Immunogenicity and Safety of Pentaxim™ in an Indian Population

Inclusion Criteria: Aged 42 to 56 days inclusive on the day of inclusion Born at full term pregnancy (> 37 weeks) with a birth weight ≥ 2.5 kg Informed consent form signed by the parent(s) or other legal representative Able to attend all scheduled visits and to comply with all trial procedures 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 corticosteroids 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. Blood or blood-derived products received in the past. Any vaccination preceding the trial vaccination (except BCG and hepatitis B) History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B or Haemophilus influenza type b (confirmed either clinically, serologically or microbiologically). Previous vaccination against the diphtheria, tetanus, pertussis, poliomyelitis diseases or Haemophilus influenza type b infection with the trial vaccine or another vaccine. Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination History of/current seizures Febrile illness (rectal temperature ≥ 38.0°C or axillary temperature ≥ 37.4°C) or acute illness on the day of inclusion.