High-Dose Influenza Vaccine in Nursing Homes

July 13, 2018 updated by: Insight Therapeutics, LLC

High Dose Influenza Vaccination and Morbidity & Mortality in U.S. Nursing Homes

The purpose of this study is to prospectively evaluate relative effectiveness of high dose influenza vaccine in preventing influenza mortality, hospitalization, and functional decline in a nursing home population in the U.S., compared to the standard dose trivalent seasonal influenza vaccine.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

SUMMARY: This nationally representative study samples from estimated 6782 Medicare-certified nursing homes co-located within 50 miles of the 122 cities reporting to Center for Disease Control and Prevention (CDC) weekly influenza surveillance. In total, 1000 facilities will be enrolled for random assignment to either: 1) the licensed high dose (HD) trivalent influenza vaccine (High-Dose Fluzone [HD vaccine]), or 2) the standard dose (SD) trivalent influenza vaccine (Fluzone [SD vaccine]) for their residents. Additionally, half the facilities will receive free SD vaccine for their staff and the remaining facilities will practice usual care (no free vaccine) for staff.

BACKGROUND: Influenza and pneumonia (P&I) are leading infectious causes of hospitalization and mortality in community-dwelling older adults and residents of long-term custodial care facilities or nursing homes (NH), and produce substantial annual health care costs. The elderly incur over 90% of this disease burden and NH residents are especially vulnerable given immune senescence, multimorbidity, and close living quarters. While hospitalization rates for NH residents vary considerably between facilities, most occur during the sixteen weeks of peak influenza activity annually. Influenza vaccination, a mainstay in prevention, is recommended in the U.S. for all individuals six months of age and older. Vaccination associates with reduced rates of stroke, heart attack, hospitalization, and death in non-institutional older adult populations. However, the benefit of influenza vaccine for the elderly in general has been questioned, a salient concern for frail elderly, such as NH residents. Influenza vaccination rates vary substantially between nursing homes. Influenza vaccine response declines with advancing age, indicating the need for a better vaccine.

OBJECTIVES: The primary objective is to estimate the differences in all-cause hospitalization rates during influenza season experienced by long-stay nursing home residents, between facilities using HD vaccine vs. SD vaccine. The secondary objective is to estimate the differences in the likelihood of Activities of Daily Living (ADL) functional decline and mortality rates in the study nursing homes.

Study Type

Interventional

Enrollment (Actual)

823

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
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Case Western Reserve University
    • Rhode Island
      • Providence, Rhode Island, United States, 02912
        • Brown University
    • Virginia
      • Norfolk, Virginia, United States, 23510
        • Insight Therapeutics, LLC

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

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Long-term care facilities within 50 miles of one of the 122 cities that serve as CDC surveillance sites

Exclusion Criteria:

  • Facilities already systematically administering HD vaccine to their residents
  • Facilities having fewer than 50 long-stay residents
  • Hospital-based facilities
  • Facilities with more than 20% of the population under age 65
  • Facilities not submitting Minimum Data Set (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 Vaccine (Residents) + Free Vaccine (Staff)
NH facilities randomized to receive high-dose trivalent influenza vaccine (Fluzone High-Dose) for the residents and provided free SD vaccine (Fluzone) for the staff.
Biological: HD Vaccine
Nursing home residents over 65 years are allocated to receive high-dose vaccine. Residents under 65 years are provided standard-dose vaccine.
Other Names:
  • Fluzone High-Dose
Biological: Free Vaccine
Nursing home facilities are provided free standard-dose vaccine for their staff.
Other Names:
  • Fluzone
Experimental: HD Vaccine (Residents) + Usual Care (Staff)
NH facilities randomized to receive high-dose trivalent influenza vaccine (Fluzone High-Dose) for the residents and not provided free vaccine for the staff.
Biological: HD Vaccine
Nursing home residents over 65 years are allocated to receive high-dose vaccine. Residents under 65 years are provided standard-dose vaccine.
Other Names:
  • Fluzone High-Dose
Biological: Usual Care
Nursing home staff will have access to influenza vaccine, per standard of care. No free vaccine provided as part of study.
Active Comparator: SD Vaccine (Residents) + Free Vaccine (Staff)
NH facilities randomized to receive standard dose influenza vaccine (Fluzone) for the residents and provided free standard dose vaccine (Fluzone) for the staff.
Biological: Free Vaccine
Nursing home facilities are provided free standard-dose vaccine for their staff.
Other Names:
  • Fluzone
Biological: SD Vaccine
Nursing home residents are allocated to receive standard-dose vaccine.
Other Names:
  • Fluzone
Active Comparator: SD Vaccine (Residents) + Usual Care (Staff)
NH facilities randomized to receive standard dose influenza vaccine (Fluzone) for the residents and not provided free vaccine for the staff.
Biological: Usual Care
Nursing home staff will have access to influenza vaccine, per standard of care. No free vaccine provided as part of study.
Biological: SD Vaccine
Nursing home residents are allocated to receive standard-dose vaccine.
Other Names:
  • Fluzone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hospitalization rate
Time Frame: up to 1 year
up to 1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in activities of daily living (ADL) scores
Time Frame: up to 1 year
up to 1 year
Facility-level mortality rate
Time Frame: up to 1 year
up to 1 year
Hospitalization rate based on vaccine type and influenza strain
Time Frame: Up to 3 years
Up to 3 years
Cost difference between vaccine types
Time Frame: up to 3 years
up to 3 years
Effect of facility policies on staff vaccination rates
Time Frame: up to 3 years
up to 3 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in hospitalization claims based on staff vaccination status
Time Frame: up to 1 year
Effect on clinical outcomes of nursing home residents based on staff vaccine uptake.
up to 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
Case Western Reserve 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

February 1, 2013

Primary Completion (Actual)

May 15, 2017

Study Completion (Anticipated)

September 1, 2018

Study Registration Dates

First Submitted

March 11, 2013

First Submitted That Met QC Criteria

March 18, 2013

First Posted (Estimate)

March 21, 2013

Study Record Updates

Last Update Posted (Actual)

July 16, 2018

Last Update Submitted That Met QC Criteria

July 13, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GRC75-EXT

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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