Safety and Immunogenicity of the 2015-2016 Formulation of Fluzone® Quadrivalent (Influenza Vaccine) Among Healthy Children
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Fluzone® Quadrivalent Influenza Vaccine, No Preservative; Fluzone® Quadrivalent Influenza Vaccine, No Preservative
Intervention description: 0.25 mL, Intramuscular (Pediatric Dose, 2015 2016 formulation); 0.5 mL, Intramuscular (2015 2016 formulation)
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: 60.0
Sex: All
Minimum age: 6 Months
Maximum age: 8 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza; Influenza virus vaccine; Fluzone® Quadrivalent Influenza Vaccine (No Preservative)

Summary:

      The study will evaluate the safety and immunogenicity of the 2015-2016 formulation of Fluzone
      Quadrivalent vaccine, administered in a 1- or 2-dose schedule, in accordance with the
      Advisory Committee on Immunization Practices (ACIP) recommendations, in children 6 months to
      < 9 years of age.

      Objective:

        -  To describe the safety of the 2015-2016 formulation of Fluzone Quadrivalent vaccine,
           administered in a 1- or 2-dose schedule, in accordance with ACIP recommendations, in
           children 6 months to < 9 years of age.

      Observational objectives:

        -  To describe the immunogenicity of the 2015-2016 formulation of Fluzone Quadrivalent
           vaccine, administered in a 1- or 2-dose schedule in accordance with ACIP
           recommendations, in children 6 months to < 9 years of age.

        -  To submit available sera from each subject 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 FDA to support formulation
           recommendations for subsequent influenza vaccines.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is 6 months to < 9 years of age on the day of first study vaccination (study
             product administration)

          -  Subject and parent/guardian are willing and able to attend scheduled visits and to
             comply with the study procedures during the entire duration of the study

          -  Assent form has been signed and dated by subjects 7 to < 9 years of age, and informed
             consent form has been signed and dated by parent(s) or guardian for subjects 6 months
             to < 9 years of age

          -  For subjects 6 months to < 12 months of age, born at full term of pregnancy (≥ 37
             weeks) and with a birth weight ≥ 2.5 kg (5.5 lbs).

        Exclusion Criteria:

          -  Known systemic hypersensitivity to eggs, chicken proteins, or any of the vaccine
             components, or a history of a life-threatening reaction to Fluzone Quadrivalent
             vaccine or to a vaccine containing any of the same substances (the complete list of
             vaccine components is included in the Prescribing Information)

          -  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 for subjects receiving 1 dose of influenza
             vaccine or Visit 3 for subjects receiving 2 doses of influenza vaccine

          -  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

          -  Prior vaccination with any formulation of 2015-2016 influenza vaccine

          -  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

          -  Thrombocytopenia, which may be a contraindication for intramuscular 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)

          -  Personal history of clinically significant developmental delay (at the discretion of
             the Investigator), neurologic disorder, or seizure disorder

          -  Chronic illness that, in the opinion of the Investigator, is at a stage where it might
             interfere with trial conduct or completion

          -  Known seropositivity for human immunodeficiency virus, hepatitis B, or hepatitis C.

          -  Moderate or severe acute illness/infection (according to Investigator judgment) on the
             day of vaccination or febrile illness (temperature ≥ 100.4°F). A prospective subject
             should not be included in the study until the condition has resolved or the febrile
             event has subsided

          -  Receipt of immune globulins, blood, or blood-derived products in the past 3 months

          -  Identified as a natural or adopted child of the Investigator or an employee with
             direct involvement in the proposed study.