Status:
COMPLETED
Comparison of DTaP-IPV-Hep B-PRP~T Combined Vaccine to CombAct-HIB® Concomitantly Given With Engerix B® Paediatric and OPV
Lead Sponsor:
Sanofi Pasteur, a Sanofi Company
Conditions:
Hepatitis B
Polio
Eligibility:
All Genders
Up to 3 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to document the immunological response to the investigational hexavalent vaccine at the 6, 10, and 14 weeks schedule The primary objective is to demonstrate that the hexa...
Eligibility Criteria
Inclusion
- 0 to 3 day old infants
- Mother seronegative for Human Immunodeficiency Virus (HIV)
- Born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg
- Apgar score \>7 at 5 or 10 minutes of life
- Informed consent form signed by a parent or other legal guardian and by an independent witness if the parent or other legal guardian is illiterate
- Able to attend all scheduled visits and to comply with all trial procedures.
Exclusion
- Current or planned participation in another clinical trial during the entire duration of the present trial
- Suspected congenital or acquired immunodeficiency
- Suspected maternal acute seroconversion syndrome to HIV after 24 weeks gestation based on clinical history
- Chronic illness at a stage that could interfere with trial conduct or completion
- Blood or blood-derived products received since birth
- Any planned vaccination (except Bacille Calmette Guérin and trial vaccinations) from birth to 18 weeks of age
- Oral Poliovirus Vaccine (OPV) administration at birth
- Known maternal history of HIV, Hepatitis B (HB) (HbsAg carrier) or Hepatitis C seropositivity
- Thrombocytopenia or bleeding disorder contraindicating intramuscular (IM) vaccination
- History of seizures
- Febrile or acute illness on the day of inclusion.
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
622 Patients enrolled
Trial Details
Trial ID
NCT00362336
Start Date
August 1 2006
End Date
August 1 2009
Last Update
May 2 2014
Active Locations (2)
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1
Soweto, Johannesburg, South Africa, 2013
2
Bertsham, South Africa