High Dose Influenza Vaccine in Nursing Home - Pilot Study
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|ClinicalTrials.gov Identifier: NCT01720277|
Recruitment Status : Completed
First Posted : November 2, 2012
Results First Posted : April 18, 2018
Last Update Posted : May 23, 2018
|Condition or disease||Intervention/treatment||Phase|
|Influenza||Biological: HD Fluzone Vaccine Biological: SD Fluzone Vaccine||Phase 4|
Influenza remains the most common preventable respiratory viral infection of older adults. Older adults incur more than 90% of the disease burden, and those residing in nursing homes are the most affected subset given their immune senescence, multi-morbidity, and close living quarters. Each year, the majority of influenza-related hospitalizations occur during the period with the greatest influenza activity.
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 high-dose 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. Estimating the benefit of influenza vaccination among older adults in long-term care settings using randomized controlled trials requires extensive effort and is costly. Instead, a pragmatic RCT in a nursing home population has several advantages as a model for comparing therapeutic approaches.
This clinical trial aims to test the feasibility of our protocol for a subsequent larger study. We aim to demonstrate that we can recruit and enroll facilities; randomly assign and coordinate vaccine delivery; collect data; conduct site audits for data validation; create outcomes using multiple data sources; and conduct analyses.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2957 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||High Dose Influenza Vaccination and Morbidity and Mortality in U.S. Nursing Homes - A Pilot Evaluation|
|Study Start Date :||September 2012|
|Actual Primary Completion Date :||May 2013|
|Actual Study Completion Date :||May 2016|
Experimental: HD Fluzone Vaccine
NH facilities randomized to receive high dose trivalent influenza vaccine (HD Fluzone) for the residents.
Biological: HD Fluzone Vaccine
Nursing home residents over 65 years are allocated to receive high dose trivalent vaccine. Residents under 65 years are provided standard dose trivalent vaccine (TIV).
Other Name: Fluzone High Dose influenza vaccine
Active Comparator: SD Fluzone Vaccine
NH facilities randomized to standard dose trivalent influenza vaccine (SD Fluzone) for the residents.
Biological: SD Fluzone Vaccine
Nursing home residents are allocated to receive standard trivalent vaccine (TIV).
Other Name: Fluzone influenza vaccine
- Total All-cause Hospitalizations [ Time Frame: 1 year ]The primary outcome will establish our methodology for measuring all-cause hospitalizations using the Minimum Data Set (MDS).
- Change in Residents' Functional Status [ Time Frame: 1 year ]The secondary outcome will establish our methodology for measuring change in functional status of nursing home residents using Activities of Daily Living (ADL) data in the Minimum Data Set (MDS). A change in functional status is defined as a decline in physical functioning by at least 4 points on the 28-point ADL scale.
- Recruit, Enroll, and Randomize Nursing Homes Per Calculated Sample Size [ Time Frame: 1 year ]This outcome evaluates our ability to recruit and enroll nursing facilities that meet our inclusion and exclusion criteria, and ensure nursing home residents receive either high-dose or standard-dose influenza vaccine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01720277
|United States, Rhode Island|
|Providence, Rhode Island, United States, 02903|
|United States, Virginia|
|Norfolk, Virginia, United States, 23510|
|Principal Investigator:||Stefan Gravenstein, MD, MPH||Case Western Reserve University|
|Principal Investigator:||Ed Davidson, PharmD, MPH||Insight Therapeutics, LLC|
|Principal Investigator:||Vincent Mor, PhD||Brown University|