High Dose Influenza Vaccine in Nursing Home - Pilot Study

Phase 4

Completed

• Conditions: Influenza
• Interventions: Biological: HD Fluzone Vaccine; Biological: SD Fluzone Vaccine

• Registration Number: NCT01720277
• Lead Sponsor: Insight Therapeutics, LLC

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.

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-10-15
• Study First Submitted QC: 2012-10-31
• Study First Posted: 2012-11-02
• Primary Completion: 2013-05
• Study Completion: 2016-05
• Results First Submitted: 2017-06-15
• Results First Submitted QC: 2018-03-20
• Status Verified: 2018-04
• Results First Posted: 2018-04-18
• Last Update Submitted: 2018-04-25
• Last Update Posted: 2018-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2957

Inclusion Criteria

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HD Fluzone Vaccine	HD Fluzone Vaccine	NH facilities randomized to receive high dose trivalent influenza vaccine (HD Fluzone) for the residents.
SD Fluzone Vaccine	SD Fluzone Vaccine	NH facilities randomized to standard dose trivalent influenza vaccine (SD Fluzone) for the residents.

Primary Outcome Measures

Name	Time	Method
Total All-cause Hospitalizations	1 year	The primary outcome will establish our methodology for measuring all-cause hospitalizations using the Minimum Data Set (MDS).

Secondary Outcome Measures

Name	Time	Method
Change in Residents' Functional Status	1 year	The secondary outcome will establish our methodology for measuring change in functional status of nursing home residents using Activities of Daily Living (ADL) data in the Minimum Data Set (MDS). A change in functional status is defined as a decline in physical functioning by at least 4 points on the 28-point ADL scale.

Trial Locations

Locations (2)

Brown Univeristy; 🇺🇸 Providence, Rhode Island, United States

Insight Therapeutics; 🇺🇸 Norfolk, Virginia, United States