T-cell And General Immune Response to Seasonal Influenza Vaccine (SLVP018) Year 5, 2013
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Fluzone® standard IIV3; Fluzone® standard IIV3 Pediatric Dose
Intervention description: Influenza Virus Vaccine Suspension (0.5ml) for Intramuscular Injection; Influenza Virus Vaccine Suspension (0.25ml) for Intramuscular Injection
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 1 Year
Maximum age: 8 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Trivalent, inactivated influenza vaccine; Child identical twins; Child fraternal twins

Summary:

      This study will investigate markers, mechanisms and define general predictors for
      immunological health by comparing influenza vaccine responses in monozygotic and dizygotic
      twins.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Otherwise healthy, twin children age 1-8 years (identical or fraternal twin pairs)

          2. Parent willing to sign the informed consent form and child willing to sign assent if
             indicated.

          3. Availability for follow-up for the planned duration of the study at least 28 days
             after last immunization.

          4. Acceptable relevant medical history and vital signs.

        Exclusion Criteria:

          1. Prior off-study vaccination with trivalent inactivated influenza vaccine (IIV3) or
             live attenuated influenza vaccine (LAIV) in Fall 2013

          2. Allergy to egg or egg products, or to vaccine components or thimerosal (if IIV3
             multidose vials used)

          3. Life-threatening reactions to previous influenza vaccinations

          4. Active systemic or serious concurrent illness, including febrile illness on the day of
             vaccination

          5. History of immunodeficiency (including HIV infection)

          6. 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.

          7. Chronic Hepatitis B or C

          8. Recent or current use of immunosuppressive medication, including glucocorticoids
             (corticosteroid nasal sprays, topical steroids are permissible). History of any
             cancer.

          9. 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.

         10. History of blood dyscrasias, or hemoglobinopathies requiring regular medical follow up
             or hospitalization during the preceding year

         11. Use of any anti-coagulation medication such as Coumadin or Lovenox, or anti-platelet
             agents such as aspirin.

         12. Receipt of blood or blood products within the past 6 months or planned receipt of
             blood products prior to completion of study visits.

         13. Medical or psychiatric condition or occupational responsibilities that preclude
             participant compliance with the protocol

         14. Receipt of inactivated vaccine 14 days prior to enrollment, or planned non-study
             vaccination prior to completion of Visit 03 or 04 (~Day 28 after the last study
             vaccination)

         15. Receipt of a live, attenuated vaccine within 30 days prior to first vaccination, or
             planned immunization with a live, attenuated vaccine before completion of study visits
             (inform study staff of any non-study vaccinations received during the study period).

         16. Need for allergy immunization (that cannot be postponed) during the study period.

         17. History of Guillain-Barre Syndrome

         18. Use of investigational agents within 30 days prior to enrollment or planned use of
             investigational agents prior to completion of study visits.

         19. 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.