A Study of mRNA-1283 Injection Compared With mRNA-1273 Injection in Participants ≥12 Years of Age to Prevent COVID-19
NCT ID: NCT05815498
Last Updated: 2025-05-07
Study Results
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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COMPLETED
PHASE3
14246 participants
INTERVENTIONAL
2023-03-28
2025-04-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Part 1: mRNA-1283.222
Participants will receive single intramuscular (IM) injection of mRNA-1283.222 on Day 1.
mRNA-1283.222
Sterile liquid for injection
Part 1: mRNA-1273.222
Participants will receive single IM injection of mRNA-1273.222 on Day 1.
mRNA-1273.222
Sterile liquid for injection
Part 2: mRNA-1283.815
Participants will receive single IM injection of mRNA-1283.815 on Day 1.
mRNA-1283.815
Sterile liquid for injection
Part 2: mRNA-1273.815
Participants will receive single IM injection of mRNA-1273.815 on Day 1.
mRNA-1273.815
Sterile liquid for injection
Interventions
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mRNA-1283.222
Sterile liquid for injection
mRNA-1273.222
Sterile liquid for injection
mRNA-1283.815
Sterile liquid for injection
mRNA-1273.815
Sterile liquid for injection
Eligibility Criteria
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Inclusion Criteria
* For female participants of childbearing potential: negative pregnancy test, adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the first injection, and agreement to continue adequate contraception or abstinence through 90 days following the vaccine administration.
* Part 1: Has previously received a primary series of an authorized/approved COVID-19 vaccine. For participants ≥18 years of age, at least 1 booster dose must have also been received. Proof of prior vaccination is required. A heterologous vaccine regimen is acceptable.
Part 2: No prior vaccination is required. For participants who have been previously vaccinated, proof of vaccination is required.
Exclusion Criteria
* Participant is acutely ill or febrile (temperature ≥38.0 degrees Celsius \[°C\]/100.4 degrees Fahrenheit \[°F\]) 72 hours prior to or at the Screening Visit or Day 1.
* Any medical, psychiatric, or occupational condition, including reported history of substance abuse, that, in the opinion of the investigator, might pose additional risk due to participation in the study or could interfere with the interpretation of study results.
* Has received systemic immunosuppressants or immune-modifying drugs for \>14 days in total within 181 days prior to Screening (for corticosteroids ≥10 milligrams (mg)/day of prednisone equivalent) or is anticipating the need for immunosuppressive treatment at any time during participation in the study.
* Has received or plans to receive any licensed vaccine ≤60 days prior to the study injection (Day 1) or plans to receive a licensed vaccine within 60 days after the study injection.
* Has received systemic immunoglobulins or blood products within 90 days prior to the Screening Visit or plans to receive during the study.
* Has donated ≥450 milliliters (mL) of blood products within 28 days prior to the Screening Visit or plans to donate blood products during the study.
* Has participated in an interventional 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.
12 Years
ALL
Yes
Sponsors
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ModernaTX, Inc.
INDUSTRY
Responsible Party
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Locations
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Optimal Research
Huntsville, Alabama, United States
Accel Research Sites- Achieve Clinical Research
Vestavia Hills, Alabama, United States
Chandler Clinical Trials
Chandler, Arizona, United States
Phoenix Clinical Research LLC
Phoenix, Arizona, United States
FRC - CCT Research
Phoenix, Arizona, United States
Headlands Research Sarasota
Scottsdale, Arizona, United States
Clinical Research Consortium
Tempe, Arizona, United States
Noble Clinical Research, LLC
Tucson, Arizona, United States
Del Sol research Management LLC.
Tucson, Arizona, United States
Lynn Institute of the Ozarks
Little Rock, Arkansas, United States
Anaheim Clinical Trials, LLC
Anaheim, California, United States
Velocity Clinical Research, Banning
Banning, California, United States
Velocity Clinical Research- Chula Vista
Chula Vista, California, United States
Benchmark Research
Colton, California, United States
Marvel Clinical Research 002, LLC
Huntington Beach, California, United States
Velocity Clinical Research Huntington Park
Huntington Park, California, United States
Velocity Clinical Research
La Mesa, California, United States
Chemidox Clinical Trials
Lancaster, California, United States
Long Beach Clinical Trials
Long Beach, California, United States
Velocity Clinical Research- Westlake
Los Angeles, California, United States
Velocity Clinical Research-North Hollywood
North Hollywood, California, United States
Empire Clinical Research
Pomona, California, United States
CenExel - CITrials
Riverside, California, United States
Artemis Institute for Clinical Research
Riverside, California, United States
Peninsula Research Associates
Rolling Hills Estates, California, United States
Benchmark Research
Sacramento, California, United States
Artemis Institute for Clinical Research
San Diego, California, United States
Acclaim Clinical Research
San Diego, California, United States
Lynn Institute of Denver
Aurora, Colorado, United States
Velocity Clinical Research Denver
Denver, Colorado, United States
Tekton Research - Fort Collins
Fort Collins, Colorado, United States
Tekton Research, Inc- Longmont Center
Longmont, Colorado, United States
Alliance for Multispeciality Research - Miami
Coral Gables, Florida, United States
Nature Coast Clinical Research
Crystal River, Florida, United States
Beautiful Minds Clinical Research Center
Cutler Bay, Florida, United States
Clinical Research Partners LLC
DeLand, Florida, United States
Hillcrest Medical Research, LLC
DeLand, Florida, United States
Velocity Clinical Research, Hallandale Beach
Hallandale, Florida, United States
Sweet Hope Research Specialty, Inc.
Hialeah, Florida, United States
CenExel Research Centers of America
Hollywood, Florida, United States
Nature Coast Clinical Research
Inverness, Florida, United States
Encore Research Group-Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
Clinical Neuroscience Solutions, Inc
Jacksonville, Florida, United States
Health Awareness INC
Jupiter, Florida, United States
Accel Clinical Research
Lakeland, Florida, United States
Accel Research Sites
Largo, Florida, United States
Acclaim Clinical Research
Maitland, Florida, United States
Suncoast Research Group, LLC
Miami, Florida, United States
Clinical Trials of Florida
Miami, Florida, United States
Suncoast Research Associates, LLC
Miami, Florida, United States
Floridian Clinical Research
Miami Lakes, Florida, United States
Global Health Research Center, Inc.
Miami Lakes, Florida, United States
Clinical Neuroscience Solutions (CNS Healthcare site)
Orlando, Florida, United States
Headlands Research Orlando
Orlando, Florida, United States
Innovation Medical Research Center
Palmetto Bay, Florida, United States
Pines Care Research Center, Inc.
Pembroke Pines, Florida, United States
Suncoast Research Associates, LLC
Pembroke Pines, Florida, United States
Synexus
Pinellas Park, Florida, United States
Precision Clinical Research
Sunrise, Florida, United States
Global Health Research Center, Inc.
Tampa, Florida, United States
Santos Research Center CORP
Tampa, Florida, United States
Palm Beach Research Center
West Palm Beach, Florida, United States
Delricht Research
Atlanta, Georgia, United States
Atlanta Clinical Research Center
Atlanta, Georgia, United States
Baybol Research Institute
Chamblee, Georgia, United States
Centricity Research
Columbus, Georgia, United States
Elite Research Network
Decatur, Georgia, United States
Accel Research Sites Lake Oconee
Eatonton, Georgia, United States
Georgia Clinic, PC/CCT Research
Norcross, Georgia, United States
Clinical Research Atlanta/Headlands
Stockbridge, Georgia, United States
Velocity Clinical Research
Meridian, Idaho, United States
Chicago Clinical Research Institute
Chicago, Illinois, United States
Great Lakes Clinical Trials
Chicago, Illinois, United States
Velocity Clinical Research Valparaiso
Valparaiso, Indiana, United States
Alliance for Multispecialty Research, LLC
El Dorado, Kansas, United States
Johnson County Clin-Trials, Inc (JCCT)
Lenexa, Kansas, United States
Alliance for Multispecialty Research, LLC- Wichita
Wichita, Kansas, United States
Tekton Research Inc
Wichita, Kansas, United States
Alliance for Multispecialty Research-Lexington
Lexington, Kentucky, United States
Versailles Family Medicine
Versailles, Kentucky, United States
Meridian Clinical Research
Baton Rouge, Louisiana, United States
Benchmark Research
Covington, Louisiana, United States
MedPharmics
Covington, Louisiana, United States
Benchmark Research
Metairie, Louisiana, United States
Delricht Research
New Orleans, Louisiana, United States
Delricht Clinical Research
Prairieville, Louisiana, United States
Centennial Medical Group
Eldridge, Maryland, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
DM Clinical Research
Brookline, Massachusetts, United States
Great Lakes Research Institute
Southfield, Michigan, United States
Clinical Research Institute
Minneapolis, Minnesota, United States
Delricht Research
Gulfport, Mississippi, United States
The Center for Pharmaceutical Research
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
Montana Medical Research, Inc
Missoula, Montana, United States
CCT research/ Methodist Physicians Clinic- Prairie Fields
Fremont, Nebraska, United States
Velocity Clinical Research
Grand Island, Nebraska, United States
Meridian Clinical Research, LLC
Lincoln, Nebraska, United States
Velocity Clinical Research
Omaha, Nebraska, United States
Papillon Research Centre
Papillion, Nebraska, United States
Wr-Crcn, Llc
Las Vegas, Nevada, United States
Las Vegas Clinical Trials
North Las Vegas, Nevada, United States
IMA Clinical Research
Warren Township, New Jersey, United States
Velocity Clinical Research- New Mexico
Albuquerque, New Mexico, United States
IMA Clinical Research
Albuquerque, New Mexico, United States
Velocity Clinical Research, Syracuse
East Syracuse, New York, United States
IMA Clinical Research
New York, New York, United States
Rochester Clinical Research, Inc.
Rochester, New York, United States
Monroe Biomedical Research
Monroe, North Carolina, United States
Trial Management Associates, LLC
Wilmington, North Carolina, United States
CTI Clinical Research Center
Cincinnati, Ohio, United States
Velocity Clinical Research, Inc
Cincinnati, Ohio, United States
Velocity Clinical Research
Cincinnati, Ohio, United States
Velocity Clinical Research - Cincinnati
Cincinnati, Ohio, United States
Velocity Clinical Research
Cleveland, Ohio, United States
Tekton Research- Edmond
Edmond, Oklahoma, United States
Tekton Research Inc
Moore, Oklahoma, United States
Delricht Research
Tulsa, Oklahoma, United States
Tekton Research- Yukon
Yukon, Oklahoma, United States
Velocity Clinical Research, Medford
Medford, Oregon, United States
Summit Research Headlands LLC
Portland, Oregon, United States
DM Clinical Research
Philadelphia, Pennsylvania, United States
Synexus Clinical Research US, Inc
Anderson, South Carolina, United States
Velocity Clinical Research-Anderson
Anderson, South Carolina, United States
Delricht Research
Charleston, South Carolina, United States
Velocity Clinical Research
Columbia, South Carolina, United States
Velocity Clinical Research, Greenville
Greenville, South Carolina, United States
Carolina Health Specialists
Myrtle Beach, South Carolina, United States
Coastal Carolina Research Center
North Charleston, South Carolina, United States
Spartanburg Medical Research
Spartanburg, South Carolina, United States
Velocity Clinical Research- Spartanburg
Spartanburg, South Carolina, United States
Delricht Research
Hendersonville, Tennessee, United States
Clinical Research Associates, Inc.
Nashville, Tennessee, United States
Benchmark Research
Austin, Texas, United States
Tekton Research Inc
Austin, Texas, United States
Tekton Research - Beaumont
Beaumont, Texas, United States
PanAmerican Clinical Research, LLC
Brownsville, Texas, United States
Headlands Research Brownsville
Brownsville, Texas, United States
Zenos Clinical Research
Dallas, Texas, United States
Ventavia Research Group
Fort Worth, Texas, United States
Benchmark Research
Fort Worth, Texas, United States
DM Clinical Research
Houston, Texas, United States
DM Clinical Research
Houston, Texas, United States
Ventavia Research Group
Keller, Texas, United States
DELRICHT RESEARCH at ZOMNIR FAMILY MEDICINE
McKinney, Texas, United States
Research Your Health
Plano, Texas, United States
Be Well Clinical Studies
Round Rock, Texas, United States
Clinical Trials of Texas, Inc.
San Antonio, Texas, United States
Diagnostics Research Group
San Antonio, Texas, United States
Tekton Research -San Antonio
San Antonio, Texas, United States
DM Clinical Research
Sugar Land, Texas, United States
DM Clinical Research
Tomball, Texas, United States
Cope Family Medicine
Bountiful, Utah, United States
Mountain View Ogden Clinic/CCT Research
Pleasant View, Utah, United States
JBR Clinical Research
Salt Lake City, Utah, United States
J. Lewis Research, Inc. / Foothill Family Clinic South
Salt Lake City, Utah, United States
Health Research of Hampton Roads, Inc.
Newport News, Virginia, United States
Velocity Clinical Research
Portsmouth, Virginia, United States
Clinical Research Partners, LLC
Richmond, Virginia, United States
Medicor Research Inc.
Greater Sudbury, Ontario, Canada
Hamilton Medical Research group
Hamilton, Ontario, Canada
Milestone Research Inc.
London, Ontario, Canada
Red Maple Trials Inc.
Ottawa, Ontario, Canada
Winterberry Family Medicine
Stoney Creek, Ontario, Canada
Dr. Anil K. Gupta Medicine Professional Corporation
Toronto, Ontario, Canada
Centricity Research Toronto Manna Multispecialty
Toronto, Ontario, Canada
Intermed groupe santé
Chicoutimi, Quebec, Canada
Centricity Research Pointe-Claire
Pointe-Claire, Quebec, Canada
Manna Research Inc.
Pointe-Claire, Quebec, Canada
Q&T Research Sherbrooke Inc.
Sherbrooke, Quebec, Canada
Clinique spécialisée en allergie
Québec, , Canada
Public Health Association.Inc
Aichi, , Japan
Tenjin Sogo Clinic
Fukuoka, , Japan
Yamasaki Family Clinic - internal medicine
Hyōgo, , Japan
Motomachi Takatsuka Naika Clinic - Internal Medicine
Kanagawa, , Japan
Arakawa Family Clinic
Nagano, , Japan
Koseikai Yotsubashi Clinic - Internal Medicine
Osaka, , Japan
Medical Corporation of Yamazaki Neurotology, Rhinolaryngology Clinic
Sapporo, , Japan
Dojinkinenkai Meiwa Hospital
Tokyo, , Japan
Medical Corporation Asbo Tokyo Asbo Clinic
Tokyo, , Japan
Metropolitan Clinic - Internal Medicine
Tokyo, , Japan
National Center for Global Health and Medicine
Tokyo, , Japan
Shinei Medical Healthcare Clinic
Tokyo, , Japan
Barnsley Hospital
Barnsley, , United Kingdom
Royal United Hospital Bath NHS Trust - Royal United Hospital
Bath, , United Kingdom
Layton Medical Centre
Blackpool, , United Kingdom
Dorset Clinical Research Centre (Bournemouth Hospital)
Bournemouth, , United Kingdom
Bradford Teaching Hospitals NHS Foundation Trust - Bradford
Bradford, , United Kingdom
Lakeside Healthcare
Corby, , United Kingdom
Rotherham Doncaster and South Humber NHS Foundation Trust
Doncaster, , United Kingdom
University of Dundee - NHS Tayside - Ninewells Hospital & Me
Dundee, , United Kingdom
Western General Hospital
Edinburgh, , United Kingdom
Royal Devon & Exeter Hospital
Exeter, , United Kingdom
CPS Research
Glasgow, , United Kingdom
NHS Greater Glasgow & Clyde
Glasgow, , United Kingdom
Panthera Biopartners - Glasgow - multispeciality
Glasgow, , United Kingdom
Queen Elizabeth University Hospital
Glasgow, , United Kingdom
Gloucestershire Hospitals NHS Foundation Trust - Cheltenham
Gloucester, , United Kingdom
Velocity Clinical Research High Wycombe
High Wycombe, , United Kingdom
University Hospitals of Leicester-Leicester Royal Hospital
Leicester, , United Kingdom
Barts Health NHS Trust
London, , United Kingdom
Egin Research
London, , United Kingdom
Guys and St. Thomas NHS Foundation Trust
London, , United Kingdom
Hammersmith Medicines Research (HMR)
London, , United Kingdom
Panthera Biopartners - Enfield
London, , United Kingdom
Richford Gate Medical Practice
London, , United Kingdom
Royal Free London NHS Foundation Trust
London, , United Kingdom
St Georges Healthcare NHS Trust - University of London
London, , United Kingdom
Manchester University NHS Foundation Trust
Manchester, , United Kingdom
Bioluminux Clinical Research
Milton Keynes, , United Kingdom
Stemax Consult Healthcare Services Ltd
Milton Keynes, , United Kingdom
Newcastle University - Institute of Cellular Medicine (ICM)
Newcastle, , United Kingdom
Velocity Clinical Research
North London, , United Kingdom
Accellacare North London
Northwood, , United Kingdom
Nottingham University Hospitals NHS Trust - Queens Medical Centre (QMC) Campus
Nottingham, , United Kingdom
Wansford and Kings Cliffe Practice
Peterborough, , United Kingdom
University Hospitals Plymouth NHS Trust
Plymouth, , United Kingdom
Southampton General Hospital - Portsmouth Research Hub
Portsmouth, , United Kingdom
GST NHS Found
Preston, , United Kingdom
Panthera Biopartners Preston
Preston, , United Kingdom
Panthera Biopartners - Manchester - multispeciality
Rochdale, , United Kingdom
Warrington and Halton Teaching hospitals NHS Foundation Trust - Halton General Hospital
Runcorn, , United Kingdom
Panthera Biopartners - Sheffield - multispeciality
Sheffield, , United Kingdom
Royal Victoria Infirmary
Sheffield, , United Kingdom
Southampton University Hospital NHS Foundation Trust
Southampton, , United Kingdom
Pier Health Group
Weston-super-Mare, , United Kingdom
Weymouth Research Hub
Weymouth, , United Kingdom
North Wales Clinical Research Centre
Wrexham, , United Kingdom
Countries
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References
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Chalkias S, Dennis P, Petersen D, Radhakrishnan K, Vaughan L, Handforth R, Rossi A, Wahid R, Edwards DK, Feng J, Deng W, Zhou H, De Windt E, Urdaneta V, Paila Y, Girard B, Faust SN, Walsh SR, Cosgrove CA, Miller J, Das R. Efficacy, immunogenicity, and safety of a next-generation mRNA-1283 COVID-19 vaccine compared with the mRNA-1273 vaccine (NextCOVE): results from a phase 3, randomised, observer-blind, active-controlled trial. Lancet Infect Dis. 2025 Jul 7:S1473-3099(25)00236-1. doi: 10.1016/S1473-3099(25)00236-1. Online ahead of print.
Other Identifiers
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2023-000884-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
mRNA-1283-P301
Identifier Type: -
Identifier Source: org_study_id
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