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

NCT07496450 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: mRNA-1018-P301
• Study Type: interventional
• Target: 4,000
• Locations: 2 countries
• Sites: 36

Brief 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.

Conditions

Influenza

Keywords

Influenza Vaccine; Moderna; mRNA-1018-H5; Viral Diseases; Vaccines; Pandemic Influenza; Avian Flu; Bird Flu; Influenza A

Outcome Measures

Primary Outcomes (5)

• Percentage of Participants With Hemagglutination Inhibition (HAI) Titer ≥ 1:40 at Day 43

  HAI Titer \>=1:40.

  Day 43

• Percentage of Participants With Seroconversion at Day 43, as Measured by HAI Assay

  Seroconversion is defined as a Day 43 titer ≥1:40 if baseline is \<1:10 or a 4-fold or greater rise if baseline is ≥1:10 in HAI titer measured by HAI assay.

  Day 43

• Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)

  Up to Day 29 (7 days after each injection)

• Number of Participants with Unsolicited Adverse Events (AEs)

  Up to Day 50 (28 days after each injection)

• Number of Participants with AEs Leading to Discontinuation, Medically-attended AEs (MAAEs), Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs)

  Day 1 to Day 205

Secondary Outcomes (4)

• Geometric Mean Titer (GMT) of Anti-H5N1 Antibodies at Day 43, as Measured by Microneutralization (MN) Assay

  Day 43

• GMT of HAI Antibodies at Days 22 and 205, as Measured by HAI Assay

  Days 22 and 205

• GMT of HAI Antibodies at Days 22 and 205, as Measured by MN Assay

  Days 22 and 205

• Percentage of Participants with HAI Titers at Different Cut-Offs

  Up to Day 205

Study Arms (2)

mRNA-1018-H5 Vaccine

EXPERIMENTAL

Participants will receive mRNA-1018-H5 vaccine by intramuscular (IM) injection on Day 1 and Day 22.

Biological: mRNA-1018-H5

Placebo

PLACEBO COMPARATOR

Participants will receive placebo matched to mRNA-1018-H5 vaccine by IM injection on Day 1 and Day 22.

Biological: Placebo

Interventions

mRNA-1018-H5 BIOLOGICAL

Sterile liquid for injection.

mRNA-1018-H5 Vaccine

Placebo BIOLOGICAL

Sterile liquid for injection.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ModernaTX, Inc.: lead

Study Sites (36)

Velocity Clinical Research, San Bernardino

San Bernardino, California, 92408, United States

RECRUITING

Velocity Clinical Research, Savannah

Savannah, Georgia, 31406, United States

RECRUITING

Velocity Clinical Research, Boise

Meridian, Idaho, 83642, United States

RECRUITING

Velocity Clinical Research, Rockville

Rockville, Maryland, 20854, United States

RECRUITING

Velocity Clinical Research, Omaha

Omaha, Nebraska, 68134, United States

RECRUITING

Velocity Clinical Research, Cleveland

Beachwood, Ohio, 44122, United States

RECRUITING

Velocity Clinical Research, Providence

East Greenwich, Rhode Island, 02818, United States

RECRUITING

Velocity Clinical Research, Anderson

Anderson, South Carolina, 29621, United States

RECRUITING

Velocity Clinical Research, Dallas

Dallas, Texas, 75230, United States

RECRUITING

Velocity Clinical Research, Suffolk

Suffolk, Virginia, 23435, United States

RECRUITING

Velocity Clinical Research-Bristol

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

RECRUITING

Velocity Clinical Research - High Wycombe

High Wycombe, Buckinghamshire, HP11 2QW, United Kingdom

RECRUITING

Wansford Research Ltd

Peterborough, Cambridgeshire, PE8 6PL, United Kingdom

RECRUITING

Futuremeds Teesside Middlefield Centre University Hospital of North Tees

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

RECRUITING

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

Bournemouth, Dorset, BH7 7DW, United Kingdom

RECRUITING

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

Weymouth, Dorset, DT4 0QE, United Kingdom

RECRUITING

Panthera Glasgow

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

RECRUITING

Panthera Enfield

Enfield, Greater London, EN3 4GS, United Kingdom

RECRUITING

Hounslow Medical Centre

Hounslow, Greater London, TW3 3ET, United Kingdom

RECRUITING

hVIVO Services Limited

London, Greater London, E1 1EQ, United Kingdom

RECRUITING

Velocity Clinical Research-North London

London, Greater London, N12 8BU, United Kingdom

RECRUITING

Accellacare North London

Northwood, Greater London, HA6 2RN, United Kingdom

RECRUITING

Accellacare South London

Orpington, Greater London, BR5 3QG, United Kingdom

RECRUITING

Velocity Clinical Research-Romford

Romford, Greater London, RM1 3PJ, United Kingdom

RECRUITING

Panthera Rochdale

Rochdale, Greater Manchester, OL11 4AU, United Kingdom

RECRUITING

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

Southampton, Hampshire, SO15 3UA, United Kingdom

RECRUITING

Fylde Coast Clinical Research at Layton Medical Centre

Blackpool, Lancashire, FY3 7EN, United Kingdom

RECRUITING

FutureMeds Liverpool

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

RECRUITING

Lakeside Healthcare

Corby, North Northamptonshire, NN17 2UR, United Kingdom

RECRUITING

Panthera York

York, North Yorkshire, YO24 4LJ, United Kingdom

RECRUITING

The University of Nottingham Health Service

Nottingham, Nottinghamshire, NG7 2QW, United Kingdom

RECRUITING

Panthera Sheffield

Sheffield, South Yorkshire, S2 5FX, United Kingdom

RECRUITING

FutureMeds Newcastle

Newcastle upon Tyne, Tyne and Wear, NE61SG, United Kingdom

RECRUITING

Accellacare Warwickshire

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

RECRUITING

FutureMeds Birmingham Soho Road Health Centre

Birmingham, West Midlands, B21 9RY, United Kingdom

RECRUITING

Accellacare Yorkshire

Shipley, West Yorkshire, BD18 3SA, United Kingdom

RECRUITING

MeSH Terms

Conditions

Influenza, Human; Virus Diseases; Influenza in Birds

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Respiratory Tract Diseases; Bird Diseases; Animal Diseases

Central Study Contacts

Moderna WeCare Team

CONTACT

1-866-663-3762; WeCareClinicalTrials@modernatx.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2026
• First Posted: March 27, 2026
• Study Start: March 23, 2026
• Primary Completion (Estimated): January 28, 2027
• Study Completion (Estimated): January 28, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

GB (26); US (10)