Status:
COMPLETED
Safety of Imovax Polio in Chinese Infants and Children
Lead Sponsor:
Sanofi Pasteur, a Sanofi Company
Conditions:
Poliomyelitis
Eligibility:
All Genders
2-18 years
Phase:
PHASE3
Brief Summary
To describe the tolerance in terms of occurrence of serious adverse reactions and severe adverse reactions (injection site and systemic) within eight days after one dose of IMOVAX Polio™ administered ...
Eligibility Criteria
Inclusion
- Group 1: Aged 18 months (18-20 months) on the day of inclusion
- Group 2: Aged 2 months (56-70 days) on the day of inclusion
Exclusion
- Participation in another clinical trial in the 4 weeks preceding the 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 3 months (for Group 1) or since birth (for Group 2)
- Any vaccination in the 4 weeks preceding the trial vaccination (except BCG and Hepatitis B \[Hep B\] for Group 2)
- Vaccination planned in the 4 weeks following the trial vaccination
- Group 1: Previous booster vaccination against the poliomyelitis infection with the trial vaccine or with another vaccine.
- Group 2: Previous vaccination against the poliomyelitis infection with the trial vaccine or with another vaccine.
- History of poliomyelitis infection (confirmed either clinically, serologically or microbiologically)
- Clinical or serological evidence of systemic illness including Hepatitis B, C and HIV
- Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
- History of/current seizures
- Febrile illness (axillary temperature ≥ 37.4°C) or acute illness on the day of inclusion
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2006
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00258843
Start Date
November 1 2005
End Date
April 1 2006
Last Update
January 22 2014
Active Locations (1)
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1
Pingle, China