A Study of Fluzone® High-Dose Vaccine Compared With Fluzone® Vaccine In Elderly Adults
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: High Dose Trivalent Inactivated Influenza Vaccine; Trivalent Inactivated Influenza Vaccine
Intervention description: 0.5 mL Intramuscular; 0.5 mL, Intramuscular
Intervention MeSH terms: Vaccines
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 31989.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza; Trivalent Inactivated Influenza Vaccine; High-Dose Trivalent Inactivated Influenza Vaccine; Fluzone® High-Dose; Influenza vaccines

Summary:

      The aim of this study is to determine the efficacy of Fluzone High-Dose compared to standard
      dose Fluzone for laboratory-confirmed or culture-confirmed influenza caused by influenza
      types/subtypes that are similar (for laboratory-confirmed) or antigenically similar (for
      culture-confirmed) to those contained in the respective annual vaccine formulations.

      Primary Objective:

        -  To compare the clinical efficacy of Fluzone High-Dose to that of Fluzone in elderly
           adults, with respect to laboratory-confirmed influenza caused by any influenza viral
           types/subtypes, associated with the occurrence of a protocol-defined
           influenza-like-illnesses (ILI).

      Secondary Objectives:

        -  To compare the clinical efficacy of Fluzone High-Dose to that of Fluzone in elderly
           adults, with respect to laboratory-confirmed influenza, caused by any influenza viral
           types/subtypes, associated with the occurrence of a protocol-defined ILI.

        -  To compare the clinical efficacy of Fluzone High-Dose to that of Fluzone in elderly
           adults, with respect to culture-confirmed influenza, caused by any influenza viral
           types/subtypes, associated with the occurrence of a protocol-defined ILI.

        -  To compare the clinical efficacy of Fluzone High-Dose to that of Fluzone in elderly
           adults, with respect to culture-confirmed influenza caused by viral types/subtypes
           antigenically similar to those contained in the respective annual vaccine formulations,
           associated with the occurrence of a modified Centers for Disease Control and Prevention
           (CDC)-defined ILI.

        -  To compare the clinical efficacy of Fluzone High-Dose to that of Fluzone in elderly
           adults, with respect to culture-confirmed influenza caused by any influenza viral
           types/subtypes, associated with the occurrence of a modified CDC-defined ILI.

        -  To compare the clinical efficacy of Fluzone High-Dose to that of Fluzone in elderly
           adults, with respect to culture-confirmed influenza caused by viral types/subtypes
           antigenically similar to those contained in the respective annual vaccine formulations,
           associated with the occurrence of a respiratory illness.

        -  To compare the clinical efficacy of Fluzone High-Dose to that of Fluzone in elderly
           adults, with respect to culture-confirmed influenza caused by any influenza viral
           types/subtypes, associated with the occurrence of a respiratory illness.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged ≥ 65 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.

        Exclusion Criteria:

          -  Participation at the time of study enrollment (or in the 4 weeks preceding the trial
             vaccination), or planned participation during each year of the trial period, in
             another clinical trial investigating a vaccine, drug, medical device, or medical
             procedure (Note: Concomitant participation in an observational trial is acceptable)

          -  Vaccination against influenza in the 6 months preceding the trial vaccination

          -  Systemic hypersensitivity to eggs, chicken proteins, or any of the vaccine components,
             or a history of a life-threatening reaction to Fluzone High-Dose or Fluzone vaccine or
             to a vaccine containing any of the same substances

          -  Personal history of Guillain-Barré Syndrome

          -  Dementia or any other cognitive condition at a stage that could interfere with
             following the trial procedures

          -  Thrombocytopenia contraindicating intramuscular (IM) vaccination, as judged by the
             investigator

          -  Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion,
             contraindicating intramuscular vaccination, as judged by the investigator

          -  Current alcohol abuse or drug addiction

          -  Subject deprived of freedom by an administrative or court order, or in an emergency
             setting, or hospitalized involuntarily

          -  Identified as an Investigator or employee of the Investigator or study center with
             direct involvement in the proposed study, or identified as an immediate family member
             (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with
             direct involvement in the proposed study

          -  Moderate or severe acute illness with or without fever (oral temperature > 99.0ºF [>
             37.2ºC]). If this contraindication exists, vaccination will be deferred until the
             individual has been medically stable and/or afebrile (temperature ≤ 99.0 ºF [≤
             37.2ºC]) for at least 24 hours

          -  Signs and symptoms of an acute infectious respiratory illness. If this exists,
             vaccination will be deferred until the symptoms resolve.