Immunogenicity and Safety of Pentaxim in South African Infants

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