Study of Inactivated, Split-Virion Influenza Vaccine Compared With Standard Fluzone Vaccine in Elderly Subjects
Condition: Orthomyxoviridae Infection; Influenza; Myxovirus Infection
MeSH terms: Infections; Communicable Diseases; Influenza, Human; Orthomyxoviridae Infections
Intervention: Split, Inactivated, Trivalent Influenza Vaccine; Split, Inactivated, Trivalent Influenza Vaccine
Intervention description: 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: 817.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza; Orthomyxoviruses; Inactivated Split-virion influenza vaccine; Elderly.

Summary:

      As a result of the safety and immunogenicity data generated from earlier dose-ranging
      studies, the present formulation has been selected for further development in the elderly.

      Primary Objective:

      To compare the immunogenicity in subjects receiving investigational Fluzone with those of
      subjects receiving standard Fluzone®.

      Secondary Objectives:

      Immunogenicity:

      To describe the immunogenicity in subjects receiving investigational Fluzone and standard
      Fluzone®.

      Safety:

      To evaluate and describe the safety profile of investigational Fluzone in terms of solicited-
      and unsolicited adverse events and serious adverse events post-vaccination.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged ≥ 65 years on the day of vaccination.

          -  Informed consent form signed.

          -  Medically stable (Subjects may have underlying illnesses such as hypertension,
             diabetes, ischemic heart disease, congestive cardiac disorders or hypothyroidism, as
             long as their symptoms/signs are controlled).

          -  Able to attend all scheduled visits and to comply with all trial procedures.

        Exclusion Criteria:

          -  Systemic hypersensitivity to eggs, chicken proteins, or any of the vaccine components,
             or a history of a life-threatening reaction to the standard-dose Fluzone® vaccine or a
             vaccine containing the same substances (the list of vaccine components is included in
             the Investigator's Brochure).

          -  Congenital or history of acquired immunodeficiency, or immunosuppressive therapy such
             as anti-cancer chemotherapy or radiation therapy within the preceding 6 months.

          -  Systemic corticosteroid therapy as follows:

          -  Continuous use with a dosage equivalent to > 15 mg/day of oral prednisone for 90 days
             preceding vaccination

          -  Sporadic use with a dose of > 40 mg/day of oral prednisone for > 14 days in the 90
             days preceding vaccination.

        Note: Use of topical or inhalant corticosteroids is acceptable.

          -  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).

          -  Current abuse of alcohol 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.

          -  Vaccination against influenza in the past 6 months.

          -  Any vaccination in the 4 weeks preceding the trial vaccination.

          -  Vaccination planned in the 4 weeks following the trial vaccination.

          -  Participation in another clinical trial in the 4 weeks preceding trial vaccination.

          -  Planned participation in another clinical trial during the present trial period.
             Concomitant participation in an observational trial (not involving drugs, vaccines, or
             medical devices) is acceptable.

          -  Chronic illness at a stage that could interfere with trial conduct or completion.

          -  Known current HIV, hepatitis B (HBsAg) or hepatitis C infection or seropositivity.

          -  Known thrombocytopenia or bleeding disorder contraindicating IM vaccination.

          -  Subject deprived of freedom by an administrative or court order, or in an emergency
             setting, or hospitalized without his/her consent.

          -  Acute illness and febrile illness with a temperature ≥ 38.0°C [or 100.4°F]) 72 hours
             before or on the day of inclusion.

          -  Received antibiotics therapy within 72 hours preceding the trial vaccination.

          -  Received any allergy shots in the 7-day period preceding trial vaccination and/or
             scheduled to receive any allergy shots in the 7-day period after trial vaccination.

          -  Any condition, which in the opinion of the investigator would pose a health risk to
             the participant.