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
Status: Recruiting
Location: See all (36) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:
• 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.
Locations
United States
California
Velocity Clinical Research, San Bernardino
NOT_YET_RECRUITING
San Bernardino
Georgia
Velocity Clinical Research, Savannah
NOT_YET_RECRUITING
Savannah
Idaho
Velocity Clinical Research, Boise
NOT_YET_RECRUITING
Meridian
Maryland
Velocity Clinical Research, Rockville
NOT_YET_RECRUITING
Rockville
Nebraska
Velocity Clinical Research, Omaha
NOT_YET_RECRUITING
Omaha
Ohio
Velocity Clinical Research, Cleveland
RECRUITING
Beachwood
Rhode Island
Velocity Clinical Research, Providence
RECRUITING
East Greenwich
South Carolina
Velocity Clinical Research, Anderson
NOT_YET_RECRUITING
Anderson
Texas
Velocity Clinical Research, Dallas
RECRUITING
Dallas
Virginia
Velocity Clinical Research, Suffolk
NOT_YET_RECRUITING
Suffolk
Other Locations
United Kingdom
FutureMeds Birmingham Soho Road Health Centre
NOT_YET_RECRUITING
Birmingham
Fylde Coast Clinical Research at Layton Medical Centre
NOT_YET_RECRUITING
Blackpool
NIHR Wessex CRDC - Bournemouth Research Hub (Under University Hospital Southampton NHS Foundation Trust)
NOT_YET_RECRUITING
Bournemouth
Velocity Clinical Research-Bristol
NOT_YET_RECRUITING
Bristol
Lakeside Healthcare
NOT_YET_RECRUITING
Corby
Accellacare Warwickshire
NOT_YET_RECRUITING
Coventry
Panthera Enfield
NOT_YET_RECRUITING
Enfield
Panthera Glasgow
NOT_YET_RECRUITING
Glasgow
Velocity Clinical Research - High Wycombe
NOT_YET_RECRUITING
High Wycombe
Hounslow Medical Centre
NOT_YET_RECRUITING
Hounslow
hVIVO Services Limited
NOT_YET_RECRUITING
London
Velocity Clinical Research-North London
NOT_YET_RECRUITING
London
FutureMeds Liverpool
NOT_YET_RECRUITING
Metropolitan Borough Of Wirral
FutureMeds Newcastle
NOT_YET_RECRUITING
Newcastle Upon Tyne
Accellacare North London
NOT_YET_RECRUITING
Northwood
The University of Nottingham Health Service
NOT_YET_RECRUITING
Nottingham
Accellacare South London
NOT_YET_RECRUITING
Orpington
Wansford Research Ltd
NOT_YET_RECRUITING
Peterborough
Panthera Rochdale
NOT_YET_RECRUITING
Rochdale
Velocity Clinical Research-Romford
NOT_YET_RECRUITING
Romford
Panthera Sheffield
NOT_YET_RECRUITING
Sheffield
Accellacare Yorkshire
NOT_YET_RECRUITING
Shipley
NIHR Wessex CRDC - Southampton Research Hub (Under University Hospital Southampton NHS FT)
NOT_YET_RECRUITING
Southampton
Futuremeds Teesside Middlefield Centre University Hospital of North Tees
NOT_YET_RECRUITING
Stockton-on-tees
NIHR Wessex CRDC - Weymouth Research Hub (Under University Hospital Southampton NHS Foundation Trust)
NOT_YET_RECRUITING
Weymouth
Panthera York
NOT_YET_RECRUITING
York
Contact Information
Primary
Moderna WeCare Team
WeCareClinicalTrials@modernatx.com
1-866-663-3762
Time Frame
Start Date: 2026-03-23
Estimated Completion Date: 2027-01-28
Participants
Target number of participants: 4000
Treatments
Experimental: mRNA-1018-H5 Vaccine
Participants will receive mRNA-1018-H5 vaccine by intramuscular (IM) injection on Day 1 and Day 22.
Placebo_comparator: Placebo
Participants will receive placebo matched to mRNA-1018-H5 vaccine by IM injection on Day 1 and Day 22.
Related Therapeutic Areas
Sponsors
Leads: ModernaTX, Inc.