Live Attenuated Influenza Vaccine (LAIV) Versus Trivalent Inactivated Influenza Vaccine in Healthy Adults 18-49 Years
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Inactivated Influenza Vaccine; Live Attenuated Influenza Vaccine
Intervention MeSH terms: Vaccines
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects will be randomized to one of two different groups to receive either licensed inactivated influenza vaccine (IIV) or licensed live attenuated influenza vaccine (LAIV) from the 2010-2011 season.
Masking: None (Open Label)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Maximum age: 49 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This randomized, open-label, single-site study at Saint Louis University will enroll
      approximately 40 subjects who are healthy, 18 to 49 years old. Subjects will be randomized in
      a 1:1 fashion to receive either licensed trivalent FluMist containing (2010-2011 season
      appropriate), or licensed inactivated trivalent influenza vaccine (2010-2011 season
      appropriate) so that approximately 20 subjects will be randomized to receive LAIV, and 20
      will receive IIV.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female age 18 to 49 years, inclusive, on the day of randomization (reached his
             or her 18th year birthday but not yet reached his or her 50th year birthday) at the
             time of the dose of study product

          -  Written informed consent and a locally required authorization (eg, HIPAA in the USA, )
             obtained from the subject prior to performing any protocol-related procedures.

          -  Females of child-bearing potential, (ie, unless surgically sterile [eg, bilateral
             tubal ligation, bilateral oophorectomy, or hysterectomy], has sterile male partner, is
             at least 1 year post-menopausal, 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 the first dose of study product, and must agree to continue using such
             precautions for 60 days after the dose of vaccine due to a potential dose of live
             vaccine product. In addition, the subject must also have a negative urine or blood
             pregnancy test at screening and, if screening and Day 0 do not occur on the same day,
             a negative urine pregnancy test on the day of vaccination prior to randomization.
             Investigator judgment is required to assess a female subject's capability of
             pregnancy.

          -  Are in good health, as determined by vital signs, medical history to ensure any
             existing medical diagnoses or conditions are stable and not considered clinically
             significant by physician investigator, and targeted physical examination based on
             medical history.

          -  Able to complete follow-up period of 180 days post dose of vaccine as required by the
             protocol

          -  Subject available by telephone

          -  Able to understand and comply with the requirements of the protocol, as judged by the
             investigator

        Exclusion Criteria:

        Any of the following would exclude the subject from participation in the study:

          -  Have an acute illness, including an oral temperature ≥ 100.4°F, within 3 days prior to
             vaccination.

          -  Participated in an investigational influenza vaccine study or had a known infection
             with "flu" since 2007 (confirmed by laboratory culture, including subtype of the
             influenza A virus (H1N1) investigational vaccines or illness).

          -  Previous vaccination against influenza in 2007, 2008, 2009 or 2010 with seasonal
             trivalent live or inactivated influenza vaccine (including H1N1 vaccines).

          -  Current or expected receipt of immunosuppressive medications (inhaled and topical
             corticosteroids are permitted) including corticosteroids (≥ 20 mg/day of prednisone
             equivalent given daily or on alternate days for ≥ 14 days) within a 30 day window
             around dose of study vaccine product Note: topical corticosteroids for uncomplicated
             dermatitis may be used throughout the study according to the judgment of the
             investigator; topical calcineurin inhibitors may be used in accordance with their
             package insert at entry and during study participation.

          -  Receipt of immunoglobulin or blood products within 90 days before randomization into
             the study or expected receipt during study participation

          -  Received an experimental agent within 1 month prior to vaccination in this study or
             expect to receive an experimental agent during the active study period (prior to Day
             60 after vaccination (Experimental agent includes: vaccine, biologic, device, or
             medication).

          -  Have received any live licensed vaccines within 4 weeks or inactivated licensed
             vaccines within 2 weeks prior to vaccination in this study or plan receipt of such
             vaccines within 60 days following the vaccination.

          -  Any known immunosuppressive condition or immune deficiency disease including known
             cancer illness or organ transplant

          -  Have known active HIV, Hepatitis B or Hepatitis C infection.

          -  Have a known allergy to eggs or other components of the vaccine (including gelatin,
             formaldehyde, octoxinol, thimerosal, gentamycin and chicken protein) or severe
             reactions to previous influenza vaccinations.

          -  History of Guillain-Barré syndrome

          -  Use of antiviral agents with activity against influenza virus (including amantadine,
             rimantadine, oseltamivir and zanamivir) within 30 days prior to dose of study vaccine
             products or anticipated use within 30 days after vaccination

          -  Breastfeeding woman

          -  History of alcohol or drug abuse that, in the opinion of the investigator, would
             affect the subject's safety or compliance with study

          -  Previous medical history, evidence of an intercurrent illness or any condition that,
             in the opinion of the investigator, would interfere with evaluation of the study
             vaccine products or interpretation of subject safety or that may compromise the safety
             of the subject in the study.