Adjuvanted Influenza Vaccination Year 2 Follow-On Survey

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

598 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-13

Study Completion Date

2023-01-25

Brief Summary

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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.

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Detailed Description

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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

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Influenza Influenza-like Illness Influenza, Human

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

Influenza

Intervention Type BIOLOGICAL

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.

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.

Influenza

Intervention Type BIOLOGICAL

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.

Interventions

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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.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes