A Study to Evaluate the Safety and Immune Responses to Fluzone® Vaccination
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Split, Inactivated, Trivalent Influenza vaccine (Fluzone®)
Intervention description: 0.5 mL, intramuscular
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 120.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza

Summary:

      To describe the safety of the inactivated, split-virion influenza vaccine, 2008-2009
      formulation.

      To evaluate the compliance, in terms of immunogenicity, of the inactivated, split-virion
      influenza vaccine 2008-2009 formulation with the requirements of the Committee for Human
      Medicinal Products (CHMP) Note for Guidance (NfG) CPMP/BWP/214/96.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant is 18 years of age or older on the day of inclusion.

          -  Participant willing and able to attend scheduled visits and to comply with the study
             procedures during the entire duration of the study.

          -  Participant in reasonably good health as assessed by the Investigator.

          -  Participant willing and able to give informed consent.

          -  For a woman, inability to bear a child or negative serum/urine pregnancy test.

        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 in the 72 hours preceding enrollment in the
             trial.

          -  Clinically significant findings in vital signs (including temperature ≥ 99.5°F oral)
             or review of systems.

          -  Self-reported history of severe adverse event to any influenza vaccine.

          -  Laboratory-confirmed influenza infection or 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 2.

          -  Participation in any other interventional drug or vaccine trial within the 30 days
             preceding or during enrollment into this study.*

          -  Immunocompromising condition or immunosuppressive therapy (including systemic steroid
             use for 2 weeks or more), cancer chemotherapy, or radiation therapy at the time of
             enrollment, planned during the period of this study, or at any time within the past 6
             months.

          -  Receipt of blood or blood products within the 3 months preceding enrollment in the
             study.

          -  Diabetes mellitus requiring pharmacological control.

          -  Any condition that in the opinion of the Investigator would pose a health risk to the
             subject if enrolled or could interfere with the evaluation of the vaccine.

          -  Person deprived of freedom by an administrative or court order (having legal or
             medical guardian).

          -  For women of childbearing potential, 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.

          -  Current use of alcohol or recreational drugs that may interfere with the subject's
             ability to comply with trial procedures.

          -  Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination.

          -  Prior personal history of Guillain-Barré syndrome. * Subjects enrolled into this study
             will not be prohibited from donating blood for non-interventional studies.