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A Study to Evaluate the Efficacy and Safety of mRNA-1283 and mRNA-1273 in Participants 50 to 64 Years of Age Without High-Risk Conditions for Severe Coronavirus Disease 2019 (COVID-19)
Sponsor: ModernaTX, Inc.
Summary
The purpose of this study is to evaluate the efficacy and safety of mRNA-1283 and mRNA-1273 (variant formulations) in adults 50 to 64 years of age without high risk factors for severe COVID-19.
Official title: A Phase 4, Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of mRNA-1283 And mRNA-1273 Variant-Containing Formulation in Adults 50 to 64 Years of Age Without Underlying Conditions That Put Them at High Risk for Severe Outcomes From COVID-19
Key Details
Gender
All
Age Range
50 Years - 64 Years
Study Type
INTERVENTIONAL
Enrollment
30000
Start Date
2025-11-26
Completion Date
2027-06-16
Last Updated
2026-09-28
Healthy Volunteers
Yes
Conditions
Interventions
mRNA-1273
Sterile liquid for injection
mRNA-1283
Sterile liquid for injection
Placebo
0.9% sodium chloride (normal saline) injection
Locations (150)
Accel Clinical Research
Birmingham, Alabama, United States
Cullman Clinical Trials
Cullman, Alabama, United States
AMR Clinical Mobile
Mobile, Alabama, United States
Velocity Clinical Research, Mobile
Mobile, Alabama, United States
Lenzmeier Family Medicine - Avacare
Glendale, Arizona, United States
Desert Clinical Research
Mesa, Arizona, United States
Velocity Clinical Research - Phoenix
Phoenix, Arizona, United States
Foothills Research Center/Avacare
Phoenix, Arizona, United States
Headlands Research Scottsdale
Scottsdale, Arizona, United States
Fiel Family and Sports Medicine / Avacare
Tempe, Arizona, United States
Avacare
Colton, California, United States
CenExel CNR
Garden Grove, California, United States
Velocity Clinical Research, Huntington Park
Huntington Park, California, United States
Velocity Clinical Research - San Diego - ERN - PPDS-Site Number:8400010
La Mesa, California, United States
Velocity Clinical Research - Los Angeles
Los Angeles, California, United States
Artemis Institute for Clinical Research
Riverside, California, United States
Peninsula Research Associates
Rolling Hills Estates, California, United States
Velocity Clinical Research -- Banning
San Bernardino, California, United States
Artemis Institute for Clinical Research
San Diego, California, United States
Tekton Research, LLC
Denver, Colorado, United States
Tekton Research, LLC
Fort Collins, Colorado, United States
Critical Care, Pulmonary and Sleep Associates, P.LLP/Avacare
Lakewood, Colorado, United States
Tekton Research, LLC
Longmont, Colorado, United States
New England Research Associates
Bridgeport, Connecticut, United States
Stamford Therapeutics Consortium
Stamford, Connecticut, United States
Velocity Clinical Research-Washington, DC
Washington D.C., District of Columbia, United States
Hillcrest Medical Research, LLC
DeLand, Florida, United States
University Clinical Research-Deland, LLC d/b/a Accel Research Sites - Deland Clinical Research Unit
DeLand, Florida, United States
Suncoast Research Associates, LLC
Doral, Florida, United States
Velocity Clinical Research, Hallandale Beach
Hallandale, Florida, United States
Indago Research & Health Center, Inc
Hialeah, Florida, United States
CenExel Research Centers of America
Hollywood, Florida, United States
NextPhase Research Florida
Hollywood, Florida, United States
Health Awareness Inc.
Jupiter, Florida, United States
Sandhill Research, LLC d/b/a Accel Research Sites - Lakeland Clinical Research Unit
Lakeland, Florida, United States
Sandhill Research, LLC d/b/a Accel Research Sites- St. Pete-Largo Clinical Research Unit
Largo, Florida, United States
Accel Research Sites
Maitland, Florida, United States
Global Health Research Center, Inc.
Miami Lakes, Florida, United States
Suncoast Clinical Research
New Port Richey, Florida, United States
Headlands Research Orlando
Orlando, Florida, United States
Innovation Medical Research Center
Palmetto Bay, Florida, United States
ForCare Clinical Research
Tampa, Florida, United States
Global Health Research Center, Inc.
Tampa, Florida, United States
Javara Inc. and PRIVIA Medical Group of Georgia, LLC
Albany, Georgia, United States
DelRicht Research
Atlanta, Georgia, United States
Atlanta Center for Medical Research
Atlanta, Georgia, United States
Accel Research Sites - Neurostudies
Decatur, Georgia, United States
CenExel iResearch, LLC
Decatur, Georgia, United States
Javara Inc. and Privia Medical Group of Georgia, LLC
Fayetteville, Georgia, United States
Velocity Clinical Research Savannah
Savannah, Georgia, United States
Clinical Research Atlanta
Stockbridge, Georgia, United States
Velocity Clinical Research - Boise - ERN - PPDS
Meridian, Idaho, United States
DM Clinical Research - Melrose Park
Melrose Park, Illinois, United States
Velocity Clinical Research Valparaiso
Valparaiso, Indiana, United States
Velocity Clinical Research - Sioux City
Sioux City, Iowa, United States
Johnson County Clin-Trials
Lenexa, Kansas, United States
Tekton Research, LLC
Wichita, Kansas, United States
DelRicht Research
Louisville, Kentucky, United States
Versailles Family Medicine - CCT Research
Versailles, Kentucky, United States
Velocity Clinical Research-Baton Rouge
Baton Rouge, Louisiana, United States
Velocity Clinical Research - Covington
Covington, Louisiana, United States
Avacare
Kenner, Louisiana, United States
Velocity Clinical Research, Lafayette
Lafayette, Louisiana, United States
DelRicht Research
Mandeville, Louisiana, United States
DelRicht Research
New Orleans, Louisiana, United States
Velocity Clinical Research, New Orleans
New Orleans, Louisiana, United States
DelRicht Research
Prairieville, Louisiana, United States
Annapolis Internal Medicine
Annapolis, Maryland, United States
Centennial Medical Group
Columbia, Maryland, United States
Velocity Clinical Research, Rockville
Rockville, Maryland, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
DM Clinical Research - Brookline
Brookline, Massachusetts, United States
ActivMed Practices & Research, LLC
Methuen, Massachusetts, United States
Headlands Research Detroit
Southfield, Michigan, United States
DM Clinical Research - Southfield
Southfield, Michigan, United States
Javara Inc. and Mankato Clinic, Ltd.
Mankato, Minnesota, United States
Velocity Clinical Research Gulfport
Gulfport, Mississippi, United States
Clinical Research Professionals
Chesterfield, Missouri, United States
AMR Clinical
Kansas City, Missouri, United States
Clay-Platte Family Medicine Clinic
Kansas City, Missouri, United States
DelRicht Research
Springfield, Missouri, United States
Sundance Clinical Research, LLC
St Louis, Missouri, United States
DelRicht Research
Town and Country, Missouri, United States
Avacare Research/Methodist Physicians Clinic
Fremont, Nebraska, United States
Velocity Clinical Research, Grand Island
Grand Island, Nebraska, United States
Velocity Clinical Research
Lincoln, Nebraska, United States
Velocity Clinical Research Norfolk
Norfolk, Nebraska, United States
Velocity Clinical Research Omaha
Omaha, Nebraska, United States
Avacare/Midwest Regional Health Services
Omaha, Nebraska, United States
Papillion Research/Avacare
Papillion, Nebraska, United States
Santa Rosa Medical Centers of Nevada
Las Vegas, Nevada, United States
DM Clinical Research - Jersey City
Jersey City, New Jersey, United States
DM Clinical Research - Albuquerque
Albuquerque, New Mexico, United States
Velocity Clinical Research - Albuquerque
Albuquerque, New Mexico, United States
Rochester Clinical Research
Rochester, New York, United States
Velocity Clinical Research, Durham
Durham, North Carolina, United States
Eximia Research - NC, LLC
Raleigh, North Carolina, United States
TMA Headlands LLC d/b/a Trial Management Associates
Wilmington, North Carolina, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Velocity Clinical Research - Cleveland
Beachwood, Ohio, United States