Immunogenicity and Safety of Sanofi Pasteur Pentaxim Combined Vaccine in Infants in Thailand

Date de début de l'étude : 1 décembre 2005

Inclusion Criteria: * Aged 53 to 70 days inclusive on the day of inclusion 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 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. * Mother known as seropositive to HIV or hepatitis B * Any vaccination in the 5 weeks preceding the first trial vaccination (except Bacille Calmette-Guerin \[BCG\]) * History of diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b infection or hepatitis B (confirmed either clinically, serologically or microbiologically). * Previous vaccination against the diphtheria, tetanus, pertussis, poliomyelitis diseases or Haemophilus influenzae 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.