Kinetics of B-Cell Responses to Live, Attenuated Influenza Vaccine (LAIV) in Young Children Two Years of Age
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: 2008-2009 FluMist LAIV (Intranasal)
Intervention description: 2008-2009 FluMist vaccine delivered intranasally
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 24 Months
Maximum age: 35 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Live, attenuated influenza vaccine; Children

Summary:

      This pilot study will investigate B-cell responses following vaccination with live,
      attenuated influenza vaccine (LAIV) in healthy children 2 years of age from blood samples
      taken at designated time points before and after vaccination.
    

Eligibility criteria:

        Inclusion Criteria

          1. Otherwise healthy children, aged 24-35 months of age, inclusive.

          2. Parent(s) or guardian(s) willing to sign informed consent.

          3. Availability for follow-up for the planned duration of the study.

          4. Acceptable medical history by screening evaluation and brief clinical assessment.

          5. Able to understand and comply with planned study procedures

        Exclusion Criteria

          1. Prior vaccination with LAIV.

          2. TIV vaccination during two prior influenza vaccine seasons

          3. Known prior MD diagnosis of, or hospitalization for influenza

          4. History of asthma, active/recurrent wheezing or reactive airways disease

          5. History of immunodeficiency

          6. Known or suspected impairment of immunologic function including, but not limited to,
             clinically significant liver disease; diabetes mellitus; moderate to severe kidney
             impairment.

          7. Known underlying medical conditions (e.g. hemoglobinopathy, congestive heart failure)
             predisposing to influenza complications.

          8. Household contact with immunodeficiency due to disease, medication or radiation

          9. Child receiving aspirin therapy or aspirin-containing therapy

         10. History of Guillain-Barré syndrome

         11. Malignancy, other than squamous cell or basal cell skin cancer

         12. Autoimmune disease

         13. Use of immunosuppressive medication. Corticosteroid nasal sprays are permissible.

         14. Use of antiviral agents against Influenza A and/or B (such as Tamiflu, Relenza,
             Flumodine, Symmetrel) less than 48 hours before and/or less than two weeks after
             administration of FluMist.

         15. History of blood dyscrasias, renal disease, or hemoglobinopathies requiring regular
             medical follow-up or hospitalization during the preceding year.

         16. Use of investigational agents within 30 days prior to study

         17. Receipt of blood products or immunoglobulin in the past 6 months

         18. Donation of the equivalent of a unit of blood within 6 weeks prior to enrollment

         19. Acute febrile illness on the day of vaccination

         20. Known allergies to any component of the vaccine, including eggs or egg products,
             gentamicin, gelatin,or arginine, or known life-threatening reactions to previous
             influenza vaccinations.

         21. Concurrent participation in other investigational protocols or receipt of an
             investigational product within the previous 30 days or planned receipt of an
             investigational product within 28 days following the last immunization dose.

         22. Any condition that, in the opinion of the investigator, might interfere with study
             objectives