Multi-Year Study of Fluzone High-Dose Influenza Vaccine Compared With Fluzone® Vaccine in Adults Aged 65 Years and Older
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Trivalent inactivated influenza vaccine High Dose; Trivalent inactivated influenza vaccine
Intervention description: 0.5 mL, Intramuscular; 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: 9172.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza; Respiratory Tract Infections; Influenza-like illness; Elderly; Fluzone®; Efficacy

Summary:

      The aim of this study is to determine the efficacy of Fluzone High Dose vaccine and that of
      Fluzone® vaccine in the elderly.

      Primary objective:

      To measure the efficacy of the vaccine, defined as the prevention of laboratory-confirmed
      influenza caused by viral types/subtypes that are antigenically similar to those contained in
      the respective annual vaccine formulations.

      Secondary objectives:

        -  To compare the clinical efficacy of Fluzone High Dose vaccine with that of Fluzone®
           vaccine in elderly adults, with respect to laboratory-confirmed influenza illness caused
           by any type or subtype of influenza virus.

        -  To compare the clinical efficacy of Fluzone High Dose vaccine with that of Fluzone®
           vaccine in elderly adults, in preventing culture-confirmed influenza illness caused by
           viral types/subtypes antigenically similar to those contained in the respective annual
           vaccine formulations.
    

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 in another interventional clinical trial investigating a vaccine, drug,
             medical device, herbal supplement, or a medical procedure in the 4 weeks preceding the
             trial vaccination or planned participation in another clinical trial investigating a
             vaccine, drug, medical device, herbal supplement, or a medical procedure during each
             year of participation in the study trial.

          -  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 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, bleeding disorder, or anticoagulation therapy contraindicating
             intramuscular (IM) vaccination.

          -  Known or suspected human immunodeficiency virus (HIV), Hepatitis B surface antigen
             (HBsAg), or Hepatitis C seropositivity.

          -  Alcohol abuse or drug addiction that could interfere with the subject's ability to
             comply with trial procedures.

          -  Subject deprived of freedom by an administrative or court order, or in an emergency
             setting, or hospitalized without his/her consent.

          -  Bedridden subjects.