Immunogenicity of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® at 2-3-4 Months Schedule

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
• •Systemic hypersensitivity to any of the vaccine components or history of a life threatening reaction to a vaccine containing the same substances
• •Chronic illness at a stage that could interfere with trial conduct or completion
• •Blood or blood-derived products received since birth
• •Any vaccination (except BCG) in the 4 weeks preceding the first trial vaccination
• •Vaccination planned in the 4 weeks following trial vaccination
• •History of documented pertussis, tetanus, diphtheria, polio, Haemophilus influenzae type b or hepatitis B infection(s) (confirmed either clinically, serologically or microbiologically)
• •Known personal or maternal history of HIV, Hepatitis B or Hepatitis C seropositivity
• •Previous vaccination against pertussis, tetanus, diphtheria, polio or Hib, and HB infection(s)
• •Coagulopathy, thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
• •History of seizures
• •Febrile (axillary temperature 37.4°C \[rectal equivalent temperature \>=38.0°C\]) or acute illness on the day of inclusion.