A Study of High-Dose Trivalent Inactivated Influenza Vaccine in Adults 50 to 64 Years of Age
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 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 300.0
Sex: All
Minimum age: 50 Years
Maximum age: 64 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza; Trivalent Inactivated Influenza Vaccine; High-Dose Trivalent Inactivated Influenza Vaccine; Influenza vaccines

Summary:

      The aim of the study is to generate data on key parameters associated with assessment of
      influenza vaccines in individuals 50-64 years of age

      Primary Objective:

        -  To describe the immunogenicity of High-Dose Trivalent Inactivated Influenza Vaccine
           (TIV) compared to TIV.

        -  To describe the safety profile of High-Dose Trivalent Inactivated Influenza Vaccine, as
           assessed by solicited adverse reactions collected for 7 days post-vaccination, and
           unsolicited adverse events (including Serious Adverse Events and Adverse Events of
           Special Interests) collected between Visit 1 and Visit 2
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged 50 to 64 years (inclusive) on the day of vaccination

          -  Informed consent form has been signed and dated

          -  Medically stable

          -  Able to attend all scheduled visits and to comply with all trial procedures

          -  For a woman of childbearing potential, use of an effective method of contraception or
             abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after
             vaccination

        Exclusion Criteria:

          -  Known pregnancy, or a positive urine pregnancy test

          -  Currently breastfeeding a child

          -  Participation in another clinical trial investigating a vaccine, drug, medical device,
             or medical procedure in the 4 weeks preceding the trial vaccination

          -  Planned participation in another clinical trial during the present trial period

          -  Planned receipt of any vaccine in the 4 weeks following the trial vaccination (prior
             to the Visit 2 blood draw)

          -  Receipt of seasonal or pandemic influenza vaccine in the past 6 months

          -  Receipt of blood or blood-derived products in the past 3 months

          -  Systemic hypersensitivity to eggs, chicken proteins, or any of the vaccine components,
             or a history of a life-threatening reaction to the standard-dose Trivalent Inactivated
             Influenza Vaccine or a vaccine containing any of the same substances

          -  Known or suspected congenital or acquired immunodeficiency; or receipt of
             immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within
             the preceding 6 months; or long-term systemic corticosteroid therapy

          -  Neoplastic disease or any hematologic malignancy

          -  Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion,
             contraindicating intramuscular vaccination

          -  Personal history of Guillain-Barré Syndrome

          -  Self-reported seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B, or
             Hepatitis C

          -  Deprived of freedom by an administrative or court order, or in an emergency setting,
             or hospitalized involuntarily

          -  Current alcohol abuse or drug addiction that might interfere with the ability to
             comply with trial procedures

          -  Identified as employees of the Investigator or study center, with direct involvement
             in the proposed study or other studies under the direction of that Investigator or
             study center, as well as family members (i.e., immediate, husband, wife and their
             children, adopted or natural) of the employees or the Investigator