A Study to Investigate the Safety and Efficacy of mRNA-1403 in Participants ≥18 Years of Age for the Prevention of Acute Gastroenteritis (Nova 301)

May 8, 2026 updated by: ModernaTX, Inc.

A Phase 3, Randomized, Observer-blinded, Placebo-controlled Study to Evaluate the Safety and Efficacy of mRNA-1403, a Multivalent Candidate Vaccine to Prevent Norovirus Acute Gastroenteritis in Adults ≥18 Years of Age

The primary objectives of this study are to evaluate the safety and reactogenicity of mRNA-1403, and to demonstrate the efficacy of mRNA-1403 to prevent protocol-defined moderate or severe norovirus acute gastroenteritis (AGE) associated with vaccine matched genotypes.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

37864

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Australia
- Australian Capital Territory
  - Bruce, Australian Capital Territory, Australia, 2617
    - Paratus Clinical Research Canberra
- New South Wales
  - Coffs Harbour, New South Wales, Australia, 2450
    - Northside Health
  - Darlinghurst, New South Wales, Australia, 2010
    - Momentum Clinical Research Darlinghurst
  - Kanwal, New South Wales, Australia, 2259
    - Paratus Clinical Research Central Coast
  - Maroubra, New South Wales, Australia, 2035
    - Australian Clinical Research Network
- Queensland
  - Herston, Queensland, Australia, 4006
    - Paratus Clinical Research Brisbane
  - Southport, Queensland, Australia, 4222
    - Griffith University Hospital
- South Australia
  - Norwood, South Australia, Australia, 5067
    - Fusion Clinical Research
- Victoria
  - Bayswater, Victoria, Australia, 3153
    - Veritus Research
  - Camberwell, Victoria, Australia, 3124
    - Emeritus Research (Melbourne)
  - North Melbourne, Victoria, Australia, 3051
    - The Peter Doherty Institute for Infection & Immunity
Canada
- - Calgary, Canada
    - CaRe Clinic
  - Chicoutimi, Canada
    - INTERMED Groupe Sante
  - 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
Japan
- - 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
Panama
- - 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
Puerto Rico
- - 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
United Kingdom
- - Aberdeen, United Kingdom
    - NHS Grampian - Aberdeen Royal Infirmary
  - Birmingham, United Kingdom
    - NIHR Welcome Trust Clinical Research Facility
  - Bournemouth, United Kingdom
    - Bournemouth Research Hub
  - Bristol, United Kingdom
    - North Bristol NHS Trust - Southmead Hospital
  - Cardiff, United Kingdom
    - Cardiff and Vale University Health Board - University Hospital Wales
  - Coventry, United Kingdom
    - Accellacare Warwickshire Quality Research Site
  - Edinburgh, United Kingdom
    - NHS Lothian - Western General Hospital
  - Enfield, United Kingdom
    - Panthera Biopartners - North London
  - Exeter, United Kingdom
    - Royal Devon & Exeter Hospital (Wonford)
  - Glasgow, United Kingdom
    - Glasgow Clinical Research Facility
  - Glasgow, United Kingdom
    - CPS Research by FutureMeds
  - Glasgow, United Kingdom
    - Panthera Biopartners - Glasgow
  - Leicester, United Kingdom
    - University Hospitals of Leicester NHS Trust
  - Liverpool, United Kingdom
    - FutureMeds Wirral
  - London, United Kingdom
    - Mile End Hospital
  - London, United Kingdom
    - Royal Free London NHS Foundation Trust - Royal Free Hospital
  - Manchester, United Kingdom
    - Manchester University NHS Foundation Trust
  - Newcastle upon Tyne, United Kingdom
    - The Newcastle Upon Tyne Hospitals NHS Foundation Trust
  - Newcastle upon Tyne, United Kingdom
    - FutureMeds Newcastle
  - Nottingham, United Kingdom
    - Leeds Teaching Hospitals NHS Trust - St James' University Hospital
  - Plymouth, United Kingdom
    - Plymouth Hospital NHS trust-Derriford Hospital
  - Portsmouth, United Kingdom
    - Portsmouth Research Hub
  - Sheffield, United Kingdom
    - Panthera Biopartners - Sheffield
  - Shipley, United Kingdom
    - Accellacare Yorkshire Quality Research Site
  - Wansford, United Kingdom
    - Wansford Research LTD
  - Weymouth, United Kingdom
    - Weymouth Research Hub
  - Witney, United Kingdom
    - Windrush Medical Practice
  - Wrexham, United Kingdom
    - North Wales Clinical Research Centre (NWCRC)
  - York, United Kingdom
    - Panthera Biopartners - York
- Buckinghamshire
  - High Wycombe, Buckinghamshire, United Kingdom
    - Velocity Clinical Research - High Wycombe
- Cheshire
  - Runcorn, Cheshire, United Kingdom
    - Warrington and Halton Teaching Hospitals NHS Foundation Trust - Halton General Hospital
- Cornwall
  - Truro, Cornwall, United Kingdom
    - Royal Cornwall Hospitals NHS Trust - Royal Cornwall Hospital
- England
  - London, England, United Kingdom
    - St George's University Hospitals NHS Foundation Trust - St George's Hospital
- Kent
  - Orpington, Kent, United Kingdom
    - Accellacare South London
- Lancashire
  - Blackpool, Lancashire, United Kingdom
    - Layton Medical Centre
- Manchester
  - Rochdale, Manchester, United Kingdom
    - Panthera Biopartners - Manchester
  - Salford, Manchester, United Kingdom
    - Northern Care Alliance NHS Foundation Trust - Salford Royal Hospital
- Northamptonshire
  - Corby, Northamptonshire, United Kingdom
    - Lakeside Healthcare
- Oxfordshire
  - Witney, Oxfordshire, United Kingdom
    - Eynsham Medical Center
United States
- Alabama
  - Birmingham, Alabama, United States, 32516
    - Accel Research Sites - Achieve Clinical Research
  - Cullman, Alabama, United States, 35055
    - Cullman Clinical Trials
  - Daphne, Alabama, United States, 36526
    - Alliance for Multispecialty Research, LLC
- Arizona
  - Phoenix, Arizona, United States, 85018
    - Hope research Institute
  - Phoenix, Arizona, United States, 85023
    - Hope research Institute
  - Phoenix, Arizona, United States, 85031
    - Abby's Research Institute
  - Phoenix, Arizona, United States, 85004
    - ClinMed, LLC
  - Phoenix, Arizona, United States, 85012
    - DM Clinical - Phoenix
  - Scottsdale, Arizona, United States, 85260
    - Headlands Research Scottsdale
  - Scottsdale, Arizona, United States, 85260
    - Scottsdale Clinical Trials
  - Tempe, Arizona, United States, 85284
    - Hope Research Institute - Tempe
  - Tucson, Arizona, United States, 85712
    - Quality of Life Medical and Research Center
  - Tucson, Arizona, United States, 85712
    - Arizona Liver Health
  - Tucson, Arizona, United States, 85715
    - Del Sol Research Management LLC.- Tucson
- Arkansas
  - Little Rock, Arkansas, United States, 72205
    - Baptist Health Center for Clinical Research
  - Little Rock, Arkansas, United States, 72204
    - Lynn Institute of the Ozarks
- California
  - Fountain Valley, California, United States, 92708
    - Ark Clinical Research, LLC
  - Fullerton, California, United States, 92835
    - ASCADA Research, LLC - Family Medicine
  - Huntington Park, California, United States, 90255
    - Matrix Clinical Research
  - La Mesa, California, United States, 91942
    - Velocity Clinical Research, San Diego
  - Long Beach, California, United States, 90815
    - Ark Clinical Research
  - Los Angeles, California, United States, 90057
    - Matrix Clinical Research
  - Los Angeles, California, United States, 90057
    - Velocity Clinical Research - Westlake
  - Redding, California, United States, 96001
    - Paradigm Research
  - Riverside, California, United States, 92503
    - Artemis Institute for Clinical Research
  - Riverside, California, United States, 92503
    - Benchmark Research
  - Rolling Hills Estates, California, United States, 90274
    - Peninsula Research Associates (PRA)
  - San Diego, California, United States, 92120
    - Apex Clinical Research
  - San Diego, California, United States, 92503
    - Artemis Institute for Clinical Research
- Colorado
  - Aurora, Colorado, United States, 80012
    - Lynn Institute of Denver
  - Fort Collins, Colorado, United States, 80525
    - Tekton Research - Fort Collins
  - Longmont, Colorado, United States, 80501
    - Tekton Research, Inc - Longmont Center
- Florida
  - Boynton Beach, Florida, United States, 33435
    - Imagine Research of Palm Beach County
  - Coral Gables, Florida, United States, 33134
    - Pioneer Clinical Studies
  - Doral, Florida, United States, 33122
    - Integrity Clinical Research, LLC (ICR SITES) - Doral
  - Doral, Florida, United States, 33134
    - Alliance for multispecialty Research - Florida
  - Hialeah, Florida, United States, 33012
    - Aga Clinical Trials
  - Hialeah, Florida, United States, 33016
    - Best Quality Research Inc.
  - Hialeah, Florida, United States, 33016
    - NeoClinical Research
  - Hollywood, Florida, United States, 33024
    - Research Centers of America
  - Inverness, Florida, United States, 34452
    - Nature Coast Clinical Research, LLC - Inverness
  - Jacksonville, Florida, United States, 32256
    - Clinical Neuroscience Solutions, Inc
  - Jacksonville, Florida, United States, 32216
    - Westside Center for Clinical Research
  - Jupiter, Florida, United States, 33458
    - Health Awareness Inc
  - Lake Mary, Florida, United States, 32746
    - University Clinical Research- Deland
  - Lakeland, Florida, United States, 33803
    - Meridien Research
  - Leesburg, Florida, United States, 34748
    - Clinical Site Partners - Leesburg
  - Maitland, Florida, United States, 32751
    - Accel Clinical Research - Maitland
  - Miami, Florida, United States, 33173
    - Florida International Research Center
  - Miami, Florida, United States, 33176
    - Miami Dade Medical Research Institute, LLC
  - Miami, Florida, United States, 33155
    - Miami Clinical Research
  - Miami, Florida, United States, 33173
    - Suncoast Research Associates, LLC
  - Miami, Florida, United States, 33166
    - Universal Axon Clinical Research
  - Miami, Florida, United States, 33126
    - Dade Research Center, LLC
  - Miami, Florida, United States, 33184
    - Felicidad Medical Research
  - Naples, Florida, United States, 34105
    - Aqualane Clinical Research
  - New Port Richey, Florida, United States, 34652
    - Suncoast Clinical Research
  - Orlando, Florida, United States, 32801
    - Clinical Neuroscience Solutions, Inc
  - Orlando, Florida, United States, 32806
    - Clinical Neuroscience Solutions, Inc
  - Pompano Beach, Florida, United States, 33060
    - Clinical Research Center of Florida
  - Port Orange, Florida, United States, 32127
    - United Medical Research
  - Port Saint Lucie, Florida, United States, 34952
    - Health Awareness, Inc
  - Saint Augustine, Florida, United States, 32086
    - St. Johns Center for Clinical Research
  - St. Petersburg, Florida, United States, 33704
    - IMA Clinical Research - St. Petersburg
  - St. Petersburg, Florida, United States, 33705
    - Global Clinical Professionals, LLC
  - Sunrise, Florida, United States, 33351
    - Precision Clinical Research, LLC
- Georgia
  - Albany, Georgia, United States, 31707
    - Albany Internal Medicine
  - Atlanta, Georgia, United States, 30331
    - Atlanta Center for Medical Research
  - Atlanta, Georgia, United States, 30329
    - Delricht Research At Springer Wellness And Restorative Health
  - Decatur, Georgia, United States, 30030
    - CenExel iResearch Atlanta, LLC
  - Fayetteville, Georgia, United States, 30214
    - Javara Inc.
  - Savannah, Georgia, United States, 31406
    - Fellows Research Alliance, Inc.
  - Savannah, Georgia, United States, 31406
    - Velocity Clinical Research-Savannah
  - Stockbridge, Georgia, United States, 30281
    - Clinical Research Atlanta/Headlands
- Idaho
  - Idaho Falls, Idaho, United States, 83404
    - Clinical Research Prime
  - Meridian, Idaho, United States, 83642
    - Velocity Clinical Research - Boise
- Illinois
  - Chicago, Illinois, United States, 60602
    - IMA Clinical Research
  - Gurnee, Illinois, United States, 60048
    - Great Lakes Clinical Trials - Gurnee
  - Naperville, Illinois, United States, 60540
    - Bioluminix Clinical Research Chicago
  - Peoria, Illinois, United States, 61614
    - Optimal Research
  - River Forest, Illinois, United States, 60305
    - DM Clinical Research- River Forest
- Indiana
  - Valparaiso, Indiana, United States, 46383
    - Velocity Clinical Research - Valparaiso
- Iowa
  - Sioux City, Iowa, United States, 51106
    - Velocity Clinical Research-Sioux City
- Kansas
  - Lenexa, Kansas, United States, 66219
    - Johnson County Clin-Trials (JCCT)
  - Overland Park, Kansas, United States, 66210
    - Velocity Clinical Research- Kansas City
  - Wichita, Kansas, United States, 67218
    - Tekton Research
- Kentucky
  - Lexington, Kentucky, United States, 40509
    - AMR Lexington
- Louisiana
  - Baton Rouge, Louisiana, United States, 70809
    - Velocity Clinical Research - Baton Rouge
  - Covington, Louisiana, United States, 70433
    - Velocity Clinical Research - Covington
  - Metairie, Louisiana, United States, 70006
    - Clinical Trials Management, LLC
  - Metairie, Louisiana, United States, 70006
    - Benchmark Research
- Maryland
  - Annapolis, Maryland, United States, 27101
    - Privia Medical Group
  - Gaithersburg, Maryland, United States, 20877
    - Cenexel CBH (CBH Health)
  - Rockville, Maryland, United States, 20854
    - Velocity Clinical Research-Rockville
  - Silver Spring, Maryland, United States, 20901
    - Javara Inc/Privia Medical Group, LLC
- Massachusetts
  - Brookline, Massachusetts, United States, 02445
    - DM Clinical Research - Brookline
  - Burlington, Massachusetts, United States, 02721
    - Skylight Health Research - Burlington
- Michigan
  - Southfield, Michigan, United States, 48075
    - Great Lakes Research Institute
  - Southfield, Michigan, United States, 48076
    - DM Clinical Research - Southfield
  - Southfield, Michigan, United States, 48034
    - Headlands Research - Detroit
  - Troy, Michigan, United States, 48085
    - Oakland Medical Research Center
- Minnesota
  - Minneapolis, Minnesota, United States, 55402
    - Clinical Research Institute, Inc.
- Mississippi
  - Gulfport, Mississippi, United States, 39503
    - Velocity Clinical Research, Gulfport
- Missouri
  - Chesterfield, Missouri, United States, 63005
    - Clinical Research Professionals
  - Springfield, Missouri, United States, 65807
    - DelRicht Research
  - Springfield, Missouri, United States, 65807
    - Clinvest Headlands Llc
- Montana
  - Missoula, Montana, United States, 59808
    - Montana Medical Research, Inc
- Nebraska
  - Lincoln, Nebraska, United States, 68510
    - Velocity Clinical Research-Lincoln
  - Norfolk, Nebraska, United States, 68701
    - Velocity Clinical Research-Norfolk
  - Omaha, Nebraska, United States, 38134
    - Velocity Clinical Research-Omaha
- Nevada
  - Carson City, Nevada, United States, 89706
    - Javara Inc. / Nevada Health Centers, Ind
  - Las Vegas, Nevada, United States, 89074
    - Vector Clinical Trials
  - Las Vegas, Nevada, United States, 89121
    - Oasis Clinical Research
- New Jersey
  - Jersey City, New Jersey, United States, 07306
    - DM Clinical Research - New Jersey
  - Warren Township, New Jersey, United States, 07059
    - IMA Clinical Research Warren
- New Mexico
  - Albuquerque, New Mexico, United States, 87107
    - Velocity Clinical Research- Albuquerque
  - Albuquerque, New Mexico, United States, 87102
    - Albuquerque Clinical Trials (ACT)
  - Albuquerque, New Mexico, United States, 87106
    - DM Clinical Research
- New York
  - Binghamton, New York, United States, 13905
    - Velocity Clinical Research - Binghamton
  - Brooklyn, New York, United States, 11226
    - Brooklyn Clinical Research
  - Brooklyn, New York, United States, 11220
    - DM Clinical - Brooklyn
  - East Syracuse, New York, United States, 13057
    - Velocity Clinical Research - Syracuse
  - Hartsdale, New York, United States, 10530
    - Drug Trials America
  - Rochester, New York, United States, 14609
    - Rochester Clinical Research, Inc
  - Vestal, New York, United States, 13850
    - Velocity Clinical Research-Vestal
- North Carolina
  - Charlotte, North Carolina, United States, 28205
    - DelRicht Research, LLC
  - Charlotte, North Carolina, United States, 28287
    - Javara Inc. - Tryon Medical-South Park
  - Durham, North Carolina, United States, 27701
    - Velocity Clinical Research, Durham
  - Morehead City, North Carolina, United States, 28557
    - West Clinical Research
  - Raleigh, North Carolina, United States, 27609
    - Accellacare Raleigh
  - Wilmington, North Carolina, United States, 28401
    - Accellacare of Wilmington
  - Winston-Salem, North Carolina, United States, 27101
    - Javara - Wake Forest University Health Sciences
- Ohio
  - Beachwood, Ohio, United States, 44122
    - Velocity Clinical Research, Cleveland
  - Cincinnati, Ohio, United States, 45219
    - Velocity Clinical Research-Mt. Auburn
  - Cincinnati, Ohio, United States, 45241
    - CTI Clinical Research Center
  - Cincinnati, Ohio, United States, 45242
    - Velocity Clinical Reseach - Blue Ash
  - Cincinnati, Ohio, United States, 45246
    - Velocity Clinical Research - Cincinnati OH
  - Columbus, Ohio, United States, 43213
    - Centricity Research
  - Columbus, Ohio, United States, 43215
    - Remington-Davis Clinical Research
- Oklahoma
  - Edmond, Oklahoma, United States, 73013
    - Tekton Research, Inc - Edmond
  - Tulsa, Oklahoma, United States, 74133
    - Delricht Tate
  - Yukon, Oklahoma, United States, 73099
    - Tekton Research, Inc - Yukon Location
- Pennsylvania
  - Duncansville, Pennsylvania, United States, 16635
    - Altoona Center for Clinical Research - Research
  - Philadelphia, Pennsylvania, United States, 19107
    - DM Clinical Research
- Rhode Island
  - East Greenwich, Rhode Island, United States, 02818
    - Velocity Clinical Research - Providence
- South Carolina
  - Anderson, South Carolina, United States, 29621
    - Velocity Clinical Research - Anderson
  - Charleston, South Carolina, United States, 29407
    - DelRicht Research
  - North Charleston, South Carolina, United States, 29405
    - Coastal Carolina Research Center - North Charleston
  - Spartanburg, South Carolina, United States, 29303
    - Velocity Clinical Research, Spartanburg
- Tennessee
  - Bristol, Tennessee, United States, 37620
    - PMG Research of Bristol, LLC
  - Hendersonville, Tennessee, United States, 37075
    - Delricht Moyer
  - Memphis, Tennessee, United States, 38119
    - CNS Healthcare DBA Clinical Neuroscience Solutions, INC
- Texas
  - Austin, Texas, United States, 78705
    - Benchmark Research
  - Austin, Texas, United States, 78745
    - IMA Clinical Research Austin
  - Beaumont, Texas, United States, 77706
    - Tekton Research, Inc. - Beaumont
  - Brownsville, Texas, United States, 78526
    - Headlands Research Brownsville
  - Carrollton, Texas, United States, 75010
    - Family Medicine Associates of Texas
  - Conroe, Texas, United States, 77384
    - Javara Inc (Conroe)
  - Dallas, Texas, United States, 75224
    - WR-Global Medical Research, LLC
  - El Paso, Texas, United States, 79936
    - El Paso Research
  - Fort Worth, Texas, United States, 76135
    - Benchmark Research
  - Houston, Texas, United States, 77055
    - West Houston Clinical Research Service
  - Houston, Texas, United States, 77065
    - DM Clinical Research - CyFair
  - Houston, Texas, United States, 77081
    - DM Clinical Research - Bellaire
  - Irving, Texas, United States, 75061
    - DM Clinical Research - Irving
  - Plano, Texas, United States, 75024
    - ACRC Trials
  - Plano, Texas, United States, 75093
    - Research Your Health
  - Prosper, Texas, United States, 75078
    - Delricht Research At Zomnir Family Medicine
  - San Antonio, Texas, United States, 78229
    - IMA Clinical Research
  - San Antonio, Texas, United States, 78229
    - Tekton Research Inc - San Antonio
  - San Antonio, Texas, United States, 78207
    - DM Clinical Research - San Antonio
  - Sugar Land, Texas, United States, 77478
    - DM Clinical Research - Sugarland
  - Tomball, Texas, United States, 77375
    - DM Clinical Research
  - Tomball, Texas, United States, 77375
    - DM Clinical Research - Tomball
- Utah
  - Bountiful, Utah, United States, 84010
    - Cope Family Medicine
  - Salt Lake City, Utah, United States, 84107
    - JBR Clinical Research
- Virginia
  - Charlottesville, Virginia, United States, 22911
    - Charlottesville Medical Research Center, LLC
  - Hampton, Virginia, United States, 23666
    - Velocity Clinical Research - Hampton
  - Newport News, Virginia, United States, 23606
    - Health Research of Hampton Roads
  - Norfolk, Virginia, United States, 37920
    - AMR Norfolk
  - Portsmouth, Virginia, United States, 23703
    - Velocity Clinical Research-Portsmouth
  - Richmond, Virginia, United States, 23226
    - Clinical Research Partners, LLC
- Washington
  - Seattle, Washington, United States, 98122
    - DM Clinical Research - Seattle
- West Virginia
  - Kingwood, West Virginia, United States, 26537
    - Frontier Clinical Research, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Participants who understand and are willing and physically able to comply with protocol mandated follow-up, including all procedures as assessed by the Investigator, and who are primarily responsible for their self-care and activities of daily living.
Participants may have chronic medical diagnoses but should be medically stable as assessed by the following criteria:
- Absence of medical events associated with underlying diagnoses and qualifying as SAEs within 1 month prior to study intervention on Day 1.
- Absence of known, current, and life-limiting diagnoses, which could continue for the duration of the study and which, in the opinion of the Investigator, would make completion of the protocol unlikely.
Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol.
Participants assigned female at birth are eligible to participate if they are not pregnant or breastfeeding/chestfeeding/bodyfeeding and meet protocol defined criteria.

Exclusion Criteria:

Participant is acutely ill or febrile (temperature ≥38.0 degrees Celsius (°C) [100.4 degrees Fahrenheit [°F]) 72 hours prior to or at the Screening Visit or Day 1.
History of AGE within 14 days prior to Day 1 or close contact with an individual with AGE symptoms (in the home, socially, or occupationally) within 14 days prior to Day 1.
History of a diagnosis or condition that in the judgment of the Investigator, is clinically unstable or may affect participant safety, assessment of safety endpoints, assessment of immune response, or adherence to study procedures.
Current diagnosis of chronic gastrointestinal (GI) disease that is associated with ongoing symptoms of regular vomiting and/or diarrhea. Participants with stable, well-controlled chronic GI disease without regular vomiting and/or diarrhea can be considered for enrollment.
Has a medical, psychiatric, or occupational condition that may pose additional risk as a result of participation or that could interfere with safety assessments or interpretation of results according to the investigator's judgment.
Has undergone surgical procedures within 7 days prior to Day 1 or is scheduled to undergo a surgical procedure within 28 days after study intervention.
Reported history of congenital or acquired immunodeficiency, immunocompromising/immunosuppressive condition, asplenia, or recurrent severe infections per protocol.
Reported history of anaphylaxis, urticaria, or other significant AR requiring medical intervention after receipt of a vaccine or intervention that includes one or more of the same components contained in the study vaccine.
History of myocarditis, pericarditis, or myopericarditis with onset within 180 days prior to Day 1 whose values have not returned to Baseline clinical status.
History of Guillain-Barré syndrome.
Reported history of coagulopathy or bleeding disorder considered a contraindication to IM injection or phlebotomy.
Dermatologic conditions that could affect local solicited AR assessments.
Diagnosis of malignancy within the previous 2 years (excluding nonmelanoma skin cancer).
Has received systemic immunosuppressive therapies for >14 days in total within 6 months prior to Day 1 (for corticosteroids ≥10 milligrams (mg)/day of prednisone equivalent) or is anticipating the need for immunosuppressive treatment at any time during participation in the study.
Has received or plans to receive any licensed vaccine ≤28 days prior to or within 28 days after study intervention (Day 1), except for influenza vaccines, which may be given 14 days before or after receipt of a study intervention.
Receipt of systemic immunoglobulins or blood products within 3 months prior to Day 1 or plans for receipt during the study.
Has donated ≥450 mL of blood products within 28 days prior to Day 1 Visit or plans to donate blood products during the study.
Participated in a clinical study with investigational treatment within 90 days prior to Day 1 (Baseline) based on the medical history interview or plans to do so while participating in this study. Participants may continue in prior interventional study follow-up activities, provided that it does not involve further investigational treatment and/or procedures that may affect safety and/or other study endpoints, and study participation does not result in a breach of either study protocol.
Is working as, has worked as, or is an immediate family member or household member of study personnel, Sponsor personnel, or study site staff directly involved with the conduct of the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Triple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: mRNA-1403 Participants will receive a single injection of mRNA-1403 on Day 1.	Biological: mRNA-1403 Intramuscular (IM) injection.
Placebo Comparator: Placebo Participants will receive a single injection of mRNA-1403 matching placebo (0.9% sodium chloride solution) on Day 1.	Biological: Placebo 0.9% sodium chloride solution by IM injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs) Time Frame: Day 1 up to Day 7 (7 days after study intervention)	Day 1 up to Day 7 (7 days after study intervention)
Number of Participants with Unsolicited Adverse Events (AEs) Time Frame: Day 1 up to Day 28 (28 days after study intervention)	Day 1 up to Day 28 (28 days after study intervention)
Number of Participants with Medically Attended Adverse Events (MAAEs) Time Frame: Day 1 through Day 181	Day 1 through Day 181
Number of Participants with Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), and AEs Leading to Study Withdrawal Time Frame: 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 Time Frame: Day 15 up to 9 months after last participant dosed	Day 15 up to 9 months after last participant dosed

Secondary Outcome Measures

Outcome Measure	Time Frame
Geometric Mean Titer (GMT) of Histo-blood Group Antigen (HBGA)-blocking Antibodies Titers Against Vaccine Matched Genotypes Time Frame: Day 1 and Day 29	Day 1 and Day 29
Geometric Mean Fold Rise (GMFR) of HBGA-blocking Antibodies Titers Against Vaccine Matched Genotypes Time Frame: Day 1 and Day 29	Day 1 and Day 29
Percentage of Participants with Seroresponse Based on HBGA-blocking Antibody Titer Time Frame: Day 29	Day 29
GMT of Binding Antibody (bAb) Against Vaccine-matched NoV Genotypes Time Frame: Day 1 and Day 29	Day 1 and Day 29
GMFR of bAb Titers Time Frame: Day 1 and Day 29	Day 1 and Day 29
Percentage of Participants with Seroresponse Based on bAb Titer Time Frame: Day 29	Day 29
VE of mRNA-1403 to Prevent First Occurrence of Protocol-defined Severe AGE Associated with Vaccine Matched Genotypes Time Frame: 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 Time Frame: 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 Time Frame: 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 Time Frame: 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 Time Frame: 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 Time Frame: 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 Time Frame: 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 Time Frame: 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 Time Frame: 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 Time Frame: Day 15 up to 18 months postdose	Day 15 up to 18 months postdose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ModernaTX, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 24, 2024

Primary Completion (Estimated)

February 15, 2027

Study Completion (Estimated)

February 15, 2027

Study Registration Dates

First Submitted

September 9, 2024

First Submitted That Met QC Criteria

September 9, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Actual)

May 13, 2026

Last Update Submitted That Met QC Criteria

May 8, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

mRNA-1403-P301

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Time Frame

Secondary Outcome Measures

Outcome Measure

Time Frame

Collaborators and Investigators

Sponsor

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Clinical Trials on Acute Gastroenteritis

Clinical Trials on mRNA-1403

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