NCT03599739

Adjuvanted Influenza Vaccination Year 2 Follow-On Survey

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 598 (actual)
• Sponsor: Insight Therapeutics, LLC · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Influenza
• Influenza-like Illness
• Influenza, Human

Interventions

Type	Name	Description
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.

Timeline

• Start date: 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 across 1 country: United States

Regulatory

• FDA-regulated drug study