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Virus Therapy
aTIV for Influenza
Phase 4
Waitlist Available
Led By Vincent Mor, PhD
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 75 miles of one of the 121 cities that serve as CDC surveillance sites
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
Study Summary
This study is powered to prospectively evaluate the relative effectiveness of adjuvanted trivalent influenza vaccine (aTIV; FLUAD) in preventing influenza mortality, hospitalization, and functional decline in a nursing home population in the U.S., compared to the commercially available, standard dose trivalent seasonal influenza vaccine (TIV; Fluvirin).
Eligible Conditions
- Influenza
- Flu
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 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Hospitalization for a respiratory-related Illness
Hospitalization for all causes
Secondary outcome measures
Activities of daily living (ADL) scores
Mortality
Other outcome measures
Influenza outbreaks
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: aTIVExperimental Treatment2 Interventions
NH facilities randomized to receive adjuvanted trivalent influenza vaccine (aTIV, FLUAD) for the residents
Group II: TIVActive Control1 Intervention
NH facilities randomized to receive standard trivalent influenza vaccine (TIV, Fluvirin) for the residents
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Influenza B virus B/Massachusetts/2/2012 BX-51B antigen (propiolactone inactivated)
FDA approved
Influenza B virus B/Brisbane/9/2014 antigen (formaldehyde inactivated)
FDA approved
Find a Location
Who is running the clinical trial?
Brown UniversityOTHER
452 Previous Clinical Trials
561,338 Total Patients Enrolled
SeqirusIndustry Sponsor
59 Previous Clinical Trials
1,080,247 Total Patients Enrolled
Insight Therapeutics, LLCLead Sponsor
8 Previous Clinical Trials
31,384 Total Patients Enrolled
Frequently Asked Questions
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