Clinical trial NCT01720277: High Dose Influenza Vaccine in Nursing Home - Pilot Study
Official title: High Dose Influenza Vaccination and Morbidity and Mortality in U.S. Nursing Homes - A Pilot Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Influenza
Keywords: Randomized Controlled Trial
Influenza
Influenza vaccine
Flu Vaccine
Fluzone
HD Fluzone
Nursing Homes
Hospitalization
Mortality
Health Care worker vaccination
ADL decline
Pilot
Effectiveness
Lead sponsor: Insight Therapeutics, LLC
Sponsor class: OTHER
Collaborators: name: Brown University
First posted: 2012-11-02
Enrollment: 2957
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: Influenza remains the most common preventable respiratory viral infection of older adults. Older adults incur more than 90% of the disease burden, and those residing in nursing homes are the most affected subset given their immune senescence, multi-morbidity, and close living quarters. Each year, the majority of influenza-related hospitalizations occur during the period with the greatest influenza activity.

Influenza vaccination has been associated with reduced hospitalization, strokes, heart attacks and death in non-institutional older adult populations, but the benefit of influenza vaccine for the oldest population has been questioned. The new high-dose influenza vaccine is considerably more immunogenic in older adults, and has recently been approved for use in individuals aged 65 years and older. No clinical data yet confirm whether the improved immunogenicity translates into added clinical benefit, such as further reduction in hospitalization or death. Estimating the benefit of influenza vaccination among older adults in long-term care settings using randomized controlled trials requires extensive effort and is costly. Instead, a pragmatic RCT in a nursing home population has several advantages as a model for comparing therapeutic approaches.

This clinical trial aims to test the feasibility of our protocol for a subsequent larger study. We aim to demonstrate that we can recruit and enroll facilities; randomly assign and coordinate vaccine delivery; collect data; conduct site audits for data validation; create outcomes using multiple data sources; and conduct analyses.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Total All-cause Hospitalizations
timeFrame: 1 year
Secondary outcomes:
measure: Change in Residents' Functional Status
timeFrame: 1 year
Other outcomes:
measure: Recruit, Enroll, and Randomize Nursing Homes Per Calculated Sample Size
timeFrame: 1 year
Locations:
city: Providence
country: United States
facility: Brown Univeristy
state: Rhode Island
city: Norfolk
country: United States
facility: Insight Therapeutics
state: Virginia
Study officials:
affiliation: Case Western Reserve University
name: Stefan Gravenstein, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Insight Therapeutics, LLC
name: Ed Davidson, PharmD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Brown University
name: Vincent Mor, PhD
role: PRINCIPAL_INVESTIGATOR
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