Immunogenicity and Safety of Pentaxim in South African Infants

Launched by SANOFI · Nov 15, 2005

Keywords

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Eligibility criteria

• Inclusion Criteria:
• • Aged \< 24 hours on the day of inclusion
• Exclusion Criteria:
• • At visit 01 (screening)
• • Illness at a stage that could interfere with trial conduct or completion.
• • Any vaccination preceding the trial participation (except Bacille Calmette-Guerin \[BCG\])
• • Acute illness on the day of screening. At visit 01 and visit 02 (screening and first study vaccination).
• • Planned participation in another clinical trial during the present trial period
• • Blood or blood-derived products received since birth.
• • Mother known as seropositive to HIV or hepatitis B.
• • Known thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
• • History of/current seizures at visit 02 (first study vaccination)
• • Participation in another clinical trial preceding the first trial vaccination
• • 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.
• • Any vaccination preceding the first trial vaccination (except BCG)
• • History of diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b and hepatitis B infection (confirmed either clinically, serologically or microbiologically).
• • Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b and hepatitis B infection with the trial vaccine or another vaccine.
• • Febrile illness (rectal temperature ≥ 38.0°C or axillary temperature ≥ 37.4°C) or acute illness on the day of first vaccination