mRNA NA vaccine for Influenza

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
AES - DRS - Optimal Research_Site 8400001, Peoria, IL
Influenza
mRNA NA vaccine - Biological
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial is testing a new vaccine for safety and how well it works. The study will give the vaccine to two groups of people, those aged 18-64 years and those aged 65 years and older, to see if it is safe and causes an immune response. The mRNA NA vaccine is used to treat Influenza and has previously been approved by the FDA for a different condition. No patients in this trial will receive a placebo. This treatment is free.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

6 Primary · 4 Secondary · Reporting Duration: From Day 1 to Day 366

Day 1 and 29
Neuraminidase inhibition (NAI) Antibodies at Day 1 and 29
Day 29
Individual Neuraminidase inhibition (NAI) titer
Percentage of participants with detectable antibody titers greater than or equal to (≥) 10 [1/dil]
Day 29
2-fold and 4-fold rise in NAI antibody titers
Number of participants with unsolicited adverse events
Day 366
Number of participants with adverse events of special interest
Number of participants with serious adverse events
Day 8
Number of participants with solicited injection site or systemic reaction
Number of patients with clinically significant changes in clinical laboratory tests
Within 30 minutes after vaccination
Number of participants with immediate adverse events

Trial Safety

Safety Progress

1 of 3

Trial Design

4 Treatment Groups

Group 4: QIV-HD
1 of 4
Group 3 mRNA NA: High dose level
1 of 4
Group 1 mRNA NA: Low dose Level
1 of 4
Group 2 mRNA NA: Medium dose level
1 of 4
Active Control
Experimental Treatment

240 Total Participants · 4 Treatment Groups

Primary Treatment: mRNA NA vaccine · No Placebo Group · Phase 1

Group 3 mRNA NA: High dose level
Biological
Experimental Group · 1 Intervention: mRNA NA vaccine · Intervention Types: Biological
Group 1 mRNA NA: Low dose Level
Biological
Experimental Group · 1 Intervention: mRNA NA vaccine · Intervention Types: Biological
Group 2 mRNA NA: Medium dose level
Biological
Experimental Group · 1 Intervention: mRNA NA vaccine · Intervention Types: Biological
Group 4: QIV-HD
Biological
ActiveComparator Group · 1 Intervention: High Dose Quadrivalent Influenza Vaccine · Intervention Types: Biological

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from day 1 to day 366
Closest Location: AES - DRS - Optimal Research_Site 8400001 · Peoria, IL
Photo of illinois 1Photo of illinois 2Photo of illinois 3
N/AFirst Recorded Clinical Trial
0 TrialsResearching Influenza
0 CompletedClinical Trials

Who is running the clinical trial?

Sanofi Pasteur, a Sanofi CompanyLead Sponsor
378 Previous Clinical Trials
5,044,138 Total Patients Enrolled
Clinical Sciences & OperationsStudy DirectorSanofi
779 Previous Clinical Trials
568,003 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.