Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

High-Dose Influenza Vaccine in Nursing Homes

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Brown University
Case Western Reserve University
Information provided by (Responsible Party):
Insight Therapeutics, LLC
ClinicalTrials.gov Identifier:
NCT01815268
First received: March 11, 2013
Last updated: February 14, 2016
Last verified: February 2016
  Purpose
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.

Condition Intervention Phase
Influenza
Biological: HD Vaccine
Biological: SD Vaccine
Biological: Free Vaccine
Biological: Usual Care
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: High Dose Influenza Vaccination and Morbidity & Mortality in U.S. Nursing Homes

Resource links provided by NLM:


Further study details as provided by Insight Therapeutics, LLC:

Primary Outcome Measures:
  • Hospitalization rate [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in activities of daily living (ADL) scores [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
  • Facility-level mortality rate [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Difference in hospitalization claims based on staff vaccination status [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
    Effect on clinical outcomes of nursing home residents based on staff vaccine uptake.


Enrollment: 823
Study Start Date: February 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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.
Other Name: Fluzone High-Dose
Biological: Free Vaccine
Nursing home facilities are provided free standard-dose vaccine for their staff.
Other Name: Fluzone
Experimental: 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.
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.
Other Name: Fluzone High-Dose
Biological: Usual Care
Nursing home staff will have access to influenza vaccine, per standard of care. No free vaccine provided as part of study.
Active Comparator: 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.
Biological: SD Vaccine
Nursing home residents are allocated to receive standard-dose vaccine.
Other Name: Fluzone
Biological: Free Vaccine
Nursing home facilities are provided free standard-dose vaccine for their staff.
Other Name: Fluzone
Active Comparator: 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.
Biological: SD Vaccine
Nursing home residents are allocated to receive standard-dose vaccine.
Other Name: Fluzone
Biological: Usual Care
Nursing home staff will have access to influenza vaccine, per standard of care. No free vaccine provided as part of study.

Detailed 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.

  Eligibility

Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01815268

Locations
United States, Ohio
Case Western Reserve University
Cleveland, Ohio, United States, 44106
United States, Rhode Island
Brown University
Providence, Rhode Island, United States, 02912
United States, Virginia
Insight Therapeutics, LLC
Norfolk, Virginia, United States, 23510
Sponsors and Collaborators
Insight Therapeutics, LLC
Brown University
Case Western Reserve University
Investigators
Principal Investigator: Stefan Gravenstein, MD, MPH Case Western Reserve University
Principal Investigator: Vincent Mor, PhD Brown University
Principal Investigator: Ed Davidson, PharmD, MPH Insight Therapeutics, LLC
  More Information

Additional Information:
Publications:
Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: doi: 10.1177/1740774515625976

We have published our study design and rationale in Clinical Trials Journal. Citation is below.

Stefan Gravenstein, Roshani Dahal, Pedro L Gozalo, H Edward Davidson, Lisa F Han, Monica Taljaard, and Vincent Mor. A cluster randomized controlled trial comparing relative effectiveness of two licensed influenza vaccines in US nursing homes: Design and rationale. Clin Trials 1740774515625976, first published on February 11, 2016 doi:10.1177/1740774515625976



Responsible Party: Insight Therapeutics, LLC
ClinicalTrials.gov Identifier: NCT01815268     History of Changes
Other Study ID Numbers: GRC75-EXT 
Study First Received: March 11, 2013
Last Updated: February 14, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Insight Therapeutics, LLC:
Randomized Controlled Trial
Influenza
Influenza vaccine
Flu Vaccine
Fluzone
HD Fluzone
Nursing Home
Hospitalization
Mortality
Health Care worker vaccination
ADL decline
Effectiveness
Elderly
Morbidity
Nursing Home resident
Frail
Institutionalized
Epidemiology
CDC
US
city

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 08, 2016