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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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00362336 |
Recruitment Status :
Completed
First Posted : August 10, 2006
Results First Posted : May 2, 2014
Last Update Posted : May 2, 2014
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Sponsor:
Sanofi Pasteur, a Sanofi Company
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
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Study Type | Interventional |
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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 |
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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 | |
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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 | |
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[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 243 participants | 242 participants | 137 participants | 622 participants | |
<=18 years |
243 100.0%
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242 100.0%
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137 100.0%
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622 100.0%
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Between 18 and 65 years |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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>=65 years |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Days |
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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 |
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Number Analyzed | 243 participants | 242 participants | 137 participants | 622 participants | |
Female |
131 53.9%
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118 48.8%
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68 49.6%
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317 51.0%
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Male |
112 46.1%
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124 51.2%
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69 50.4%
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305 49.0%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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South Africa | Number Analyzed | 243 participants | 242 participants | 137 participants | 622 participants |
243 | 242 | 137 | 622 |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
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. |
EMail: | RegistryContactUs@sanofipasteur.com |
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 |