A Clinical Study to Assess the Safety of a New Influenza Vaccine
Condition: Healthy
Intervention: Monovalent Frozen FluMist®; Placebo
Intervention description: Single dose of monovalent vaccine (240 subjects) by intranasal spray on Study Day 1.; Single dose of placebo (60 subjects) by intranasal spray on Study Day 1
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 300.0
Sex: All
Minimum age: 18 Years
Maximum age: 49 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To assess the safety of a new influenza virus vaccine containing a new virus strain in
      healthy patients prior to the release of the vaccine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, 18 through 49 years of age (not yet reached their 50th birthday) at
             the time of investigational product administration

          -  Healthy by medical history and physical examination

          -  Written informed consent and any locally required authorization (eg, Health Insurance
             Portability and Accountability Act in the United States of America, European Union
             [EU] Data Privacy Directive in the EU) obtained from the subject/legal representative
             prior to performing any protocol-related procedures, including screening evaluations

          -  Female subjects of child-bearing potential, (ie, unless at least 2 years
             postmenopausal, surgically sterile [eg, bilateral tubal ligation, bilateral
             oophorectomy, or hysterectomy], has sterile male partner, or practices abstinence)
             must use an effective method of avoiding pregnancy (including oral, transdermal, or
             implanted contraceptives, intrauterine device, female condom with spermicide,
             diaphragm with spermicide, cervical cap, or use of a condom with spermicide by the
             sexual partner) for 30 days prior to administration of investigational product, and
             must agree to continue using such precautions for 60 days after investigational
             product administration. In addition, the subject must also have a negative urine or
             blood pregnancy test at screening and, if screening and Day 1 do not occur on the same
             day, on the day of vaccination prior to randomization.

          -  Males, unless surgically sterile must use an effective method of birth control with a
             female partner and must agree to continue using such contraceptive precautions for at
             least 30 days after dosing with investigational product (from Study Day 1 through
             Study Day 31)

          -  Subject available by telephone

          -  Ability to understand and comply with the requirements of the protocol, as judged by
             the investigator

          -  Ability to complete follow-up period of 180 days after dosing as required by the
             protocol

        Exclusion Criteria:

          -  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

          -  History of hypersensitivity to gentamicin

          -  Any condition for which the inactivated influenza vaccine is indicated, including
             chronic disorders of the pulmonary or cardiovascular systems (eg, asthma), chronic
             metabolic diseases (eg, diabetes mellitus), renal dysfunction, or hemoglobinopathies
             that required regular medical follow-up or hospitalization during the preceding year
             Note: A history of asthma that requires regular medical follow-up or hospitalization
             during the preceding 2 years is exclusionary. Investigator judgment is required to
             determine whether or not a subject has a history of asthma; however, for adult
             subjects, a remote history of wheezing or a remote diagnosis of asthma that the
             investigator does not consider to be relevant to current health does not need to be
             considered to be a history of asthma. For example, childhood asthma that has not
             required treatment in adulthood is not necessarily exclusionary

          -  Acute febrile (> 100.0°F oral or equivalent) and/or clinically significant respiratory
             illness (eg, cough or sore throat) within 14 days prior to randomization

          -  Any known immunosuppressive condition or immune deficiency disease, including human
             immunodeficiency virus (HIV) infection, or ongoing immunosuppressive therapy

          -  History of Guillain-Barré syndrome

          -  A household contact who is severely immunocompromised (eg, hematopoietic stem cell
             transplant recipient, during those periods in which the immunocompromised individual
             requires care in a protective environment); additionally, subject should avoid close
             contact with severely immunocompromised individuals for at least 21 days after receipt
             of investigational product

          -  Receipt of any investigational agent within 30 days prior to randomization, or
             expected receipt through 30 days after the dose of investigational product

          -  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
             Note: A daily dose of up to 81 mg of aspirin for prophylactic use is not considered a
             contraindication to enrollment.

          -  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 antiviral agents within 48 hours prior to
             investigational product administration or expected receipt of influenza antiviral
             therapy or antiviral agents through 14 days after receipt of each dose of
             investigational product

          -  Known or suspected mitochondrial encephalomyopathy

          -  Nursing mother

          -  Any condition (eg, chronic cough) that, in the opinion of the investigator, would
             interfere with evaluation of the investigational product or interpretation of subject
             safety or study results

          -  Employees of the clinical study site, any other individuals involved with the conduct
             of the study, or immediate family members of such individuals