Status:
COMPLETED
Elderly Influenza Vaccine Immunogenicity Substudy
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Influenza
Eligibility:
All Genders
65-99 years
Brief Summary
The body's immune system (fights infection) is known to decline during the aging process, resulting in an increased risk of catching infections. Vaccinations also are not as effective in protecting ol...
Detailed Description
There is a need to increase protection against influenza conveyed to elderly persons by inactivated influenza virus vaccines. Serum antibody titer is the primary surrogate marker for immunity to influ...
Eligibility Criteria
Inclusion
- 1\. Volunteers who participate in Division of Microbiology and Infectious Diseases (DMID) study 04-100, "Comparisons of the Reactogenicity and Immunogenicity in Ambulatory Elderly Subjects of a Standard-Dose Fluzone® (15 µg HA/Virus Strain) and a High-Dose (60 µg HA/Virus Strain) of a Trivalent Inactivated Influenza Virus Vaccine" 2. Ambulatory medically stable persons at least 65 years of age on the date of vaccination 2. Provides written informed consent and will be available for all study visits 4. Able to understand and comply with planned study procedures Subjects will be considered ambulatory if they are not institutionalized, bedridden, or homebound. Medically stable subjects may have underlying illnesses such as hypertension, diabetes, ischemic heart disease, or hypothyroidism, but their symptoms/signs must be controlled with medical therapy. Subjects with acute febrile illnesses \[oral temperature equal to or exceeding 99.5 degrees F (37.5 degrees C)\] will be deferred until 3 days after illness resolution.
Exclusion
- 1\. Known allergy to eggs or other components of the vaccine (eg, thimerosal) 2. History of a severe reaction following influenza vaccination, systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to a vaccine containing the same substances 3. History of Guillain-Barré Syndrome 4. Immunosuppression as a result of underlying illness or treatment 5. Use of oral steroids, parenteral steroids, or high-dose inhaled steroids (\> 800 µg per day of beclomethasone dipropionate or equivalent) within 1 month prior to vaccination 6. Use of other immunosuppressive or cytotoxic drugs or radiation therapy within the six months prior to vaccination 7. Active neoplastic disease or history of any hematologic malignancy in the past 5 years (except localized skin or prostate cancer that is stable in the absence of therapy) 8. Acute or chronic condition that (in the opinion of the Investigator) would render vaccination unsafe or would interfere with the evaluation of responses including, but not limited to the following: known chronic liver disease, significant renal disease, oxygen-dependent chronic lung disease, New York Heart Association Functional Class III or IV, unstable or progressive neurologic disorder, insulin-treated diabetes mellitus 9. Use of experimental vaccines or medications within the month prior to study entry, or expected use of experimental vaccines or medications during the entire study period, including the 6-month follow-up phone call, after inoculation with study vaccine 10. Use of experimental devices or participation in a medical procedure trial within the month prior to study entry, or expected use of experimental devices or participation in a medical procedure trial during the entire study period, including the 6-month follow-up phone call, after inoculation with study vaccine 11. Receipt of immunoglobulin or other blood product within 3 months prior to enrollment 12. Receipt of other licensed vaccines within the preceding 4 weeks or expected to receive a licensed vaccine within 1 month (prior to visit 2) following trial vaccination 13. Subject is enrolled in a conflicting clinical trial 14. Thrombocytopenia or bleeding disorder or therapy contraindicating intramuscular (IM) vaccination.
Key Trial Info
Start Date :
April 25 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 30 2005
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00170482
Start Date
April 25 2005
End Date
May 30 2005
Last Update
January 28 2019
Active Locations (1)
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1
University of Maryland School of Medicine - Center for Vaccine Development - Baltimore
Baltimore, Maryland, United States, 21201-1509