Acute GastroenteritisPhase 3Nova 301NCT06592794
A Study to Investigate the Safety and Efficacy of mRNA-1403 in Participants ≥18 Years of Age for the Prevention of Acute Gastroenteritis
A Phase 3 study testing mRNA-1403 in people with Acute Gastroenteritis and Norovirus Acute Gastroenteritis, run by ModernaTX, Inc. at 283 sites in 7 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Gastroenteritis, Norovirus Acute Gastroenteritis
- What is being tested?
- mRNA-1403
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37,864 participants
- Where
- 283 sitesin 7 countries
- Study dates
- 24 Sep 2024to 15 Feb 2027
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
283 sites in 7 countries.
283 sites in 7 countries
United States184 sites
Albany Internal Medicine
Albany, Georgia, 31707
Albuquerque Clinical Trials (ACT)
Albuquerque, New Mexico, 87102
DM Clinical Research
Albuquerque, New Mexico, 87106
Velocity Clinical Research- Albuquerque
Albuquerque, New Mexico, 87107
Velocity Clinical Research - Anderson
Anderson, South Carolina, 29621
Privia Medical Group
Annapolis, Maryland, 27101
Delricht Research At Springer Wellness And Restorative Health
Atlanta, Georgia, 30329
Atlanta Center for Medical Research
Atlanta, Georgia, 30331
Lynn Institute of Denver
Aurora, Colorado, 80012
Benchmark Research
Austin, Texas, 78705
IMA Clinical Research Austin
Austin, Texas, 78745
Velocity Clinical Research - Baton Rouge
Baton Rouge, Louisiana, 70809
Velocity Clinical Research, Cleveland
Beachwood, Ohio, 44122
Tekton Research, Inc. - Beaumont
Beaumont, Texas, 77706
Velocity Clinical Research - Binghamton
Binghamton, New York, 13905
Accel Research Sites - Achieve Clinical Research
Birmingham, Alabama, 32516
Cope Family Medicine
Bountiful, Utah, 84010
Imagine Research of Palm Beach County
Boynton Beach, Florida, 33435
PMG Research of Bristol, LLC
Bristol, Tennessee, 37620
DM Clinical Research - Brookline
Brookline, Massachusetts, 02445
DM Clinical - Brooklyn
Brooklyn, New York, 11220
Brooklyn Clinical Research
Brooklyn, New York, 11226
Headlands Research Brownsville
Brownsville, Texas, 78526
Skylight Health Research - Burlington
Burlington, Massachusetts, 02721
Family Medicine Associates of Texas
Carrollton, Texas, 75010
Javara Inc. / Nevada Health Centers, Ind
Carson City, Nevada, 89706
DelRicht Research
Charleston, South Carolina, 29407
DelRicht Research, LLC
Charlotte, North Carolina, 28205
Javara Inc. - Tryon Medical-South Park
Charlotte, North Carolina, 28287
Charlottesville Medical Research Center, LLC
Charlottesville, Virginia, 22911
Clinical Research Professionals
Chesterfield, Missouri, 63005
IMA Clinical Research
Chicago, Illinois, 60602
Velocity Clinical Research-Mt. Auburn
Cincinnati, Ohio, 45219
CTI Clinical Research Center
Cincinnati, Ohio, 45241
Velocity Clinical Reseach - Blue Ash
Cincinnati, Ohio, 45242
Velocity Clinical Research - Cincinnati OH
Cincinnati, Ohio, 45246
Centricity Research
Columbus, Ohio, 43213
Remington-Davis Clinical Research
Columbus, Ohio, 43215
Javara Inc (Conroe)
Conroe, Texas, 77384
Pioneer Clinical Studies
Coral Gables, Florida, 33134
Velocity Clinical Research - Covington
Covington, Louisiana, 70433
Cullman Clinical Trials
Cullman, Alabama, 35055
WR-Global Medical Research, LLC
Dallas, Texas, 75224
Alliance for Multispecialty Research, LLC
Daphne, Alabama, 36526
CenExel iResearch Atlanta, LLC
Decatur, Georgia, 30030
Integrity Clinical Research, LLC (ICR SITES) - Doral
Doral, Florida, 33122
Alliance for multispecialty Research - Florida
Doral, Florida, 33134
Altoona Center for Clinical Research - Research
Duncansville, Pennsylvania, 16635
Velocity Clinical Research, Durham
Durham, North Carolina, 27701
Velocity Clinical Research - Providence
East Greenwich, Rhode Island, 02818
Velocity Clinical Research - Syracuse
East Syracuse, New York, 13057
Tekton Research, Inc - Edmond
Edmond, Oklahoma, 73013
El Paso Research
El Paso, Texas, 79936
Javara Inc.
Fayetteville, Georgia, 30214
Tekton Research - Fort Collins
Fort Collins, Colorado, 80525
Benchmark Research
Fort Worth, Texas, 76135
ARK Clinical Research, LLC
Fountain Valley, California, 92708
ASCADA Research, LLC - Family Medicine
Fullerton, California, 92835
Cenexel CBH (CBH Health)
Gaithersburg, Maryland, 20877
Velocity Clinical Research, Gulfport
Gulfport, Mississippi, 39503
Great Lakes Clinical Trials - Gurnee
Gurnee, Illinois, 60048
Velocity Clinical Research - Hampton
Hampton, Virginia, 23666
Drug Trials America
Hartsdale, New York, 10530
Delricht Moyer
Hendersonville, Tennessee, 37075
AGA Clinical Trials
Hialeah, Florida, 33012
Best Quality Research Inc.
Hialeah, Florida, 33016
Neoclinical Research
Hialeah, Florida, 33016
Research Centers of America
Hollywood, Florida, 33024
West Houston Clinical Research Service
Houston, Texas, 77055
DM Clinical Research - CyFair
Houston, Texas, 77065
DM Clinical Research - Bellaire
Houston, Texas, 77081
Matrix Clinical Research
Huntington Park, California, 90255
Clinical Research Prime
Idaho Falls, Idaho, 83404
Nature Coast Clinical Research, LLC - Inverness
Inverness, Florida, 34452
DM Clinical Research - Irving
Irving, Texas, 75061
Westside Center for Clinical Research
Jacksonville, Florida, 32216
Clinical Neuroscience Solutions, Inc
Jacksonville, Florida, 32256
DM Clinical Research - New Jersey
Jersey City, New Jersey, 07306
Health Awareness INC
Jupiter, Florida, 33458
Frontier Clinical Research, LLC
Kingwood, West Virginia, 26537
Velocity Clinical Research, San Diego
La Mesa, California, 91942
University Clinical Research- Deland
Lake Mary, Florida, 32746
Meridien Research
Lakeland, Florida, 33803
Vector Clinical Trials
Las Vegas, Nevada, 89074
Oasis Clinical Research
Las Vegas, Nevada, 89121
Clinical Site Partners - Leesburg
Leesburg, Florida, 34748
Johnson County Clin-Trials (JCCT)
Lenexa, Kansas, 66219
AMR Lexington
Lexington, Kentucky, 40509
Velocity Clinical Research-Lincoln
Lincoln, Nebraska, 68510
Lynn Institute of the Ozarks
Little Rock, Arkansas, 72204
Baptist Health Center for Clinical Research
Little Rock, Arkansas, 72205
Ark Clinical Research
Long Beach, California, 90815
Tekton Research, Inc - Longmont Center
Longmont, Colorado, 80501
Matrix Clinical Research
Los Angeles, California, 90057
Velocity Clinical Research - Westlake
Los Angeles, California, 90057
Accel Clinical Research - Maitland
Maitland, Florida, 32751
CNS Healthcare DBA Clinical Neuroscience Solutions, INC
Memphis, Tennessee, 38119
Velocity Clinical Research - Boise
Meridian, Idaho, 83642
Benchmark Research
Metairie, Louisiana, 70006
Clinical Trials Management, LLC
Metairie, Louisiana, 70006
Dade Research Center, LLC
Miami, Florida, 33126
Miami Clinical Research
Miami, Florida, 33155
Universal Axon Clinical Research
Miami, Florida, 33166
Florida International Research Center
Miami, Florida, 33173
Suncoast Research Associates, LLC
Miami, Florida, 33173
Miami Dade Medical Research Institute, LLC
Miami, Florida, 33176
Felicidad Medical Research
Miami, Florida, 33184
Clinical Research Institute, Inc.
Minneapolis, Minnesota, 55402
Montana Medical Research, Inc
Missoula, Montana, 59808
West Clinical Research
Morehead City, North Carolina, 28557
Bioluminix Clinical Research Chicago
Naperville, Illinois, 60540
Aqualane Clinical Research
Naples, Florida, 34105
SUNCOAST Clinical Research
New Port Richey, Florida, 34652
Health Research of Hampton Roads
Newport News, Virginia, 23606
Velocity Clinical Research-Norfolk
Norfolk, Nebraska, 68701
AMR Norfolk
Norfolk, Virginia, 37920
Coastal Carolina Research Center - North Charleston
North Charleston, South Carolina, 29405
Velocity Clinical Research-Omaha
Omaha, Nebraska, 38134
Clinical Neuroscience Solutions, Inc
Orlando, Florida, 32801
Clinical Neuroscience Solutions, Inc
Orlando, Florida, 32806
Velocity Clinical Research- Kansas City
Overland Park, Kansas, 66210
Optimal Research
Peoria, Illinois, 61614
DM Clinical Research
Philadelphia, Pennsylvania, 19107
ClinMed, LLC
Phoenix, Arizona, 85004
DM Clinical - Phoenix
Phoenix, Arizona, 85012
HOPE Research Institute
Phoenix, Arizona, 85018
HOPE Research Institute
Phoenix, Arizona, 85023
Abby's Research Institute
Phoenix, Arizona, 85031
ACRC Trials
Plano, Texas, 75024
Research Your Health
Plano, Texas, 75093
Clinical Research Center of Florida
Pompano Beach, Florida, 33060
United Medical Research
Port Orange, Florida, 32127
Health Awareness, Inc
Port Saint Lucie, Florida, 34952
Velocity Clinical Research-Portsmouth
Portsmouth, Virginia, 23703
Delricht Research At Zomnir Family Medicine
Prosper, Texas, 75078
Accellacare Raleigh
Raleigh, North Carolina, 27609
Paradigm Research
Redding, California, 96001
Clinical Research Partners, LLC
Richmond, Virginia, 23226
DM Clinical Research- River Forest
River Forest, Illinois, 60305
Artemis Institute for Clinical Research
Riverside, California, 92503
Benchmark Research
Riverside, California, 92503
Rochester Clinical Research, Inc
Rochester, New York, 14609
Velocity Clinical Research-Rockville
Rockville, Maryland, 20854
Peninsula Research Associates (PRA)
Rolling Hills Estates, California, 90274
St. Johns Center for Clinical Research
Saint Augustine, Florida, 32086
JBR Clinical Research
Salt Lake City, Utah, 84107
DM Clinical Research - San Antonio
San Antonio, Texas, 78207
IMA Clinical Research
San Antonio, Texas, 78229
Tekton Research Inc - San Antonio
San Antonio, Texas, 78229
Apex Clinical Research
San Diego, California, 92120
Artemis Institute for Clinical Research
San Diego, California, 92503
Fellows Research Alliance, Inc.
Savannah, Georgia, 31406
Velocity Clinical Research-Savannah
Savannah, Georgia, 31406
Headlands Research Scottsdale
Scottsdale, Arizona, 85260
Scottsdale Clinical Trials
Scottsdale, Arizona, 85260
DM Clinical Research - Seattle
Seattle, Washington, 98122
Javara Inc/Privia Medical Group, LLC
Silver Spring, Maryland, 20901
Velocity Clinical Research-Sioux City
Sioux City, Iowa, 51106
Headlands Research - Detroit
Southfield, Michigan, 48034
Great Lakes Research Institute
Southfield, Michigan, 48075
DM Clinical Research - Southfield
Southfield, Michigan, 48076
Velocity Clinical Research, Spartanburg
Spartanburg, South Carolina, 29303
Clinvest Headlands LLC
Springfield, Missouri, 65807
Delricht Research
Springfield, Missouri, 65807
IMA Clinical Research - St. Petersburg
St. Petersburg, Florida, 33704
Global Clinical Professionals, LLC
St. Petersburg, Florida, 33705
Clinical Research Atlanta/Headlands
Stockbridge, Georgia, 30281
DM Clinical Research - Sugarland
Sugar Land, Texas, 77478
Precision Clinical Research, LLC
Sunrise, Florida, 33351
Hope Research Institute - Tempe
Tempe, Arizona, 85284
DM Clinical Research - Tomball
Tomball, Texas, 77375
DM Clinical Research
Tomball, Texas, 77375
Oakland Medical Research Center
Troy, Michigan, 48085
Arizona Liver Health
Tucson, Arizona, 85712
Quality of Life Medical and Research Center
Tucson, Arizona, 85712
Del Sol Research Management LLC.- Tucson
Tucson, Arizona, 85715
Delricht Tate
Tulsa, Oklahoma, 74133
Velocity Clinical Research - Valparaiso
Valparaiso, Indiana, 46383
Velocity Clinical Research-Vestal
Vestal, New York, 13850
IMA Clinical Research Warren
Warren Township, New Jersey, 07059
Tekton Research
Wichita, Kansas, 67218
Accellacare of Wilmington
Wilmington, North Carolina, 28401
Javara - Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27101
Tekton Research, Inc - Yukon Location
Yukon, Oklahoma, 73099
United Kingdom39 sites
NHS Grampian - Aberdeen Royal Infirmary
Aberdeen
NIHR Welcome Trust Clinical Research Facility
Birmingham
Layton Medical Centre
Blackpool, Lancashire
Bournemouth Research Hub
Bournemouth
North Bristol NHS Trust - Southmead Hospital
Bristol
Cardiff and Vale University Health Board - University Hospital Wales
Cardiff
Lakeside Healthcare
Corby, Northamptonshire
Accellacare Warwickshire Quality Research Site
Coventry
NHS Lothian - Western General Hospital
Edinburgh
Panthera Biopartners - North London
Enfield
Royal Devon & Exeter Hospital (Wonford)
Exeter
CPS Research by FutureMeds
Glasgow
Glasgow Clinical Research Facility
Glasgow
Panthera Biopartners - Glasgow
Glasgow
Velocity Clinical Research - High Wycombe
High Wycombe, Buckinghamshire
University Hospitals of Leicester NHS Trust
Leicester
FutureMeds Wirral
Liverpool
St George's University Hospitals NHS Foundation Trust - St George's Hospital
London, England
Mile End Hospital
London
Royal Free London NHS Foundation Trust - Royal Free Hospital
London
Manchester University NHS Foundation Trust
Manchester
FutureMeds Newcastle
Newcastle upon Tyne
The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne
Leeds Teaching Hospitals NHS Trust - St James' University Hospital
Nottingham
Accellacare South London
Orpington, Kent
Plymouth Hospital NHS trust-Derriford Hospital
Plymouth
Portsmouth Research Hub
Portsmouth
Panthera Biopartners - Manchester
Rochdale, Manchester
Warrington and Halton Teaching Hospitals NHS Foundation Trust - Halton General Hospital
Runcorn, Cheshire
Northern Care Alliance NHS Foundation Trust - Salford Royal Hospital
Salford, Manchester
Panthera Biopartners - Sheffield
Sheffield
Accellacare Yorkshire Quality Research Site
Shipley
Royal Cornwall Hospitals NHS Trust - Royal Cornwall Hospital
Truro, Cornwall
Wansford Research Ltd
Wansford
Weymouth Research Hub
Weymouth
Eynsham Medical Center
Witney, Oxfordshire
Windrush Medical Practice
Witney
North Wales Clinical Research Centre (NWCRC)
Wrexham
Panthera Biopartners - York
York
Japan23 sites
Dojinkinenkai Meiwa Hospital
Chiyoda-ku, Tôkyô [Tokyo]
Nihonbashi Sakura Clinic
Chūōku, Tôkyô [Tokyo]
Tenjin Sogo Clinic
Fukuoka, Hukuoka [Fukuoka]
P-one Clinic
Hachiōji, Tôkyô
Medical Corporation JR Hiroshima Hospital
Hiroshima, Hirosima [Hiroshima]
Sasaki Clinic
Hyōgo
NewHeart Watanabe Institute
Kanazawa
Asano Clinic
Kawagoe-shi, Saitama
Matsuba Clinic
Kawasaki-shi, Kanagawa
Izumino Hospital
Kochi
Hayashi-Katagihara Clinic
Kyoto, Kyôto [Kyoto]
Medical Corporation Asbo Tokyo Asbo Clinic
Minatoku, Tôkyô [Tokyo]
Tokyo Saiseikai Central Hospital
Minatoku, Tôkyô [Tokyo]
Yokoi Medicine Clinic
Minoh, Osaka
Chubu Rosai Hospital - Rheumatology & Collageous
Nagoya, Aichi-ken
Daido clinic
Nagoya, Aichi-ken
Denenchofu Family Clinic
Ōta-ku, Tôkyô [Tokyo]
Kotoni Medical Support Clinic
Sapporo, Hokkaidô [Hokkaido]
Sapporo Odori Endoscopy Clinic
Sapporo
Higashi-Shinjuku Clinic - Internal Medicine
Shinjuku-ku, Tôkyô [Tokyo]
Shimamura Memorial Hospital
Suginami City, Tôkyô [Tokyo]
Takatsuki General Hosiptal
Takatsuki-shi
Omi Medical Center
Yabasecho, Shiga
Canada19 sites
CARe Clinic
Calgary
Intermed Groupe Sante
Chicoutimi
Medicor Research Inc.
Greater Sudbury
Apex Trials
Guelph
Isaak Walton Killam Health Centre
Halifax
Okanagan Clinical Trials
Kelowna
Centricity Research Quebec City
Lévis
Milestone Research Inc.
London
Centricity Research Mirabel
Mirabel
Centricity Research Pointe-Claire
Pointe-Claire
Centre de Recherche Saint-Louis
Québec
Clinique Spécialisée en Allergie de la Capitale
Québec
CARe Clinic Red Deer
Red Deer
Richmond Clinical Trials
Richmond
Bluewater Clinical Research Group, Inc
Sarnia
Diex Research Sherbrooke Inc
Sherbrooke
Centricity Research Toronto LMC
Toronto
Diex Recherche Trois-Rivières
Trois-Rivières
Colchester Research Group
Truro
Australia11 sites
Veritus Research
Bayswater, Victoria, 3153
Paratus Clinical Research Canberra
Bruce, Australian Capital Territory, 2617
Emeritus Research (Melbourne)
Camberwell, Victoria, 3124
Northside Health
Coffs Harbour, New South Wales, 2450
Momentum Clinical Research Darlinghurst
Darlinghurst, New South Wales, 2010
Paratus Clinical Research Brisbane
Herston, Queensland, 4006
Paratus Clinical Research Central Coast
Kanwal, New South Wales, 2259
Australian Clinical Research Network
Maroubra, New South Wales, 2035
The Peter Doherty Institute for Infection & Immunity
North Melbourne, Victoria, 3051
Fusion Clinical Research
Norwood, South Australia, 5067
Griffith University Hospital
Southport, Queensland, 4222
Panama4 sites
CEVAXIN David
David, Chiriquí Province
CEVAXIN Chorrera
La Chorrera
CEVAXIN 24 de Diciembre
Panama City
CEVAXIN Avenida Mexico
Panama City
Puerto Rico3 sites
BRCR Global
Ponce, 00717
Clinical Research Puerto Rico, Inc.
San Juan, 00909-1711
Research Works San Juan
San Juan, 00966
About this study
Official title: 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.
- Being tested
- mRNA-1403, Placebo
- Keywords
- Acute Gastroenteritis, Norovirus Acute Gastroenteritis, mRNA-1403, Viral Gastroenteritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mRNA-1403Biological
Intramuscular (IM) injection.
PlaceboBiological
0.9% sodium chloride solution by IM injection.
| Study group | Role | What they receive |
|---|---|---|
| mRNA-1403 | Experimental | Participants will receive a single injection of mRNA-1403 on Day 1. Receives: Biological: mRNA-1403 |
| Placebo | Placebo comparator | Participants will receive a single injection of mRNA-1403 matching placebo (0.9% sodium chloride solution) on Day 1. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
Measured: Day 1 up to Day 7 (7 days after study intervention)
Number of Participants with Unsolicited Adverse Events (AEs)
Measured: Day 1 up to Day 28 (28 days after study intervention)
Number of Participants with Medically Attended Adverse Events (MAAEs)
Measured: Day 1 through Day 181
Number of Participants with Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), and AEs Leading to Study Withdrawal
Measured: 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
Measured: Day 15 up to 9 months after last participant dosed
Secondary outcomes (16)
VE of mRNA-1403 to Prevent First Occurrence of Protocol-defined Severe AGE Associated with Vaccine Matched Genotypes
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Day 15 up to Day 546
Geometric Mean Titer (GMT) of Histo-blood Group Antigen (HBGA)-blocking Antibodies Titers Against Vaccine Matched Genotypes
Measured: Day 1 and Day 29
Geometric Mean Fold Rise (GMFR) of HBGA-blocking Antibodies Titers Against Vaccine Matched Genotypes
Measured: Day 1 and Day 29
Percentage of Participants with Seroresponse Based on HBGA-blocking Antibody Titer
Measured: Day 29
GMT of Binding Antibody (bAb) Against Vaccine-matched NoV Genotypes
Measured: Day 1 and Day 29
GMFR of bAb Titers
Measured: Day 1 and Day 29
Percentage of Participants with Seroresponse Based on bAb Titer
Measured: Day 29
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
Measured: 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
Measured: Day 15 up to 18 months postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start24 Sep 2024
- Primary completion15 Feb 2027 (estimated)
- Study completion15 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute GastroenteritisStudies of the same condition, open and under way.
- More trials run by ModernaTX, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 37,864 participants (actual)
Sponsor and investigators
- Lead sponsor
- ModernaTX, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06592794
- Sponsor's protocol ID
- mRNA-1403-P301
- Acronym
- Nova 301
- Status last verified
- May 2026
- First submitted
- 9 Sep 2024
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No