Evaluate the Shedding and Immunogencity of Different Formulations of FluMist in Children 24 to <48 Months of Age
Condition: Influenza; Healthy
MeSH terms: Influenza, Human
Intervention: FluMist trivalent (2015-2016); FluMist Quadrivalent (2015-2016); FluMist Quadrivalent (2017-2018)
Intervention description: 0.2 mL (total dose in both nostrils) on Days 1 and 28. Each 0.2 mL dose will contain 10^7±0.5 FFU of each vaccine strain.; 0.2 mL (total dose in both nostrils) on Days 1 and 28. Each 0.2 mL dose will contain 10^7±0.5 FFU of each vaccine strain.; 0.2 mL (total dose in both nostrils) on Days 1 and 28. Each 0.2 mL dose will contain 10^7±0.5 FFU of each vaccine strain.
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Double-blind
Enrollment: 200.0
Sex: All
Minimum age: 24 Months
Maximum age: 47 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: FluMist Quadrivalent; Trivalent; Influenza; Vaccine; Prevention

Summary:

      This study is being conducted to compare the immunogenicity, safety, and viral shedding of a
      new A/H1N1 strain that will be incorporated into the FluMist quadrivalent formulation for the
      2017-2018 influenza season with the previous A/H1N1 strain that was included in the vaccine
      in the 2015-2016 influenza season.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Age 24 months to < 48 months of age

          -  Healthy by medical history and physical examination or presence of stable underlying
             chronic medical condition for which hospitalization has not been required in the
             previous year

        Key Exclusion Criteria:

          -  History of allergic disease or reactions likely to be exacerbated by any component of
             the investigational product

          -  Acute illness or evidence of significant active infection (including fever >= 100.4
             degrees Fahrenheit (38.0 degrees Celsius) at randomization

          -  History of asthma or history of recurrent wheezing

          -  Any known immunosuppressive condition or immune deficiency disease

          -  Current or expected receipt of immunosuppressive medications within a 28 day window
             around vaccination

          -  Use of aspirin or salicylate-containing medications within 28 days prior to
             randomization or expected receipt thru 28 days after vaccination

          -  Use of antiviral agents with activity against influenza viruses within 48 hours prior
             to first dose of investigational product or anticipated use of such agents through the
             end of the study follow-up period

          -  Receipt of any non-study seasonal influenza vaccine within 90 days of Dose 1 or
             planned receipt of non-study seasonal influenza vaccine prior to 28 days after last
             vaccination

          -  Receipt of immunoglobulin or blood products within 90 days before randomization into
             the study or expected receipt during study participation

          -  Known or suspected mitochondrial encephalomyopathy

          -  History of Guillian-Barre syndrome

          -  Administration of intranasal medications within 10 days prior to randomization, for
             expected receipt through 10 days after administration of each dose of investigational
             product