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New mRNA flu shot shows promise in older adults

NCT ID NCT06744205

Vaccine Sponsor: Sanofi Pasteur, a Sanofi Company Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new mRNA-based flu vaccine in over 1,100 adults aged 50 and older. The vaccine targets multiple flu virus proteins to potentially provide stronger protection. Researchers compared it to standard flu shots and monitored safety and immune response for six months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
hexavalent influenza mRNA vaccine (mRNA HA + mRNA NA)
What this could lead to
If successful, this could lead to a more effective flu vaccine that offers broader protection for older adults.
What could go wrong
This is an early-phase trial (Phase 1/2) with a limited number of participants. The vaccine may not prove more effective than existing flu shots, and side effects are still being evaluated.

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

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

1,162 people

The number who actually took part.

Started

Jan 2025

Finished

May 2026

Lead sponsor

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

50 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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: * Participant aged 50 years on the day of inclusion * A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies: * Is of non-childbearing potential. To be considered of non-childbearing potential, a female must be postmenopausal for at least 1 year, or surgically sterile. OR * Is of childbearing potential and agrees 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 have a negative highly sensitive pregnancy test (urine or serum as required by local regulation) within 8 hours prior to administration of study intervention. Exclusion Criteria: Participants are not eligible for the study if any of the following criteria are met: * 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 Guillain-Barré syndrome, neuritis (including Bell's palsy), convulsions, encephalitis, transverse myelitis, and vasculitis * Participants with an electrocardiogram 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 (IM) vaccination based on Investigator's judgment * Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination based on Investigator's judgment * Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with study conduct or completion * Moderate or severe acute illness / infection (according to investigator's judgement) or febrile illness (temperature ≥ 38.0°C \[≥ 100.4°F\]) on the day of vaccination. A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided. * Alcohol, prescription drug, or substance abuse that, in the opinion of the Investigator, might interfere with the study conduct or completion * Participant who had acute infectious symptoms or a positive SARS-CoV-2 RT-PCR or antigen test in the past 10 days prior to the first 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 or planned receipt of any mRNA vaccine in the 2 months after study vaccination * Participation at the time of study enrollment (or in the 4 weeks preceding study intervention administration) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure * Self-reported or documented seropositivity for human immunodeficiency virus, hepatitis B virus, or hepatitis C virus

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Conditions

The condition(s) this trial relates to.

influenza prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Healthy volunteers Influenza

Contacts and locations

Locations

  • AMR - Chicago- Site Number : 8400012

    Oak Brook, Illinois, 60532, United States

  • AMR Las Vegas - Site Number : 8400016

    Las Vegas, Nevada, 89119, United States

  • AMR Miami- Site Number : 8400021

    Coral Gables, Florida, 33134, United States

  • AMR Mobile- Site Number : 8400022

    Mobile, Alabama, 36608, United States

  • Accel Research Site - NeuroStudies.net, LLC - ERN - PPDS- Site Number : 8400001

    Decatur, Georgia, 30030-2627, United States

  • Accel Research Sites - Maitland- Site Number : 8400007

    Maitland, Florida, 32751, United States

  • Accel Research Sites Network - Birmingham- Site Number : 8400008

    Birmingham, Alabama, 35216, United States

  • Accel Research Sites Network - DeLand Clinical Research Unit- Site Number : 8400003

    DeLand, Florida, 32720, United States

  • ActivMed Practices & Research- Site Number : 8400005

    Methuen, Massachusetts, 03110, United States

  • Alliance for Multispeciality Research - Clinical Research Consortium- Site Number : 8400015

    Tempe, Arizona, 85281, United States

  • Alliance for Multispeciality Research - Fort Myers- Site Number : 8400013

    Fort Myers, Florida, 33912, United States

  • Alliance for Multispeciality Research - Kansas City- Site Number : 8400019

    Kansas City, Missouri, 64114, United States

  • Alliance for Multispeciality Research - Knoxville- Site Number : 8400017

    Knoxville, Tennessee, 37920, United States

  • Alliance for Multispeciality Research - Lexington- Site Number : 8400018

    Lexington, Kentucky, 40509, United States

  • Alliance for Multispeciality Research - Newton- Site Number : 8400020

    Newton, Kansas, 67114, United States

  • Alliance for Multispeciality Research - Wichita East- Site Number : 8400014

    Wichita, Kansas, 67207, United States

  • Boston Clinical Trials- Site Number : 8400009

    Boston, Massachusetts, 02131, United States

  • Charlottesville Medical Research- Site Number : 8400004

    Charlottesville, Virginia, 22911, United States

  • Coastal Carolina Research Center - North Charleston- Site Number : 8400002

    North Charleston, South Carolina, 29405, United States

  • Innovation Medical Research Center - Palmetto Bay- Site Number : 8400011

    Palmetto Bay, Florida, 33157, United States

  • Investigational Site Number : 0360001

    Botany, New South Wales, 2019, Australia

  • Investigational Site Number : 0360002

    Melbourne, Victoria, 3124, Australia

  • Investigational Site Number : 0360003

    Bayswater, Victoria, 3153, Australia

  • Quest Research Institute- Site Number : 8400010

    Farmington Hills, Michigan, 48334, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.