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)

NCT ID: NCT07266558

Last Updated: 2026-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

30000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-26

Study Completion Date

2027-06-16

Brief Summary

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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.

Detailed Description

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Conditions

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SARS-CoV-2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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mRNA-1273 (Variant Formulation)

Participants will receive a single intramuscular (IM) injection of mRNA-1273 on Day 1.

Group Type EXPERIMENTAL

mRNA-1273

Intervention Type BIOLOGICAL

Sterile liquid for injection

mRNA-1283 (Variant Formulation)

Participants will receive a single IM injection of mRNA-1283 on Day 1.

Group Type EXPERIMENTAL

mRNA-1283

Intervention Type BIOLOGICAL

Sterile liquid for injection

Placebo

Participants will receive a single IM injection of placebo on Day 1.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

0.9% sodium chloride (normal saline) injection

Interventions

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mRNA-1273

Sterile liquid for injection

Intervention Type BIOLOGICAL

mRNA-1283

Sterile liquid for injection

Intervention Type BIOLOGICAL

Placebo

0.9% sodium chloride (normal saline) injection

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Healthy and without underlying medical conditions that may put them at higher risk of experiencing severe outcomes of COVID-19, as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.

Exclusion Criteria

* History of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 3 months prior to enrollment.
* Acutely ill or febrile within 72 hours prior to or at the Screening Visit or Day 1.
* Receipt of any of the following:

* COVID-19 vaccine within 3 months prior to enrollment,
* Any licensed non COVID-19 vaccine within 28 days before or planned receipt within 28 days after the study intervention, except an influenza vaccine, which may be given 14 days before or after receipt of the study intervention,
* Corticosteroids at ≥10 milligrams (mg)/day of prednisone or equivalent for \>14 days in total within 90 days prior to Day 1 or is anticipating the need for corticosteroids at any time during the study or,
* Systemic immunosuppressive treatment within 180 days prior to the Screening or is anticipating the need for systemic immunosuppressive treatment at any time during participation in the study.
* Has donated ≥450 mL of blood products within 28 days prior to the Screening Visit or plans to donate blood products within 28 days post study injection.
* Has participated in an investigational clinical study within 28 days prior to the Screening Visit based on the medical history interview or plans to do so while participating in this study.
Minimum Eligible Age

50 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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ModernaTX, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Accel Clinical Research

Birmingham, Alabama, United States

Site Status RECRUITING

Cullman Clinical Trials

Cullman, Alabama, United States

Site Status RECRUITING

AMR Clinical Mobile

Mobile, Alabama, United States

Site Status RECRUITING

Velocity Clinical Research, Mobile

Mobile, Alabama, United States

Site Status RECRUITING

Lenzmeier Family Medicine - Avacare

Glendale, Arizona, United States

Site Status RECRUITING

Desert Clinical Research

Mesa, Arizona, United States

Site Status RECRUITING

Velocity Clinical Research - Phoenix

Phoenix, Arizona, United States

Site Status RECRUITING

Foothills Research Center/Avacare

Phoenix, Arizona, United States

Site Status RECRUITING

Headlands Research Scottsdale

Scottsdale, Arizona, United States

Site Status RECRUITING

Fiel Family and Sports Medicine / Avacare

Tempe, Arizona, United States

Site Status RECRUITING

Avacare

Colton, California, United States

Site Status RECRUITING

CenExel CNR

Garden Grove, California, United States

Site Status RECRUITING

Velocity Clinical Research, Huntington Park

Huntington Park, California, United States

Site Status RECRUITING

Velocity Clinical Research - San Diego - ERN - PPDS-Site Number:8400010

La Mesa, California, United States

Site Status RECRUITING

Velocity Clinical Research - Los Angeles

Los Angeles, California, United States

Site Status RECRUITING

Artemis Institute for Clinical Research

Riverside, California, United States

Site Status RECRUITING

Peninsula Research Associates

Rolling Hills Estates, California, United States

Site Status RECRUITING

Velocity Clinical Research -- Banning

San Bernardino, California, United States

Site Status RECRUITING

Artemis Institute for Clinical Research

San Diego, California, United States

Site Status RECRUITING

Tekton Research, LLC

Denver, Colorado, United States

Site Status RECRUITING

Tekton Research, LLC

Fort Collins, Colorado, United States

Site Status RECRUITING

Critical Care, Pulmonary and Sleep Associates, P.LLP/Avacare

Lakewood, Colorado, United States

Site Status RECRUITING

Tekton Research, LLC

Longmont, Colorado, United States

Site Status RECRUITING

New England Research Associates

Bridgeport, Connecticut, United States

Site Status RECRUITING

Stamford Therapeutics Consortium

Stamford, Connecticut, United States

Site Status RECRUITING

Velocity Clinical Research-Washington, DC

Washington D.C., District of Columbia, United States

Site Status RECRUITING

Hillcrest Medical Research, LLC

DeLand, Florida, United States

Site Status RECRUITING

University Clinical Research-Deland, LLC d/b/a Accel Research Sites - Deland Clinical Research Unit

DeLand, Florida, United States

Site Status RECRUITING

Suncoast Research Associates, LLC

Doral, Florida, United States

Site Status RECRUITING

Velocity Clinical Research, Hallandale Beach

Hallandale, Florida, United States

Site Status RECRUITING

Indago Research & Health Center, Inc

Hialeah, Florida, United States

Site Status RECRUITING

CenExel Research Centers of America

Hollywood, Florida, United States

Site Status RECRUITING

NextPhase Research Florida

Hollywood, Florida, United States

Site Status RECRUITING

Health Awareness Inc.

Jupiter, Florida, United States

Site Status RECRUITING

Sandhill Research, LLC d/b/a Accel Research Sites - Lakeland Clinical Research Unit

Lakeland, Florida, United States

Site Status RECRUITING

Sandhill Research, LLC d/b/a Accel Research Sites- St. Pete-Largo Clinical Research Unit

Largo, Florida, United States

Site Status RECRUITING

Accel Research Sites

Maitland, Florida, United States

Site Status RECRUITING

Global Health Research Center, Inc.

Miami Lakes, Florida, United States

Site Status RECRUITING

Suncoast Clinical Research

New Port Richey, Florida, United States

Site Status RECRUITING

Headlands Research Orlando

Orlando, Florida, United States

Site Status RECRUITING

Innovation Medical Research Center

Palmetto Bay, Florida, United States

Site Status RECRUITING

ForCare Clinical Research

Tampa, Florida, United States

Site Status RECRUITING

Global Health Research Center, Inc.

Tampa, Florida, United States

Site Status RECRUITING

Javara Inc. and PRIVIA Medical Group of Georgia, LLC

Albany, Georgia, United States

Site Status RECRUITING

DelRicht Research

Atlanta, Georgia, United States

Site Status RECRUITING

Atlanta Center for Medical Research

Atlanta, Georgia, United States

Site Status RECRUITING

Accel Research Sites - Neurostudies

Decatur, Georgia, United States

Site Status RECRUITING

CenExel iResearch, LLC

Decatur, Georgia, United States

Site Status RECRUITING

Javara Inc. and Privia Medical Group of Georgia, LLC

Fayetteville, Georgia, United States

Site Status RECRUITING

Velocity Clinical Research Savannah

Savannah, Georgia, United States

Site Status RECRUITING

Clinical Research Atlanta

Stockbridge, Georgia, United States

Site Status RECRUITING

Velocity Clinical Research - Boise - ERN - PPDS

Meridian, Idaho, United States

Site Status RECRUITING

DM Clinical Research - Melrose Park

Melrose Park, Illinois, United States

Site Status RECRUITING

Velocity Clinical Research Valparaiso

Valparaiso, Indiana, United States

Site Status RECRUITING

Velocity Clinical Research - Sioux City

Sioux City, Iowa, United States

Site Status RECRUITING

Johnson County Clin-Trials

Lenexa, Kansas, United States

Site Status RECRUITING

Tekton Research, LLC

Wichita, Kansas, United States

Site Status RECRUITING

DelRicht Research

Louisville, Kentucky, United States

Site Status RECRUITING

Versailles Family Medicine - CCT Research

Versailles, Kentucky, United States

Site Status RECRUITING

Velocity Clinical Research-Baton Rouge

Baton Rouge, Louisiana, United States

Site Status RECRUITING

Velocity Clinical Research - Covington

Covington, Louisiana, United States

Site Status RECRUITING

Avacare

Kenner, Louisiana, United States

Site Status RECRUITING

Velocity Clinical Research, Lafayette

Lafayette, Louisiana, United States

Site Status RECRUITING

DelRicht Research

Mandeville, Louisiana, United States

Site Status RECRUITING

DelRicht Research

New Orleans, Louisiana, United States

Site Status RECRUITING

Velocity Clinical Research, New Orleans

New Orleans, Louisiana, United States

Site Status RECRUITING

DelRicht Research

Prairieville, Louisiana, United States

Site Status RECRUITING

Annapolis Internal Medicine

Annapolis, Maryland, United States

Site Status RECRUITING

Centennial Medical Group

Columbia, Maryland, United States

Site Status RECRUITING

Velocity Clinical Research, Rockville

Rockville, Maryland, United States

Site Status RECRUITING

Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status NOT_YET_RECRUITING

DM Clinical Research - Brookline

Brookline, Massachusetts, United States

Site Status ACTIVE_NOT_RECRUITING

ActivMed Practices & Research, LLC

Methuen, Massachusetts, United States

Site Status RECRUITING

Headlands Research Detroit

Southfield, Michigan, United States

Site Status RECRUITING

DM Clinical Research - Southfield

Southfield, Michigan, United States

Site Status RECRUITING

Javara Inc. and Mankato Clinic, Ltd.

Mankato, Minnesota, United States

Site Status RECRUITING

Velocity Clinical Research Gulfport

Gulfport, Mississippi, United States

Site Status RECRUITING

Clinical Research Professionals

Chesterfield, Missouri, United States

Site Status RECRUITING

AMR Clinical

Kansas City, Missouri, United States

Site Status RECRUITING

Clay-Platte Family Medicine Clinic

Kansas City, Missouri, United States

Site Status RECRUITING

DelRicht Research

Springfield, Missouri, United States

Site Status RECRUITING

Sundance Clinical Research, LLC

St Louis, Missouri, United States

Site Status RECRUITING

DelRicht Research

Town and Country, Missouri, United States

Site Status RECRUITING

Avacare Research/Methodist Physicians Clinic

Fremont, Nebraska, United States

Site Status RECRUITING

Velocity Clinical Research, Grand Island

Grand Island, Nebraska, United States

Site Status RECRUITING

Velocity Clinical Research

Lincoln, Nebraska, United States

Site Status RECRUITING

Velocity Clinical Research Norfolk

Norfolk, Nebraska, United States

Site Status RECRUITING

Velocity Clinical Research Omaha

Omaha, Nebraska, United States

Site Status RECRUITING

Avacare/Midwest Regional Health Services

Omaha, Nebraska, United States

Site Status RECRUITING

Papillion Research/Avacare

Papillion, Nebraska, United States

Site Status RECRUITING

Santa Rosa Medical Centers of Nevada

Las Vegas, Nevada, United States

Site Status RECRUITING

DM Clinical Research - Jersey City

Jersey City, New Jersey, United States

Site Status RECRUITING

DM Clinical Research - Albuquerque

Albuquerque, New Mexico, United States

Site Status RECRUITING

Velocity Clinical Research - Albuquerque

Albuquerque, New Mexico, United States

Site Status RECRUITING

Rochester Clinical Research

Rochester, New York, United States

Site Status RECRUITING

Velocity Clinical Research, Durham

Durham, North Carolina, United States

Site Status RECRUITING

Eximia Research - NC, LLC

Raleigh, North Carolina, United States

Site Status RECRUITING

TMA Headlands LLC d/b/a Trial Management Associates

Wilmington, North Carolina, United States

Site Status RECRUITING

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Site Status RECRUITING

Velocity Clinical Research - Cleveland

Beachwood, Ohio, United States

Site Status RECRUITING

CTI Clinical Research Center

Cincinnati, Ohio, United States

Site Status RECRUITING

Velocity Clinical Research-Mt. Auburn

Cincinnati, Ohio, United States

Site Status RECRUITING

Velocity Clinical Research Springdale

Cincinnati, Ohio, United States

Site Status RECRUITING

Tekton Research, LLC

Edmond, Oklahoma, United States

Site Status RECRUITING

Tekton Research, LLC

Moore, Oklahoma, United States

Site Status RECRUITING

DelRicht Research

Tulsa, Oklahoma, United States

Site Status RECRUITING

Tekton Research, LLC

Yukon, Oklahoma, United States

Site Status RECRUITING

Velocity Clinical Research - Medford

Medford, Oregon, United States

Site Status RECRUITING

Summit Headlands LLC

Portland, Oregon, United States

Site Status RECRUITING

Hatboro Medical Associates/Avacare

Horsham, Pennsylvania, United States

Site Status RECRUITING

DM Clinical Research - Philadelphia

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Velocity Clinical Research - East Greenwich

East Greenwich, Rhode Island, United States

Site Status RECRUITING

Velocity Clinical Research, Anderson

Anderson, South Carolina, United States

Site Status RECRUITING

DelRicht Research

Charleston, South Carolina, United States

Site Status RECRUITING

Velocity Clinical Research - Columbia

Columbia, South Carolina, United States

Site Status RECRUITING

Coastal Carolina Research Center, LLC

North Charleston, South Carolina, United States

Site Status RECRUITING

Velocity Clinical Research Spartanburg

Spartanburg, South Carolina, United States

Site Status RECRUITING

Velocity Clinical Research Union

Union, South Carolina, United States

Site Status RECRUITING

DelRicht Research

Hendersonville, Tennessee, United States

Site Status RECRUITING

Velocity Clinical Research, Abilene

Abilene, Texas, United States

Site Status RECRUITING

Tekton Research, LLC

Austin, Texas, United States

Site Status RECRUITING

Velocity Clinical Research - Austin

Austin, Texas, United States

Site Status RECRUITING

Tekton Research, LLC

Beaumont, Texas, United States

Site Status RECRUITING

Javara Inc. and Privia Medical Group Gulf Coast, PLLC

Conroe, Texas, United States

Site Status RECRUITING

Velocity Clinical Research - Dallas

Dallas, Texas, United States

Site Status RECRUITING

Avacare

Fort Worth, Texas, United States

Site Status RECRUITING

DM Clinical Research - Houston

Houston, Texas, United States

Site Status RECRUITING

DM Clinical Research - Houston

Houston, Texas, United States

Site Status RECRUITING

DelRicht Research

Prosper, Texas, United States

Site Status RECRUITING

Be Well Clinical Studies

Round Rock, Texas, United States

Site Status RECRUITING

DM Clinical Research - San Antonio

San Antonio, Texas, United States

Site Status RECRUITING

Tekton Research, LLC

San Antonio, Texas, United States

Site Status RECRUITING

Javara Inc. and Privia Medical Group Gulf Coast, PLLC

San Marcos, Texas, United States

Site Status RECRUITING

Javara Inc. and Privia Medical Group - North Texas

Stephenville, Texas, United States

Site Status RECRUITING

DM Clinical Research - Sugar Land

Sugar Land, Texas, United States

Site Status RECRUITING

Javara Inc. and Privia Medical Group Gulf Coast, PLLC

Sugar Land, Texas, United States

Site Status RECRUITING

Olympus Clinical Research

Sugar Land, Texas, United States

Site Status RECRUITING

DM Clinical Research - Tomball

Tomball, Texas, United States

Site Status RECRUITING

Cope Family Medicine / Avacare

Bountiful, Utah, United States

Site Status RECRUITING

Mountain View/Avacare

Pleasant View, Utah, United States

Site Status RECRUITING

JBR Clinical Research

Salt Lake City, Utah, United States

Site Status RECRUITING

Olympus Family Medicine/Avacare

Salt Lake City, Utah, United States

Site Status RECRUITING

J. Lewis Research, Inc/Jordan River Family Medicine

South Jordan, Utah, United States

Site Status RECRUITING

South Ogden Family Medicine/ Avacare

South Ogden, Utah, United States

Site Status RECRUITING

Velocity Clinical Research - Salt Lake City (West Jordan)

West Jordan, Utah, United States

Site Status RECRUITING

Charlottesville Medical Research, LLC

Charlottesville, Virginia, United States

Site Status RECRUITING

Velocity Clinical Research-Hampton

Hampton, Virginia, United States

Site Status RECRUITING

Clinical Research Partners, LLC

Richmond, Virginia, United States

Site Status RECRUITING

Velocity Clinical Research - Suffolk

Suffolk, Virginia, United States

Site Status RECRUITING

Velocity Clinical Research, Spokane

Spokane, Washington, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Moderna WeCare Team

Role: CONTACT

+1-866-663-3762

Other Identifiers

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mRNA-1273_1283-P401

Identifier Type: -

Identifier Source: org_study_id

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