T-cell And General Immune Response to Seasonal Influenza Vaccine (SLVP018) Year 2, 2010
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: High Dose Fluzone® (intramuscular); Fluzone® (intramuscular)
Intervention description: Licensed seasonal High dose trivalent inactivated influenza; Licensed seasonal trivalent inactivated influenza
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 82.0
Sex: All
Minimum age: 8 Years
Maximum age: 100 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Inactivated influenza vaccine; Identical twins; Fraternal twins; High-Dose influenza vaccine; Elderly twins; Child twins; Inactivated influenza vaccine, high-dose

Summary:

      This study will investigate response to influenza vaccines in monozygotic and dizygotic twins
      of different ages.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Otherwise healthy, ambulatory children or adults, ages 8-17 years (identical twins),
             18-30 years (identical or fraternal twins), 40-59 years (identical or fraternal twins)
             or 70-100 years (identical twins).

          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.

          5. All female of childbearing potential, must use an acceptable method of contraception
             and not become pregnant for the duration of the study (approximately 1 month or to
             completion of Visit 3). (Acceptable contraception includes implants, injectables,
             combined oral contraceptives, effective intrauterine devices (IUDs), sexual
             abstinence, or a vasectomized partner).

        Exclusion Criteria:

          1. Prior off-study vaccination with trivalent inactivated influenza vaccine (TIV) or live
             attenuated influenza vaccine (LAIV) in Fall 2010

          2. Allergy to egg or egg products, or to vaccine components, including thimerosal (if TIV
             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

          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. Blood pressure >150 systolic or > 95 diastolic at Visit 1

          8. Hospitalization in the past year for congestive heart failure or emphysema.

          9. Chronic Hepatitis B or C

         10. Recent or current use of immunosuppressive medication, including glucocorticoids
             (corticosteroid nasal sprays and inhaled steroids are permissible). Use of oral
             steroids (<20mg prednisone-equivalent/day) may be acceptable after review by the
             investigator.

         11. 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).

         12. 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.

         13. History of blood dyscrasias, renal disease, or hemoglobinopathies requiring regular
             medical follow up or hospitalization during the preceding year

         14. Use of any anti-coagulation medication such as Coumadin or Lovenox, or anti-platelet
             agents such as aspirin, Plavix, Aggrenox must be reviewed by investigator to determine
             if this would affect the volunteer's safety.

         15. Receipt of blood or blood products within the past 6 months

         16. Medical or psychiatric condition or occupational responsibilities that preclude
             subject compliance with the protocol

         17. Inactivated vaccine 14 days prior to vaccination

         18. Live, attenuated vaccine within 60 days of vaccination

         19. History of Guillain-Barre Syndrome

         20. Pregnant or lactating woman

         21. Use of investigational agents within 30 days prior to enrollment

         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.