Status:
COMPLETED
REVAXIS® Versus DT Polio® as a Second Booster in 6 Year-old Children
Lead Sponsor:
Sanofi Pasteur, a Sanofi Company
Conditions:
Diphtheria
Tetanus
Eligibility:
All Genders
6-6 years
Phase:
PHASE3
Brief Summary
Primary objective: To demonstrate the non inferiority between REVAXIS® and DT Polio® when given as a second booster to healthy 6 year-old children . Secondary objectives: * Additional immunogenicit...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
760 Patients enrolled
Trial Details
Trial ID
NCT00447525
Start Date
February 1 2007
End Date
January 1 2008
Last Update
September 11 2017
Active Locations (64)
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1
Albertville, France, 95880
2
Albi, France, 81000
3
Angers, France, 49100
4
Annecy, France, 74000