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Virus Therapy

Quadrivalent Influenza mRNA Vaccine MRT5429 Dose 1 for Flu Shot

Phase 1 & 2

Recruiting

Research Sponsored by Sanofi Pasteur, a Sanofi Company

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 throughout the study (approximately 12 months)

Awards & highlights

Study Summary

This trial aims to test the safety and effectiveness of a new flu vaccine given as a single shot in the muscle. Researchers will compare different formulations of this vaccine to other flu vaccines in adults aged 18

Who is the study for?

Adults aged 18 and older can join this study to test new flu vaccines. People with a history of severe allergic reactions to any vaccine ingredients or who are immunocompromised may not be eligible.Check my eligibility

What is being tested?

The trial is testing the safety and immune response of three different mRNA flu vaccines against standard dose, high-dose, and recombinant flu vaccines given as a single shot in the muscle.See study design

What are the potential side effects?

Possible side effects include pain at the injection site, fatigue, headache, muscle pain, chills, fever, nausea; these are common for most flu shots.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ throughout the study (approximately 12 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~throughout the study (approximately 12 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and throughout the study (approximately 12 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

AESIs reported throughout the study

Geometric Mean Titer (GMT)

Geometric Mean of individual Titer Ratio (GMTR)

+10 more

Secondary outcome measures

2-fold and 4-fold increase in neutralizing titers

Individual neutralizing antibodies titer ratio

Neutralizing Ab titers at D01 and D29

Trial Design

10Treatment groups

Experimental Treatment

Active Control

Group I: Quadrivalent Influenza mRNA Vaccine MRT5429 Dose 4Experimental Treatment1 Intervention

participants will receive a single dose of QIV mRNA vaccine MRT5429

Group II: Quadrivalent Influenza mRNA Vaccine MRT5429 Dose 3Experimental Treatment1 Intervention

participants will receive a single dose of QIV mRNA vaccine MRT5429

Group III: Quadrivalent Influenza mRNA Vaccine MRT5429 Dose 2Experimental Treatment1 Intervention

participants will receive a single dose of QIV mRNA vaccine MRT5429

Group IV: Quadrivalent Influenza mRNA Vaccine MRT5429 Dose 1Experimental Treatment1 Intervention

participants will receive a single dose of QIV mRNA vaccine MRT5429

Group V: Quadrivalent Influenza mRNA Vaccine MRT5424 Dose 2Experimental Treatment1 Intervention

participants will receive a single dose of QIV mRNA vaccine MRT5424

Group VI: Quadrivalent Influenza mRNA Vaccine MRT5424 Dose 1Experimental Treatment1 Intervention

participants will receive a single dose of QIV mRNA vaccine MRT5424

Group VII: Quadrivalent Influenza mRNA Vaccine MRT5421 Dose 1Experimental Treatment1 Intervention

participants will receive a single dose of QIV mRNA vaccine MRT5421

Group VIII: Quadrivalent Influenza HD VaccineActive Control1 Intervention

participants will receive a single dose of QIV -HD vaccine (for adults ≥ 65 years of age only)

Group IX: Quadrivalent Influenza SD VaccineActive Control1 Intervention

participants will receive a single dose of QIV-SD vaccine

Group X: Quadrivalent Influenza RIV4 VaccineActive Control1 Intervention

participants will receive a single dose of RIV4 vaccine

Do I qualify?Apply below to find out

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Sanofi Pasteur, a Sanofi CompanyLead Sponsor

407 Previous Clinical Trials

6,090,979 Total Patients Enrolled

Frequently Asked Questions

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

Are researchers currently seeking participants for this study?

"The details provided on clinicaltrials.gov indicate that this trial is presently enrolling participants. It was first made available on April 1, 2024, and the latest update was recorded on April 10, 2024."

Answered by AI

What is the upper limit for participant enrollment in this research investigation?

"The recruitment target for this study is set at 1002 eligible participants. Interested individuals have the opportunity to partake in this research endeavor from various locations, such as Investigational Site Number: 6300002 situated in Barrio Sabana, Nebraska and Velocity Clinical Research Norfolk Site Number: 8400046 located in Norfolk, Utah."

Answered by AI

At how many different sites is this medical trial being conducted?

"Currently, enrollment of participants is ongoing at 21 medical facilities. These include sites in Barrio Sabana, Norfolk, and Salt Lake City among others. Opting for a site nearby could reduce travel burdens for potential participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Investigate the Safety and Immunogenicity of the Quadrivalent Influenza mRNA Vaccines in Adults Aged 18 Years and Above

2024. "A Study to Investigate the Safety and Immunogenicity of the Quadrivalent Influenza mRNA Vaccines in Adults Aged 18 Years and Above". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06361875.

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