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Trial record 2 of 3 for:    A3L15

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
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
Hide 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
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
Hide 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
Hide 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
243 242 137 622
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)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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).
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
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
Hide 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   --/--      --/--      --/--    
Show Serious Adverse Events Hide 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
Show Other (Not Including Serious) Adverse Events Hide 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
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
Name/Title: Medical Director
Organization: Sanofi Pasteur Inc.
Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00362336     History of Changes
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