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Vaccine
HD Vaccine (Residents) + Free Vaccine (Staff) for Influenza
Phase 4
Waitlist Available
Led By Stefan Gravenstein, MD, MPH
Research Sponsored by Insight Therapeutics, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Long-term care facilities within 50 miles of one of the 122 cities that serve as CDC surveillance sites
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study Summary
The purpose of this study is to prospectively evaluate relative effectiveness of high dose influenza vaccine in preventing influenza mortality, hospitalization, and functional decline in a nursing home population in the U.S., compared to the standard dose trivalent seasonal influenza vaccine.
Eligible Conditions
- Influenza
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Hospitalization rate
Secondary outcome measures
Change in activities of daily living (ADL) scores
Cost difference between vaccine types
Effect of facility policies on staff vaccination rates
+2 moreOther outcome measures
Difference in hospitalization claims based on staff vaccination status
Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: HD Vaccine (Residents) + Usual Care (Staff)Experimental Treatment2 Interventions
NH facilities randomized to receive high-dose trivalent influenza vaccine (Fluzone High-Dose) for the residents and not provided free vaccine for the staff.
Group II: HD Vaccine (Residents) + Free Vaccine (Staff)Experimental Treatment2 Interventions
NH facilities randomized to receive high-dose trivalent influenza vaccine (Fluzone High-Dose) for the residents and provided free SD vaccine (Fluzone) for the staff.
Group III: SD Vaccine (Residents) + Usual Care (Staff)Active Control2 Interventions
NH facilities randomized to receive standard dose influenza vaccine (Fluzone) for the residents and not provided free vaccine for the staff.
Group IV: SD Vaccine (Residents) + Free Vaccine (Staff)Active Control2 Interventions
NH facilities randomized to receive standard dose influenza vaccine (Fluzone) for the residents and provided free standard dose vaccine (Fluzone) for the staff.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Usual Care
1990
Completed Phase 4
~7710
Find a Location
Who is running the clinical trial?
Case Western Reserve UniversityOTHER
299 Previous Clinical Trials
259,264 Total Patients Enrolled
Brown UniversityOTHER
452 Previous Clinical Trials
561,373 Total Patients Enrolled
Insight Therapeutics, LLCLead Sponsor
8 Previous Clinical Trials
31,384 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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