A Phase 2 Study to Evaluate Immune Responses of FluMist®
Condition: Influenza Vaccine
MeSH terms: Influenza, Human
Intervention: TIV, Trivalent Inactivated Influenza Virus Vaccine; FluMist, Influenza Virus Vaccine Live
Intervention description: 0.25 mL will be administered intramuscularly for each of two doses; 0.5 mL will be administered intranasally (approximately 0.25 mL into each nostril) for each of two doses
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 101.0
Sex: All
Minimum age: 12 Months
Maximum age: 35 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Live, attenuated influenza virus vaccine (LAIV); Trivalent inactivated influenza virus vaccine (TIV); FluMist

Summary:

      The primary objective of this study is to describe the level of serum antibody and cellular
      immune responses conferred by FluMist and TIV against influenza virus strains.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female aged 12 to <36 months (reached their 1st year but not yet reached their
             3rd year birthday) at the time of randomization

          -  Written informed consent and HIPAA authorization obtained from the subject's legal
             representative

          -  Ability of the subject's legal representative to understand and comply with the
             requirements of the study

          -  Subject's legal representative available by telephone

          -  Ability to complete follow-up period of 180 days after final study vaccination as
             required by the protocol

        Exclusion Criteria:

          -  History of hypersensitivity to any component of FluMist or TIV, including egg or egg
             products

          -  History of hypersensitivity to gentamicin

          -  Any known immunosuppressive condition or immune deficiency disease (including HIV
             infection), or ongoing receipt of any immunosuppressive therapy

          -  Household contact who is immunocompromised (participants should also avoid close
             contact with immunocompromised individuals for at least 21 days after each study
             vaccination)

          -  History of Guillain-Barré syndrome

          -  Any prior history of wheezing or asthma

          -  Acute febrile (≥100.0°F oral or equivalent) and/or clinically significant respiratory
             illness (e.g., cough or sore throat) within 72 hours prior to either study vaccination

          -  Use of aspirin or aspirin-containing products within the 30 days prior to
             randomization, or expected receipt through 180 days after final study vaccination

          -  Receipt of any prior influenza vaccine

          -  Use of anti-influenza medications (including amantadine, rimantadine, oseltamivir, and
             zanamivir) within 14 days prior to randomization, or expected receipt through 35 days
             after final study vaccination

          -  Administration of any live virus vaccine, other than measles, mumps, rubella, and
             varicella-containing vaccine(s), within 30 days prior to randomization, or expected
             receipt through 30 days after final study vaccination

          -  Administration of any inactivated (i.e., non-live) vaccine within 14 days prior to
             randomization, or expected receipt within 14 days before or 14 days after either study
             vaccination

          -  Receipt of any investigational agent within 30 days prior to randomization, or
             expected receipt through 180 days after final study vaccination (use of licensed
             agents for indications not listed in the package insert is permitted)

          -  Receipt of any blood product within 90 days prior to randomization, or expected
             receipt through 35 days after final study vaccination

          -  Family member or household contact who is an employee of the research center or
             otherwise involved with the conduct of the study

          -  Any condition that in the opinion of the investigator would interfere with evaluation
             of the vaccine or interpretation of study results