Status:
COMPLETED
Safety and Immunogenicity of H5N1 Adjuvanted, Inactivated, Split-Virion Pandemic Influenza Vaccine in Healthy Adults
Lead Sponsor:
Sanofi Pasteur, a Sanofi Company
Conditions:
Pandemic Influenza
Influenza A Virus Infection
Eligibility:
All Genders
18-40 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to test different adjuvanted vaccine formulations as a two-dose schedule in immunologically naïve adults against one vaccine formulation without adjuvant in terms of toler...
Eligibility Criteria
Inclusion
- Inclusion Criteria :
- Aged 18 to 40 years on 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.
- Exclusion Criteria :
- Participation in another clinical trial in the 4 weeks preceding the first trial vaccination.
- Planned participation in another clinical trial during the present trial period.
- Previous participation in a clinical trial involving an investigational flu pandemic vaccine.
- Vaccination with an influenza vaccine during the past 6 months
- Any vaccination in the 4 weeks preceding the first trial vaccination
- Vaccination planned in the 4 weeks following any trial vaccination
- Breast-feeding.
- For a woman of child-bearing potential, the absence of an effective method of contraception or abstinence non observed for at least 4 weeks prior to the first vaccination and at least 4 weeks after the last vaccination.
- Congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroid therapy.
- Known human immunodeficiency virus (HIV), hepatitis B (AgHBs) or hepatitis C seropositivity.
- Known systemic hypersensitivity to egg proteins, chick proteins, or to any of the vaccine components, or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances.
- Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination.
- Chronic illness at a stage that could interfere with trial conduct or completion.
- Current abuse of alcohol or drug addiction that may interfere with the subject's ability to comply with trial procedures.
- Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.
- Blood or blood-derived products received in the past 3 months.
- Febrile illness (temperature ≥ 37.5°C) on the day of inclusion.
- Laboratory abnormalities considered clinically significant upon the Investigator's judgment in blood sample taken at screening (for Step 1 only)
Exclusion
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
251 Patients enrolled
Trial Details
Trial ID
NCT00457509
Start Date
January 1 2007
End Date
September 1 2010
Last Update
January 14 2014
Active Locations (3)
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1
Brussels, Belgium
2
Ghent, Belgium
3
Leuven, Belgium