Trial Outcomes & Findings for Comparison of DTaP-IPV-Hep B-PRP~T Combined Vaccine to CombAct-HIB® Concomitantly Given With Engerix B® Paediatric and OPV (NCT NCT00362336)

Last Updated: 2014-05-02

Results Overview

Antibodies were measured by the following methods: anti-Hepatitis B (Hep B) by enhanced chemiluminescence detection, anti-Haemophilus influenzae type b (Hib) by Farr type radio immunoassay, anti-Diphtheria (D) by toxin neutralization assay, anti-Tetanus (T) by indirect enzyme-linked immunosorbent assay (ELISA), and anti-Poliovirus types 1, 2, and 3 by neutralization assay. Seroprotection was defined as the following antibody titers: Anti-Tetanus ≥ 0.01 International Unit (IU)/mL; Anti-Diphtheria ≥ 0.01 IU/mL; Anti-Hepatitis B ≥ 10 mIU/mL; Anti-Polyribosyl ribitol phosphate ≥ 0.15 µg/mL; Anti-polio 1, 2, and 3 ≥ 8 (1/dil).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

622 participants

Primary outcome timeframe

1 month post-Dose 3

Results posted on

2014-05-02

Participant Flow

Participants were enrolled from 28 August 2006 to 11 February 2007 in 2 clinical centers in South Africa.

A total of 622 of the 715 recruited participants who met the inclusion and exclusion criteria were enrolled and vaccinated.

Participant milestones

Participant milestones
Measure	DTaP-IPV-Hep B-PRP~T Group Participants received a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular(aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.	CombAct-Hib™ + Engerix B™ + OPV Group Participants received a primary series of 3 doses of commercial CombAct-Hib™ vaccine, Engerix B™ vaccine, and oral poliovirus vaccine, with 1 dose of each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.	DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group Participants received Engerix B™ vaccine at birth, followed by a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular (aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
Overall Study STARTED	243	242	137
Overall Study COMPLETED	233	235	134
Overall Study NOT COMPLETED	10	7	3

Reasons for withdrawal

Reasons for withdrawal
Measure	DTaP-IPV-Hep B-PRP~T Group Participants received a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular(aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.	CombAct-Hib™ + Engerix B™ + OPV Group Participants received a primary series of 3 doses of commercial CombAct-Hib™ vaccine, Engerix B™ vaccine, and oral poliovirus vaccine, with 1 dose of each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.	DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group Participants received Engerix B™ vaccine at birth, followed by a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular (aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
Overall Study Serious Adverse Event	1	0	1
Overall Study Protocol Violation	0	0	1
Overall Study Lost to Follow-up	6	4	0
Overall Study Withdrawal by Subject	3	3	1

Baseline Characteristics

Comparison of DTaP-IPV-Hep B-PRP~T Combined Vaccine to CombAct-HIB® Concomitantly Given With Engerix B® Paediatric and OPV

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DTaP-IPV-Hep B-PRP~T Group n=243 Participants Participants received a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular(aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.	CombAct-Hib™ + Engerix B™ + OPV Group n=242 Participants Participants received a primary series of 3 doses of commercial CombAct-Hib™ vaccine, Engerix B™ vaccine, and oral poliovirus vaccine, with 1 dose of each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.	DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group n=137 Participants Participants received Engerix B™ vaccine at birth, followed by a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular (aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.	Total n=622 Participants Total of all reporting groups
Age, Categorical <=18 years	243 Participants n=5 Participants	242 Participants n=7 Participants	137 Participants n=5 Participants	622 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	1.04 Days STANDARD_DEVIATION 0.729 • n=5 Participants	1.07 Days STANDARD_DEVIATION 0.762 • n=7 Participants	1.11 Days STANDARD_DEVIATION 0.773 • n=5 Participants	1.07 Days STANDARD_DEVIATION 0.751 • n=4 Participants
Sex: Female, Male Female	131 Participants n=5 Participants	118 Participants n=7 Participants	68 Participants n=5 Participants	317 Participants n=4 Participants
Sex: Female, Male Male	112 Participants n=5 Participants	124 Participants n=7 Participants	69 Participants n=5 Participants	305 Participants n=4 Participants
Region of Enrollment South Africa	243 Participants n=5 Participants	242 Participants n=7 Participants	137 Participants n=5 Participants	622 Participants n=4 Participants

PRIMARY outcome

Timeframe: 1 month post-Dose 3

Population: Seroprotection was assessed in all participants who did not have any protocol violation that might have interfered with primary criteria evaluation (Per-Protocol Population).

Outcome measures

Outcome measures
Measure	DTaP-IPV-Hep B-PRP~T Group n=220 Participants Participants received a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular(aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.	CombAct-Hib™ + Engerix B™ + OPV Group n=212 Participants Participants received a primary series of 3 doses of commercial CombAct-Hib™ vaccine, Engerix B™ vaccine, and oral poliovirus vaccine, with 1 dose of each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.	DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group n=123 Participants Participants received Engerix B™ vaccine at birth, followed by a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular (aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
Number of Participants With Seroprotection After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) Anti-Tetanus (N = 213, 210, 122)	213 Participants	210 Participants Interval 0.0 to 0.0	122 Participants Interval 0.0 to 0.0
Number of Participants With Seroprotection After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) Anti-Polio Type 1 (N = 186, 187, 104)	186 Participants	174 Participants Interval 0.0 to 0.0	103 Participants Interval 0.0 to 0.0
Number of Participants With Seroprotection After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) Anti-Hep B (N = 184, 194, 98)	176 Participants	185 Participants Interval 0.0 to 0.0	97 Participants Interval 0.0 to 0.0
Number of Participants With Seroprotection After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) Anti-PRP (N = 219, 212, 122)	209 Participants	212 Participants Interval 0.0 to 0.0	119 Participants Interval 0.0 to 0.0
Number of Participants With Seroprotection After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) Anti-Polio Type 2 (N = 196, 192, 113)	193 Participants	192 Participants Interval 0.0 to 0.0	111 Participants Interval 0.0 to 0.0
Number of Participants With Seroprotection After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) Anti-Polio Type 3 (N = 182, 179, 98)	182 Participants	176 Participants Interval 0.0 to 0.0	98 Participants Interval 0.0 to 0.0
Number of Participants With Seroprotection After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) Anti-Diphtheria (N = 206, 206, 122)	201 Participants	198 Participants Interval 0.0 to 0.0	116 Participants Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: 1 month post-Dose 3

Population: Seroprotection was assessed in all participants who did not have any protocol violation that might have interfered with primary criteria evaluation (Per-Protocol Population).

Anti-Hepatitis B (Hep B) was measured by enhanced chemiluminescence detection, anti-Haemophilus influenzae type b (Hib) by Farr type radio immunoassay, anti diphtheria by toxin neutralization assay, anti-Tetanus (T) by indirect enzyme-linked immunosorbent assay (ELISA), and anti-Pertussis toxoid (PT) and anti-Filamentous hemagglutinin (FHA) by ELISA. Seroprotection was defined as a titer ≥ 100 mIU/mL for anti-Hep B; ≥ 1 µg/mL for anti-PRP; ≥ 0.1 IU/mL (Level 1) and ≥ 1.0 IU/mL (Level 2) for anti-Diphtheria and anti-Tetanus. Seroconversion for anti-PT and anti-FHA was a ≥ 4-fold increase from baseline.

Outcome measures

Outcome measures
Measure	DTaP-IPV-Hep B-PRP~T Group n=220 Participants Participants received a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular(aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.	CombAct-Hib™ + Engerix B™ + OPV Group n=212 Participants Participants received a primary series of 3 doses of commercial CombAct-Hib™ vaccine, Engerix B™ vaccine, and oral poliovirus vaccine, with 1 dose of each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.	DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group n=123 Participants Participants received Engerix B™ vaccine at birth, followed by a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular (aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
Number of Participants Attaining Other Seroprotection and Seroconversion Titers After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) Anti-Hep B (N = 184, 194, 98)	145 Participants	127 Participants Interval 0.0 to 0.0	95 Participants Interval 0.0 to 0.0
Number of Participants Attaining Other Seroprotection and Seroconversion Titers After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) Anti-PRP (N = 219, 212, 122)	174 Participants	196 Participants Interval 0.0 to 0.0	97 Participants Interval 0.0 to 0.0
Number of Participants Attaining Other Seroprotection and Seroconversion Titers After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) Anti-Diphtheria Level 1 ( N = 206, 206, 122)	82 Participants	28 Participants Interval 0.0 to 0.0	48 Participants Interval 0.0 to 0.0
Number of Participants Attaining Other Seroprotection and Seroconversion Titers After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) Anti-Diphtheria Level 2 (N = 206, 206, 122)	3 Participants	0 Participants Interval 0.0 to 0.0	4 Participants Interval 0.0 to 0.0
Number of Participants Attaining Other Seroprotection and Seroconversion Titers After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) Anti-Tetanus Level 1 (N = 213, 210, 122)	213 Participants	210 Participants Interval 0.0 to 0.0	122 Participants Interval 0.0 to 0.0
Number of Participants Attaining Other Seroprotection and Seroconversion Titers After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) Anti-Tetanus Level 2 (N = 213, 210, 122)	158 Participants	173 Participants Interval 0.0 to 0.0	83 Participants Interval 0.0 to 0.0
Number of Participants Attaining Other Seroprotection and Seroconversion Titers After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) Anti-Pertussis Toxoid (N = 172, 137, 103)	161 Participants	114 Participants Interval 0.0 to 0.0	98 Participants Interval 0.0 to 0.0
Number of Participants Attaining Other Seroprotection and Seroconversion Titers After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) Anti-FHA (N = 160, 130, 90)	149 Participants	75 Participants Interval 0.0 to 0.0	81 Participants Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: Day 42 before Dose 1 and 1 month post-Dose 3

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

Anti-Hepatitis B (Hep B) was measured by enhanced chemiluminescence detection, anti-Haemophilus influenzae type b (Hib) by Farr type radio-immunoassay, anti-Diphtheria by toxin neutralization assay, anti-Tetanus by indirect enzyme-linked immunosorbent assay (ELISA), anti-Poliovirus types 1, 2, and 3 by neutralization assay, and anti-Pertussis toxoid (PT) and anti-Filamentous hemagglutinin (FHA) by ELISA.

Outcome measures

Outcome measures
Measure	DTaP-IPV-Hep B-PRP~T Group n=220 Participants Participants received a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular(aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.	CombAct-Hib™ + Engerix B™ + OPV Group n=212 Participants Participants received a primary series of 3 doses of commercial CombAct-Hib™ vaccine, Engerix B™ vaccine, and oral poliovirus vaccine, with 1 dose of each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.	DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group n=123 Participants Participants received Engerix B™ vaccine at birth, followed by a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular (aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
Geometric Mean Titers (GMTs) of Antibodies After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) Anti-FHA Pre-dose 1 (N = 192, 175, 107)	9.27 Titers Interval 8.02 to 10.7	8.02 Titers Interval 6.82 to 9.42	8.30 Titers Interval 6.8 to 10.1
Geometric Mean Titers (GMTs) of Antibodies After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) Anti-Hep B Post-dose 3 (N = 184, 194, 98)	330 Titers Interval 259.0 to 420.0	148 Titers Interval 120.0 to 181.0	1913 Titers Interval 1457.0 to 2513.0
Geometric Mean Titers (GMTs) of Antibodies After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) Anti-PRP Post-dose 3 (N = 219, 212, 122)	3.31 Titers Interval 2.69 to 4.08	5.18 Titers Interval 4.47 to 6.0	3.83 Titers Interval 2.92 to 5.02
Geometric Mean Titers (GMTs) of Antibodies After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) Anti-Diphtheria Post-dose 3 (N = 206, 206, 122)	0.074 Titers Interval 0.062 to 0.088	0.040 Titers Interval 0.035 to 0.046	0.074 Titers Interval 0.059 to 0.094
Geometric Mean Titers (GMTs) of Antibodies After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) Anti-Tetanus Post-dose 3 (N = 213, 210, 122)	1.51 Titers Interval 1.37 to 1.65	1.88 Titers Interval 1.7 to 2.07	1.33 Titers Interval 1.17 to 1.51
Geometric Mean Titers (GMTs) of Antibodies After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) Anti-Polio Type 1 Post-dose 3 (N = 186, 187, 104)	579 Titers Interval 478.0 to 702.0	198 Titers Interval 153.0 to 256.0	557 Titers Interval 410.0 to 756.0
Geometric Mean Titers (GMTs) of Antibodies After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) Anti-Polio Type 2 Post-dose 3 (N = 196, 192, 113)	620 Titers Interval 512.0 to 750.0	446 Titers Interval 374.0 to 533.0	371 Titers Interval 281.0 to 489.0
Geometric Mean Titers (GMTs) of Antibodies After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) Anti-Polio Type 3 Post-dose 3 (N = 182, 179, 98)	975 Titers Interval 812.0 to 1170.0	228 Titers Interval 185.0 to 280.0	811 Titers Interval 645.0 to 1020.0
Geometric Mean Titers (GMTs) of Antibodies After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) Anti-PT Pre-Dose 1 (N = 192, 174, 118)	7.77 Titers Interval 6.56 to 9.21	7.66 Titers Interval 6.23 to 9.42	6.62 Titers Interval 5.29 to 8.3
Geometric Mean Titers (GMTs) of Antibodies After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) Anti-PT Post-dose 3 (N = 192, 156, 108)	332 Titers Interval 304.0 to 362.0	191 Titers Interval 147.0 to 249.0	288 Titers Interval 256.0 to 323.0
Geometric Mean Titers (GMTs) of Antibodies After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) Anti-FHA Post-dose 3 (N = 178, 153, 99)	207 Titers Interval 190.0 to 226.0	37.4 Titers Interval 33.4 to 41.9	188 Titers Interval 166.0 to 212.0

SECONDARY outcome

Timeframe: Day 540 pre-booster and Day 570 post-booster

Population: Seroprotection was assessed in all participants who did not have any protocol violation that might have interfered with primary criteria evaluation (Per-Protocol Population).

Antibodies were measured by the following methods: anti-Hepatitis B (Hep B) by enhanced chemiluminescence detection, anti-Haemophilus influenzae type b (PRP) by Farr type radio immunoassay, anti-Diphtheria by toxin neutralization assay, anti-Tetanus by indirect enzyme-linked immunosorbent assay (ELISA), anti-poliovirus types 1, 2, and 3 by neutralization assay. Persistence and response were defined as a titer ≥ 10 mIU/mL for anti-Hep B, ≥ 0.15 µg/mL for anti-PRP, ≥ 0.01 IU/mL for anti-Diphtheria and anti-Tetanus, ≥ 8 (1/dil) for anti-Poliovirus, and ≥ 4 EU/mL for anti-PT and anti-FHA.

Outcome measures

Outcome measures
Measure	DTaP-IPV-Hep B-PRP~T Group n=204 Participants Participants received a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular(aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.	CombAct-Hib™ + Engerix B™ + OPV Group n=202 Participants Participants received a primary series of 3 doses of commercial CombAct-Hib™ vaccine, Engerix B™ vaccine, and oral poliovirus vaccine, with 1 dose of each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.	DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group n=116 Participants Participants received Engerix B™ vaccine at birth, followed by a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular (aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
Number of Participants With Antibody Persistence Pre-Booster and Response Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV Anti-Hep B Pre (N = 199, 199, 113)	157 Participants	183 Participants Interval 0.0 to 0.0	107 Participants Interval 0.0 to 0.0
Number of Participants With Antibody Persistence Pre-Booster and Response Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV Anti-Hep B Post (N = 197, 0, 113)	194 Participants	0 Participants Interval 0.0 to 0.0	113 Participants Interval 0.0 to 0.0
Number of Participants With Antibody Persistence Pre-Booster and Response Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV Anti-PRP Pre (N =2 04, 200, 116)	166 Participants	185 Participants Interval 0.0 to 0.0	88 Participants Interval 0.0 to 0.0
Number of Participants With Antibody Persistence Pre-Booster and Response Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV Anti-PRP Post (N = 203, 201, 115)	203 Participants	201 Participants Interval 0.0 to 0.0	115 Participants Interval 0.0 to 0.0
Number of Participants With Antibody Persistence Pre-Booster and Response Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV Anti-Diphtheria Pre (N = 197, 201, 116)	184 Participants	173 Participants Interval 0.0 to 0.0	98 Participants Interval 0.0 to 0.0
Number of Participants With Antibody Persistence Pre-Booster and Response Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV Anti-Diphtheria Post (N = 195, 200, 111)	195 Participants	200 Participants Interval 0.0 to 0.0	111 Participants Interval 0.0 to 0.0
Number of Participants With Antibody Persistence Pre-Booster and Response Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV Anti-Tetanus Pre (N = 189, 195, 116)	189 Participants	195 Participants Interval 0.0 to 0.0	116 Participants Interval 0.0 to 0.0
Number of Participants With Antibody Persistence Pre-Booster and Response Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV Anti-Tetanus Post (N = 200, 199, 114)	200 Participants	199 Participants Interval 0.0 to 0.0	114 Participants Interval 0.0 to 0.0
Number of Participants With Antibody Persistence Pre-Booster and Response Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV Anti-Polio Type 1 Pre (N = 190, 189, 112)	185 Participants	178 Participants Interval 0.0 to 0.0	108 Participants Interval 0.0 to 0.0
Number of Participants With Antibody Persistence Pre-Booster and Response Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV Anti-Polio Type 1 Post (N = 189, 191, 108)	189 Participants	186 Participants Interval 0.0 to 0.0	108 Participants Interval 0.0 to 0.0
Number of Participants With Antibody Persistence Pre-Booster and Response Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV Anti-Polio Type 2 Pre (N = 190, 191, 111)	187 Participants	190 Participants Interval 0.0 to 0.0	109 Participants Interval 0.0 to 0.0
Number of Participants With Antibody Persistence Pre-Booster and Response Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV Anti-Polio Type 2 Post (N = 191, 190, 107)	191 Participants	190 Participants Interval 0.0 to 0.0	107 Participants Interval 0.0 to 0.0
Number of Participants With Antibody Persistence Pre-Booster and Response Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV Anti-Polio Type 3 Pre (N = 189, 189, 111)	186 Participants	185 Participants Interval 0.0 to 0.0	110 Participants Interval 0.0 to 0.0
Number of Participants With Antibody Persistence Pre-Booster and Response Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV Anti-Polio Type 3 Post (N = 188, 187, 108)	188 Participants	185 Participants Interval 0.0 to 0.0	108 Participants Interval 0.0 to 0.0
Number of Participants With Antibody Persistence Pre-Booster and Response Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV Anti-PT Pre (N = 164, 141, 104)	151 Participants	100 Participants Interval 0.0 to 0.0	95 Participants Interval 0.0 to 0.0
Number of Participants With Antibody Persistence Pre-Booster and Response Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV Anti-PT Post (N= 187, 184, 109)	187 Participants	173 Participants Interval 0.0 to 0.0	109 Participants Interval 0.0 to 0.0
Number of Participants With Antibody Persistence Pre-Booster and Response Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV Anti-PT Post/Pre Ratio (N = 153, 133, 99)	145 Participants	111 Participants Interval 0.0 to 0.0	93 Participants Interval 0.0 to 0.0
Number of Participants With Antibody Persistence Pre-Booster and Response Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV Anti-FHA Pre (N = 173, 148, 103)	170 Participants	99 Participants Interval 0.0 to 0.0	102 Participants Interval 0.0 to 0.0
Number of Participants With Antibody Persistence Pre-Booster and Response Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV Anti-FHA Post (N = 184, 190, 105)	184 Participants	190 Participants Interval 0.0 to 0.0	105 Participants Interval 0.0 to 0.0
Number of Participants With Antibody Persistence Pre-Booster and Response Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV Anti-FHA Post/Pre Ratio (N = 159, 143, 94)	145 Participants	138 Participants Interval 0.0 to 0.0	89 Participants Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: Day 540 pre-booster and Day 570, post-booster

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

Anti-Hepatitis B (Hep B) was measured by enhanced chemiluminescence detection, anti-Haemophilus influenzae type b (PRP) by Farr type radio immunoassay, anti-Diphtheria by toxin neutralization assay, anti-Tetanus (T) by indirect enzyme-linked immunosorbent assay (ELISA), anti-Poliovirus types 1, 2, and 3 by neutralization assay, and anti-Pertussis toxoid (PT) and anti-Filamentous hemagglutinin (FHA) by ELISA.

Outcome measures

Outcome measures
Measure	DTaP-IPV-Hep B-PRP~T Group n=204 Participants Participants received a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular(aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.	CombAct-Hib™ + Engerix B™ + OPV Group n=202 Participants Participants received a primary series of 3 doses of commercial CombAct-Hib™ vaccine, Engerix B™ vaccine, and oral poliovirus vaccine, with 1 dose of each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.	DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group n=116 Participants Participants received Engerix B™ vaccine at birth, followed by a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular (aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV Anti-Polio Type 3 Post/Pre Ratio (N=176, 180, 106)	40.5 Titers Interval 31.0 to 53.0	2.92 Titers Interval 2.26 to 3.77	41.2 Titers Interval 29.3 to 57.9
Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV Anti-Hep B Pre (N = 199, 199, 113)	51.3 Titers Interval 40.0 to 65.8	103 Titers Interval 83.3 to 127.0	228 Titers Interval 172.0 to 303.0
Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV Anti-Hep B Post (N = 197, 0, 113)	4630 Titers Interval 3402.0 to 6302.0	0 Titers Interval 0.0 to 0.0	44893 Titers Interval 33652.0 to 59890.0
Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV Anti-Hep B Post/Pre Ratio (N = 192, 0, 112)	88.7 Titers Interval 74.0 to 106.0	0 Titers Interval 0.0 to 0.0	191 Titers Interval 157.0 to 231.0
Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV Anti-PRP Pre (N = 204, 200, 116)	0.757 Titers Interval 0.585 to 0.98	1.19 Titers Interval 0.948 to 1.48	0.631 Titers Interval 0.448 to 0.889
Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV Anti-PRP Post (N = 203, 201, 116)	68.5 Titers Interval 55.7 to 84.2	52.2 Titers Interval 43.9 to 62.2	63.1 Titers Interval 47.6 to 83.8
Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV Anti-PRP Post/Pre Ratio (N = 203, 199, 115)	89.0 Titers Interval 71.4 to 111.0	43.6 Titers Interval 34.5 to 55.0	97.4 Titers Interval 71.7 to 132.0
Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV Anti-Diphtheria Pre (N = 197, 201, 116)	0.060 Titers Interval 0.05 to 0.073	0.027 Titers Interval 0.023 to 0.032	0.045 Titers Interval 0.033 to 0.059
Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV Anti-Diphtheria Post (N = 195, 200, 111)	9.37 Titers Interval 8.05 to 10.9	3.33 Titers Interval 2.92 to 3.8	7.00 Titers Interval 5.61 to 8.72
Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV Anti-Diphtheria Post/Pre Ratio (N = 189, 199, 111)	158 Titers Interval 137.0 to 182.0	123 Titers Interval 108.0 to 140.0	153 Titers Interval 125.0 to 189.0
Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV Anti-Tetanus Pre (N = 189, 195, 116)	0.219 Titers Interval 0.189 to 0.254	0.311 Titers Interval 0.276 to 0.352	0.173 Titers Interval 0.143 to 0.208
Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV Anti-Tetanus Post (N = 200, 199, 114)	10.0 Titers Interval 8.65 to 11.7	8.23 Titers Interval 7.49 to 9.04	8.13 Titers Interval 6.68 to 9.89
Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV Anti-Tetanus Post/Pre Ratio (N = 185, 192, 114)	45.5 Titers Interval 40.0 to 51.8	26.5 Titers Interval 23.5 to 29.9	47.4 Titers Interval 39.8 to 56.3
Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV Anti-Polio Type 1 Pre (N = 190, 189, 112)	127 Titers Interval 104.0 to 155.0	151 Titers Interval 118.0 to 192.0	142 Titers Interval 107.0 to 190.0
Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV Anti-Polio Type 1 Post (N = 189, 191, 108)	7298 Titers Interval 6202.0 to 8588.0	329 Titers Interval 260.0 to 417.0	5346 Titers Interval 4309.0 to 6633.0
Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV Anti-Polio Type 1 Post/Pre Ratio (N=178, 181, 105)	59.0 Titers Interval 47.0 to 74.0	2.27 Titers Interval 1.8 to 2.85	38.4 Titers Interval 27.4 to 53.7
Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV Anti-Polio Type 2 Pre (N = 190, 191, 111)	210 Titers Interval 170.0 to 260.0	246 Titers Interval 204.0 to 296.0	191 Titers Interval 144.0 to 255.0
Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV Anti-Polio Type 2 Post (N = 191, 190, 107)	6637 Titers Interval 5745.0 to 7668.0	863 Titers Interval 665.0 to 1118.0	4190 Titers Interval 3460.0 to 5074.0
Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV Anti-Polio Type 2 Post/Pre Ratio (N=179, 182, 103)	32.4 Titers Interval 24.9 to 42.3	3.82 Titers Interval 2.9 to 5.04	23.2 Titers Interval 16.2 to 33.3
Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV Anti-Polio Type 3 Pre (N = 189, 189, 111)	161 Titers Interval 130.0 to 199.0	114 Titers Interval 96.4 to 135.0	127 Titers Interval 97.9 to 165.0
Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV Anti-Polio Type 3 Post (N = 188, 187, 108)	6411 Titers Interval 5525.0 to 7493.0	315 Titers Interval 245.0 to 404.0	5144 Titers Interval 4156.0 to 6367.0
Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV Anti PT Pre (N=164, 141, 104)	11.6 Titers Interval 9.88 to 13.6	10.4 Titers Interval 8.03 to 13.6	12.0 Titers Interval 9.62 to 14.9
Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV Anti PT Post (N=187, 184, 109)	288 Titers Interval 260.0 to 318.0	110 Titers Interval 88.7 to 137.0	235 Titers Interval 206.0 to 268.0
Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV Anti-PT Post/Pre Ratio (N=153, 133, 99)	26.1 Titers Interval 21.8 to 31.1	10.6 Titers Interval 8.56 to 13.1	20.5 Titers Interval 16.5 to 25.4
Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV Anti-FHA Pre (N = 173, 148, 103)	30.5 Titers Interval 25.4 to 36.7	5.43 Titers Interval 4.52 to 6.53	25.1 Titers Interval 19.7 to 31.9
Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV Anti-FHA Post (N = 184, 190, 105)	570 Titers Interval 514.0 to 630.0	211 Titers Interval 193.0 to 231.0	472 Titers Interval 419.0 to 533.0
Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV Anti-FHA Post/Pre Ratio (N = 159, 143, 94)	18.9 Titers Interval 15.8 to 22.6	40.8 Titers Interval 34.5 to 48.1	20.3 Titers Interval 16.5 to 24.9

SECONDARY outcome

Timeframe: Day 0 up to Day 7 post each dose

Population: Solicited reactions were assessed in all participants who received at least 1 dose of investigational or reference vaccine, according to the vaccine actually received - Safety Analysis Population.

Solicited Injection Site Reactions: Pain, Erythema, Swelling. Solicited System Reactions: Fever (Temperature), Vomiting, Crying, Somnolence, Anorexia, Irritability. Grade 3 was defined as: Pain - crying when injected limb is moved or the movement reduced; Erythema and Swelling - ≥ 5 cm; Fever - temperature ≥ 39.0ºC; Vomiting - ≥ 6 episodes/24 hours or requiring parenteral hydration; Crying abnormal - \> 3 hours; Somnolence - sleeping most of the time or difficulty to wake up; Anorexia - refusing ≥ 3 feeds or refusing most feeds/meals; and Irritability - inconsolable.

Outcome measures

Outcome measures
Measure	DTaP-IPV-Hep B-PRP~T Group n=243 Participants Participants received a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular(aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.	CombAct-Hib™ + Engerix B™ + OPV Group n=242 Participants Participants received a primary series of 3 doses of commercial CombAct-Hib™ vaccine, Engerix B™ vaccine, and oral poliovirus vaccine, with 1 dose of each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.	DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group n=137 Participants Participants received Engerix B™ vaccine at birth, followed by a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular (aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). Grd 3 Irritability Post-Any Dose (N=236, 238, 135)	18 Participants	16 Participants Interval 0.0 to 0.0	5 Participants Interval 0.0 to 0.0
Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). Pain Post-dose 1 (N = 234, 237, 134)	166 Participants	177 Participants Interval 0.0 to 0.0	95 Participants Interval 0.0 to 0.0
Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). Pain Post-dose 2 (N = 234, 233, 134)	171 Participants	171 Participants Interval 0.0 to 0.0	97 Participants Interval 0.0 to 0.0
Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). Pain Post-dose 3 ( N = 232, 234, 134)	143 Participants	162 Participants Interval 0.0 to 0.0	83 Participants Interval 0.0 to 0.0
Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). Grade 3 Pain Post-Any Dose (N = 237, 238, 136)	17 Participants	24 Participants Interval 0.0 to 0.0	7 Participants Interval 0.0 to 0.0
Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). Erythema Post-dose 1 (N = 233, 237, 132)	112 Participants	133 Participants Interval 0.0 to 0.0	69 Participants Interval 0.0 to 0.0
Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). Erythema Post-dose 2 (N = 232, 231, 133)	116 Participants	114 Participants Interval 0.0 to 0.0	59 Participants Interval 0.0 to 0.0
Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). Erythema Post-dose 3 (N = 231, 234, 132)	103 Participants	106 Participants Interval 0.0 to 0.0	56 Participants Interval 0.0 to 0.0
Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). Grade 3 Erythema Post-Any Dose (N = 236, 238, 135)	9 Participants	15 Participants Interval 0.0 to 0.0	2 Participants Interval 0.0 to 0.0
Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). Swelling Post-dose 1 (N = 231, 238, 134)	87 Participants	102 Participants Interval 0.0 to 0.0	48 Participants Interval 0.0 to 0.0
Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). Swelling Post-dose 2 (N = 233, 230, 133)	88 Participants	109 Participants Interval 0.0 to 0.0	43 Participants Interval 0.0 to 0.0
Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). Swelling Post-dose 3 (N = 232, 232, 133)	74 Participants	89 Participants Interval 0.0 to 0.0	39 Participants Interval 0.0 to 0.0
Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). Grade 3 Swelling Post-Any Dose (N = 236, 238, 136)	9 Participants	10 Participants Interval 0.0 to 0.0	4 Participants Interval 0.0 to 0.0
Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). Pyrexia Post-dose 1 (N = 234, 238, 132)	50 Participants	38 Participants Interval 0.0 to 0.0	27 Participants Interval 0.0 to 0.0
Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). Pyrexia Post-dose 2 (N = 234, 232, 134)	43 Participants	35 Participants Interval 0.0 to 0.0	18 Participants Interval 0.0 to 0.0
Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). Pyrexia Post-dose 3 (N = 230, 232, 134)	48 Participants	34 Participants Interval 0.0 to 0.0	21 Participants Interval 0.0 to 0.0
Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). Grade 3 Pyrexia Post-Any Dose (N = 236, 238, 136)	4 Participants	1 Participants Interval 0.0 to 0.0	0 Participants Interval 0.0 to 0.0
Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). Vomiting Post-dose 1 (N = 233, 238, 133)	59 Participants	59 Participants Interval 0.0 to 0.0	30 Participants Interval 0.0 to 0.0
Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). Vomiting Post-dose 2 (N = 234, 233, 134)	52 Participants	56 Participants Interval 0.0 to 0.0	35 Participants Interval 0.0 to 0.0
Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). Vomiting Post-dose 3 (N = 231, 233, 134)	56 Participants	49 Participants Interval 0.0 to 0.0	31 Participants Interval 0.0 to 0.0
Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). Grade 3 Vomiting Post-Any Dose (N = 236, 238, 135)	14 Participants	7 Participants Interval 0.0 to 0.0	6 Participants Interval 0.0 to 0.0
Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). Crying Post-dose 1 (N = 234, 238, 133)	138 Participants	154 Participants Interval 0.0 to 0.0	91 Participants Interval 0.0 to 0.0
Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). Crying Post-dose 2 (N = 234, 233, 134)	131 Participants	135 Participants Interval 0.0 to 0.0	74 Participants Interval 0.0 to 0.0
Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). Crying Post-dose 3 (N = 231, 233, 134)	106 Participants	116 Participants Interval 0.0 to 0.0	66 Participants Interval 0.0 to 0.0
Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). Grade 3 Crying Post-Any Dose (N = 236, 238, 135)	15 Participants	20 Participants Interval 0.0 to 0.0	9 Participants Interval 0.0 to 0.0
Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). Somnolence Post-dose 1 (N = 232, 238, 133)	100 Participants	103 Participants Interval 0.0 to 0.0	57 Participants Interval 0.0 to 0.0
Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). Somnolence Post-dose 2 (N = 234, 232, 134)	79 Participants	90 Participants Interval 0.0 to 0.0	47 Participants Interval 0.0 to 0.0
Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). Somnolence Post-dose 3 (N = 231, 232, 134)	72 Participants	69 Participants Interval 0.0 to 0.0	43 Participants Interval 0.0 to 0.0
Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). Grade 3 Somnolence Post-Any Dose (N=236, 238, 135)	9 Participants	9 Participants Interval 0.0 to 0.0	8 Participants Interval 0.0 to 0.0
Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). Anorexia Post-dose 1 (N = 233, 238, 134)	62 Participants	87 Participants Interval 0.0 to 0.0	42 Participants Interval 0.0 to 0.0
Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). Anorexia Post-dose 2 (N = 234, 232, 134)	66 Participants	68 Participants Interval 0.0 to 0.0	39 Participants Interval 0.0 to 0.0
Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). Anorexia Post-dose 3 (N = 231, 232, 134)	64 Participants	76 Participants Interval 0.0 to 0.0	39 Participants Interval 0.0 to 0.0
Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). Grade 3 Anorexia Post-Any Dose (N=236, 238, 136)	9 Participants	13 Participants Interval 0.0 to 0.0	5 Participants Interval 0.0 to 0.0
Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). Irritability Post-dose 1 (N=234, 238, 132)	128 Participants	137 Participants Interval 0.0 to 0.0	77 Participants Interval 0.0 to 0.0
Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). Irritability Post-dose 2 (N = 234, 232, 134)	114 Participants	118 Participants Interval 0.0 to 0.0	66 Participants Interval 0.0 to 0.0
Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). Irritability Post-dose 3 (N = 231, 232, 134)	94 Participants	99 Participants Interval 0.0 to 0.0	53 Participants Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: Day 0 up to 7 post-booster vaccination

Solicited Injection Site Reactions: Pain, Erythema, Swelling, and Extensive swelling of vaccinated limb. Solicited System Reactions: Fever (Temperature), Vomiting, Crying, Somnolence, Anorexia, and Irritability. Grade 3 was defined as: Pain, crying when injected limb is moved or the movement reduced; Erythema and Swelling, ≥ 5 cm; Fever, temperature ≥ 39.0ºC; Vomiting, ≥ 6 episodes/24 hours or requiring parenteral hydration; Crying, \> 3 hours; Somnolence, sleeping most of the time or difficulty to wake up; Anorexia, refusing ≥ 3 feeds or refusing most feeds/meals; and Irritability, inconsolable.

Outcome measures

Outcome measures
Measure	DTaP-IPV-Hep B-PRP~T Group n=218 Participants Participants received a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular(aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.	CombAct-Hib™ + Engerix B™ + OPV Group n=219 Participants Participants received a primary series of 3 doses of commercial CombAct-Hib™ vaccine, Engerix B™ vaccine, and oral poliovirus vaccine, with 1 dose of each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.	DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group n=130 Participants Participants received Engerix B™ vaccine at birth, followed by a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular (aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
Number of Participants With Solicited Injection Site (Study Vaccine Site) and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) Pain	138 Participants	149 Participants Interval 0.0 to 0.0	84 Participants Interval 0.0 to 0.0
Number of Participants With Solicited Injection Site (Study Vaccine Site) and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) Grade 3 Pain	5 Participants	4 Participants Interval 0.0 to 0.0	1 Participants Interval 0.0 to 0.0
Number of Participants With Solicited Injection Site (Study Vaccine Site) and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) Erythema	102 Participants	104 Participants Interval 0.0 to 0.0	54 Participants Interval 0.0 to 0.0
Number of Participants With Solicited Injection Site (Study Vaccine Site) and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) Grade 3 Erythema	3 Participants	2 Participants Interval 0.0 to 0.0	2 Participants Interval 0.0 to 0.0
Number of Participants With Solicited Injection Site (Study Vaccine Site) and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) Swelling	75 Participants	98 Participants Interval 0.0 to 0.0	48 Participants Interval 0.0 to 0.0
Number of Participants With Solicited Injection Site (Study Vaccine Site) and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) Grade 3 Swelling	2 Participants	11 Participants Interval 0.0 to 0.0	5 Participants Interval 0.0 to 0.0
Number of Participants With Solicited Injection Site (Study Vaccine Site) and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) Extensive swelling of vaccinated limb	0 Participants	0 Participants	0 Participants
Number of Participants With Solicited Injection Site (Study Vaccine Site) and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) Grade 3 Extensive swelling of vaccinated limb	0 Participants	0 Participants	0 Participants
Number of Participants With Solicited Injection Site (Study Vaccine Site) and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) Pyrexia	61 Participants	50 Participants Interval 0.0 to 0.0	37 Participants Interval 0.0 to 0.0
Number of Participants With Solicited Injection Site (Study Vaccine Site) and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) Grade 3 Pyrexia	1 Participants	2 Participants Interval 0.0 to 0.0	2 Participants Interval 0.0 to 0.0
Number of Participants With Solicited Injection Site (Study Vaccine Site) and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) Vomiting	22 Participants	28 Participants Interval 0.0 to 0.0	14 Participants Interval 0.0 to 0.0
Number of Participants With Solicited Injection Site (Study Vaccine Site) and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) Grade 3 Vomiting	0 Participants	2 Participants Interval 0.0 to 0.0	0 Participants Interval 0.0 to 0.0
Number of Participants With Solicited Injection Site (Study Vaccine Site) and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) Crying	106 Participants	115 Participants Interval 0.0 to 0.0	58 Participants Interval 0.0 to 0.0
Number of Participants With Solicited Injection Site (Study Vaccine Site) and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) Grade 3 Crying	3 Participants	0 Participants Interval 0.0 to 0.0	2 Participants Interval 0.0 to 0.0
Number of Participants With Solicited Injection Site (Study Vaccine Site) and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) Somnolence	85 Participants	80 Participants Interval 0.0 to 0.0	43 Participants Interval 0.0 to 0.0
Number of Participants With Solicited Injection Site (Study Vaccine Site) and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) Grade 3 Somnolence	3 Participants	1 Participants Interval 0.0 to 0.0	1 Participants Interval 0.0 to 0.0
Number of Participants With Solicited Injection Site (Study Vaccine Site) and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) Anorexia	88 Participants	99 Participants Interval 0.0 to 0.0	55 Participants Interval 0.0 to 0.0
Number of Participants With Solicited Injection Site (Study Vaccine Site) and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) Grade 3 Anorexia	8 Participants	4 Participants Interval 0.0 to 0.0	4 Participants Interval 0.0 to 0.0
Number of Participants With Solicited Injection Site (Study Vaccine Site) and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) Irritability	98 Participants	103 Participants Interval 0.0 to 0.0	52 Participants Interval 0.0 to 0.0
Number of Participants With Solicited Injection Site (Study Vaccine Site) and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) Grade 3 Irritability	2 Participants	1 Participants Interval 0.0 to 0.0	1 Participants Interval 0.0 to 0.0

Adverse Events

DTaP-IPV-Hep B-PRP~T Group

Serious events: 7 serious events

Other events: 202 other events

Deaths: 0 deaths

CombAct-Hib™ + Engerix B™ + OPV Group

Serious events: 6 serious events

Other events: 210 other events

Deaths: 0 deaths

DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group

Serious events: 5 serious events

Other events: 119 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	DTaP-IPV-Hep B-PRP~T Group n=243 participants at risk Participants received a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular(aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.	CombAct-Hib™ + Engerix B™ + OPV Group n=242 participants at risk Participants received a primary series of 3 doses of commercial CombAct-Hib™ vaccine, Engerix B™ vaccine, and oral poliovirus vaccine, with 1 dose of each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.	DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group n=137 participants at risk Participants received Engerix B™ vaccine at birth, followed by a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular (aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
Gastrointestinal disorders Vomiting	44.9% 106/236 • Number of events 106 • Adverse events data were collected from the time of each vaccination up to 28 days after each primary and the booster vaccination. The total number of participants for which safety data were collected following booster vaccination were less than those for the primary vaccination. The total number for each event represents participants that were available for the data or endpoint.	42.0% 100/238 • Number of events 100 • Adverse events data were collected from the time of each vaccination up to 28 days after each primary and the booster vaccination. The total number of participants for which safety data were collected following booster vaccination were less than those for the primary vaccination. The total number for each event represents participants that were available for the data or endpoint.	40.0% 54/135 • Number of events 54 • Adverse events data were collected from the time of each vaccination up to 28 days after each primary and the booster vaccination. The total number of participants for which safety data were collected following booster vaccination were less than those for the primary vaccination. The total number for each event represents participants that were available for the data or endpoint.
General disorders Injection Site Bruising	2.5% 6/237 • Number of events 6 • Adverse events data were collected from the time of each vaccination up to 28 days after each primary and the booster vaccination. The total number of participants for which safety data were collected following booster vaccination were less than those for the primary vaccination. The total number for each event represents participants that were available for the data or endpoint.	3.8% 9/238 • Number of events 9 • Adverse events data were collected from the time of each vaccination up to 28 days after each primary and the booster vaccination. The total number of participants for which safety data were collected following booster vaccination were less than those for the primary vaccination. The total number for each event represents participants that were available for the data or endpoint.	6.6% 9/136 • Number of events 9 • Adverse events data were collected from the time of each vaccination up to 28 days after each primary and the booster vaccination. The total number of participants for which safety data were collected following booster vaccination were less than those for the primary vaccination. The total number for each event represents participants that were available for the data or endpoint.
General disorders Injection Site Pain	85.2% 202/237 • Number of events 202 • Adverse events data were collected from the time of each vaccination up to 28 days after each primary and the booster vaccination. The total number of participants for which safety data were collected following booster vaccination were less than those for the primary vaccination. The total number for each event represents participants that were available for the data or endpoint.	88.2% 210/238 • Number of events 210 • Adverse events data were collected from the time of each vaccination up to 28 days after each primary and the booster vaccination. The total number of participants for which safety data were collected following booster vaccination were less than those for the primary vaccination. The total number for each event represents participants that were available for the data or endpoint.	87.5% 119/136 • Number of events 119 • Adverse events data were collected from the time of each vaccination up to 28 days after each primary and the booster vaccination. The total number of participants for which safety data were collected following booster vaccination were less than those for the primary vaccination. The total number for each event represents participants that were available for the data or endpoint.
General disorders Injection Site Erythema	67.8% 160/236 • Number of events 160 • Adverse events data were collected from the time of each vaccination up to 28 days after each primary and the booster vaccination. The total number of participants for which safety data were collected following booster vaccination were less than those for the primary vaccination. The total number for each event represents participants that were available for the data or endpoint.	72.7% 173/238 • Number of events 173 • Adverse events data were collected from the time of each vaccination up to 28 days after each primary and the booster vaccination. The total number of participants for which safety data were collected following booster vaccination were less than those for the primary vaccination. The total number for each event represents participants that were available for the data or endpoint.	67.4% 91/135 • Number of events 91 • Adverse events data were collected from the time of each vaccination up to 28 days after each primary and the booster vaccination. The total number of participants for which safety data were collected following booster vaccination were less than those for the primary vaccination. The total number for each event represents participants that were available for the data or endpoint.
General disorders Injection Site Swelling	55.1% 130/236 • Number of events 130 • Adverse events data were collected from the time of each vaccination up to 28 days after each primary and the booster vaccination. The total number of participants for which safety data were collected following booster vaccination were less than those for the primary vaccination. The total number for each event represents participants that were available for the data or endpoint.	63.0% 150/238 • Number of events 150 • Adverse events data were collected from the time of each vaccination up to 28 days after each primary and the booster vaccination. The total number of participants for which safety data were collected following booster vaccination were less than those for the primary vaccination. The total number for each event represents participants that were available for the data or endpoint.	47.8% 65/136 • Number of events 65 • Adverse events data were collected from the time of each vaccination up to 28 days after each primary and the booster vaccination. The total number of participants for which safety data were collected following booster vaccination were less than those for the primary vaccination. The total number for each event represents participants that were available for the data or endpoint.
General disorders Irritability	66.5% 157/236 • Number of events 157 • Adverse events data were collected from the time of each vaccination up to 28 days after each primary and the booster vaccination. The total number of participants for which safety data were collected following booster vaccination were less than those for the primary vaccination. The total number for each event represents participants that were available for the data or endpoint.	69.3% 165/238 • Number of events 165 • Adverse events data were collected from the time of each vaccination up to 28 days after each primary and the booster vaccination. The total number of participants for which safety data were collected following booster vaccination were less than those for the primary vaccination. The total number for each event represents participants that were available for the data or endpoint.	69.6% 94/135 • Number of events 94 • Adverse events data were collected from the time of each vaccination up to 28 days after each primary and the booster vaccination. The total number of participants for which safety data were collected following booster vaccination were less than those for the primary vaccination. The total number for each event represents participants that were available for the data or endpoint.
General disorders Pyrexia	44.5% 105/236 • Number of events 105 • Adverse events data were collected from the time of each vaccination up to 28 days after each primary and the booster vaccination. The total number of participants for which safety data were collected following booster vaccination were less than those for the primary vaccination. The total number for each event represents participants that were available for the data or endpoint.	33.2% 79/238 • Number of events 79 • Adverse events data were collected from the time of each vaccination up to 28 days after each primary and the booster vaccination. The total number of participants for which safety data were collected following booster vaccination were less than those for the primary vaccination. The total number for each event represents participants that were available for the data or endpoint.	33.1% 45/136 • Number of events 45 • Adverse events data were collected from the time of each vaccination up to 28 days after each primary and the booster vaccination. The total number of participants for which safety data were collected following booster vaccination were less than those for the primary vaccination. The total number for each event represents participants that were available for the data or endpoint.
Infections and infestations Upper Respiratory Tract Infection	4.6% 11/237 • Number of events 11 • Adverse events data were collected from the time of each vaccination up to 28 days after each primary and the booster vaccination. The total number of participants for which safety data were collected following booster vaccination were less than those for the primary vaccination. The total number for each event represents participants that were available for the data or endpoint.	5.5% 13/238 • Number of events 13 • Adverse events data were collected from the time of each vaccination up to 28 days after each primary and the booster vaccination. The total number of participants for which safety data were collected following booster vaccination were less than those for the primary vaccination. The total number for each event represents participants that were available for the data or endpoint.	2.9% 4/136 • Number of events 4 • Adverse events data were collected from the time of each vaccination up to 28 days after each primary and the booster vaccination. The total number of participants for which safety data were collected following booster vaccination were less than those for the primary vaccination. The total number for each event represents participants that were available for the data or endpoint.
Metabolism and nutrition disorders Anorexia	46.6% 110/236 • Number of events 110 • Adverse events data were collected from the time of each vaccination up to 28 days after each primary and the booster vaccination. The total number of participants for which safety data were collected following booster vaccination were less than those for the primary vaccination. The total number for each event represents participants that were available for the data or endpoint.	55.9% 133/238 • Number of events 133 • Adverse events data were collected from the time of each vaccination up to 28 days after each primary and the booster vaccination. The total number of participants for which safety data were collected following booster vaccination were less than those for the primary vaccination. The total number for each event represents participants that were available for the data or endpoint.	49.3% 67/136 • Number of events 67 • Adverse events data were collected from the time of each vaccination up to 28 days after each primary and the booster vaccination. The total number of participants for which safety data were collected following booster vaccination were less than those for the primary vaccination. The total number for each event represents participants that were available for the data or endpoint.
Nervous system disorders Somnolence	60.6% 143/236 • Number of events 143 • Adverse events data were collected from the time of each vaccination up to 28 days after each primary and the booster vaccination. The total number of participants for which safety data were collected following booster vaccination were less than those for the primary vaccination. The total number for each event represents participants that were available for the data or endpoint.	60.1% 143/238 • Number of events 143 • Adverse events data were collected from the time of each vaccination up to 28 days after each primary and the booster vaccination. The total number of participants for which safety data were collected following booster vaccination were less than those for the primary vaccination. The total number for each event represents participants that were available for the data or endpoint.	57.8% 78/135 • Number of events 78 • Adverse events data were collected from the time of each vaccination up to 28 days after each primary and the booster vaccination. The total number of participants for which safety data were collected following booster vaccination were less than those for the primary vaccination. The total number for each event represents participants that were available for the data or endpoint.
Psychiatric disorders Crying	76.3% 180/236 • Number of events 180 • Adverse events data were collected from the time of each vaccination up to 28 days after each primary and the booster vaccination. The total number of participants for which safety data were collected following booster vaccination were less than those for the primary vaccination. The total number for each event represents participants that were available for the data or endpoint.	78.2% 186/238 • Number of events 186 • Adverse events data were collected from the time of each vaccination up to 28 days after each primary and the booster vaccination. The total number of participants for which safety data were collected following booster vaccination were less than those for the primary vaccination. The total number for each event represents participants that were available for the data or endpoint.	83.0% 112/135 • Number of events 112 • Adverse events data were collected from the time of each vaccination up to 28 days after each primary and the booster vaccination. The total number of participants for which safety data were collected following booster vaccination were less than those for the primary vaccination. The total number for each event represents participants that were available for the data or endpoint.
Respiratory, thoracic and mediastinal disorders Cough	5.5% 13/237 • Number of events 13 • Adverse events data were collected from the time of each vaccination up to 28 days after each primary and the booster vaccination. The total number of participants for which safety data were collected following booster vaccination were less than those for the primary vaccination. The total number for each event represents participants that were available for the data or endpoint.	1.7% 4/238 • Number of events 4 • Adverse events data were collected from the time of each vaccination up to 28 days after each primary and the booster vaccination. The total number of participants for which safety data were collected following booster vaccination were less than those for the primary vaccination. The total number for each event represents participants that were available for the data or endpoint.	2.9% 4/136 • Number of events 4 • Adverse events data were collected from the time of each vaccination up to 28 days after each primary and the booster vaccination. The total number of participants for which safety data were collected following booster vaccination were less than those for the primary vaccination. The total number for each event represents participants that were available for the data or endpoint.

Additional Information

Medical Director

Sanofi Pasteur Inc.

Email: [email protected]

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