MRNA tech takes on the flu: could new shots outsmart seasonal strains?
NCT ID NCT06361875
First seen Aug 04, 2026 · Last updated Aug 05, 2026 · Updated 1 time
Summary
This trial is testing three experimental mRNA-based flu vaccines in healthy adults aged 18 and older. The goal is to see how safe they are and how well they trigger an immune response compared to standard flu vaccines. Participants receive a single injection, and researchers monitor side effects and measure antibody levels over the following month.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Quadrivalent influenza mRNA vaccines (MRT5421, MRT5424, MRT5429)
- What this could lead to
- If successful, these mRNA-based flu vaccines could offer a faster, more adaptable alternative to traditional flu shots, potentially improving protection each season.
- What could go wrong
- This is an early-stage trial, so the vaccines may not prove safe or effective in larger populations. Possible side effects include injection-site reactions, fever, and rare serious events like myocarditis.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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908 people
The number who actually took part.
- Started
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Apr 2024
- Finished
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Jun 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Aged from 18 years on the day of inclusion or aged from 21 years on the days of inclusion, depending on the countries. * A female participant was eligible to participate if she was not pregnant or breastfeeding and one of the following conditions applied: * Was of non-childbearing potential. To be considered of non-childbearing potential, a female must of been postmenopausal for at least 1 year, or surgically sterile OR * Was of childbearing potential and agreed to use an effective contraceptive method or abstinence from at least 4 weeks prior to study intervention administration until at least 12 weeks after study intervention administration. * A female participant of childbearing potential must of had a negative highly sensitive pregnancy test (urine or serum as required by local regulation) within 8 hours before the 1st dose of study intervention Exclusion Criteria: Participants were excluded from the study if any of the following criteria applied: * Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months) * Known systemic hypersensitivity to any of the study intervention components (eg, polyethylene glycol, polysorbate); history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances; any allergic reaction (eg, anaphylaxis) after administration of mRNA vaccine * Previous history of myocarditis, pericarditis, and / or myopericarditis * Known history of previous episodes of Gillian-Barre Syndrome (GBS), neuritis (including Bell's palsy), convulsions, encephalitis, transverse myelitis, and vasculitis * Participants with an ECG that is consistent with possible myocarditis or pericarditis or, in the opinion of the investigator, demonstrates clinically relevant abnormalities that may affect participant safety or study results * Self-reported thrombocytopenia, contraindicating Intramuscular vaccination based on Investigator's judgment * Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating Intramuscular vaccination based on Investigator's judgment * Chronic illness that, in the opinion of the Investigator, was at a stage where it might have interfered with study conduct or completion * Moderate or severe acute illness / infection (according to Investigator's judgment) or febrile illness (temperature ≥ 38.0°C \[≥ 100.4°F\]) on the day of vaccination. A prospective participant was not included in the study until the condition was resolved or the febrile event subsided * Participant who had acute infection symptoms or a positive SARS-CoV-2 RT-PCR or antigen test in the past 10 days prior to the 1st visit (V01) * Receipt of any vaccine in the 4 weeks preceding study intervention administration or planned receipt of any vaccine in the 4 weeks following study intervention administration * Receipt of immune globulins, blood or blood-derived products in the past 3 months * Previous vaccination against influenza in the previous 6 months with an investigational or marketed vaccine * Receipt of any mRNA vaccine/product in the 2 months preceding study intervention administration NOTE: The above information was not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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AMR Knoxville- Site Number : 8400043
Knoxville, Tennessee, 37909, United States
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AMR Lexington- Site Number : 8400042
Lexington, Kentucky, 40509, United States
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Brengle Family Medicine Site Number : 8400045
Indianapolis, Indiana, 46260, United States
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California Research Foundation Site Number : 8400038
San Diego, California, 92123-1881, United States
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Cenexel JBR- Site Number : 8400051
Salt Lake City, Utah, 84107, United States
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Cenexel Research Centers of America- Site Number : 8400037
Hollywood, Florida, 33024, United States
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Clinical Trials of Texas, Inc. - PPDS- Site Number : 8400029
San Antonio, Texas, 78229, United States
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Indago Research and Health Center- Site Number : 8400032
Hialeah, Florida, 33012, United States
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Investigational Site Number : 3400001
San Pedro Sula, 21104, Honduras
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Investigational Site Number : 6300002
Barrio Sabana, 00694, Puerto Rico
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The Alliance for Multispecialty Research - KCM, LLC- Site Number : 8400034
Kansas City, Missouri, 64114, United States
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Velocity Clinical Research Norfolk- Site Number : 8400046
Norfolk, Nebraska, 68701, United States
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Velocity Clinical Research- New Orleans Site Number : 8400053
New Orleans, Louisiana, 70119, United States
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