T-cell Response-Flu Risk in Older Adults
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ClinicalTrials.gov Identifier: NCT00138398 |
Recruitment Status
: Unknown
Verified October 2007 by National Institute of Allergy and Infectious Diseases (NIAID).
Recruitment status was: Recruiting
First Posted
: August 30, 2005
Last Update Posted
: August 27, 2010
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Influenza | Biological: Commercial TriValent Split Influenza Virus | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 850 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | T-cell Responses Predict Influenza Risk in Older Adults |
Study Start Date : | October 2005 |
Study Completion Date : | October 2007 |


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Ages Eligible for Study: | 20 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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 Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00138398
Contact: Janet McElhaney | (757) 466-7040 |
United States, Connecticut | |
University of Connecticut Health Center | Recruiting |
Farmington, Connecticut, United States, 06030 |
ClinicalTrials.gov Identifier: | NCT00138398 History of Changes |
Other Study ID Numbers: |
05-0056 |
First Posted: | August 30, 2005 Key Record Dates |
Last Update Posted: | August 27, 2010 |
Last Verified: | October 2007 |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Influenza, T cell, vaccine, Congestive heart failure |
Additional relevant MeSH terms:
Influenza, Human Orthomyxoviridae Infections RNA Virus Infections |
Virus Diseases Respiratory Tract Infections Respiratory Tract Diseases |