A Study of mRNA-1283 Injection Compared With mRNA-1273 Injection in Participants ≥12 Years of Age to Prevent COVID-19 (NextCOVE)

April 10, 2026 updated by: ModernaTX, Inc.

A Randomized, Observer-Blind, Active-Controlled Phase 3 Study to Investigate the Safety, Immunogenicity, and Relative Vaccine Efficacy of mRNA-1283 Compared With mRNA-1273 in Participants Aged ≥12 Years for the Prevention of COVID-19

The purpose of this study (Part 1 and Part 2) is to evaluate the relative vaccine efficacy (rVE), safety, reactogenicity, and immunogenicity of mRNA-1283.222 versus mRNA-1273.222 (Part 1) and mRNA-1283.815 versus mRNA-1273.815 (Part 2).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13553

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Québec, Canada, G1V 4W2
        • Clinique spécialisée en allergie
    • Ontario
      • Greater Sudbury, Ontario, Canada, P3C 1X3
        • Medicor Research Inc.
      • Hamilton, Ontario, Canada, L8M 1K7
        • Hamilton Medical Research Group
      • London, Ontario, Canada, N5W 6A2
        • Milestone Research Inc.
      • Ottawa, Ontario, Canada, K1H1E4
        • Red Maple Trials Inc.
      • Stoney Creek, Ontario, Canada, L8J0B6
        • Winterberry Family Medicine
      • Toronto, Ontario, Canada, M9V 4B4
        • Dr. Anil K. Gupta Medicine Professional Corporation
      • Toronto, Ontario, Canada, M9W 4L6
        • Centricity Research Toronto Manna Multispecialty
    • Quebec
      • Chicoutimi, Quebec, Canada, G7H 7Y8
        • INTERMED Groupe Sante
      • Pointe-Claire, Quebec, Canada, H9R 4S3
        • Centricity Research Pointe-Claire
      • Pointe-Claire, Quebec, Canada, H9R 4S3
        • Manna Research Inc.
      • Sherbrooke, Quebec, Canada, J1J 2G2
        • Q&T Research Sherbrooke Inc.
  • Japan
      • Aichi, Japan
        • Public Health Association.Inc
      • Fukuoka, Japan
        • Tenjin Sogo Clinic
      • Hyōgo, Japan
        • Yamasaki Family Clinic - internal medicine
      • Kanagawa, Japan
        • Motomachi Takatsuka Naika Clinic - Internal Medicine
      • Nagano, Japan
        • Arakawa Family Clinic
      • Osaka, Japan
        • Koseikai Yotsubashi Clinic - Internal Medicine
      • Sapporo, Japan
        • Medical Corporation of Yamazaki Neurotology, Rhinolaryngology Clinic
      • Tokyo, Japan
        • Dojinkinenkai Meiwa Hospital
      • Tokyo, Japan
        • Medical Corporation Asbo Tokyo Asbo Clinic
      • Tokyo, Japan
        • National Center for Global Health and Medicine
      • Tokyo, Japan
        • Metropolitan Clinic - Internal Medicine
      • Tokyo, Japan
        • Shinei Medical Healthcare Clinic
  • United Kingdom
      • Barnsley, United Kingdom
        • Barnsley Hospital
      • Bath, United Kingdom
        • Royal United Hospital Bath NHS Trust - Royal United Hospital
      • Blackpool, United Kingdom
        • Layton Medical Centre
      • Bournemouth, United Kingdom
        • Dorset Clinical Research Centre (Bournemouth Hospital)
      • Bradford, United Kingdom
        • Bradford Teaching Hospitals NHS Foundation Trust - Bradford
      • Corby, United Kingdom
        • Lakeside Healthcare
      • Doncaster, United Kingdom
        • Rotherham Doncaster and South Humber NHS Foundation Trust
      • Dundee, United Kingdom
        • University of Dundee - NHS Tayside - Ninewells Hospital & Me
      • Edinburgh, United Kingdom
        • Western General Hospital
      • Exeter, United Kingdom
        • Royal Devon & Exeter Hospital
      • Glasgow, United Kingdom
        • CPS Research
      • Glasgow, United Kingdom
        • Queen Elizabeth University Hospital
      • Glasgow, United Kingdom
        • NHS Greater Glasgow & Clyde
      • Glasgow, United Kingdom
        • Panthera Biopartners - Glasgow - multispeciality
      • Gloucester, United Kingdom
        • Gloucestershire Hospitals NHS Foundation Trust - Cheltenham
      • High Wycombe, United Kingdom
        • Velocity Clinical Research High Wycombe
      • Leicester, United Kingdom
        • University Hospitals of Leicester-Leicester Royal Hospital
      • London, United Kingdom
        • Royal Free London NHS Foundation Trust
      • London, United Kingdom
        • Guys and St. Thomas NHS Foundation Trust
      • London, United Kingdom
        • Barts Health NHS Trust
      • London, United Kingdom
        • Hammersmith Medicines Research (HMR)
      • London, United Kingdom
        • Egin Research
      • London, United Kingdom
        • Panthera Biopartners - Enfield
      • London, United Kingdom
        • Richford Gate Medical Practice
      • London, United Kingdom
        • St Georges Healthcare NHS Trust - University of London
      • Manchester, United Kingdom
        • Manchester University NHS Foundation Trust
      • Milton Keynes, United Kingdom
        • Bioluminux Clinical Research
      • Milton Keynes, United Kingdom
        • Stemax Consult Healthcare Services Ltd
      • Newcastle, United Kingdom
        • Newcastle University - Institute of Cellular Medicine (ICM)
      • North London, United Kingdom
        • Velocity Clinical Research
      • Northwood, United Kingdom
        • Accellacare North London
      • Nottingham, United Kingdom
        • Nottingham University Hospitals NHS Trust - Queens Medical Centre (QMC) Campus
      • Peterborough, United Kingdom
        • Wansford and Kings Cliffe Practice
      • Plymouth, United Kingdom
        • University Hospitals Plymouth NHS Trust
      • Portsmouth, United Kingdom
        • Southampton General Hospital - Portsmouth Research Hub
      • Preston, United Kingdom
        • GST NHS Found
      • Preston, United Kingdom
        • Panthera Biopartners Preston
      • Rochdale, United Kingdom
        • Panthera Biopartners - Manchester - multispeciality
      • Runcorn, United Kingdom
        • Warrington and Halton Teaching Hospitals NHS Foundation Trust - Halton General Hospital
      • Sheffield, United Kingdom
        • Panthera Biopartners - Sheffield - multispeciality
      • Sheffield, United Kingdom
        • Royal Victoria Infirmary
      • Southampton, United Kingdom
        • Southampton University Hospital NHS Foundation Trust
      • Weston-super-Mare, United Kingdom
        • Pier Health Group
      • Weymouth, United Kingdom
        • Weymouth Research Hub
      • Wrexham, United Kingdom
        • North Wales Clinical Research Centre
  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35802
        • Optimal Research
      • Vestavia Hills, Alabama, United States, 35216
        • Accel Research Sites- Achieve Clinical Research
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Chandler Clinical Trials
      • Phoenix, Arizona, United States, 85014
        • Phoenix Clinical Research LLC
      • Phoenix, Arizona, United States, 85244
        • FRC - CCT Research
      • Scottsdale, Arizona, United States, 85260
        • Headlands Research Sarasota
      • Tempe, Arizona, United States, 85281
        • Clinical Research Consortium
      • Tucson, Arizona, United States, 85704
        • Noble Clinical Research, LLC
      • Tucson, Arizona, United States, 85715
        • Del Sol research Management LLC.
    • Arkansas
      • Little Rock, Arkansas, United States, 72204
        • Lynn Institute of the Ozarks
    • California
      • Anaheim, California, United States, 92801
        • Anaheim Clinical Trials, LLC
      • Banning, California, United States, 92220
        • Velocity Clinical Research, Banning
      • Chula Vista, California, United States, 91911
        • Velocity Clinical Research- Chula Vista
      • Colton, California, United States, 92324
        • Benchmark Research
      • Huntington Beach, California, United States, 92647
        • Marvel Clinical Research 002, LLC
      • Huntington Park, California, United States, 90255
        • Velocity Clinical Research Huntington Park
      • La Mesa, California, United States, 91942
        • Velocity Clinical Research
      • Lancaster, California, United States, 93534
        • Chemidox Clinical Trials
      • Long Beach, California, United States, 90806
        • Long Beach Clinical Trials
      • Los Angeles, California, United States, 90057
        • Velocity Clinical Research- Westlake
      • North Hollywood, California, United States, 90036
        • Velocity Clinical Research-North Hollywood
      • Pomona, California, United States, 91786
        • Empire Clinical Research
      • Riverside, California, United States, 92503
        • Artemis Institute for Clinical Research
      • Riverside, California, United States, 82506
        • CenExel - CITrials
      • Rolling Hills Estates, California, United States, 90274
        • Peninsula Research Associates
      • Sacramento, California, United States, 95864
        • Benchmark Research
      • San Diego, California, United States, 92103
        • Artemis Institute for Clinical Research
      • San Diego, California, United States, 92120
        • Acclaim Clinical Research
    • Colorado
      • Aurora, Colorado, United States, 80012
        • Lynn Institute of Denver
      • Denver, Colorado, United States, 80209
        • Velocity Clinical Research Denver
      • Fort Collins, Colorado, United States, 80525
        • Tekton Research - Fort Collins
      • Longmont, Colorado, United States, 80501
        • Tekton Research, Inc- Longmont Center
    • Florida
      • Coral Gables, Florida, United States, 33134
        • Alliance for Multispeciality Research - Miami
      • Crystal River, Florida, United States, 34429
        • Nature Coast Clinical Research
      • Cutler Bay, Florida, United States, 33157
        • Beautiful Minds Clinical Research Center
      • DeLand, Florida, United States, 32720
        • Clinical Research Partners LLC
      • DeLand, Florida, United States, 32720
        • Hillcrest Medical Research, LLC
      • Hallandale, Florida, United States, 33009
        • Velocity Clinical Research, Hallandale Beach
      • Hialeah, Florida, United States, 33016
        • Sweet Hope Research Specialty, Inc.
      • Hollywood, Florida, United States, 33024
        • CenExel Research Centers of America
      • Inverness, Florida, United States, 34452
        • Nature Coast Clinical Research
      • Jacksonville, Florida, United States, 32256
        • Clinical Neuroscience Solutions, Inc
      • Jacksonville, Florida, United States, 32216
        • Encore Research Group-Jacksonville Center for Clinical Research
      • Jupiter, Florida, United States, 33458
        • Health Awareness Inc
      • Lakeland, Florida, United States, 33803
        • Accel Clinical Research
      • Largo, Florida, United States, 33709
        • Accel Research Sites
      • Maitland, Florida, United States, 32751
        • Acclaim Clinical Research
      • Miami, Florida, United States, 33135
        • Suncoast Research Group, LLC
      • Miami, Florida, United States, 33186
        • Clinical Trials of Florida
      • Miami, Florida, United States, 33713
        • Suncoast Research Associates, LLC
      • Miami Lakes, Florida, United States, 33016
        • Global Health Research Center, Inc.
      • Miami Lakes, Florida, United States, 33016
        • Floridian Clinical Research
      • Orlando, Florida, United States, 32819
        • Headlands Research Orlando
      • Orlando, Florida, United States, 32801
        • Clinical Neuroscience Solutions (CNS Healthcare site)
      • Palmetto Bay, Florida, United States, 33157
        • Innovation Medical Research Center
      • Pembroke Pines, Florida, United States, 33024
        • Pines Care Research Center, Inc.
      • Pembroke Pines, Florida, United States, 33324
        • Suncoast Research Associates, LLC
      • Pinellas Park, Florida, United States, 33781
        • Synexus
      • Sunrise, Florida, United States, 33351
        • Precision Clinical Research
      • Tampa, Florida, United States, 33615
        • Global Health Research Center, Inc.
      • Tampa, Florida, United States, 33615
        • Santos Research Center CORP
      • West Palm Beach, Florida, United States, 33409
        • Palm Beach Research Center
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Atlanta Clinical Research Center
      • Atlanta, Georgia, United States, 30329
        • DelRicht Research
      • Chamblee, Georgia, United States, 30341
        • Baybol Research Institute
      • Columbus, Georgia, United States, 31904
        • Centricity Research
      • Decatur, Georgia, United States, 30030
        • Elite Research Network
      • Eatonton, Georgia, United States, 31024
        • Accel Research Sites Lake Oconee
      • Norcross, Georgia, United States, 30092
        • Georgia Clinic, PC/CCT Research
      • Stockbridge, Georgia, United States, 30281
        • Clinical Research Atlanta/Headlands
    • Idaho
      • Meridian, Idaho, United States, 83642
        • Velocity Clinical Research
    • Illinois
      • Chicago, Illinois, United States, 60640
        • Great Lakes Clinical Trials
      • Chicago, Illinois, United States, 60607
        • Chicago Clinical Research Institute
    • Indiana
      • Valparaiso, Indiana, United States, 46383
        • Velocity Clinical Research Valparaiso
    • Kansas
      • El Dorado, Kansas, United States, 67042
        • Alliance for Multispecialty Research, LLC
      • Lenexa, Kansas, United States, 66219
        • Johnson County Clin-Trials, Inc (JCCT)
      • Wichita, Kansas, United States, 67207
        • Alliance for Multispecialty Research, LLC- Wichita
      • Wichita, Kansas, United States, 67218
        • Tekton Research Inc
    • Kentucky
      • Lexington, Kentucky, United States, 40509
        • Alliance for Multispecialty Research-Lexington
      • Versailles, Kentucky, United States, 40383
        • Versailles Family Medicine
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Meridian Clinical Research
      • Covington, Louisiana, United States, 70433
        • MedPharmics
      • Covington, Louisiana, United States, 70006
        • Benchmark Research
      • Metairie, Louisiana, United States, 70006
        • Benchmark Research
      • New Orleans, Louisiana, United States, 70115
        • DelRicht Research
      • Prairieville, Louisiana, United States, 70769
        • DelRicht Clinical Research
    • Maryland
      • Eldridge, Maryland, United States, 21075
        • Centennial Medical Group
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
      • Brookline, Massachusetts, United States, 02445
        • DM Clinical Research
    • Michigan
      • Southfield, Michigan, United States, 48075
        • Great Lakes Research Institute
    • Minnesota
      • Minneapolis, Minnesota, United States, 55402
        • Clinical Research Institute
    • Mississippi
      • Gulfport, Mississippi, United States, 39503
        • DelRicht Research
    • Missouri
      • Kansas City, Missouri, United States, 64114
        • The Center for Pharmaceutical Research
      • Springfield, Missouri, United States, 65807
        • DelRicht Research
      • St Louis, Missouri, United States, 63141
        • Sundance Clinical Research, LLC
      • Town and Country, Missouri, United States, 63017
        • DelRicht Research
    • Montana
      • Missoula, Montana, United States, 59808
        • Montana Medical Research, Inc
    • Nebraska
      • Fremont, Nebraska, United States, 68025
        • CCT research/ Methodist Physicians Clinic- Prairie Fields
      • Grand Island, Nebraska, United States, 68803
        • Velocity Clinical Research
      • Lincoln, Nebraska, United States, 68510
        • Meridian Clinical Research, LLC
      • Omaha, Nebraska, United States, 68134
        • Velocity Clinical Research
      • Papillion, Nebraska, United States, 68046
        • Papillon Research Centre
    • Nevada
      • Las Vegas, Nevada, United States, 89113
        • Wr-Crcn, Llc
      • North Las Vegas, Nevada, United States, 89030
        • Las Vegas Clinical Trials
    • New Jersey
      • Warren Township, New Jersey, United States, 07059
        • Ima Clinical Research
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • Ima Clinical Research
      • Albuquerque, New Mexico, United States, 87102
        • Velocity Clinical Research- New Mexico
    • New York
      • East Syracuse, New York, United States, 13057
        • Velocity Clinical Research, Syracuse
      • New York, New York, United States, 10036
        • Ima Clinical Research
      • Rochester, New York, United States, 14609
        • Rochester Clinical Research, Inc.
    • North Carolina
      • Monroe, North Carolina, United States, 28112
        • Monroe Biomedical Research
      • Wilmington, North Carolina, United States, 28403
        • Trial Management Associates, LLC
    • Ohio
      • Cincinnati, Ohio, United States, 45212
        • CTI Clinical Research Center
      • Cincinnati, Ohio, United States, 45242
        • Velocity Clinical Research
      • Cincinnati, Ohio, United States, 45219
        • Velocity Clinical Research, Inc
      • Cincinnati, Ohio, United States, 45246
        • Velocity Clinical Research - Cincinnati
      • Cleveland, Ohio, United States, 44122
        • Velocity Clinical Research
    • Oklahoma
      • Edmond, Oklahoma, United States, 73013
        • Tekton Research- Edmond
      • Moore, Oklahoma, United States, 73160
        • Tekton Research Inc
      • Tulsa, Oklahoma, United States, 74133
        • DelRicht Research
      • Yukon, Oklahoma, United States, 73099
        • Tekton Research- Yukon
    • Oregon
      • Medford, Oregon, United States, 97504
        • Velocity Clinical Research, Medford
      • Portland, Oregon, United States, 97210
        • Summit Research Headlands LLC
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • DM Clinical Research
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • Synexus Clinical Research US, Inc
      • Anderson, South Carolina, United States, 29621
        • Velocity Clinical Research-Anderson
      • Charleston, South Carolina, United States, 29407
        • DelRicht Research
      • Columbia, South Carolina, United States, 29204
        • Velocity Clinical Research
      • Greenville, South Carolina, United States, 29615
        • Velocity Clinical Research, Greenville
      • Myrtle Beach, South Carolina, United States, 29572
        • Carolina Health Specialists
      • North Charleston, South Carolina, United States, 29464
        • Coastal Carolina Research Center
      • Spartanburg, South Carolina, United States, 29303
        • Spartanburg Medical Research
      • Spartanburg, South Carolina, United States, 29303
        • Velocity Clinical Research- Spartanburg
    • Tennessee
      • Hendersonville, Tennessee, United States, 37075
        • DelRicht Research
      • Nashville, Tennessee, United States, 37203
        • Clinical Research Associates, Inc.
    • Texas
      • Austin, Texas, United States, 78705
        • Benchmark Research
      • Austin, Texas, United States, 78745
        • Tekton Research Inc
      • Beaumont, Texas, United States, 77706
        • Tekton Research - Beaumont
      • Brownsville, Texas, United States, 78520
        • PanAmerican Clinical Research, LLC
      • Brownsville, Texas, United States, 78526
        • Headlands Research Brownsville
      • Dallas, Texas, United States, 75230
        • Zenos Clinical Research
      • Fort Worth, Texas, United States, 76135
        • Benchmark Research
      • Fort Worth, Texas, United States, 76104
        • Ventavia Research Group
      • Houston, Texas, United States, 77065
        • DM Clinical Research
      • Houston, Texas, United States, 77081
        • DM Clinical Research
      • Keller, Texas, United States, 76248
        • Ventavia Research Group
      • McKinney, Texas, United States, 75072
        • Delricht Research At Zomnir Family Medicine
      • Plano, Texas, United States, 75093
        • Research Your Health
      • Round Rock, Texas, United States, 78681
        • Be Well Clinical Studies
      • San Antonio, Texas, United States, 78229
        • Diagnostics Research Group
      • San Antonio, Texas, United States, 78229
        • Clinical Trials of Texas, Inc.
      • San Antonio, Texas, United States, 78240
        • Tekton Research -San Antonio
      • Sugar Land, Texas, United States, 77478
        • DM Clinical Research
      • Tomball, Texas, United States, 77375
        • DM Clinical Research
    • Utah
      • Bountiful, Utah, United States, 84010
        • Cope Family Medicine
      • Pleasant View, Utah, United States, 84404
        • Mountain View Ogden Clinic/CCT Research
      • Salt Lake City, Utah, United States, 84107
        • JBR Clinical Research
      • Salt Lake City, Utah, United States, 84121
        • J. Lewis Research, Inc. / Foothill Family Clinic South
    • Virginia
      • Newport News, Virginia, United States, 23606
        • Health Research of Hampton Roads, Inc.
      • Portsmouth, Virginia, United States, 23703
        • Velocity Clinical Research
      • Richmond, Virginia, United States, 23226
        • Clinical Research Partners, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Key Inclusion Criteria:

  • Investigator's assessment that the participant understands and is willing and physically able to comply with protocol-mandated follow-up, including all procedures.
  • 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.

Key Exclusion Criteria:

  • Has had close contact, as defined by the Centers for Disease Control and Prevention (CDC), with someone who had a SARS-CoV-2 infection in the past 14 days, or COVID-19 in the past 10 days.
  • 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.

Note: Other inclusion and exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part 1: mRNA-1283.222
Participants will receive single intramuscular (IM) injection of mRNA-1283.222 on Day 1.
Biological: mRNA-1283.222
Sterile liquid for injection
Experimental: Part 1: mRNA-1273.222
Participants will receive single IM injection of mRNA-1273.222 on Day 1.
Biological: mRNA-1273.222
Sterile liquid for injection
Experimental: Part 2: mRNA-1283.815
Participants will receive single IM injection of mRNA-1283.815 on Day 1.
Biological: mRNA-1283.815
Sterile liquid for injection
Experimental: Part 2: mRNA-1273.815
Participants will receive single IM injection of mRNA-1273.815 on Day 1.
Biological: mRNA-1273.815
Sterile liquid for injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Part 1: Geometric Mean (GM) of Omicron BA.4/5 at Day 29
Time Frame: Day 29
Antibody values reported as below the lower limit of quantification (LLOQ) were replaced by 0.5*LLOQ. Values greater than the upper limit of quantification (ULOQ) were replaced by the ULOQ if actual values were not available. LLOQ was 103 arbitrary units (AU)/milliliter (mL) and ULOQ was 28571 AU/mL.
Day 29
Part 1: Seroresponse Rate (SRR) Omicron BA.4/5 at Day 29
Time Frame: Day 29
Seroresponse was defined as an antibody value change from baseline below the LLOQ to ≥4*LLOQ, or at least a 4-fold rise if baseline was ≥LLOQ and <4*LLOQ, or at least a 2-fold rise if baseline was ≥4*LLOQ, where baseline referred to pre-booster. LLOQ was 103 AU/mL and ULOQ was 28571 AU/mL.
Day 29
Part 1: GM of the Ancestral Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) D614G at Day 29
Time Frame: Day 29
Antibody values reported as below the LLOQ were replaced by 0.5*LLOQ. Values greater than the ULOQ were replaced by the ULOQ if actual values were not available. LLOQ was 10 AU/mL and ULOQ was 111433 AU/mL.
Day 29
Part 1: SRR of Ancestral SARS-CoV-2 D641G at Day 29
Time Frame: Day 29
Seroresponse was defined as an antibody value change from baseline below the LLOQ to ≥4*LLOQ, or at least a 4-fold rise if baseline was ≥LLOQ and <4*LLOQ, or at least a 2-fold rise if baseline was ≥4*LLOQ, where baseline referred to pre-booster. LLOQ was 10 AU/mL and ULOQ was 111433AU/mL.
Day 29
Part 1: Number of Participants With First Event of Centers for Disease Control and Prevention (CDC)-Defined COVID-19
Time Frame: From 14 days after injection up to Day 365
CDC COVID-19 definition: the presence of at least 1 CDC listed symptom and positive reverse transcriptase polymerase chain reaction (RT-PCR) test on a respiratory sample.
From 14 days after injection up to Day 365
Part 1: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)
Time Frame: Up to Day 7 (7-day follow-up after vaccination)
Solicited ARs were recorded daily using electronic diaries (eDiaries). Local ARs: injection site pain, erythema (redness), swelling/induration (hardness); and axillary (underarm) swelling or tenderness ipsilateral to the side of injection. Systemic ARs: fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills. Note, not all solicited ARs were considered adverse events (AEs). Investigator reviewed whether the solicited AR was also to be recorded as an AE. A Summary of serious AEs (SAEs) and nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.
Up to Day 7 (7-day follow-up after vaccination)
Part 3: Number of Participants With Solicited Local and Systemic ARs
Time Frame: Up to Day 7 (7-day follow-up after vaccination)
Solicited ARs were recorded daily using eDiaries. Local ARs: injection site pain, erythema (redness), swelling/induration (hardness); and axillary (underarm) swelling or tenderness ipsilateral to the side of injection. Systemic ARs: fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills. Note, not all solicited ARs were considered AEs. Investigator reviewed whether the solicited AR was also to be recorded as an AE. A Summary of SAEs and nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.
Up to Day 7 (7-day follow-up after vaccination)
Part 1: Number of Participants With Unsolicited Adverse Events (AEs)
Time Frame: Up to Day 28 (28-day follow-up after vaccination)
An unsolicited AE was defined as any AE reported by the participant that was not specified as a solicited AR in the protocol. An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Up to Day 28 (28-day follow-up after vaccination)
Part 3: Number of Participants With Unsolicited AEs
Time Frame: Up to Day 28 (28-day follow-up after vaccination)
An unsolicited AE was defined as any AE reported by the participant that was not specified as a solicited AR in the protocol. An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Up to Day 28 (28-day follow-up after vaccination)
Part 1: Number of Participants With Any Serious AEs (SAEs), Medically Attended AEs (MAAEs), AEs Leading to Withdrawal From Study, and AEs of Special Interest (AESIs)
Time Frame: Day 1 up to Day 365
SAEs were AEs that resulted in death, were life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, a congenital anomaly or birth defect, or was a medically important event. MAAEs were AEs that lead to an unscheduled visit to a healthcare provider. AESIs were AEs (serious or nonserious) of scientific and medical concern specific to the Sponsor's product or program for which ongoing monitoring and immediate notification by the investigator to the Sponsor was required. AEs leading to the withdrawal from study reported for this endpoint also include the AEs that led to death. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Day 1 up to Day 365
Part 3: Number of Participants With Any SAEs, MAAEs, AEs Leading to Withdrawal From Study, and AESIs
Time Frame: Day 1 up to Day 181
SAEs were AEs that resulted in death, were life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, a congenital anomaly or birth defect, or was a medically important event. MAAEs were AEs that lead to an unscheduled visit to a healthcare provider. AESIs were AEs (serious or nonserious) of scientific and medical concern specific to the Sponsor's product or program for which ongoing monitoring and immediate notification by the investigator to the Sponsor was required. AEs leading to the withdrawal from study reported for this endpoint also include the AEs that led to death. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Day 1 up to Day 181

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Part 1: GMs of Omicron BA.4/5 and Ancestral SARS-CoV-2 D614G
Time Frame: Days 91, 181, and 365
Antibody values reported as below the LLOQ were replaced by 0.5*LLOQ. Values greater than the ULOQ were replaced by the ULOQ if actual values were not available. LLOQ was 103 AU/mL and ULOQ was 28571 AU/mL for Omicron BA.4/5. LLOQ was 10 AU/mL and ULOQ was 111433 AU/mL for ancestral SARS-CoV-2 D614G.
Days 91, 181, and 365
Part 1: SRR Against Omicron BA.4/5 and Ancestral SARS-CoV-2 D614G at Days 91, 181, and 365
Time Frame: Days 91, 181, and 365
Seroresponse was defined as an antibody value change from baseline below the LLOQ to ≥4*LLOQ, or at least a 4-fold rise if baseline was ≥LLOQ and <4*LLOQ, or at least a 2-fold rise if baseline was ≥4*LLOQ, where baseline referred to pre-booster. LLOQ was 103 AU/mL and ULOQ was 28571 AU/mL for Omicron BA.4/5. LLOQ was 10 AU/mL and ULOQ was 111433 AU/mL for ancestral SARS-CoV-2 D614G.
Days 91, 181, and 365
Part 1: Number of Participants With a SARS-CoV-2 Infection (Symptomatic or Asymptomatic)
Time Frame: From 14 days after injection up to Day 365
SARS-CoV-2 infection (symptomatic or asymptomatic) was defined as (1) negative binding antibody (bAb) level against SARS-CoV-2 nucleocapsid protein and negative RT-PCR at baseline that became positive bAb level against SARS-CoV-2 nucleocapsid protein post-baseline, or (2) positive RT-PCR post-baseline. Asymptomatic SARS-CoV-2 infection was characterized by the absence of COVID-19 symptoms.
From 14 days after injection up to Day 365
Part 3: GM of Omicron XBB.1.5 in Unvaccinated Participants
Time Frame: Day 29
Antibody values reported as below the LLOQ were replaced by 0.5*LLOQ. Values greater than the ULOQ were replaced by the ULOQ if actual values were not available. LLOQ was 38 AU/mL and ULOQ was 6960 AU/mL.
Day 29
Part 3: GM of Omicron XBB.1.5 in All Study Participants
Time Frame: Day 29
Antibody values reported as below the LLOQ were replaced by 0.5*LLOQ. Values greater than the ULOQ were replaced by the ULOQ if actual values were not available. LLOQ was 38 AU/mL and ULOQ was 6960 AU/mL.
Day 29
Part 3: SRR Against Omicron XBB.1.5 in Unvaccinated Participants
Time Frame: Day 29
Seroresponse was defined as an antibody value change from baseline below the LLOQ to ≥4*LLOQ, or at least a 4-fold rise if baseline was ≥LLOQ and <4*LLOQ, or at least a 2-fold rise if baseline was ≥4*LLOQ, where baseline referred to last non-missing measurement on or before study vaccination day. LLOQ was 38 AU/mL and ULOQ was 6960 AU/mL.
Day 29
Part 3: SRR Against Omicron XBB.1.5 in All Study Participants
Time Frame: Day 29
Seroresponse was defined as an antibody value change from baseline below the LLOQ to ≥4*LLOQ, or at least a 4-fold rise if baseline was ≥LLOQ and <4*LLOQ, or at least a 2-fold rise if baseline was ≥4*LLOQ, where baseline referred to last non-missing measurement on or before study vaccination day. LLOQ was 38 AU/mL and ULOQ was 6960 AU/mL.
Day 29

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ModernaTX, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 28, 2023

Primary Completion (Actual)

April 12, 2025

Study Completion (Actual)

April 12, 2025

Study Registration Dates

First Submitted

April 13, 2023

First Submitted That Met QC Criteria

April 13, 2023

First Posted (Actual)

April 18, 2023

Study Record Updates

Last Update Posted (Actual)

May 1, 2026

Last Update Submitted That Met QC Criteria

April 10, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • mRNA-1283-P301
  • 2023-000884-30 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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