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Clinical Trials in the UK / NCT07496450
Active, not recruiting Phase 3

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

NCT07496450 · tracked via the Priya Life Science UK tracker
Sponsor
ModernaTX, Inc.
Phase
Phase 3
Started
2026-03-23
Last updated
2026-08-11

Condition(s) studied

Influenza

Investigational drug(s) / intervention(s)

mRNA-1018-H5Placebo

mRNA-1018-H5: Sterile liquid for injection.

Placebo: Sterile liquid for injection.

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

Trial sites (35)

FacilityCityRegionStatus
Velocity Clinical Research, San Bernardino San Bernardino California
Velocity Clinical Research, Savannah Savannah Georgia
Velocity Clinical Research, Boise Meridian Idaho
Velocity Clinical Research, Rockville Rockville Maryland
Velocity Clinical Research, Omaha Omaha Nebraska
Velocity Clinical Research, Cleveland Beachwood Ohio
Velocity Clinical Research, Providence East Greenwich Rhode Island
Velocity Clinical Research, Anderson Anderson South Carolina
Velocity Clinical Research, Dallas Dallas Texas
Velocity Clinical Research, Suffolk Suffolk Virginia
Velocity Clinical Research-Bristol Bristol Bristol (Unitary Authority)
Velocity Clinical Research - High Wycombe High Wycombe Buckinghamshire
Wansford Research Ltd Peterborough Cambridgeshire
Futuremeds Teesside Middlefield Centre University Hospital of North Tees Stockton-on-Tees County Durham
NIHR Wessex CRDC - Bournemouth Research Hub (Under University Hospital Southampton NHS Foundation Trust) Bournemouth Dorset
NIHR Wessex CRDC - Weymouth Research Hub (Under University Hospital Southampton NHS Foundation Trust) Weymouth Dorset
Panthera Glasgow Glasgow Glasgow City (Scotland)
Panthera Enfield Enfield Greater London
Hounslow Medical Centre Hounslow Greater London
hVIVO Services Limited London Greater London
Velocity Clinical Research-North London London Greater London
Accellacare North London Northwood Greater London
Accellacare South London Orpington Greater London
Velocity Clinical Research-Romford Romford Greater London
Panthera Rochdale Rochdale Greater Manchester
NIHR Wessex CRDC - Southampton Research Hub (Under University Hospital Southampton NHS FT) Southampton Hampshire
Fylde Coast Clinical Research at Layton Medical Centre Blackpool Lancashire
FutureMeds Liverpool Metropolitan Borough of Wirral Merseyside
Lakeside Healthcare Corby North Northamptonshire
Panthera York York North Yorkshire
The University of Nottingham Health Service Nottingham Nottinghamshire
Panthera Sheffield Sheffield South Yorkshire
Accellacare Warwickshire Coventry West Midlands (Coventry)
FutureMeds Birmingham Soho Road Health Centre Birmingham West Midlands
Accellacare Yorkshire Shipley West Yorkshire

More ModernaTX, Inc. trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07496450 on ClinicalTrials.gov ↗ ← All trials in the UK