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

Launched by SANOFI · Nov 15, 2005

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• 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.