Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

En undersøgelse af mRNA-1283.222-injektion sammenlignet med mRNA-1273.222-injektion hos deltagere ≥12 år for at forhindre COVID-19 (NextCOVE)

10. april 2026 opdateret af: ModernaTX, Inc.

Et randomiseret, observatørblindt, aktivt kontrolleret fase 3-studie for at undersøge sikkerheden, immunogeniciteten og den relative vaccineeffektivitet af mRNA-1283.222 administreret som en boosterdosis sammenlignet med mRNA-1273.222 hos deltagere i alderen 12 år og ældre til forebyggelse af COVID -19

Formålet med denne undersøgelse er at evaluere sikkerheden, reaktogeniciteten og den relative vaccineeffektivitet (rVE) af mRNA-1283.222 vaccine såvel som dens immunogenicitet i sammenligning med mRNA-1273.222 vaccine.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

13553

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Beskrivelse

Nøgleinklusionskriterier:

  • Undersøgers vurdering af, at deltageren forstår og er villig og fysisk i stand til at overholde protokolpålagt opfølgning, herunder alle procedurer.
  • For kvindelige deltagere i den fødedygtige alder: negativ graviditetstest, tilstrækkelig prævention eller har afholdt sig fra alle aktiviteter, der kunne resultere i graviditet i mindst 28 dage før den første injektion, og aftale om at fortsætte med tilstrækkelig prævention eller afholdenhed i 90 dage efter vaccineindgivelsen .
  • Har tidligere modtaget en primær serie af en autoriseret/godkendt COVID-19-vaccine. For deltagere ≥18 år skal der også være modtaget mindst 1 boosterdosis. Et heterologt vaccineregime er acceptabelt.

Nøgleekskluderingskriterier:

  • Har haft tæt kontakt, som defineret af Centers for Disease Control and Prevention (CDC), med en person, der har haft en SARS-CoV-2-infektion inden for de seneste 14 dage eller COVID-19 inden for de seneste 10 dage.
  • Deltageren er akut syg eller har feber (temperatur ≥38,0 grader Celsius [°C]/100,4 grader Fahrenheit [°F]) 72 timer før eller ved screeningsbesøget eller dag 1.
  • Enhver medicinsk, psykiatrisk eller arbejdsbetinget tilstand, herunder rapporteret historie om stofmisbrug, som efter investigatorens mening kan udgøre yderligere risiko på grund af deltagelse i undersøgelsen eller kan forstyrre fortolkningen af ​​undersøgelsesresultater.
  • Har modtaget systemiske immunsuppressiva eller immunmodificerende lægemidler i >14 dage i alt inden for 181 dage før screening (for kortikosteroider ≥10 mg/dag af prednisonækvivalent) eller forventer behovet for immunsuppressiv behandling på et hvilket som helst tidspunkt under deltagelse i undersøgelsen.
  • Har modtaget eller planlægger at modtage en licenseret vaccine ≤60 dage før undersøgelsesinjektionen (dag 1) eller planlægger at modtage en licenseret vaccine inden for 60 dage efter undersøgelsens injektion.
  • Har modtaget systemiske immunglobuliner eller blodprodukter inden for 90 dage før screeningsbesøget eller planlægger at modtage under undersøgelsen.
  • Har doneret ≥450 milliliter (mL) blodprodukter inden for 28 dage før screeningsbesøget eller planlægger at donere blodprodukter under undersøgelsen.
  • Har deltaget i et interventionelt klinisk studie inden for 28 dage før screeningsbesøget baseret på sygehistorieinterviewet eller planlægger at gøre det, mens han deltog i denne undersøgelse.

Bemærk: Andre inklusions- og eksklusionskriterier kan være gældende.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Del 1: mRNA-1283.222
Deltagerne vil modtage en enkelt intramuskulær (IM) injektion af mRNA-1283.222 på dag 1.
Biologisk: mRNA-1283.222
Steril væske til injektion
Eksperimentel: Del 1: mRNA-1273.222
Deltagerne vil modtage en enkelt IM-injektion af mRNA-1273.222 på dag 1.
Biologisk: mRNA-1273.222
Steril væske til injektion
Eksperimentel: Del 2: mRNA-1283.815
Deltagerne vil modtage en enkelt IM-injektion af mRNA-1283.815 på dag 1.
Biologisk: mRNA-1283.815
Steril væske til injektion
Eksperimentel: Del 2: mRNA-1273.815
Deltagerne vil modtage en enkelt IM-injektion af mRNA-1273.815 på dag 1.
Biologisk: mRNA-1273.815
Steril væske til injektion

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Part 1: Geometric Mean (GM) of Omicron BA.4/5 at Day 29
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

ModernaTX, Inc.

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

28. marts 2023

Primær færdiggørelse (Faktiske)

12. april 2025

Studieafslutning (Faktiske)

12. april 2025

Datoer for studieregistrering

Først indsendt

13. april 2023

Først indsendt, der opfyldte QC-kriterier

13. april 2023

Først opslået (Faktiske)

18. april 2023

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. april 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner