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RECRUITING
NCT07266558
PHASE4

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.

View on ClinicalTrials.gov

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

2026-03-12

Healthy Volunteers

Yes

Conditions

Interventions

BIOLOGICAL

mRNA-1273

Sterile liquid for injection

BIOLOGICAL

mRNA-1283

Sterile liquid for injection

BIOLOGICAL

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

CTI Clinical Research Center

Cincinnati, Ohio, United States

Velocity Clinical Research-Mt. Auburn

Cincinnati, Ohio, United States

Velocity Clinical Research Springdale

Cincinnati, Ohio, United States

Tekton Research, LLC

Edmond, Oklahoma, United States

Tekton Research, LLC

Moore, Oklahoma, United States

DelRicht Research

Tulsa, Oklahoma, United States

Tekton Research, LLC

Yukon, Oklahoma, United States

Velocity Clinical Research - Medford

Medford, Oregon, United States

Summit Headlands LLC

Portland, Oregon, United States

Hatboro Medical Associates/Avacare

Horsham, Pennsylvania, United States

DM Clinical Research - Philadelphia

Philadelphia, Pennsylvania, United States

Velocity Clinical Research - East Greenwich

East Greenwich, Rhode Island, United States

Velocity Clinical Research, Anderson

Anderson, South Carolina, United States

DelRicht Research

Charleston, South Carolina, United States

Velocity Clinical Research - Columbia

Columbia, South Carolina, United States

Coastal Carolina Research Center, LLC

North Charleston, South Carolina, United States

Velocity Clinical Research Spartanburg

Spartanburg, South Carolina, United States

Velocity Clinical Research Union

Union, South Carolina, United States

DelRicht Research

Hendersonville, Tennessee, United States

Velocity Clinical Research, Abilene

Abilene, Texas, United States

Tekton Research, LLC

Austin, Texas, United States

Velocity Clinical Research - Austin

Austin, Texas, United States

Tekton Research, LLC

Beaumont, Texas, United States

Javara Inc. and Privia Medical Group Gulf Coast, PLLC

Conroe, Texas, United States

Velocity Clinical Research - Dallas

Dallas, Texas, United States

Avacare

Fort Worth, Texas, United States

DM Clinical Research - Houston

Houston, Texas, United States

DM Clinical Research - Houston

Houston, Texas, United States

DelRicht Research

Prosper, Texas, United States

Be Well Clinical Studies

Round Rock, Texas, United States

DM Clinical Research - San Antonio

San Antonio, Texas, United States

Tekton Research, LLC

San Antonio, Texas, United States

Javara Inc. and Privia Medical Group Gulf Coast, PLLC

San Marcos, Texas, United States

Javara Inc. and Privia Medical Group - North Texas

Stephenville, Texas, United States

DM Clinical Research - Sugar Land

Sugar Land, Texas, United States

Javara Inc. and Privia Medical Group Gulf Coast, PLLC

Sugar Land, Texas, United States

Olympus Clinical Research

Sugar Land, Texas, United States

DM Clinical Research - Tomball

Tomball, Texas, United States

Cope Family Medicine / Avacare

Bountiful, Utah, United States

Mountain View/Avacare

Pleasant View, Utah, United States

JBR Clinical Research

Salt Lake City, Utah, United States

Olympus Family Medicine/Avacare

Salt Lake City, Utah, United States

J. Lewis Research, Inc/Jordan River Family Medicine

South Jordan, Utah, United States

South Ogden Family Medicine/ Avacare

South Ogden, Utah, United States

Velocity Clinical Research - Salt Lake City (West Jordan)

West Jordan, Utah, United States

Charlottesville Medical Research, LLC

Charlottesville, Virginia, United States

Velocity Clinical Research-Hampton

Hampton, Virginia, United States

Clinical Research Partners, LLC

Richmond, Virginia, United States

Velocity Clinical Research - Suffolk

Suffolk, Virginia, United States

Velocity Clinical Research, Spokane

Spokane, Washington, United States