AzTrials
AzTrials

COVID-19Phase 3NextCOVENCT05815498

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

A Phase 3 study testing mRNA-1283.222, mRNA-1273.222 and mRNA-1283.815 in people with COVID-19, run by ModernaTX, Inc. at 230 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 12 years and olderHealthy volunteers can take part
Conditions the study is for
COVID-19
What is being tested?
mRNA-1283.222, mRNA-1273.222 and mRNA-1283.815
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13,553 participants
Where
230 sitesin 4 countries
Study dates
28 Mar 2023to 12 Apr 2025
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 12 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

230 sites in 4 countries.

230 sites in 4 countries

United States161 sites

  • Velocity Clinical Research- New Mexico

    Albuquerque, New Mexico, 87102

  • IMA Clinical Research

    Albuquerque, New Mexico, 87109

  • Anaheim Clinical Trials, LLC

    Anaheim, California, 92801

  • Synexus Clinical Research US, Inc

    Anderson, South Carolina, 29621

  • Velocity Clinical Research-Anderson

    Anderson, South Carolina, 29621

  • Delricht Research

    Atlanta, Georgia, 30329

  • Atlanta Clinical Research Center

    Atlanta, Georgia, 30342

  • Lynn Institute of Denver

    Aurora, Colorado, 80012

  • Benchmark Research

    Austin, Texas, 78705

  • Tekton Research Inc

    Austin, Texas, 78745

  • Velocity Clinical Research, Banning

    Banning, California, 92220

  • Meridian Clinical Research

    Baton Rouge, Louisiana, 70809

  • Tekton Research - Beaumont

    Beaumont, Texas, 77706

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Cope Family Medicine

    Bountiful, Utah, 84010

  • DM Clinical Research

    Brookline, Massachusetts, 02445

  • PanAmerican Clinical Research, LLC

    Brownsville, Texas, 78520

  • Headlands Research Brownsville

    Brownsville, Texas, 78526

  • Baybol Research Institute

    Chamblee, Georgia, 30341

  • Chandler Clinical Trials

    Chandler, Arizona, 85224

  • Delricht Research

    Charleston, South Carolina, 29407

  • Chicago Clinical Research Institute

    Chicago, Illinois, 60607

  • Great Lakes Clinical Trials

    Chicago, Illinois, 60640

  • Velocity Clinical Research- Chula Vista

    Chula Vista, California, 91911

  • CTI Clinical Research Center

    Cincinnati, Ohio, 45212

  • Velocity Clinical Research, Inc

    Cincinnati, Ohio, 45219

  • Velocity Clinical Research

    Cincinnati, Ohio, 45242

  • Velocity Clinical Research - Cincinnati

    Cincinnati, Ohio, 45246

  • Velocity Clinical Research

    Cleveland, Ohio, 44122

  • Benchmark Research

    Colton, California, 92324

  • Velocity Clinical Research

    Columbia, South Carolina, 29204

  • Centricity Research

    Columbus, Georgia, 31904

  • Alliance for Multispeciality Research - Miami

    Coral Gables, Florida, 33134

  • Benchmark Research

    Covington, Louisiana, 70006

  • MedPharmics

    Covington, Louisiana, 70433

  • Nature Coast Clinical Research

    Crystal River, Florida, 34429

  • Beautiful Minds Clinical Research Center

    Cutler Bay, Florida, 33157

  • Zenos Clinical Research

    Dallas, Texas, 75230

  • Elite Research Network

    Decatur, Georgia, 30030

  • Clinical Research Partners LLC

    DeLand, Florida, 32720

  • Hillcrest Medical Research, LLC

    DeLand, Florida, 32720

  • Velocity Clinical Research Denver

    Denver, Colorado, 80209

  • Velocity Clinical Research, Syracuse

    East Syracuse, New York, 13057

  • Accel Research Sites Lake Oconee

    Eatonton, Georgia, 31024

  • Tekton Research- Edmond

    Edmond, Oklahoma, 73013

  • Alliance for Multispecialty Research, LLC

    El Dorado, Kansas, 67042

  • Centennial Medical Group

    Eldridge, Maryland, 21075

  • Tekton Research - Fort Collins

    Fort Collins, Colorado, 80525

  • Ventavia Research Group

    Fort Worth, Texas, 76104

  • Benchmark Research

    Fort Worth, Texas, 76135

  • CCT research/ Methodist Physicians Clinic- Prairie Fields

    Fremont, Nebraska, 68025

  • Velocity Clinical Research

    Grand Island, Nebraska, 68803

  • Velocity Clinical Research, Greenville

    Greenville, South Carolina, 29615

  • Delricht Research

    Gulfport, Mississippi, 39503

  • Velocity Clinical Research, Hallandale Beach

    Hallandale, Florida, 33009

  • Delricht Research

    Hendersonville, Tennessee, 37075

  • Sweet Hope Research Specialty, Inc.

    Hialeah, Florida, 33016

  • CenExel Research Centers of America

    Hollywood, Florida, 33024

  • DM Clinical Research

    Houston, Texas, 77065

  • DM Clinical Research

    Houston, Texas, 77081

  • Marvel Clinical Research 002, LLC

    Huntington Beach, California, 92647

  • Velocity Clinical Research Huntington Park

    Huntington Park, California, 90255

  • Optimal Research

    Huntsville, Alabama, 35802

  • Nature Coast Clinical Research

    Inverness, Florida, 34452

  • Encore Research Group-Jacksonville Center for Clinical Research

    Jacksonville, Florida, 32216

  • Clinical Neuroscience Solutions, Inc

    Jacksonville, Florida, 32256

  • Health Awareness INC

    Jupiter, Florida, 33458

  • The Center for Pharmaceutical Research

    Kansas City, Missouri, 64114

  • Ventavia Research Group

    Keller, Texas, 76248

  • Velocity Clinical Research

    La Mesa, California, 91942

  • Accel Clinical Research

    Lakeland, Florida, 33803

  • Chemidox Clinical Trials

    Lancaster, California, 93534

  • Accel Research Sites

    Largo, Florida, 33709

  • Wr-Crcn, Llc

    Las Vegas, Nevada, 89113

  • Johnson County Clin-Trials, Inc (JCCT)

    Lenexa, Kansas, 66219

  • Alliance for Multispecialty Research-Lexington

    Lexington, Kentucky, 40509

  • Meridian Clinical Research, LLC

    Lincoln, Nebraska, 68510

  • Lynn Institute of the Ozarks

    Little Rock, Arkansas, 72204

  • Long Beach Clinical Trials

    Long Beach, California, 90806

  • Tekton Research, Inc- Longmont Center

    Longmont, Colorado, 80501

  • Velocity Clinical Research- Westlake

    Los Angeles, California, 90057

  • Acclaim Clinical Research

    Maitland, Florida, 32751

  • DELRICHT RESEARCH at ZOMNIR FAMILY MEDICINE

    McKinney, Texas, 75072

  • Velocity Clinical Research, Medford

    Medford, Oregon, 97504

  • Velocity Clinical Research

    Meridian, Idaho, 83642

  • Benchmark Research

    Metairie, Louisiana, 70006

  • Suncoast Research Group, LLC

    Miami, Florida, 33135

  • Clinical Trials of Florida

    Miami, Florida, 33186

  • Suncoast Research Associates, LLC

    Miami, Florida, 33713

  • Floridian Clinical Research

    Miami Lakes, Florida, 33016

  • Global Health Research Center, Inc.

    Miami Lakes, Florida, 33016

  • Clinical Research Institute

    Minneapolis, Minnesota, 55402

  • Montana Medical Research, Inc

    Missoula, Montana, 59808

  • Monroe Biomedical Research

    Monroe, North Carolina, 28112

  • Tekton Research Inc

    Moore, Oklahoma, 73160

  • Carolina Health Specialists

    Myrtle Beach, South Carolina, 29572

  • Clinical Research Associates, Inc.

    Nashville, Tennessee, 37203

  • Delricht Research

    New Orleans, Louisiana, 70115

  • IMA Clinical Research

    New York, New York, 10036

  • Health Research of Hampton Roads, Inc.

    Newport News, Virginia, 23606

  • Georgia Clinic, PC/CCT Research

    Norcross, Georgia, 30092

  • Coastal Carolina Research Center

    North Charleston, South Carolina, 29464

  • Velocity Clinical Research-North Hollywood

    North Hollywood, California, 90036

  • Las Vegas Clinical Trials

    North Las Vegas, Nevada, 89030

  • Velocity Clinical Research

    Omaha, Nebraska, 68134

  • Clinical Neuroscience Solutions (CNS Healthcare site)

    Orlando, Florida, 32801

  • Headlands Research Orlando

    Orlando, Florida, 32819

  • Innovation Medical Research Center

    Palmetto Bay, Florida, 33157

  • Papillon Research Centre

    Papillion, Nebraska, 68046

  • Pines Care Research Center, Inc.

    Pembroke Pines, Florida, 33024

  • Suncoast Research Associates, LLC

    Pembroke Pines, Florida, 33324

  • DM Clinical Research

    Philadelphia, Pennsylvania, 19107

  • Phoenix Clinical Research LLC

    Phoenix, Arizona, 85014

  • FRC - CCT Research

    Phoenix, Arizona, 85244

  • Synexus

    Pinellas Park, Florida, 33781

  • Research Your Health

    Plano, Texas, 75093

  • Mountain View Ogden Clinic/CCT Research

    Pleasant View, Utah, 84404

  • Empire Clinical Research

    Pomona, California, 91786

  • Summit Research Headlands LLC

    Portland, Oregon, 97210

  • Velocity Clinical Research

    Portsmouth, Virginia, 23703

  • Delricht Clinical Research

    Prairieville, Louisiana, 70769

  • Clinical Research Partners, LLC

    Richmond, Virginia, 23226

  • CenExel - CITrials

    Riverside, California, 82506

  • Artemis Institute for Clinical Research

    Riverside, California, 92503

  • Rochester Clinical Research, Inc.

    Rochester, New York, 14609

  • Peninsula Research Associates

    Rolling Hills Estates, California, 90274

  • Be Well Clinical Studies

    Round Rock, Texas, 78681

  • Benchmark Research

    Sacramento, California, 95864

  • JBR Clinical Research

    Salt Lake City, Utah, 84107

  • J. Lewis Research, Inc. / Foothill Family Clinic South

    Salt Lake City, Utah, 84121

  • Clinical Trials of Texas, Inc.

    San Antonio, Texas, 78229

  • Diagnostics Research Group

    San Antonio, Texas, 78229

  • Tekton Research -San Antonio

    San Antonio, Texas, 78240

  • Artemis Institute for Clinical Research

    San Diego, California, 92103

  • Acclaim Clinical Research

    San Diego, California, 92120

  • Headlands Research Sarasota

    Scottsdale, Arizona, 85260

  • Great Lakes Research Institute

    Southfield, Michigan, 48075

  • Spartanburg Medical Research

    Spartanburg, South Carolina, 29303

  • Velocity Clinical Research- Spartanburg

    Spartanburg, South Carolina, 29303

  • Delricht Research

    Springfield, Missouri, 65807

  • Sundance Clinical Research, LLC

    St Louis, Missouri, 63141

  • Clinical Research Atlanta/Headlands

    Stockbridge, Georgia, 30281

  • DM Clinical Research

    Sugar Land, Texas, 77478

  • Precision Clinical Research

    Sunrise, Florida, 33351

  • Global Health Research Center, Inc.

    Tampa, Florida, 33615

  • Santos Research Center CORP

    Tampa, Florida, 33615

  • Clinical Research Consortium

    Tempe, Arizona, 85281

  • DM Clinical Research

    Tomball, Texas, 77375

  • Delricht Research

    Town and Country, Missouri, 63017

  • Noble Clinical Research, LLC

    Tucson, Arizona, 85704

  • Del Sol research Management LLC.

    Tucson, Arizona, 85715

  • Delricht Research

    Tulsa, Oklahoma, 74133

  • Velocity Clinical Research Valparaiso

    Valparaiso, Indiana, 46383

  • Versailles Family Medicine

    Versailles, Kentucky, 40383

  • Accel Research Sites- Achieve Clinical Research

    Vestavia Hills, Alabama, 35216

  • IMA Clinical Research

    Warren Township, New Jersey, 07059

  • Palm Beach Research Center

    West Palm Beach, Florida, 33409

  • Alliance for Multispecialty Research, LLC- Wichita

    Wichita, Kansas, 67207

  • Tekton Research Inc

    Wichita, Kansas, 67218

  • Trial Management Associates, LLC

    Wilmington, North Carolina, 28403

  • Tekton Research- Yukon

    Yukon, Oklahoma, 73099

Other trials in United States

United Kingdom45 sites

  • Barnsley Hospital

    Barnsley

  • Royal United Hospital Bath NHS Trust - Royal United Hospital

    Bath

  • Layton Medical Centre

    Blackpool

  • Dorset Clinical Research Centre (Bournemouth Hospital)

    Bournemouth

  • Bradford Teaching Hospitals NHS Foundation Trust - Bradford

    Bradford

  • Lakeside Healthcare

    Corby

  • Rotherham Doncaster and South Humber NHS Foundation Trust

    Doncaster

  • University of Dundee - NHS Tayside - Ninewells Hospital & Me

    Dundee

  • Western General Hospital

    Edinburgh

  • Royal Devon & Exeter Hospital

    Exeter

  • CPS Research

    Glasgow

  • NHS Greater Glasgow & Clyde

    Glasgow

  • Panthera Biopartners - Glasgow - multispeciality

    Glasgow

  • Queen Elizabeth University Hospital

    Glasgow

  • Gloucestershire Hospitals NHS Foundation Trust - Cheltenham

    Gloucester

  • Velocity Clinical Research High Wycombe

    High Wycombe

  • University Hospitals of Leicester-Leicester Royal Hospital

    Leicester

  • Barts Health NHS Trust

    London

  • Egin Research

    London

  • Guys and St. Thomas NHS Foundation Trust

    London

  • Hammersmith Medicines Research (HMR)

    London

  • Panthera Biopartners - Enfield

    London

  • Richford Gate Medical Practice

    London

  • Royal Free London NHS Foundation Trust

    London

  • St Georges Healthcare NHS Trust - University of London

    London

  • Manchester University NHS Foundation Trust

    Manchester

  • Bioluminux Clinical Research

    Milton Keynes

  • Stemax Consult Healthcare Services Ltd

    Milton Keynes

  • Newcastle University - Institute of Cellular Medicine (ICM)

    Newcastle

  • Velocity Clinical Research

    North London

  • Accellacare North London

    Northwood

  • Nottingham University Hospitals NHS Trust - Queens Medical Centre (QMC) Campus

    Nottingham

  • Wansford and Kings Cliffe Practice

    Peterborough

  • University Hospitals Plymouth NHS Trust

    Plymouth

  • Southampton General Hospital - Portsmouth Research Hub

    Portsmouth

  • GST NHS Found

    Preston

  • Panthera Biopartners Preston

    Preston

  • Panthera Biopartners - Manchester - multispeciality

    Rochdale

  • Warrington and Halton Teaching hospitals NHS Foundation Trust - Halton General Hospital

    Runcorn

  • Panthera Biopartners - Sheffield - multispeciality

    Sheffield

  • Royal Victoria Infirmary

    Sheffield

  • Southampton University Hospital NHS Foundation Trust

    Southampton

  • Pier Health Group

    Weston-super-Mare

  • Weymouth Research Hub

    Weymouth

  • North Wales Clinical Research Centre

    Wrexham

Other trials in United Kingdom

Canada12 sites

  • Intermed groupe santé

    Chicoutimi, Quebec, G7H 7Y8

  • Medicor Research Inc.

    Greater Sudbury, Ontario, P3C 1X3

  • Hamilton Medical Research group

    Hamilton, Ontario, L8M 1K7

  • Milestone Research Inc.

    London, Ontario, N5W 6A2

  • Red Maple Trials Inc.

    Ottawa, Ontario, K1H1E4

  • Centricity Research Pointe-Claire

    Pointe-Claire, Quebec, H9R 4S3

  • Manna Research Inc.

    Pointe-Claire, Quebec, H9R 4S3

  • Clinique spécialisée en allergie

    Québec, G1V 4W2

  • Q&T Research Sherbrooke Inc.

    Sherbrooke, Quebec, J1J 2G2

  • Winterberry Family Medicine

    Stoney Creek, Ontario, L8J0B6

  • Dr. Anil K. Gupta Medicine Professional Corporation

    Toronto, Ontario, M9V 4B4

  • Centricity Research Toronto Manna Multispecialty

    Toronto, Ontario, M9W 4L6

Other trials in Canada

Japan12 sites

  • Public Health Association.Inc

    Aichi

  • Tenjin Sogo Clinic

    Fukuoka

  • Yamasaki Family Clinic - internal medicine

    Hyōgo

  • Motomachi Takatsuka Naika Clinic - Internal Medicine

    Kanagawa

  • Arakawa Family Clinic

    Nagano

  • Koseikai Yotsubashi Clinic - Internal Medicine

    Osaka

  • Medical Corporation of Yamazaki Neurotology, Rhinolaryngology Clinic

    Sapporo

  • Dojinkinenkai Meiwa Hospital

    Tokyo

  • Medical Corporation Asbo Tokyo Asbo Clinic

    Tokyo

  • Metropolitan Clinic - Internal Medicine

    Tokyo

  • National Center for Global Health and Medicine

    Tokyo

  • Shinei Medical Healthcare Clinic

    Tokyo

Other trials in Japan

About this study

Official title: 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).

Conditions
COVID-19
Being tested
mRNA-1283.222, mRNA-1273.222, mRNA-1283.815, mRNA-1273.815
Keywords
mRNA-1283.222, mRNA-1273.222, mRNA-1283.815, mRNA-1273.815, SARS-CoV-2, SARS-CoV-2 Vaccine, Coronavirus, Virus Diseases, Messenger RNA, COVID-19, COVID-19 Vaccine, Moderna
Medical subject headings
COVID-19, Coronavirus Infections, Virus Diseases

What participants receive

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

  • mRNA-1283.222Biological

    Sterile liquid for injection

  • mRNA-1273.222Biological

    Sterile liquid for injection

  • mRNA-1283.815Biological

    Sterile liquid for injection

  • mRNA-1273.815Biological

    Sterile liquid for injection

Study groups in NCT05815498
Study groupRoleWhat they receive
Part 1: mRNA-1283.222ExperimentalParticipants will receive single intramuscular (IM) injection of mRNA-1283.222 on Day 1.
Receives: Biological: mRNA-1283.222
Part 1: mRNA-1273.222ExperimentalParticipants will receive single IM injection of mRNA-1273.222 on Day 1.
Receives: Biological: mRNA-1273.222
Part 2: mRNA-1283.815ExperimentalParticipants will receive single IM injection of mRNA-1283.815 on Day 1.
Receives: Biological: mRNA-1283.815
Part 2: mRNA-1273.815ExperimentalParticipants will receive single IM injection of mRNA-1273.815 on Day 1.
Receives: Biological: mRNA-1273.815

What is being measured

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

  1. Part 1: Geometric Mean (GM) of Omicron BA.4/5 at 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.

    Measured: Day 29

  2. Part 1: Seroresponse Rate (SRR) Omicron BA.4/5 at 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.

    Measured: Day 29

  3. Part 1: GM of the Ancestral Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) D614G at 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.

    Measured: Day 29

  4. Part 1: SRR of Ancestral SARS-CoV-2 D641G at 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.

    Measured: Day 29

  5. Part 1: Number of Participants With First Event of Centers for Disease Control and Prevention (CDC)-Defined COVID-19

    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.

    Measured: From 14 days after injection up to Day 365

  6. Part 1: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)

    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.

    Measured: Up to Day 7 (7-day follow-up after vaccination)

  7. Part 3: Number of Participants With Solicited Local and Systemic ARs

    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.

    Measured: Up to Day 7 (7-day follow-up after vaccination)

  8. Part 1: Number of Participants With Unsolicited Adverse Events (AEs)

    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.

    Measured: Up to Day 28 (28-day follow-up after vaccination)

  9. Part 3: Number of Participants With Unsolicited AEs

    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.

    Measured: Up to Day 28 (28-day follow-up after vaccination)

  10. 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)

    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.

    Measured: Day 1 up to Day 365

  11. Part 3: Number of Participants With Any SAEs, MAAEs, AEs Leading to Withdrawal From Study, and AESIs

    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.

    Measured: Day 1 up to Day 181

Secondary outcomes (7)

  1. Part 1: GMs of Omicron BA.4/5 and Ancestral SARS-CoV-2 D614G

    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.

    Measured: Days 91, 181, and 365

  2. Part 1: SRR Against Omicron BA.4/5 and Ancestral SARS-CoV-2 D614G at 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.

    Measured: Days 91, 181, and 365

  3. Part 1: Number of Participants With a SARS-CoV-2 Infection (Symptomatic or Asymptomatic)

    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.

    Measured: From 14 days after injection up to Day 365

  4. Part 3: GM of Omicron XBB.1.5 in Unvaccinated Participants

    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.

    Measured: Day 29

  5. Part 3: GM of Omicron XBB.1.5 in All Study Participants

    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.

    Measured: Day 29

  6. Part 3: SRR Against Omicron XBB.1.5 in Unvaccinated Participants

    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.

    Measured: Day 29

  7. Part 3: SRR Against Omicron XBB.1.5 in All Study Participants

    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.

    Measured: Day 29

Timeline

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

  1. First posted18 Apr 2023
  2. Study start28 Mar 2023
  3. Primary completion12 Apr 2025
  4. Study completion12 Apr 2025

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 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
13,553 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05815498
Sponsor's protocol ID
mRNA-1283-P301
Other IDs
2023-000884-30, 2023
Acronym
NextCOVE
Status last verified
Apr 2026
First submitted
13 Apr 2023
Last updated
1 May 2026
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • 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 Nov;25(11):1230-1242. doi: 10.1016/S1473-3099(25)00236-1. Epub 2025 Jul 7.

    PubMed 40639387

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing mRNA-1283.222, mRNA-1273.222 and mRNA-1283.815 in people with COVID-19, run by ModernaTX, Inc. at 230 sites in 4 countries.

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 4 inclusion and 9 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: finished, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 230 sites in United States, United Kingdom, Canada, Japan. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Part 1: Geometric Mean (GM) of Omicron BA.4/5 at Day 29 (time frame: Day 29). The study lists 11 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 NCT05815498, which also lists 1 linked publication.

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 1 May 2026.

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