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High-Dose Influenza Vaccine in Nursing Homes

13. juli 2018 oppdatert av: 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.

Studieoversikt

Status

Ukjent

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Faktiske)

823

Fase

  • Fase 4

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

65 år og eldre (Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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 navn:
  • Fluzone høydose
Biologisk: Free Vaccine
Nursing home facilities are provided free standard-dose vaccine for their staff.
Andre navn:
  • Fluzon
Eksperimentell: 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 navn:
  • Fluzone høydose
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 navn:
  • Fluzon
Biologisk: SD Vaccine
Nursing home residents are allocated to receive standard-dose vaccine.
Andre navn:
  • 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 navn:
  • Fluzon

Hva måler studien?

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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Insight Therapeutics, LLC

Samarbeidspartnere

Brown University
Case Western Reserve University

Etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. februar 2013

Primær fullføring (Faktiske)

15. mai 2017

Studiet fullført (Forventet)

1. september 2018

Datoer for studieregistrering

Først innsendt

11. mars 2013

Først innsendt som oppfylte QC-kriteriene

18. mars 2013

Først lagt ut (Anslag)

21. mars 2013

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

16. juli 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

13. juli 2018

Sist bekreftet

1. juli 2018

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • GRC75-EXT

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

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