Trial record 2 of 3 for: A3L15

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

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ClinicalTrials.gov Identifier: NCT00362336

Recruitment Status : Completed

First Posted : August 10, 2006

Results First Posted : May 2, 2014

Last Update Posted : May 2, 2014

Sponsor:

Information provided by (Responsible Party):

Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention
Conditions	Hepatitis B Polio Diphtheria Pertussis Haemophilus Influenzae Type b
Interventions	Biological: DTaP-IPV-HB-PRP~T Biological: CombAct-HIB® Biological: Engerix B® Pediatric
Enrollment	622

Participant Flow

Recruitment Details	Participants were enrolled from 28 August 2006 to 11 February 2007 in 2 clinical centers in South Africa.
Pre-assignment Details	A total of 622 of the 715 recruited participants who met the inclusion and exclusion criteria were enrolled and vaccinated.


Arm/Group Title	DTaP-IPV-Hep B-PRP~T Group	CombAct-Hib™ + Engerix B™ + OPV Group	DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group
Arm/Group Description	Participants received a primary ser...	Participants received a primary ser...	Participants received Engerix B™ va...
Arm/Group Description	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.	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.	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.
Period Title: Overall Study
Started	243	242	137
Completed	233	235	134
Not Completed	10	7	3
Reason Not Completed
Serious Adverse Event	1	0	1
Protocol Violation	0	0	1
Lost to Follow-up	6	4	0
Withdrawal by Subject	3	3	1

Baseline Characteristics

Arm/Group Title		DTaP-IPV-Hep B-PRP~T Group	CombAct-Hib™ + Engerix B™ + OPV Group	DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group	Total
Arm/Group Description		Participants received a primary ser...	Participants received a primary ser...	Participants received Engerix B™ va...	Total of all reporting groups
Arm/Group Description		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.	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.	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 of all reporting groups
Overall Number of Baseline Participants		243	242	137	622
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Categorical Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	243 participants	242 participants	137 participants	622 participants
	<=18 years	243 100.0%	242 100.0%	137 100.0%	622 100.0%
	Between 18 and 65 years	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	>=65 years	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Age, Continuous Mean (Standard Deviation) Unit of measure: Days
	Number Analyzed	243 participants	242 participants	137 participants	622 participants
		1.04 (0.729)	1.07 (0.762)	1.11 (0.773)	1.07 (0.751)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	243 participants	242 participants	137 participants	622 participants
	Female	131 53.9%	118 48.8%	68 49.6%	317 51.0%
	Male	112 46.1%	124 51.2%	69 50.4%	305 49.0%
Region of Enrollment Measure Type: Number Unit of measure: Participants
South Africa	Number Analyzed	243 participants	242 participants	137 participants	622 participants
South Africa		243	242	137	622

Outcome Measures

1.Primary Outcome


Title	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)
Description	Antibodies were measured by the following methods: anti-Hepatitis B (H...
Description	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).
Time Frame	1 month post-Dose 3

Outcome Measure Data

Analysis Population Description

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


Arm/Group Title	DTaP-IPV-Hep B-PRP~T Group	CombAct-Hib™ + Engerix B™ + OPV Group	DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group
Arm/Group Description:	Participants received a primary ser...	Participants received a primary ser...	Participants received Engerix B™ va...
Arm/Group Description:	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.	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.	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 Number of Participants Analyzed	220	212	123
Measure Type: Number Unit of Measure: Participants
Anti-Hep B (N = 184, 194, 98)	176	185	97
Anti-PRP (N = 219, 212, 122)	209	212	119
Anti-Diphtheria (N = 206, 206, 122)	201	198	116
Anti-Tetanus (N = 213, 210, 122)	213	210	122
Anti-Polio Type 1 (N = 186, 187, 104)	186	174	103
Anti-Polio Type 2 (N = 196, 192, 113)	193	192	111
Anti-Polio Type 3 (N = 182, 179, 98)	182	176	98

2.Secondary Outcome


Title	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)
Description	Anti-Hepatitis B (Hep B) was measured by enhanced chemiluminescence de...
Description	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.
Time Frame	1 month post-Dose 3

Outcome Measure Data

Analysis Population Description

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


Arm/Group Title	DTaP-IPV-Hep B-PRP~T Group	CombAct-Hib™ + Engerix B™ + OPV Group	DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group
Arm/Group Description:	Participants received a primary ser...	Participants received a primary ser...	Participants received Engerix B™ va...
Arm/Group Description:	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.	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.	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 Number of Participants Analyzed	220	212	123
Measure Type: Number Unit of Measure: Participants
Anti-Hep B (N = 184, 194, 98)	145	127	95
Anti-PRP (N = 219, 212, 122)	174	196	97
Anti-Diphtheria Level 1 ( N = 206, 206, 122)	82	28	48
Anti-Diphtheria Level 2 (N = 206, 206, 122)	3	0	4
Anti-Tetanus Level 1 (N = 213, 210, 122)	213	210	122
Anti-Tetanus Level 2 (N = 213, 210, 122)	158	173	83
Anti-Pertussis Toxoid (N = 172, 137, 103)	161	114	98
Anti-FHA (N = 160, 130, 90)	149	75	81

3.Secondary Outcome


Title	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)
Description	Anti-Hepatitis B (Hep B) was measured by enhanced chemiluminescence de...
Description	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.
Time Frame	Day 42 before Dose 1 and 1 month post-Dose 3

Outcome Measure Data

Analysis Population Description

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


Arm/Group Title	DTaP-IPV-Hep B-PRP~T Group	CombAct-Hib™ + Engerix B™ + OPV Group	DTaP-IPV-Hep B-PRP-T (Engerix B™ at Birth) Group
Arm/Group Description:	Participants received a primary ser...	Participants received a primary ser...	Participants received Engerix B™ va...
Arm/Group Description:	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.	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.	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 Number of Participants Analyzed	220	212	123
Geometric Mean (95% Confidence Interval) Unit of Measure: Titers
Anti-Hep B Post-dose 3 (N = 184, 194, 98)	330 (259 to 420)	148 (120 to 181)	1913 (1457 to 2513)
Anti-PRP Post-dose 3 (N = 219, 212, 122)	3.31 (2.69 to 4.08)	5.18 (4.47 to 6.00)	3.83 (2.92 to 5.02)
Anti-Diphtheria Post-dose 3 (N = 206, 206, 122)	0.074 (0.062 to 0.088)	0.040 (0.035 to 0.046)	0.074 (0.059 to 0.094)
Anti-Tetanus Post-dose 3 (N = 213, 210, 122)	1.51 (1.37 to 1.65)	1.88 (1.70 to 2.07)	1.33 (1.17 to 1.51)
Anti-Polio Type 1 Post-dose 3 (N = 186, 187, 104)	579 (478 to 702)	198 (153 to 256)	557 (410 to 756)
Anti-Polio Type 2 Post-dose 3 (N = 196, 192, 113)	620 (512 to 750)	446 (374 to 533)	371 (281 to 489)
Anti-Polio Type 3 Post-dose 3 (N = 182, 179, 98)	975 (812 to 1170)	228 (185 to 280)	811 (645 to 1020)
Anti-PT Pre-Dose 1 (N = 192, 174, 118)	7.77 (6.56 to 9.21)	7.66 (6.23 to 9.42)	6.62 (5.29 to 8.30)
Anti-PT Post-dose 3 (N = 192, 156, 108)	332 (304 to 362)	191 (147 to 249)	288 (256 to 323)
Anti-FHA Pre-dose 1 (N = 192, 175, 107)	9.27 (8.02 to 10.7)	8.02 (6.82 to 9.42)	8.30 (6.80 to 10.1)
Anti-FHA Post-dose 3 (N = 178, 153, 99)	207 (190 to 226)	37.4 (33.4 to 41.9)	188 (166 to 212)

4.Secondary Outcome


Title	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
Description	Antibodies were measured by the following methods: anti-Hepatitis B (H...
Description	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.
Time Frame	Day 540 pre-booster and Day 570 post-booster

Outcome Measure Data

Analysis Population Description

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


Arm/Group Title	DTaP-IPV-Hep B-PRP-T Group	CombAct-Hib™ + Engerix B™ + OPV Group	DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group
Arm/Group Description:	Participants received a primary ser...	Participants received a primary ser...	Participants received Engerix B™ va...
Arm/Group Description:	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.	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.	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 Number of Participants Analyzed	204	202	116
Measure Type: Number Unit of Measure: Participants
Anti-Hep B Pre (N = 199, 199, 113)	157	183	107
Anti-Hep B Post (N = 197, 0, 113)	194	0	113
Anti-PRP Pre (N =2 04, 200, 116)	166	185	88
Anti-PRP Post (N = 203, 201, 115)	203	201	115
Anti-Diphtheria Pre (N = 197, 201, 116)	184	173	98
Anti-Diphtheria Post (N = 195, 200, 111)	195	200	111
Anti-Tetanus Pre (N = 189, 195, 116)	189	195	116
Anti-Tetanus Post (N = 200, 199, 114)	200	199	114
Anti-Polio Type 1 Pre (N = 190, 189, 112)	185	178	108
Anti-Polio Type 1 Post (N = 189, 191, 108)	189	186	108
Anti-Polio Type 2 Pre (N = 190, 191, 111)	187	190	109
Anti-Polio Type 2 Post (N = 191, 190, 107)	191	190	107
Anti-Polio Type 3 Pre (N = 189, 189, 111)	186	185	110
Anti-Polio Type 3 Post (N = 188, 187, 108)	188	185	108
Anti-PT Pre (N = 164, 141, 104)	151	100	95
Anti-PT Post (N= 187, 184, 109)	187	173	109
Anti-PT Post/Pre Ratio (N = 153, 133, 99)	145	111	93
Anti-FHA Pre (N = 173, 148, 103)	170	99	102
Anti-FHA Post (N = 184, 190, 105)	184	190	105
Anti-FHA Post/Pre Ratio (N = 159, 143, 94)	145	138	89

5.Secondary Outcome


Title	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
Description	Anti-Hepatitis B (Hep B) was measured by enhanced chemiluminescence de...
Description	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.
Time Frame	Day 540 pre-booster and Day 570, post-booster

Outcome Measure Data

Analysis Population Description

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


Arm/Group Title	DTaP-IPV-Hep B-PRP-T Group	CombAct-Hib™ + Engerix B™ + OPV Group	DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group
Arm/Group Description:	Participants received a primary ser...	Participants received a primary ser...	Participants received Engerix B™ va...
Arm/Group Description:	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.	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.	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 Number of Participants Analyzed	204	202	116
Geometric Mean (95% Confidence Interval) Unit of Measure: Titers
Anti-Hep B Pre (N = 199, 199, 113)	51.3 (40.0 to 65.8)	103 (83.3 to 127)	228 (172 to 303)
Anti-Hep B Post (N = 197, 0, 113)	4630 (3402 to 6302)	0 (0 to 0)	44893 (33652 to 59890)
Anti-Hep B Post/Pre Ratio (N = 192, 0, 112)	88.7 (74.0 to 106)	0 (0 to 0)	191 (157 to 231)
Anti-PRP Pre (N = 204, 200, 116)	0.757 (0.585 to 0.980)	1.19 (0.948 to 1.48)	0.631 (0.448 to 0.889)
Anti-PRP Post (N = 203, 201, 116)	68.5 (55.7 to 84.2)	52.2 (43.9 to 62.2)	63.1 (47.6 to 83.8)
Anti-PRP Post/Pre Ratio (N = 203, 199, 115)	89.0 (71.4 to 111)	43.6 (34.5 to 55.0)	97.4 (71.7 to 132)
Anti-Diphtheria Pre (N = 197, 201, 116)	0.060 (0.050 to 0.073)	0.027 (0.023 to 0.032)	0.045 (0.033 to 0.059)
Anti-Diphtheria Post (N = 195, 200, 111)	9.37 (8.05 to 10.9)	3.33 (2.92 to 3.80)	7.00 (5.61 to 8.72)
Anti-Diphtheria Post/Pre Ratio (N = 189, 199, 111)	158 (137 to 182)	123 (108 to 140)	153 (125 to 189)
Anti-Tetanus Pre (N = 189, 195, 116)	0.219 (0.189 to 0.254)	0.311 (0.276 to 0.352)	0.173 (0.143 to 0.208)
Anti-Tetanus Post (N = 200, 199, 114)	10.0 (8.65 to 11.7)	8.23 (7.49 to 9.04)	8.13 (6.68 to 9.89)
Anti-Tetanus Post/Pre Ratio (N = 185, 192, 114)	45.5 (40.0 to 51.8)	26.5 (23.5 to 29.9)	47.4 (39.8 to 56.3)
Anti-Polio Type 1 Pre (N = 190, 189, 112)	127 (104 to 155)	151 (118 to 192)	142 (107 to 190)
Anti-Polio Type 1 Post (N = 189, 191, 108)	7298 (6202 to 8588)	329 (260 to 417)	5346 (4309 to 6633)
Anti-Polio Type 1 Post/Pre Ratio (N=178, 181, 105)	59.0 (47.0 to 74.0)	2.27 (1.80 to 2.85)	38.4 (27.4 to 53.7)
Anti-Polio Type 2 Pre (N = 190, 191, 111)	210 (170 to 260)	246 (204 to 296)	191 (144 to 255)
Anti-Polio Type 2 Post (N = 191, 190, 107)	6637 (5745 to 7668)	863 (665 to 1118)	4190 (3460 to 5074)
Anti-Polio Type 2 Post/Pre Ratio (N=179, 182, 103)	32.4 (24.9 to 42.3)	3.82 (2.90 to 5.04)	23.2 (16.2 to 33.3)
Anti-Polio Type 3 Pre (N = 189, 189, 111)	161 (130 to 199)	114 (96.4 to 135)	127 (97.9 to 165)
Anti-Polio Type 3 Post (N = 188, 187, 108)	6411 (5525 to 7493)	315 (245 to 404)	5144 (4156 to 6367)
Anti-Polio Type 3 Post/Pre Ratio (N=176, 180, 106)	40.5 (31.0 to 53.0)	2.92 (2.26 to 3.77)	41.2 (29.3 to 57.9)
Anti PT Pre (N=164, 141, 104)	11.6 (9.88 to 13.6)	10.4 (8.03 to 13.6)	12.0 (9.62 to 14.9)
Anti PT Post (N=187, 184, 109)	288 (260 to 318)	110 (88.7 to 137)	235 (206 to 268)
Anti-PT Post/Pre Ratio (N=153, 133, 99)	26.1 (21.8 to 31.1)	10.6 (8.56 to 13.1)	20.5 (16.5 to 25.4)
Anti-FHA Pre (N = 173, 148, 103)	30.5 (25.4 to 36.7)	5.43 (4.52 to 6.53)	25.1 (19.7 to 31.9)
Anti-FHA Post (N = 184, 190, 105)	570 (514 to 630)	211 (193 to 231)	472 (419 to 533)
Anti-FHA Post/Pre Ratio (N = 159, 143, 94)	18.9 (15.8 to 22.6)	40.8 (34.5 to 48.1)	20.3 (16.5 to 24.9)

6.Secondary Outcome


Title	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).
Description	Solicited Injection Site Reactions: Pain, Erythema, Swelling. Solicite...
Description	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.
Time Frame	Day 0 up to Day 7 post each dose

Outcome Measure Data

Analysis Population Description

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.


Arm/Group Title	DTaP-IPV-Hep B-PRP~T Group	CombAct-Hib™ + Engerix B™ + OPV Group	DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group
Arm/Group Description:	Participants received a primary ser...	Participants received a primary ser...	Participants received Engerix B™ va...
Arm/Group Description:	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.	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.	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 Number of Participants Analyzed	243	242	137
Measure Type: Number Unit of Measure: Participants
Pain Post-dose 1 (N = 234, 237, 134)	166	177	95
Pain Post-dose 2 (N = 234, 233, 134)	171	171	97
Pain Post-dose 3 ( N = 232, 234, 134)	143	162	83
Grade 3 Pain Post-Any Dose (N = 237, 238, 136)	17	24	7
Erythema Post-dose 1 (N = 233, 237, 132)	112	133	69
Erythema Post-dose 2 (N = 232, 231, 133)	116	114	59
Erythema Post-dose 3 (N = 231, 234, 132)	103	106	56
Grade 3 Erythema Post-Any Dose (N = 236, 238, 135)	9	15	2
Swelling Post-dose 1 (N = 231, 238, 134)	87	102	48
Swelling Post-dose 2 (N = 233, 230, 133)	88	109	43
Swelling Post-dose 3 (N = 232, 232, 133)	74	89	39
Grade 3 Swelling Post-Any Dose (N = 236, 238, 136)	9	10	4
Pyrexia Post-dose 1 (N = 234, 238, 132)	50	38	27
Pyrexia Post-dose 2 (N = 234, 232, 134)	43	35	18
Pyrexia Post-dose 3 (N = 230, 232, 134)	48	34	21
Grade 3 Pyrexia Post-Any Dose (N = 236, 238, 136)	4	1	0
Vomiting Post-dose 1 (N = 233, 238, 133)	59	59	30
Vomiting Post-dose 2 (N = 234, 233, 134)	52	56	35
Vomiting Post-dose 3 (N = 231, 233, 134)	56	49	31
Grade 3 Vomiting Post-Any Dose (N = 236, 238, 135)	14	7	6
Crying Post-dose 1 (N = 234, 238, 133)	138	154	91
Crying Post-dose 2 (N = 234, 233, 134)	131	135	74
Crying Post-dose 3 (N = 231, 233, 134)	106	116	66
Grade 3 Crying Post-Any Dose (N = 236, 238, 135)	15	20	9
Somnolence Post-dose 1 (N = 232, 238, 133)	100	103	57
Somnolence Post-dose 2 (N = 234, 232, 134)	79	90	47
Somnolence Post-dose 3 (N = 231, 232, 134)	72	69	43
Grade 3 Somnolence Post-Any Dose (N=236, 238, 135)	9	9	8
Anorexia Post-dose 1 (N = 233, 238, 134)	62	87	42
Anorexia Post-dose 2 (N = 234, 232, 134)	66	68	39
Anorexia Post-dose 3 (N = 231, 232, 134)	64	76	39
Grade 3 Anorexia Post-Any Dose (N=236, 238, 136)	9	13	5
Irritability Post-dose 1 (N=234, 238, 132)	128	137	77
Irritability Post-dose 2 (N = 234, 232, 134)	114	118	66
Irritability Post-dose 3 (N = 231, 232, 134)	94	99	53
Grd 3 Irritability Post-Any Dose (N=236, 238, 135)	18	16	5

7.Secondary Outcome


Title	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)
Description	Solicited Injection Site Reactions: Pain, Erythema, Swelling, and Exte...
Description	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.
Time Frame	Day 0 up to 7 post-booster vaccination

Outcome Measure Data

Analysis Population Description

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).


Arm/Group Title	DTaP-IPV-Hep B-PRP~T Group	CombAct-Hib™ + Engerix B™ + OPV Group	DTaP-IPV-Hep B-PRP-T (Engerix B™ at Birth) Group
Arm/Group Description:	Participants received a primary ser...	Participants received a primary ser...	Participants received Engerix B™ va...
Arm/Group Description:	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.	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.	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 Number of Participants Analyzed	218	219	130
Measure Type: Number Unit of Measure: Participants
Pain	138	149	84
Grade 3 Pain	5	4	1
Erythema	102	104	54
Grade 3 Erythema	3	2	2
Swelling	75	98	48
Grade 3 Swelling	2	11	5
Extensive swelling of vaccinated limb	0	0	0
Grade 3 Extensive swelling of vaccinated limb	0	0	0
Pyrexia	61	50	37
Grade 3 Pyrexia	1	2	2
Vomiting	22	28	14
Grade 3 Vomiting	0	2	0
Crying	106	115	58
Grade 3 Crying	3	0	2
Somnolence	85	80	43
Grade 3 Somnolence	3	1	1
Anorexia	88	99	55
Grade 3 Anorexia	8	4	4
Irritability	98	103	52
Grade 3 Irritability	2	1	1

Adverse Events

Time Frame	Adverse events data were collected from the time of each vaccination up to 28 days after each primary and the booster vaccination.
Adverse Event Reporting Description	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.

Arm/Group Title	DTaP-IPV-Hep B-PRP~T Group		CombAct-Hib™ + Engerix B™ + OPV Group		DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group
Arm/Group Description	Participants received a primary ser...		Participants received a primary ser...		Participants received Engerix B™ va...
Arm/Group Description	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.		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.		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.
All-Cause Mortality
	DTaP-IPV-Hep B-PRP~T Group		CombAct-Hib™ + Engerix B™ + OPV Group		DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group
	Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)
Total	--/--		--/--		--/--
Serious Adverse Events Serious Adverse Events
	DTaP-IPV-Hep B-PRP~T Group		CombAct-Hib™ + Engerix B™ + OPV Group		DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/243 (2.88%)		6/242 (2.48%)		5/137 (3.65%)
Cardiac disorders
Pulmonary Valve Stenosis ^* 1	1/243 (0.41%)	1	0/242 (0.00%)	0	0/137 (0.00%)	0
Congenital, familial and genetic disorders
Heart Disease Congenital ^* 1	1/243 (0.41%)	1	1/242 (0.41%)	1	0/137 (0.00%)	0
Ventricular Septal Defect ^* 1	0/243 (0.00%)	0	0/242 (0.00%)	0	1/137 (0.73%)	1
Infections and infestations
Abscess Limb ^* 1	0/243 (0.00%)	0	1/242 (0.41%)	1	0/137 (0.00%)	0
Bronchiolitis ^* 1	1/243 (0.41%)	1	0/242 (0.00%)	0	1/137 (0.73%)	1
Bronchitis ^* 1	1/243 (0.41%)	1	0/242 (0.00%)	0	0/137 (0.00%)	0
Bronchopneumonia ^* 1	2/243 (0.82%)	2	2/242 (0.83%)	2	2/137 (1.46%)	2
Dysentery ^* 1	0/218 (0.00%)	0	0/242 (0.00%)	0	1/130 (0.77%)	1
Gastroenteritis ^* 1	2/243 (0.82%)	2	1/242 (0.41%)	1	1/130 (0.77%)	1
Lobar Pneumonia ^* 1	0/243 (0.00%)	0	0/242 (0.00%)	0	1/137 (0.73%)	1
Pneumonia ^* 1	0/243 (0.00%)	0	0/242 (0.00%)	0	1/137 (0.73%)	1
Pulmonary Tuberculosis ^* 1	0/243 (0.00%)	0	1/242 (0.41%)	1	0/137 (0.00%)	0
Respiratory Tract Infection ^* 1	0/243 (0.00%)	0	1/242 (0.41%)	1	0/137 (0.00%)	0
Urinary Tract Infection ^* 1	1/243 (0.41%)	1	0/242 (0.00%)	0	0/0	0
Metabolism and nutrition disorders
Failure to Thrive ^* 1	1/218 (0.46%)	1	0/219 (0.00%)	0	0/137 (0.00%)	0
Renal and urinary disorders
Hydronephrosis ^* 1	1/243 (0.41%)	1	0/242 (0.00%)	0	0/137 (0.00%)	0
Renal Impairment ^* 1	1/243 (0.41%)	1	0/242 (0.00%)	0	0/137 (0.00%)	0
* Indicates events were collected by non-systematic assessment 1 Term from vocabulary, MedDRA 9.0
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5.00%
	DTaP-IPV-Hep B-PRP~T Group		CombAct-Hib™ + Engerix B™ + OPV Group		DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	202/243 (83.13%)		210/242 (86.78%)		119/137 (86.86%)
Gastrointestinal disorders
Vomiting ^† 1	106/236 (44.92%)	106	100/238 (42.02%)	100	54/135 (40.00%)	54
General disorders
Injection Site Bruising ^* 1	6/237 (2.53%)	6	9/238 (3.78%)	9	9/136 (6.62%)	9
Injection Site Pain ^† 1	202/237 (85.23%)	202	210/238 (88.24%)	210	119/136 (87.50%)	119
Injection Site Erythema ^† 1	160/236 (67.80%)	160	173/238 (72.69%)	173	91/135 (67.41%)	91
Injection Site Swelling ^† 1	130/236 (55.08%)	130	150/238 (63.03%)	150	65/136 (47.79%)	65
Irritability ^† 1	157/236 (66.53%)	157	165/238 (69.33%)	165	94/135 (69.63%)	94
Pyrexia ^† 1	105/236 (44.49%)	105	79/238 (33.19%)	79	45/136 (33.09%)	45
Infections and infestations
Upper Respiratory Tract Infection ^* 1	11/237 (4.64%)	11	13/238 (5.46%)	13	4/136 (2.94%)	4
Metabolism and nutrition disorders
Anorexia ^† 1	110/236 (46.61%)	110	133/238 (55.88%)	133	67/136 (49.26%)	67
Nervous system disorders
Somnolence ^† 1	143/236 (60.59%)	143	143/238 (60.08%)	143	78/135 (57.78%)	78
Psychiatric disorders
Crying ^† 1	180/236 (76.27%)	180	186/238 (78.15%)	186	112/135 (82.96%)	112
Respiratory, thoracic and mediastinal disorders
Cough ^* 1	13/237 (5.49%)	13	4/238 (1.68%)	4	4/136 (2.94%)	4
† Indicates events were collected by systematic assessment * Indicates events were collected by non-systematic assessment 1 Term from vocabulary, MedDRA 9.0

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

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

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Medical Director
Organization:	Sanofi Pasteur Inc.
EMail:	RegistryContactUs@sanofipasteur.com

Publications of Results:

Madhi SA, Mitha I, Cutland C, Groome M, Santos-Lima E. Immunogenicity and safety of an investigational fully liquid hexavalent combination vaccine versus licensed combination vaccines at 6, 10, and 14 weeks of age in healthy South African infants. Pediatr Infect Dis J. 2011 Apr;30(4):e68-74. doi: 10.1097/INF.0b013e31820b93d2.

Layout table for additonal information

Responsible Party:	Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:	NCT00362336
Other Study ID Numbers:	A3L15
First Submitted:	August 8, 2006
First Posted:	August 10, 2006
Results First Submitted:	February 14, 2014
Results First Posted:	May 2, 2014
Last Update Posted:	May 2, 2014

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