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ACTIVE NOT RECRUITINGPhase3

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

Sponsor: ModernaTX, Inc.

NCT ID: NCT07496450

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
mRNA-1018-H5 (biological), Placebo (biological)
How long the study runs
Study runs about 10 months (dates as stated)
About the drug or intervention
mRNA-1018-H5 — biological: Sterile liquid for injection. · Placebo — biological: Sterile liquid for injection.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
4,050
Started
2026-03-23
Last checked
2026-08

Plain English Summary

What is this study?

  • • Testing a new treatment for influenza
  • • Phase3 - 4,050 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with influenza

Where?

  • • Bristol - Velocity Clinical Research-Bristol
  • • High Wycombe - Velocity Clinical Research - High Wycombe
  • • Peterborough - Wansford Research Ltd
  • • Stockton-on-Tees - Futuremeds Teesside Middlefield Centre University Hospital of North Tees
  • • +21 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Influenza

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

have a negative

What the study is looking for

  • ✓Healthy as determined by medical evaluation including medical history; and physical examination. Participants with...
  • ✓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...

Who cannot take part

  • ✗Participant is acutely ill or febrile (body temperature ≥ 38.0 degrees Celsius \[°C\]/100.4 degrees Fahrenheit...
  • ✗History of myocarditis, pericarditis, or myopericarditis.
  • ✗History of Guillain-Barre syndrome.
  • ✗Reported history of congenital or acquired immunodeficiency, immunosuppressive condition, asplenia, or recurrent...
  • ✗Treated with antiviral therapies for influenza (eg, Tamiflu, Xofluza) within 28 days prior to Day 1.
See the full criteria
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.

Where Is This Study? (25 UK sites)

Velocity Clinical Research-Bristol

Bristol BS8 2RA, United Kingdom

Velocity Clinical Research - High Wycombe

High Wycombe HP11 2QW, United Kingdom

Wansford Research Ltd

Peterborough PE8 6PL, United Kingdom

Futuremeds Teesside Middlefield Centre University Hospital of North Tees

Stockton-on-Tees TS19 8PE, United Kingdom

Hospital R&D contact (matched)

Research and Development

nth-tr.ntandh.researchdevelopment@nhs.net01642 624090

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

Bournemouth BH7 7DW, United Kingdom

Hospital R&D contact (matched)

Dr Mikayala King

researchmanagement@uhs.nhs.uk023 81208215

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

Weymouth DT4 0QE, United Kingdom

Hospital R&D contact (matched)

Dr Mikayala King

researchmanagement@uhs.nhs.uk023 81208215

Panthera Glasgow

Glasgow G51 4TF, United Kingdom

Panthera Enfield

Enfield EN3 4GS, United Kingdom

Hounslow Medical Centre

Hounslow TW3 3ET, United Kingdom

hVIVO Services Limited

London E1 1EQ, United Kingdom

Velocity Clinical Research-North London

London N12 8BU, United Kingdom

Hospital R&D contact (matched)

Noclor

contact.noclor@nhs.net020 3317 3034

Accellacare North London

Northwood HA6 2RN, United Kingdom

Hospital R&D contact (matched)

Noclor

contact.noclor@nhs.net020 3317 3034

Accellacare South London

Orpington BR5 3QG, United Kingdom

Hospital R&D contact (matched)

Dale Batham

slam-ioppn.research@kcl.ac.uk0207 848 0790

Velocity Clinical Research-Romford

Romford RM1 3PJ, United Kingdom

Panthera Rochdale

Rochdale OL11 4AU, United Kingdom

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

Southampton SO15 3UA, United Kingdom

Hospital R&D contact (matched)

Dr Mikayala King

researchmanagement@uhs.nhs.uk023 81208215

Fylde Coast Clinical Research at Layton Medical Centre

Blackpool FY3 7EN, United Kingdom

FutureMeds Liverpool

Metropolitan Borough of Wirral CH62 6EE, United Kingdom

Lakeside Healthcare

Corby NN17 2UR, United Kingdom

Panthera York

York YO24 4LJ, United Kingdom

The University of Nottingham Health Service

Nottingham NG7 2QW, United Kingdom

Hospital R&D contact (matched)

Alison Lloyd

nuhnt.researchsponsor@nhs.net0115 9249924

Panthera Sheffield

Sheffield S2 5FX, United Kingdom

Hospital R&D contact (matched)

Alessia Dunn

STH.ResearchAdministration@nhs.net0114 2712550

Accellacare Warwickshire

Coventry CV3 4FJ, United Kingdom

FutureMeds Birmingham Soho Road Health Centre

Birmingham B21 9RY, United Kingdom

Hospital R&D contact (matched)

Sarah Pountain Head of Research Governance

R&D@uhb.nhs.uk0121 371 4185

Accellacare Yorkshire

Shipley BD18 3SA, United Kingdom

Data sourced from ClinicalTrials.gov · Last verified: 2026-08