Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

RECRUITING

NCT07496450

PHASE3

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

Sponsor: ModernaTX, Inc.

View on ClinicalTrials.gov

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.

Official title: A Phase 3, Randomized, Observer-blind, Placebo-controlled Study to Evaluate the Immunogenicity, Safety, and Reactogenicity of mRNA-1018-H5 Pandemic Influenza Vaccine in Adults ≥18 Years of Age

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

4000

Start Date

2026-03-23

Completion Date

2027-01-28

Last Updated

2026-04-03

Healthy Volunteers

Yes

Conditions

Influenza

Interventions

BIOLOGICAL

mRNA-1018-H5

Sterile liquid for injection.

BIOLOGICAL

Placebo

Sterile liquid for injection.

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.

Locations (36)

Velocity Clinical Research, San Bernardino

San Bernardino, California, United States

Velocity Clinical Research, Savannah

Savannah, Georgia, United States

Velocity Clinical Research, Boise

Meridian, Idaho, United States

Velocity Clinical Research, Rockville

Rockville, Maryland, United States

Velocity Clinical Research, Omaha

Omaha, Nebraska, United States

Velocity Clinical Research, Cleveland

Beachwood, Ohio, United States

Velocity Clinical Research, Providence

East Greenwich, Rhode Island, United States

Velocity Clinical Research, Anderson

Anderson, South Carolina, United States

Velocity Clinical Research, Dallas

Dallas, Texas, United States

Velocity Clinical Research, Suffolk

Suffolk, Virginia, United States

Velocity Clinical Research-Bristol

Bristol, Bristol (Unitary Authority), United Kingdom

Velocity Clinical Research - High Wycombe

High Wycombe, Buckinghamshire, United Kingdom

Wansford Research Ltd

Peterborough, Cambridgeshire, United Kingdom

Futuremeds Teesside Middlefield Centre University Hospital of North Tees

Stockton-on-Tees, County Durham, United Kingdom

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

Bournemouth, Dorset, United Kingdom

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

Weymouth, Dorset, United Kingdom

Panthera Glasgow

Glasgow, Glasgow City (Scotland), United Kingdom

Panthera Enfield

Enfield, Greater London, United Kingdom

Hounslow Medical Centre

Hounslow, Greater London, United Kingdom

hVIVO Services Limited

London, Greater London, United Kingdom

Velocity Clinical Research-North London

London, Greater London, United Kingdom

Accellacare North London

Northwood, Greater London, United Kingdom

Accellacare South London

Orpington, Greater London, United Kingdom

Velocity Clinical Research-Romford

Romford, Greater London, United Kingdom

Panthera Rochdale

Rochdale, Greater Manchester, United Kingdom

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

Southampton, Hampshire, United Kingdom

Fylde Coast Clinical Research at Layton Medical Centre

Blackpool, Lancashire, United Kingdom

FutureMeds Liverpool

Metropolitan Borough of Wirral, Merseyside, United Kingdom

Lakeside Healthcare

Corby, North Northamptonshire, United Kingdom

Panthera York

York, North Yorkshire, United Kingdom

The University of Nottingham Health Service

Nottingham, Nottinghamshire, United Kingdom

Panthera Sheffield

Sheffield, South Yorkshire, United Kingdom

FutureMeds Newcastle

Newcastle upon Tyne, Tyne and Wear, United Kingdom

Accellacare Warwickshire

Coventry, West Midlands (Coventry), United Kingdom

FutureMeds Birmingham Soho Road Health Centre

Birmingham, West Midlands, United Kingdom

Accellacare Yorkshire

Shipley, West Yorkshire, United Kingdom