Comparison of DTaP-HB-PRP~T Combined Vaccine to Tritanrix-HepB/Hib™, Both Given Concomitantly With Oral Polio Vaccine
This study has been completed.
Sponsor:
Sanofi
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00343889
First received: June 21, 2006
Last updated: April 13, 2012
Last verified: April 2012
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Purpose
The purpose of this study is to support the registration of the pentavalent DTaP-HB-PRP~T vaccine in countries that follow the World Health Organization-Expanded Program of Immunization (WHO-EPI) schedule.
The primary objective is:
- To demonstrate that the pentavalent DTaP-HB-PRP~T combined vaccine does not induce a lower immune response than Tritanrix-HepB/Hib™ in terms of the seroprotection rate to hepatitis B (HB) one month after a 3-dose primary series at 6, 10, and 14 weeks of age.
The secondary objectives are:
- To describe in each group the immunogenicity parameters one month after the 3-dose primary series at 6, 10, and 14 weeks of age; and
- To evaluate the overall safety in terms of any adverse events in the first 28 days after each injection and any serious adverse events during the entire trial.
| Condition | Intervention | Phase |
|---|---|---|
|
Diphtheria Tetanus Pertussis Hepatitis B Haemophilus Infections |
Biological: DTaP-HB-PRP~T vaccine Biological: Tritanrix-HepB/Hib™ |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Immunogenicity Study of a DTaP-Hep B-PRP-T Combined Vaccine Compared to Tritanrix-HepB/Hib™, Both Given Concomitantly With the Oral Polio Vaccine at 6, 10, and 14 Weeks of Age in Healthy Infants in the Philippines |
Resource links provided by NLM:
MedlinePlus related topics:
Diphtheria
Hepatitis
Hepatitis A
Hepatitis B
Polio and Post-Polio Syndrome
Tetanus
Whooping Cough
U.S. FDA Resources
Further study details as provided by Sanofi:
Primary Outcome Measures:
- To provide information concerning the immunogenicity of DTaP-HB-PRP~T vaccine [ Time Frame: 1 month post-dose 3 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To provide information concerning safety after administration of DTaP-HB-PRP~T vaccine [ Time Frame: 6 months post-dose 3 ] [ Designated as safety issue: Yes ]
| Enrollment: | 379 |
| Study Start Date: | August 2006 |
| Study Completion Date: | April 2008 |
| Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Group 1
DTaP-Hep B-PRP-T + OPV group.
|
Biological: DTaP-HB-PRP~T vaccine
0.5 mL, IM
|
|
Active Comparator: Group 2
Tritanrix HepB/Hib™ vaccine group
|
Biological: Tritanrix-HepB/Hib™
0.5 mL, IM
|
Eligibility| Ages Eligible for Study: | 42 Days to 50 Days |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Six week old infants (42 to 50 days old) on the day of inclusion; of either gender.
- Mother tested as seronegative for hepatitis B surface antigen (HBsAg) between 28 weeks of pregnancy and up to 4 days after delivery
- Born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg
- Informed consent form signed by one parent or other legal representative if appropriate (independent witness is mandatory if parent is illiterate)
- Able to attend all scheduled visits and to comply with all trial procedures.
Exclusion Criteria:
- Participation in another clinical trial in the 4 weeks preceding the first trial vaccination
- Planned participation in another clinical trial during the present trial period
- Congenital or acquired immunodeficiency; immunosuppressive therapy such as long-term systemic corticosteroid therapy.
- Chronic illness at a stage that could interfere with the conduct or completion of the trial
- Blood or blood-derived products received since birth
- HB vaccination since birth
- Any vaccination in the four weeks preceding the first trial vaccination
- Any planned vaccination (except trial vaccines and bacillus Calmette-Guerin [BCG]) during the trial
- Documented history of pertussis, tetanus (T), diphtheria (D), polio, or Haemophilus influenzae type b (Hib) infection(s) (confirmed either clinically, serologically, or microbiologically)
- Known personal or maternal history of HIV, HBsAg or hepatitis C seropositivity
- Thrombocytopenia or a bleeding disorder contraindicating intramuscular (IM) vaccination
- History of seizures
- Febrile (rectal temperature ≥ 38.0°C) or acute illness on the day of inclusion.
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Sanofi |
| ClinicalTrials.gov Identifier: | NCT00343889 History of Changes |
| Other Study ID Numbers: | AL203 |
| Study First Received: | June 21, 2006 |
| Last Updated: | April 13, 2012 |
| Health Authority: | Philippines: Department of Health |
Keywords provided by Sanofi:
|
Diphtheria Tetanus Pertussis |
Hepatitis B Hansenula (HB) Haemophilus influenzae type b Haemophilus Influenzae |
Additional relevant MeSH terms:
|
Diphtheria Haemophilus Infections Hepatitis Hepatitis A Hepatitis B Whooping Cough Tetanus Tetany Corynebacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections Pasteurellaceae Infections Gram-Negative Bacterial Infections Liver Diseases |
Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Hepadnaviridae Infections DNA Virus Infections Bordetella Infections Respiratory Tract Infections Infection Respiratory Tract Diseases Clostridium Infections Neuromuscular Manifestations Neurologic Manifestations |
ClinicalTrials.gov processed this record on May 19, 2013