A Study to Evaluate the Shedding and Safety of Trivalent Influenza Virus Vaccine Live, Intranasal in Infants and Young Children
Condition: Healthy
Intervention: Trivalent influenza virus vaccine live, intranasal
Intervention description: A single, intranasal dose of 0.2 mL (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 FFU of three influenza virus strains.
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 200.0
Sex: All
Minimum age: 6 Months
Maximum age: 59 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: children, FluMist, shedding,

Summary:

      Open label, single arm, multicenter study of the shedding and safety of a single dose of
      trivalent, influenza virus vaccine live, intranasal in children 6 to < 60 months of age, with
      28-day shedding follow-up and 180-day safety follow-up.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, 6 months to less than 60 months of age (reached their 6th month but
             not yet reached their 5th year birthday) at the time of study vaccination

          -  Written informed consent and Health Insurance Portability and Accountability Act
             (HIPAA) authorization obtained from the participants parent/legal representative

          -  Ability of the participants parent/legal representative to understand and comply with
             the requirements of the study

          -  Participants parent/legal representative available by telephone

          -  Ability to complete follow-up period of 180 days after study vaccination as required
             by the protocol

        Exclusion Criteria:

          -  History of hypersensitivity to any component of trivalent influenza virus vaccine
             live, intranasal, including egg or egg products, monosodium glutamate, or porcine
             gelatin

          -  History of hypersensitivity to gentamicin

          -  History of Guillain-Barré syndrome

          -  Medically diagnosed wheezing, bronchodilator use, or steroid use (systemic or
             inhaled), by parent/legal representative report or chart review, within the 42 days
             prior to study vaccination (i.e., children with recent persistent asthma were
             excluded); or history of severe persistent asthma according to the criteria described
             in the National Asthma Education and Prevention Program (NAEPP) Expert Panel Report

          -  Acute febrile (greater than or equal to [>=] 100.0 degree Fahrenheit [°F] oral or
             equivalent) and/or clinically significant respiratory illness (e.g., cough or sore
             throat) within 72 hours prior to study vaccination

          -  Any known immunosuppressive condition or immune deficiency disease (including human
             immunodeficiency virus [HIV] infection), or ongoing receipt of any immunosuppressive
             therapy

          -  Household contact who was immunocompromised (participants were also to avoid close
             contact with immunocompromised individuals for at least 21 days after study
             vaccination)

          -  Use of aspirin or aspirin-containing products within the 30 days prior to study
             vaccination, or expected receipt through 180 days after study vaccination

          -  Use of anti-influenza medications (including amantadine, rimantadine, oseltamivir, and
             zanamivir) within the 14 days prior to study vaccination, or expected receipt through
             28 days after study vaccination

          -  Use of any intranasal medication within the 14 days prior to study vaccination, or
             expected receipt through 28 days after study vaccination

          -  Administration of any live virus vaccine within the 30 days prior to study
             vaccination, or expected receipt through 30 days after study vaccination

          -  Administration of any inactivated (i.e., non-live) vaccine within the 14 days prior to
             study vaccination, or expected receipt through 14 days after study vaccination

          -  Receipt of any investigational agent within the 30 days prior to study vaccination, or
             expected receipt through 180 days after study vaccination (use of licensed agents for
             indications not listed in the package insert was permitted)

          -  Receipt of any blood product within the 90 days prior to study vaccination, or
             expected receipt through 28 days after study vaccination

          -  Family member or household contact who was an employee of the research center or
             otherwise involved with the conduct of the study

          -  Any condition that in the opinion of the investigator would have interfered with
             evaluation of the vaccine or interpretation of study results