Un estudio de la inyección de ARNm-1283.222 en comparación con la inyección de ARNm-1273.222 en participantes ≥12 años de edad para prevenir la COVID-19 (NextCOVE)
10 de abril de 2026 actualizado por: ModernaTX, Inc.
Un estudio de fase 3 aleatorizado, observador ciego, con control activo para investigar la seguridad, la inmunogenicidad y la eficacia relativa de la vacuna mRNA-1283.222 administrada como dosis de refuerzo en comparación con mRNA-1273.222 en participantes de 12 años o más para la prevención de COVID -19
El propósito de este estudio es evaluar la seguridad, la reactogenicidad y la eficacia vacunal relativa (rVE) del mRNA-1283.222
vacuna así como su inmunogenicidad en comparación con el mRNA-1273.222
vacuna.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
13553
Fase
- Fase 3
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Québec, Canadá, G1V 4W2
- Clinique spécialisée en allergie
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Ontario
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Greater Sudbury, Ontario, Canadá, P3C 1X3
- Medicor Research Inc.
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Hamilton, Ontario, Canadá, L8M 1K7
- Hamilton Medical Research Group
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London, Ontario, Canadá, N5W 6A2
- Milestone Research Inc.
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Ottawa, Ontario, Canadá, K1H1E4
- Red Maple Trials Inc.
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Stoney Creek, Ontario, Canadá, L8J0B6
- Winterberry Family Medicine
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Toronto, Ontario, Canadá, M9V 4B4
- Dr. Anil K. Gupta Medicine Professional Corporation
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Toronto, Ontario, Canadá, M9W 4L6
- Centricity Research Toronto Manna Multispecialty
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Quebec
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Chicoutimi, Quebec, Canadá, G7H 7Y8
- INTERMED groupe santé
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Pointe-Claire, Quebec, Canadá, H9R 4S3
- Centricity Research Pointe-Claire
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Pointe-Claire, Quebec, Canadá, H9R 4S3
- Manna Research Inc.
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Sherbrooke, Quebec, Canadá, J1J 2G2
- Q&T Research Sherbrooke Inc.
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Alabama
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Huntsville, Alabama, Estados Unidos, 35802
- Optimal Research
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Vestavia Hills, Alabama, Estados Unidos, 35216
- Accel Research Sites- Achieve Clinical Research
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Arizona
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Chandler, Arizona, Estados Unidos, 85224
- Chandler Clinical Trials
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Phoenix, Arizona, Estados Unidos, 85014
- Phoenix Clinical Research LLC
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Phoenix, Arizona, Estados Unidos, 85244
- FRC - CCT Research
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Scottsdale, Arizona, Estados Unidos, 85260
- Headlands Research Sarasota
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Tempe, Arizona, Estados Unidos, 85281
- Clinical Research Consortium
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Tucson, Arizona, Estados Unidos, 85704
- Noble Clinical Research, LLC
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Tucson, Arizona, Estados Unidos, 85715
- Del Sol research Management LLC.
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Arkansas
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Little Rock, Arkansas, Estados Unidos, 72204
- Lynn Institute of the Ozarks
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California
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Anaheim, California, Estados Unidos, 92801
- Anaheim Clinical Trials, LLC
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Banning, California, Estados Unidos, 92220
- Velocity Clinical Research, Banning
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Chula Vista, California, Estados Unidos, 91911
- Velocity Clinical Research- Chula Vista
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Colton, California, Estados Unidos, 92324
- Benchmark Research
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Huntington Beach, California, Estados Unidos, 92647
- Marvel Clinical Research 002, LLC
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Huntington Park, California, Estados Unidos, 90255
- Velocity Clinical Research Huntington Park
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La Mesa, California, Estados Unidos, 91942
- Velocity Clinical Research
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Lancaster, California, Estados Unidos, 93534
- Chemidox Clinical Trials
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Long Beach, California, Estados Unidos, 90806
- Long Beach Clinical Trials
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Los Angeles, California, Estados Unidos, 90057
- Velocity Clinical Research- Westlake
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North Hollywood, California, Estados Unidos, 90036
- Velocity Clinical Research-North Hollywood
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Pomona, California, Estados Unidos, 91786
- Empire Clinical Research
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Riverside, California, Estados Unidos, 92503
- Artemis Institute for Clinical Research
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Riverside, California, Estados Unidos, 82506
- CenExel - CITrials
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Rolling Hills Estates, California, Estados Unidos, 90274
- Peninsula Research Associates
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Sacramento, California, Estados Unidos, 95864
- Benchmark Research
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San Diego, California, Estados Unidos, 92103
- Artemis Institute for Clinical Research
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San Diego, California, Estados Unidos, 92120
- Acclaim Clinical Research
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Colorado
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Aurora, Colorado, Estados Unidos, 80012
- Lynn Institute of Denver
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Denver, Colorado, Estados Unidos, 80209
- Velocity Clinical Research Denver
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Fort Collins, Colorado, Estados Unidos, 80525
- Tekton Research - Fort Collins
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Longmont, Colorado, Estados Unidos, 80501
- Tekton Research, Inc- Longmont Center
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Florida
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Coral Gables, Florida, Estados Unidos, 33134
- Alliance for Multispeciality Research - Miami
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Crystal River, Florida, Estados Unidos, 34429
- Nature Coast Clinical Research
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Cutler Bay, Florida, Estados Unidos, 33157
- Beautiful Minds Clinical Research Center
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DeLand, Florida, Estados Unidos, 32720
- Clinical Research Partners LLC
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DeLand, Florida, Estados Unidos, 32720
- Hillcrest Medical Research, LLC
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Hallandale, Florida, Estados Unidos, 33009
- Velocity Clinical Research, Hallandale Beach
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Hialeah, Florida, Estados Unidos, 33016
- Sweet Hope Research Specialty, Inc.
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Hollywood, Florida, Estados Unidos, 33024
- CenExel Research Centers of America
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Inverness, Florida, Estados Unidos, 34452
- Nature Coast Clinical Research
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Jacksonville, Florida, Estados Unidos, 32256
- Clinical Neuroscience Solutions, Inc
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Jacksonville, Florida, Estados Unidos, 32216
- Encore Research Group-Jacksonville Center for Clinical Research
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Jupiter, Florida, Estados Unidos, 33458
- Health Awareness INC
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Lakeland, Florida, Estados Unidos, 33803
- Accel Clinical Research
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Largo, Florida, Estados Unidos, 33709
- Accel Research Sites
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Maitland, Florida, Estados Unidos, 32751
- Acclaim Clinical Research
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Miami, Florida, Estados Unidos, 33135
- Suncoast Research Group, LLC
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Miami, Florida, Estados Unidos, 33186
- Clinical Trials of Florida
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Miami, Florida, Estados Unidos, 33713
- Suncoast Research Associates, LLC
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Miami Lakes, Florida, Estados Unidos, 33016
- Global Health Research Center, Inc.
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Miami Lakes, Florida, Estados Unidos, 33016
- Floridian Clinical Research
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Orlando, Florida, Estados Unidos, 32819
- Headlands Research Orlando
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Orlando, Florida, Estados Unidos, 32801
- Clinical Neuroscience Solutions (CNS Healthcare site)
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Palmetto Bay, Florida, Estados Unidos, 33157
- Innovation Medical Research Center
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Pembroke Pines, Florida, Estados Unidos, 33024
- Pines Care Research Center, Inc.
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Pembroke Pines, Florida, Estados Unidos, 33324
- Suncoast Research Associates, LLC
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Pinellas Park, Florida, Estados Unidos, 33781
- SYNEXUS
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Sunrise, Florida, Estados Unidos, 33351
- Precision Clinical Research
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Tampa, Florida, Estados Unidos, 33615
- Global Health Research Center, Inc.
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Tampa, Florida, Estados Unidos, 33615
- Santos Research Center CORP
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West Palm Beach, Florida, Estados Unidos, 33409
- Palm Beach Research Center
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Georgia
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Atlanta, Georgia, Estados Unidos, 30342
- Atlanta Clinical Research Center
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Atlanta, Georgia, Estados Unidos, 30329
- DelRicht Research
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Chamblee, Georgia, Estados Unidos, 30341
- Baybol Research Institute
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Columbus, Georgia, Estados Unidos, 31904
- Centricity Research
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Decatur, Georgia, Estados Unidos, 30030
- Elite Research Network
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Eatonton, Georgia, Estados Unidos, 31024
- Accel Research Sites Lake Oconee
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Norcross, Georgia, Estados Unidos, 30092
- Georgia Clinic, PC/CCT Research
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Stockbridge, Georgia, Estados Unidos, 30281
- Clinical Research Atlanta/Headlands
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Idaho
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Meridian, Idaho, Estados Unidos, 83642
- Velocity Clinical Research
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Illinois
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Chicago, Illinois, Estados Unidos, 60640
- Great Lakes Clinical Trials
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Chicago, Illinois, Estados Unidos, 60607
- Chicago Clinical Research Institute
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Indiana
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Valparaiso, Indiana, Estados Unidos, 46383
- Velocity Clinical Research Valparaiso
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Kansas
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El Dorado, Kansas, Estados Unidos, 67042
- Alliance for Multispecialty Research, LLC
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Lenexa, Kansas, Estados Unidos, 66219
- Johnson County Clin-Trials, Inc (JCCT)
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Wichita, Kansas, Estados Unidos, 67207
- Alliance for Multispecialty Research, LLC- Wichita
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Wichita, Kansas, Estados Unidos, 67218
- Tekton Research Inc
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Kentucky
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Lexington, Kentucky, Estados Unidos, 40509
- Alliance for Multispecialty Research-Lexington
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Versailles, Kentucky, Estados Unidos, 40383
- Versailles Family Medicine
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Louisiana
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Baton Rouge, Louisiana, Estados Unidos, 70809
- Meridian Clinical Research
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Covington, Louisiana, Estados Unidos, 70433
- MedPharmics
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Covington, Louisiana, Estados Unidos, 70006
- Benchmark Research
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Metairie, Louisiana, Estados Unidos, 70006
- Benchmark Research
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New Orleans, Louisiana, Estados Unidos, 70115
- DelRicht Research
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Prairieville, Louisiana, Estados Unidos, 70769
- DelRicht Clinical Research
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Maryland
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Eldridge, Maryland, Estados Unidos, 21075
- Centennial Medical Group
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02115
- Brigham and Women's Hospital
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Brookline, Massachusetts, Estados Unidos, 02445
- DM Clinical Research
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Michigan
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Southfield, Michigan, Estados Unidos, 48075
- Great Lakes Research Institute
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Minnesota
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Minneapolis, Minnesota, Estados Unidos, 55402
- Clinical Research Institute
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Mississippi
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Gulfport, Mississippi, Estados Unidos, 39503
- DelRicht Research
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Missouri
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Kansas City, Missouri, Estados Unidos, 64114
- The Center for Pharmaceutical Research
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Springfield, Missouri, Estados Unidos, 65807
- DelRicht Research
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St Louis, Missouri, Estados Unidos, 63141
- Sundance Clinical Research, LLC
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Town and Country, Missouri, Estados Unidos, 63017
- DelRicht Research
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Montana
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Missoula, Montana, Estados Unidos, 59808
- Montana Medical Research, Inc
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Nebraska
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Fremont, Nebraska, Estados Unidos, 68025
- CCT research/ Methodist Physicians Clinic- Prairie Fields
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Grand Island, Nebraska, Estados Unidos, 68803
- Velocity Clinical Research
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Lincoln, Nebraska, Estados Unidos, 68510
- Meridian Clinical Research, LLC
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Omaha, Nebraska, Estados Unidos, 68134
- Velocity Clinical Research
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Papillion, Nebraska, Estados Unidos, 68046
- Papillon Research Centre
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Nevada
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Las Vegas, Nevada, Estados Unidos, 89113
- Wr-Crcn, Llc
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North Las Vegas, Nevada, Estados Unidos, 89030
- Las Vegas Clinical Trials
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New Jersey
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Warren Township, New Jersey, Estados Unidos, 07059
- IMA Clinical Research
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New Mexico
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Albuquerque, New Mexico, Estados Unidos, 87109
- IMA Clinical Research
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Albuquerque, New Mexico, Estados Unidos, 87102
- Velocity Clinical Research- New Mexico
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New York
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East Syracuse, New York, Estados Unidos, 13057
- Velocity Clinical Research, Syracuse
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New York, New York, Estados Unidos, 10036
- IMA Clinical Research
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Rochester, New York, Estados Unidos, 14609
- Rochester Clinical Research, Inc.
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North Carolina
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Monroe, North Carolina, Estados Unidos, 28112
- Monroe Biomedical Research
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Wilmington, North Carolina, Estados Unidos, 28403
- Trial Management Associates, LLC
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Ohio
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Cincinnati, Ohio, Estados Unidos, 45212
- CTI Clinical Research Center
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Cincinnati, Ohio, Estados Unidos, 45242
- Velocity Clinical Research
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Cincinnati, Ohio, Estados Unidos, 45219
- Velocity Clinical Research, Inc
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Cincinnati, Ohio, Estados Unidos, 45246
- Velocity Clinical Research - Cincinnati
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Cleveland, Ohio, Estados Unidos, 44122
- Velocity Clinical Research
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Oklahoma
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Edmond, Oklahoma, Estados Unidos, 73013
- Tekton Research- Edmond
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Moore, Oklahoma, Estados Unidos, 73160
- Tekton Research Inc
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Tulsa, Oklahoma, Estados Unidos, 74133
- DelRicht Research
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Yukon, Oklahoma, Estados Unidos, 73099
- Tekton Research- Yukon
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Oregon
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Medford, Oregon, Estados Unidos, 97504
- Velocity Clinical Research, Medford
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Portland, Oregon, Estados Unidos, 97210
- Summit Research Headlands LLC
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19107
- DM Clinical Research
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South Carolina
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Anderson, South Carolina, Estados Unidos, 29621
- Synexus Clinical Research US, Inc
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Anderson, South Carolina, Estados Unidos, 29621
- Velocity Clinical Research-Anderson
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Charleston, South Carolina, Estados Unidos, 29407
- DelRicht Research
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Columbia, South Carolina, Estados Unidos, 29204
- Velocity Clinical Research
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Greenville, South Carolina, Estados Unidos, 29615
- Velocity Clinical Research, Greenville
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Myrtle Beach, South Carolina, Estados Unidos, 29572
- Carolina Health Specialists
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North Charleston, South Carolina, Estados Unidos, 29464
- Coastal Carolina Research Center
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Spartanburg, South Carolina, Estados Unidos, 29303
- Spartanburg Medical Research
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Spartanburg, South Carolina, Estados Unidos, 29303
- Velocity Clinical Research- Spartanburg
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Tennessee
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Hendersonville, Tennessee, Estados Unidos, 37075
- DelRicht Research
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Nashville, Tennessee, Estados Unidos, 37203
- Clinical Research Associates, Inc.
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Texas
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Austin, Texas, Estados Unidos, 78705
- Benchmark Research
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Austin, Texas, Estados Unidos, 78745
- Tekton Research Inc
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Beaumont, Texas, Estados Unidos, 77706
- Tekton Research - Beaumont
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Brownsville, Texas, Estados Unidos, 78520
- PanAmerican Clinical Research, LLC
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Brownsville, Texas, Estados Unidos, 78526
- Headlands Research Brownsville
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Dallas, Texas, Estados Unidos, 75230
- Zenos Clinical Research
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Fort Worth, Texas, Estados Unidos, 76135
- Benchmark Research
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Fort Worth, Texas, Estados Unidos, 76104
- Ventavia Research Group
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Houston, Texas, Estados Unidos, 77065
- DM Clinical Research
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Houston, Texas, Estados Unidos, 77081
- DM Clinical Research
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Keller, Texas, Estados Unidos, 76248
- Ventavia Research Group
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McKinney, Texas, Estados Unidos, 75072
- DELRICHT RESEARCH at ZOMNIR FAMILY MEDICINE
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Plano, Texas, Estados Unidos, 75093
- Research Your Health
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Round Rock, Texas, Estados Unidos, 78681
- Be Well Clinical Studies
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San Antonio, Texas, Estados Unidos, 78229
- Diagnostics Research Group
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San Antonio, Texas, Estados Unidos, 78229
- Clinical Trials of Texas, Inc.
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San Antonio, Texas, Estados Unidos, 78240
- Tekton Research -San Antonio
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Sugar Land, Texas, Estados Unidos, 77478
- DM Clinical Research
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Tomball, Texas, Estados Unidos, 77375
- DM Clinical Research
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Utah
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Bountiful, Utah, Estados Unidos, 84010
- Cope Family Medicine
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Pleasant View, Utah, Estados Unidos, 84404
- Mountain View Ogden Clinic/CCT Research
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Salt Lake City, Utah, Estados Unidos, 84107
- JBR Clinical Research
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Salt Lake City, Utah, Estados Unidos, 84121
- J. Lewis Research, Inc. / Foothill Family Clinic South
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Virginia
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Newport News, Virginia, Estados Unidos, 23606
- Health Research of Hampton Roads, Inc.
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Portsmouth, Virginia, Estados Unidos, 23703
- Velocity Clinical Research
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Richmond, Virginia, Estados Unidos, 23226
- Clinical Research Partners, LLC
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Aichi, Japón
- Public Health Association.Inc
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Fukuoka, Japón
- Tenjin Sogo Clinic
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Hyōgo, Japón
- Yamasaki Family Clinic - internal medicine
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Kanagawa, Japón
- Motomachi Takatsuka Naika Clinic - Internal Medicine
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Nagano, Japón
- Arakawa Family Clinic
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Osaka, Japón
- Koseikai Yotsubashi Clinic - Internal Medicine
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Sapporo, Japón
- Medical Corporation of Yamazaki Neurotology, Rhinolaryngology Clinic
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Tokyo, Japón
- Dojinkinenkai Meiwa Hospital
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Tokyo, Japón
- Medical Corporation Asbo Tokyo Asbo Clinic
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Tokyo, Japón
- National Center for Global Health and Medicine
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Tokyo, Japón
- Metropolitan Clinic - Internal Medicine
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Tokyo, Japón
- Shinei Medical Healthcare Clinic
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Barnsley, Reino Unido
- Barnsley Hospital
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Bath, Reino Unido
- Royal United Hospital Bath NHS Trust - Royal United Hospital
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Blackpool, Reino Unido
- Layton Medical Centre
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Bournemouth, Reino Unido
- Dorset Clinical Research Centre (Bournemouth Hospital)
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Bradford, Reino Unido
- Bradford Teaching Hospitals NHS Foundation Trust - Bradford
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Corby, Reino Unido
- Lakeside Healthcare
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Doncaster, Reino Unido
- Rotherham Doncaster and South Humber NHS Foundation Trust
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Dundee, Reino Unido
- University of Dundee - NHS Tayside - Ninewells Hospital & Me
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Edinburgh, Reino Unido
- Western General Hospital
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Exeter, Reino Unido
- Royal Devon & Exeter Hospital
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Glasgow, Reino Unido
- CPS Research
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Glasgow, Reino Unido
- Queen Elizabeth University Hospital
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Glasgow, Reino Unido
- NHS Greater Glasgow & Clyde
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Glasgow, Reino Unido
- Panthera Biopartners - Glasgow - multispeciality
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Gloucester, Reino Unido
- Gloucestershire Hospitals NHS Foundation Trust - Cheltenham
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High Wycombe, Reino Unido
- Velocity Clinical Research High Wycombe
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Leicester, Reino Unido
- University Hospitals of Leicester-Leicester Royal Hospital
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London, Reino Unido
- Royal Free London NHS Foundation Trust
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London, Reino Unido
- Guys and St. Thomas NHS Foundation Trust
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London, Reino Unido
- Barts Health NHS Trust
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London, Reino Unido
- Hammersmith Medicines Research (HMR)
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London, Reino Unido
- Egin Research
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London, Reino Unido
- Panthera Biopartners - Enfield
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London, Reino Unido
- Richford Gate Medical Practice
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London, Reino Unido
- St Georges Healthcare NHS Trust - University of London
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Manchester, Reino Unido
- Manchester University NHS Foundation Trust
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Milton Keynes, Reino Unido
- Bioluminux Clinical Research
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Milton Keynes, Reino Unido
- Stemax Consult Healthcare Services Ltd
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Newcastle, Reino Unido
- Newcastle University - Institute of Cellular Medicine (ICM)
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North London, Reino Unido
- Velocity Clinical Research
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Northwood, Reino Unido
- Accellacare North London
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Nottingham, Reino Unido
- Nottingham University Hospitals NHS Trust - Queens Medical Centre (QMC) Campus
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Peterborough, Reino Unido
- Wansford and Kings Cliffe Practice
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Plymouth, Reino Unido
- University Hospitals Plymouth NHS Trust
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Portsmouth, Reino Unido
- Southampton General Hospital - Portsmouth Research Hub
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Preston, Reino Unido
- GST NHS Found
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Preston, Reino Unido
- Panthera Biopartners Preston
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Rochdale, Reino Unido
- Panthera Biopartners - Manchester - multispeciality
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Runcorn, Reino Unido
- Warrington and Halton Teaching Hospitals NHS Foundation Trust - Halton General Hospital
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Sheffield, Reino Unido
- Panthera Biopartners - Sheffield - multispeciality
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Sheffield, Reino Unido
- Royal Victoria Infirmary
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Southampton, Reino Unido
- Southampton University Hospital NHS Foundation Trust
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Weston-super-Mare, Reino Unido
- Pier Health Group
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Weymouth, Reino Unido
- Weymouth Research Hub
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Wrexham, Reino Unido
- North Wales Clinical Research Centre
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Descripción
Criterios clave de inclusión:
- La evaluación del investigador de que el participante comprende y está dispuesto y es físicamente capaz de cumplir con el seguimiento obligatorio del protocolo, incluidos todos los procedimientos.
- Para participantes femeninas en edad fértil: prueba de embarazo negativa, anticoncepción adecuada o se ha abstenido de todas las actividades que podrían resultar en un embarazo durante al menos 28 días antes de la primera inyección, y acuerdo para continuar con la anticoncepción adecuada o la abstinencia durante los 90 días posteriores a la administración de la vacuna. .
- Ha recibido previamente una serie primaria de una vacuna COVID-19 autorizada/aprobada. Para participantes ≥18 años de edad, también se debe haber recibido al menos 1 dosis de refuerzo. Un régimen de vacunas heterólogas es aceptable.
Criterios clave de exclusión:
- Ha tenido contacto cercano, según lo definido por los Centros para el Control y la Prevención de Enfermedades (CDC), con alguien que tuvo una infección por SARS-CoV-2 en los últimos 14 días o COVID-19 en los últimos 10 días.
- El participante está gravemente enfermo o febril (temperatura ≥38,0 grados Celsius [°C]/100,4 grados Fahrenheit [°F]) 72 horas antes o durante la visita de selección o el día 1.
- Cualquier condición médica, psiquiátrica u ocupacional, incluidos los antecedentes informados de abuso de sustancias, que, en opinión del investigador, podría presentar un riesgo adicional debido a la participación en el estudio o podría interferir con la interpretación de los resultados del estudio.
- Ha recibido inmunosupresores sistémicos o fármacos inmunomodificadores durante >14 días en total dentro de los 181 días anteriores a la Selección (para corticosteroides ≥10 mg/día de equivalente de prednisona) o está anticipando la necesidad de tratamiento inmunosupresor en cualquier momento durante la participación en el estudio.
- Ha recibido o planea recibir cualquier vacuna autorizada ≤60 días antes de la inyección del estudio (Día 1) o planea recibir una vacuna autorizada dentro de los 60 días posteriores a la inyección del estudio.
- Ha recibido inmunoglobulinas sistémicas o hemoderivados dentro de los 90 días anteriores a la visita de selección o planea recibirlos durante el estudio.
- Ha donado ≥450 mililitros (ml) de hemoderivados en los 28 días anteriores a la visita de selección o planea donar hemoderivados durante el estudio.
- Ha participado en un estudio clínico de intervención dentro de los 28 días anteriores a la visita de selección según la entrevista de historial médico o planea hacerlo mientras participa en este estudio.
Nota: Pueden aplicarse otros criterios de inclusión y exclusión.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Parte 1: ARNm-1283.222
Los participantes recibirán una única inyección intramuscular (IM) de ARNm-1283.222.
el día 1.
|
Líquido estéril para inyección
|
|
Experimental: Parte 1: ARNm-1273.222
Los participantes recibirán una única inyección IM de ARNm-1273.222.
el día 1.
|
Líquido estéril para inyección
|
|
Experimental: Parte 2: ARNm-1283.815
Los participantes recibirán una única inyección IM de ARNm-1283.815.
el día 1.
|
Líquido estéril para inyección.
|
|
Experimental: Parte 2: ARNm-1273.815
Los participantes recibirán una única inyección IM de ARNm-1273.815.
el día 1.
|
Líquido estéril para inyección
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Part 1: Geometric Mean (GM) of Omicron BA.4/5 at Day 29
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Part 1: GMs of Omicron BA.4/5 and Ancestral SARS-CoV-2 D614G
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
28 de marzo de 2023
Finalización primaria (Actual)
12 de abril de 2025
Finalización del estudio (Actual)
12 de abril de 2025
Fechas de registro del estudio
Enviado por primera vez
13 de abril de 2023
Primero enviado que cumplió con los criterios de control de calidad
13 de abril de 2023
Publicado por primera vez (Actual)
18 de abril de 2023
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
1 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
10 de abril de 2026
Última verificación
1 de abril de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- mRNA-1283-P301
- 2023-000884-30 (Número EudraCT)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .