Recombinant Influenza Vaccination in U.S. Nursing Homes
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 1000
Summary
- Conditions
- Influenza
- Influenza -Like Illness
- Influenza, Human
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Prevention
Participation Requirements
- Age
- Between 18 years and 120 years
- Gender
- Both males and females
Description
A study sample goal of 1000 U.S. NHs, housing approximately 112,000 overall residents and 92,000 over the age of 65 years, of whom 64,500 are long-stay NH residents, will be recruited for each of the 2019-20 and 2020-21 influenza seasons. Participating facilities will be randomly allocated in a 1:1 ...
A study sample goal of 1000 U.S. NHs, housing approximately 112,000 overall residents and 92,000 over the age of 65 years, of whom 64,500 are long-stay NH residents, will be recruited for each of the 2019-20 and 2020-21 influenza seasons. Participating facilities will be randomly allocated in a 1:1 ratio to RIV4 or IV4 vaccine for their residents. Also, all staff must be offered the same vaccine in both allocation groups, in order to eliminate differences in transmission of influenza through staff to residents related to differences in vaccine-related protection of staff and will reduce heterogeneity between clusters. The Minimum Data Set from the NH resident assessment instrument will be evaluated from all evaluable facilities meeting inclusion criteria and will be cross-referenced to Medicare claims and drug use data.
Tracking Information
- NCT #
- NCT03965195
- Collaborators
- Sanofi Pasteur, a Sanofi Company
- Brown University
- Case Western Reserve University
- Investigators
- Principal Investigator: H. Edward Davidson, PharmD, MPH Insight Therapeutics, LLC Principal Investigator: Stefan Gravenstein, MD, MPH Insight Therapeutics, LLC
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