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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

Study Summary

This trial is testing the safety and effectiveness of a new influenza vaccine compared to existing ones.

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.Check my eligibility
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.See study design
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 below
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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 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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
Hemagglutination Inhibition Tests
Individual Hemagglutination inhibition (HAI) titer
Antigens, Fungal
+8 more
Secondary outcome measures
Individual HAI Ab titer ratio
Antibodies
Individual neutralizing antibodies titer ratio
+3 more

Side effects data

From 2012 Phase 3 trial • 6104 Patients • NCT01346592
27%
Injection site pain
25%
Pyrexia
14%
Upper respiratory tract infection
14%
Decreased appetite
14%
Diarrhea
10%
Injection site erythema
9%
Nasopharyngitis
9%
Irritability postvaccinal
9%
Headache
8%
Vomiting
8%
Injection site induration
7%
Hypersomnia
7%
Myalgia
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

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 5: QIV-HDActive Control1 Intervention
participants will receive a single dose of QIV -HD vaccine (for elderly only)
Group IV: Group 4: QIV-SDActive Control1 Intervention
participants will receive a single dose of QIV-SD vaccine
Group V: Group 3: RIV4Active Control1 Intervention
participants will receive a single dose of RIV4 vaccine

Find a Location

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
404 Previous Clinical Trials
6,056,987 Total Patients Enrolled
Clinical Sciences & OperationsStudy DirectorSanofi
857 Previous Clinical Trials
2,018,395 Total Patients Enrolled

Media Library

Quadrivalent Influenza mRNA Vaccine MRT5407 (Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT05553301 — Phase 1 & 2
Flu Shot Research Study Groups: Group 5: QIV-HD, Group 4: QIV-SD, Group 1: Quadrivalent Influenza mRNA Vaccine MRT5407 dose level 1, Group 2: Quadrivalent Influenza mRNA Vaccine MRT5407 dose level 2, Group 3: RIV4
Flu Shot Clinical Trial 2023: Quadrivalent Influenza mRNA Vaccine MRT5407 Highlights & Side Effects. Trial Name: NCT05553301 — Phase 1 & 2
Quadrivalent Influenza mRNA Vaccine MRT5407 (Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05553301 — Phase 1 & 2
Flu Shot Patient Testimony for trial: Trial Name: NCT05553301 — Phase 1 & 2

Frequently Asked Questions

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

How many venues is this clinical research taking place in?

"This trial is currently open at 5 sites, including Lexington and Austin, with other locations in Knoxville plus an additional five. To reduce travel time for potential participants, it may be wise to select the nearest site of enrolment."

Answered by AI

Is recruitment open for the current trial?

"Per clinicaltrials.gov, this medical trial is currently advertising for participants. The listing was first published on October 3rd 2022 and recently updated 6 days later."

Answered by AI

How many participants are engaged in this experiment?

"To complete this clinical trial, 560 eligible participants are needed to sign up. These individuals can register at medical sites such as AMR Lexington-Site Number:8400054 in Kentucky and Elligo Health Research in Texas."

Answered by AI

Who else is applying?

What state do they live in?
Iowa
Kentucky
Other
Texas
How old are they?
65+
18 - 65
What site did they apply to?
Artemis Research - Riverside-Site Number:8400044
AMR Kansas City-Site Number:8400006
Other
Elligo Health Research
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
1
0

Why did patients apply to this trial?

I want to help. To receive a flu vaccine. I’m interested in the trail. Willing to help future medical research.
PatientReceived 1 prior treatment
i could use the extra money, and i should get the vaccine.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

How long are the screenings? How long do the visits take? Is this a double blind study meaning i may not get the actual vax only placebo?
PatientReceived no prior treatments

How responsive is this trial?

Typically responds via
Phone Call
~232 spots leftby Mar 2025