Safety and Immunogenicity of the 2015-2016 Formulation of Fluzone® Quadrivalent (Influenza Vaccine) Among Healthy Children
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      Study participants will be assigned to the appropriate age group (6 months to < 36 months of
      age or 3 years to < 9 years of age) based on the subject's age at the time of enrollment.
      Participants aged 6 months to < 36 months will receive a 0.25 mL dose of Fluzone Quadrivalent
      vaccine and those aged 3 years to < 9 years will receive a 0.5 mL dose of Fluzone
      Quadrivalent vaccine. Participants, for whom 2 doses of influenza vaccine are recommended per
      ACIP guidance, will receive a second dose of Fluzone Quadrivalent vaccine during Visit 2 (28
      days after Visit 1).

      Solicited adverse event (AE) information will be collected for 7 days after each vaccination,
      unsolicited AE information will be collected from Visit 1 to Visit 2 or to Visit 3 for those
      subjects receiving 2 doses. Serious adverse event (SAE) information will be collected from
      Visit 1 to Visit 2 or Visit 3, as appropriate.

      Immunogenicity will be evaluated in all subjects prior to vaccination on Day 0 (Visit 1) and
      at Day 28 after the final vaccination using the hemagglutination inhibition (HAI) technique.
      For each influenza vaccine strain, pre- and post-vaccination geometric mean titers (GMTs)
      will be calculated.
    

Intervention name(s): Fluzone® Quadrivalent Influenza Vaccine, No Preservative; Fluzone® Quadrivalent Influenza Vaccine, No Preservative
Intervention type(s): Biological; Biological
Intervention description(s): 0.25 mL, Intramuscular (Pediatric Dose, 2015 2016 formulation); 0.5 mL, Intramuscular (2015 2016 formulation)
Other intervention name(s): Fluzone® Quadrivalent, No Preservative; Fluzone® Quadrivalent, No Preservative
Intervention MeSH terms: Vaccines
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Influenza; Influenza virus vaccine; Fluzone® Quadrivalent Influenza Vaccine (No Preservative)