High-Dose Influenza Vaccine in Nursing Homes

Insight Therapeutics

Status and phase: Unknown; Phase 4

Conditions: Influenza

Treatments: Biological: Usual Care; Biological: Free Vaccine; Biological: HD Vaccine; Biological: SD Vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT01815268

GRC75-EXT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 823 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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823 participants in 4 patient groups

HD Vaccine (Residents) + Free Vaccine (Staff)

Experimental group

Description:

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.

Treatment:

Biological: HD Vaccine

Biological: Free Vaccine

HD Vaccine (Residents) + Usual Care (Staff)

Experimental group

Description:

NH facilities randomized to receive high-dose trivalent influenza vaccine (Fluzone High-Dose) for the residents and not provided free vaccine for the staff.

Treatment:

Biological: Usual Care

Biological: HD Vaccine

SD Vaccine (Residents) + Free Vaccine (Staff)

Active Comparator group

Description:

NH facilities randomized to receive standard dose influenza vaccine (Fluzone) for the residents and provided free standard dose vaccine (Fluzone) for the staff.

Treatment:

Biological: SD Vaccine

Biological: Free Vaccine

SD Vaccine (Residents) + Usual Care (Staff)

Active Comparator group

Description:

NH facilities randomized to receive standard dose influenza vaccine (Fluzone) for the residents and not provided free vaccine for the staff.

Treatment:

Biological: SD Vaccine

Biological: Usual Care