to 0.0
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	385 Participants Interval 0.0 to 0.0	254 Participants Interval 0.0 to 0.0
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	385 Participants Interval 0.0 to 0.0	254 Participants Interval 0.0 to 0.0

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster n=396 Participants 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)	Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster n=393 Participants Participants who were previously primed with DTaP IPV Hep B PRP T received one dose of Infanrix Hexa vaccine and one dose of PCV7.	Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster n=260 Participants Participants who were previously primed with Infanrix Hexa vaccine received one dose of DTaP IPV Hep B PRP T and one dose of PCV7
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	391 Participants Interval 0.0 to 0.0	259 Participants Interval 0.0 to 0.0
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	349 Participants Interval 0.0 to 0.0	225 Participants Interval 0.0 to 0.0
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	383 Participants Interval 0.0 to 0.0	254 Participants Interval 0.0 to 0.0
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	351 Participants Interval 0.0 to 0.0	234 Participants Interval 0.0 to 0.0
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	365 Participants Interval 0.0 to 0.0	245 Participants Interval 0.0 to 0.0
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	390 Participants Interval 0.0 to 0.0	259 Participants Interval 0.0 to 0.0
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	384 Participants Interval 0.0 to 0.0	253 Participants Interval 0.0 to 0.0
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	385 Participants Interval 0.0 to 0.0	254 Participants Interval 0.0 to 0.0
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	334 Participants Interval 0.0 to 0.0	235 Participants Interval 0.0 to 0.0
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	367 Participants Interval 0.0 to 0.0	249 Participants Interval 0.0 to 0.0

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster n=396 Participants 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)	Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster n=393 Participants Participants who were previously primed with DTaP IPV Hep B PRP T received one dose of Infanrix Hexa vaccine and one dose of PCV7.	Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster n=260 Participants Participants who were previously primed with Infanrix Hexa vaccine received one dose of DTaP IPV Hep B PRP T and one dose of PCV7
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	329 Participants Interval 0.0 to 0.0	214 Participants Interval 0.0 to 0.0
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	320 Participants Interval 0.0 to 0.0	210 Participants Interval 0.0 to 0.0
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	327 Participants Interval 0.0 to 0.0	212 Participants Interval 0.0 to 0.0
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	327 Participants Interval 0.0 to 0.0	214 Participants Interval 0.0 to 0.0
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	328 Participants Interval 0.0 to 0.0	213 Participants Interval 0.0 to 0.0
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	327 Participants Interval 0.0 to 0.0	212 Participants Interval 0.0 to 0.0
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	328 Participants Interval 0.0 to 0.0	214 Participants Interval 0.0 to 0.0
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	309 Participants Interval 0.0 to 0.0	211 Participants Interval 0.0 to 0.0
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	326 Participants Interval 0.0 to 0.0	212 Participants Interval 0.0 to 0.0

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster n=396 Participants 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)	Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster n=393 Participants Participants who were previously primed with DTaP IPV Hep B PRP T received one dose of Infanrix Hexa vaccine and one dose of PCV7.	Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster n=260 Participants Participants who were previously primed with Infanrix Hexa vaccine received one dose of DTaP IPV Hep B PRP T and one dose of PCV7
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	305 Participants Interval 0.0 to 0.0	188 Participants Interval 0.0 to 0.0
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	391 Participants Interval 0.0 to 0.0	260 Participants Interval 0.0 to 0.0
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	387 Participants Interval 0.0 to 0.0	259 Participants Interval 0.0 to 0.0
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	382 Participants Interval 0.0 to 0.0	257 Participants Interval 0.0 to 0.0
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	333 Participants Interval 0.0 to 0.0	213 Participants Interval 0.0 to 0.0
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	391 Participants Interval 0.0 to 0.0	259 Participants Interval 0.0 to 0.0
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	384 Participants Interval 0.0 to 0.0	257 Participants Interval 0.0 to 0.0
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	375 Participants Interval 0.0 to 0.0	246 Participants Interval 0.0 to 0.0
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	304 Participants Interval 0.0 to 0.0	197 Participants Interval 0.0 to 0.0
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	129 Participants Interval 0.0 to 0.0	73 Participants Interval 0.0 to 0.0
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	391 Participants Interval 0.0 to 0.0	258 Participants Interval 0.0 to 0.0
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	387 Participants Interval 0.0 to 0.0	258 Participants Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster n=396 Participants 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)	Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster n=393 Participants Participants who were previously primed with DTaP IPV Hep B PRP T received one dose of Infanrix Hexa vaccine and one dose of PCV7.	Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster n=260 Participants Participants who were previously primed with Infanrix Hexa vaccine received one dose of DTaP IPV Hep B PRP T and one dose of PCV7
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 Interval 169.0 to 190.0	187 Titers Interval 176.0 to 199.0	120 Titers Interval 112.0 to 129.0
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 Interval 18.9 to 23.8	23.4 Titers Interval 20.8 to 26.3	14.4 Titers Interval 12.5 to 16.8
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 Interval 332.0 to 449.0	406 Titers Interval 349.0 to 472.0	336 Titers Interval 284.0 to 397.0
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 Interval 7154.0 to 10010.0	11218 Titers Interval 9482.0 to 13272.0	9688 Titers Interval 7940.0 to 11821.0
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 Interval 2.69 to 3.78	3.60 Titers Interval 3.05 to 4.25	2.13 Titers Interval 1.78 to 2.54
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 Interval 0.406 to 0.573	0.556 Titers Interval 0.472 to 0.656	0.455 Titers Interval 0.375 to 0.553
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 Interval 1025.0 to 1332.0	1108 Titers Interval 979.0 to 1255.0	1948 Titers Interval 1647.0 to 2304.0
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 Interval 109.0 to 149.0	126 Titers Interval 106.0 to 150.0	207 Titers Interval 173.0 to 248.0
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 Interval 3164.0 to 4027.0	3322 Titers Interval 2939.0 to 3755.0	6015 Titers Interval 5244.0 to 6898.0
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 Interval 2715.0 to 3427.0	3180 Titers Interval 2834.0 to 3568.0	2910 Titers Interval 2556.0 to 3313.0
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 Interval 37.0 to 48.6	41.5 Titers Interval 36.6 to 47.0	56.5 Titers Interval 48.4 to 65.9
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 Interval 0.237 to 0.295	0.254 Titers Interval 0.227 to 0.285	0.251 Titers Interval 0.22 to 0.286
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 Interval 0.069 to 0.086	0.074 Titers Interval 0.066 to 0.083	0.059 Titers Interval 0.051 to 0.068
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 Interval 5.07 to 6.08	4.40 Titers Interval 3.99 to 4.86	6.05 Titers Interval 5.41 to 6.76
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 Interval 1.39 to 1.61	1.54 Titers Interval 1.44 to 1.65	1.80 Titers Interval 1.68 to 1.93
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 Interval 0.188 to 0.231	0.224 Titers Interval 0.2 to 0.251	0.201 Titers Interval 0.18 to 0.225
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 Interval 5.21 to 6.27	5.21 Titers Interval 4.78 to 5.68	7.52 Titers Interval 6.63 to 8.52
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 Interval 94.0 to 106.0	102 Titers Interval 96.6 to 108.0	97.0 Titers Interval 90.1 to 105.0
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 Interval 6.63 to 8.32	8.47 Titers Interval 7.52 to 9.56	7.41 Titers Interval 6.38 to 8.61
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 Interval 143.0 to 166.0	191 Titers Interval 178.0 to 206.0	140 Titers Interval 127.0 to 153.0
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 Interval 293.0 to 342.0	418 Titers Interval 386.0 to 454.0	260 Titers Interval 231.0 to 293.0
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 Interval 587.0 to 734.0	705 Titers Interval 625.0 to 796.0	1276 Titers Interval 1098.0 to 1484.0
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 Interval 116.0 to 150.0	134 Titers Interval 116.0 to 154.0	224 Titers Interval 188.0 to 267.0
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 Interval 1937.0 to 2364.0	2633 Titers Interval 2363.0 to 2933.0	2978 Titers Interval 2592.0 to 3421.0
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 Interval 1035.0 to 1282.0	1241 Titers Interval 1101.0 to 1398.0	1945 Titers Interval 1676.0 to 2256.0
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 Interval 214.0 to 294.0	289 Titers Interval 245.0 to 341.0	380 Titers Interval 313.0 to 461.0
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 Interval 3821.0 to 4688.0	4887 Titers Interval 4372.0 to 5463.0	6369 Titers Interval 5569.0 to 7283.0

SECONDARY outcome

Timeframe: Day 30 after final booster vaccination

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

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.

Outcome measures

Outcome measures
Measure	Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster n=396 Participants 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)	Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster n=393 Participants Participants who were previously primed with DTaP IPV Hep B PRP T received one dose of Infanrix Hexa vaccine and one dose of PCV7.	Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster n=260 Participants Participants who were previously primed with Infanrix Hexa vaccine received one dose of DTaP IPV Hep B PRP T and one dose of PCV7
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	146 Participants Interval 0.0 to 0.0	94 Participants Interval 0.0 to 0.0
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	145 Participants Interval 0.0 to 0.0	93 Participants Interval 0.0 to 0.0
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	147 Participants Interval 0.0 to 0.0	94 Participants Interval 0.0 to 0.0
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	147 Participants Interval 0.0 to 0.0	94 Participants Interval 0.0 to 0.0
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	147 Participants Interval 0.0 to 0.0	94 Participants Interval 0.0 to 0.0
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	144 Participants Interval 0.0 to 0.0	94 Participants Interval 0.0 to 0.0
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	144 Participants Interval 0.0 to 0.0	93 Participants Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: Day 30 after final booster vaccination

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

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

Outcome measures

Outcome measures
Measure	Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster n=396 Participants 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)	Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster n=393 Participants Participants who were previously primed with DTaP IPV Hep B PRP T received one dose of Infanrix Hexa vaccine and one dose of PCV7.	Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster n=260 Participants Participants who were previously primed with Infanrix Hexa vaccine received one dose of DTaP IPV Hep B PRP T and one dose of PCV7
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 Interval 5.68 to 8.31	8.98 Titers Interval 7.86 to 10.3	9.34 Titers Interval 7.76 to 11.2
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 Interval 2.47 to 3.15	3.03 Titers Interval 2.64 to 3.47	3.58 Titers Interval 3.07 to 4.17
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 Interval 2.22 to 2.85	2.86 Titers Interval 2.57 to 3.19	2.92 Titers Interval 2.5 to 3.42
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 Interval 10.2 to 13.2	13.2 Titers Interval 11.5 to 15.2	12.3 Titers Interval 10.2 to 14.7
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 Interval 2.1 to 2.67	2.63 Titers Interval 2.35 to 2.95	3.40 Titers Interval 2.92 to 3.94
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 Interval 2.62 to 3.47	3.74 Titers Interval 3.19 to 4.38	3.72 Titers Interval 3.19 to 4.32
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 Interval 6.14 to 7.94	7.20 Titers Interval 6.23 to 8.33	9.30 Titers Interval 7.79 to 11.1

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster n=396 Participants 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)	Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster n=393 Participants Participants who were previously primed with DTaP IPV Hep B PRP T received one dose of Infanrix Hexa vaccine and one dose of PCV7.	Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster n=260 Participants Participants who were previously primed with Infanrix Hexa vaccine received one dose of DTaP IPV Hep B PRP T and one dose of PCV7
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	104 Participants Interval 0.0 to 0.0	61 Participants Interval 0.0 to 0.0
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	92 Participants Interval 0.0 to 0.0	53 Participants Interval 0.0 to 0.0
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	99 Participants Interval 0.0 to 0.0	56 Participants Interval 0.0 to 0.0
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	118 Participants Interval 0.0 to 0.0	86 Participants Interval 0.0 to 0.0
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	121 Participants Interval 0.0 to 0.0	89 Participants Interval 0.0 to 0.0
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	125 Participants Interval 0.0 to 0.0	94 Participants Interval 0.0 to 0.0
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	127 Participants Interval 0.0 to 0.0	78 Participants Interval 0.0 to 0.0
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	138 Participants Interval 0.0 to 0.0	92 Participants Interval 0.0 to 0.0
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	141 Participants Interval 0.0 to 0.0	95 Participants Interval 0.0 to 0.0
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	105 Participants Interval 0.0 to 0.0	59 Participants Interval 0.0 to 0.0
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	78 Participants Interval 0.0 to 0.0	53 Participants Interval 0.0 to 0.0
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	99 Participants Interval 0.0 to 0.0	58 Participants Interval 0.0 to 0.0
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	130 Participants Interval 0.0 to 0.0	95 Participants Interval 0.0 to 0.0
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	118 Participants Interval 0.0 to 0.0	88 Participants Interval 0.0 to 0.0
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	124 Participants Interval 0.0 to 0.0	94 Participants Interval 0.0 to 0.0
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	149 Participants Interval 0.0 to 0.0	99 Participants Interval 0.0 to 0.0
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	138 Participants Interval 0.0 to 0.0	94 Participants Interval 0.0 to 0.0
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	144 Participants Interval 0.0 to 0.0	97 Participants Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: Day 30 after final booster vaccination

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

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.

Outcome measures

Outcome measures
Measure	Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster n=396 Participants 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)	Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster n=393 Participants Participants who were previously primed with DTaP IPV Hep B PRP T received one dose of Infanrix Hexa vaccine and one dose of PCV7.	Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster n=260 Participants Participants who were previously primed with Infanrix Hexa vaccine received one dose of DTaP IPV Hep B PRP T and one dose of PCV7
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 Interval 5.56 to 7.34	4.77 Titers Interval 3.98 to 5.72	6.56 Titers Interval 5.43 to 7.92
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 Interval 3265.0 to 4764.0	3261 Titers Interval 2585.0 to 4113.0	5409 Titers Interval 4359.0 to 6713.0
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 Interval 2.72 to 3.76	2.73 Titers Interval 2.3 to 3.24	3.82 Titers Interval 3.01 to 4.84
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 Interval 6.17 to 8.26	5.77 Titers Interval 5.0 to 6.66	7.34 Titers Interval 6.3 to 8.56
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 Interval 209.0 to 263.0	268 Titers Interval 233.0 to 308.0	197 Titers Interval 156.0 to 248.0
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 Interval 294.0 to 392.0	453 Titers Interval 392.0 to 524.0	280 Titers Interval 236.0 to 331.0
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 Interval 322.0 to 414.0	533 Titers Interval 473.0 to 599.0	287 Titers Interval 232.0 to 356.0
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 Interval 1944.0 to 3240.0	2616 Titers Interval 2098.0 to 3263.0	5617 Titers Interval 4006.0 to 7876.0
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 Interval 3398.0 to 4993.0	4061 Titers Interval 3387.0 to 4869.0	6889 Titers Interval 5583.0 to 8499.0

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster n=416 Participants 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)	Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster n=415 Participants Participants who were previously primed with DTaP IPV Hep B PRP T received one dose of Infanrix Hexa vaccine and one dose of PCV7.	Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster n=275 Participants Participants who were previously primed with Infanrix Hexa vaccine received one dose of DTaP IPV Hep B PRP T and one dose of PCV7
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	205 Participants Interval 0.0 to 0.0	160 Participants Interval 0.0 to 0.0
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	0 Participants Interval 0.0 to 0.0	0 Participants Interval 0.0 to 0.0
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	0 Participants	0 Participants
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	99 Participants Interval 0.0 to 0.0	91 Participants Interval 0.0 to 0.0
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	6 Participants	1 Participants
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	1 Participants	2 Participants
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	113 Participants Interval 0.0 to 0.0	85 Participants Interval 0.0 to 0.0
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	6 Participants	6 Participants
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	100 Participants Interval 0.0 to 0.0	86 Participants Interval 0.0 to 0.0
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	3 Participants	7 Participants
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	56 Participants Interval 0.0 to 0.0	49 Participants Interval 0.0 to 0.0
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	3 Participants	1 Participants
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	39 Participants Interval 0.0 to 0.0	19 Participants Interval 0.0 to 0.0
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	1 Participants	0 Participants
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	139 Participants Interval 0.0 to 0.0	102 Participants Interval 0.0 to 0.0
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	1 Participants	2 Participants
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	121 Participants Interval 0.0 to 0.0	90 Participants Interval 0.0 to 0.0
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	3 Participants	4 Participants
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	176 Participants Interval 0.0 to 0.0	146 Participants Interval 0.0 to 0.0
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	3 Participants	2 Participants

SECONDARY outcome

Timeframe: Day 0 up to Day 7 after final booster vaccination

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

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.

Outcome measures

Outcome measures
Measure	Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster n=416 Participants 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)	Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster n=415 Participants Participants who were previously primed with DTaP IPV Hep B PRP T received one dose of Infanrix Hexa vaccine and one dose of PCV7.	Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster n=275 Participants Participants who were previously primed with Infanrix Hexa vaccine received one dose of DTaP IPV Hep B PRP T and one dose of PCV7
Number of Participants Reporting a Solicited Injection Site Following Booster Vaccination With Prevenar Vaccine Injection site Erythema (N=413,412,272)	84 Participants	77 Participants Interval 0.0 to 0.0	52 Participants Interval 0.0 to 0.0
Number of Participants Reporting a Solicited Injection Site Following Booster Vaccination With Prevenar Vaccine Injection site Swelling (N=413,412,272)	51 Participants	42 Participants Interval 0.0 to 0.0	33 Participants Interval 0.0 to 0.0
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	1 Participants	1 Participants
Number of Participants Reporting a Solicited Injection Site Following Booster Vaccination With Prevenar Vaccine Injection site Pain (N=413,412,272)	224 Participants	184 Participants Interval 0.0 to 0.0	140 Participants Interval 0.0 to 0.0
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	9 Participants	5 Participants
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	0 Participants	0 Participants

Adverse Events

Group 1: DTaP-IPV-Hep B-PRP~T + Prevenar™ Primary and Booster

Serious events: 13 serious events

Other events: 253 other events

Deaths: 0 deaths

Group 2:DTaP-IPV-HepB-PRP~T Primary/Infanrix Hexa+PCV7 Booster

Serious events: 15 serious events

Other events: 221 other events

Deaths: 0 deaths

Group 3:Infanrix Hexa Primary/DTaP-IPV-HepB-PRP~T+PCV7 Booster

Serious events: 9 serious events

Other events: 168 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Group 1: DTaP-IPV-Hep B-PRP~T + Prevenar™ Primary and Booster n=416 participants at risk 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)	Group 2:DTaP-IPV-HepB-PRP~T Primary/Infanrix Hexa+PCV7 Booster n=415 participants at risk Participants who were previously primed with DTaP-IPV-Hep B-PRP\~T received one dose of Infanrix Hexa vaccine and one dose of PCV7.	Group 3:Infanrix Hexa Primary/DTaP-IPV-HepB-PRP~T+PCV7 Booster n=275 participants at risk Participants who were previously primed with Infanrix Hexa vaccine received one dose of DTaP-IPV-Hep B-PRP\~T and one dose of PCV7
Infections and infestations Nasopharyngitis	6.5% 27/416 • Number of events 27 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 after final booster vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.	5.5% 23/415 • Number of events 23 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 after final booster vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.	4.4% 12/275 • Number of events 12 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 after final booster vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.
General disorders Injection site Pain	55.8% 232/416 • Number of events 232 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 after final booster vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.	49.8% 205/412 • Number of events 205 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 after final booster vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.	58.8% 160/272 • Number of events 160 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 after final booster vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.
General disorders Injection site Erythema	27.1% 112/413 • Number of events 112 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 after final booster vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.	24.3% 100/412 • Number of events 100 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 after final booster vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.	31.6% 86/272 • Number of events 86 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 after final booster vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.
General disorders Injection site Swelling	14.6% 60/412 • Number of events 60 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 after final booster vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.	13.6% 56/412 • Number of events 56 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 after final booster vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.	18.0% 49/272 • Number of events 49 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 after final booster vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.
General disorders Pyrexia	27.6% 114/413 • Number of events 114 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 after final booster vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.	24.0% 99/412 • Number of events 99 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 after final booster vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.	33.5% 91/272 • Number of events 91 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 after final booster vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.
Gastrointestinal disorders Vomiting	8.2% 34/413 • Number of events 34 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 after final booster vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.	9.5% 39/412 • Number of events 39 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 after final booster vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.	7.0% 19/272 • Number of events 19 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 after final booster vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.
Psychiatric disorders Crying	35.8% 148/413 • Number of events 148 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 after final booster vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.	33.7% 139/412 • Number of events 139 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 after final booster vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.	37.5% 102/272 • Number of events 102 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 after final booster vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.
Nervous system disorders Drowsiness	30.0% 124/413 • Number of events 124 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 after final booster vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.	27.4% 113/412 • Number of events 113 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 after final booster vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.	31.2% 85/272 • Number of events 85 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 after final booster vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.
Metabolism and nutrition disorders Anorexia	28.6% 118/413 • Number of events 118 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 after final booster vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.	29.4% 121/412 • Number of events 121 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 after final booster vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.	33.1% 90/272 • Number of events 90 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 after final booster vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.
Psychiatric disorders Irritability	48.7% 201/413 • Number of events 201 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 after final booster vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.	42.7% 176/412 • Number of events 176 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 after final booster vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.	53.7% 146/272 • Number of events 146 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 after final booster vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.

Additional Information

Medical Director

Sanofi Pasteur Inc.

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
Publication restrictions are in place

Restriction type: OTHER

Measure	Group 1: DTaP-IPV-Hep B-PRP~T + Prevenar™ Primary and Booster n=416 participants at risk 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)	Group 2:DTaP-IPV-HepB-PRP~T Primary/Infanrix Hexa+PCV7 Booster n=415 participants at risk Participants who were previously primed with DTaP-IPV-Hep B-PRP\~T received one dose of Infanrix Hexa vaccine and one dose of PCV7.	Group 3:Infanrix Hexa Primary/DTaP-IPV-HepB-PRP~T+PCV7 Booster n=275 participants at risk Participants who were previously primed with Infanrix Hexa vaccine received one dose of DTaP-IPV-Hep B-PRP\~T and one dose of PCV7
Blood and lymphatic system disorders Idiopathic thrombocytopenic purpura	0.00% 0/416 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 after final booster vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.	0.24% 1/415 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 after final booster vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.	0.00% 0/275 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 after final booster vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.
General disorders Adverse drug reaction	0.24% 1/416 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 after final booster vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.	0.00% 0/415 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 after final booster vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.	0.00% 0/275 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 after final booster vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.
Infections and infestations Acute sinusitis	0.00% 0/416 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 after final booster vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.	0.24% 1/415 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 after final booster vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.	0.00% 0/275 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 after final booster vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.
Infections and infestations Cellulitis	0.24% 1/416 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 after final booster vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.	0.00% 0/415 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 after final booster vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.	0.36% 1/275 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 after final booster vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.
Infections and infestations Gastroenteritis	0.24% 1/416 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 after final booster vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.	0.00% 0/415 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 after final booster vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.	0.36% 1/275 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 after final booster vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.
Infections and infestations Kawasaki's disease	0.24% 1/416 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 after final booster vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.	0.00% 0/415 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 after final booster vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.	0.00% 0/275 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 after final booster vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.
Infections and infestations Osteomyelitis acute	0.00% 0/416 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 after final booster vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.	0.24% 1/415 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 after final booster vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.	0.00% 0/275 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 after final booster vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.
Infections and infestations Pneumonia	1.2% 5/416 • Number of events 5 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 after final booster vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.	0.96% 4/415 • Number of events 4 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 after final booster vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.	1.8% 5/275 • Number of events 5 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 after final booster vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.
Infections and infestations Pyelonephritis acute	0.00% 0/416 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 after final booster vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.	0.24% 1/415 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 after final booster vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.	0.00% 0/275 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 after final booster vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.
Infections and infestations Subcutaneous abscess	0.00% 0/416 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 after final booster vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.	0.00% 0/415 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 after final booster vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.	0.36% 1/275 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 after final booster vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.
Infections and infestations Urinary tract infection	0.00% 0/416 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 after final booster vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.	0.48% 2/415 • Number of events 2 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 after final booster vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.	0.00% 0/275 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 after final booster vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.
Infections and infestations Viral infection	0.00% 0/416 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 after final booster vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.	0.24% 1/415 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 after final booster vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.	0.00% 0/275 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 after final booster vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.
Musculoskeletal and connective tissue disorders Arthropathy	0.00% 0/416 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 after final booster vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.	0.24% 1/415 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 after final booster vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.	0.00% 0/275 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 after final booster vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.
Nervous system disorders Febrile convulsion	0.48% 2/416 • Number of events 2 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 after final booster vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.	0.48% 2/415 • Number of events 2 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 after final booster vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.	0.36% 1/275 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 after final booster vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.
Renal and urinary disorders Haematuria	0.00% 0/416 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 after final booster vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.	0.24% 1/415 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 after final booster vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.	0.00% 0/275 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 after final booster vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.
Respiratory, thoracic and mediastinal disorders Asthma	0.48% 2/416 • Number of events 2 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 after final booster vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.	0.24% 1/415 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 after final booster vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.	0.00% 0/275 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 after final booster vaccination. The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.