Status:
COMPLETED
Safety and Immunogenicity of an Intramuscular Pandemic Influenza Vaccine in Adults and the Elderly
Lead Sponsor:
Sanofi Pasteur, a Sanofi Company
Conditions:
Influenza
Orthomyxoviridae Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Based on the results from a previous formulation/dosage ranging trial, this phase II multicenter, open trial was designed to determine the safety and immunogenicity of two vaccine formulation/dosages ...
Eligibility Criteria
Inclusion
- Inclusion Criteria :
- Aged over 18 years on the day of inclusion
- Informed consent form signed
- Able to attend all scheduled visits and to comply with all trial procedures
- For a woman, inability to bear a child or negative urine pregnancy test
- For a woman of child-bearing potential, use of an effective method of contraception or abstinence for at least 4 weeks prior and at least 4 weeks after to each vaccination.
- Exclusion Criteria :
- Systemic hypersensitivity to any component of the vaccine or a life-threatening reaction after previous administration of a vaccine containing the same substances
- Febrile illness (oral temperature ≥ 37.5°C) on the day of inclusion
- Breast-feeding
- Previous vaccination with an avian flu vaccine
- Participation in a clinical trial (drug, device, or medical procedure) within 4 weeks prior to the first vaccination
- Planned participation in another clinical trial during the present trial period
- Congenital or acquired immunodeficiency, or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months or long-term systemic corticosteroid therapy
- Chronic illness that could interfere with trial conduct or completion (e.g. cardiac, renal, diabetes, or auto-immune disorders)
- Current alcohol or drug abuse that may interfere with the subject's ability to comply with trial procedures
- Receipt of blood or blood-derived products within the past 3 months
- Any vaccination within 4 weeks prior to the first trial vaccination
- Vaccination planned within 4 weeks after any trial vaccination
- Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination
- Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.
Exclusion
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT00415129
Start Date
June 1 2006
End Date
March 1 2009
Last Update
January 14 2014
Active Locations (4)
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1
Ghent, Belgium
2
Leuven, Belgium
3
Wilrijk, Belgium
4
Oxford, United Kingdom