Study of Fluzone® Quadrivalent, Fluzone® Intradermal Quadrivalent, and Fluzone® High-Dose, Influenza Vaccines in Adults
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Fluzone Quadrivalent vaccine, 2015-2016 formulation, No Preservative; Fluzone Intradermal Quadrivalent vaccine, 2015-2016 formulation; Fluzone Quadrivalent vaccine, 2015-2016 formulation, No Preservative; Fluzone High-Dose vaccine, 2015-2016 formulation
Intervention description: 0.5 mL, Intramuscular (IM); 0.1 mL, Intradermal; 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: None (Open Label)
Enrollment: 208.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza; Fluzone® Quadrivalent, Influenza Vaccine; Fluzone® Intradermal Quadrivalent, Influenza Vaccine; Fluzone® High Dose, Influenza Vaccine

Summary:

      The aim of the study is to evaluate the safety and immunogenicity of the 2015-2016
      formulations of Fluzone Quadrivalent and Fluzone Intradermal Quadrivalent vaccines in adults
      18 to < 65 years of age, and of the 2015-2016 formulations of Fluzone Quadrivalent and
      Fluzone High-Dose vaccines in adults ≥ 65 years of age.

      Primary Objective:

      - To describe the safety of the 2015-2016 formulations of Fluzone Quadrivalent and Fluzone
      Intradermal Quadrivalent vaccines in adults 18 to < 65 years of age and the safety of the
      2015-2016 formulations of Fluzone Quadrivalent and Fluzone High-Dose vaccines in adults ≥ 65
      years of age.

      Observational Objectives:

        -  To describe the immunogenicity of the 2015-2016 formulations of Fluzone Quadrivalent and
           Fluzone Intradermal Quadrivalent vaccines in adults 18 to < 65 years of age and the
           immunogenicity of the 2015-2016 formulations of Fluzone Quadrivalent and Fluzone
           High-Dose vaccines in adults ≥ 65 years of age.

        -  To evaluate the compliance, in terms of immunogenicity, of each study vaccine (Fluzone
           Quadrivalent, Fluzone Intradermal Quadrivalent, and Fluzone High-Dose) in the applicable
           age group with the historical requirements of the Committee for Human Medicinal Products
           (CHMP) Note for Guidance (NfG) Committee for Propriety Medicinal Products (CPMP) - CHMP
           NfG CPMP/BWP/214/96.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is ≥ 18 years of age on the day of inclusion

          -  Informed consent form has been signed and dated

          -  Able to attend all scheduled visits and to comply with all trial procedures.

        Exclusion Criteria:

          -  History of serious adverse reaction to any influenza vaccine

          -  Receipt of any vaccine within 30 days before receiving study vaccine, or plans to
             receive another vaccine before Visit 2

          -  Participation in another interventional clinical trial investigating a vaccine, drug,
             medical device, or medical procedure in the 30 days preceding the first study
             vaccination or during the course of the study, unless no intervention for the other
             study occurred within the 30 days prior to the first study vaccination and none are
             planned before the subject would complete safety surveillance for the present study

          -  Thrombocytopenia, which may be a contraindication for intramuscular vaccination, at
             the discretion of the Investigator

          -  Prior vaccination with any 2015-2016 formulation of influenza vaccine

          -  Known systemic hypersensitivity to eggs, chicken proteins, or any of the vaccine
             components, or a history of a life-threatening reaction to Fluzone Quadrivalent,
             Fluzone Intradermal Quadrivalent, or Fluzone High-Dose vaccine or to a vaccine
             containing any of the same substances (the complete list of vaccine components is
             included in the Prescribing Information)

          -  Receipt of immune globulins, blood, or blood-derived products in the past 3 months

          -  Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion,
             which may be a contraindication for intramuscular vaccination, at the discretion of
             the Investigator

          -  Subject is pregnant, or lactating, or of childbearing potential (to be considered of
             non-childbearing potential, a female must be post-menopausal for at least 1 year,
             surgically sterile, or using an effective method of contraception or abstinence from
             at least 4 weeks prior to vaccination and until at least 4 weeks after vaccination)

          -  Any condition that in the opinion of the Investigator would pose a health risk to the
             subject if enrolled or could interfere with the evaluation of the vaccine

          -  Personal history of Guillain-Barré syndrome

          -  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
             (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)

          -  Chronic illness that, in the opinion of the Investigator, is at a stage where it might
             interfere with trial conduct or completion

          -  Seropositivity for human immunodeficiency virus, hepatitis B, or hepatitis C, as
             reported by the subject.

          -  Deprived of freedom by an administrative or court order, or in an emergency setting,
             or hospitalized involuntarily

          -  Current alcohol or drug addiction that, in the opinion of the Investigator, might
             interfere with the ability to comply with trial procedures

          -  Moderate or severe acute illness/infection (according to Investigator judgment) or
             febrile illness (temperature ≥ 100.4°F) on the day of vaccination. A prospective
             subject should not be included in the study until the condition has resolved or the
             febrile event has subsided

          -  Identified as an Investigator or employee of an 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 an Investigator or employee with
             direct involvement in the proposed study.