High Dose Influenza Vaccine in Nursing Home - Pilot Study

Completed · Phase 4

Conditions studied: Influenza

In brief

The purpose of this pilot evaluation is to help determine the feasibility and power needed to prospectively evaluate relative effectiveness of high-dose influenza vaccine in preventing influenza mortality and hospitalization in a nursing home population in the U.S., compared to the standard-dose influenza vaccine.

Key facts

Study ID

NCT01720277

Run by

Insight Therapeutics, LLC

People needed

2957

Starts

2012-09-01

Expected to finish

2016-05-01

Last updated by the study team

2018-05-23

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Long-term care facilities in one of the 122 cities that serve as Center for Disease Control and Prevention (CDC) surveillance sites

You may not qualify if…

• Facilities already systematically administering HD vaccine to their residents
• Facilities for whom over half the residents are on Medicare (short-stay)
• Facilities in which over half the residents are on Medicare Part A (SNF)
• Facilities having fewer than 50 long-stay residents
• Hospital-based facilities
• Facilities with more than 20% of the population under age 65
• Facilities with mandated (employment-dependent) seasonal influenza vaccination
• Facilities not submitting MDS data

Where it is running

• Brown Univeristy — Providence, Rhode Island, United States
• Insight Therapeutics — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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