Study of Fluzone Vaccine Administered by Intradermal Route in Comparison With Standard Fluzone® in Adults
Condition: Orthomyxoviridae Infection; Influenza; 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
Intervention description: 0.1 mL, Intradermal; 0.1 mL, Intradermal; 0.1 mL, Intradermal; 0.5 mL, Intramuscular
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 4292.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza; Orthomyxoviruses; Inactivated Split-virion influenza vaccine; Fluzone®; Adults

Summary:

      This study is designed to test lot consistency of three different manufacturing lots and to
      generate safety and immunogenicity data of the investigational vaccine administered via the
      ID route.

      Primary Objective:

        -  To demonstrate lot consistency of the Fluzone ID manufacturing process.

        -  To provide information concerning the immune response of Fluzone ID.

      Secondary Objectives:

      Safety

        -  To describe the safety profile of subjects who receive of Fluzone ID.
    

Eligibility criteria:

        Inclusion Criteria :

          -  Aged 18 to 64 years on the day of vaccination.

          -  Informed consent form signed and dated.

          -  Able to attend all scheduled visits and to comply with all trial procedures.

          -  For women 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.

          -  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.

          -  Previous vaccination against influenza in the past 6 months with the trial vaccine or
             another vaccine.

          -  Thrombocytopenia or bleeding disorder in the 3 weeks preceding inclusion.

          -  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, and
             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.