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Virus Therapy
Recombinant Influenza Vaccine for Influenza
Phase 4
Waitlist Available
Led By H. Edward Davidson, PharmD, 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 8 months each influenza season
Awards & highlights
Study Summary
This trial will compare the effectiveness of two different influenza vaccines in nursing home residents.
Eligible Conditions
- Flu
- Influenza
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 8 months each influenza season
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 8 months each influenza season
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Differences in all-cause hospitalization rates during the 2019-20 and 2020-21 influenza seasons
Secondary outcome measures
Differences in ICU stay
Differences in activities of daily living (ADL) function score
Differences in all-cause hospitalization rates
+6 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: RIV4Experimental Treatment1 Intervention
Nursing homes randomized to receive quadrivalent recombinant influenza vaccine (Flublok) for the residents and staff
Group II: IV4Active Control1 Intervention
Nursing homes randomized to receive standard dose quadrivalent influenza vaccine for the residents and staff
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Influenza A virus A/California/7/2009 (H1N1) recombinant hemagglutinin antigen
FDA approved
Find a Location
Who is running the clinical trial?
Insight Therapeutics, LLCLead Sponsor
8 Previous Clinical Trials
30,218 Total Patients Enrolled
Sanofi Pasteur, a Sanofi CompanyIndustry Sponsor
407 Previous Clinical Trials
6,089,992 Total Patients Enrolled
Brown UniversityOTHER
456 Previous Clinical Trials
561,092 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: RIV4
- Group 2: IV4
Awards:
This trial has 4 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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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