A Study to Evaluate the Safety of 3 New 6:2 Influenza Virus Reassortants in Adults
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Trivalent Influenza Virus Vaccine; Placebo
Intervention description: Trivalent vaccine is supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose phosphate buffer, egg allantoic fluid and approximately 10^7 FFU (fluorescent focus units) of each of 3 cold-adapted, attenuated 6:2 reassortant influenza strains: A/H1N1 (A/California/7/2009), A/H3N2 (A/Victoria/361/2011), B (B Wisconsin/1/2010). A single dose of investigational product was administered on Day 1.; Placebo is suppllied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer. A single dose of investigational product was administered on Day 1.
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 303.0
Sex: All
Minimum age: 18 Years
Maximum age: 49 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Trivalent, Influenza, FluMist, Vaccine, Prevention

Summary:

      This prospective annual release study was designed to assess the safety of a trivalent
      influenza virus vaccine using two new strains recommended for the 2012-2013 influenza season
      not previously contained in the trivalent intranasal FluMist vaccine.

      Three hundred healthy adults will receive a single dose of vaccine or placebo and will be
      followed for 180 days after study vaccination.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age 18 through 49 years at the time of investigational product administration

          2. Written informed consent and any locally required authorization (ie, HIPAA in the USA)
             obtained from the subject/legal representative prior to performing any
             protocol-related procedures, including screening evaluations

          3. Females of childbearing potential who are sexually active with a nonsterilized male
             partner must use effective contraception for 30 days prior to study vaccination, and
             must agree to continue using such precautions for 60 days after study vaccination

          4. Nonsterilized males who are sexually active with a female partner of child-bearing
             potential must use an effective method of contraception from prior to study
             vaccination amd must agree to continue using such precautions for at least 30 days
             after receipt study vaccination

          5. Healthy by medical history and physical examination

          6. Female subjects of child-bearing potential 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.

          7. Subject available by telephone

          8. Ability to understand and comply with the requirements of the protocol, as judged by
             the investigator

          9. Ability to complete follow-up period of 180 days after dosing as required by the
             protocol

        Exclusion Criteria:

          1. Any condition that, in the opinion of the investigator, would interfere with
             evaluation of the investigational product or interpretation of subject safety or study
             results

          2. Concurrent enrollment in another clinical study up to 180 days after receipt of
             investigational product (Day 181)

          3. Employees of the clinical study site or any other individuals involved with the
             conduct of the study, or immediate family members of such individuals

          4. 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

          5. History of hypersensitivity to gentamicin

          6. 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

          7. 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

          8. Any known immunosuppressive condition or immune deficiency disease, including human
             immunodeficiency virus infection, or ongoing immunosuppressive therapy

          9. History of Guillain-Barré syndrome

         10. 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 study
             vaccination

         11. Receipt of any investigational agent within 30 days prior to randomization, or
             expected receipt through 30 days after study vaccination (use of licensed agents for
             indications not listed in the package insert is permitted)

         12. Receipt of any non-study vaccine within 30 days prior to randomization, or expected
             receipt through 30 days after study vaccination

         13. Expected receipt of antipyretic or analgesic medication on a daily or every other day
             basis from randomization through 14 days after study vaccination

         14. Administration of intranasal medications within 14 days prior to randomization, or
             expected receipt through 14 days after study vaccination

         15. Receipt of influenza antiviral therapy or antiviral agents within 48 hours prior to
             study vaccination or expected receipt of influenza antiviral therapy or antiviral
             agents through 14 days after study vaccination

         16. Known or suspected mitochondrial encephalomyopathy

         17. Nursing mother