Adjuvanted Influenza Vaccination Year 2 Follow-On Survey
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Follow-On Cohort 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. |
Biological: Influenza
Facilities will be asked to complete a survey to evaluate the impact of the influenza vaccine choice on hospitalization risk for the 2017-2018 influenza season.
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| Parallel Cohort 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. |
Biological: Influenza
Facilities will be asked to complete a survey to evaluate the impact of the influenza vaccine choice on hospitalization risk for the 2017-2018 influenza season.
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Outcome Measures
Primary Outcome Measures
- Hospitalization for all causes [up to 1 year]
Time to first occurrence of hospitalization for all-causes.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Participated in the Adjuvanted Influenza Vaccination and Morbidity and Mortality in U.S. Nursing Homes study
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OR
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Long-term care facilities within 75 miles of one of the 121 cities that serve as CDC surveillance sites
Exclusion Criteria:
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Facilities having fewer than 50 long-stay residents
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Hospital based facilities
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Facilities with more than 20% of the population under age 65
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Facilities not submitting Minimum Data Set (MDS) data
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Insight Therapeutics, LLC | Norfolk | Virginia | United States | 23510 |
Sponsors and Collaborators
- Insight Therapeutics, LLC
- Seqirus
- Brown University
Investigators
- Principal Investigator: Stefan Gravenstein, MD, MPH, Brown University
- Principal Investigator: Vincent Mor, PhD, Brown University
- Principal Investigator: Pedro Gozalo, Phd, Brown University
- Principal Investigator: H. Edward Davidson, PharmD, MPH, Insight Therapeutics, LLC
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- DiazGranados CA, Dunning AJ, Robertson CA, Talbot HK, Landolfi V, Greenberg DP. Effect of Previous-Year Vaccination on the Efficacy, Immunogenicity, and Safety of High-Dose Inactivated Influenza Vaccine in Older Adults. Clin Infect Dis. 2016 May 1;62(9):1092-1099. doi: 10.1093/cid/ciw085. Epub 2016 Feb 21.
- Flannery B, Chung JR, Thaker SN, Monto AS, Martin ET, Belongia EA, McLean HQ, Gaglani M, Murthy K, Zimmerman RK, Nowalk MP, Jackson ML, Jackson LA, Foust A, Sessions W, Berman L, Spencer S, Fry AM. Interim Estimates of 2016-17 Seasonal Influenza Vaccine Effectiveness - United States, February 2017. MMWR Morb Mortal Wkly Rep. 2017 Feb 17;66(6):167-171. doi: 10.15585/mmwr.mm6606a3.
- Gravenstein S, Davidson HE, Taljaard M, Ogarek J, Gozalo P, Han L, Mor V. Comparative effectiveness of high-dose versus standard-dose influenza vaccination on numbers of US nursing home residents admitted to hospital: a cluster-randomised trial. Lancet Respir Med. 2017 Sep;5(9):738-746. doi: 10.1016/S2213-2600(17)30235-7. Epub 2017 Jul 20.
- INSI-201805