B-cell Immunity to Influenza (SLVP017)- Year 5, 2013
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Fluzone
Intervention description: Fluzone (Influenza Virus Vaccine) Suspension for Intramuscular Injection 2013-2014 Formula.
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 1 Year
Maximum age: 30 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Trivalent inactivated influenza vaccine; Young children; Young adults

Summary:

      In this exploratory study, investigators will be looking at immune response differences
      between age groups and between the two different vaccines given to identical twins and
      vaccine-naive young adults.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Healthy, ambulatory children 1-2 years of age or 18-30 year-old young adults.

          2. Willing to complete the informed consent process.

          3. Availability for follow-up for the planned duration of the study (after last study
             immunization, approximately 8 weeks for Group A and 4 weeks for Group B).

          4. Acceptable medical history by medical history and vital signs.

        Exclusion Criteria:

          1. Group A: Prior vaccination with a seasonal flu vaccine (IIV). Group B: Prior
             vaccination with the 2012-2013 seasonal flu vaccine (IIV or LAIV).

          2. Prior off-study vaccination with the current 2013-2014 seasonal IIV or LAIV

          3. Allergy to egg or egg products, or to vaccine components.

          4. Life-threatening reactions to previous influenza vaccinations

          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. Chronic Hepatitis B or C.

          9. Recent or current use of immunosuppressive medication, including systemic
             glucocorticoids (corticosteroid nasal sprays and topical steroids are permissible; use
             of inhaled steroids, or oral steroids (<20mg prednisone-equivalent/day), may be
             acceptable after review by the investigator.

         10. 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).

         11. 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.

         12. History of blood dyscrasias, renal disease, or hemoglobinopathies requiring regular
             medical follow up or hospitalization during the preceding year

         13. 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.

         14. Receipt of blood or blood products within the past 6 months

         15. Medical or psychiatric condition or occupational responsibilities that preclude
             participant compliance with the protocol

         16. Inactivated vaccine within 14 days prior to study vaccination (inform study staff of
             any non-study vaccinations received during study period)

         17. Live, attenuated vaccine within 30 days prior to first study vaccination, or planned
             immunization with a live, attenuated vaccine before completion of study visits (inform
             study staff of any non-study vaccinations received during study period).

         18. Need for allergy immunizations (that cannot be rescheduled if necessary) during the
             study period

         19. History of Guillain-Barre Syndrome

         20. Pregnant or lactating woman

         21. Use of investigational agents within 30 days prior to enrollment or planned use of
             investigational agents prior to completion of study visits

         22. Donation of the equivalent of a unit of blood within 6 weeks prior to enrollment

         23. 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.