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High-Dose Influenza Vaccine in Nursing Homes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01815268
Recruitment Status : Unknown
Verified July 2018 by Insight Therapeutics, LLC.
Recruitment status was:  Active, not recruiting
First Posted : March 21, 2013
Last Update Posted : July 16, 2018
Sponsor:
Collaborators:
Brown University
Case Western Reserve University
Information provided by (Responsible Party):
Insight Therapeutics, LLC

Tracking Information
First Submitted Date  ICMJE March 11, 2013
First Posted Date  ICMJE March 21, 2013
Last Update Posted Date July 16, 2018
Study Start Date  ICMJE February 2013
Actual Primary Completion Date May 15, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 14, 2016)
Hospitalization rate [ Time Frame: up to 1 year ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 18, 2013)
Total influenza mortality per nursing home based on vaccination status [ Time Frame: up to 1 year ]
LINKED AT THE FACILITY LEVEL. The primary outcome measure will determine influenza mortality. [Vaccine uptake information will be collected for flu season November 2013 to March 2014. There is a data lag of 18 months for this cohort, therefore data analysis will be completed by December 2016.]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 16, 2016)
  • Change in activities of daily living (ADL) scores [ Time Frame: up to 1 year ]
  • Facility-level mortality rate [ Time Frame: up to 1 year ]
  • Hospitalization rate based on vaccine type and influenza strain [ Time Frame: Up to 3 years ]
  • Cost difference between vaccine types [ Time Frame: up to 3 years ]
  • Effect of facility policies on staff vaccination rates [ Time Frame: up to 3 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 18, 2013)
Change in activities of daily living (ADL) scores per NH resident by vaccination status [ Time Frame: up to 1 year ]
LINKED AT THE RESIDENT LEVEL. The secondary outcome measure evaluates comparative vaccine effectiveness for functional status of HD vaccine compared to no or SD vaccine. Changes in ADL scores from baseline (Oct 2013 or prior and closest to Oct 2013) to any post-baseline MDS assessment (2014). [Vaccine uptake information will be collected for flu season November 2013 to March 2014. There is a data lag of 18 months for this cohort, therefore data analysis will be completed by December 2016.]
Current Other Pre-specified Outcome Measures
 (submitted: February 14, 2016)
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.
Original Other Pre-specified Outcome Measures
 (submitted: March 18, 2013)
Difference in hospitalization claims based on staff vaccination status [ Time Frame: up to 1 year ]
LINKED AT THE FACILITY LEVEL. The exploratory outcome measure evaluates comparative cost effectiveness high dose vaccine compared to no or standard dose vaccine, and effect on clinical outcomes based on staff vaccine uptake. The facilities will be compared to test the main effect of staff vaccination on NH resident hospitalization rate. [Staff vaccine uptake information will be collected for flu season November 2013 to March 2014. There is a data lag of 18 months for the NH cohort, therefore data analysis will be completed by December 2016.]
 
Descriptive Information
Brief Title  ICMJE High-Dose Influenza Vaccine in Nursing Homes
Official Title  ICMJE High Dose Influenza Vaccination and Morbidity & Mortality in U.S. Nursing Homes
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Influenza
Intervention  ICMJE
  • 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 Name: Fluzone High-Dose
  • Biological: SD Vaccine
    Nursing home residents are allocated to receive standard-dose vaccine.
    Other Name: Fluzone
  • Biological: Free Vaccine
    Nursing home facilities are provided free standard-dose vaccine for their staff.
    Other Name: Fluzone
  • Biological: Usual Care
    Nursing home staff will have access to influenza vaccine, per standard of care. No free vaccine provided as part of study.
Study Arms  ICMJE
  • 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.
    Interventions:
    • Biological: HD Vaccine
    • Biological: Free Vaccine
  • 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.
    Interventions:
    • Biological: HD Vaccine
    • Biological: Usual Care
  • 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.
    Interventions:
    • Biological: SD Vaccine
    • Biological: Free Vaccine
  • 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.
    Interventions:
    • Biological: SD Vaccine
    • Biological: Usual Care
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: February 23, 2015)
823
Original Estimated Enrollment  ICMJE
 (submitted: March 18, 2013)
1000
Estimated Study Completion Date  ICMJE September 2018
Actual Primary Completion Date May 15, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01815268
Other Study ID Numbers  ICMJE GRC75-EXT
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Insight Therapeutics, LLC
Study Sponsor  ICMJE Insight Therapeutics, LLC
Collaborators  ICMJE
  • Brown University
  • Case Western Reserve University
Investigators  ICMJE
Principal Investigator: Stefan Gravenstein, MD, MPH Case Western Reserve University
Principal Investigator: Vincent Mor, PhD Brown University
Principal Investigator: Ed Davidson, PharmD, MPH Insight Therapeutics, LLC
PRS Account Insight Therapeutics, LLC
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP