Status:
COMPLETED
T-cell Response-Flu Risk in Older Adults
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Influenza
Eligibility:
All Genders
20-99 years
Phase:
NA
Brief Summary
The purpose of this study is to determine how the immune system changes with aging and makes influenza a more serious illness in older people. Influenza vaccination not only can protect people from ge...
Detailed Description
This study will increase the understanding of how age, congestive heart failure (CHF) or a prior hospitalization for an influenza-related acute coronary event affect the immune response to influenza v...
Eligibility Criteria
Inclusion
- Willing to be vaccinated with the current influenza vaccine.
- Healthy young adults are 20-40 years and have no underlying chronic diseases.
- 'Healthy' older adult participants are age 60 and older who may have underlying chronic diseases but no diagnosis of CHF, advanced kidney disease or diabetes requiring insulin.
- High-risk older adults with cardiovascular disease are age 60 years and older and have a diagnosis of CHF, or IHD including ACS in the previous winter season.
Exclusion
- Allergic reactions to eggs or preservatives such as those contained in contact lens solutions.
- A previous significant reaction to vaccination or if they refuse to receive influenza vaccination.
- Known immunosuppressive disorders or medications (including oral prednisone in doses \>10 mg daily) or have not received influenza vaccination in the past.
- Subjects who report respiratory illness within the two-week period prior to vaccination. Subjects reporting respiratory symptoms at the first study visit are re-scheduled to a time when they have not had a respiratory illness (at least two symptoms of cough, runny nose, malaise and fever) within the two-week period prior to vaccination.
- Cardiovascular diseases due to intravenous drug abuse, myocarditis or congenital abnormalities
- Any condition that in the opinion of the investigator would interfere with the interpretation or the evaluation of the vaccine
Key Trial Info
Start Date :
October 25 2005
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
850 Patients enrolled
Trial Details
Trial ID
NCT00138398
Start Date
October 25 2005
Last Update
February 15 2019
Active Locations (1)
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1
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030