A Prospective Study to Evaluate the Safety of a New Trivalent Intranasal Influenza Vaccine
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Trivalent influenza virus vaccine; Placebo
Intervention description: Trivalent vaccine was 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 three cold-adapted, attenuated, 6:2 reassortant influenza strains A/South Dakota/6/07 (H1N1), A/Uruguay/716/07 (H3N2), and B/Florida/4/2006.; Placebo was supplied in intranasal sprayers containing 0.5 ml of sucrose-phosphate buffer.
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
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
Keywords: Influenza; FluMist; vaccine; prevention; trivalent

Summary:

      This prospective annual release study was designed to assess the safety of a trivalent
      influenza virus vaccine using a new strain recommended for the 2008-2009 influenza season not
      previously contained in the trivalent intranasal FluMist vaccine. Three hundred healthy
      adults received a single dose of vaccine or placebo and were followed for 180 days.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, 18 to 49 years of age (not yet reached their 50th birthday) at the
             time of study vaccination

          -  Healthy by medical history and health assessment

          -  Sexually active females, unless surgically sterile or at least 1 year post-menopausal,
             must have used an effective method of avoiding pregnancy (including oral, implanted,
             injectable, or transdermal contraceptives, IUD, female condom, diaphragm with
             spermicide, cervical cap, abstinence, use of a condom by the sexual partner or sterile
             sexual partner) for at least 30 days prior to study vaccination, and must agree to
             continue using such precautions for at least 90 days after study vaccination; the
             subject must also have a negative serum or urine pregnancy test within 14 days prior
             to study vaccination (if screening and study vaccination do not occur on the same day)
             and on the day of study vaccination prior to randomization

          -  Sexually active males, unless surgically sterile, must use an effective method of
             birth control (condom or abstinence) and must agree to continue using such precautions
             for at least 30 days after study vaccination

          -  Available by telephone

          -  Provide written informed consent (and HIPAA authorization, if applicable)

          -  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 study vaccination as required
             by the protocol

        Exclusion Criteria:

          -  History of hypersensitivity to any component of the vaccine, including egg or egg
             protein

          -  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

          -  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 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); subject should additionally avoid close
             contact with severely immunocompromised individuals for at least 21 days after study
             vaccination

          -  Receipt of any investigational agent within 30 days prior to randomization, or
             expected receipt through 180 days after study vaccination (use of licensed agents for
             indications not listed in the package insert is permitted)

          -  Expected receipt of anti-pyretic or analgesic medication on a daily or every other day
             basis from randomization through 14 days after study vaccination 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 study vaccination

          -  Nursing mother

          -  Employee of the research center, any individual involved with the conduct of the
             study, or any family member of such individuals

          -  Any condition (eg, chronic cough, allergic rhinitis) that, in the opinion of the
             investigator, would interfere with evaluation of the vaccine or interpretation of
             study results