Comparison of DTaP-IPV-Hep B-PRP~T Combined Vaccine to CombAct-HIB® Concomitantly Given With Engerix B® Paediatric and OPV

Launched by SANOFI PASTEUR, A SANOFI COMPANY · Aug 8, 2006

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Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.