Safety and Immunogenicity of the World Health Organization (WHO) Formulation of the 2004-2005 Fluzone® Vaccine
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Fluzone®: Influenza virus vaccine 2004-2005 formulation; Fluzone®: Influenza virus vaccine 2004-2005 formulation
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: 120.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Fluzone®; Influenza; Adults

Summary:

      To observe and to describe the safety during Days 0 to 21 following injection of the
      2004-2005 formulation of the inactivated, split-virion influenza vaccine Fluzone® in subjects
      aged 18-59 years and subjects aged ≥ 60 years.

      To measure and to describe the immune response (antibodies to hemagglutinin) 21 days
      following injection of the 2004-2005 formulation of the inactivated, split-virion influenza
      vaccine Fluzone®, in subjects aged 18-59 years and subjects aged ≥ 60 years.
    

Eligibility criteria:

        Inclusion Criteria :

          -  Participant aged 18 years or older.

          -  Participant able to attend scheduled visits and to comply with the study procedures
             during the entire duration of the study.

          -  Participant is in reasonably good health as assessed by the investigator.

          -  Participant willing and able to meet protocol requirements.

          -  Participant 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) on
             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.

          -  Immunogenicity 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 3 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 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.