This trial is active, not recruiting.

Condition influenza
Treatments hd fluzone vaccine, sd fluzone vaccine
Phase phase 4
Sponsor Insight Therapeutics, LLC
Collaborator Brown University
Start date September 2012
End date April 2013
Trial size 210 participants
Trial identifier NCT01720277, GRC75-HD Nursing Home Pilot


The purpose of this pilot evaluation is to help determine the feasibility and power needed to prospectively evaluate relative effectiveness of high dose influenza vaccine in preventing influenza mortality and hospitalization in a nursing home population in the U.S., compared to the standard dose influenza vaccine.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose prevention
NH facilities randomized to receive high dose trivalent influenza vaccine (HD Fluzone) for the residents.
hd fluzone vaccine
(Active Comparator)
NH facilities randomized to standard dose trivalent influenza vaccine (SD Fluzone) for the residents.
sd fluzone vaccine
NH facilities randomized to receive free SD influenza vaccine (SD Fluzone) for the staff.
sd fluzone vaccine
(No Intervention)
NH facilities randomized not to receive free influenza vaccine for the staff.

Primary Outcomes

Total Number of Hospitalization Claims per Nursing Home Based on Vaccination Status
time frame: 1 year
Total Influenza Mortality per Nursing Home Based on Vaccination Status
time frame: 1 year

Secondary Outcomes

Change in Activities of Daily Living (ADL) Scores per NH Resident by Vaccination Status
time frame: 1 year
Difference in ADL Duration per NH Resident by Vaccination Status
time frame: 1 year
New Coded Claims for Stroke, Heart Attack or Pneumonia for a NH Resident
time frame: 1 year

Eligibility Criteria

Male or female participants at least 65 years old.

Inclusion Criteria: - Long-term care facilities in one of the 122 cities that serve as Center for Disease Control and Prevention (CDC) surveillance sites Exclusion Criteria: - Facilities already systematically administering HD vaccine to their residents - Facilities for whom over half the residents are on Medicare (short-stay) - Facilities in which over half the residents are on Medicare Part A (SNF) - Facilities having fewer than 50 long-stay residents - Hospital-based facilities - Facilities with more than 20% of the population under age 65 - Facilities with mandated (employment-dependent) seasonal influenza vaccination - Facilities not submitting MDS data

Additional Information

Official title High Dose Influenza Vaccination and Morbidity and Mortality in U.S. Nursing Homes - A Pilot Evaluation
Principal investigator Stefan Gravenstein, MD, MPH
Description Lower respiratory tract infection (LRI), which includes pneumonia, bronchitis, and tracheobronchitis, is the leading cause of mortality and hospitalization in older adults and nursing home (NH) residents. Often, the signs and symptoms of pneumonia, in particular, are not apparent in elderly patients, making diagnosis more complicated. In addition, clinician visits to these residents are few and sporadic and radiological facilities are not readily available. LRI may or may not directly lead to hospitalization, but LRIs are associated with considerable other morbidity than can result in hospitalization. Hospitalization rates for NH residents vary considerably between facilities, but the majority of hospitalizations occur during the 12 weeks during which influenza peaks each year. Influenza vaccination has been associated with reduced hospitalization, strokes, heart attacks and death in non-institutional older adult populations, but the benefit of influenza vaccine for the oldest population has been questioned. The new HD influenza vaccine is considerably more immunogenic in older adults, and has recently been approved for use in individuals aged 65 years and older. No clinical data yet confirm whether the improved immunogenicity translates into added clinical benefit, such as further reduction in hospitalization or death. The primary objective is to: 1. estimate the differences in all-cause hospitalization rates during flu season experienced by long stay nursing home residents, in facilities using the HD vaccine vs. facilities using the SD vaccine, as pilot data to inform feasibility, design and power calculation for a subsequent larger study. 2. To develop estimates, at the nursing home resident level, about the relationship between influenza vaccination status (none, SD, HD) and Medicare Minimum Data Set (MDS) coded claims for all-cause hospitalization and overall mortality among the long-stay residents from a single season 2012-2013, for use in a subsequent longitudinal evaluation of national nursing home data and regional publicly reported influenza severity.
Trial information was received from ClinicalTrials.gov and was last updated in January 2013.
Information provided to ClinicalTrials.gov by Insight Therapeutics, LLC.