Status:
COMPLETED
Comparison of DTaP-HB-PRP~T Combined Vaccine to Tritanrix-HepB/Hib™, Both Given Concomitantly With Oral Polio Vaccine
Lead Sponsor:
Sanofi Pasteur, a Sanofi Company
Conditions:
Diphtheria
Tetanus
Eligibility:
All Genders
42-50 years
Phase:
PHASE3
Brief Summary
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) sch...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
379 Patients enrolled
Trial Details
Trial ID
NCT00343889
Start Date
August 1 2006
End Date
April 1 2008
Last Update
December 10 2013
Active Locations (2)
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1
Manila, Philippines
2
Quezon City, Philippines