Study of Influenza Vaccine Revaccination in Healthy Adults Previously Vaccinated With Fluzone ID or Fluzone IM
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Influenza Virus Vaccine USP Trivalent Types A and B; Influenza Virus Vaccine USP Trivalent Types A and B; Influenza Virus Vaccine USP Trivalent Types A and B; Influenza Virus Vaccine USP Trivalent Types A and B
Intervention description: 0.1 mL, Intradermal; 0.5 mL, Intramuscular; 0.5 mL, Intramuscular; 0.1 mL, Intradermal
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1250.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza; Fluzone Vaccine; Intradermal Injections; Adults

Summary:

      The purpose of this study is to generate additional data on the immunogenicity and safety of
      revaccination with Fluzone Intradermal (ID) or Fluzone Intramuscular (IM) vaccine.

      Primary Objective:

        -  To evaluate and describe the safety profile of revaccination with Fluzone ID for all
           participants.

      Secondary Objective:

        -  To describe immunogenicity following revaccination with Fluzone ID or Fluzone IM.
    

Eligibility criteria:

        Inclusion Criteria :

          -  Aged 18 to 64 years on the day of vaccination in study FID33

          -  Enrolled in and completed study FID31 (NCT 00772109) and received the correct vaccine
             (Fluzone ID or Fluzone® IM) for the group to which they were randomized

          -  Informed consent form signed and dated

          -  Able to attend all scheduled visits and to comply with all trial procedures

          -  For a woman 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
             (observational trials will be allowed)

          -  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

          -  Known human immunodeficiency virus (HIV), hepatitis B surface (HBs) antigen, or
             Hepatitis C seropositivity.

          -  Previous vaccination against influenza in the past 6 months with the trial vaccine or
             another vaccine

          -  Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding
             inclusion contraindicating IM vaccination

          -  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, (those who have localized skin or
             prostate cancer that is stable at the time of vaccination in the absence of therapy,
             as well as subjects who have a history of neoplastic disease and who have been disease
             free for ≥ 5 years will not be excluded).

          -  Personal or family history of Guillain-Barré Syndrome

        Temporary Exclusion Criteria:

        A prospective subject should not be included in the study until the following conditions
        and/or symptoms are resolved:

          -  Febrile illness (temperature ≥ 37.5°C [or ≥ 99.5°F]) or moderate or severe acute
             illness/infection on the day of vaccination, according to investigator judgment

          -  Signs and symptoms of an acute infectious respiratory illness.