Status:
COMPLETED
Study Comparing a DTaP-HB-PRP~T Combined Vaccine With Tritanrix HepB/Hib™, Concomitantly With OPV in Healthy Infants
Lead Sponsor:
Sanofi Pasteur, a Sanofi Company
Conditions:
Diphtheria
Tetanus
Eligibility:
All Genders
42-50 years
Phase:
PHASE3
Brief Summary
This is a study to compare the safety and immune response of a pentavalent DTaP-HB-PRP\~T combined vaccine with Tritanrix-HepB/Hib™, when both are given concomitantly with OPV at 6, 10, and 14 weeks o...
Eligibility Criteria
Inclusion
- At Screening:
- 0 to 3 day old infants
- Born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg
- Apgar score ≥ 7 at three minutes after birth
- Informed consent form signed by one parent or legal representative if appropriate (independent witness mandatory if parent is illiterate)
- At Inclusion:
- Six weeks of age
- Received a dose of Hepatitis B (HB) in the first three days of life
- Able to attend all scheduled visits and to comply with all trial procedures.
Exclusion
- At Screening:
- Illness at a stage that could interfere with trial conduct or completion
- Any vaccination before HB vaccination (except bacille Calmette-Guérin \[BCG\] given at birth)
- Vaccination planned in the 4 to 6 weeks following the first trial vaccination (except BCG if not given at birth)
- Acute illness on the day of screening.
- At Screening and at Inclusion:
- Blood or blood-derived products received since birth
- Planned participation in another clinical trial during the present trial period
- Mother known as seropositive to Human immunodeficiency virus (HIV) or Hepatitis C, or as carrying the HB surface antigen (HBsAg)
- Known thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination
- Known hypersensitivity to any component of any vaccine to be used in the trial (including neomycin and polymixin B)
- At Inclusion:
- Non-trial vaccine administered since birth, except Bacille Calmette-Guérin (BCG)
- Participation in another clinical trial before the first trial vaccination
- Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroid therapy
- Systemic hypersensitivity to any of the vaccine components or history of a life threatening reaction to the trial vaccine or a vaccine containing the same substances
- Chronic illness at a stage that could interfere with trial conduct or completion
- Vaccination other than with the study vaccines planned in the 12 weeks following inclusion
- Documented history of pertussis, tetanus, diphtheria, polio, H. influenza type b, or HB infection (confirmed clinically, serologically, or microbiologically)
- History of seizures
- Febrile (rectal temperature ≥ 38.0°C) or acute illness on the day of inclusion.
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
2133 Patients enrolled
Trial Details
Trial ID
NCT00348881
Start Date
June 1 2006
End Date
June 1 2008
Last Update
October 22 2013
Active Locations (4)
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1
Alabang, Muntinlupa City, Philippines
2
Putatan, Muntinlupa City, Philippines
3
Tunasan, Muntinlupa City, Philippines
4
Filinvest
Corporate City, Philippines