Study of Fluzone Vaccine Administered by Intradermal Route in Comparison With Standard Fluzone® in Adults

Three lots of the investigational Fluzone vaccine with the 2008/2009 Northern Hemisphere formulation will be administered intradermally (ID) using the Becton Dickinson Micro Injection System.

Inclusion criteria

• Aged 18 to 64 years on the day of vaccination.
• Informed consent form signed and dated.
• Able to attend all scheduled visits and to comply with all trial procedures.
• For women 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 at least 4 weeks after vaccination.

Exclusion criteria

• 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.
• For a woman of child-bearing potential: known pregnancy or positive serum/urine pregnancy test.
• Breast-feeding woman.
• Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the four 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
• 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 that may interfere with the subject's ability to comply with trial procedures.
• Receipt of blood or blood-derived products in the past 3 months that might interfere with the assessment of immune response.
• Receipt of any vaccination in the 4 weeks preceding the trial vaccination.
• Planned receipt of any vaccine in the 4 weeks following the trial vaccination.
• Previous vaccination against influenza in the past 6 months with the trial vaccine or another vaccine.
• Thrombocytopenia or bleeding disorder in the 3 weeks preceding inclusion.
• Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.
• Neoplastic disease or any hematologic malignancy, (except localized skin or prostate cancer that is stable at the time of vaccination in the absence of therapy, and subjects who have a history of neoplastic disease and who have been disease free for >=5 years).
• Personal or family history of Guillain-Barré Syndrome.