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, 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
1 other identifier
interventional
30,000
1 country
150
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Nov 2025
150 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 25, 2025
CompletedStudy Start
First participant enrolled
November 26, 2025
CompletedFirst Posted
Study publicly available on registry
December 5, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 16, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 16, 2027
April 28, 2026
April 1, 2026
1.6 years
November 25, 2025
April 24, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
VE of mRNA-1273 (Variant Formulation) to Prevent the First Event of Symptomatic COVID-19 after Study Injection
The VE is defined as the percent reduction in the hazard of the first event of symptomatic COVID-19 after study injection (each vaccine arm versus placebo) and will be estimated using 1-hazard ratio (HR).
Day 1 through Day 181
Vaccine Efficacy (VE) of mRNA-1283 (Variant Formulation) to Prevent the First Event of Symptomatic COVID-19 after Study Injection
The VE is defined as the percent reduction in the hazard of the first event of symptomatic COVID-19 after study injection (each vaccine arm versus placebo) and will be estimated using 1-hazard ratio (HR).
Day 1 through Day 181
Number of Participants with Unsolicited Adverse Events (AEs)
Day 1 through Day 28
Number of Participants with Serious AEs (SAEs), Medically Attended AEs (MAAEs), AEs of Special Interest (AESIs), and AEs Leading to Discontinuation
Day 1 through Day 181
Secondary Outcomes (1)
Number of Participants with a First Event of Severe COVID-19 after Study Injection
Day 1 through Day 181
Study Arms (3)
mRNA-1273 (Variant Formulation)
EXPERIMENTALParticipants will receive a single intramuscular (IM) injection of mRNA-1273 on Day 1.
mRNA-1283 (Variant Formulation)
EXPERIMENTALParticipants will receive a single IM injection of mRNA-1283 on Day 1.
Placebo
PLACEBO COMPARATORParticipants will receive a single IM injection of placebo on Day 1.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ModernaTX, Inc.lead
Study Sites (150)
Accel Clinical Research
Birmingham, Alabama, 35216, United States
Cullman Clinical Trials
Cullman, Alabama, 35055, United States
AMR Clinical Mobile
Mobile, Alabama, 36608, United States
Velocity Clinical Research, Mobile
Mobile, Alabama, 36608, United States
Lenzmeier Family Medicine - Avacare
Glendale, Arizona, 85308, United States
Desert Clinical Research
Mesa, Arizona, 85213, United States
Velocity Clinical Research - Phoenix
Phoenix, Arizona, 85006, United States
Foothills Research Center/Avacare
Phoenix, Arizona, 85044, United States
Headlands Research Scottsdale
Scottsdale, Arizona, 85260, United States
Fiel Family and Sports Medicine / Avacare
Tempe, Arizona, 85283, United States
Avacare
Colton, California, 92324, United States
CenExel CNR
Garden Grove, California, 92845, United States
Velocity Clinical Research, Huntington Park
Huntington Park, California, 90255, United States
Velocity Clinical Research - San Diego - ERN - PPDS-Site Number:8400010
La Mesa, California, 91942, United States
Velocity Clinical Research - Los Angeles
Los Angeles, California, 90017, United States
Artemis Institute for Clinical Research
Riverside, California, 92503, United States
Peninsula Research Associates
Rolling Hills Estates, California, 90274, United States
Velocity Clinical Research -- Banning
San Bernardino, California, 92408, United States
Artemis Institute for Clinical Research
San Diego, California, 92103, United States
Tekton Research, LLC
Denver, Colorado, 80238, United States
Tekton Research, LLC
Fort Collins, Colorado, 80525, United States
Critical Care, Pulmonary and Sleep Associates, P.LLP/Avacare
Lakewood, Colorado, 80228, United States
Tekton Research, LLC
Longmont, Colorado, 80501, United States
New England Research Associates
Bridgeport, Connecticut, 06606, United States
Stamford Therapeutics Consortium
Stamford, Connecticut, 06905, United States
Velocity Clinical Research-Washington, DC
Washington D.C., District of Columbia, 20016, United States
Hillcrest Medical Research, LLC
DeLand, Florida, 32720, United States
University Clinical Research-Deland, LLC d/b/a Accel Research Sites - Deland Clinical Research Unit
DeLand, Florida, 32720, United States
Suncoast Research Associates, LLC
Doral, Florida, 33172, United States
Velocity Clinical Research, Hallandale Beach
Hallandale, Florida, 33009, United States
Indago Research & Health Center, Inc
Hialeah, Florida, 33012, United States
CenExel Research Centers of America
Hollywood, Florida, 33024, United States
NextPhase Research Florida
Hollywood, Florida, 33024, United States
Health Awareness Inc.
Jupiter, Florida, 33458, United States
Sandhill Research, LLC d/b/a Accel Research Sites - Lakeland Clinical Research Unit
Lakeland, Florida, 33803, United States
Sandhill Research, LLC d/b/a Accel Research Sites- St. Pete-Largo Clinical Research Unit
Largo, Florida, 33777, United States
Accel Research Sites
Maitland, Florida, 32751, United States
Global Health Research Center, Inc.
Miami Lakes, Florida, 33016, United States
Suncoast Clinical Research
New Port Richey, Florida, 34652, United States
Headlands Research Orlando
Orlando, Florida, 32819, United States
Innovation Medical Research Center
Palmetto Bay, Florida, 33157, United States
ForCare Clinical Research
Tampa, Florida, 33613, United States
Global Health Research Center, Inc.
Tampa, Florida, 33615, United States
Javara Inc. and PRIVIA Medical Group of Georgia, LLC
Albany, Georgia, 31707, United States
DelRicht Research
Atlanta, Georgia, 30329, United States
Atlanta Center for Medical Research
Atlanta, Georgia, 30331, United States
Accel Research Sites - Neurostudies
Decatur, Georgia, 30030, United States
CenExel iResearch, LLC
Decatur, Georgia, 30030, United States
Javara Inc. and Privia Medical Group of Georgia, LLC
Fayetteville, Georgia, 30214, United States
Velocity Clinical Research Savannah
Savannah, Georgia, 31406, United States
Clinical Research Atlanta
Stockbridge, Georgia, 30281, United States
Velocity Clinical Research - Boise - ERN - PPDS
Meridian, Idaho, 83642, United States
DM Clinical Research - Melrose Park
Melrose Park, Illinois, 60160, United States
Velocity Clinical Research Valparaiso
Valparaiso, Indiana, 46383, United States
Velocity Clinical Research - Sioux City
Sioux City, Iowa, 51106, United States
Johnson County Clin-Trials
Lenexa, Kansas, 66212, United States
Tekton Research, LLC
Wichita, Kansas, 67218, United States
DelRicht Research
Louisville, Kentucky, 40205, United States
Versailles Family Medicine - CCT Research
Versailles, Kentucky, 40383, United States
Velocity Clinical Research-Baton Rouge
Baton Rouge, Louisiana, 70809, United States
Velocity Clinical Research - Covington
Covington, Louisiana, 70433, United States
Avacare
Kenner, Louisiana, 70065, United States
Velocity Clinical Research, Lafayette
Lafayette, Louisiana, 70508, United States
DelRicht Research
Mandeville, Louisiana, 70471, United States
DelRicht Research
New Orleans, Louisiana, 70115, United States
Velocity Clinical Research, New Orleans
New Orleans, Louisiana, 70119, United States
DelRicht Research
Prairieville, Louisiana, 70769, United States
Annapolis Internal Medicine
Annapolis, Maryland, 21401, United States
Centennial Medical Group
Columbia, Maryland, 21045, United States
Velocity Clinical Research, Rockville
Rockville, Maryland, 20854, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
DM Clinical Research - Brookline
Brookline, Massachusetts, 02446, United States
ActivMed Practices & Research, LLC
Methuen, Massachusetts, 01844, United States
Headlands Research Detroit
Southfield, Michigan, 48034, United States
DM Clinical Research - Southfield
Southfield, Michigan, 48076, United States
Javara Inc. and Mankato Clinic, Ltd.
Mankato, Minnesota, 56001, United States
Velocity Clinical Research Gulfport
Gulfport, Mississippi, 39503, United States
Clinical Research Professionals
Chesterfield, Missouri, 63005, United States
AMR Clinical
Kansas City, Missouri, 64116, United States
Clay-Platte Family Medicine Clinic
Kansas City, Missouri, 64151, United States
DelRicht Research
Springfield, Missouri, 65807, United States
Sundance Clinical Research, LLC
St Louis, Missouri, 63141, United States
DelRicht Research
Town and Country, Missouri, 63017, United States
Avacare Research/Methodist Physicians Clinic
Fremont, Nebraska, 68025, United States
Velocity Clinical Research, Grand Island
Grand Island, Nebraska, 68803, United States
Velocity Clinical Research
Lincoln, Nebraska, 68510, United States
Velocity Clinical Research Norfolk
Norfolk, Nebraska, 68701, United States
Velocity Clinical Research Omaha
Omaha, Nebraska, 68134, United States
Avacare/Midwest Regional Health Services
Omaha, Nebraska, 68144, United States
Papillion Research/Avacare
Papillion, Nebraska, 68046, United States
Santa Rosa Medical Centers of Nevada
Las Vegas, Nevada, 89119, United States
DM Clinical Research - Jersey City
Jersey City, New Jersey, 07306, United States
DM Clinical Research - Albuquerque
Albuquerque, New Mexico, 87106, United States
Velocity Clinical Research - Albuquerque
Albuquerque, New Mexico, 87107, United States
Rochester Clinical Research
Rochester, New York, 14609, United States
Velocity Clinical Research, Durham
Durham, North Carolina, 27701, United States
Eximia Research - NC, LLC
Raleigh, North Carolina, 27607, United States
TMA Headlands LLC d/b/a Trial Management Associates
Wilmington, North Carolina, 28403, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
Velocity Clinical Research - Cleveland
Beachwood, Ohio, 44122, United States
CTI Clinical Research Center
Cincinnati, Ohio, 45212, United States
Velocity Clinical Research-Mt. Auburn
Cincinnati, Ohio, 45242, United States
Velocity Clinical Research Springdale
Cincinnati, Ohio, 45246, United States
Tekton Research, LLC
Edmond, Oklahoma, 73013, United States
Tekton Research, LLC
Moore, Oklahoma, 73160, United States
DelRicht Research
Tulsa, Oklahoma, 74133, United States
Tekton Research, LLC
Yukon, Oklahoma, 73099, United States
Velocity Clinical Research - Medford
Medford, Oregon, 97504, United States
Summit Headlands LLC
Portland, Oregon, 97210, United States
Hatboro Medical Associates/Avacare
Horsham, Pennsylvania, 19044, United States
DM Clinical Research - Philadelphia
Philadelphia, Pennsylvania, 19107, United States
Velocity Clinical Research - East Greenwich
East Greenwich, Rhode Island, 02818, United States
Velocity Clinical Research, Anderson
Anderson, South Carolina, 29621, United States
DelRicht Research
Charleston, South Carolina, 29407, United States
Velocity Clinical Research - Columbia
Columbia, South Carolina, 29204, United States
Coastal Carolina Research Center, LLC
North Charleston, South Carolina, 29405, United States
Velocity Clinical Research Spartanburg
Spartanburg, South Carolina, 29303, United States
Velocity Clinical Research Union
Union, South Carolina, 29379, United States
DelRicht Research
Hendersonville, Tennessee, 37075, United States
Velocity Clinical Research, Abilene
Abilene, Texas, 79606, United States
Tekton Research, LLC
Austin, Texas, 78745, United States
Velocity Clinical Research - Austin
Austin, Texas, 78759, United States
Tekton Research, LLC
Beaumont, Texas, 77706, United States
Javara Inc. and Privia Medical Group Gulf Coast, PLLC
Conroe, Texas, 77384, United States
Velocity Clinical Research - Dallas
Dallas, Texas, 75230, United States
Avacare
Fort Worth, Texas, 76135, United States
DM Clinical Research - Houston
Houston, Texas, 77065, United States
DM Clinical Research - Houston
Houston, Texas, 77081, United States
DelRicht Research
Prosper, Texas, 75078, United States
Be Well Clinical Studies
Round Rock, Texas, 78681, United States
DM Clinical Research - San Antonio
San Antonio, Texas, 78207, United States
Tekton Research, LLC
San Antonio, Texas, 78229, United States
Javara Inc. and Privia Medical Group Gulf Coast, PLLC
San Marcos, Texas, 78666, United States
Javara Inc. and Privia Medical Group - North Texas
Stephenville, Texas, 76401, United States
DM Clinical Research - Sugar Land
Sugar Land, Texas, 77478, United States
Javara Inc. and Privia Medical Group Gulf Coast, PLLC
Sugar Land, Texas, 77478, United States
Olympus Clinical Research
Sugar Land, Texas, 77479, United States
DM Clinical Research - Tomball
Tomball, Texas, 77375, United States
Cope Family Medicine / Avacare
Bountiful, Utah, 84010, United States
Mountain View/Avacare
Pleasant View, Utah, 84404, United States
JBR Clinical Research
Salt Lake City, Utah, 84107, United States
Olympus Family Medicine/Avacare
Salt Lake City, Utah, 84117, United States
J. Lewis Research, Inc/Jordan River Family Medicine
South Jordan, Utah, 84095, United States
South Ogden Family Medicine/ Avacare
South Ogden, Utah, 84405, United States
Velocity Clinical Research - Salt Lake City (West Jordan)
West Jordan, Utah, 84088, United States
Charlottesville Medical Research, LLC
Charlottesville, Virginia, 22911, United States
Velocity Clinical Research-Hampton
Hampton, Virginia, 23666, United States
Clinical Research Partners, LLC
Richmond, Virginia, 23226, United States
Velocity Clinical Research - Suffolk
Suffolk, Virginia, 23435, United States
Velocity Clinical Research, Spokane
Spokane, Washington, 99218, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 25, 2025
First Posted
December 5, 2025
Study Start
November 26, 2025
Primary Completion (Estimated)
June 16, 2027
Study Completion (Estimated)
June 16, 2027
Last Updated
April 28, 2026
Record last verified: 2026-04