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

Inclusion criteria

• Healthy child without chronic severe disease of either gender,
• 6 year-old child on vaccination day,
• 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),
• Consent form signed by both parents, or by the legal representative, properly informed about the study.

Exclusion criteria

• Child who had received less or more than 4 doses of a diphtheria, tetanus and/or poliomyelitis containing vaccine,
• Previous clinical or bacteriological diagnosis of diphtheria, tetanus or poliomyelitis,
• Child who had received any vaccine in the previous 30 days or with a vaccination scheduled during the course of the study,
• Child who present with immune impairment or humoral/cellular deficiency, neoplastic disease or depressed immunity,
• 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,
• Child with true hypersensitivity to at least one of the components of a study vaccine or to streptomycin, neomycin or polymixin B,
• Known personal history of encephalopathy, seizure disorder or progressive, evolving or unstable neurological condition,
• Child who had presented severe hypersensitivity following an earlier immunization against diphtheria and/or tetanus,
• Known history of thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection,
• Acute severe febrile illness and/or oral temperature ≥37.5°C at the time of vaccination