A Study to Evaluate the Safety and Immune Responses to Fluzone® Vaccination

Safety and Immunogenicity of Influenza Virus Vaccine USP Trivalent Types A and B (Zonal Purified Subvirion) Fluzone® 2003/2004

To describe the safety during days 0 to 21 following injection of the 2003-2004 formulation of the inactivated, split-virion influenza vaccine Fluzone® in subjects aged 18-59 years and subjects aged ≥ 60 years.

To describe the immune response at 21 days following injection of the 2003-2004 formulation of the inactivated, split-virion influenza vaccine Fluzone®, in subjects aged 18-59 years and subjects aged ≥ 60 years.

Safety will be assessed throughout the trial period. Using antigens provided by Aventis Pasteur Inc., pre- and post-vaccination serum antibody titers for each of the three vaccine strains will be measured.

Inclusion Criteria :

• Age of 18 years or greater.
• Ambulatory.
• In reasonably good health as assessed by the investigator.
• Available for duration of the study (21 days + 2d).
• Willing and able to meet protocol requirements.
• Willing and able to give informed consent.

Exclusion Criteria :

• Self-reported allergy to egg proteins, chicken proteins, or one of the constituents of the vaccine, such as thimerosal or formaldehyde.
• An acute illness with or without fever (temperature >100.4°F) in the 72 hours preceding enrollment in the trial.
• Clinically significant findings in vital signs (including temperature >100.4°F) or review of systems.
• Self-reported history of severe adverse event to any influenza vaccine.
• Vaccination against influenza in the 6 months preceding enrollment in the study.
• Any vaccination in the 14 days preceding enrollment in the study or scheduled between Visit 1 and Visit 3.
• Participation in any other experimental drug or vaccine trial within the 30 days preceding enrollment into the study.
• Immunosuppressive therapy including long-term (> 2 weeks) systemic corticosteroids or cancer therapy within the past 3 months or ongoing.
• Receipt of blood or blood products within the 3 months preceding enrollment in the study.
• Diabetes
• Any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the evaluation of the vaccine (e.g., existing severe chronic illness such as pulmonary disorders, cardiovascular disorders, chronic blood disorders, etc.).
• Person deprived of freedom by an administrative or court order (having legal or medical guardian).
• For women of childbearing age, a positive urine pregnancy test, breast feeding, or not using a medically approved and reliable form of contraception (oral contraceptives or double barrier method) for the duration of the trial.