Adjuvanted Influenza Vaccination Year 2 Follow-On Survey

Insight Therapeutics

Status: Completed

Conditions: Influenza, Human; Influenza-like Illness; Influenza

Treatments: Biological: Influenza

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03599739

INSI-201805

Details and patient eligibility

About

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.

Full 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.

Enrollment: 598 patients

Sex: All

Ages: 65+ years old

Volunteers: 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

Trial design

598 participants in 2 patient groups

Follow-On Cohort

Description:

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.

Treatment:

Biological: Influenza

Parallel Cohort

Description:

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.

Treatment:

Biological: Influenza