Trial Search Results
B-cell Immunity to Influenza (SLVP017) - Years 2 (2010) & 3 (2011)
In this exploratory study, investigators will be looking at immune response differences between age groups and between the two different influenza vaccines given to identical twins, vaccine-naive young adults and elderly participants.
Stanford is currently not accepting patients for this trial.
Collaborator: National Institute of Allergy and Infectious Diseases (NIAID)
- Biological: Fluzone
- Biological: FluMist
1. Healthy, ambulatory 8-17 year old identical twins, 8-30 year old non-twins, or 70-100
year old elderly 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 by medical history and vital signs.
1. Prior vaccination with seasonal TIV or LAIV or H1N1.
2. Prior off-study vaccination with the current seasonal TIV or LAIV
3. Allergy to egg or egg products, or to vaccine components
4. Life-threatening reactions to previous influenza vaccinations
5. Asthma or history of wheezing
6. Active systemic or serious concurrent illness, including febrile illness on the day of
7. History of immunodeficiency (including HIV infection)
8. 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.
9. Blood pressure >150 systolic or >95 diastolic at first study visit
10. Hospitalization in the past year for congestive heart failure or emphysema.
11. Chronic Hepatitis B or C.
12. Recent or current use of immunosuppressive medication, including systemic
glucocorticoids (corticosteroid nasal sprays and topical steroids are permissible in
all groups; inhaled steroid use is not permissible except for non-LAIV Group C only).
Use of oral steroids (<20mg prednisone-equivalent/day) may be acceptable for
volunteers 70-100 yrs of age after review by the investigator.
13. Participants in close contact with anyone who has a severely weakened immune system
should not receive LAIV (Groups A and B only)
14. 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).
15. 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
16. History of blood dyscrasias, renal disease, or hemoglobinopathies requiring regular
medical follow up or hospitalization during the preceding year
17. 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.
18. Receipt of blood or blood products within the past 6 months
19. Medical or psychiatric condition or occupational responsibilities that preclude
participant compliance with the protocol
20. Inactivated vaccine 14 days prior to vaccination
21. Live, attenuated vaccine within 60 days of vaccination
22. History of Guillain-Barré Syndrome
23. Pregnant or lactating woman
24. Use of investigational agents within 30 days prior to enrollment
25. Donation of the equivalent of a unit of blood within 6 weeks prior to enrollment
26. 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.
Ages Eligible for Study
8 Years - 100 Years
Genders Eligible for Study