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mRNA Vaccine
mRNA Flu Vaccine for Flu
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
Answer yes if you have *not* had a flu vaccine within the last 6 months
Aged 18 years on the day of inclusion (US) and aged 21 years on the day of inclusion (Puerto Rico)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1, day 91, day 181 and day 366
Awards & highlights
Summary
This trial is testing a new mRNA flu vaccine in adults aged 18 and older. The vaccine uses mRNA to help the body recognize and fight four different strains of the flu. The study will last about a year.
Who is the study for?
This trial is for adults over 18 in the US or over 21 in Puerto Rico who haven't had a flu shot in the last 6 months. Women must be postmenopausal, surgically sterile, or willing to use contraception. Participants should not be pregnant and must agree to follow study procedures.
What is being tested?
The trial tests a new Quadrivalent Influenza mRNA Vaccine MRT5413 given as one injection. It's compared with three other flu vaccines: standard-dose, high-dose (for those ≥65), and recombinant influenza vaccine. The goal is to check safety and immune response.
What are the potential side effects?
Possible side effects may include pain at the injection site, fatigue, headache, muscle pain, joint pain, fever, chills and nausea. These are common reactions similar to other flu vaccines but can vary from person to person.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
Have you had a flu vaccine in the last 6 months? If your answer is yes, you will be excluded from the study.
Select...
I am at least 18 years old (21 if in Puerto Rico) on the day I join the study.
Select...
I cannot become pregnant or agree to use birth control during and after the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1, day 91, day 181 and day 366
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1, day 91, day 181 and day 366
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Individual HAI titer ratio
Individual Hemagglutination inhibition (HAI) titer
Number of participants archiving HAI seroconversion against Antigens
+8 moreSecondary study objectives
Individual HAI Ab titer ratio
Individual antibodies HAI titer ratio
Individual neutralizing antibodies titer ratio
+3 moreSide effects data
From 2023 Phase 4 trial • 267 Patients • NCT050070418%
COVID-19 Infection
7%
Upper Respiratory Infection
1%
Cardiovascular Accident (CVA), Unspecified Mechanism
1%
Left partial cranial nerve III palsy
1%
Acute Hyperkalemia
1%
Shortness of Breath
1%
Acute pulmonary embolism and acute deep vein thrombosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Recombinant Zoster Vaccine (RZV) and High-Dose Quadrivalent Influenza Vaccine
Recombinant Zoster Vaccine (RZV) and Quadrivalent Adjuvanted Influenza Vaccine
Trial Design
6Treatment groups
Experimental Treatment
Active Control
Group I: Group 3: Quadrivalent Influenza mRNA Vaccine MRT5413 high doseExperimental Treatment1 Intervention
participants will receive a single dose of QIV mRNA vaccine (high dose)
Group II: Group 2: Quadrivalent Influenza mRNA Vaccine MRT5413 medium doseExperimental Treatment1 Intervention
participants will receive a single dose of QIV mRNA vaccine (medium dose)
Group III: Group 1: Quadrivalent Influenza mRNA Vaccine MRT5413 low doseExperimental Treatment1 Intervention
participants will receive a single dose of QIV mRNA vaccine (low dose)
Group IV: Group 4: RIV4Active Control1 Intervention
participants will receive a single dose of RIV4 vaccine
Group V: Group 5: QIV-SDActive Control1 Intervention
participants will receive a single dose of QIV-SD vaccine
Group VI: Group 6: QIV-HDActive Control1 Intervention
participants will receive a single dose of QIV -HD vaccine (for elderly only)
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 mRNA Vaccine MRT5413, work by instructing cells to produce specific proteins that trigger an immune response against the influenza virus. This immune response helps the body recognize and combat the virus if exposed later.
This method is important for flu shot patients as it offers a targeted and efficient way to build immunity without using live virus, thereby enhancing vaccine safety and reducing the risk of adverse reactions.
How far have we reached in development of effective influenza vaccine?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.
How far have we reached in development of effective influenza vaccine?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.
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
414 Previous Clinical Trials
6,104,806 Total Patients Enrolled
Clinical Sciences & OperationsStudy DirectorSanofi
870 Previous Clinical Trials
2,020,118 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot become pregnant or agree to use birth control during and after the study.I am at least 18 years old (21 if in Puerto Rico) on the day I join the study.Have you had a flu vaccine in the last 6 months? If your answer is yes, you will be excluded from the study.
Research Study Groups:
This trial has the following groups:- Group 1: Group 1: Quadrivalent Influenza mRNA Vaccine MRT5413 low dose
- Group 2: Group 2: Quadrivalent Influenza mRNA Vaccine MRT5413 medium dose
- Group 3: Group 3: Quadrivalent Influenza mRNA Vaccine MRT5413 high dose
- Group 4: Group 4: RIV4
- Group 5: Group 5: QIV-SD
- Group 6: Group 6: 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: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Flu Shot Patient Testimony for trial: Trial Name: NCT05650554 — Phase 1 & 2
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