Safety and Immunogenicity Among Healthy Children Receiving Fluzone® Influenza Virus Vaccine (2012-2013 Formulation)
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Fluzone®: Influenza Virus Vaccine, No Preservative: Pediatric Dose; Fluzone®; Influenza Virus Vaccine, No Preservative
Intervention description: 0.25 mL dose, Intramuscular; 0.5 mL dose, 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: 60.0
Sex: All
Minimum age: 6 Months
Maximum age: 8 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza; Fluzone® (Influenza Virus Vaccine) 2012-2013 Formulation; Influenza virus vaccine; Trivalent Inactivated Influenza Vaccine

Summary:

      The aim of this clinical study is to demonstrate safety and immunogenicity of Fluzone
      vaccine.

      Objective:

        -  To describe the safety of the 2012-2013 formulation of Fluzone vaccine, administered in
           a 1- or 2-dose schedule, in accordance with Advisory Committee on Immunization Practices
           (ACIP) recommendations, in children 6 months to < 9 years of age.

      Observational Objectives:

        -  To describe the immunogenicity of the 2012-2013 formulation of Fluzone 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 remaining available sera from subjects to the 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 selection and recommendation of strains for subsequent years' influenza
           vaccines.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is 6 months to < 9 years of age on the day of inclusion

          -  Parent/guardian is 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 another legally acceptable
             representative

          -  For subjects 6 months to < 24 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, latex, or any of the
             vaccine components, or a history of a life-threatening reaction to Fluzone 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 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 2012-2013 influenza vaccine

          -  Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion,
             which may be a contraindication for intramuscular (IM) vaccination, at the discretion
             of the Investigator

          -  Thrombocytopenia, 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)

          -  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 (HIV), 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.