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Completed

NCT Number: NCT03599739

Adjuvanted Influenza Vaccination Year 2 Follow-On Survey

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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Key information

Conditions

Influenza Infections Influenza, Human Influenza-like Illness Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Insight Therapeutics, LLC

Norfolk, Virginia, 23510, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Influenza

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.

Primary outcomes

  1. Hospitalization for all causes

    Time frame: up to 1 year

    Time to first occurrence of hospitalization for all-causes.

Sponsors and collaborators

Lead sponsor

Insight Therapeutics, LLC

Other

Collaborators

  • Brown University
  • Seqirus

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2023
First posted
Jul 26, 2018
Registry last updated
Mar 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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