Safety and Immunogenicity of Fluzone® Quadrivalent and Fluzone® High-Dose, Influenza Vaccines, 2016-2017 Formulations
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Fluzone Quadrivalent vaccine, 2016-2017 formulation, No Preservative; Fluzone Quadrivalent vaccine, 2016-2017 formulation, No Preservative; Fluzone High-Dose, vaccine, 2016-2017 formulation
Intervention description: 0.5 mL, Intramuscular; 0.5 mL, Intramuscular; 0.5 mL, Intramuscular
Intervention MeSH terms: Vaccines
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 180.0
Sex: All
Minimum age: 3 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza; Fluzone® Quadrivalent, Influenza Vaccine (2016-2017 formulation); Fluzone® High-Dose, Influenza Vaccine (2016-2017 formulation)

Summary:

      The aim of the study was to describe the safety and immunogenicity of the 2016-2017
      formulations of Fluzone Quadrivalent vaccine in children 3 to < 9 years of age and in adults
      18 to < 65 years or age, and of the 2016-2017 formulation of Fluzone High-Dose vaccine in
      adults ≥65 years of age.

      Primary Observational Objectives

        -  To describe the safety of the 2016-2017 formulation of Fluzone Quadrivalent vaccine in
           children 3 to < 9 years of age and adults 18 to < 65 years of age, and the safety of the
           2016-2017 formulation of Fluzone High-Dose vaccine in adults ≥ 65 years of age.

      Observational Objectives:

        -  To describe the immunogenicity of the 2016-2017 formulation of Fluzone Quadrivalent
           vaccine in children 3 to < 9 years of age and adults 18 to < 65 years of age, and the
           immunogenicity of the 2016-2017 formulation of Fluzone High-Dose vaccine in adults ≥ 65
           years of age.

        -  To submit available sera from approximately 90 participants (30 participants 3 to < 9
           years of age and 30 participants 18 to < 65 years of age who receive Fluzone
           Quadrivalent vaccine, and 30 participants ≥ 65 years of age who receive Fluzone
           High-Dose vaccine) to Center for Biologics Evaluation and Research (CBER) for further
           analysis by the World Health Organization (WHO), the Centers for Disease Control and
           Prevention (CDC), and the Food and Drug Administration (FDA) to support formulation
           recommendations for subsequent influenza vaccines.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged 3 to <9 years or adult aged ≥ 18 years on the day of first study vaccination
             (study product administration) .

          -  Informed consent form had been signed and dated by participants ≥ 18 years of age.

          -  Assent form had been signed and dated by participants 7 to <9 years of age, and
             informed consent form (ICF) has been signed and dated by parent(s) or guardian(s) for
             participants 3 to <9 years of age.

          -  Participant and parent/guardian (of participants 3 to <9 years of age) were able to
             attend all scheduled visits and to comply with all trial procedures.

        Exclusion Criteria:

          -  Participant was pregnant, or lactating, or of childbearing potential and not using an
             effective method of contraception or abstinence from at least 4 weeks prior to
             vaccination and until at least 4 weeks after vaccination. To be considered of
             non-childbearing potential, a female must be pre-menarche, or post-menopausal for at
             least 1 year, or surgically sterile.

          -  Participation at the time of study enrollment (or in the 30 days preceding the first
             trial vaccination) or planned participation during the present trial period in another
             clinical trial investigating a vaccine, drug, medical device, or medical procedure.

          -  Receipt of any vaccine in the 30 days preceding the first trial vaccination, or
             planned receipt of any vaccine before Visit 2 for participants receiving 1 dose of
             influenza vaccine or Visit 3 for participants receiving 2 doses of influenza vaccine.

          -  Previous vaccination against influenza (in the 2016-2017 influenza season) with either
             the trial vaccine or another vaccine.

          -  Receipt of immune globulins, blood, or blood-derived products in the past 3 months.

          -  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).

          -  Known systemic hypersensitivity to any of the vaccine components, or history of a
             life-threatening reaction to the vaccine used in the trial or to a vaccine containing
             any of the same substances.

          -  Thrombocytopenia, which may be a contraindication for intramuscular vaccination, at
             the discretion of the Investigator.

          -  Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion,
             contraindicating intramuscular vaccination.

          -  Deprived of freedom by an administrative or court order, or in an emergency setting,
             or hospitalized involuntarily.

          -  Current alcohol abuse or drug addiction.

          -  Chronic illness that, in the opinion of the Investigator, is at a stage where it might
             interfere with trial conduct or completion.

          -  Moderate or severe acute illness/infection (according to Investigator judgment) on the
             day of planned vaccination or febrile illness (temperature ≥100.4°F [38.0°C]). A
             prospective participant 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 (participants ≥18 years of age) 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 (all
             participants).

          -  History of serious adverse reaction to any influenza vaccine.

          -  Personal history of Guillain-Barré syndrome.

          -  Any condition that in the opinion of the Investigator would pose a health risk to the
             participant if enrolled or could interfere with the evaluation of the vaccine.

          -  Personal history of clinically significant developmental delay (at the discretion of
             the Investigator), neurologic disorder, or seizure disorder.

          -  Known seropositivity for human immunodeficiency virus, hepatitis B, or hepatitis C.