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SARS-CoV-2Phase 4NCT07266558

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)

A Phase 4 study testing mRNA-1273 and mRNA-1283 in people with SARS-CoV-2, run by ModernaTX, Inc. at 150 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 to 64 yearsHealthy volunteers can take part
Conditions the study is for
SARS-CoV-2
What is being tested?
mRNA-1273 and mRNA-1283
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30,000 participants
Where
150 sitesUnited States
Study dates
26 Nov 2025to 16 Jun 2027
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 64 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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,
Show all 10Show fewer
  • 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.
  • Note: Additional inclusion/exclusion criteria may apply, per protocol.

Trial locations and contacts

150 sites in 1 country.

150 sites in 1 country

United States150 sites

  • Velocity Clinical Research, Abilene

    Abilene, Texas, 79606

  • Javara Inc. and PRIVIA Medical Group of Georgia, LLC

    Albany, Georgia, 31707

  • DM Clinical Research - Albuquerque

    Albuquerque, New Mexico, 87106

  • Velocity Clinical Research - Albuquerque

    Albuquerque, New Mexico, 87107

  • Velocity Clinical Research, Anderson

    Anderson, South Carolina, 29621

  • Annapolis Internal Medicine

    Annapolis, Maryland, 21401

  • DelRicht Research

    Atlanta, Georgia, 30329

  • Atlanta Center for Medical Research

    Atlanta, Georgia, 30331

  • Tekton Research, LLC

    Austin, Texas, 78745

  • Velocity Clinical Research - Austin

    Austin, Texas, 78759

  • Velocity Clinical Research-Baton Rouge

    Baton Rouge, Louisiana, 70809

  • Velocity Clinical Research - Cleveland

    Beachwood, Ohio, 44122

  • Tekton Research, LLC

    Beaumont, Texas, 77706

  • Accel Clinical Research

    Birmingham, Alabama, 35216

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Cope Family Medicine / Avacare

    Bountiful, Utah, 84010

  • New England Research Associates

    Bridgeport, Connecticut, 06606

  • DM Clinical Research - Brookline

    Brookline, Massachusetts, 02446

  • DelRicht Research

    Charleston, South Carolina, 29407

  • Charlottesville Medical Research, LLC

    Charlottesville, Virginia, 22911

  • Clinical Research Professionals

    Chesterfield, Missouri, 63005

  • CTI Clinical Research Center

    Cincinnati, Ohio, 45212

  • Velocity Clinical Research-Mt. Auburn

    Cincinnati, Ohio, 45242

  • Velocity Clinical Research Springdale

    Cincinnati, Ohio, 45246

  • Avacare

    Colton, California, 92324

  • Centennial Medical Group

    Columbia, Maryland, 21045

  • Velocity Clinical Research - Columbia

    Columbia, South Carolina, 29204

  • Javara Inc. and Privia Medical Group Gulf Coast, PLLC

    Conroe, Texas, 77384

  • Velocity Clinical Research - Covington

    Covington, Louisiana, 70433

  • Cullman Clinical Trials

    Cullman, Alabama, 35055

  • Velocity Clinical Research - Dallas

    Dallas, Texas, 75230

  • Accel Research Sites - Neurostudies

    Decatur, Georgia, 30030

  • CenExel iResearch, LLC

    Decatur, Georgia, 30030

  • Hillcrest Medical Research, LLC

    DeLand, Florida, 32720

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

    DeLand, Florida, 32720

  • Tekton Research, LLC

    Denver, Colorado, 80238

  • Suncoast Research Associates, LLC

    Doral, Florida, 33172

  • Velocity Clinical Research, Durham

    Durham, North Carolina, 27701

  • Velocity Clinical Research - East Greenwich

    East Greenwich, Rhode Island, 02818

  • Tekton Research, LLC

    Edmond, Oklahoma, 73013

  • Javara Inc. and Privia Medical Group of Georgia, LLC

    Fayetteville, Georgia, 30214

  • Tekton Research, LLC

    Fort Collins, Colorado, 80525

  • Avacare

    Fort Worth, Texas, 76135

  • Avacare Research/Methodist Physicians Clinic

    Fremont, Nebraska, 68025

  • CenExel CNR

    Garden Grove, California, 92845

  • Lenzmeier Family Medicine - Avacare

    Glendale, Arizona, 85308

  • Velocity Clinical Research, Grand Island

    Grand Island, Nebraska, 68803

  • Velocity Clinical Research Gulfport

    Gulfport, Mississippi, 39503

  • Velocity Clinical Research, Hallandale Beach

    Hallandale, Florida, 33009

  • Velocity Clinical Research-Hampton

    Hampton, Virginia, 23666

  • DelRicht Research

    Hendersonville, Tennessee, 37075

  • Indago Research & Health Center, Inc

    Hialeah, Florida, 33012

  • CenExel Research Centers of America

    Hollywood, Florida, 33024

  • NextPhase Research Florida

    Hollywood, Florida, 33024

  • Hatboro Medical Associates/Avacare

    Horsham, Pennsylvania, 19044

  • DM Clinical Research - Houston

    Houston, Texas, 77065

  • DM Clinical Research - Houston

    Houston, Texas, 77081

  • Velocity Clinical Research, Huntington Park

    Huntington Park, California, 90255

  • DM Clinical Research - Jersey City

    Jersey City, New Jersey, 07306

  • Health Awareness Inc.

    Jupiter, Florida, 33458

  • AMR Clinical

    Kansas City, Missouri, 64116

  • Clay-Platte Family Medicine Clinic

    Kansas City, Missouri, 64151

  • Avacare

    Kenner, Louisiana, 70065

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

    La Mesa, California, 91942

  • Velocity Clinical Research, Lafayette

    Lafayette, Louisiana, 70508

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

    Lakeland, Florida, 33803

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

    Lakewood, Colorado, 80228

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

    Largo, Florida, 33777

  • Santa Rosa Medical Centers of Nevada

    Las Vegas, Nevada, 89119

  • Johnson County Clin-Trials

    Lenexa, Kansas, 66212

  • Velocity Clinical Research

    Lincoln, Nebraska, 68510

  • Tekton Research, LLC

    Longmont, Colorado, 80501

  • Velocity Clinical Research - Los Angeles

    Los Angeles, California, 90017

  • DelRicht Research

    Louisville, Kentucky, 40205

  • Accel Research Sites

    Maitland, Florida, 32751

  • DelRicht Research

    Mandeville, Louisiana, 70471

  • Javara Inc. and Mankato Clinic, Ltd.

    Mankato, Minnesota, 56001

  • Velocity Clinical Research - Medford

    Medford, Oregon, 97504

  • DM Clinical Research - Melrose Park

    Melrose Park, Illinois, 60160

  • Velocity Clinical Research - Boise - ERN - PPDS

    Meridian, Idaho, 83642

  • Desert Clinical Research

    Mesa, Arizona, 85213

  • ActivMed Practices & Research, LLC

    Methuen, Massachusetts, 01844

  • Global Health Research Center, Inc.

    Miami Lakes, Florida, 33016

  • AMR Clinical Mobile

    Mobile, Alabama, 36608

  • Velocity Clinical Research, Mobile

    Mobile, Alabama, 36608

  • Tekton Research, LLC

    Moore, Oklahoma, 73160

  • DelRicht Research

    New Orleans, Louisiana, 70115

  • Velocity Clinical Research, New Orleans

    New Orleans, Louisiana, 70119

  • Suncoast Clinical Research

    New Port Richey, Florida, 34652

  • Velocity Clinical Research Norfolk

    Norfolk, Nebraska, 68701

  • Coastal Carolina Research Center, LLC

    North Charleston, South Carolina, 29405

  • Velocity Clinical Research Omaha

    Omaha, Nebraska, 68134

  • Avacare/Midwest Regional Health Services

    Omaha, Nebraska, 68144

  • Headlands Research Orlando

    Orlando, Florida, 32819

  • Innovation Medical Research Center

    Palmetto Bay, Florida, 33157

  • Papillion Research/Avacare

    Papillion, Nebraska, 68046

  • DM Clinical Research - Philadelphia

    Philadelphia, Pennsylvania, 19107

  • Velocity Clinical Research - Phoenix

    Phoenix, Arizona, 85006

  • Foothills Research Center/Avacare

    Phoenix, Arizona, 85044

  • Mountain View/Avacare

    Pleasant View, Utah, 84404

  • Summit Headlands LLC

    Portland, Oregon, 97210

  • DelRicht Research

    Prairieville, Louisiana, 70769

  • DelRicht Research

    Prosper, Texas, 75078

  • Eximia Research - NC, LLC

    Raleigh, North Carolina, 27607

  • Clinical Research Partners, LLC

    Richmond, Virginia, 23226

  • Artemis Institute for Clinical Research

    Riverside, California, 92503

  • Rochester Clinical Research

    Rochester, New York, 14609

  • Velocity Clinical Research, Rockville

    Rockville, Maryland, 20854

  • Peninsula Research Associates

    Rolling Hills Estates, California, 90274

  • Be Well Clinical Studies

    Round Rock, Texas, 78681

  • JBR Clinical Research

    Salt Lake City, Utah, 84107

  • Olympus Family Medicine/Avacare

    Salt Lake City, Utah, 84117

  • DM Clinical Research - San Antonio

    San Antonio, Texas, 78207

  • Tekton Research, LLC

    San Antonio, Texas, 78229

  • Velocity Clinical Research -- Banning

    San Bernardino, California, 92408

  • Artemis Institute for Clinical Research

    San Diego, California, 92103

  • Javara Inc. and Privia Medical Group Gulf Coast, PLLC

    San Marcos, Texas, 78666

  • Velocity Clinical Research Savannah

    Savannah, Georgia, 31406

  • Headlands Research Scottsdale

    Scottsdale, Arizona, 85260

  • Velocity Clinical Research - Sioux City

    Sioux City, Iowa, 51106

  • J. Lewis Research, Inc/Jordan River Family Medicine

    South Jordan, Utah, 84095

  • South Ogden Family Medicine/ Avacare

    South Ogden, Utah, 84405

  • Headlands Research Detroit

    Southfield, Michigan, 48034

  • DM Clinical Research - Southfield

    Southfield, Michigan, 48076

  • Velocity Clinical Research Spartanburg

    Spartanburg, South Carolina, 29303

  • Velocity Clinical Research, Spokane

    Spokane, Washington, 99218

  • DelRicht Research

    Springfield, Missouri, 65807

  • Sundance Clinical Research, LLC

    St Louis, Missouri, 63141

  • Stamford Therapeutics Consortium

    Stamford, Connecticut, 06905

  • Javara Inc. and Privia Medical Group - North Texas

    Stephenville, Texas, 76401

  • Clinical Research Atlanta

    Stockbridge, Georgia, 30281

  • Velocity Clinical Research - Suffolk

    Suffolk, Virginia, 23435

  • DM Clinical Research - Sugar Land

    Sugar Land, Texas, 77478

  • Javara Inc. and Privia Medical Group Gulf Coast, PLLC

    Sugar Land, Texas, 77478

  • Olympus Clinical Research

    Sugar Land, Texas, 77479

  • ForCare Clinical Research

    Tampa, Florida, 33613

  • Global Health Research Center, Inc.

    Tampa, Florida, 33615

  • Fiel Family and Sports Medicine / Avacare

    Tempe, Arizona, 85283

  • DM Clinical Research - Tomball

    Tomball, Texas, 77375

  • DelRicht Research

    Town and Country, Missouri, 63017

  • DelRicht Research

    Tulsa, Oklahoma, 74133

  • Velocity Clinical Research Union

    Union, South Carolina, 29379

  • Velocity Clinical Research Valparaiso

    Valparaiso, Indiana, 46383

  • Versailles Family Medicine - CCT Research

    Versailles, Kentucky, 40383

  • Velocity Clinical Research-Washington, DC

    Washington D.C., District of Columbia, 20016

  • Velocity Clinical Research - Salt Lake City (West Jordan)

    West Jordan, Utah, 84088

  • Tekton Research, LLC

    Wichita, Kansas, 67218

  • TMA Headlands LLC d/b/a Trial Management Associates

    Wilmington, North Carolina, 28403

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

  • Tekton Research, LLC

    Yukon, Oklahoma, 73099

Other trials in United States

About this study

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

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.

Conditions
SARS-CoV-2
Being tested
mRNA-1273, mRNA-1283, Placebo
Keywords
mRNA-1273, mRNA-1283, SARS-CoV-2, mRNA vaccine, Coronavirus, Messenger RNA, COVID-19, COVID-19 Vaccine, Moderna
Medical subject headings
Coronavirus Infections, COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • mRNA-1273Biological

    Sterile liquid for injection

  • mRNA-1283Biological

    Sterile liquid for injection

  • PlaceboBiological

    0.9% sodium chloride (normal saline) injection

Study groups in NCT07266558
Study groupRoleWhat they receive
mRNA-1273 (Variant Formulation)ExperimentalParticipants will receive a single intramuscular (IM) injection of mRNA-1273 on Day 1.
Receives: Biological: mRNA-1273
mRNA-1283 (Variant Formulation)ExperimentalParticipants will receive a single IM injection of mRNA-1283 on Day 1.
Receives: Biological: mRNA-1283
PlaceboPlacebo comparatorParticipants will receive a single IM injection of placebo on Day 1.
Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. VE of mRNA-1273 (Variant Formulation) to Prevent the First Event of COVID-19 after Study Injection

    The VE is defined as the percent reduction in the hazard of the first event of COVID-19 after study injection (each vaccine arm versus placebo) and will be estimated using 1-hazard ratio (HR).

    Measured: Day 1 through Day 181

  2. Vaccine Efficacy (VE) of mRNA-1283 (Variant Formulation) to Prevent the First Event of COVID-19 after Study Injection

    The VE is defined as the percent reduction in the hazard of the first event of COVID-19 after study injection (each vaccine arm versus placebo) and will be estimated using 1-hazard ratio (HR).

    Measured: Day 1 through Day 181

  3. Number of Participants with Unsolicited Adverse Events (AEs)

    Measured: Day 1 through Day 28

  4. Number of Participants with Serious AEs (SAEs), Medically Attended AEs (MAAEs), AEs of Special Interest (AESIs), and AEs Leading to Discontinuation

    Measured: Day 1 through Day 181

Secondary outcomes (1)

  1. Number of Participants with a First Event of Severe COVID-19 after Study Injection

    Measured: Day 1 through Day 181

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Dec 2025
  2. Study start26 Nov 2025
  3. Primary completion16 Jun 2027 (estimated)
  4. Study completion16 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
30,000 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07266558
Sponsor's protocol ID
mRNA-1273_1283-P401
Status last verified
Sep 2026
First submitted
25 Nov 2025
Last updated
28 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing mRNA-1273 and mRNA-1283 in people with SARS-CoV-2, run by ModernaTX, Inc. at 150 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 150 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

VE of mRNA-1273 (Variant Formulation) to Prevent the First Event of COVID-19 after Study Injection (time frame: Day 1 through Day 181). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07266558.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.

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