Adjuvanted Influenza Vaccination and Morbidity and Mortality in U.S. Nursing Homes: Assessment of Vaccine Selection and Outcomes for the Follow-on Study Year
| Registry | NCT03599739 |
|---|---|
| Status | Completed |
| Study type | Observational |
| Enrollment | 598 (Actual) |
| Sponsor | Insight Therapeutics, LLC (Other); collaborators: Seqirus, Brown University |
| Conditions | Influenza, Influenza-like Illness, Influenza, Human |
| Interventions | Influenza (Biological) |
| Dates | start 2018-07-13, primary completion 2019-02-15, completion 2023-01-25, first posted 2018-07-26, last updated 2023-03-16 |
| Locations | 1 site in United States |
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The purpose of this study is to determine if different influenza vaccines produce different outcomes in nursing facility residents receiving the required annual influenza vaccination.
This study will enroll facilities who participated in the adjuvanted influenza vaccine study in 2016-2017 to document the vaccine choice for the 2017-2018 influenza season through a survey. Additional facilities will be enrolled that did not participate to answer a survey responding to questions regarding the vaccine choice for the 2017-2018 and 2018-2019 flu season. Both groups will also gather information on vaccination rates for residents and staff, policies and procedures, and influenza outbreaks.
The facility will complete a profile and answer questions regarding influenza vaccination in their facilities for the 2017-2018 and 2018-2019 flu seasons.
The study team will obtain data from the Centers for Medicare \& Medicaid Services in 2019 to determine the study outcomes. None of the data used in the analysis will be linked to individual residents in facilities.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Follow-On Cohort | Biological: Influenza | We will survey 823 nursing facilities who participated in the aTIV Influenza Vaccination and Morbitiy and Mortality in U.S. Nursing Homes study in 2016-2017. We anticipate a 70% response rate from this sample for participation. | |
| Parallel Cohort | Biological: Influenza | We will survey an additional 1000 facilities (i.e., facilities not participating in the original 2016-2017 study, but meeting the same entry criteria, except prior use of high dose vaccine will be allowed) in order to capture a cohort that used a wide range of self-selected vaccine choices. We anticipate a 50% response rate from this sample. |
Sex: All, ages: 65 Years to any, accepts healthy volunteers
Inclusion Criteria: * Participated in the Adjuvanted Influenza Vaccination and Morbidity and Mortality in U.S. Nursing Homes study * OR * Long-term care facilities within 75 miles of one of the 121 cities that serve as CDC surveillance sites Exclusion Criteria: * 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
| Facility | City | Country | Status |
|---|---|---|---|
| Insight Therapeutics, LLC | Norfolk, Virginia | United States |