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临床试验/NCT03599739
NCT03599739已完成不适用

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

Insight Therapeutics, LLC1 个研究点 分布在 1 个国家目标入组 598 人开始时间: 2018年7月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
598
试验地点
1
主要终点
Hospitalization for all causes

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participated in the Adjuvanted Influenza Vaccination and Morbidity and Mortality in U.S. Nursing Homes study
  • Long-term care facilities within 75 miles of one of the 121 cities that serve as CDC surveillance sites

排除标准

  • 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

结局指标

主要结局

Hospitalization for all causes

时间窗: up to 1 year

Time to first occurrence of hospitalization for all-causes.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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