Protective Mechanisms Against a Pandemic Respiratory Virus (SLVP024)
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: FluMist®
Intervention description: Influenza Virus Vaccine Live, Intranasal Spray
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 2 Years
Maximum age: 49 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Live, attenuated influenza vaccine; Children and young adults

Summary:

      The purpose of the study is to investigate and compare the human immune response in
      epithelial cells of the nasopharyngeal mucosa and in blood to live, attenuated influenza
      vaccine (LAIV) in adults and in children.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Otherwise healthy, ambulatory 2-8 years old (Group A) or 18-49 years old (Group B).

          2. Willing to complete the informed consent process (including assent for minors 7 years
             old and above).

          3. Availability for follow-up for the planned duration of the study at least 28 days
             after immunization.

          4. Acceptable medical history by review of inclusion and exclusion criteria and vital
             signs.

        Exclusion Criteria:

          1. Prior off-study vaccination with the current 2012-2013 seasonal TIV or LAIV.

          2. Allergy to egg or egg products, or to vaccine components, including gentamicin,
             gelatin, arginine or MSG (LAIV)

          3. Life-threatening reactions to previous influenza vaccinations

          4. Asthma or history of wheezing

          5. Active systemic or serious concurrent illness, including febrile illness on the day of
             vaccination

          6. History of immunodeficiency (including HIV infection)

          7. Known or suspected impairment of immunologic function, including, but not limited to,
             clinically significant liver disease, diabetes mellitus treated with insulin, moderate
             to severe renal disease, or any other chronic disorder which, in the opinion of the
             investigator, might jeopardize volunteer safety or compliance with the protocol.

          8. Blood pressure >150 systolic or >95 diastolic at the first study visit and on the day
             of vaccination.

          9. Hospitalization in the past year for congestive heart failure or emphysema.

         10. Chronic Hepatitis B or C.

         11. Recent or current use of immunosuppressive medication, including systemic
             glucocorticoids (corticosteroid nasal sprays and topical steroids are permissible in
             all groups; inhaled steroid use is not permissible)

         12. Participants in close contact with anyone who has a severely weakened immune system
             should not receive LAIV

         13. Malignancy, other than squamous cell or basal cell skin cancer (includes solid tumors
             such as breast cancer or prostate cancer with recurrence in the past year, and any
             hematologic cancer such as leukemia).

         14. Autoimmune disease (including rheumatoid arthritis treated with immunosuppressive
             medication such as Plaquenil, methotrexate, prednisone, Enbrel) which, in the opinion
             of the investigator, might jeopardize volunteer safety or compliance with the
             protocol.

         15. History of blood dyscrasias, renal disease, or hemoglobinopathies requiring regular
             medical follow up or hospitalization during the preceding year

         16. Use of any anti-coagulation medication such as Coumadin or Lovenox, or anti-platelet
             agents such as aspirin (except up to 325 mg. per day), Plavix, or Aggrenox must be
             reviewed by investigator to determine if this would affect the volunteer's safety.

         17. Receipt of blood or blood products within the past 6 months or planned used during the
             study.

         18. Medical or psychiatric condition or occupational responsibilities that preclude
             participant compliance with the protocol

         19. Receipt of Inactivated vaccine 14 days prior to study enrollment, or planned
             vaccinations prior to completion of last visit ( Day ~28 after study vaccination)

         20. Receipt of live, attenuated vaccine within 60 days prior to enrollment of planned
             vaccination prior to completion of last visit (Day ~28 after study vaccination)

         21. Need for allergy immunization (that cannot be postponed) during the study period.

         22. History of Guillain-Barré syndrome

         23. Pregnant or lactating woman (NA for children in Group A)

         24. Use of investigational agents within 30 days prior to enrollment or planned use during
             the study.

         25. Donation of the equivalent of a unit of blood within 6 weeks prior to enrollment or
             planned donation prior to completion of the last visit.

         26. A current member of the clinical study team.

         27. Any condition which, in the opinion of the investigator, might interfere with
             volunteer safety, study objectives or the ability of the participant to understand or
             comply with the study protocol.