Immunogenicity and Safety of Tetraxim Versus Local DTP + IPV

Launched by SANOFI · Apr 28, 2006

Keywords

ClinConnect Summary

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Gender

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Eligibility criteria

• Inclusion Criteria:
• • Aged 56 to 70 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 or planned administration during the trial (including immunoglobulins).
• • Any vaccination in the 3 weeks preceding the first trial vaccination.
• • History of diphtheria, tetanus, pertussis, poliomyelitis infection (confirmed either clinically, serologically or microbiologically).
• • Previous vaccination against the diphtheria, tetanus, pertussis, poliomyelitis diseases with the trial vaccine or another vaccine.
• • Thrombocytopenia or a bleeding disorders contraindicating intramuscular vaccination
• • History of major neurological diseases or seizures.
• • Febrile illness (rectal temperature ≥ 38.0°C or axillary temperature ≥ 37.4°C) on the day of inclusion.
• • Known family history of congenital or genetic immuno-deficiency.