Uno studio sull'iniezione di mRNA-1283.222 rispetto all'iniezione di mRNA-1273.222 in partecipanti di età ≥12 anni per prevenire COVID-19 (NextCOVE)
10 aprile 2026 aggiornato da: ModernaTX, Inc.
Uno studio di fase 3 randomizzato, in cieco per l'osservatore, con controllo attivo per studiare la sicurezza, l'immunogenicità e l'efficacia relativa del vaccino dell'mRNA-1283.222 somministrato come dose di richiamo rispetto all'mRNA-1273.222 nei partecipanti di età pari o superiore a 12 anni per la prevenzione del COVID -19
Lo scopo di questo studio è valutare la sicurezza, la reattogenicità e l'efficacia relativa del vaccino (rVE) dell'mRNA-1283.222
vaccino così come la sua immunogenicità rispetto al mRNA-1273.222
vaccino.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
13553
Fase
- Fase 3
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Québec, Canada, G1V 4W2
- Clinique spécialisée en allergie
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Ontario
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Greater Sudbury, Ontario, Canada, P3C 1X3
- Medicor Research Inc.
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Hamilton, Ontario, Canada, L8M 1K7
- Hamilton Medical Research Group
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London, Ontario, Canada, N5W 6A2
- Milestone Research Inc.
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Ottawa, Ontario, Canada, K1H1E4
- Red Maple Trials Inc.
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Stoney Creek, Ontario, Canada, L8J0B6
- Winterberry Family Medicine
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Toronto, Ontario, Canada, M9V 4B4
- Dr. Anil K. Gupta Medicine Professional Corporation
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Toronto, Ontario, Canada, M9W 4L6
- Centricity Research Toronto Manna Multispecialty
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Quebec
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Chicoutimi, Quebec, Canada, G7H 7Y8
- INTERMED Groupe Sante
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Pointe-Claire, Quebec, Canada, H9R 4S3
- Centricity Research Pointe-Claire
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Pointe-Claire, Quebec, Canada, H9R 4S3
- Manna Research Inc.
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Sherbrooke, Quebec, Canada, J1J 2G2
- Q&T Research Sherbrooke Inc.
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Aichi, Giappone
- Public Health Association.Inc
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Fukuoka, Giappone
- Tenjin Sogo Clinic
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Hyōgo, Giappone
- Yamasaki Family Clinic - internal medicine
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Kanagawa, Giappone
- Motomachi Takatsuka Naika Clinic - Internal Medicine
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Nagano, Giappone
- Arakawa Family Clinic
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Osaka, Giappone
- Koseikai Yotsubashi Clinic - Internal Medicine
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Sapporo, Giappone
- Medical Corporation of Yamazaki Neurotology, Rhinolaryngology Clinic
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Tokyo, Giappone
- Dojinkinenkai Meiwa Hospital
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Tokyo, Giappone
- Medical Corporation Asbo Tokyo Asbo Clinic
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Tokyo, Giappone
- National Center for Global Health and Medicine
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Tokyo, Giappone
- Metropolitan Clinic - Internal Medicine
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Tokyo, Giappone
- Shinei Medical Healthcare Clinic
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Barnsley, Regno Unito
- Barnsley Hospital
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Bath, Regno Unito
- Royal United Hospital Bath NHS Trust - Royal United Hospital
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Blackpool, Regno Unito
- Layton Medical Centre
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Bournemouth, Regno Unito
- Dorset Clinical Research Centre (Bournemouth Hospital)
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Bradford, Regno Unito
- Bradford Teaching Hospitals NHS Foundation Trust - Bradford
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Corby, Regno Unito
- Lakeside Healthcare
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Doncaster, Regno Unito
- Rotherham Doncaster and South Humber NHS Foundation Trust
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Dundee, Regno Unito
- University of Dundee - NHS Tayside - Ninewells Hospital & Me
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Edinburgh, Regno Unito
- Western General Hospital
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Exeter, Regno Unito
- Royal Devon & Exeter Hospital
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Glasgow, Regno Unito
- CPS Research
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Glasgow, Regno Unito
- Queen Elizabeth University Hospital
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Glasgow, Regno Unito
- NHS Greater Glasgow & Clyde
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Glasgow, Regno Unito
- Panthera Biopartners - Glasgow - multispeciality
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Gloucester, Regno Unito
- Gloucestershire Hospitals NHS Foundation Trust - Cheltenham
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High Wycombe, Regno Unito
- Velocity Clinical Research High Wycombe
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Leicester, Regno Unito
- University Hospitals of Leicester-Leicester Royal Hospital
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London, Regno Unito
- Royal Free London NHS Foundation Trust
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London, Regno Unito
- Guys and St. Thomas NHS Foundation Trust
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London, Regno Unito
- Barts Health Nhs Trust
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London, Regno Unito
- Hammersmith Medicines Research (HMR)
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London, Regno Unito
- Egin Research
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London, Regno Unito
- Panthera Biopartners - Enfield
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London, Regno Unito
- Richford Gate Medical Practice
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London, Regno Unito
- St Georges Healthcare NHS Trust - University of London
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Manchester, Regno Unito
- Manchester University NHS Foundation Trust
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Milton Keynes, Regno Unito
- Bioluminux Clinical Research
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Milton Keynes, Regno Unito
- Stemax Consult Healthcare Services Ltd
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Newcastle, Regno Unito
- Newcastle University - Institute of Cellular Medicine (ICM)
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North London, Regno Unito
- Velocity Clinical Research
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Northwood, Regno Unito
- Accellacare North London
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Nottingham, Regno Unito
- Nottingham University Hospitals NHS Trust - Queens Medical Centre (QMC) Campus
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Peterborough, Regno Unito
- Wansford and Kings Cliffe Practice
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Plymouth, Regno Unito
- University Hospitals Plymouth NHS Trust
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Portsmouth, Regno Unito
- Southampton General Hospital - Portsmouth Research Hub
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Preston, Regno Unito
- GST NHS Found
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Preston, Regno Unito
- Panthera Biopartners Preston
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Rochdale, Regno Unito
- Panthera Biopartners - Manchester - multispeciality
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Runcorn, Regno Unito
- Warrington and Halton Teaching Hospitals NHS Foundation Trust - Halton General Hospital
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Sheffield, Regno Unito
- Panthera Biopartners - Sheffield - multispeciality
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Sheffield, Regno Unito
- Royal Victoria Infirmary
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Southampton, Regno Unito
- Southampton University Hospital NHS Foundation Trust
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Weston-super-Mare, Regno Unito
- Pier Health Group
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Weymouth, Regno Unito
- Weymouth Research Hub
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Wrexham, Regno Unito
- North Wales Clinical Research Centre
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Alabama
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Huntsville, Alabama, Stati Uniti, 35802
- Optimal Research
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Vestavia Hills, Alabama, Stati Uniti, 35216
- Accel Research Sites- Achieve Clinical Research
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Arizona
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Chandler, Arizona, Stati Uniti, 85224
- Chandler Clinical Trials
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Phoenix, Arizona, Stati Uniti, 85014
- Phoenix Clinical Research LLC
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Phoenix, Arizona, Stati Uniti, 85244
- FRC - CCT Research
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Scottsdale, Arizona, Stati Uniti, 85260
- Headlands Research Sarasota
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Tempe, Arizona, Stati Uniti, 85281
- Clinical Research Consortium
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Tucson, Arizona, Stati Uniti, 85704
- Noble Clinical Research, LLC
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Tucson, Arizona, Stati Uniti, 85715
- Del Sol research Management LLC.
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Arkansas
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Little Rock, Arkansas, Stati Uniti, 72204
- Lynn Institute of the Ozarks
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California
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Anaheim, California, Stati Uniti, 92801
- Anaheim Clinical Trials, LLC
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Banning, California, Stati Uniti, 92220
- Velocity Clinical Research, Banning
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Chula Vista, California, Stati Uniti, 91911
- Velocity Clinical Research- Chula Vista
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Colton, California, Stati Uniti, 92324
- Benchmark Research
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Huntington Beach, California, Stati Uniti, 92647
- Marvel Clinical Research 002, LLC
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Huntington Park, California, Stati Uniti, 90255
- Velocity Clinical Research Huntington Park
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La Mesa, California, Stati Uniti, 91942
- Velocity Clinical Research
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Lancaster, California, Stati Uniti, 93534
- Chemidox Clinical Trials
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Long Beach, California, Stati Uniti, 90806
- Long Beach Clinical Trials
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Los Angeles, California, Stati Uniti, 90057
- Velocity Clinical Research- Westlake
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North Hollywood, California, Stati Uniti, 90036
- Velocity Clinical Research-North Hollywood
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Pomona, California, Stati Uniti, 91786
- Empire Clinical Research
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Riverside, California, Stati Uniti, 92503
- Artemis Institute for Clinical Research
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Riverside, California, Stati Uniti, 82506
- CenExel - CITrials
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Rolling Hills Estates, California, Stati Uniti, 90274
- Peninsula Research Associates
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Sacramento, California, Stati Uniti, 95864
- Benchmark Research
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San Diego, California, Stati Uniti, 92103
- Artemis Institute for Clinical Research
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San Diego, California, Stati Uniti, 92120
- Acclaim Clinical Research
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Colorado
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Aurora, Colorado, Stati Uniti, 80012
- Lynn Institute of Denver
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Denver, Colorado, Stati Uniti, 80209
- Velocity Clinical Research Denver
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Fort Collins, Colorado, Stati Uniti, 80525
- Tekton Research - Fort Collins
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Longmont, Colorado, Stati Uniti, 80501
- Tekton Research, Inc- Longmont Center
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Florida
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Coral Gables, Florida, Stati Uniti, 33134
- Alliance for Multispeciality Research - Miami
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Crystal River, Florida, Stati Uniti, 34429
- Nature Coast Clinical Research
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Cutler Bay, Florida, Stati Uniti, 33157
- Beautiful Minds Clinical Research Center
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DeLand, Florida, Stati Uniti, 32720
- Clinical Research Partners LLC
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DeLand, Florida, Stati Uniti, 32720
- Hillcrest Medical Research, LLC
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Hallandale, Florida, Stati Uniti, 33009
- Velocity Clinical Research, Hallandale Beach
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Hialeah, Florida, Stati Uniti, 33016
- Sweet Hope Research Specialty, Inc.
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Hollywood, Florida, Stati Uniti, 33024
- CenExel Research Centers of America
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Inverness, Florida, Stati Uniti, 34452
- Nature Coast Clinical Research
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Jacksonville, Florida, Stati Uniti, 32256
- Clinical Neuroscience Solutions, Inc
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Jacksonville, Florida, Stati Uniti, 32216
- Encore Research Group-Jacksonville Center for Clinical Research
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Jupiter, Florida, Stati Uniti, 33458
- Health Awareness Inc
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Lakeland, Florida, Stati Uniti, 33803
- Accel Clinical Research
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Largo, Florida, Stati Uniti, 33709
- Accel Research Sites
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Maitland, Florida, Stati Uniti, 32751
- Acclaim Clinical Research
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Miami, Florida, Stati Uniti, 33135
- Suncoast Research Group, LLC
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Miami, Florida, Stati Uniti, 33186
- Clinical Trials of Florida
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Miami, Florida, Stati Uniti, 33713
- Suncoast Research Associates, LLC
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Miami Lakes, Florida, Stati Uniti, 33016
- Global Health Research Center, Inc.
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Miami Lakes, Florida, Stati Uniti, 33016
- Floridian Clinical Research
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Orlando, Florida, Stati Uniti, 32819
- Headlands Research Orlando
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Orlando, Florida, Stati Uniti, 32801
- Clinical Neuroscience Solutions (CNS Healthcare site)
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Palmetto Bay, Florida, Stati Uniti, 33157
- Innovation Medical Research Center
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Pembroke Pines, Florida, Stati Uniti, 33024
- Pines Care Research Center, Inc.
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Pembroke Pines, Florida, Stati Uniti, 33324
- Suncoast Research Associates, LLC
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Pinellas Park, Florida, Stati Uniti, 33781
- Synexus
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Sunrise, Florida, Stati Uniti, 33351
- Precision Clinical Research
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Tampa, Florida, Stati Uniti, 33615
- Global Health Research Center, Inc.
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Tampa, Florida, Stati Uniti, 33615
- Santos Research Center CORP
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West Palm Beach, Florida, Stati Uniti, 33409
- Palm Beach Research Center
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Georgia
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Atlanta, Georgia, Stati Uniti, 30342
- Atlanta Clinical Research Center
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Atlanta, Georgia, Stati Uniti, 30329
- DelRicht Research
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Chamblee, Georgia, Stati Uniti, 30341
- Baybol Research Institute
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Columbus, Georgia, Stati Uniti, 31904
- Centricity Research
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Decatur, Georgia, Stati Uniti, 30030
- Elite Research Network
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Eatonton, Georgia, Stati Uniti, 31024
- Accel Research Sites Lake Oconee
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Norcross, Georgia, Stati Uniti, 30092
- Georgia Clinic, PC/CCT Research
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Stockbridge, Georgia, Stati Uniti, 30281
- Clinical Research Atlanta/Headlands
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Idaho
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Meridian, Idaho, Stati Uniti, 83642
- Velocity Clinical Research
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Illinois
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Chicago, Illinois, Stati Uniti, 60640
- Great Lakes Clinical Trials
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Chicago, Illinois, Stati Uniti, 60607
- Chicago Clinical Research Institute
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Indiana
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Valparaiso, Indiana, Stati Uniti, 46383
- Velocity Clinical Research Valparaiso
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Kansas
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El Dorado, Kansas, Stati Uniti, 67042
- Alliance for Multispecialty Research, LLC
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Lenexa, Kansas, Stati Uniti, 66219
- Johnson County Clin-Trials, Inc (JCCT)
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Wichita, Kansas, Stati Uniti, 67207
- Alliance for Multispecialty Research, LLC- Wichita
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Wichita, Kansas, Stati Uniti, 67218
- Tekton Research Inc
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Kentucky
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Lexington, Kentucky, Stati Uniti, 40509
- Alliance for Multispecialty Research-Lexington
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Versailles, Kentucky, Stati Uniti, 40383
- Versailles Family Medicine
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Louisiana
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Baton Rouge, Louisiana, Stati Uniti, 70809
- Meridian Clinical Research
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Covington, Louisiana, Stati Uniti, 70433
- MedPharmics
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Covington, Louisiana, Stati Uniti, 70006
- Benchmark Research
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Metairie, Louisiana, Stati Uniti, 70006
- Benchmark Research
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New Orleans, Louisiana, Stati Uniti, 70115
- DelRicht Research
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Prairieville, Louisiana, Stati Uniti, 70769
- DelRicht Clinical Research
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Maryland
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Eldridge, Maryland, Stati Uniti, 21075
- Centennial Medical Group
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Massachusetts
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Boston, Massachusetts, Stati Uniti, 02115
- Brigham and Women's Hospital
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Brookline, Massachusetts, Stati Uniti, 02445
- DM Clinical Research
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Michigan
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Southfield, Michigan, Stati Uniti, 48075
- Great Lakes Research Institute
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Minnesota
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Minneapolis, Minnesota, Stati Uniti, 55402
- Clinical Research Institute
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Mississippi
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Gulfport, Mississippi, Stati Uniti, 39503
- DelRicht Research
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Missouri
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Kansas City, Missouri, Stati Uniti, 64114
- The Center for Pharmaceutical Research
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Springfield, Missouri, Stati Uniti, 65807
- DelRicht Research
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St Louis, Missouri, Stati Uniti, 63141
- Sundance Clinical Research, LLC
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Town and Country, Missouri, Stati Uniti, 63017
- DelRicht Research
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Montana
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Missoula, Montana, Stati Uniti, 59808
- Montana Medical Research, Inc
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Nebraska
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Fremont, Nebraska, Stati Uniti, 68025
- CCT research/ Methodist Physicians Clinic- Prairie Fields
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Grand Island, Nebraska, Stati Uniti, 68803
- Velocity Clinical Research
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Lincoln, Nebraska, Stati Uniti, 68510
- Meridian Clinical Research, LLC
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Omaha, Nebraska, Stati Uniti, 68134
- Velocity Clinical Research
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Papillion, Nebraska, Stati Uniti, 68046
- Papillon Research Centre
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Nevada
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Las Vegas, Nevada, Stati Uniti, 89113
- Wr-Crcn, Llc
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North Las Vegas, Nevada, Stati Uniti, 89030
- Las Vegas Clinical Trials
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New Jersey
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Warren Township, New Jersey, Stati Uniti, 07059
- IMA Clinical Research
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New Mexico
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Albuquerque, New Mexico, Stati Uniti, 87109
- IMA Clinical Research
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Albuquerque, New Mexico, Stati Uniti, 87102
- Velocity Clinical Research- New Mexico
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New York
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East Syracuse, New York, Stati Uniti, 13057
- Velocity Clinical Research, Syracuse
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New York, New York, Stati Uniti, 10036
- IMA Clinical Research
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Rochester, New York, Stati Uniti, 14609
- Rochester Clinical Research, Inc.
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North Carolina
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Monroe, North Carolina, Stati Uniti, 28112
- Monroe Biomedical Research
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Wilmington, North Carolina, Stati Uniti, 28403
- Trial Management Associates, LLC
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Ohio
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Cincinnati, Ohio, Stati Uniti, 45212
- CTI Clinical Research Center
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Cincinnati, Ohio, Stati Uniti, 45242
- Velocity Clinical Research
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Cincinnati, Ohio, Stati Uniti, 45219
- Velocity Clinical Research, Inc
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Cincinnati, Ohio, Stati Uniti, 45246
- Velocity Clinical Research - Cincinnati
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Cleveland, Ohio, Stati Uniti, 44122
- Velocity Clinical Research
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Oklahoma
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Edmond, Oklahoma, Stati Uniti, 73013
- Tekton Research- Edmond
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Moore, Oklahoma, Stati Uniti, 73160
- Tekton Research Inc
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Tulsa, Oklahoma, Stati Uniti, 74133
- DelRicht Research
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Yukon, Oklahoma, Stati Uniti, 73099
- Tekton Research- Yukon
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Oregon
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Medford, Oregon, Stati Uniti, 97504
- Velocity Clinical Research, Medford
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Portland, Oregon, Stati Uniti, 97210
- Summit Research Headlands LLC
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Pennsylvania
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Philadelphia, Pennsylvania, Stati Uniti, 19107
- DM Clinical Research
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South Carolina
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Anderson, South Carolina, Stati Uniti, 29621
- Synexus Clinical Research US, Inc
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Anderson, South Carolina, Stati Uniti, 29621
- Velocity Clinical Research-Anderson
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Charleston, South Carolina, Stati Uniti, 29407
- DelRicht Research
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Columbia, South Carolina, Stati Uniti, 29204
- Velocity Clinical Research
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Greenville, South Carolina, Stati Uniti, 29615
- Velocity Clinical Research, Greenville
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Myrtle Beach, South Carolina, Stati Uniti, 29572
- Carolina Health Specialists
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North Charleston, South Carolina, Stati Uniti, 29464
- Coastal Carolina Research Center
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Spartanburg, South Carolina, Stati Uniti, 29303
- Spartanburg Medical Research
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Spartanburg, South Carolina, Stati Uniti, 29303
- Velocity Clinical Research- Spartanburg
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Tennessee
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Hendersonville, Tennessee, Stati Uniti, 37075
- DelRicht Research
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Nashville, Tennessee, Stati Uniti, 37203
- Clinical Research Associates, Inc.
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Texas
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Austin, Texas, Stati Uniti, 78705
- Benchmark Research
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Austin, Texas, Stati Uniti, 78745
- Tekton Research Inc
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Beaumont, Texas, Stati Uniti, 77706
- Tekton Research - Beaumont
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Brownsville, Texas, Stati Uniti, 78520
- PanAmerican Clinical Research, LLC
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Brownsville, Texas, Stati Uniti, 78526
- Headlands Research Brownsville
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Dallas, Texas, Stati Uniti, 75230
- Zenos Clinical Research
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Fort Worth, Texas, Stati Uniti, 76135
- Benchmark Research
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Fort Worth, Texas, Stati Uniti, 76104
- Ventavia Research Group
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Houston, Texas, Stati Uniti, 77065
- DM Clinical Research
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Houston, Texas, Stati Uniti, 77081
- DM Clinical Research
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Keller, Texas, Stati Uniti, 76248
- Ventavia Research Group
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McKinney, Texas, Stati Uniti, 75072
- Delricht Research At Zomnir Family Medicine
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Plano, Texas, Stati Uniti, 75093
- Research Your Health
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Round Rock, Texas, Stati Uniti, 78681
- Be Well Clinical Studies
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San Antonio, Texas, Stati Uniti, 78229
- Diagnostics Research Group
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San Antonio, Texas, Stati Uniti, 78229
- Clinical Trials of Texas, Inc.
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San Antonio, Texas, Stati Uniti, 78240
- Tekton Research -San Antonio
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Sugar Land, Texas, Stati Uniti, 77478
- DM Clinical Research
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Tomball, Texas, Stati Uniti, 77375
- DM Clinical Research
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Utah
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Bountiful, Utah, Stati Uniti, 84010
- Cope Family Medicine
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Pleasant View, Utah, Stati Uniti, 84404
- Mountain View Ogden Clinic/CCT Research
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Salt Lake City, Utah, Stati Uniti, 84107
- JBR Clinical Research
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Salt Lake City, Utah, Stati Uniti, 84121
- J. Lewis Research, Inc. / Foothill Family Clinic South
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Virginia
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Newport News, Virginia, Stati Uniti, 23606
- Health Research of Hampton Roads, Inc.
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Portsmouth, Virginia, Stati Uniti, 23703
- Velocity Clinical Research
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Richmond, Virginia, Stati Uniti, 23226
- Clinical Research Partners, LLC
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
Sì
Descrizione
Criteri chiave di inclusione:
- Valutazione dello sperimentatore secondo cui il partecipante comprende ed è disposto e fisicamente in grado di rispettare il follow-up richiesto dal protocollo, comprese tutte le procedure.
- Per le partecipanti di sesso femminile in età fertile: test di gravidanza negativo, contraccezione adeguata o si è astenuta da tutte le attività che potrebbero portare a una gravidanza per almeno 28 giorni prima della prima iniezione e accordo a continuare una contraccezione adeguata o l'astinenza per 90 giorni dopo la somministrazione del vaccino .
- Ha precedentemente ricevuto una serie primaria di un vaccino COVID-19 autorizzato/approvato. Per i partecipanti di età ≥18 anni, deve essere stata ricevuta anche almeno 1 dose di richiamo. Un regime vaccinale eterologo è accettabile.
Criteri chiave di esclusione:
- Ha avuto uno stretto contatto, come definito dai Centers for Disease Control and Prevention (CDC), con qualcuno che ha avuto un'infezione da SARS-CoV-2 negli ultimi 14 giorni o COVID-19 negli ultimi 10 giorni.
- Il partecipante è gravemente malato o febbrile (temperatura ≥38,0 gradi Celsius [°C]/100,4 gradi Fahrenheit [°F]) 72 ore prima o durante la visita di screening o il giorno 1.
- Qualsiasi condizione medica, psichiatrica o professionale, inclusa la storia segnalata di abuso di sostanze, che, a parere dello sperimentatore, potrebbe comportare un rischio aggiuntivo a causa della partecipazione allo studio o potrebbe interferire con l'interpretazione dei risultati dello studio.
- - Ha ricevuto immunosoppressori sistemici o farmaci immuno-modificanti per> 14 giorni in totale entro 181 giorni prima dello screening (per corticosteroidi ≥10 mg / die di prednisone equivalente) o prevede la necessità di un trattamento immunosoppressivo in qualsiasi momento durante la partecipazione allo studio.
- Ha ricevuto o prevede di ricevere qualsiasi vaccino autorizzato ≤60 giorni prima dell'iniezione dello studio (giorno 1) o prevede di ricevere un vaccino autorizzato entro 60 giorni dall'iniezione dello studio.
- - Ha ricevuto immunoglobuline sistemiche o emoderivati entro 90 giorni prima della visita di screening o prevede di riceverle durante lo studio.
- - Ha donato ≥450 millilitri (ml) di emoderivati entro 28 giorni prima della visita di screening o prevede di donare emoderivati durante lo studio.
- Ha partecipato a uno studio clinico interventistico entro 28 giorni prima della visita di screening sulla base dell'intervista sull'anamnesi o prevede di farlo durante la partecipazione a questo studio.
Nota: potrebbero essere applicati altri criteri di inclusione ed esclusione.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Parte 1: mRNA-1283.222
I partecipanti riceveranno una singola iniezione intramuscolare (IM) di mRNA-1283.222
il giorno 1.
|
Liquido sterile per iniezione
|
|
Sperimentale: Parte 1: mRNA-1273.222
I partecipanti riceveranno una singola iniezione IM di mRNA-1273.222
il giorno 1.
|
Liquido sterile per iniezione
|
|
Sperimentale: Parte 2: mRNA-1283.815
I partecipanti riceveranno una singola iniezione IM di mRNA-1283.815
il giorno 1.
|
Liquido sterile per iniezione
|
|
Sperimentale: Parte 2: mRNA-1273.815
I partecipanti riceveranno una singola iniezione IM di mRNA-1273.815
il giorno 1.
|
Liquido sterile per iniezione
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Part 1: Geometric Mean (GM) of Omicron BA.4/5 at Day 29
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Part 1: GMs of Omicron BA.4/5 and Ancestral SARS-CoV-2 D614G
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
28 marzo 2023
Completamento primario (Effettivo)
12 aprile 2025
Completamento dello studio (Effettivo)
12 aprile 2025
Date di iscrizione allo studio
Primo inviato
13 aprile 2023
Primo inviato che soddisfa i criteri di controllo qualità
13 aprile 2023
Primo Inserito (Effettivo)
18 aprile 2023
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
1 maggio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
10 aprile 2026
Ultimo verificato
1 aprile 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- mRNA-1283-P301
- 2023-000884-30 (Numero EudraCT)
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Sì
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .