En undersøgelse til at undersøge sikkerheden og effektiviteten af mRNA-1403 hos deltagere ≥18 år til forebyggelse af akut gastroenteritis (Nova 301)
8. maj 2026 opdateret af: ModernaTX, Inc.
En fase 3, randomiseret, observatør-blindet, placebokontrolleret undersøgelse til evaluering af sikkerheden og effektiviteten af mRNA-1403, en multivalent kandidatvaccine til forebyggelse af norovirus akut gastroenteritis hos voksne ≥18 år
De primære formål med denne undersøgelse er at evaluere sikkerheden og reaktogeniciteten af mRNA-1403 og at demonstrere effektiviteten af mRNA-1403 til at forhindre protokoldefineret moderat eller svær norovirus akut gastroenteritis (AGE) forbundet med vaccinematchede genotyper.
Studieoversigt
Status
Aktiv, ikke rekrutterende
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
37864
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Australian Capital Territory
-
Bruce, Australian Capital Territory, Australien, 2617
- Paratus Clinical Research Canberra
-
-
New South Wales
-
Coffs Harbour, New South Wales, Australien, 2450
- Northside Health
-
Darlinghurst, New South Wales, Australien, 2010
- Momentum Clinical Research Darlinghurst
-
Kanwal, New South Wales, Australien, 2259
- Paratus Clinical Research Central Coast
-
Maroubra, New South Wales, Australien, 2035
- Australian Clinical Research Network
-
-
Queensland
-
Herston, Queensland, Australien, 4006
- Paratus Clinical Research Brisbane
-
Southport, Queensland, Australien, 4222
- Griffith University Hospital
-
-
South Australia
-
Norwood, South Australia, Australien, 5067
- Fusion Clinical Research
-
-
Victoria
-
Bayswater, Victoria, Australien, 3153
- Veritus Research
-
Camberwell, Victoria, Australien, 3124
- Emeritus Research (Melbourne)
-
North Melbourne, Victoria, Australien, 3051
- The Peter Doherty Institute for Infection & Immunity
-
-
-
-
-
Calgary, Canada
- Care Clinic
-
Chicoutimi, Canada
- INTERMED groupe santé
-
Greater Sudbury, Canada
- Medicor Research Inc.
-
Guelph, Canada
- Apex Trials
-
Halifax, Canada
- Isaak Walton Killam Health Centre
-
Kelowna, Canada
- Okanagan Clinical Trials
-
London, Canada
- Milestone Research Inc.
-
Lévis, Canada
- Centricity Research Quebec City
-
Mirabel, Canada
- Centricity Research Mirabel
-
Pointe-Claire, Canada
- Centricity Research Pointe-Claire
-
Québec, Canada
- Clinique Specialisee En Allergie De La Capitale
-
Québec, Canada
- Centre de Recherche Saint-Louis
-
Red Deer, Canada
- CaRe Clinic Red Deer
-
Richmond, Canada
- Richmond Clinical Trials
-
Sarnia, Canada
- Bluewater Clinical Research Group, Inc
-
Sherbrooke, Canada
- Diex Research Sherbrooke Inc
-
Toronto, Canada
- Centricity Research Toronto LMC
-
Trois-Rivières, Canada
- Diex Recherche Trois-rivieres
-
Truro, Canada
- Colchester Research Group
-
-
-
-
-
Aberdeen, Det Forenede Kongerige
- NHS Grampian - Aberdeen Royal Infirmary
-
Birmingham, Det Forenede Kongerige
- NIHR Welcome Trust Clinical Research Facility
-
Bournemouth, Det Forenede Kongerige
- Bournemouth Research Hub
-
Bristol, Det Forenede Kongerige
- North Bristol NHS Trust - Southmead Hospital
-
Cardiff, Det Forenede Kongerige
- Cardiff and Vale University Health Board - University Hospital Wales
-
Coventry, Det Forenede Kongerige
- Accellacare Warwickshire Quality Research Site
-
Edinburgh, Det Forenede Kongerige
- NHS Lothian - Western General Hospital
-
Enfield, Det Forenede Kongerige
- Panthera Biopartners - North London
-
Exeter, Det Forenede Kongerige
- Royal Devon & Exeter Hospital (Wonford)
-
Glasgow, Det Forenede Kongerige
- Glasgow Clinical Research Facility
-
Glasgow, Det Forenede Kongerige
- CPS Research by FutureMeds
-
Glasgow, Det Forenede Kongerige
- Panthera Biopartners - Glasgow
-
Leicester, Det Forenede Kongerige
- University Hospitals of Leicester NHS Trust
-
Liverpool, Det Forenede Kongerige
- FutureMeds Wirral
-
London, Det Forenede Kongerige
- Mile End Hospital
-
London, Det Forenede Kongerige
- Royal Free London NHS Foundation Trust - Royal Free Hospital
-
Manchester, Det Forenede Kongerige
- Manchester University NHS Foundation Trust
-
Newcastle upon Tyne, Det Forenede Kongerige
- The Newcastle upon Tyne Hospitals NHS Foundation Trust
-
Newcastle upon Tyne, Det Forenede Kongerige
- FutureMeds Newcastle
-
Nottingham, Det Forenede Kongerige
- Leeds Teaching Hospitals NHS Trust - St James' University Hospital
-
Plymouth, Det Forenede Kongerige
- Plymouth Hospital NHS trust-Derriford Hospital
-
Portsmouth, Det Forenede Kongerige
- Portsmouth Research Hub
-
Sheffield, Det Forenede Kongerige
- Panthera Biopartners - Sheffield
-
Shipley, Det Forenede Kongerige
- Accellacare Yorkshire Quality Research Site
-
Wansford, Det Forenede Kongerige
- Wansford Research LTD
-
Weymouth, Det Forenede Kongerige
- Weymouth Research Hub
-
Witney, Det Forenede Kongerige
- Windrush Medical Practice
-
Wrexham, Det Forenede Kongerige
- North Wales Clinical Research Centre (NWCRC)
-
York, Det Forenede Kongerige
- Panthera Biopartners - York
-
-
Buckinghamshire
-
High Wycombe, Buckinghamshire, Det Forenede Kongerige
- Velocity Clinical Research - High Wycombe
-
-
Cheshire
-
Runcorn, Cheshire, Det Forenede Kongerige
- Warrington and Halton Teaching Hospitals NHS Foundation Trust - Halton General Hospital
-
-
Cornwall
-
Truro, Cornwall, Det Forenede Kongerige
- Royal Cornwall Hospitals NHS Trust - Royal Cornwall Hospital
-
-
England
-
London, England, Det Forenede Kongerige
- St George's University Hospitals NHS Foundation Trust - St George's Hospital
-
-
Kent
-
Orpington, Kent, Det Forenede Kongerige
- Accellacare South London
-
-
Lancashire
-
Blackpool, Lancashire, Det Forenede Kongerige
- Layton Medical Centre
-
-
Manchester
-
Rochdale, Manchester, Det Forenede Kongerige
- Panthera Biopartners - Manchester
-
Salford, Manchester, Det Forenede Kongerige
- Northern Care Alliance NHS Foundation Trust - Salford Royal Hospital
-
-
Northamptonshire
-
Corby, Northamptonshire, Det Forenede Kongerige
- Lakeside Healthcare
-
-
Oxfordshire
-
Witney, Oxfordshire, Det Forenede Kongerige
- Eynsham Medical Center
-
-
-
-
Alabama
-
Birmingham, Alabama, Forenede Stater, 32516
- Accel Research Sites - Achieve Clinical Research
-
Cullman, Alabama, Forenede Stater, 35055
- Cullman Clinical Trials
-
Daphne, Alabama, Forenede Stater, 36526
- Alliance for Multispecialty Research, LLC
-
-
Arizona
-
Phoenix, Arizona, Forenede Stater, 85018
- HOPE Research Institute
-
Phoenix, Arizona, Forenede Stater, 85023
- HOPE Research Institute
-
Phoenix, Arizona, Forenede Stater, 85031
- Abby's Research Institute
-
Phoenix, Arizona, Forenede Stater, 85004
- ClinMed, LLC
-
Phoenix, Arizona, Forenede Stater, 85012
- DM Clinical - Phoenix
-
Scottsdale, Arizona, Forenede Stater, 85260
- Headlands Research Scottsdale
-
Scottsdale, Arizona, Forenede Stater, 85260
- Scottsdale Clinical Trials
-
Tempe, Arizona, Forenede Stater, 85284
- Hope Research Institute - Tempe
-
Tucson, Arizona, Forenede Stater, 85712
- Quality of Life Medical and Research Center
-
Tucson, Arizona, Forenede Stater, 85712
- Arizona Liver Health
-
Tucson, Arizona, Forenede Stater, 85715
- Del Sol Research Management LLC.- Tucson
-
-
Arkansas
-
Little Rock, Arkansas, Forenede Stater, 72205
- Baptist Health Center for Clinical Research
-
Little Rock, Arkansas, Forenede Stater, 72204
- Lynn Institute of the Ozarks
-
-
California
-
Fountain Valley, California, Forenede Stater, 92708
- Ark Clinical Research, LLC
-
Fullerton, California, Forenede Stater, 92835
- ASCADA Research, LLC - Family Medicine
-
Huntington Park, California, Forenede Stater, 90255
- Matrix Clinical Research
-
La Mesa, California, Forenede Stater, 91942
- Velocity Clinical Research, San Diego
-
Long Beach, California, Forenede Stater, 90815
- ARK Clinical Research
-
Los Angeles, California, Forenede Stater, 90057
- Matrix Clinical Research
-
Los Angeles, California, Forenede Stater, 90057
- Velocity Clinical Research - Westlake
-
Redding, California, Forenede Stater, 96001
- Paradigm Research
-
Riverside, California, Forenede Stater, 92503
- Artemis Institute for Clinical Research
-
Riverside, California, Forenede Stater, 92503
- Benchmark Research
-
Rolling Hills Estates, California, Forenede Stater, 90274
- Peninsula Research Associates (PRA)
-
San Diego, California, Forenede Stater, 92120
- Apex Clinical Research
-
San Diego, California, Forenede Stater, 92503
- Artemis Institute for Clinical Research
-
-
Colorado
-
Aurora, Colorado, Forenede Stater, 80012
- Lynn Institute of Denver
-
Fort Collins, Colorado, Forenede Stater, 80525
- Tekton Research - Fort Collins
-
Longmont, Colorado, Forenede Stater, 80501
- Tekton Research, Inc - Longmont Center
-
-
Florida
-
Boynton Beach, Florida, Forenede Stater, 33435
- Imagine Research of Palm Beach County
-
Coral Gables, Florida, Forenede Stater, 33134
- Pioneer Clinical Studies
-
Doral, Florida, Forenede Stater, 33122
- Integrity Clinical Research, LLC (ICR SITES) - Doral
-
Doral, Florida, Forenede Stater, 33134
- Alliance for multispecialty Research - Florida
-
Hialeah, Florida, Forenede Stater, 33012
- AGA Clinical Trials
-
Hialeah, Florida, Forenede Stater, 33016
- Best Quality Research Inc.
-
Hialeah, Florida, Forenede Stater, 33016
- Neoclinical Research
-
Hollywood, Florida, Forenede Stater, 33024
- Research Centers of America
-
Inverness, Florida, Forenede Stater, 34452
- Nature Coast Clinical Research, LLC - Inverness
-
Jacksonville, Florida, Forenede Stater, 32256
- Clinical Neuroscience Solutions, Inc
-
Jacksonville, Florida, Forenede Stater, 32216
- Westside Center for Clinical Research
-
Jupiter, Florida, Forenede Stater, 33458
- Health Awareness INC
-
Lake Mary, Florida, Forenede Stater, 32746
- University Clinical Research- Deland
-
Lakeland, Florida, Forenede Stater, 33803
- Meridien Research
-
Leesburg, Florida, Forenede Stater, 34748
- Clinical Site Partners - Leesburg
-
Maitland, Florida, Forenede Stater, 32751
- Accel Clinical Research - Maitland
-
Miami, Florida, Forenede Stater, 33173
- Florida International Research Center
-
Miami, Florida, Forenede Stater, 33176
- Miami Dade Medical Research Institute, LLC
-
Miami, Florida, Forenede Stater, 33155
- Miami Clinical Research
-
Miami, Florida, Forenede Stater, 33173
- Suncoast Research Associates, LLC
-
Miami, Florida, Forenede Stater, 33166
- Universal Axon Clinical Research
-
Miami, Florida, Forenede Stater, 33126
- Dade Research Center, LLC
-
Miami, Florida, Forenede Stater, 33184
- Felicidad Medical Research
-
Naples, Florida, Forenede Stater, 34105
- Aqualane Clinical Research
-
New Port Richey, Florida, Forenede Stater, 34652
- Suncoast Clinical Research
-
Orlando, Florida, Forenede Stater, 32801
- Clinical Neuroscience Solutions, Inc
-
Orlando, Florida, Forenede Stater, 32806
- Clinical Neuroscience Solutions, Inc
-
Pompano Beach, Florida, Forenede Stater, 33060
- Clinical Research Center of Florida
-
Port Orange, Florida, Forenede Stater, 32127
- United Medical Research
-
Port Saint Lucie, Florida, Forenede Stater, 34952
- Health Awareness, Inc
-
Saint Augustine, Florida, Forenede Stater, 32086
- St. Johns Center for Clinical Research
-
St. Petersburg, Florida, Forenede Stater, 33704
- IMA Clinical Research - St. Petersburg
-
St. Petersburg, Florida, Forenede Stater, 33705
- Global Clinical Professionals, LLC
-
Sunrise, Florida, Forenede Stater, 33351
- Precision Clinical Research, LLC
-
-
Georgia
-
Albany, Georgia, Forenede Stater, 31707
- Albany Internal Medicine
-
Atlanta, Georgia, Forenede Stater, 30331
- Atlanta Center for Medical Research
-
Atlanta, Georgia, Forenede Stater, 30329
- Delricht Research At Springer Wellness And Restorative Health
-
Decatur, Georgia, Forenede Stater, 30030
- CenExel iResearch Atlanta, LLC
-
Fayetteville, Georgia, Forenede Stater, 30214
- Javara inc.
-
Savannah, Georgia, Forenede Stater, 31406
- Fellows Research Alliance, Inc.
-
Savannah, Georgia, Forenede Stater, 31406
- Velocity Clinical Research-Savannah
-
Stockbridge, Georgia, Forenede Stater, 30281
- Clinical Research Atlanta/Headlands
-
-
Idaho
-
Idaho Falls, Idaho, Forenede Stater, 83404
- Clinical Research Prime
-
Meridian, Idaho, Forenede Stater, 83642
- Velocity Clinical Research - Boise
-
-
Illinois
-
Chicago, Illinois, Forenede Stater, 60602
- IMA Clinical Research
-
Gurnee, Illinois, Forenede Stater, 60048
- Great Lakes Clinical Trials - Gurnee
-
Naperville, Illinois, Forenede Stater, 60540
- Bioluminix Clinical Research Chicago
-
Peoria, Illinois, Forenede Stater, 61614
- Optimal Research
-
River Forest, Illinois, Forenede Stater, 60305
- DM Clinical Research- River Forest
-
-
Indiana
-
Valparaiso, Indiana, Forenede Stater, 46383
- Velocity Clinical Research - Valparaiso
-
-
Iowa
-
Sioux City, Iowa, Forenede Stater, 51106
- Velocity Clinical Research-Sioux City
-
-
Kansas
-
Lenexa, Kansas, Forenede Stater, 66219
- Johnson County Clin-Trials (JCCT)
-
Overland Park, Kansas, Forenede Stater, 66210
- Velocity Clinical Research- Kansas City
-
Wichita, Kansas, Forenede Stater, 67218
- Tekton Research
-
-
Kentucky
-
Lexington, Kentucky, Forenede Stater, 40509
- AMR Lexington
-
-
Louisiana
-
Baton Rouge, Louisiana, Forenede Stater, 70809
- Velocity Clinical Research - Baton Rouge
-
Covington, Louisiana, Forenede Stater, 70433
- Velocity Clinical Research - Covington
-
Metairie, Louisiana, Forenede Stater, 70006
- Clinical Trials Management, LLC
-
Metairie, Louisiana, Forenede Stater, 70006
- Benchmark Research
-
-
Maryland
-
Annapolis, Maryland, Forenede Stater, 27101
- Privia Medical Group
-
Gaithersburg, Maryland, Forenede Stater, 20877
- Cenexel CBH (CBH Health)
-
Rockville, Maryland, Forenede Stater, 20854
- Velocity Clinical Research-Rockville
-
Silver Spring, Maryland, Forenede Stater, 20901
- Javara Inc/Privia Medical Group, LLC
-
-
Massachusetts
-
Brookline, Massachusetts, Forenede Stater, 02445
- DM Clinical Research - Brookline
-
Burlington, Massachusetts, Forenede Stater, 02721
- Skylight Health Research - Burlington
-
-
Michigan
-
Southfield, Michigan, Forenede Stater, 48075
- Great Lakes Research Institute
-
Southfield, Michigan, Forenede Stater, 48076
- DM Clinical Research - Southfield
-
Southfield, Michigan, Forenede Stater, 48034
- Headlands Research - Detroit
-
Troy, Michigan, Forenede Stater, 48085
- Oakland Medical Research Center
-
-
Minnesota
-
Minneapolis, Minnesota, Forenede Stater, 55402
- Clinical Research Institute, Inc.
-
-
Mississippi
-
Gulfport, Mississippi, Forenede Stater, 39503
- Velocity Clinical Research, Gulfport
-
-
Missouri
-
Chesterfield, Missouri, Forenede Stater, 63005
- Clinical Research Professionals
-
Springfield, Missouri, Forenede Stater, 65807
- DelRicht Research
-
Springfield, Missouri, Forenede Stater, 65807
- Clinvest Headlands Llc
-
-
Montana
-
Missoula, Montana, Forenede Stater, 59808
- Montana Medical Research, Inc
-
-
Nebraska
-
Lincoln, Nebraska, Forenede Stater, 68510
- Velocity Clinical Research-Lincoln
-
Norfolk, Nebraska, Forenede Stater, 68701
- Velocity Clinical Research-Norfolk
-
Omaha, Nebraska, Forenede Stater, 38134
- Velocity Clinical Research-Omaha
-
-
Nevada
-
Carson City, Nevada, Forenede Stater, 89706
- Javara Inc. / Nevada Health Centers, Ind
-
Las Vegas, Nevada, Forenede Stater, 89074
- Vector Clinical Trials
-
Las Vegas, Nevada, Forenede Stater, 89121
- Oasis Clinical Research
-
-
New Jersey
-
Jersey City, New Jersey, Forenede Stater, 07306
- DM Clinical Research - New Jersey
-
Warren Township, New Jersey, Forenede Stater, 07059
- IMA Clinical Research Warren
-
-
New Mexico
-
Albuquerque, New Mexico, Forenede Stater, 87107
- Velocity Clinical Research- Albuquerque
-
Albuquerque, New Mexico, Forenede Stater, 87102
- Albuquerque Clinical Trials (ACT)
-
Albuquerque, New Mexico, Forenede Stater, 87106
- DM Clinical Research
-
-
New York
-
Binghamton, New York, Forenede Stater, 13905
- Velocity Clinical Research - Binghamton
-
Brooklyn, New York, Forenede Stater, 11226
- Brooklyn Clinical Research
-
Brooklyn, New York, Forenede Stater, 11220
- DM Clinical - Brooklyn
-
East Syracuse, New York, Forenede Stater, 13057
- Velocity Clinical Research - Syracuse
-
Hartsdale, New York, Forenede Stater, 10530
- Drug Trials America
-
Rochester, New York, Forenede Stater, 14609
- Rochester Clinical Research, Inc
-
Vestal, New York, Forenede Stater, 13850
- Velocity Clinical Research-Vestal
-
-
North Carolina
-
Charlotte, North Carolina, Forenede Stater, 28205
- DelRicht Research, LLC
-
Charlotte, North Carolina, Forenede Stater, 28287
- Javara Inc. - Tryon Medical-South Park
-
Durham, North Carolina, Forenede Stater, 27701
- Velocity Clinical Research, Durham
-
Morehead City, North Carolina, Forenede Stater, 28557
- West Clinical Research
-
Raleigh, North Carolina, Forenede Stater, 27609
- Accellacare Raleigh
-
Wilmington, North Carolina, Forenede Stater, 28401
- Accellacare of Wilmington
-
Winston-Salem, North Carolina, Forenede Stater, 27101
- Javara - Wake Forest University Health Sciences
-
-
Ohio
-
Beachwood, Ohio, Forenede Stater, 44122
- Velocity Clinical Research, Cleveland
-
Cincinnati, Ohio, Forenede Stater, 45219
- Velocity Clinical Research-Mt. Auburn
-
Cincinnati, Ohio, Forenede Stater, 45241
- CTI Clinical Research Center
-
Cincinnati, Ohio, Forenede Stater, 45242
- Velocity Clinical Reseach - Blue Ash
-
Cincinnati, Ohio, Forenede Stater, 45246
- Velocity Clinical Research - Cincinnati OH
-
Columbus, Ohio, Forenede Stater, 43213
- Centricity Research
-
Columbus, Ohio, Forenede Stater, 43215
- Remington-Davis Clinical Research
-
-
Oklahoma
-
Edmond, Oklahoma, Forenede Stater, 73013
- Tekton Research, Inc - Edmond
-
Tulsa, Oklahoma, Forenede Stater, 74133
- Delricht Tate
-
Yukon, Oklahoma, Forenede Stater, 73099
- Tekton Research, Inc - Yukon Location
-
-
Pennsylvania
-
Duncansville, Pennsylvania, Forenede Stater, 16635
- Altoona Center for Clinical Research - Research
-
Philadelphia, Pennsylvania, Forenede Stater, 19107
- DM Clinical Research
-
-
Rhode Island
-
East Greenwich, Rhode Island, Forenede Stater, 02818
- Velocity Clinical Research - Providence
-
-
South Carolina
-
Anderson, South Carolina, Forenede Stater, 29621
- Velocity Clinical Research - Anderson
-
Charleston, South Carolina, Forenede Stater, 29407
- DelRicht Research
-
North Charleston, South Carolina, Forenede Stater, 29405
- Coastal Carolina Research Center - North Charleston
-
Spartanburg, South Carolina, Forenede Stater, 29303
- Velocity Clinical Research, Spartanburg
-
-
Tennessee
-
Bristol, Tennessee, Forenede Stater, 37620
- PMG Research of Bristol, LLC
-
Hendersonville, Tennessee, Forenede Stater, 37075
- Delricht Moyer
-
Memphis, Tennessee, Forenede Stater, 38119
- CNS Healthcare DBA Clinical Neuroscience Solutions, INC
-
-
Texas
-
Austin, Texas, Forenede Stater, 78705
- Benchmark Research
-
Austin, Texas, Forenede Stater, 78745
- IMA Clinical Research Austin
-
Beaumont, Texas, Forenede Stater, 77706
- Tekton Research, Inc. - Beaumont
-
Brownsville, Texas, Forenede Stater, 78526
- Headlands Research Brownsville
-
Carrollton, Texas, Forenede Stater, 75010
- Family Medicine Associates of Texas
-
Conroe, Texas, Forenede Stater, 77384
- Javara Inc (Conroe)
-
Dallas, Texas, Forenede Stater, 75224
- WR-Global Medical Research, LLC
-
El Paso, Texas, Forenede Stater, 79936
- El Paso Research
-
Fort Worth, Texas, Forenede Stater, 76135
- Benchmark Research
-
Houston, Texas, Forenede Stater, 77055
- West Houston Clinical Research Service
-
Houston, Texas, Forenede Stater, 77065
- DM Clinical Research - CyFair
-
Houston, Texas, Forenede Stater, 77081
- DM Clinical Research - Bellaire
-
Irving, Texas, Forenede Stater, 75061
- DM Clinical Research - Irving
-
Plano, Texas, Forenede Stater, 75024
- Acrc Trials
-
Plano, Texas, Forenede Stater, 75093
- Research Your Health
-
Prosper, Texas, Forenede Stater, 75078
- DELRICHT RESEARCH at ZOMNIR FAMILY MEDICINE
-
San Antonio, Texas, Forenede Stater, 78229
- IMA Clinical Research
-
San Antonio, Texas, Forenede Stater, 78229
- Tekton Research Inc - San Antonio
-
San Antonio, Texas, Forenede Stater, 78207
- DM Clinical Research - San Antonio
-
Sugar Land, Texas, Forenede Stater, 77478
- DM Clinical Research - Sugarland
-
Tomball, Texas, Forenede Stater, 77375
- DM Clinical Research
-
Tomball, Texas, Forenede Stater, 77375
- DM Clinical Research - Tomball
-
-
Utah
-
Bountiful, Utah, Forenede Stater, 84010
- Cope Family Medicine
-
Salt Lake City, Utah, Forenede Stater, 84107
- JBR Clinical Research
-
-
Virginia
-
Charlottesville, Virginia, Forenede Stater, 22911
- Charlottesville Medical Research Center, LLC
-
Hampton, Virginia, Forenede Stater, 23666
- Velocity Clinical Research - Hampton
-
Newport News, Virginia, Forenede Stater, 23606
- Health Research of Hampton Roads
-
Norfolk, Virginia, Forenede Stater, 37920
- AMR Norfolk
-
Portsmouth, Virginia, Forenede Stater, 23703
- Velocity Clinical Research-Portsmouth
-
Richmond, Virginia, Forenede Stater, 23226
- Clinical Research Partners, LLC
-
-
Washington
-
Seattle, Washington, Forenede Stater, 98122
- DM Clinical Research - Seattle
-
-
West Virginia
-
Kingwood, West Virginia, Forenede Stater, 26537
- Frontier Clinical Research, LLC
-
-
-
-
-
Hyōgo, Japan
- Sasaki Clinic
-
Kanazawa, Japan
- NewHeart Watanabe Institute
-
Kochi, Japan
- Izumino Hospital
-
Sapporo, Japan
- Sapporo Odori Endoscopy Clinic
-
Takatsuki-shi, Japan
- Takatsuki General Hosiptal
-
-
Aichi-ken
-
Nagoya, Aichi-ken, Japan
- Daido Clinic
-
Nagoya, Aichi-ken, Japan
- Chubu Rosai Hospital - Rheumatology & Collageous
-
-
Hirosima [Hiroshima]
-
Hiroshima, Hirosima [Hiroshima], Japan
- Medical Corporation JR Hiroshima Hospital
-
-
Hokkaidô [Hokkaido]
-
Sapporo, Hokkaidô [Hokkaido], Japan
- Kotoni Medical Support Clinic
-
-
Hukuoka [Fukuoka]
-
Fukuoka, Hukuoka [Fukuoka], Japan
- Tenjin Sogo Clinic
-
-
Kanagawa
-
Kawasaki-shi, Kanagawa, Japan
- Matsuba Clinic
-
-
Kyôto [Kyoto]
-
Kyoto, Kyôto [Kyoto], Japan
- Hayashi-Katagihara Clinic
-
-
Osaka
-
Minoh, Osaka, Japan
- Yokoi Medicine Clinic
-
-
Saitama
-
Kawagoe-shi, Saitama, Japan
- Asano Clinic
-
-
Shiga
-
Yabasecho, Shiga, Japan
- Omi Medical Center
-
-
Tôkyô
-
Hachiōji, Tôkyô, Japan
- P-One Clinic
-
-
Tôkyô [Tokyo]
-
Chiyoda-ku, Tôkyô [Tokyo], Japan
- Dojinkinenkai Meiwa Hospital
-
Chūōku, Tôkyô [Tokyo], Japan
- Nihonbashi Sakura Clinic
-
Minatoku, Tôkyô [Tokyo], Japan
- Medical Corporation Asbo Tokyo Asbo Clinic
-
Minatoku, Tôkyô [Tokyo], Japan
- Tokyo Saiseikai Central Hospital
-
Shinjuku-ku, Tôkyô [Tokyo], Japan
- Higashi-Shinjuku Clinic - Internal Medicine
-
Suginami City, Tôkyô [Tokyo], Japan
- Shimamura Memorial Hospital
-
Ōta-ku, Tôkyô [Tokyo], Japan
- Denenchofu Family Clinic
-
-
-
-
-
La Chorrera, Panama
- CEVAXIN Chorrera
-
Panama City, Panama
- CEVAXIN 24 de Diciembre
-
Panama City, Panama
- CEVAXIN Avenida Mexico
-
-
Chiriquí Province
-
David, Chiriquí Province, Panama
- CEVAXIN David
-
-
-
-
-
Ponce, Puerto Rico, 00717
- BRCR Global
-
San Juan, Puerto Rico, 00909-1711
- Clinical Research Puerto Rico, Inc.
-
San Juan, Puerto Rico, 00966
- Research Works San Juan
-
-
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
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ja
Beskrivelse
Inklusionskriterier:
- Deltagere, der forstår og er villige og fysisk i stand til at overholde protokolmanderet opfølgning, herunder alle procedurer som vurderet af Investigator, og som er primært ansvarlige for deres egenomsorg og daglige aktiviteter.
Deltagerne kan have kroniske medicinske diagnoser, men bør være medicinsk stabile, vurderet ud fra følgende kriterier:
- Fravær af medicinske hændelser forbundet med underliggende diagnoser og kvalificeret som SAE'er inden for 1 måned før undersøgelsesintervention på dag 1.
- Fravær af kendte, aktuelle og livsbegrænsende diagnoser, som kunne fortsætte under undersøgelsens varighed, og som efter investigatorens opfattelse ville gøre fuldførelse af protokollen usandsynlig.
- I stand til at give underskrevet informeret samtykke, hvilket omfatter overholdelse af kravene og begrænsninger, der er anført i formularen til informeret samtykke (ICF) og i protokollen.
- Deltagere, der tildeles kvinder ved fødslen, er berettiget til at deltage, hvis de ikke er gravide eller ammer/ammer/ammer krop og opfylder protokoldefinerede kriterier.
Ekskluderingskriterier:
- 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.
- Anamnese med AGE inden for 14 dage før dag 1 eller tæt kontakt med en person med AGE-symptomer (i hjemmet, socialt eller erhvervsmæssigt) inden for 14 dage før dag 1.
- Anamnese med en diagnose eller tilstand, som efter investigatorens vurdering er klinisk ustabil eller kan påvirke deltagernes sikkerhed, vurdering af sikkerhedsendepunkter, vurdering af immunrespons eller overholdelse af undersøgelsesprocedurer.
- Nuværende diagnose af kronisk gastrointestinal (GI) sygdom, der er forbundet med vedvarende symptomer på regelmæssig opkastning og/eller diarré. Deltagere med stabil, velkontrolleret kronisk GI-sygdom uden regelmæssige opkastninger og/eller diarré kan overvejes til optagelse.
- Har en medicinsk, psykiatrisk eller erhvervsmæssig tilstand, der kan udgøre yderligere risiko som følge af deltagelse, eller som kan forstyrre sikkerhedsvurderinger eller fortolkning af resultater i henhold til efterforskerens vurdering.
- Har gennemgået kirurgiske indgreb inden for 7 dage før dag 1 eller er planlagt til at gennemgå en kirurgisk procedure inden for 28 dage efter undersøgelsesintervention.
- Rapporteret historie med medfødt eller erhvervet immundefekt, immunkompromitterende/immunsuppressiv tilstand, aspleni eller tilbagevendende alvorlige infektioner i henhold til protokol.
- Rapporteret anamnese med anafylaksi, nældefeber eller anden væsentlig AR, der kræver medicinsk intervention efter modtagelse af en vaccine eller intervention, der omfatter en eller flere af de samme komponenter indeholdt i undersøgelsesvaccinen.
- Anamnese med myocarditis, pericarditis eller myopericarditis med debut inden for 180 dage før dag 1, hvis værdier ikke er vendt tilbage til baseline klinisk status.
- Historie om Guillain-Barre syndrom.
- Rapporteret historie med koagulopati eller blødningsforstyrrelser betragtes som en kontraindikation for IM-injektion eller flebotomi.
- Dermatologiske tilstande, der kan påvirke lokale anmodede AR-vurderinger.
- Diagnose af malignitet inden for de foregående 2 år (eksklusive ikke-melanom hudkræft).
- Har modtaget systemisk immunsuppressiv behandling i >14 dage i alt inden for 6 måneder før dag 1 (for kortikosteroider ≥10 milligram (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 ≤28 dage før eller inden for 28 dage efter undersøgelsesintervention (dag 1), bortset fra influenzavacciner, som kan gives 14 dage før eller efter modtagelse af en undersøgelsesintervention.
- Modtagelse af systemiske immunglobuliner eller blodprodukter inden for 3 måneder før dag 1 eller planer om modtagelse under undersøgelsen.
- Har doneret ≥450 ml blodprodukter inden for 28 dage før dag 1 besøg eller planlægger at donere blodprodukter under undersøgelsen.
- Deltog i et klinisk studie med forsøgsbehandling inden for 90 dage før dag 1 (baseline) baseret på sygehistorieinterviewet eller planlægger at gøre det, mens han deltog i denne undersøgelse. Deltagerne kan fortsætte i tidligere interventionelle undersøgelsesopfølgningsaktiviteter, forudsat at det ikke involverer yderligere undersøgelsesbehandling og/eller procedurer, der kan påvirke sikkerheden og/eller andre undersøgelsens endepunkter, og undersøgelsesdeltagelse ikke resulterer i brud på nogen af undersøgelsesprotokollerne.
- Arbejder som, har arbejdet som eller er et umiddelbart familiemedlem eller husstandsmedlem af studiepersonale, sponsorpersonale eller studiestedspersonale direkte involveret i gennemførelsen af undersøgelsen.
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: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: mRNA-1403
Deltagerne vil modtage en enkelt injektion af mRNA-1403 på dag 1.
|
Intramuskulær (IM) injektion.
|
|
Placebo komparator: Placebo
Deltagerne vil modtage en enkelt injektion af mRNA-1403 matchende placebo (0,9 % natriumchloridopløsning) på dag 1.
|
0,9 % natriumchloridopløsning ved IM-injektion.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Antal deltagere med anmodede lokale og systemiske bivirkninger (AR'er)
Tidsramme: Dag 1 op til dag 7 (7 dage efter undersøgelsesintervention)
|
Dag 1 op til dag 7 (7 dage efter undersøgelsesintervention)
|
|
Antal deltagere med uopfordrede bivirkninger (AE'er)
Tidsramme: Dag 1 op til dag 28 (28 dage efter undersøgelsesintervention)
|
Dag 1 op til dag 28 (28 dage efter undersøgelsesintervention)
|
|
Antal deltagere med medicinsk overværede bivirkninger (MAAE'er)
Tidsramme: Dag 1 til og med dag 181
|
Dag 1 til og med dag 181
|
|
Number of Participants with Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), and AEs Leading to Study Withdrawal
Tidsramme: Day 1 up to Day 546
|
Day 1 up to Day 546
|
|
Vaccine Efficacy (VE) of mRNA-1403 to Prevent First Occurrence of Protocol-defined Moderate or Severe AGE Associated with Vaccine Matched Genotypes
Tidsramme: Day 15 up to 9 months after last participant dosed
|
Day 15 up to 9 months after last participant dosed
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Geometrisk middeltiter (GMT) af histo-blodgruppeantigen (HBGA)-blokerende antistoffertitre mod vaccinematchede genotyper
Tidsramme: Dag 1 og dag 29
|
Dag 1 og dag 29
|
|
Geometrisk middelfoldningsstigning (GMFR) af HBGA-blokerende antistoftitre mod vaccinematchede genotyper
Tidsramme: Dag 1 og dag 29
|
Dag 1 og dag 29
|
|
Procentdel af deltagere med serorespons baseret på HBGA-blokerende antistoftiter
Tidsramme: Dag 29
|
Dag 29
|
|
GMT af bindende antistof (bAb) mod vaccine-matchede NoV-genotyper
Tidsramme: Dag 1 og dag 29
|
Dag 1 og dag 29
|
|
GMFR af bAb-titre
Tidsramme: Dag 1 og dag 29
|
Dag 1 og dag 29
|
|
Procentdel af deltagere med serorespons baseret på bAb-titer
Tidsramme: Dag 29
|
Dag 29
|
|
VE of mRNA-1403 to Prevent First Occurrence of Protocol-defined Severe AGE Associated with Vaccine Matched Genotypes
Tidsramme: Day 15 up to 9 months after last participant dosed
|
Day 15 up to 9 months after last participant dosed
|
|
VE of mRNA-1403 to Prevent First Occurrence of Protocol-defined Severe Norovirus (NoV) AGE Associated with Any Genogroup I or II Norovirus (NoV) Genotype
Tidsramme: Day 15 up to 9 months after last participant dosed
|
Day 15 up to 9 months after last participant dosed
|
|
VE of mRNA-1403 to Prevent First Occurrence of Protocol-defined Moderate or Severe AGE Associated with Any Genogroup I or II NoV Genotype
Tidsramme: Day 15 up to 9 months after last participant dosed
|
Day 15 up to 9 months after last participant dosed
|
|
VE of mRNA-1403 to Prevent First Occurrence of Protocol-defined AGE of Any Severity Associated with Vaccine Matched NoV Genotypes
Tidsramme: Day 15 up to 9 months after last participant dosed
|
Day 15 up to 9 months after last participant dosed
|
|
VE of mRNA-1403 to Prevent Any Occurrence of Medically Attended AGE Associated with Vaccine Matched NoV Genotypes, as well as any Genogroup I or II NoV Genotype
Tidsramme: Day 15 up to Day 546
|
Day 15 up to Day 546
|
|
VE of mRNA-1403 to Prevent Any Occurrence of AGE Hospitalizations Associated With Vaccine Matched NoV Genotypes, as well as any Genogroup I or II NoV Genotype
Tidsramme: Day 15 up to Day 546
|
Day 15 up to Day 546
|
|
VE of mRNA-1403 to Prevent Any Occurrence of Protocol-defined Moderate or Severe AGE Associated with Vaccine Matched Genotypes
Tidsramme: Day 15 up to Day 546
|
Day 15 up to Day 546
|
|
VE of mRNA-1403 to Prevent Any Occurrence of Protocol-defined AGE of Any Severity Associated with Any Genogroup I or II NoV Genotype
Tidsramme: Day 15 up to Day 546
|
Day 15 up to Day 546
|
|
VE of mRNA-1403 to Prevent First Occurrence of Protocol-Defined Moderate or Severe AGE Associated with Vaccine-Matched NoV Genotypes Up to 12 Months
Tidsramme: Day 15 up to 12 months postdose
|
Day 15 up to 12 months postdose
|
|
VE of mRNA-1403 to Prevent First Occurrence of Protocol-Defined Moderate or Severe AGE Associated with Vaccine-Matched NoV Genotypes Up to 18 Months
Tidsramme: Day 15 up to 18 months postdose
|
Day 15 up to 18 months postdose
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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)
24. september 2024
Primær færdiggørelse (Anslået)
15. februar 2027
Studieafslutning (Anslået)
15. februar 2027
Datoer for studieregistrering
Først indsendt
9. september 2024
Først indsendt, der opfyldte QC-kriterier
9. september 2024
Først opslået (Faktiske)
19. september 2024
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
13. maj 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
8. maj 2026
Sidst verificeret
1. maj 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- mRNA-1403-P301
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 .