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NCT01815268 Clinical Trial

High-Dose Influenza Vaccine in Nursing Homes

Influenza Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT01815268
Other study ID # GRC75-EXT
Secondary ID
Status Active, not recruiting
Phase Phase 4
First received
Last updated
Start date February 2013
Est. completion date September 2018

Study information
Verified date July 2018
Source Insight Therapeutics, LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 823
Est. completion date September 2018
Est. primary completion date May 15, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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.
• SD Vaccine
Nursing home residents are allocated to receive standard-dose vaccine.
• Free Vaccine
Nursing home facilities are provided free standard-dose vaccine for their staff.
• Usual Care
Nursing home staff will have access to influenza vaccine, per standard of care. No free vaccine provided as part of study.

Locations
Country Name City State
United States Case Western Reserve University Cleveland Ohio
United States Insight Therapeutics, LLC Norfolk Virginia
United States Brown University Providence Rhode Island

Sponsors (3)
Lead Sponsor Collaborator
Insight Therapeutics, LLC Brown University, Case Western Reserve University

Country where clinical trial is conducted

United States, 

References & Publications (5)

DiazGranados CA, Dunning AJ, Kimmel M, Kirby D, Treanor J, Collins A, Pollak R, Christoff J, Earl J, Landolfi V, Martin E, Gurunathan S, Nathan R, Greenberg DP, Tornieporth NG, Decker MD, Talbot HK. Efficacy of high-dose versus standard-dose influenza vaccine in older adults. N Engl J Med. 2014 Aug 14;371(7):635-45. doi: 10.1056/NEJMoa1315727. — View Citation

Falsey AR, Treanor JJ, Tornieporth N, Capellan J, Gorse GJ. Randomized, double-blind controlled phase 3 trial comparing the immunogenicity of high-dose and standard-dose influenza vaccine in adults 65 years of age and older. J Infect Dis. 2009 Jul 15;200(2):172-80. doi: 10.1086/599790. — View Citation

Fiore AE, Shay DK, Haber P, Iskander JK, Uyeki TM, Mootrey G, Bresee JS, Cox NJ; Advisory Committee on Immunization Practices (ACIP), Centers for Disease Control and Prevention (CDC). Prevention and control of influenza. Recommendations of the Advisory Committee on Immunization Practices (ACIP), 2007. MMWR Recomm Rep. 2007 Jul 13;56(RR-6):1-54. — View Citation

Gozalo PL, Pop-Vicas A, Feng Z, Gravenstein S, Mor V. Effect of influenza on functional decline. J Am Geriatr Soc. 2012 Jul;60(7):1260-7. doi: 10.1111/j.1532-5415.2012.04048.x. Epub 2012 Jun 21. — View Citation

Keitel WA, Atmar RL, Cate TR, Petersen NJ, Greenberg SB, Ruben F, Couch RB. Safety of high doses of influenza vaccine and effect on antibody responses in elderly persons. Arch Intern Med. 2006 May 22;166(10):1121-7. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Other Difference in hospitalization claims based on staff vaccination status Effect on clinical outcomes of nursing home residents based on staff vaccine uptake. up to 1 year
Primary Hospitalization rate up to 1 year
Secondary Change in activities of daily living (ADL) scores up to 1 year
Secondary Facility-level mortality rate up to 1 year
Secondary Hospitalization rate based on vaccine type and influenza strain Up to 3 years
Secondary Cost difference between vaccine types up to 3 years
Secondary Effect of facility policies on staff vaccination rates up to 3 years
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