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Vaccine
Group 1: Quadrivalent Influenza mRNA Vaccine MRT5407 dose level 1 for Influenza Immunization
Verified Trial
Phase 1 & 2
Waitlist Available
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
Aged 18 years on the day of inclusion
You do not have an immune deficiencies
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new mRNA flu vaccine in adults aged 18 and older. The vaccine helps the body learn to fight the flu by mimicking part of the virus. The study will last about a year.
Who is the study for?
This trial is for adults over 18 who haven't had an mRNA vaccine in the last 2 months. Women must be postmenopausal, surgically sterile, or agree to use contraception. People with immune deficiencies can't participate.
What is being tested?
The study tests a new Quadrivalent Influenza mRNA Vaccine MRT5407 against three flu vaccines: standard dose, high-dose (for those ≥65), and recombinant. Participants will receive one intramuscular injection and be monitored.
What are the potential side effects?
Possible side effects may include typical reactions at the injection site like pain and swelling, general symptoms such as fever or fatigue, muscle aches, headache, and potential allergic responses.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
You are at least 18 years old.
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Your immune system is working properly.
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You have not received an mRNA vaccine in the last two months.
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You cannot have children, either because you have gone through menopause or have had a surgical procedure to prevent pregnancy. If you can have children, you need to use a reliable form of birth control for at least 4 weeks before starting the study and for 12 weeks after the study ends.
Timeline
Screening ~ 3 weeks1 visit
Treatment ~ Varies
Follow Up ~ 12 months7 visits
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Hemagglutination Inhibition Tests
Individual Hemagglutination inhibition (HAI) titer
Antigens, Fungal
+6 moreSecondary study objectives
Neutralization Tests
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
5Treatment groups
Experimental Treatment
Active Control
Group I: Group 2: Quadrivalent Influenza mRNA Vaccine MRT5407 dose level 2Experimental Treatment1 Intervention
participants will receive a single dose of QIV mRNA vaccine (dose level 2)
Group II: Group 1: Quadrivalent Influenza mRNA Vaccine MRT5407 dose level 1Experimental Treatment1 Intervention
participants will receive a single dose of QIV mRNA vaccine (dose level 1)
Group III: Group 3: RIV4Active Control1 Intervention
participants will receive a single dose of RIV4 vaccine
Group IV: Group 4: QIV-SDActive Control1 Intervention
participants will receive a single dose of QIV-SD vaccine
Group V: Group 5: QIV-HDActive Control1 Intervention
participants will receive a single dose of QIV -HD vaccine (for elderly only)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Quadrivalent Influenza mRNA Vaccine MRT5407
2022
Completed Phase 2
~560
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
Flu shots, including the Quadrivalent Influenza mRNA Vaccine (MRT5407), work by instructing cells to produce viral proteins that trigger an immune response. mRNA vaccines like MRT5407 use messenger RNA to teach cells to make a protein that is part of the influenza virus, prompting the immune system to recognize and fight the virus if encountered in the future. Traditional inactivated vaccines contain killed virus particles, while recombinant vaccines use viral proteins produced through genetic engineering.
These methods help the immune system develop memory against the virus, reducing the risk of severe illness. This is crucial for flu shot patients as it enhances their ability to combat influenza, potentially preventing complications and hospitalizations.
Oral Modeling of an Adenovirus-Based Quadrivalent Influenza Vaccine in Ferrets and Mice.Vaccination with recombinant 4 × M2e.HSP70c fusion protein as a universal vaccine candidate enhances both humoral and cell-mediated immune responses and decreases viral shedding against experimental challenge of H9N2 influenza in chickens.A TaqMan reverse transcription polymerase chain reaction (RT-PCR) in vitro potency assay for plasmid-based vaccine products.
Oral Modeling of an Adenovirus-Based Quadrivalent Influenza Vaccine in Ferrets and Mice.Vaccination with recombinant 4 × M2e.HSP70c fusion protein as a universal vaccine candidate enhances both humoral and cell-mediated immune responses and decreases viral shedding against experimental challenge of H9N2 influenza in chickens.A TaqMan reverse transcription polymerase chain reaction (RT-PCR) in vitro potency assay for plasmid-based vaccine products.
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Travel, including flights, are covered
Your expenses for travel tickets for this trial will be reimbursed.
Other reimbursement is provided
Other forms of reimbursement are provided for this trial.
Who is running the clinical trial?
Sanofi Pasteur, a Sanofi CompanyLead Sponsor
422 Previous Clinical Trials
6,112,542 Total Patients Enrolled
Clinical Sciences & OperationsStudy DirectorSanofi
877 Previous Clinical Trials
2,022,256 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are at least 18 years old.Your immune system is working properly.You cannot have children, either because you have gone through menopause or have had a surgical procedure to prevent pregnancy. If you can have children, you need to use a reliable form of birth control for at least 4 weeks before starting the study and for 12 weeks after the study ends.You have not received an mRNA vaccine in the last two months.
Research Study Groups:
This trial has the following groups:- Group 1: Group 1: Quadrivalent Influenza mRNA Vaccine MRT5407 dose level 1
- Group 2: Group 2: Quadrivalent Influenza mRNA Vaccine MRT5407 dose level 2
- Group 3: Group 3: RIV4
- Group 4: Group 4: QIV-SD
- Group 5: Group 5: QIV-HD
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 1 null
- Follow Ups: You may be asked to continue sharing information regarding the trial for 12 Months after you stop receiving the treatment.
Flu Shot Patient Testimony for trial: Trial Name: NCT05553301 — Phase 1 & 2