Study of Fluzone® Influenza Virus Vaccine 2011-2012 Formulation (Intramuscular Route) Among Adults
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Influenza Virus Vaccine: Fluzone® 2011-2012 Formulation; Influenza Virus Vaccine: Fluzone® High-Dose 2011-2012 Formulation
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: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 300.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza; Influenza Virus Vaccine; Fluzone® 2011-2012 Formulation; Fluzone® High-Dose 2011-2012 Formulation; Trivalent Inactivated Influenza Vaccine

Summary:

      The aim of the study is to evaluate the safety and immunogenicity of the 2011-2012
      formulation of Fluzone and Fluzone High-Dose vaccines in participants aged 65 years and
      older.

      Objectives:

        -  To describe the safety of Fluzone vaccine and Fluzone High-Dose vaccine among adults ≥
           65 years of age.

        -  To describe the immunogenicity of Fluzone vaccine and Fluzone High-Dose vaccine among
           adults ≥ 65 years of age.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is ≥ 65 years of age on the day of inclusion.

          -  Informed consent form (ICF) 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 the 2nd visit.

          -  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.

          -  Influenza vaccination in the 6 months preceding enrollment in the study.

          -  Known systemic hypersensitivity to eggs, chicken proteins, latex, or any of the
             vaccine components, or a history of a life-threatening reaction to Fluzone 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 Investigator's Brochure and/or the
             package insert) .

          -  Receipt of immune globulins, blood, or blood-derived products in the past 3 months.

          -  Thrombocytopenia, which may be a contraindication for intramuscular (IM) vaccination,
             at the discretion of the Investigator.

          -  Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion,
             which may be a contraindication for IM vaccination, at the discretion of the
             Investigator.

          -  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 (HIV), 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 ≥ 38.0°C [≥ 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 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.