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Virus Therapy

Flu Vaccine for Adults

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

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 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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
mRNA-based flu vaccines, such as the Quadrivalent Influenza Vaccine (QIV), work by using messenger RNA to instruct cells in the body to produce antigens that mimic the influenza virus. These antigens then trigger the immune system to mount a response, creating antibodies that can recognize and fight the actual virus if the person is exposed in the future. This mechanism is significant for flu shot patients because it allows for a rapid and robust immune response, potentially offering better protection against multiple strains of the flu virus included in the vaccine.
Effect of vibration associated with cryotherapy on vaccine-related pain and anxiety levels in adults: study protocol for a randomized clinical trial.

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
409 Previous Clinical Trials
6,093,418 Total Patients Enrolled
~668 spots leftby May 2025