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Randomized Trial of High Dose Influenza Vaccine in Long Term Care Setting

CompletedPhase 4

Sponsor: University of Pittsburgh

Conditions: Influenza

Interventions: High Dose Inactivated Influenza Vaccine, Standard Dose Inactivated Influenza Vaccine

Countries: United States

The purpose of the study is to compare the performance of two currently available influenza (flu) vaccines. This study will try and determine if the high dose flu vaccine provides protection that is the same or better than that of regular dose flu vaccine. Both the regular dose and the high dose flu vaccines are approved by the FDA for use in older adults.

Eligibility overview

Sex: ALL

Age: 65 Years to —

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Residents of one of the participating LTC sites
* 65 years or older at the time of consent
* require assistance in two or more Instrumental Activities of Daily Living and/or one or more Activities of Daily Living as identified by facility staff

Exclusion Criteria:

* Age less than 65 years
* Life expectancy less than 6 months
* History of allergic reaction to influenza vaccine, its components, or eggs
* History of severe allergic reaction to latex
* History of Guillian-Barre Syndrome
* Actively undergoing chemotherapy
* Actively undergoing radiation therapy
* Use of prednisone (or other steroid) at prednisone-equivalent dosages of 10mg or higher within the past 14 days
* Serious current immunosuppression or immunosuppression expected in the next 6 weeks
* Any condition that, in the opinion of the investigator,might interfere with the evaluation of study objectives

Locations (1)

Pittsburgh, Pennsylvania, United States