Study to Evaluate the Safety of 1 New 6:2 Influenza Virus Reassortant in Adults for the 2017-2018 Season
Condition: Influenza; Healthy
MeSH terms: Influenza, Human
Intervention: Monovalent Influenza Vaccine; Placebo
Intervention description: A single dose of monovalent influenza vaccine [10^7.0 +/- 0.5 FFU of each of 1 ca, att, ts 6:2 reassortant influenza strain] will be administered as intranasal spray on Day 1.; A single dose of placebo matching with monovalent influenza vaccine will be administered as intranasal spray on Day 1.
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: 300.0
Sex: All
Minimum age: 18 Years
Maximum age: 49 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Trivalent; Influenza; FluMist Quadrivalent; Vaccine; Prevention; Healthy; Monovalent

Summary:

      This prospective annual release study is designed to evaluate the safety of 1 new influenza
      virus vaccine strain to be included in FluMist Quadrivalent for the 2017-2018 influenza
      season.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Age 18 through 49 years

          -  Written informed consent

          -  Participant available by telephone

          -  Ability to understand and comply with the requirements of the protocol, as judged by
             the Investigator

        Key Exclusion Criteria:

          -  Concurrent enrollment in another clinical study up to 180 days after receipt of
             investigational product (Day 181)

          -  History of hypersensitivity to any component of the vaccine, including egg or egg
             protein or serious, life threatening, or severe reactions to previous influenza
             vaccinations

          -  Any condition for which the inactivated influenza vaccine is indicated, including
             chronic disorders of the pulmonary or cardiovascular systems (example [eg], asthma),
             chronic metabolic diseases (eg, diabetes mellitus), renal dysfunction, or
             hemoglobinopathies that required regular medical follow-up or hospitalization during
             the preceding year

          -  Acute febrile (greater than [>] 100.0 degrees Fahrenheit [F] oral or equivalent)
             and/or clinically significant respiratory illness (example, cough or sore throat)
             within 14 days to randomization

          -  Any known immunosuppressive condition or immune deficiency diseases, including human
             immunodeficiency virus infection, or ongoing immunosuppressive therapy

          -  History of Guillain-Barre syndrome

          -  Receipt of any investigational agent within 30 days prior to randomization, or
             expected receipt through 30 days after the dose of investigational product (use of
             licensed agents for indications not listed in the Package Insert is permitted)

          -  Receipt of any non-study vaccine within 30 days prior to randomization, or expected
             receipt through 30 days after receipt of investigational product

          -  Expected receipt of antipyretic or analgesic medication on a daily or every other day
             basis from randomization through 14 days after receipt of investigational product

          -  Administration of intranasal medications within 14 days prior to randomization, or
             expected receipt through 14 days after administration of investigational product

          -  Receipt of influenza antiviral therapy or influenza antiviral agents within 48 hours
             prior to investigational product administration or expected receipt of influenza
             antiviral therapy or influenza antiviral agents through 14 days after receipt of
             investigational product