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New mRNA shot targets bird flu: 4,000 volunteers needed

NCT ID NCT07496450

Vaccine Sponsor: ModernaTX, Inc. 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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Aug 12, 2026 · Updated 3 times

Summary

This large phase 3 trial is testing an experimental mRNA vaccine (mRNA-1018-H5) designed to protect against H5N1 pandemic influenza. Around 4,000 healthy adults aged 18 and older will receive two doses of the vaccine or a placebo. Researchers will measure immune responses and monitor for side effects to see if the vaccine is safe and effective.

What this could mean

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

Active substance
mRNA-1018-H5 vaccine
What this could lead to
If successful, this could provide a safe and effective vaccine to protect against a future H5N1 bird flu pandemic.
What could go wrong
This is still an experimental vaccine. Even if it triggers an immune response, it may not prevent infection in the real world, and side effects are possible.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

4,050 people

The number who actually took part.

Started

Mar 2026

Expected to finish

Jan 2027

An estimate. End dates often move.

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

18 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.

Key Inclusion Criteria: * Healthy as determined by medical evaluation including medical history; and physical examination. Participants with clinically stable chronic medical conditions are permitted. * Participants who are assigned female at birth or could become pregnant are eligible to participate if the participant is not pregnant or breast/chest feeding, and one of the following conditions applies: * Is a person of nonchildbearing potential (PONCBP) OR * Is a person of childbearing potential (POCBP) * A POCBP must have a negative highly sensitive pregnancy test at Screening and on the day of the first dose of study intervention. Key Exclusion Criteria: * Participant is acutely ill or febrile (body temperature ≥ 38.0 degrees Celsius \[°C\]/100.4 degrees Fahrenheit \[°F\]) within 72 hours prior to or at the Screening Visit or Day 1. * History of myocarditis, pericarditis, or myopericarditis. * History of Guillain-Barre syndrome. * Reported history of congenital or acquired immunodeficiency, immunosuppressive condition, asplenia, or recurrent severe infections disease. * Treated with antiviral therapies for influenza (eg, Tamiflu, Xofluza) within 28 days prior to Day 1. * Prior receipt of a pandemic influenza vaccine or participation in any pandemic influenza vaccine clinical study, including the mRNA-1018-P101 study. * Any medical, psychiatric, or occupational condition, that, in the opinion of the Investigator, might pose additional risk due to participation in the study or could interfere with adherence to study procedures or the interpretation of study results. * Participant has received systemic immunosuppressants including long-acting biological therapies that affect immune responses (eg, infliximab, methotrexate, omalizumab, etc.), within 180 days prior to Screening or plans to do so at any time during participation in the study. * Participant has received corticosteroids at ≥10 mg/day of prednisone or equivalent for \>14 days in total within 90 days prior to Day 1 (Baseline) or is anticipating the need for corticosteroids at any time during the study. * Participants has received any licensed vaccine authorized or approved by local health agency including mRNA vaccine ≤28 days prior to study intervention (Day 1) or plans to receive a vaccine authorized or approved by local health agency within 21 days after the study intervention. * Participant has participated in an interventional clinical study within 90 days prior to the Screening visit based on the medical history interview or plans to do so while participating in this study. Note: Other inclusion/exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

avian influenza viral infectious disease influenza prevention target

As listed by the trial registrant

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

Influenza

Contacts and locations

Locations

  • Accellacare North London

    Northwood, Greater London, HA6 2RN, United Kingdom

  • Accellacare South London

    Orpington, Greater London, BR5 3QG, United Kingdom

  • Accellacare Warwickshire

    Coventry, West Midlands (Coventry), CV3 4FJ, United Kingdom

  • Accellacare Yorkshire

    Shipley, West Yorkshire, BD18 3SA, United Kingdom

  • FutureMeds Birmingham Soho Road Health Centre

    Birmingham, West Midlands, B21 9RY, United Kingdom

  • FutureMeds Liverpool

    Metropolitan Borough of Wirral, Merseyside, CH62 6EE, United Kingdom

  • Futuremeds Teesside Middlefield Centre University Hospital of North Tees

    Stockton-on-Tees, County Durham, TS19 8PE, United Kingdom

  • Fylde Coast Clinical Research at Layton Medical Centre

    Blackpool, Lancashire, FY3 7EN, United Kingdom

  • Hounslow Medical Centre

    Hounslow, Greater London, TW3 3ET, United Kingdom

  • Lakeside Healthcare

    Corby, North Northamptonshire, NN17 2UR, United Kingdom

  • NIHR Wessex CRDC - Bournemouth Research Hub (Under University Hospital Southampton NHS Foundation Trust)

    Bournemouth, Dorset, BH7 7DW, United Kingdom

  • NIHR Wessex CRDC - Southampton Research Hub (Under University Hospital Southampton NHS FT)

    Southampton, Hampshire, SO15 3UA, United Kingdom

  • NIHR Wessex CRDC - Weymouth Research Hub (Under University Hospital Southampton NHS Foundation Trust)

    Weymouth, Dorset, DT4 0QE, United Kingdom

  • Panthera Enfield

    Enfield, Greater London, EN3 4GS, United Kingdom

  • Panthera Glasgow

    Glasgow, Glasgow City (Scotland), G51 4TF, United Kingdom

  • Panthera Rochdale

    Rochdale, Greater Manchester, OL11 4AU, United Kingdom

  • Panthera Sheffield

    Sheffield, South Yorkshire, S2 5FX, United Kingdom

  • Panthera York

    York, North Yorkshire, YO24 4LJ, United Kingdom

  • The University of Nottingham Health Service

    Nottingham, Nottinghamshire, NG7 2QW, United Kingdom

  • Velocity Clinical Research - High Wycombe

    High Wycombe, Buckinghamshire, HP11 2QW, United Kingdom

  • Velocity Clinical Research, Anderson

    Anderson, South Carolina, 29621, United States

  • Velocity Clinical Research, Boise

    Meridian, Idaho, 83642, United States

  • Velocity Clinical Research, Cleveland

    Beachwood, Ohio, 44122, United States

  • Velocity Clinical Research, Dallas

    Dallas, Texas, 75230, United States

  • Velocity Clinical Research, Omaha

    Omaha, Nebraska, 68134, United States

  • Velocity Clinical Research, Providence

    East Greenwich, Rhode Island, 02818, United States

  • Velocity Clinical Research, Rockville

    Rockville, Maryland, 20854, United States

  • Velocity Clinical Research, San Bernardino

    San Bernardino, California, 92408, United States

  • Velocity Clinical Research, Savannah

    Savannah, Georgia, 31406, United States

  • Velocity Clinical Research, Suffolk

    Suffolk, Virginia, 23435, United States

  • Velocity Clinical Research-Bristol

    Bristol, Bristol (Unitary Authority), BS8 2RA, United Kingdom

  • Velocity Clinical Research-North London

    London, Greater London, N12 8BU, United Kingdom

  • Velocity Clinical Research-Romford

    Romford, Greater London, RM1 3PJ, United Kingdom

  • Wansford Research Ltd

    Peterborough, Cambridgeshire, PE8 6PL, United Kingdom

  • hVIVO Services Limited

    London, Greater London, E1 1EQ, United Kingdom

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