REVAXIS® Versus DT Polio® as a Second Booster in 6 Year-old Children

Launched by SANOFI PASTEUR, A SANOFI COMPANY · Mar 13, 2007

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Healthy child without chronic severe disease of either gender,
• • 2. 6 year-old child on vaccination day,
• • 3. Child previously vaccinated with three doses of a diphtheria, tetanus and poliomyelitis containing vaccine given alone or in combination within the first 6 months of life and a booster dose of a diphtheria, tetanus and poliomyelitis containing vaccine given alone or in combination at 16 - 18 months of life (±2 months),
• • 4. Consent form signed by both parents, or by the legal representative, properly informed about the study.
• Exclusion Criteria:
• • 1. Child who had received less or more than 4 doses of a diphtheria, tetanus and/or poliomyelitis containing vaccine,
• • 2. Previous clinical or bacteriological diagnosis of diphtheria, tetanus or poliomyelitis,
• • 3. Child who had received any vaccine in the previous 30 days or with a vaccination scheduled during the course of the study,
• • 4. Child who present with immune impairment or humoral/cellular deficiency, neoplastic disease or depressed immunity,
• • 5. Child who had received within the previous 150 days or who will receive during the course of the study, any immunoglobulins or blood derived products,
• • 6. Child with true hypersensitivity to at least one of the components of a study vaccine or to streptomycin, neomycin or polymixin B,
• • 7. Known personal history of encephalopathy, seizure disorder or progressive, evolving or unstable neurological condition,
• • 8. Child who had presented severe hypersensitivity following an earlier immunization against diphtheria and/or tetanus,
• • 9. Known history of thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection,
• • 10. Acute severe febrile illness and/or oral temperature ≥37.5°C at the time of vaccination