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NCT03599739 Clinical Trial

Adjuvanted Influenza Vaccination Year 2 Follow-On Survey

Influenza Clinical Trial

Official title:
Adjuvanted Influenza Vaccination and Morbidity and Mortality in U.S. Nursing Homes: Assessment of Vaccine Selection and Outcomes for the Follow-on Study Year

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03599739
Other study ID # INSI-201805
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 13, 2018
Est. completion date January 25, 2023

Study information
Verified date March 2023
Source Insight Therapeutics, LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 598
Est. completion date January 25, 2023
Est. primary completion date February 15, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
United States Insight Therapeutics, LLC Norfolk Virginia

Sponsors (3)
Lead Sponsor Collaborator
Insight Therapeutics, LLC Brown University, Seqirus

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Hospitalization for all causes Time to first occurrence of hospitalization for all-causes. up to 1 year
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