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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
All Individual Drugs Already Approved
No Placebo-Only Group
Pivotal Trial
Drug Has Already Been Approved

Summary

This trial will compare the effectiveness of two different influenza vaccines in nursing home residents.

Eligible Conditions
  • Flu-Related Pain
  • Flu
  • Influenza

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 8 months each influenza season
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 8 months each influenza season for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Differences in all-cause hospitalization rates during the 2019-20 and 2020-21 influenza seasons
Secondary study objectives
Differences in ICU stay
Differences in activities of daily living (ADL) function score
Differences in all-cause hospitalization rates
+6 more

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial 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
419 Previous Clinical Trials
6,108,049 Total Patients Enrolled
Brown UniversityOTHER
466 Previous Clinical Trials
696,998 Total Patients Enrolled
Case Western Reserve UniversityOTHER
309 Previous Clinical Trials
249,270 Total Patients Enrolled
H. Edward Davidson, PharmD, MPHPrincipal InvestigatorInsight Therapeutics, LLC
2 Previous Clinical Trials
1,421 Total Patients Enrolled
Stefan Gravenstein, MD, MPHPrincipal InvestigatorInsight Therapeutics, LLC
5 Previous Clinical Trials
5,250 Total Patients Enrolled

Media Library

Recombinant Influenza Vaccine (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03965195 — Phase 4
Flu-Related Pain Research Study Groups: RIV4, IV4
Flu-Related Pain Clinical Trial 2023: Recombinant Influenza Vaccine Highlights & Side Effects. Trial Name: NCT03965195 — Phase 4
Recombinant Influenza Vaccine (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03965195 — Phase 4
~310 spots leftby Dec 2025
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