High Dose Influenza Vaccine in Nursing Home - Pilot Study

April 25, 2018 updated by: Stefan Gravenstein, MD, MPH, Insight Therapeutics, LLC

High Dose Influenza Vaccination and Morbidity and Mortality in U.S. Nursing Homes - A Pilot Evaluation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

2957

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Brown Univeristy
    • Virginia
      • Norfolk, Virginia, United States, 23510
        • Insight Therapeutics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

63 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HD Fluzone Vaccine
NH facilities randomized to receive high dose trivalent influenza vaccine (HD Fluzone) for the residents.
Biological: HD Fluzone Vaccine
Nursing home residents over 65 years are allocated to receive high dose trivalent vaccine. Residents under 65 years are provided standard dose trivalent vaccine (TIV).
Other Names:
  • Fluzone High Dose influenza vaccine
Active Comparator: SD Fluzone Vaccine
NH facilities randomized to standard dose trivalent influenza vaccine (SD Fluzone) for the residents.
Biological: SD Fluzone Vaccine
Nursing home residents are allocated to receive standard trivalent vaccine (TIV).
Other Names:
  • Fluzone influenza vaccine

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Residents' Functional Status
Time Frame: 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.
1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recruit, Enroll, and Randomize Nursing Homes Per Calculated Sample Size
Time Frame: 1 year
This outcome evaluates our ability to recruit and enroll nursing facilities that meet our inclusion and exclusion criteria, and ensure nursing home residents receive either high-dose or standard-dose influenza vaccine
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Insight Therapeutics, LLC

Collaborators

Brown University

Investigators

  • Principal Investigator: Vincent Mor, PhD, Brown University
  • Principal Investigator: Stefan Gravenstein, MD, MPH, Case Western Reserve University
  • Principal Investigator: Ed Davidson, PharmD, MPH, Insight Therapeutics, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

October 15, 2012

First Submitted That Met QC Criteria

October 31, 2012

First Posted (Estimate)

November 2, 2012

Study Record Updates

Last Update Posted (Actual)

May 23, 2018

Last Update Submitted That Met QC Criteria

April 25, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GRC75-HD Nursing Home Pilot

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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