Influenza Vaccine Revaccination in Ambulatory Elderly Subjects
Condition: Influenza; Orthomyxovirus Infection; Myxovirus Infection
MeSH terms: Infections; Communicable Diseases; Influenza, Human; Orthomyxoviridae Infections
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; 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; 0.5 mL, Intramuscular
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 807.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza; Orthomyxovirus Infection; Inactivated Split-virion influenza vaccine; Elderly

Summary:

      This is a multi-center study designed to evaluate the safety and immunogenicity of a Fluzone
      revaccination in elderly adults aged ≥ 65 years.

      Primary Objective:

      To describe the safety profile for all subjects.

      Secondary Objective:

      To describe immunogenicity 28 days following revaccination with one of three Fluzone
      formulations.
    

Eligibility criteria:

        Inclusion Criteria :

          -  Aged ≥ 65 years on the day of vaccination

          -  Enrolled in and completed study FID29 and received the correct vaccine 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

          -  Subject is medically stable.

        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

          -  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

          -  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 (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 intramuscular (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, (except 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).

          -  Personal or family history of Guillain-Barré Syndrome.