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T-cell And General Immune Response to Seasonal Influenza Vaccine (SLVP018) - Year 1, 2009
Trial ID: NCT01987349
This study will compare influenza vaccine responses in monozygotic and dizygotic twins.
Protective Mechanisms Against a Pandemic Respiratory Virus: B- Cell, T-cell, and General Immune Response to Seasonal Influenza Vaccine. Year 1, 2009
1. Otherwise healthy, ambulatory children or adults, ages 8-17 years (identical twin
pairs), 18-30 years (identical or fraternal twin pairs), 40-49 years (identical or
fraternal twin pairs) or 70-100 years (twin or non-twin adults).
2. Willing to complete the informed consent process.
3. Availability for follow-up for the planned duration of the study at least 28 days
4. Acceptable medical history and vital signs.
5. Negative urine pregnancy test for women of childbearing potential
6. If the subject is female and of childbearing potential, she must use an acceptable
method of contraception and not become pregnant for the duration of the study.
(Acceptable contraception includes implants, injectables, combined oral
contraceptives, effective intrauterine devices (IUDs), sexual abstinence, or a
1. Prior vaccination with TIV or LAIV in Fall 2009
2. Allergy to egg or egg products, or to vaccine components, including gentamicin,
gelatin, arginine or MSG (for LAIV only), or thimerosal (TIV multidose vials only).
3. Life-threatening reactions to previous influenza vaccinations
4. Asthma (LAIV groups only)
5. Active systemic or serious concurrent illness, including febrile illness on the day of
6. History of immune deficiency
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, blood pressure >150/95 at screening, or any other chronic
disorder which, in the opinion of the investigator, might jeopardize volunteer safety
or compliance with the protocol.
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 are permissible).
11. Subjects in close contact with anyone who has a severely weakened immune system should
not receive LAIV.
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
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, Plavix, Aggrenox may be acceptable after review by
16. Receipt of blood or blood products within the past 6 months
17. Medical or psychiatric condition or occupational responsibilities that preclude
subject 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.
biological: Fluzone® (intramuscular)
biological: Flumist® (intranasal)
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