1345. Effectiveness of High-Dose Influenza Vaccination on Hospitalizations of Older Adults in United States Nursing Homes: Results from a Cluster-Randomized Controlled Trial
Session: Poster Abstract Session: Clinical Trials
Friday, October 28, 2016
Room: Poster Hall
Posters
  • IDSA_Poster_Flu Full Study FINAL 2016.pdf (862.4 kB)
  • Background: Response to influenza (flu) vaccine declines with age, reducing clinical effectiveness. Our primary objective was to determine whether a more immunogenic Fluzone® High-Dose vaccine (HD), compared with a Fluzone® standard dose vaccine (SD) can reduce hospitalizations among nursing home (NH) residents.

    Methods: In this pragmatic, comparative effectiveness, cluster-randomized trial, enrolled NHs were randomized to administer either HD or SD vaccine to long stay residents for the 2013-14 season. Facilities were also allocated to free vaccine for staff or usual procedure in a 2x2 factorial design. Data were collected from CMS under data-use agreements and from enrolled facilities. All analyses were by Intent-To-Treat. We analyzed hospitalization incidence using marginal Poisson regression accounting for clustering of residents within facilities, and adjusting for a priori facility and resident covariates. We analyzed secondary outcomes (mortality, activities of daily living) using Cox proportional hazards and logistic regression.

    Results: We randomized 823 facilities with 53,008 long stay residents; facility and resident characteristics were similar between arms. Flu A/H1N1 was the dominant flu strain during the study period. Incidence of hospitalization was significantly lower in HD than SD facilities for all-causes (Adjusted RR=0.951, 95% CI 0.907-.996, p=0.0347) and respiratory conditions (ARR=0.883, CI 0.787-0.989, p=0.032) and lower but NS so for pneumonia and influenza.

    Conclusion: High dose flu vaccine reduces risk of all-cause hospitalization and hospitalization for respiratory conditions in long-term care residents in an A/H1N1 dominant season.

    Registration:NCT01815268

    Funding: Sanofi Pasteur

    Stefan Gravenstein, MD, MPH1,2,3,4, H. Edward Davidson, PharmD, MPH5, Monica Taljaard, PhD6, Jessica Ogarek, MS2, Lisa Han, MPH5, Roshani Dahal, MPH2, Pedro Gozalo, PhD7 and Vincent Mor, PhD7,8, (1)Center for Geriatrics and Palliative Care, UH Case Medical Center, Cleveland, OH, (2)Center for Gerontology and Healthcare Research, Brown University School of Public Health, Providence, RI, (3)Medicine, Geriatrics, Case Western Reserve University, Cleveland, OH, (4)Healthcentric Advisors, Providence, RI, (5)Insight Therapeutics, LLC, Norfolk, VA, (6)Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada, (7)Department of Health Services, Policy & Practice, Brown University School of Public Health, Providence, RI, (8)Providence VA Medical Center, Providence, RI

    Disclosures:

    S. Gravenstein, Sanofi: Consultant , Grant Investigator , Investigator , Scientific Advisor and Speaker's Bureau , Consulting fee , Research support and Speaker honorarium

    H. E. Davidson, Sanofi: Grant Investigator , Grant recipient and Research support

    M. Taljaard, None

    J. Ogarek, Sanofi: analyst , Research support

    L. Han, Sanofi: Investigator , Grant recipient , Research grant and Research support

    R. Dahal, Sanofi: analyst , Research support

    P. Gozalo, Sanofi: Grant Investigator , Research support

    V. Mor, Sanofi: Grant Investigator , Research grant and Research support

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