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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
Study Summary
This trial tests the safety and effectiveness of a new flu vaccine given as a single shot for adults 18+ compared to existing vaccines.
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.Check my eligibility
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.See study design
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Individual HAI titer ratio
Individual Hemagglutination inhibition (HAI) titer
Number of participants archiving HAI seroconversion against Antigens
+8 moreSecondary outcome measures
Individual HAI Ab titer ratio
Individual antibodies HAI titer ratio
Individual neutralizing antibodies titer ratio
+3 moreSide effects data
From 2012 Phase 3 trial • 6104 Patients • NCT0134659227%
Injection site pain
25%
Pyrexia
14%
Decreased appetite
14%
Upper respiratory tract infection
14%
Diarrhea
10%
Injection site erythema
9%
Nasopharyngitis
9%
Irritability postvaccinal
9%
Headache
8%
Vomiting
8%
Injection site induration
7%
Myalgia
7%
Hypersomnia
7%
Injection site swelling
7%
Fatigue
6%
Crying
6%
Injection site hemorrhage
4%
Gastroenteritis
1%
Pneumonia
1%
Animal Bite
100%
80%
60%
40%
20%
0%
Study treatment Arm
ATIV (6 to <72 Months)
TIV (6 to <72 Months)
Comparator TIV (6 to <72 Months)
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)
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
6,091,297 Total Patients Enrolled
Clinical Sciences & OperationsStudy DirectorSanofi
857 Previous Clinical Trials
2,018,615 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
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are applicants currently being sought for enrollment in this research project?
"According to clinicaltrials.gov, the recruitment period for this experiment is ongoing - it was initially listed on December 6th 2022 and has recently been updated in that same month."
Answered by AI
What is the aggregate number of participants in this clinical trial?
"Affirmative. The clinical trial is still in the process of selecting participants and pertinent information can be found on clinicaltrials.gov. It was first published on December 6th, 2022 and has been recently revised with a goal to recruit 682 individuals from two distinct medical facilities."
Answered by AI
Who else is applying?
What state do they live in?
California
Nebraska
Other
Texas
What site did they apply to?
Velocity Gardena-Site Number:8400062
Velocity Clinical Research - Providence-Site Number:8400019
Other
Elligo Health Research, Inc.-Site Number:8400002
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
3+
0
Why did patients apply to this trial?
Hoping to get a flu shot. Hopefully to help medical advancement. I’ve gotten the old flu shot for 45 year.
PatientReceived 2+ prior treatments
Basically healthy woman for my age. For Science.and Monetary. I've done this in the past for the COVID Vaccine. I liked it.
PatientReceived 1 prior treatment
What questions have other patients asked about this trial?
How long is initial visit? How many visits needed? What’s the pay?
PatientReceived 1 prior treatment
How responsive is this trial?
Typically responds via
Email
Phone Call
Most responsive sites:
- Elligo Health Research, Inc.-Site Number:8400002: < 48 hours
Average response time
- < 2 Days
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