Safety and Immunogenicity of Fluzone® Quadrivalent Vaccine Administered to Healthy Children
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of the study was to describe the safety and immunogenicity of a 0.5-mL dose (15 μg
      hemagglutinin [HA] per strain) of Fluzone Quadrivalent vaccine in children 6 to <36 months of
      age.

      Primary objective:

        -  To compare the rate of any fever (temperature ≥100.4 degrees Fahrenheit [38.0 degrees
           Celsius) following a 0.5-mL dose of Fluzone Quadrivalent vaccine to that following a
           0.25-mL dose of Fluzone Quadrivalent vaccine during the 7 days after either vaccination
           (Dose 1 and Dose 2 combined) in participants 6 to < 36 months of age.

      Secondary objective:

        -  To compare antibody responses induced by a 0.5-mL dose of Fluzone Quadrivalent vaccine
           to those induced by a 0.25-mL dose of Fluzone Quadrivalent vaccine as assessed by
           geometric mean titer (GMT) ratios and seroconversion rate differences after the final
           vaccination in participants 6 to < 36 months of age.

      Other objectives:

        -  To describe the safety of 2 different dose levels of the 2016-2017 formulation of
           Fluzone Quadrivalent vaccine in participants 6 to < 36 months of age.

        -  To describe the immunogenicity of 2 different dose levels of the 2016-2017 formulation
           of Fluzone Quadrivalent vaccine in participants 6 months to < 36 months of age.

        -  To submit available sera from approximately 30 participants to the Center for Biologics
           Evaluation and Research for further analysis by the World Health Organization, the
           Centers for Disease Control and Prevention, and the FDA to support formulation
           recommendations for subsequent influenza vaccines.
    

Detailed description: 
      All participants received 1 intramuscular dose of Fluzone Quadrivalent vaccine during Visit
      1. For participants, for whom 2 doses of influenza vaccine were recommended per Advisory
      Committee on Immunization Practices (ACIP) guidance, a second dose of Fluzone Quadrivalent
      vaccine (of the same volume as the first dose) was administered during Visit 2 (28 days after
      Visit 1).

      Solicited adverse event (AE) information was collected for 7 days after each vaccination,
      unsolicited AE information was collected from Visit 1 to Visit 2 or to Visit 3 for
      participants receiving 2 doses of study vaccine. Serious adverse event (SAE) information was
      collected for 28 days after each vaccination.

      Immunogenicity was evaluated in a planned subset of 1600 randomly selected participants prior
      to vaccination on Day 0 (Visit 1) and at Day 28 after the final vaccination.
    

Intervention name(s): Fluzone Quadrivalent vaccine, No Preservative; Fluzone Quadrivalent vaccine, No Preservative
Intervention type(s): Biological; Biological
Intervention description(s): 0.25-mL (Pediatric Dose), Intramuscular (2016-2017 formulation); 0.5-mL, Intramuscular (2016-2017 formulation)
Other intervention name(s): Fluzone® Quadrivalent Influenza Vaccine; Fluzone® Quadrivalent Influenza Vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Influenza; Influenza virus vaccine; Fluzone® Quadrivalent Influenza Vaccine (No Preservative)