A Study to Evaluate the Safety and Immune Responses to Fluzone® Vaccination
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Influenza virus vaccine; Influenza virus vaccine
Intervention description: 0.5 mL, Intramuscular; 0.5 mL, Intramuscular
Intervention MeSH terms: Vaccines
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 121.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza; Fluzone®

Summary:

      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.
    

Eligibility criteria:

        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.