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: Active_not_recruiting
Location: See all (35) 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
San Bernardino
Georgia
Velocity Clinical Research, Savannah
Savannah
Idaho
Velocity Clinical Research, Boise
Meridian
Maryland
Velocity Clinical Research, Rockville
Rockville
Nebraska
Velocity Clinical Research, Omaha
Omaha
Ohio
Velocity Clinical Research, Cleveland
Beachwood
Rhode Island
Velocity Clinical Research, Providence
East Greenwich
South Carolina
Velocity Clinical Research, Anderson
Anderson
Texas
Velocity Clinical Research, Dallas
Dallas
Virginia
Velocity Clinical Research, Suffolk
Suffolk
Other Locations
United Kingdom
FutureMeds Birmingham Soho Road Health Centre
Birmingham
Fylde Coast Clinical Research at Layton Medical Centre
Blackpool
NIHR Wessex CRDC - Bournemouth Research Hub (Under University Hospital Southampton NHS Foundation Trust)
Bournemouth
Velocity Clinical Research-Bristol
Bristol
Lakeside Healthcare
Corby
Accellacare Warwickshire
Coventry
Panthera Enfield
Enfield
Panthera Glasgow
Glasgow
Velocity Clinical Research - High Wycombe
High Wycombe
Hounslow Medical Centre
Hounslow
hVIVO Services Limited
London
Velocity Clinical Research-North London
London
FutureMeds Liverpool
Metropolitan Borough Of Wirral
Accellacare North London
Northwood
The University of Nottingham Health Service
Nottingham
Accellacare South London
Orpington
Wansford Research Ltd
Peterborough
Panthera Rochdale
Rochdale
Velocity Clinical Research-Romford
Romford
Panthera Sheffield
Sheffield
Accellacare Yorkshire
Shipley
NIHR Wessex CRDC - Southampton Research Hub (Under University Hospital Southampton NHS FT)
Southampton
Futuremeds Teesside Middlefield Centre University Hospital of North Tees
Stockton-on-tees
NIHR Wessex CRDC - Weymouth Research Hub (Under University Hospital Southampton NHS Foundation Trust)
Weymouth
Panthera York
York
Time Frame
Start Date:2026-03-23
Completion Date:2027-01-28
Participants
Target number of participants:4050
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.