Status:
COMPLETED
Safety of REPEVAX® Given One Month After REVAXIS®
Lead Sponsor:
Sanofi Pasteur, a Sanofi Company
Conditions:
Healthy Adult
Eligibility:
All Genders
18-40 years
Phase:
PHASE3
Brief Summary
Primary objective: * To describe the safety profile of a Tetanus, Diphtheria, Poliomyelitis and Pertussis vaccine (REPEVAX®) when administered as a pertussis booster 1 month after a Tetanus, Diphther...
Eligibility Criteria
Inclusion
- Healthy adult, with vaccination history (by written evidence) of a minimum of 5 doses of a tetanus, diphtheria and poliomyelitis containing vaccine as recommended in the French vaccination calendar at 18 years old, and a maximum of 8 doses.
- Last dose of a tetanus and/or diphtheria and/or poliomyelitis containing vaccine administered either alone or in combination at least 5 years prior to the administration of the first study vaccine.
Exclusion
- Prior known hypersensitivity reaction to any diphtheria and/or tetanus and/or poliomyelitis and/or pertussis containing vaccine
- Any current (≤ 3 days) significant underlying disease or acute febrile illness (oral temperature ≥37.5°C)
- Known immunological deficiency
- Known malignant disease
- Known neurological disorder
- Any long-term (≥ 14 days) non steroid anti-inflammatory therapy given daily within the previous 30 days
- Known history of severe thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection
- Any previous (≤ 90 days) administration of blood-derived products or immunoglobulins or scheduled to be administered through Visit 3
- Any recent administration (≤ 30 days) of a vaccine or scheduled vaccination
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2007
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT00400309
Start Date
June 1 2006
End Date
February 1 2007
Last Update
September 11 2017
Active Locations (4)
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1
Clermont-Ferrand, France
2
Lyon, France
3
Montpellier, France
4
Paris, France