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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  1. 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. 2. 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. 3. 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. 4. 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

  1. 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. 2. 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. 3. 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. 4. 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. 5. 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. 6. 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. 7. Reported history of congenital or acquired immunodeficiency, immunocompromising/immunosuppressive condition, asplenia, or recurrent severe infections per protocol. 8. 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. 9. History of myocarditis, pericarditis, or myopericarditis with onset within 180 days prior to Day 1 whose values have not returned to Baseline clinical status. 10. History of Guillain-Barré syndrome. 11. Reported history of coagulopathy or bleeding disorder considered a contraindication to IM injection or phlebotomy. 12. Dermatologic conditions that could affect local solicited AR assessments. 13. Diagnosis of malignancy within the previous 2 years (excluding nonmelanoma skin cancer). 14. 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. 15. 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. 16. Receipt of systemic immunoglobulins or blood products within 3 months prior to Day 1 or plans for receipt during the study. 17. Has donated ≥450 mL of blood products within 28 days prior to Day 1 Visit or plans to donate blood products during the study. 18. 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. 19. 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 Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

HOPE Research Institute
Phoenix 5308655, Arizona 5551752 85023

Hope Research Institute - Tempe
Tempe 5317058, Arizona 5551752 85284

Arizona Liver Health
Tucson 5318313, Arizona 5551752 85712

Baptist Health Center for Clinical Research
Little Rock 4119403, Arkansas 4099753 72205

Artemis Institute for Clinical Research
Riverside 5387877, California 5332921 92503

Artemis Institute for Clinical Research
San Diego 5391811, California 5332921 92503

Tekton Research - Fort Collins
Fort Collins 5577147, Colorado 5417618 80525

Tekton Research, Inc - Longmont Center
Longmont 5579276, Colorado 5417618 80501

Pioneer Clinical Studies
Coral Gables 4151871, Florida 4155751 33134

Clinical Neuroscience Solutions, Inc
Jacksonville 4160021, Florida 4155751 32256

Accel Clinical Research - Maitland
Maitland 4163220, Florida 4155751 32751

Health Awareness, Inc
Port Saint Lucie 4169171, Florida 4155751 34952

St. Johns Center for Clinical Research
Saint Augustine 4170894, Florida 4155751 32086

Precision Clinical Research, LLC
Sunrise 4174402, Florida 4155751 33351

CenExel iResearch Atlanta, LLC
Decatur 4191124, Georgia 4197000 30030

Clinical Research Prime
Idaho Falls 5596475, Idaho 5596512 83404

Bioluminix Clinical Research Chicago
Naperville 4903279, Illinois 4896861 60540

DM Clinical Research- River Forest
River Forest 4907637, Illinois 4896861 60305

Velocity Clinical Research - Valparaiso
Valparaiso 4927537, Indiana 4921868 46383

Velocity Clinical Research-Sioux City
Sioux City 4876523, Iowa 4862182 51106

Johnson County Clin-Trials (JCCT)
Lenexa 4274356, Kansas 4273857 66219

Velocity Clinical Research - Covington
Covington 4321005, Louisiana 4331987 70433

Benchmark Research
Metairie 4333177, Louisiana 4331987 70006

Velocity Clinical Research-Rockville
Rockville 4367175, Maryland 4361885 20854

Javara Inc/Privia Medical Group, LLC
Silver Spring 4369596, Maryland 4361885 20901

DM Clinical Research - Brookline
Brookline 4931482, Massachusetts 6254926 02445

Skylight Health Research - Burlington
Burlington 4931737, Massachusetts 6254926 02721

Headlands Research - Detroit
Southfield 5010636, Michigan 5001836 48034

DM Clinical Research - Southfield
Southfield 5010636, Michigan 5001836 48076

Clinical Research Institute, Inc.
Minneapolis 5037649, Minnesota 5037779 55402

Velocity Clinical Research, Gulfport
Gulfport 4428667, Mississippi 4436296 39503

Clinical Research Professionals
Chesterfield 4381072, Missouri 4398678 63005

Delricht Research
Springfield 4409896, Missouri 4398678 65807

Velocity Clinical Research-Lincoln
Lincoln 5072006, Nebraska 5073708 68510

Velocity Clinical Research-Omaha
Omaha 5074472, Nebraska 5073708 38134

Javara Inc. / Nevada Health Centers, Ind
Carson City 5501344, Nevada 5509151 89706

Vector Clinical Trials
Las Vegas 5506956, Nevada 5509151 89074

DM Clinical Research - New Jersey
Jersey City 5099836, New Jersey 5101760 07306

IMA Clinical Research Warren
Warren Township 8299577, New Jersey 5101760 07059

Albuquerque Clinical Trials (ACT)
Albuquerque 5454711, New Mexico 5481136 87102

DM Clinical Research
Albuquerque 5454711, New Mexico 5481136 87106

Velocity Clinical Research - Syracuse
East Syracuse 5116079, New York 5128638 13057

Drug Trials America
Hartsdale 5120141, New York 5128638 10530

Rochester Clinical Research, Inc
Rochester 5134086, New York 5128638 14609

West Clinical Research
Morehead City 4480153, North Carolina 4482348 28557

Javara - Wake Forest University Health Sciences
Winston-Salem 4499612, North Carolina 4482348 27101

Velocity Clinical Research, Cleveland
Beachwood 5146711, Ohio 5165418 44122

CTI Clinical Research Center
Cincinnati 4508722, Ohio 5165418 45241

Velocity Clinical Reseach - Blue Ash
Cincinnati 4508722, Ohio 5165418 45242

Remington-Davis Clinical Research
Columbus 4509177, Ohio 5165418 43215

Tekton Research, Inc - Edmond
Edmond 4535740, Oklahoma 4544379 73013

Delricht Tate
Tulsa 4553433, Oklahoma 4544379 74133

Tekton Research, Inc - Yukon Location
Yukon 4556165, Oklahoma 4544379 73099

DM Clinical Research
Philadelphia 4560349, Pennsylvania 6254927 19107

Velocity Clinical Research - Providence
East Greenwich 5221875, Rhode Island 5224323 02818

Velocity Clinical Research, Spartanburg
Spartanburg 4597200, South Carolina 4597040 29303

Delricht Moyer
Hendersonville 4628735, Tennessee 4662168 37075

Benchmark Research
Austin 4671654, Texas 4736286 78705

Headlands Research Brownsville
Brownsville 4676740, Texas 4736286 78526

Family Medicine Associates of Texas
Carrollton 4679195, Texas 4736286 75010

Benchmark Research
Fort Worth 4691930, Texas 4736286 76135

DM Clinical Research - Bellaire
Houston 4699066, Texas 4736286 77081

DM Clinical Research - Irving
Irving 4700168, Texas 4736286 75061

ACRC Trials
Plano 4719457, Texas 4736286 75024

DM Clinical Research - San Antonio
San Antonio 4726206, Texas 4736286 78207

IMA Clinical Research
San Antonio 4726206, Texas 4736286 78229

DM Clinical Research - Sugarland
Sugar Land 4734825, Texas 4736286 77478

DM Clinical Research - Tomball
Tomball 4737094, Texas 4736286 77375

JBR Clinical Research
Salt Lake City 5780993, Utah 5549030 84107

Charlottesville Medical Research Center, LLC
Charlottesville 4752031, Virginia 6254928 22911

Velocity Clinical Research - Hampton
Hampton 4762894, Virginia 6254928 23666

Health Research of Hampton Roads
Newport News 4776024, Virginia 6254928 23606

Clinical Research Partners, LLC
Richmond 4781708, Virginia 6254928 23226

More Details

NCT ID
NCT06592794
Status
Recruiting
Sponsor
ModernaTX, Inc.

Study Contact

Moderna WeCare Team
1-866-663-3762
WeCareClinicalTrials@modernatx.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

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