T-cell And General Immune Response to Seasonal Influenza Vaccine (SLVP018) Year 3, 2011
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: TIV; High-Dose TIV
Intervention description: Influenza Virus Vaccine Suspension for Intramuscular Injection; High-Dose Influenza Virus Vaccine supplied in a prefilled, single-dose syringe for intramuscular injection
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 63.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Trivalent, inactivated influenza vaccine; High-Dose trivalent, inactivated influenza vaccine; Adult and elderly identical twins; Adult 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, ambulatory adults, ages 18-30 years (identical or fraternal twin
             pairs), 40-64 years (identical or fraternal twin pairs) or 65-100 years (identical
             twin pairs).

          2. Willing to complete the informed consent process.

          3. Availability for follow-up for the planned duration of the study at least 28 days
             after immunization.

          4. Acceptable medical history and vital signs.

        Exclusion Criteria:

          1. Prior off-study vaccination with trivalent inactivated influenza vaccine (TIV) or live
             attenuated influenza vaccine (LAIV) in Fall 2011

          2. Allergy to egg or egg products, or to vaccine components, including thimerosal (if TIV
             multidose vials used)

          3. Allergy to latex (for Group F only - may be assigned to Fluzone High-Dose). Review
             with investigator.

          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. Blood pressure >150 systolic or > 95 diastolic at Visit 1

          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 glucocorticoids
             (corticosteroid nasal sprays, topical steroids and inhaled steroids are permissible).
             Use of oral steroids (<20mg prednisone-equivalent/day) may be acceptable after review
             by the investigator.

         12. 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).

         13. 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.

         14. History of blood dyscrasias, renal disease, or hemoglobinopathies requiring regular
             medical follow up or hospitalization during the preceding year

         15. Use of any anti-coagulation medication such as Coumadin or Lovenox, or anti-platelet
             agents such as aspirin (except aspirin up to 325 mg.day), Plavix, or Aggrenox must be
             reviewed by investigator to determine if this would affect the volunteer's safety.

         16. Receipt of blood or blood products within the past 6 months

         17. Medical or psychiatric condition or occupational responsibilities that preclude
             participant compliance with the protocol

         18. Inactivated vaccine 14 days prior to vaccination

         19. Live, attenuated vaccine within 60 days of vaccination

         20. History of Guillain-Barre Syndrome

         21. Pregnant or lactating woman

         22. Use of investigational agents within 30 days prior to enrollment

         23. Donation of the equivalent of a unit of blood within 6 weeks prior to enrollment

         24. 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.