Status:
COMPLETED
Study of Immune Response in Adults and Elderly Subjects Vaccinated With Inactivated Influenza Vaccines
Lead Sponsor:
Sanofi Pasteur, a Sanofi Company
Conditions:
Influenza
Orthomyxovirus Infections
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
Brief Summary
To further characterize the immune responses induced after an influenza vaccination performed either via the ID or the IM routes in two clearly distinct populations. Objectives: * To describe the im...
Eligibility Criteria
Inclusion
- Inclusion Criteria :
- Aged 18 to 40 years (adults) or 60 to 85 years (elderly)
- Provision of a signed informed consent
- Able to attend all scheduled visits and comply with all trial procedures
- For a woman of child-bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks prior to vaccination, until 4 weeks after vaccination
- Entitlement to national social security.
- Exclusion Criteria :
- For a woman of child-bearing potential, known pregnancy or positive urine pregnancy test
- Breast-feeding woman
- Participation in another clinical trial investigating a vaccine, drug, medical device or a medical procedure in the 4 weeks preceding the trial vaccination
- Planned participation in another clinical trial during the present trial period
- Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy
- Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances
- Chronic illness, at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator
- Current alcohol abuse or drug addiction, which may interfere with the subject's ability to comply with trial procedures
- Receipt of blood or blood-derived products in the past 3 months, which might interfere with the assessment of immune response
- Receipt of any vaccine in the 4 weeks preceding the trial vaccination
- Planned receipt of any vaccine in the 4 weeks following the trial vaccination
- Known Human Immunodeficiency Virus, Hepatitis B or Hepatitis C seropositivity
- Previous vaccination against Influenza in the previous 6 months
- Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding the inclusion contraindicating IM vaccination
- Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent
- Febrile illness (oral temperature \>=37.5°C) or moderate or severe acute illness/infection on the day of vaccination, according to investigator judgment
Exclusion
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT00776438
Start Date
September 1 2007
End Date
April 1 2009
Last Update
June 17 2015
Active Locations (1)
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1
Lyon Sud, France