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Virus Vaccine

Recombinant vs Egg-Based Flu Vaccine for Adults

Phase 4
Waitlist Available
Led By Fatimah S Dawood, MD
Research Sponsored by Fatimah Dawood
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Aged 18-64 years
OR Currently employed as a frontline worker defined as an occupation that cannot be done from home or alone AND have direct face-to-face contact, defined as being within 6 feet, or about two arms' lengths, with co-workers, patients or the public as part of full-time (at least 20 hours per week) job responsibilities
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at approximately 7 and 28 days and 6 months post-vaccination
Awards & highlights

Study Summary

This trial will compare the clinical efficacy of a new recombinant influenza vaccine to a standard egg-based influenza vaccine among adults aged 18-64 years. The primary hypothesis is that the new vaccine is superior to the standard vaccine in preventing and attenuating influenza-like illness. Relative efficacy and immunogenicity will be assessed by comparing rates of influenza virus infection and measures of infection and illness attenuation among participants who receive the new vaccine versus the standard vaccine.

Who is the study for?
Adults aged 18-64, either students attending in-person classes or frontline workers with face-to-face contact. Participants must have internet and mobile access, live/work in the study area through May 2023/2024, and be comfortable with English, Spanish, or Chinese communications. Those already vaccinated for flu after July 1, 2022 or living with another participant are excluded.Check my eligibility
What is being tested?
This trial is testing if a recombinant influenza vaccine (RIV) is more effective than a standard egg-based vaccine (SD IIV) at preventing flu-like illness in adults. It compares rates of confirmed infections and immune responses between the two vaccines.See study design
What are the potential side effects?
Potential side effects may include typical reactions to vaccines such as soreness at injection site, mild fever, fatigue, headache and muscle pain. Severe allergic reactions are rare but possible.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You are between 18 and 64 years old.
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You have a job that requires you to work in close contact with others and cannot be done from home.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at approximately 7 and 28 days and 6 months post-vaccination
This trial's timeline: 3 weeks for screening, Varies for treatment, and at approximately 7 and 28 days and 6 months post-vaccination for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
ILI-associated RT-PCR-confirmed influenza virus infection
Secondary outcome measures
Duration (in days) of missed work or school influenza virus infections
Geometric mean viral ribonucleic acid (RNA) load measured by quantitative PCR, as feasible
Granulin Matrix Proteins
+4 more
Other outcome measures
B and T cell repertoires in a subset of subjects
Frequencies of natural killer cells and innate lymphoid cell subsets
GMT by NAI and antibody dependent cellular cytotoxicity function assays pre- and post- vaccination
+7 more

Trial Design

2Treatment groups
Active Control
Group I: Recombinant Influenza Vaccine (RIV)Active Control1 Intervention
Group II: Standard-Dose Inactivate Influenza Vaccine (SD IIV)Active Control1 Intervention

Find a Location

Who is running the clinical trial?

Center for Asian Health EquityUNKNOWN
University of UtahOTHER
1,088 Previous Clinical Trials
1,724,361 Total Patients Enrolled
University of ArizonaOTHER
511 Previous Clinical Trials
144,300 Total Patients Enrolled

Media Library

Flublok Quadrivalent (Virus Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT05514002 — Phase 4
Flu Research Study Groups: Recombinant Influenza Vaccine (RIV), Standard-Dose Inactivate Influenza Vaccine (SD IIV)
Flu Clinical Trial 2023: Flublok Quadrivalent Highlights & Side Effects. Trial Name: NCT05514002 — Phase 4
Flublok Quadrivalent (Virus Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05514002 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the protocol for this trial restrict participation to individuals under a certain age?

"This clinical trial permits participation from individuals aged 18 to 64. Additionally, there are 40 trials for minors and 70 for seniors."

Answered by AI

What kind of participants are eligible for this clinical investigation?

"To qualify for inclusion in this study, participants should possess a diagnosis of influenza and be between 18 to 64 years old. Approximately 16247 individuals are being invited to participate."

Answered by AI

Are any Canadian medical centers administering this research?

"Florida A&M University in Tallahassee, the University of Utah in Salt Lake City and Baylor College of Medicine in Houston are some of the sites that have been approved to recruit patients for this trial. Additionally, there are four other locations participating."

Answered by AI

What potential adverse reactions should recipients of Recombinant Influenza Vaccine (RIV) anticipate?

"The safety of Recombinant Influenza Vaccine (RIV) was given the highest score, a 3, due to its Phase 4 status and long-term approval."

Answered by AI

How many people are being enrolled in this experiment at its peak capacity?

"Affirmative. According to clinicaltrials.gov, recruitment for this research is currently underway and began on September 13th 2022. It was last updated a day later on the 14th of September, requiring 16247 volunteers from 4 different sites."

Answered by AI

Are there vacancies available for study participants in this clinical investigation?

"According to clinicaltrials.gov, this trial is currently recruiting participants as of September 14th 2022 and was first posted on the 13th of that month."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
Baylor College of Medicine
~1595 spots leftby Mar 2025