Pandemic Influenza Clinical Trial
Verified date | January 2014 |
Source | Sanofi |
Contact | n/a |
Is FDA regulated | No |
Health authority | Belgium: Federal Agency for Medicines and Health Products, FAMHP |
Study type | Interventional |
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 tolerance and immunogenicity
Primary Objective:
To describe the safety profile and immunogenicity following each injection.
Status | Completed |
Enrollment | 251 |
Est. completion date | September 2010 |
Est. primary completion date | November 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 40 Years |
Eligibility |
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) |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Sanofi Pasteur, a Sanofi Company |
Belgium,
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---|---|---|---|---|
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