Influenza Clinical Trial
Official title:
Comparative Effectiveness of Recombinant Versus Standard Dose Quadrivalent Influenza Vaccine in U.S. Nursing Homes
Verified date | March 2023 |
Source | Insight Therapeutics, LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Based on recent evidence on the mutation of the A/H3N2 strain in egg-grown vaccine, the investigators will study the quadrivalent recombinant influenza vaccine (RIV4, Flublok) compared to the standard dose quadrivalent vaccine (IV4) in a cohort of long-stay NH residents with a primary endpoint of all-cause hospitalization.
Status | Active, not recruiting |
Enrollment | 1989 |
Est. completion date | December 2023 |
Est. primary completion date | August 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 120 Years |
Eligibility | Inclusion Criteria: - Medicare-certified NHs with at least 50 long-stay residents = 18 years of age - Facilities with at least 80% of their long-stay population = 65 years of age or at least 70 long stay residents = 65 years of age that make up = 45% of their total number of beds Exclusion Criteria: - Hospital-based facilities - Facilities where Fluzone High-Dose or Fluad was used in the previous influenza season (2018-19 or 2019-20), or who's leadership plans to use one of these vaccines in the 2019- 2020 or 2020-21 season - Facilities not submitting MDS data - Facilities not in one of the 50 U.S. states |
Country | Name | City | State |
---|---|---|---|
United States | Insight Therapeutics, LLC | Norfolk | Virginia |
Lead Sponsor | Collaborator |
---|---|
Insight Therapeutics, LLC | Brown University, Case Western Reserve University, Sanofi Pasteur, a Sanofi Company |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Differences in all-cause hospitalization rates during the 2019-20 and 2020-21 influenza seasons | To determine the differences in all-cause hospitalization rates during the 2019-20 and 2020-21 influenza seasons experienced by all long-stay nursing home residents 18 years of age and older in facilities randomized to offer either quadrivalent recombinant influenza vaccine (RIV4) or standard dose quadrivalent influenza vaccine (IV4). | Up to 8 months each influenza season | |
Secondary | Differences in each pneumonia and influenza-related hospitalization rates | To determine the differences in each pneumonia and influenza-related hospitalization rates during the 2019-20 and 2020-21 influenza seasons experienced by long-stay nursing home residents in facilities randomized to either RIV4 or IV4 for each, residents 18 years of age and older and those 65 years of age and older. | Up to 8 months each influenza season | |
Secondary | Differences in pneumonia-related hospitalization rates | To determine the differences in each pneumonia-related hospitalization rates during the 2019-20 and 2020-21 influenza seasons experienced by long-stay nursing home residents in facilities randomized to either RIV4 or IV4 for each, residents 18 years of age and older and those 65 years of age and older. | Up to 8 months each influenza season | |
Secondary | Differences in major adverse cardiovascular event-related (MACE) hospitalization rates | To determine the differences in each major adverse cardiovascular event-related (MACE) hospitalization rates during the 2019-20 and 2020-21 influenza seasons experienced by long-stay nursing home residents in facilities randomized to either RIV4 or IV4 for each, residents 18 years of age and older and those 65 years of age and older. | Up to 8 months each influenza season | |
Secondary | Differences in cardiorespiratory-related hospitalization rates | To determine the differences in long-stay residents' cardiorespiratory-related hospitalization rates each season and across two seasons in facilities randomized to either RIV4 or IV4 for each, residents 18 years of age and older and those 65 years of age and older. | Up to 8 months each influenza season | |
Secondary | Differences in ICU stay | To determine the differences in long-stay residents' ICU stay each season and across two seasons in facilities randomized to either RIV4 or IV4 for each, residents 18 years of age and older and those 65 years of age and older. | Up to 8 months each influenza season | |
Secondary | Differences in mortality rates | To determine the differences in long-stay residents' mortality rates each influenza season and both seasons in facilities randomized to either RIV4 or IV4 for each, residents 18 years of age and older and those 65 years of age and older. | Up to 8 months each influenza season | |
Secondary | Differences in activities of daily living (ADL) function score | To determine the differences in long-stay residents' composite Activities of Daily Living (ADL) function score based on the MDS experienced during the influenza season by selected comorbidities and specific to respiratory illness, in facilities randomized to either RIV4 or IV4 combined over two seasons for each, residents 18 years of age and older and those 65 years of age and older. | Up to 8 months each influenza season | |
Secondary | Differences in facility-reported outbreaks | To determine differences in facility-reported outbreaks each season and across two seasons in facilities randomized to either RIV4 or IV4 | Up to 8 months each influenza season | |
Secondary | Differences in all-cause hospitalization rates | To determine differences in long-stay residents' all-cause hospitalization rates as an interim exploratory analysis based on the Minimum Data Set 3.0 for each, residents 18 years of age and older and those 65 years of age and older. | Up to 8 months each influenza season |
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