COVID-19 예방을 위해 12세 이상 참가자를 대상으로 한 mRNA-1273.222 주사와 mRNA-1273.222 주사 비교 연구 (NextCOVE)
2026년 4월 10일 업데이트: ModernaTX, Inc.
COVID 예방을 위해 12세 이상 참가자에서 mRNA-1273.222와 비교하여 부스터 용량으로 투여된 mRNA-1283.222의 안전성, 면역원성 및 상대적 백신 효능을 조사하기 위한 무작위, 관찰자 맹검, 활성 제어 3상 연구 -19
본 연구의 목적은 mRNA-1283의 안전성, 반응성 및 상대적 백신 효능(rVE)을 평가하는 것입니다.222
mRNA-1273.222와 비교한 백신 및 면역원성
백신.
연구 개요
상태
완전한
연구 유형
중재적
등록 (실제)
13553
단계
- 3단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Alabama
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Huntsville, Alabama, 미국, 35802
- Optimal Research
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Vestavia Hills, Alabama, 미국, 35216
- Accel Research Sites- Achieve Clinical Research
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Arizona
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Chandler, Arizona, 미국, 85224
- Chandler Clinical Trials
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Phoenix, Arizona, 미국, 85014
- Phoenix Clinical Research LLC
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Phoenix, Arizona, 미국, 85244
- FRC - CCT Research
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Scottsdale, Arizona, 미국, 85260
- Headlands Research Sarasota
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Tempe, Arizona, 미국, 85281
- Clinical Research Consortium
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Tucson, Arizona, 미국, 85704
- Noble Clinical Research, LLC
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Tucson, Arizona, 미국, 85715
- Del Sol research Management LLC.
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Arkansas
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Little Rock, Arkansas, 미국, 72204
- Lynn Institute of the Ozarks
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California
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Anaheim, California, 미국, 92801
- Anaheim Clinical Trials, LLC
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Banning, California, 미국, 92220
- Velocity Clinical Research, Banning
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Chula Vista, California, 미국, 91911
- Velocity Clinical Research- Chula Vista
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Colton, California, 미국, 92324
- Benchmark Research
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Huntington Beach, California, 미국, 92647
- Marvel Clinical Research 002, LLC
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Huntington Park, California, 미국, 90255
- Velocity Clinical Research Huntington Park
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La Mesa, California, 미국, 91942
- Velocity Clinical Research
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Lancaster, California, 미국, 93534
- Chemidox Clinical Trials
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Long Beach, California, 미국, 90806
- Long Beach Clinical Trials
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Los Angeles, California, 미국, 90057
- Velocity Clinical Research- Westlake
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North Hollywood, California, 미국, 90036
- Velocity Clinical Research-North Hollywood
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Pomona, California, 미국, 91786
- Empire Clinical Research
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Riverside, California, 미국, 92503
- Artemis Institute for Clinical Research
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Riverside, California, 미국, 82506
- CenExel - CITrials
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Rolling Hills Estates, California, 미국, 90274
- Peninsula Research Associates
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Sacramento, California, 미국, 95864
- Benchmark Research
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San Diego, California, 미국, 92103
- Artemis Institute for Clinical Research
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San Diego, California, 미국, 92120
- Acclaim Clinical Research
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Colorado
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Aurora, Colorado, 미국, 80012
- Lynn Institute of Denver
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Denver, Colorado, 미국, 80209
- Velocity Clinical Research Denver
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Fort Collins, Colorado, 미국, 80525
- Tekton Research - Fort Collins
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Longmont, Colorado, 미국, 80501
- Tekton Research, Inc- Longmont Center
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Florida
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Coral Gables, Florida, 미국, 33134
- Alliance for Multispeciality Research - Miami
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Crystal River, Florida, 미국, 34429
- Nature Coast Clinical Research
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Cutler Bay, Florida, 미국, 33157
- Beautiful Minds Clinical Research Center
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DeLand, Florida, 미국, 32720
- Clinical Research Partners LLC
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DeLand, Florida, 미국, 32720
- Hillcrest Medical Research, LLC
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Hallandale, Florida, 미국, 33009
- Velocity Clinical Research, Hallandale Beach
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Hialeah, Florida, 미국, 33016
- Sweet Hope Research Specialty, Inc.
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Hollywood, Florida, 미국, 33024
- CenExel Research Centers of America
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Inverness, Florida, 미국, 34452
- Nature Coast Clinical Research
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Jacksonville, Florida, 미국, 32256
- Clinical Neuroscience Solutions, Inc
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Jacksonville, Florida, 미국, 32216
- Encore Research Group-Jacksonville Center for Clinical Research
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Jupiter, Florida, 미국, 33458
- Health Awareness INC
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Lakeland, Florida, 미국, 33803
- Accel Clinical Research
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Largo, Florida, 미국, 33709
- Accel Research Sites
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Maitland, Florida, 미국, 32751
- Acclaim Clinical Research
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Miami, Florida, 미국, 33135
- Suncoast Research Group, LLC
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Miami, Florida, 미국, 33186
- Clinical Trials of Florida
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Miami, Florida, 미국, 33713
- Suncoast Research Associates, LLC
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Miami Lakes, Florida, 미국, 33016
- Global Health Research Center, Inc.
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Miami Lakes, Florida, 미국, 33016
- Floridian Clinical Research
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Orlando, Florida, 미국, 32819
- Headlands Research Orlando
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Orlando, Florida, 미국, 32801
- Clinical Neuroscience Solutions (CNS Healthcare site)
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Palmetto Bay, Florida, 미국, 33157
- Innovation Medical Research Center
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Pembroke Pines, Florida, 미국, 33024
- Pines Care Research Center, Inc.
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Pembroke Pines, Florida, 미국, 33324
- Suncoast Research Associates, LLC
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Pinellas Park, Florida, 미국, 33781
- SYNEXUS
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Sunrise, Florida, 미국, 33351
- Precision Clinical Research
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Tampa, Florida, 미국, 33615
- Global Health Research Center, Inc.
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Tampa, Florida, 미국, 33615
- Santos Research Center CORP
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West Palm Beach, Florida, 미국, 33409
- Palm Beach Research Center
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Georgia
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Atlanta, Georgia, 미국, 30342
- Atlanta Clinical Research Center
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Atlanta, Georgia, 미국, 30329
- DelRicht Research
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Chamblee, Georgia, 미국, 30341
- Baybol Research Institute
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Columbus, Georgia, 미국, 31904
- Centricity Research
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Decatur, Georgia, 미국, 30030
- Elite Research Network
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Eatonton, Georgia, 미국, 31024
- Accel Research Sites Lake Oconee
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Norcross, Georgia, 미국, 30092
- Georgia Clinic, PC/CCT Research
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Stockbridge, Georgia, 미국, 30281
- Clinical Research Atlanta/Headlands
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Idaho
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Meridian, Idaho, 미국, 83642
- Velocity Clinical Research
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Illinois
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Chicago, Illinois, 미국, 60640
- Great Lakes Clinical Trials
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Chicago, Illinois, 미국, 60607
- Chicago Clinical Research Institute
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Indiana
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Valparaiso, Indiana, 미국, 46383
- Velocity Clinical Research Valparaiso
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Kansas
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El Dorado, Kansas, 미국, 67042
- Alliance for Multispecialty Research, LLC
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Lenexa, Kansas, 미국, 66219
- Johnson County Clin-Trials, Inc (JCCT)
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Wichita, Kansas, 미국, 67207
- Alliance for Multispecialty Research, LLC- Wichita
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Wichita, Kansas, 미국, 67218
- Tekton Research Inc
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Kentucky
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Lexington, Kentucky, 미국, 40509
- Alliance for Multispecialty Research-Lexington
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Versailles, Kentucky, 미국, 40383
- Versailles Family Medicine
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Louisiana
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Baton Rouge, Louisiana, 미국, 70809
- Meridian Clinical Research
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Covington, Louisiana, 미국, 70433
- MedPharmics
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Covington, Louisiana, 미국, 70006
- Benchmark Research
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Metairie, Louisiana, 미국, 70006
- Benchmark Research
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New Orleans, Louisiana, 미국, 70115
- DelRicht Research
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Prairieville, Louisiana, 미국, 70769
- DelRicht Clinical Research
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Maryland
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Eldridge, Maryland, 미국, 21075
- Centennial Medical Group
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Massachusetts
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Boston, Massachusetts, 미국, 02115
- Brigham and Women's Hospital
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Brookline, Massachusetts, 미국, 02445
- DM Clinical Research
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Michigan
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Southfield, Michigan, 미국, 48075
- Great Lakes Research Institute
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Minnesota
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Minneapolis, Minnesota, 미국, 55402
- Clinical Research Institute
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Mississippi
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Gulfport, Mississippi, 미국, 39503
- DelRicht Research
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Missouri
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Kansas City, Missouri, 미국, 64114
- The Center for Pharmaceutical Research
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Springfield, Missouri, 미국, 65807
- DelRicht Research
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St Louis, Missouri, 미국, 63141
- Sundance Clinical Research, LLC
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Town and Country, Missouri, 미국, 63017
- DelRicht Research
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Montana
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Missoula, Montana, 미국, 59808
- Montana Medical Research, Inc
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Nebraska
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Fremont, Nebraska, 미국, 68025
- CCT research/ Methodist Physicians Clinic- Prairie Fields
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Grand Island, Nebraska, 미국, 68803
- Velocity Clinical Research
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Lincoln, Nebraska, 미국, 68510
- Meridian Clinical Research, LLC
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Omaha, Nebraska, 미국, 68134
- Velocity Clinical Research
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Papillion, Nebraska, 미국, 68046
- Papillon Research Centre
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Nevada
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Las Vegas, Nevada, 미국, 89113
- Wr-Crcn, Llc
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North Las Vegas, Nevada, 미국, 89030
- Las Vegas Clinical Trials
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New Jersey
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Warren Township, New Jersey, 미국, 07059
- IMA Clinical Research
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New Mexico
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Albuquerque, New Mexico, 미국, 87109
- IMA Clinical Research
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Albuquerque, New Mexico, 미국, 87102
- Velocity Clinical Research- New Mexico
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New York
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East Syracuse, New York, 미국, 13057
- Velocity Clinical Research, Syracuse
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New York, New York, 미국, 10036
- IMA Clinical Research
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Rochester, New York, 미국, 14609
- Rochester Clinical Research, Inc.
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North Carolina
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Monroe, North Carolina, 미국, 28112
- Monroe Biomedical Research
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Wilmington, North Carolina, 미국, 28403
- Trial Management Associates, LLC
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Ohio
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Cincinnati, Ohio, 미국, 45212
- CTI Clinical Research Center
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Cincinnati, Ohio, 미국, 45242
- Velocity Clinical Research
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Cincinnati, Ohio, 미국, 45219
- Velocity Clinical Research, Inc
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Cincinnati, Ohio, 미국, 45246
- Velocity Clinical Research - Cincinnati
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Cleveland, Ohio, 미국, 44122
- Velocity Clinical Research
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Oklahoma
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Edmond, Oklahoma, 미국, 73013
- Tekton Research- Edmond
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Moore, Oklahoma, 미국, 73160
- Tekton Research Inc
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Tulsa, Oklahoma, 미국, 74133
- DelRicht Research
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Yukon, Oklahoma, 미국, 73099
- Tekton Research- Yukon
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Oregon
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Medford, Oregon, 미국, 97504
- Velocity Clinical Research, Medford
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Portland, Oregon, 미국, 97210
- Summit Research Headlands LLC
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Pennsylvania
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Philadelphia, Pennsylvania, 미국, 19107
- DM Clinical Research
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South Carolina
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Anderson, South Carolina, 미국, 29621
- Synexus Clinical Research US, Inc
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Anderson, South Carolina, 미국, 29621
- Velocity Clinical Research-Anderson
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Charleston, South Carolina, 미국, 29407
- DelRicht Research
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Columbia, South Carolina, 미국, 29204
- Velocity Clinical Research
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Greenville, South Carolina, 미국, 29615
- Velocity Clinical Research, Greenville
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Myrtle Beach, South Carolina, 미국, 29572
- Carolina Health Specialists
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North Charleston, South Carolina, 미국, 29464
- Coastal Carolina Research Center
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Spartanburg, South Carolina, 미국, 29303
- Spartanburg Medical Research
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Spartanburg, South Carolina, 미국, 29303
- Velocity Clinical Research- Spartanburg
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Tennessee
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Hendersonville, Tennessee, 미국, 37075
- DelRicht Research
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Nashville, Tennessee, 미국, 37203
- Clinical Research Associates, Inc.
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Texas
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Austin, Texas, 미국, 78705
- Benchmark Research
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Austin, Texas, 미국, 78745
- Tekton Research Inc
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Beaumont, Texas, 미국, 77706
- Tekton Research - Beaumont
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Brownsville, Texas, 미국, 78520
- PanAmerican Clinical Research, LLC
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Brownsville, Texas, 미국, 78526
- Headlands Research Brownsville
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Dallas, Texas, 미국, 75230
- Zenos Clinical Research
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Fort Worth, Texas, 미국, 76135
- Benchmark Research
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Fort Worth, Texas, 미국, 76104
- Ventavia Research Group
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Houston, Texas, 미국, 77065
- DM Clinical Research
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Houston, Texas, 미국, 77081
- DM Clinical Research
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Keller, Texas, 미국, 76248
- Ventavia Research Group
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McKinney, Texas, 미국, 75072
- DELRICHT RESEARCH at ZOMNIR FAMILY MEDICINE
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Plano, Texas, 미국, 75093
- Research Your Health
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Round Rock, Texas, 미국, 78681
- Be Well Clinical Studies
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San Antonio, Texas, 미국, 78229
- Diagnostics Research Group
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San Antonio, Texas, 미국, 78229
- Clinical Trials of Texas, Inc.
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San Antonio, Texas, 미국, 78240
- Tekton Research -San Antonio
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Sugar Land, Texas, 미국, 77478
- DM Clinical Research
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Tomball, Texas, 미국, 77375
- DM Clinical Research
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Utah
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Bountiful, Utah, 미국, 84010
- Cope Family Medicine
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Pleasant View, Utah, 미국, 84404
- Mountain View Ogden Clinic/CCT Research
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Salt Lake City, Utah, 미국, 84107
- JBR Clinical Research
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Salt Lake City, Utah, 미국, 84121
- J. Lewis Research, Inc. / Foothill Family Clinic South
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Virginia
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Newport News, Virginia, 미국, 23606
- Health Research of Hampton Roads, Inc.
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Portsmouth, Virginia, 미국, 23703
- Velocity Clinical Research
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Richmond, Virginia, 미국, 23226
- Clinical Research Partners, LLC
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Barnsley, 영국
- Barnsley Hospital
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Bath, 영국
- Royal United Hospital Bath NHS Trust - Royal United Hospital
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Blackpool, 영국
- Layton Medical Centre
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Bournemouth, 영국
- Dorset Clinical Research Centre (Bournemouth Hospital)
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Bradford, 영국
- Bradford Teaching Hospitals NHS Foundation Trust - Bradford
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Corby, 영국
- Lakeside Healthcare
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Doncaster, 영국
- Rotherham Doncaster and South Humber NHS Foundation Trust
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Dundee, 영국
- University of Dundee - NHS Tayside - Ninewells Hospital & Me
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Edinburgh, 영국
- Western General Hospital
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Exeter, 영국
- Royal Devon & Exeter Hospital
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Glasgow, 영국
- CPS Research
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Glasgow, 영국
- Queen Elizabeth University Hospital
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Glasgow, 영국
- NHS Greater Glasgow & Clyde
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Glasgow, 영국
- Panthera Biopartners - Glasgow - multispeciality
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Gloucester, 영국
- Gloucestershire Hospitals NHS Foundation Trust - Cheltenham
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High Wycombe, 영국
- Velocity Clinical Research High Wycombe
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Leicester, 영국
- University Hospitals of Leicester-Leicester Royal Hospital
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London, 영국
- Royal Free London NHS Foundation Trust
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London, 영국
- Guys and St. Thomas NHS Foundation Trust
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London, 영국
- Barts Health NHS Trust
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London, 영국
- Hammersmith Medicines Research (HMR)
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London, 영국
- Egin Research
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London, 영국
- Panthera Biopartners - Enfield
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London, 영국
- Richford Gate Medical Practice
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London, 영국
- St Georges Healthcare NHS Trust - University of London
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Manchester, 영국
- Manchester University NHS Foundation Trust
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Milton Keynes, 영국
- Bioluminux Clinical Research
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Milton Keynes, 영국
- Stemax Consult Healthcare Services Ltd
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Newcastle, 영국
- Newcastle University - Institute of Cellular Medicine (ICM)
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North London, 영국
- Velocity Clinical Research
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Northwood, 영국
- Accellacare North London
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Nottingham, 영국
- Nottingham University Hospitals NHS Trust - Queens Medical Centre (QMC) Campus
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Peterborough, 영국
- Wansford and Kings Cliffe Practice
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Plymouth, 영국
- University Hospitals Plymouth NHS Trust
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Portsmouth, 영국
- Southampton General Hospital - Portsmouth Research Hub
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Preston, 영국
- GST NHS Found
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Preston, 영국
- Panthera Biopartners Preston
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Rochdale, 영국
- Panthera Biopartners - Manchester - multispeciality
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Runcorn, 영국
- Warrington and Halton Teaching Hospitals NHS Foundation Trust - Halton General Hospital
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Sheffield, 영국
- Panthera Biopartners - Sheffield - multispeciality
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Sheffield, 영국
- Royal Victoria Infirmary
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Southampton, 영국
- Southampton University Hospital NHS Foundation Trust
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Weston-super-Mare, 영국
- Pier Health Group
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Weymouth, 영국
- Weymouth Research Hub
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Wrexham, 영국
- North Wales Clinical Research Centre
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Aichi, 일본
- Public Health Association.Inc
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Fukuoka, 일본
- Tenjin Sogo Clinic
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Hyōgo, 일본
- Yamasaki Family Clinic - internal medicine
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Kanagawa, 일본
- Motomachi Takatsuka Naika Clinic - Internal Medicine
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Nagano, 일본
- Arakawa Family Clinic
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Osaka, 일본
- Koseikai Yotsubashi Clinic - Internal Medicine
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Sapporo, 일본
- Medical Corporation of Yamazaki Neurotology, Rhinolaryngology Clinic
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Tokyo, 일본
- Dojinkinenkai Meiwa Hospital
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Tokyo, 일본
- Medical Corporation Asbo Tokyo Asbo Clinic
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Tokyo, 일본
- National Center for Global Health and Medicine
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Tokyo, 일본
- Metropolitan Clinic - Internal Medicine
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Tokyo, 일본
- Shinei Medical Healthcare Clinic
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Québec, 캐나다, G1V 4W2
- Clinique spécialisée en allergie
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Ontario
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Greater Sudbury, Ontario, 캐나다, P3C 1X3
- Medicor Research Inc.
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Hamilton, Ontario, 캐나다, L8M 1K7
- Hamilton Medical Research Group
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London, Ontario, 캐나다, N5W 6A2
- Milestone Research Inc.
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Ottawa, Ontario, 캐나다, K1H1E4
- Red Maple Trials Inc.
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Stoney Creek, Ontario, 캐나다, L8J0B6
- Winterberry Family Medicine
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Toronto, Ontario, 캐나다, M9V 4B4
- Dr. Anil K. Gupta Medicine Professional Corporation
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Toronto, Ontario, 캐나다, M9W 4L6
- Centricity Research Toronto Manna Multispecialty
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Quebec
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Chicoutimi, Quebec, 캐나다, G7H 7Y8
- INTERMED groupe santé
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Pointe-Claire, Quebec, 캐나다, H9R 4S3
- Centricity Research Pointe-Claire
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Pointe-Claire, Quebec, 캐나다, H9R 4S3
- Manna Research Inc.
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Sherbrooke, Quebec, 캐나다, J1J 2G2
- Q&T Research Sherbrooke Inc.
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
예
설명
주요 포함 기준:
- 참가자가 모든 절차를 포함하여 프로토콜에서 요구하는 후속 조치를 이해하고 준수할 의지와 신체적 능력이 있다는 조사자의 평가.
- 임신 가능성이 있는 여성 참가자의 경우: 임신 검사 음성, 적절한 피임 또는 첫 번째 주사 전 최소 28일 동안 임신으로 이어질 수 있는 모든 활동을 삼가했으며, 백신 투여 후 90일 동안 적절한 피임 또는 금욕을 지속하기로 동의했습니다. .
- 이전에 승인/승인된 COVID-19 백신의 기본 시리즈를 접종받았습니다. 18세 이상의 참가자의 경우 최소 1회의 추가 접종도 받아야 합니다. 이종 백신 요법이 허용됩니다.
주요 제외 기준:
- 지난 14일 동안 SARS-CoV-2에 감염되었거나 지난 10일 동안 COVID-19에 걸린 사람과 질병 통제 예방 센터(CDC)의 정의에 따라 밀접 접촉한 적이 있습니다.
- 참가자가 심하게 아프거나 열이 있는 경우(체온 ≥38.0 섭씨[°C]/100.4 화씨 온도[°F]) 72시간 전 또는 스크리닝 방문 시 또는 1일.
- 약물 남용의 보고된 이력을 포함하여 연구자의 의견에 연구 참여로 인해 추가 위험을 초래할 수 있거나 연구 결과의 해석을 방해할 수 있는 모든 의학적, 정신과적 또는 직업적 상태.
- 스크리닝 전 181일 이내에 총 >14일 동안 전신성 면역억제제 또는 면역 조절 약물을 투여받았거나(코르티코스테로이드 ≥10mg/일의 프레드니손 등가물의 경우) 연구에 참여하는 동안 언제든지 면역억제 치료가 필요할 것으로 예상됩니다.
- 연구 주사 전(1일) ≤60일 이전에 허가된 백신을 받았거나 받을 계획이거나 연구 주사 후 60일 이내에 허가된 백신을 받을 계획입니다.
- 스크리닝 방문 전 90일 이내에 전신성 면역글로불린 또는 혈액 제품을 받았거나 연구 동안 받을 계획입니다.
- 스크리닝 방문 전 28일 이내에 ≥450밀리리터(mL)의 혈액 제품을 기증했거나 연구 기간 동안 혈액 제품을 기증할 계획입니다.
- 병력 면담을 기반으로 스크리닝 방문 전 28일 이내에 중재적 임상 연구에 참여했거나 이 연구에 참여하는 동안 그렇게 할 계획입니다.
참고: 기타 포함 및 제외 기준이 적용될 수 있습니다.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 파트 1: mRNA-1283.222
참가자는 mRNA-1283.222의 단일 근육 내(IM) 주사를 받게 됩니다.
1일차에.
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주사용 멸균액
|
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실험적: 파트 1: mRNA-1273.222
참가자는 mRNA-1273.222의 단일 IM 주사를 받게 됩니다.
1일차에.
|
주사용 멸균액
|
|
실험적: 파트 2: mRNA-1283.815
참가자는 mRNA-1283.815의 단일 IM 주사를 받게 됩니다.
1일차에.
|
주사용 멸균액
|
|
실험적: 파트 2: mRNA-1273.815
참가자는 mRNA-1273.815의 단일 IM 주사를 받게 됩니다.
1일차에.
|
주사용 멸균액
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Part 1: Geometric Mean (GM) of Omicron BA.4/5 at Day 29
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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)
|
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Part 3: Number of Participants With Solicited Local and Systemic ARs
기간: 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)
기간: 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
기간: 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)
기간: 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
|
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Part 3: Number of Participants With Any SAEs, MAAEs, AEs Leading to Withdrawal From Study, and AESIs
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Part 1: GMs of Omicron BA.4/5 and Ancestral SARS-CoV-2 D614G
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2023년 3월 28일
기본 완료 (실제)
2025년 4월 12일
연구 완료 (실제)
2025년 4월 12일
연구 등록 날짜
최초 제출
2023년 4월 13일
QC 기준을 충족하는 최초 제출
2023년 4월 13일
처음 게시됨 (실제)
2023년 4월 18일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 5월 1일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 4월 10일
마지막으로 확인됨
2026년 4월 1일
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- mRNA-1283-P301
- 2023-000884-30 (EudraCT 번호)
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
예
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .