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High-Dose Influenza Vaccine in Nursing Homes

13. juli 2018 opdateret af: 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.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

823

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

65 år og ældre (Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Biologisk: HD Vaccine
Nursing home residents over 65 years are allocated to receive high-dose vaccine. Residents under 65 years are provided standard-dose vaccine.
Andre navne:
  • Fluzone højdosis
Biologisk: Free Vaccine
Nursing home facilities are provided free standard-dose vaccine for their staff.
Andre navne:
  • Fluzon
Eksperimentel: 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.
Biologisk: HD Vaccine
Nursing home residents over 65 years are allocated to receive high-dose vaccine. Residents under 65 years are provided standard-dose vaccine.
Andre navne:
  • Fluzone højdosis
Biologisk: Usual Care
Nursing home staff will have access to influenza vaccine, per standard of care. No free vaccine provided as part of study.
Aktiv komparator: 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.
Biologisk: Free Vaccine
Nursing home facilities are provided free standard-dose vaccine for their staff.
Andre navne:
  • Fluzon
Biologisk: SD Vaccine
Nursing home residents are allocated to receive standard-dose vaccine.
Andre navne:
  • Fluzon
Aktiv komparator: 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.
Biologisk: Usual Care
Nursing home staff will have access to influenza vaccine, per standard of care. No free vaccine provided as part of study.
Biologisk: SD Vaccine
Nursing home residents are allocated to receive standard-dose vaccine.
Andre navne:
  • Fluzon

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Hospitalization rate
Tidsramme: up to 1 year
up to 1 year

Sekundære resultatmål

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

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Difference in hospitalization claims based on staff vaccination status
Tidsramme: up to 1 year
Effect on clinical outcomes of nursing home residents based on staff vaccine uptake.
up to 1 year

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Insight Therapeutics, LLC

Samarbejdspartnere

Brown University
Case Western Reserve University

Efterforskere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. februar 2013

Primær færdiggørelse (Faktiske)

15. maj 2017

Studieafslutning (Forventet)

1. september 2018

Datoer for studieregistrering

Først indsendt

11. marts 2013

Først indsendt, der opfyldte QC-kriterier

18. marts 2013

Først opslået (Skøn)

21. marts 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. juli 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. juli 2018

Sidst verificeret

1. juli 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • GRC75-EXT

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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