Trial Outcomes & Findings for A Study of DTaP-IPV-Hep B-PRP-T Vaccine Given With Prevenar™ and Rotarix™ in Healthy Latin American Infants (NCT NCT01177722)

NCT ID: NCT01177722

Last Updated: 2014-05-05

Results Overview

Antibodies against Hepatitis B (Hep B) were measured by chemiluminescence detection.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1375 participants

Primary outcome timeframe

Day 0 (pre-vaccination) Dose 1 and 30 days post-vaccination

Results posted on

2014-05-05

Participant Flow

Participants were enrolled from 03 August 2010 to 23 November 2010 in 2 clinical centers in Columbia and 1 clinical center in Costa Rica.

A total of 1375 participants who met all inclusion criteria and none of the exclusion criteria were enrolled and vaccinated.

Participant milestones

Participant milestones
Measure	DTap-IPV-Hep B-PRP~T Batch A Participants received a 3-dose primary series of vaccinations with Batch A of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine \[polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP\~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.	DTaP-IPV-Hep B-PRP~T Batch B Participants received a 3-dose primary series of vaccinations with Batch B of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine \[polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP\~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.	DTaP-IPV-Hep B-PRP~T Batch C Participants received a 3-dose primary series of vaccinations with Batch C of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine \[polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP\~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.	Infanrix Hexa Participants received a 3-dose primary series of vaccinations with the licensed Infanrix hexa™, with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
Overall Study STARTED	344	344	342	345
Overall Study COMPLETED	331	334	333	338
Overall Study NOT COMPLETED	13	10	9	7

Reasons for withdrawal

Reasons for withdrawal
Measure	DTap-IPV-Hep B-PRP~T Batch A Participants received a 3-dose primary series of vaccinations with Batch A of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine \[polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP\~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.	DTaP-IPV-Hep B-PRP~T Batch B Participants received a 3-dose primary series of vaccinations with Batch B of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine \[polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP\~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.	DTaP-IPV-Hep B-PRP~T Batch C Participants received a 3-dose primary series of vaccinations with Batch C of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine \[polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP\~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.	Infanrix Hexa Participants received a 3-dose primary series of vaccinations with the licensed Infanrix hexa™, with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
Overall Study Serious Adverse Event	0	0	1	0
Overall Study Protocol Violation	0	0	1	0
Overall Study Lost to Follow-up	3	4	3	1
Overall Study Withdrawal by Subject	10	6	4	6

Baseline Characteristics

A Study of DTaP-IPV-Hep B-PRP-T Vaccine Given With Prevenar™ and Rotarix™ in Healthy Latin American Infants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DTap-IPV-Hep B-PRP~T Batch A n=344 Participants Participants received a 3-dose primary series of vaccinations with Batch A of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine \[polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP\~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.	DTaP-IPV-Hep B-PRP~T Batch B n=344 Participants Participants received a 3-dose primary series of vaccinations with Batch B of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine \[polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP\~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.	DTaP-IPV-Hep B-PRP~T Batch C n=342 Participants Participants received a 3-dose primary series of vaccinations with Batch C of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine \[polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP\~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.	Infanrix Hexa n=345 Participants Participants received a 3-dose primary series of vaccinations with the licensed Infanrix hexa™, with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.	Total n=1375 Participants Total of all reporting groups
Age, Categorical <=18 years	344 Participants n=93 Participants	344 Participants n=4 Participants	342 Participants n=27 Participants	345 Participants n=483 Participants	1375 Participants n=36 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Age, Continuous	58.8 Days STANDARD_DEVIATION 3.49 • n=93 Participants	58.7 Days STANDARD_DEVIATION 3.25 • n=4 Participants	58.5 Days STANDARD_DEVIATION 3.16 • n=27 Participants	58.7 Days STANDARD_DEVIATION 3.31 • n=483 Participants	58.7 Days STANDARD_DEVIATION 3.30 • n=36 Participants
Sex: Female, Male Female	161 Participants n=93 Participants	165 Participants n=4 Participants	152 Participants n=27 Participants	156 Participants n=483 Participants	634 Participants n=36 Participants
Sex: Female, Male Male	183 Participants n=93 Participants	179 Participants n=4 Participants	190 Participants n=27 Participants	189 Participants n=483 Participants	741 Participants n=36 Participants
Region of Enrollment Colombia	233 Participants n=93 Participants	234 Participants n=4 Participants	233 Participants n=27 Participants	233 Participants n=483 Participants	933 Participants n=36 Participants
Region of Enrollment Costa Rica	111 Participants n=93 Participants	110 Participants n=4 Participants	109 Participants n=27 Participants	112 Participants n=483 Participants	442 Participants n=36 Participants

PRIMARY outcome

Timeframe: Day 0 (pre-vaccination) Dose 1 and 30 days post-vaccination

Population: GMTs were assessed in all subjects who did not have any protocol violation that might interfere with primary criteria evaluation (Per-Protocol Population).

Antibodies against Hepatitis B (Hep B) were measured by chemiluminescence detection.

Outcome measures

Outcome measures
Measure	DTap-IPV-Hep B-PRP~T Batch A n=312 Participants Participants received a 3-dose primary series of vaccinations with Batch A of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine \[polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP\~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.	DTaP-IPV-Hep B-PRP~T Batch B n=310 Participants Participants received a 3-dose primary series of vaccinations with Batch B of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine \[polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP\~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.	DTaP-IPV-Hep B-PRP~T Batch C n=313 Participants Participants received a 3-dose primary series of vaccinations with Batch C of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine \[polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP\~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.	Infanrix Hexa n=316 Participants Participants received a 3-dose primary series of vaccinations with the licensed Infanrix hexa™, with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
Geometric Mean Titers (GMTs) of Anti-Hepatitis B Before and After 3 Dose Primary Vaccination With Either DTaP-IPV-Hep B-PRP~T Batch A, B, or C, or Infanrix Hexa™ Anti-Hep B Pre-dose 1	4.02 Titers Interval 3.5 to 4.61	4.07 Titers Interval 3.58 to 4.62	4.93 Titers Interval 4.2 to 5.79	4.30 Titers Interval 3.68 to 5.03
Geometric Mean Titers (GMTs) of Anti-Hepatitis B Before and After 3 Dose Primary Vaccination With Either DTaP-IPV-Hep B-PRP~T Batch A, B, or C, or Infanrix Hexa™ Anti-Hep B Post-dose 3	3048 Titers Interval 2672.0 to 3476.0	2801 Titers Interval 2467.0 to 3181.0	3202 Titers Interval 2794.0 to 3668.0	2766 Titers Interval 2466.0 to 3102.0

PRIMARY outcome

Timeframe: 30 Days post-dose 3

Population: Seroprotection and vaccine response were assessed in all subjects who did not have any protocol violation that might interfere with primary criteria evaluation (Per Protocol Population).

Seroprotection was defined as titers ≥ 0.01 IU/mL for Diphtheria (D) and Tetanus (T); ≥ 10 IU/mL for Hep B; ≥ 0.15 µg/mL for PRP, and ≥ 8 (1/dil) for Poliovirus. Vaccine response for PT and FHA were defined as a titer ≥ lower limit of quantitation (LLOQ) in initially seronegative participants, or at least persistence (post-vaccination titer ≥ pre-vaccination titer) in initially seropositive subjects (titer ≥ LLOQ).

Outcome measures

Outcome measures
Measure	DTap-IPV-Hep B-PRP~T Batch A n=312 Participants Participants received a 3-dose primary series of vaccinations with Batch A of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine \[polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP\~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.	DTaP-IPV-Hep B-PRP~T Batch B n=310 Participants Participants received a 3-dose primary series of vaccinations with Batch B of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine \[polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP\~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.	DTaP-IPV-Hep B-PRP~T Batch C n=313 Participants Participants received a 3-dose primary series of vaccinations with Batch C of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine \[polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP\~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.	Infanrix Hexa n=316 Participants Participants received a 3-dose primary series of vaccinations with the licensed Infanrix hexa™, with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
Number of Participants With Seroprotection or Vaccine Response After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine Anti-FHA (N = 306, 306, 304, 311)	306 Participants	305 Participants	303 Participants	309 Participants
Number of Participants With Seroprotection or Vaccine Response After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine Anti-Diphtheria (N = 310, 310, 312, 315)	310 Participants	310 Participants	312 Participants	315 Participants
Number of Participants With Seroprotection or Vaccine Response After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine Anti-Tetanus (N = 311, 310, 311, 314)	311 Participants	310 Participants	311 Participants	314 Participants
Number of Participants With Seroprotection or Vaccine Response After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine Anti-PT (N = 308, 309, 308, 312)	304 Participants	299 Participants	299 Participants	307 Participants
Number of Participants With Seroprotection or Vaccine Response After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine Anti-Polio 1 (N = 310, 309, 308, 311)	310 Participants	309 Participants	308 Participants	311 Participants
Number of Participants With Seroprotection or Vaccine Response After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine Anti-Polio 2 (N = 309, 309, 307, 312)	309 Participants	309 Participants	307 Participants	312 Participants
Number of Participants With Seroprotection or Vaccine Response After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine Anti-Polio 3 (N = 310, 309, 307, 312)	310 Participants	309 Participants	307 Participants	311 Participants
Number of Participants With Seroprotection or Vaccine Response After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine Anti-Hep B (N = 312, 310, 312, 316)	311 Participants	310 Participants	310 Participants	316 Participants
Number of Participants With Seroprotection or Vaccine Response After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine Anti-PRP (N = 312, 310, 312, 316)	299 Participants	298 Participants	287 Participants	303 Participants

SECONDARY outcome

Timeframe: Day 0 (pre-vaccination) and 30 days post-dose 3

Population: GMTs were assessed in all subjects who did not have any protocol violation that might interfere with primary criteria evaluation (Per Protocol Population).

Antibodies were measured by toxin neutralization test for Diphtheria (D); enzyme-linked immunosorbent assay (ELISA) for Tetanus (T), Pertussis toxoid (PT), and Filamentous hemagglutinin (FHA); neutralization assay for Poliovirus types 1, 2, and 3; chemiluminescence detection for Hepatitis B (Hep B), and Farr type radioimmunoassay for Haemophilus influenza type b (PRP).

Outcome measures

Outcome measures
Measure	DTap-IPV-Hep B-PRP~T Batch A n=312 Participants Participants received a 3-dose primary series of vaccinations with Batch A of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine \[polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP\~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.	DTaP-IPV-Hep B-PRP~T Batch B n=310 Participants Participants received a 3-dose primary series of vaccinations with Batch B of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine \[polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP\~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.	DTaP-IPV-Hep B-PRP~T Batch C n=313 Participants Participants received a 3-dose primary series of vaccinations with Batch C of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine \[polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP\~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.	Infanrix Hexa n=316 Participants Participants received a 3-dose primary series of vaccinations with the licensed Infanrix hexa™, with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
Geometric Mean Titers (GMTs) of Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine Anti-PRP Post-dose 3 (N = 312, 310, 312, 316)	3.37 Titers Interval 2.8 to 4.05	4.02 Titers Interval 3.35 to 4.82	3.33 Titers Interval 2.72 to 4.07	2.24 Titers Interval 1.9 to 2.64
Geometric Mean Titers (GMTs) of Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine Anti-Polio 1 Post-dose 3 (N = 310, 309, 308, 311)	755 Titers Interval 674.0 to 847.0	655 Titers Interval 580.0 to 739.0	636 Titers Interval 561.0 to 722.0	1298 Titers Interval 1151.0 to 1464.0
Geometric Mean Titers (GMTs) of Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine Anti-Polio 2 Post-dose 3 (N = 309, 309, 307, 312)	1190 Titers Interval 1054.0 to 1344.0	1232 Titers Interval 1101.0 to 1379.0	1120 Titers Interval 994.0 to 1261.0	1981 Titers Interval 1756.0 to 2234.0
Geometric Mean Titers (GMTs) of Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine Anti-Polio 3 Post-dose 3 (N = 310, 309, 307, 312)	1102 Titers Interval 972.0 to 1250.0	1119 Titers Interval 975.0 to 1284.0	1097 Titers Interval 963.0 to 1250.0	1944 Titers Interval 1680.0 to 2249.0
Geometric Mean Titers (GMTs) of Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine Anti-Diphtheria Post-dose 3 (N=310, 310, 312, 315)	0.252 Titers Interval 0.224 to 0.285	0.279 Titers Interval 0.247 to 0.316	0.228 Titers Interval 0.201 to 0.26	0.240 Titers Interval 0.214 to 0.269
Geometric Mean Titers (GMTs) of Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine Anti-Diphtheria Pre-dose 1 (N= 312, 308, 311, 315)	0.599 Titers Interval 0.513 to 0.699	0.596 Titers Interval 0.505 to 0.703	0.641 Titers Interval 0.547 to 0.752	0.630 Titers Interval 0.53 to 0.749
Geometric Mean Titers (GMTs) of Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine Anti-Tetanus Post-dose 3 (N = 311, 310, 311, 314)	1.66 Titers Interval 1.54 to 1.78	1.55 Titers Interval 1.43 to 1.68	1.45 Titers Interval 1.33 to 1.59	1.80 Titers Interval 1.69 to 1.93
Geometric Mean Titers (GMTs) of Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine Anti-PT Pre-dose 1 (N = 308, 309, 310, 314)	3.02 Titers Interval 2.65 to 3.45	3.50 Titers Interval 3.03 to 4.04	3.54 Titers Interval 3.1 to 4.05	3.11 Titers Interval 2.7 to 3.59
Geometric Mean Titers (GMTs) of Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine Anti-PT Post-dose 3 (N = 312, 310, 311, 314)	102 Titers Interval 96.1 to 108.0	103 Titers Interval 95.9 to 110.0	102 Titers Interval 95.0 to 110.0	98.9 Titers Interval 92.3 to 106.0
Geometric Mean Titers (GMTs) of Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine Anti-FHA Pre-dose 1(N = 307, 307, 307, 312)	5.36 Titers Interval 4.77 to 6.02	5.66 Titers Interval 5.01 to 6.39	5.76 Titers Interval 5.12 to 6.49	5.13 Titers Interval 4.61 to 5.7
Geometric Mean Titers (GMTs) of Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine Anti-FHA Post-dose 3 (N=311, 309, 310, 315)	186 Titers Interval 174.0 to 199.0	175 Titers Interval 163.0 to 188.0	183 Titers Interval 171.0 to 197.0	118 Titers Interval 110.0 to 127.0

SECONDARY outcome

Timeframe: Day 0 up to 7 after each dose

Population: Solicited injection site and systemic reactions were assessed in all participants who received at least one dose of study vaccine (Safety Analysis Set).

Solicited Injection Site Reactions: Pain, Erythema, and Swelling. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia,and Irritability. Grade 3 was defined as: Pain, cries when injected limb is moved or movement of the limb is reduced; Erythema and Swelling, ≥ 5 cm; Pyrexia, (Temperature) ≥ 39.6°C; Vomiting, ≥ 6 episodes/24 hours or requiring parenteral hydration; Crying, \> 3 hours; Somnolence, sleeping most of time or difficult to wake up; Anorexia, refuses ≥ 3 feed/meals or refuses most feeds/meals; and Irritability, inconsolable.

Outcome measures

Outcome measures
Measure	DTap-IPV-Hep B-PRP~T Batch A n=345 Participants Participants received a 3-dose primary series of vaccinations with Batch A of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine \[polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP\~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.	DTaP-IPV-Hep B-PRP~T Batch B n=343 Participants Participants received a 3-dose primary series of vaccinations with Batch B of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine \[polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP\~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.	DTaP-IPV-Hep B-PRP~T Batch C n=342 Participants Participants received a 3-dose primary series of vaccinations with Batch C of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine \[polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP\~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.	Infanrix Hexa n=345 Participants Participants received a 3-dose primary series of vaccinations with the licensed Infanrix hexa™, with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine Pain Post-dose 1 (N = 338, 341, 340, 344)	199 Participants	194 Participants	216 Participants	185 Participants
Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine Swelling Post dose 1 (N = 338, 341, 340, 344)	47 Participants	30 Participants	47 Participants	33 Participants
Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine Grad 3 Somnolence Post-dose 1 N=338, 341, 341, 344	3 Participants	14 Participants	19 Participants	9 Participants
Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine Grade 3 Anorexia Post-dose 1(N=338, 341, 341, 344)	3 Participants	4 Participants	8 Participants	3 Participants
Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine Irritability Post dose 3 (N = 331, 332, 334, 337)	155 Participants	161 Participants	154 Participants	144 Participants
Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine Pain Post-dose 2 (N = 333, 337, 335, 340)	180 Participants	196 Participants	203 Participants	188 Participants
Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine Pain Post-dose 3 (N = 331, 331, 334, 337)	168 Participants	163 Participants	162 Participants	147 Participants
Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine Grade 3 Pain Post Dose 1 (N = 338, 341, 344, 344)	21 Participants	22 Participants	22 Participants	7 Participants
Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine Grade 3 Pain Post Dose 3 (N=331, 331, 334, 338)	10 Participants	9 Participants Interval 0.0 to 0.0	8 Participants	8 Participants
Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine Erythema Post-dose 1 (N = 338, 341, 340, 344	72 Participants	63 Participants	82 Participants	52 Participants
Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine Erythema Post-dose 2 (N = 333, 337, 335, 340	87 Participants	78 Participants	80 Participants	67 Participants
Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine Erythema Post-dose 3 (N = 331, 331, 334, 337)	85 Participants	79 Participants	96 Participants	68 Participants
Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine Grade 3 Erythema Post-dose 1(N=338, 341, 340, 344)	2 Participants	3 Participants	2 Participants	0 Participants
Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine Grade 3 Erythema Post-dose 3(N=331, 331, 334, 337)	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine Swelling Post dose 2 (N = 333, 337, 335, 340)	44 Participants	35 Participants	45 Participants	44 Participants
Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine Swelling Post dose 3 (N = 331, 331, 334, 337)	43 Participants	34 Participants	48 Participants	42 Participants
Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine Grade 3 Swelling Post-dose 1(N=338, 341, 340, 344)	2 Participants	3 Participants	2 Participants	0 Participants
Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine Grade 3 Swelling post-dose 3(N=331, 331, 340, 338)	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine Pyrexia Post dose 1 (N = 338, 341, 340, 344)	46 Participants	42 Participants	68 Participants	46 Participants
Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine Pyrexia Post dose 2 (N = 333, 337, 335, 340)	70 Participants	68 Participants	68 Participants	70 Participants
Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine Pyrexia Post dose 3 (N = 331, 331, 333, 337)	67 Participants	63 Participants	72 Participants	65 Participants
Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine Grade 3 Pyrexia Post-dose 1 (N=338, 341, 340, 344)	2 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine Grade 3 Pyrexia Post-dose 3 (N=331, 331, 333, 337)	4 Participants	1 Participants	1 Participants	2 Participants
Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine Vomiting Post dose 1 (N = 338, 341, 340, 344)	85 Participants	90 Participants	86 Participants	94 Participants
Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine Vomiting Post dose 2 (N = 333, 337, 335, 340)	58 Participants	80 Participants	64 Participants	62 Participants
Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine Vomiting Post dose 3 (N = 331, 331, 334, 337)	32 Participants	58 Participants	46 Participants	39 Participants
Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine Grade 3 Vomiting Post-dose 1(N=338, 341, 340, 344)	4 Participants	5 Participants	6 Participants	5 Participants
Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine Grade 3 Vomiting post-dose 3(N=331, 331, 334, 337)	3 Participants	1 Participants	2 Participants	2 Participants
Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine Crying Post dose 1 (N = 338, 341, 340, 344)	198 Participants	186 Participants	189 Participants	161 Participants
Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine Crying Post dose 2 (N = 333, 337, 335, 340)	163 Participants	179 Participants	169 Participants	161 Participants
Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine Crying Post dose 3 (N = 331, 331, 334, 337)	141 Participants	145 Participants	142 Participants	120 Participants
Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine Grade 3 Crying Post-dose 1 (N =338, 341, 340, 344)	15 Participants	10 Participants	23 Participants	9 Participants
Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine Grade 3 Crying Post-dose 3 (N =331, 331, 334, 337)	8 Participants	6 Participants	10 Participants	6 Participants
Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine Somnolence Post dose 1 (N = 338, 341, 341, 344)	159 Participants	146 Participants	160 Participants	147 Participants
Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine Somnolence Post dose 2 (N = 333, 337, 335, 340)	109 Participants	108 Participants	110 Participants	111 Participants
Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine Somnolence Post dose 3 (N = 331, 331, 334, 337)	85 Participants	99 Participants	96 Participants	81 Participants
Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine Grad 3 Somnolence Post-dose 3 N=331, 331, 334, 337	5 Participants	2 Participants	4 Participants	4 Participants
Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine Anorexia Post dose 1 (N = 338, 341, 341, 344)	78 Participants	97 Participants	96 Participants	75 Participants
Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine Anorexia Post dose 2 (N = 333, 337, 335, 340)	75 Participants	93 Participants	86 Participants	74 Participants
Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine Anorexia Post dose 3 (N = 331, 331, 334, 337)	63 Participants	64 Participants	60 Participants	54 Participants
Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine Grade 3 Anorexia Post-dose 3(N=331, 331, 334, 337)	4 Participants	7 Participants	4 Participants	3 Participants
Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine Irritability Post dose 1 (N = 338, 341, 341, 344)	208 Participants	206 Participants	208 Participants	180 Participants
Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine Irritability Post dose 2 (N = 333, 337, 335, 340)	193 Participants	199 Participants	191 Participants	193 Participants
Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine Grd 3 Irritability Post-dose 1N=338, 341, 341, 344	15 Participants	17 Participants	20 Participants	8 Participants
Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine Grd 3 Irritability Post-dose 3N=331, 332, 334, 337	11 Participants	13 Participants	12 Participants	5 Participants

SECONDARY outcome

Timeframe: Day 0 up to 7 post each vaccination

Population: Solicited injection site and systemic reactions were assessed in all participants who received at least one dose of study vaccine (Safety Analysis Set).

Solicited Injection Site Reactions: Pain, Erythema, and Swelling. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, and Irritability. Grade 3 was defined as: Pain, cries when injected limb is moved or movement of the limb is reduced; Erythema and Swelling, ≥ 5 cm; Pyrexia (Temperature), ≥ 39.6ºC; Vomiting, ≥ 6 episodes/24 hours or requiring parenteral hydration; Crying, \> 3 hours; Somnolence, sleeping most of time or difficult to wake up; Anorexia, refuses ≥ 3 feed/meals or refuses most feeds/meals; and Irritability, inconsolable.

Outcome measures

Outcome measures
Measure	DTap-IPV-Hep B-PRP~T Batch A n=345 Participants Participants received a 3-dose primary series of vaccinations with Batch A of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine \[polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP\~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.	DTaP-IPV-Hep B-PRP~T Batch B n=341 Participants Participants received a 3-dose primary series of vaccinations with Batch B of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine \[polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP\~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.	DTaP-IPV-Hep B-PRP~T Batch C n=342 Participants Participants received a 3-dose primary series of vaccinations with Batch C of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine \[polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP\~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.	Infanrix Hexa n=345 Participants Participants received a 3-dose primary series of vaccinations with the licensed Infanrix hexa™, with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine Pain Post-dose 3 (N =331, 331, 334, 337)	146 Participants	105 Participants	146 Participants	125 Participants
Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine Grade 3 Swelling Post-dose 3 (N=331, 331, 334, 337	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine Pain Post-dose 1 (N = 338, 341, 340, 344)	171 Participants	173 Participants	184 Participants	169 Participants
Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine Grade 3 Pain Post-dose 1 (N = 338, 341, 340, 344)	15 Participants	15 Participants	16 Participants	8 Participants
Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine Pain Post-dose 2 (N = 333, 337, 335, 340)	160 Participants	183 Participants	180 Participants	174 Participants
Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine Grade 3 Pain Post-dose 2 (N = 333, 337, 335, 340)	14 Participants	17 Participants	16 Participants	13 Participants
Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine Grade 3 Pain Post-dose 3 (N = 331, 331, 334, 337)	8 Participants	9 Participants	10 Participants	7 Participants
Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine Erythema Post-dose 1 (N = 338, 341, 340, 344)	47 Participants	48 Participants	55 Participants	42 Participants
Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine Grade 3 Erythema Post-dose 1 (N=338, 341, 340, 344	0 Participants	1 Participants	2 Participants	0 Participants
Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine Erythema Post-dose 2 (N = 333, 337, 335, 340)	65 Participants	55 Participants	62 Participants	53 Participants
Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine Grade 3 Erythema Post-dose 2 (N=333, 337, 335, 340	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine Erythema Post-dose 3 (N = 331, 331, 334, 337)	63 Participants	57 Participants	69 Participants	49 Participants
Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine Grade 3 Erythema Post-dose 3 (N=331, 331, 334, 337	1 Participants	1 Participants	0 Participants	0 Participants
Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine Swelling Post-dose 1 (N = 338, 341, 340, 344)	34 Participants	21 Participants	33 Participants	31 Participants
Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine Grade 3 Swelling Post-dose 1 (N=338, 341, 340, 344	0 Participants	0 Participants	2 Participants	1 Participants
Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine Swelling Post-dose 2 (N = 333, 337, 335, 340)	32 Participants	28 Participants	36 Participants	32 Participants
Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine Grade 3 Swelling Post-dose 2 (N=333, 337, 335, 340	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine Swelling Post-dose 3 (N = 331, 331, 334, 337)	27 Participants	29 Participants	36 Participants	29 Participants

Adverse Events

DTap-IPV-Hep B-PRP~T Batch A

Serious events: 10 serious events

Other events: 208 other events

Deaths: 0 deaths

DTaP-IPV-Hep B-PRP~T Batch B

Serious events: 14 serious events

Other events: 206 other events

Deaths: 0 deaths

DTaP-IPV-Hep B-PRP~T Batch C

Serious events: 16 serious events

Other events: 216 other events

Deaths: 0 deaths

Infanrix Hexa

Serious events: 10 serious events

Other events: 193 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	DTap-IPV-Hep B-PRP~T Batch A n=345 participants at risk Participants received a 3-dose primary series of vaccinations with Batch A of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine \[polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP\~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.	DTaP-IPV-Hep B-PRP~T Batch B n=343 participants at risk Participants received a 3-dose primary series of vaccinations with Batch B of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine \[polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP\~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.	DTaP-IPV-Hep B-PRP~T Batch C n=342 participants at risk Participants received a 3-dose primary series of vaccinations with Batch C of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine \[polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP\~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.	Infanrix Hexa n=345 participants at risk Participants received a 3-dose primary series of vaccinations with the licensed Infanrix hexa™, with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
Gastrointestinal disorders Vomiting	25.1% 85/338 • Number of events 85 • Adverse events data were collected from Day 0 after Dose 1 through up to 6 months after the last dose. A participant randomized to Batch B got the Batch A vaccine, safety analyses was according to the actual vaccine administered. Total number reported for each solicited event reflects those with available data for the indicated event.	26.4% 90/341 • Number of events 90 • Adverse events data were collected from Day 0 after Dose 1 through up to 6 months after the last dose. A participant randomized to Batch B got the Batch A vaccine, safety analyses was according to the actual vaccine administered. Total number reported for each solicited event reflects those with available data for the indicated event.	25.3% 86/340 • Number of events 86 • Adverse events data were collected from Day 0 after Dose 1 through up to 6 months after the last dose. A participant randomized to Batch B got the Batch A vaccine, safety analyses was according to the actual vaccine administered. Total number reported for each solicited event reflects those with available data for the indicated event.	27.3% 94/344 • Number of events 94 • Adverse events data were collected from Day 0 after Dose 1 through up to 6 months after the last dose. A participant randomized to Batch B got the Batch A vaccine, safety analyses was according to the actual vaccine administered. Total number reported for each solicited event reflects those with available data for the indicated event.
General disorders Injection Site Erythema	25.7% 87/338 • Number of events 87 • Adverse events data were collected from Day 0 after Dose 1 through up to 6 months after the last dose. A participant randomized to Batch B got the Batch A vaccine, safety analyses was according to the actual vaccine administered. Total number reported for each solicited event reflects those with available data for the indicated event.	23.2% 79/341 • Number of events 79 • Adverse events data were collected from Day 0 after Dose 1 through up to 6 months after the last dose. A participant randomized to Batch B got the Batch A vaccine, safety analyses was according to the actual vaccine administered. Total number reported for each solicited event reflects those with available data for the indicated event.	28.2% 96/340 • Number of events 96 • Adverse events data were collected from Day 0 after Dose 1 through up to 6 months after the last dose. A participant randomized to Batch B got the Batch A vaccine, safety analyses was according to the actual vaccine administered. Total number reported for each solicited event reflects those with available data for the indicated event.	19.8% 68/344 • Number of events 68 • Adverse events data were collected from Day 0 after Dose 1 through up to 6 months after the last dose. A participant randomized to Batch B got the Batch A vaccine, safety analyses was according to the actual vaccine administered. Total number reported for each solicited event reflects those with available data for the indicated event.
General disorders Injection Site Pain	58.9% 199/338 • Number of events 199 • Adverse events data were collected from Day 0 after Dose 1 through up to 6 months after the last dose. A participant randomized to Batch B got the Batch A vaccine, safety analyses was according to the actual vaccine administered. Total number reported for each solicited event reflects those with available data for the indicated event.	57.5% 196/341 • Number of events 196 • Adverse events data were collected from Day 0 after Dose 1 through up to 6 months after the last dose. A participant randomized to Batch B got the Batch A vaccine, safety analyses was according to the actual vaccine administered. Total number reported for each solicited event reflects those with available data for the indicated event.	63.5% 216/340 • Number of events 216 • Adverse events data were collected from Day 0 after Dose 1 through up to 6 months after the last dose. A participant randomized to Batch B got the Batch A vaccine, safety analyses was according to the actual vaccine administered. Total number reported for each solicited event reflects those with available data for the indicated event.	54.7% 188/344 • Number of events 188 • Adverse events data were collected from Day 0 after Dose 1 through up to 6 months after the last dose. A participant randomized to Batch B got the Batch A vaccine, safety analyses was according to the actual vaccine administered. Total number reported for each solicited event reflects those with available data for the indicated event.
General disorders Injection Site Swelling	13.9% 47/338 • Number of events 47 • Adverse events data were collected from Day 0 after Dose 1 through up to 6 months after the last dose. A participant randomized to Batch B got the Batch A vaccine, safety analyses was according to the actual vaccine administered. Total number reported for each solicited event reflects those with available data for the indicated event.	10.3% 35/341 • Number of events 35 • Adverse events data were collected from Day 0 after Dose 1 through up to 6 months after the last dose. A participant randomized to Batch B got the Batch A vaccine, safety analyses was according to the actual vaccine administered. Total number reported for each solicited event reflects those with available data for the indicated event.	14.1% 48/340 • Number of events 48 • Adverse events data were collected from Day 0 after Dose 1 through up to 6 months after the last dose. A participant randomized to Batch B got the Batch A vaccine, safety analyses was according to the actual vaccine administered. Total number reported for each solicited event reflects those with available data for the indicated event.	12.8% 44/344 • Number of events 44 • Adverse events data were collected from Day 0 after Dose 1 through up to 6 months after the last dose. A participant randomized to Batch B got the Batch A vaccine, safety analyses was according to the actual vaccine administered. Total number reported for each solicited event reflects those with available data for the indicated event.
General disorders Irritability	61.5% 208/338 • Number of events 208 • Adverse events data were collected from Day 0 after Dose 1 through up to 6 months after the last dose. A participant randomized to Batch B got the Batch A vaccine, safety analyses was according to the actual vaccine administered. Total number reported for each solicited event reflects those with available data for the indicated event.	60.4% 206/341 • Number of events 206 • Adverse events data were collected from Day 0 after Dose 1 through up to 6 months after the last dose. A participant randomized to Batch B got the Batch A vaccine, safety analyses was according to the actual vaccine administered. Total number reported for each solicited event reflects those with available data for the indicated event.	61.0% 208/341 • Number of events 208 • Adverse events data were collected from Day 0 after Dose 1 through up to 6 months after the last dose. A participant randomized to Batch B got the Batch A vaccine, safety analyses was according to the actual vaccine administered. Total number reported for each solicited event reflects those with available data for the indicated event.	56.1% 193/344 • Number of events 193 • Adverse events data were collected from Day 0 after Dose 1 through up to 6 months after the last dose. A participant randomized to Batch B got the Batch A vaccine, safety analyses was according to the actual vaccine administered. Total number reported for each solicited event reflects those with available data for the indicated event.
General disorders Pyrexia	20.7% 70/338 • Number of events 70 • Adverse events data were collected from Day 0 after Dose 1 through up to 6 months after the last dose. A participant randomized to Batch B got the Batch A vaccine, safety analyses was according to the actual vaccine administered. Total number reported for each solicited event reflects those with available data for the indicated event.	19.9% 68/341 • Number of events 68 • Adverse events data were collected from Day 0 after Dose 1 through up to 6 months after the last dose. A participant randomized to Batch B got the Batch A vaccine, safety analyses was according to the actual vaccine administered. Total number reported for each solicited event reflects those with available data for the indicated event.	21.2% 72/340 • Number of events 72 • Adverse events data were collected from Day 0 after Dose 1 through up to 6 months after the last dose. A participant randomized to Batch B got the Batch A vaccine, safety analyses was according to the actual vaccine administered. Total number reported for each solicited event reflects those with available data for the indicated event.	20.3% 70/344 • Number of events 70 • Adverse events data were collected from Day 0 after Dose 1 through up to 6 months after the last dose. A participant randomized to Batch B got the Batch A vaccine, safety analyses was according to the actual vaccine administered. Total number reported for each solicited event reflects those with available data for the indicated event.
Infections and infestations Nasopharyngitis	28.7% 99/345 • Number of events 125 • Adverse events data were collected from Day 0 after Dose 1 through up to 6 months after the last dose. A participant randomized to Batch B got the Batch A vaccine, safety analyses was according to the actual vaccine administered. Total number reported for each solicited event reflects those with available data for the indicated event.	28.0% 96/343 • Number of events 132 • Adverse events data were collected from Day 0 after Dose 1 through up to 6 months after the last dose. A participant randomized to Batch B got the Batch A vaccine, safety analyses was according to the actual vaccine administered. Total number reported for each solicited event reflects those with available data for the indicated event.	26.3% 90/342 • Number of events 116 • Adverse events data were collected from Day 0 after Dose 1 through up to 6 months after the last dose. A participant randomized to Batch B got the Batch A vaccine, safety analyses was according to the actual vaccine administered. Total number reported for each solicited event reflects those with available data for the indicated event.	25.2% 87/345 • Number of events 105 • Adverse events data were collected from Day 0 after Dose 1 through up to 6 months after the last dose. A participant randomized to Batch B got the Batch A vaccine, safety analyses was according to the actual vaccine administered. Total number reported for each solicited event reflects those with available data for the indicated event.
Metabolism and nutrition disorders Anorexia	22.2% 75/338 • Number of events 75 • Adverse events data were collected from Day 0 after Dose 1 through up to 6 months after the last dose. A participant randomized to Batch B got the Batch A vaccine, safety analyses was according to the actual vaccine administered. Total number reported for each solicited event reflects those with available data for the indicated event.	28.4% 97/341 • Number of events 97 • Adverse events data were collected from Day 0 after Dose 1 through up to 6 months after the last dose. A participant randomized to Batch B got the Batch A vaccine, safety analyses was according to the actual vaccine administered. Total number reported for each solicited event reflects those with available data for the indicated event.	28.2% 96/341 • Number of events 96 • Adverse events data were collected from Day 0 after Dose 1 through up to 6 months after the last dose. A participant randomized to Batch B got the Batch A vaccine, safety analyses was according to the actual vaccine administered. Total number reported for each solicited event reflects those with available data for the indicated event.	21.8% 75/344 • Number of events 75 • Adverse events data were collected from Day 0 after Dose 1 through up to 6 months after the last dose. A participant randomized to Batch B got the Batch A vaccine, safety analyses was according to the actual vaccine administered. Total number reported for each solicited event reflects those with available data for the indicated event.
Nervous system disorders Somnolence	47.0% 159/338 • Number of events 159 • Adverse events data were collected from Day 0 after Dose 1 through up to 6 months after the last dose. A participant randomized to Batch B got the Batch A vaccine, safety analyses was according to the actual vaccine administered. Total number reported for each solicited event reflects those with available data for the indicated event.	42.8% 146/341 • Number of events 146 • Adverse events data were collected from Day 0 after Dose 1 through up to 6 months after the last dose. A participant randomized to Batch B got the Batch A vaccine, safety analyses was according to the actual vaccine administered. Total number reported for each solicited event reflects those with available data for the indicated event.	46.9% 160/341 • Number of events 160 • Adverse events data were collected from Day 0 after Dose 1 through up to 6 months after the last dose. A participant randomized to Batch B got the Batch A vaccine, safety analyses was according to the actual vaccine administered. Total number reported for each solicited event reflects those with available data for the indicated event.	42.7% 147/344 • Number of events 147 • Adverse events data were collected from Day 0 after Dose 1 through up to 6 months after the last dose. A participant randomized to Batch B got the Batch A vaccine, safety analyses was according to the actual vaccine administered. Total number reported for each solicited event reflects those with available data for the indicated event.
Psychiatric disorders Crying	58.6% 198/338 • Number of events 198 • Adverse events data were collected from Day 0 after Dose 1 through up to 6 months after the last dose. A participant randomized to Batch B got the Batch A vaccine, safety analyses was according to the actual vaccine administered. Total number reported for each solicited event reflects those with available data for the indicated event.	54.5% 186/341 • Number of events 186 • Adverse events data were collected from Day 0 after Dose 1 through up to 6 months after the last dose. A participant randomized to Batch B got the Batch A vaccine, safety analyses was according to the actual vaccine administered. Total number reported for each solicited event reflects those with available data for the indicated event.	55.6% 189/340 • Number of events 189 • Adverse events data were collected from Day 0 after Dose 1 through up to 6 months after the last dose. A participant randomized to Batch B got the Batch A vaccine, safety analyses was according to the actual vaccine administered. Total number reported for each solicited event reflects those with available data for the indicated event.	46.8% 161/344 • Number of events 161 • Adverse events data were collected from Day 0 after Dose 1 through up to 6 months after the last dose. A participant randomized to Batch B got the Batch A vaccine, safety analyses was according to the actual vaccine administered. Total number reported for each solicited event reflects those with available data for the indicated event.
Respiratory, thoracic and mediastinal disorders Cough	6.1% 21/345 • Number of events 24 • Adverse events data were collected from Day 0 after Dose 1 through up to 6 months after the last dose. A participant randomized to Batch B got the Batch A vaccine, safety analyses was according to the actual vaccine administered. Total number reported for each solicited event reflects those with available data for the indicated event.	5.0% 17/343 • Number of events 17 • Adverse events data were collected from Day 0 after Dose 1 through up to 6 months after the last dose. A participant randomized to Batch B got the Batch A vaccine, safety analyses was according to the actual vaccine administered. Total number reported for each solicited event reflects those with available data for the indicated event.	6.7% 23/342 • Number of events 25 • Adverse events data were collected from Day 0 after Dose 1 through up to 6 months after the last dose. A participant randomized to Batch B got the Batch A vaccine, safety analyses was according to the actual vaccine administered. Total number reported for each solicited event reflects those with available data for the indicated event.	4.9% 17/345 • Number of events 18 • Adverse events data were collected from Day 0 after Dose 1 through up to 6 months after the last dose. A participant randomized to Batch B got the Batch A vaccine, safety analyses was according to the actual vaccine administered. Total number reported for each solicited event reflects those with available data for the indicated event.

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.
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