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High Dose Influenza Vaccine in Nursing Home - Pilot Study

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ClinicalTrials.gov Identifier: NCT01720277
Recruitment Status : Completed
First Posted : November 2, 2012
Results First Posted : April 18, 2018
Last Update Posted : May 23, 2018
Sponsor:
Collaborator:
Brown University
Information provided by (Responsible Party):
Stefan Gravenstein, MD, MPH, Brown University

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.

Condition or disease Intervention/treatment Phase
Influenza Biological: HD Fluzone Vaccine Biological: SD Fluzone Vaccine Phase 4

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  (Clinical Trial)
Actual Enrollment : 2957 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: High Dose Influenza Vaccination and Morbidity and Mortality in U.S. Nursing Homes - A Pilot Evaluation
Study Start Date : September 2012
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Name: 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 Name: Fluzone influenza vaccine



Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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



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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01720277


Locations
United States, Rhode Island
Brown Univeristy
Providence, Rhode Island, United States, 02903
United States, Virginia
Insight Therapeutics
Norfolk, Virginia, United States, 23510
Sponsors and Collaborators
Insight Therapeutics, LLC
Brown University
Investigators
Principal Investigator: Stefan Gravenstein, MD, MPH Case Western Reserve University
Principal Investigator: Ed Davidson, PharmD, MPH Insight Therapeutics, LLC
Principal Investigator: Vincent Mor, PhD Brown University

Publications:

Responsible Party: Stefan Gravenstein, MD, MPH, Professor, Brown University
ClinicalTrials.gov Identifier: NCT01720277     History of Changes
Other Study ID Numbers: GRC75-HD Nursing Home Pilot
First Posted: November 2, 2012    Key Record Dates
Results First Posted: April 18, 2018
Last Update Posted: May 23, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Stefan Gravenstein, MD, MPH, Brown University:
Randomized Controlled Trial
Influenza
Influenza vaccine
Flu Vaccine
Fluzone
HD Fluzone
Nursing Homes
Hospitalization
Mortality
Health Care worker vaccination
ADL decline
Pilot
Effectiveness

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs