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NCT07496450PHASE3RecruitingAccepts Healthy Volunteers

A Study of mRNA-1018-H5 Pandemic Influenza Vaccine in Healthy Adults

ModernaTX, Inc.

Start Date

3/23/2026

Completion Date

1/28/2027

Summary

The purpose of this study is to evaluate humoral immunogenicity after 2 doses of mRNA-1018-H5, and to evaluate the safety and reactogenicity of mRNA-1018-H5 in adults ≥18 years of age.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

BIOLOGICAL

mRNA-1018-H5

BIOLOGICAL

Placebo

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Conditions

Influenza

Locations

Velocity Clinical Research, San Bernardino

San Bernardino, California 92408

United States

Velocity Clinical Research, Savannah

Savannah, Georgia 31406

United States

Velocity Clinical Research, Boise

Meridian, Idaho 83642

United States

Velocity Clinical Research, Rockville

Rockville, Maryland 20854

United States

Velocity Clinical Research, Omaha

Omaha, Nebraska 68134

United States

Velocity Clinical Research, Cleveland

Beachwood, Ohio 44122

United States

Velocity Clinical Research, Providence

East Greenwich, Rhode Island 02818

United States

Velocity Clinical Research, Anderson

Anderson, South Carolina 29621

United States

Velocity Clinical Research, Dallas

Dallas, Texas 75230

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 - High Wycombe

High Wycombe, Buckinghamshire HP11 2QW

United Kingdom

Wansford Research Ltd

Peterborough, Cambridgeshire PE8 6PL

United Kingdom

Futuremeds Teesside Middlefield Centre University Hospital of North Tees

Stockton-on-Tees, County Durham TS19 8PE

United Kingdom

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

Bournemouth, Dorset BH7 7DW

United Kingdom

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

Weymouth, Dorset DT4 0QE

United Kingdom

Panthera Glasgow

Glasgow, Glasgow City (Scotland) G51 4TF

United Kingdom

Panthera Enfield

Enfield, Greater London EN3 4GS

United Kingdom

Hounslow Medical Centre

Hounslow, Greater London TW3 3ET

United Kingdom

hVIVO Services Limited

London, Greater London E1 1EQ

United Kingdom

Velocity Clinical Research-North London

London, Greater London N12 8BU

United Kingdom

Accellacare North London

Northwood, Greater London HA6 2RN

United Kingdom

Accellacare South London

Orpington, Greater London BR5 3QG

United Kingdom

Velocity Clinical Research-Romford

Romford, Greater London RM1 3PJ

United Kingdom

Panthera Rochdale

Rochdale, Greater Manchester OL11 4AU

United Kingdom

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

Southampton, Hampshire SO15 3UA

United Kingdom

Fylde Coast Clinical Research at Layton Medical Centre

Blackpool, Lancashire FY3 7EN

United Kingdom

FutureMeds Liverpool

Metropolitan Borough of Wirral, Merseyside CH62 6EE

United Kingdom

Lakeside Healthcare

Corby, North Northamptonshire NN17 2UR

United Kingdom

Panthera York

York, North Yorkshire YO24 4LJ

United Kingdom

The University of Nottingham Health Service

Nottingham, Nottinghamshire NG7 2QW

United Kingdom

Panthera Sheffield

Sheffield, South Yorkshire S2 5FX

United Kingdom

FutureMeds Newcastle

Newcastle upon Tyne, Tyne and Wear NE61SG

United Kingdom

Accellacare Warwickshire

Coventry, West Midlands (Coventry) CV3 4FJ

United Kingdom

FutureMeds Birmingham Soho Road Health Centre

Birmingham, West Midlands B21 9RY

United Kingdom

Accellacare Yorkshire

Shipley, West Yorkshire BD18 3SA

United Kingdom