RECRUITING

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

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Conditions

Acute GastroenteritisNorovirus Acute GastroenteritismRNA-1403Viral Gastroenteritis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2024-09-24
Study Completion:2027-02-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06592794

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 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. 2. Participants may have chronic medical diagnoses but should be medically stable as assessed by the following criteria:
  3. * Absence of medical events associated with underlying diagnoses and qualifying as SAEs within 1 month prior to study intervention on Day 1.
  4. * 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.
  5. 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.
  6. 4. Participants assigned female at birth are eligible to participate if they are not pregnant or breastfeeding/chestfeeding/bodyfeeding and meet protocol defined criteria.
  1. 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. 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. 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. 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. 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. 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. 7. Reported history of congenital or acquired immunodeficiency, immunocompromising/immunosuppressive condition, asplenia, or recurrent severe infections per protocol.
  8. 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. 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. 10. History of Guillain-Barré syndrome.
  11. 11. Reported history of coagulopathy or bleeding disorder considered a contraindication to IM injection or phlebotomy.
  12. 12. Dermatologic conditions that could affect local solicited AR assessments.
  13. 13. Diagnosis of malignancy within the previous 2 years (excluding nonmelanoma skin cancer).
  14. 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. 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. 16. Receipt of systemic immunoglobulins or blood products within 3 months prior to Day 1 or plans for receipt during the study.
  17. 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. 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. 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.

Contacts and Locations

Study Contact

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

Study Locations (Sites)

Accel Research Sites - Achieve Clinical Research
Birmingham, Alabama, 32516
United States
Cullman Clinical Trials
Cullman, Alabama, 35055
United States
Alliance for Multispecialty Research, LLC
Daphne, Alabama, 36526
United States
ClinMed, LLC
Phoenix, Arizona, 85004
United States
DM Clinical - Phoenix
Phoenix, Arizona, 85012
United States
HOPE Research Institute
Phoenix, Arizona, 85018
United States
HOPE Research Institute
Phoenix, Arizona, 85023
United States
Abby's Research Institute
Phoenix, Arizona, 85031
United States
Headlands Research Scottsdale
Scottsdale, Arizona, 85260
United States
Scottsdale Clinical Trials
Scottsdale, Arizona, 85260
United States
Hope Research Institute - Tempe
Tempe, Arizona, 85284
United States
Arizona Liver Health
Tucson, Arizona, 85712
United States
Quality of Life Medical and Research Center
Tucson, Arizona, 85712
United States
Del Sol Research Management LLC.- Tucson
Tucson, Arizona, 85715
United States
Lynn Institute of the Ozarks
Little Rock, Arkansas, 72204
United States
Baptist Health Center for Clinical Research
Little Rock, Arkansas, 72205
United States
ARK Clinical Research, LLC
Fountain Valley, California, 92708
United States
ASCADA Research, LLC - Family Medicine
Fullerton, California, 92835
United States
Matrix Clinical Research
Huntington Park, California, 90255
United States
Velocity Clinical Research, San Diego
La Mesa, California, 91942
United States
Ark Clinical Research
Long Beach, California, 90815
United States
Matrix Clinical Research
Los Angeles, California, 90057
United States
Velocity Clinical Research - Westlake
Los Angeles, California, 90057
United States
Paradigm Research
Redding, California, 96001
United States
Artemis Institute for Clinical Research
Riverside, California, 92503
United States
Benchmark Research
Riverside, California, 92503
United States
Peninsula Research Associates (PRA)
Rolling Hills Estates, California, 90274
United States
Apex Clinical Research
San Diego, California, 92120
United States
Artemis Institute for Clinical Research
San Diego, California, 92503
United States
Lynn Institute of Denver
Aurora, Colorado, 80012
United States
Tekton Research - Fort Collins
Fort Collins, Colorado, 80525
United States
Tekton Research, Inc - Longmont Center
Longmont, Colorado, 80501
United States
Imagine Research of Palm Beach County
Boynton Beach, Florida, 33435
United States
Pioneer Clinical Studies
Coral Gables, Florida, 33134
United States
Integrity Clinical Research, LLC (ICR SITES) - Doral
Doral, Florida, 33122
United States
Alliance for multispecialty Research - Florida
Doral, Florida, 33134
United States
AGA Clinical Trials
Hialeah, Florida, 33012
United States
Best Quality Research Inc.
Hialeah, Florida, 33016
United States
Neoclinical Research
Hialeah, Florida, 33016
United States
Research Centers of America
Hollywood, Florida, 33024
United States
Nature Coast Clinical Research, LLC - Inverness
Inverness, Florida, 34452
United States
Westside Center for Clinical Research
Jacksonville, Florida, 32216
United States
Clinical Neuroscience Solutions, Inc
Jacksonville, Florida, 32256
United States
Health Awareness INC
Jupiter, Florida, 33458
United States
University Clinical Research- Deland
Lake Mary, Florida, 32746
United States
Meridien Research
Lakeland, Florida, 33803
United States
Clinical Site Partners - Leesburg
Leesburg, Florida, 34748
United States
Accel Clinical Research - Maitland
Maitland, Florida, 32751
United States
Dade Research Center, LLC
Miami, Florida, 33126
United States
Miami Clinical Research
Miami, Florida, 33155
United States
Universal Axon Clinical Research
Miami, Florida, 33166
United States
Florida International Research Center
Miami, Florida, 33173
United States
Suncoast Research Associates, LLC
Miami, Florida, 33173
United States
Miami Dade Medical Research Institute, LLC
Miami, Florida, 33176
United States
Felicidad Medical Research
Miami, Florida, 33184
United States
Aqualane Clinical Research
Naples, Florida, 34105
United States
SUNCOAST Clinical Research
New Port Richey, Florida, 34652
United States
Clinical Neuroscience Solutions, Inc
Orlando, Florida, 32801
United States
Clinical Neuroscience Solutions, Inc
Orlando, Florida, 32806
United States
Clinical Research Center of Florida
Pompano Beach, Florida, 33060
United States
United Medical Research
Port Orange, Florida, 32127
United States
Health Awareness, Inc
Port Saint Lucie, Florida, 34952
United States
St. Johns Center for Clinical Research
Saint Augustine, Florida, 32086
United States
IMA Clinical Research - St. Petersburg
St. Petersburg, Florida, 33704
United States
Global Clinical Professionals, LLC
St. Petersburg, Florida, 33705
United States
Precision Clinical Research, LLC
Sunrise, Florida, 33351
United States
Albany Internal Medicine
Albany, Georgia, 31707
United States
Delricht Research At Springer Wellness And Restorative Health
Atlanta, Georgia, 30329
United States
Atlanta Center for Medical Research
Atlanta, Georgia, 30331
United States
CenExel iResearch Atlanta, LLC
Decatur, Georgia, 30030
United States
Javara Inc.
Fayetteville, Georgia, 30214
United States
Fellows Research Alliance, Inc.
Savannah, Georgia, 31406
United States
Velocity Clinical Research-Savannah
Savannah, Georgia, 31406
United States
Clinical Research Atlanta/Headlands
Stockbridge, Georgia, 30281
United States
Clinical Research Prime
Idaho Falls, Idaho, 83404
United States
Velocity Clinical Research - Boise
Meridian, Idaho, 83642
United States
IMA Clinical Research
Chicago, Illinois, 60602
United States
Great Lakes Clinical Trials - Gurnee
Gurnee, Illinois, 60048
United States
Bioluminix Clinical Research Chicago
Naperville, Illinois, 60540
United States
Optimal Research
Peoria, Illinois, 61614
United States
DM Clinical Research- River Forest
River Forest, Illinois, 60305
United States
Velocity Clinical Research - Valparaiso
Valparaiso, Indiana, 46383
United States
Velocity Clinical Research-Sioux City
Sioux City, Iowa, 51106
United States
Johnson County Clin-Trials (JCCT)
Lenexa, Kansas, 66219
United States
Velocity Clinical Research- Kansas City
Overland Park, Kansas, 66210
United States
Tekton Research
Wichita, Kansas, 67218
United States
AMR Lexington
Lexington, Kentucky, 40509
United States
Velocity Clinical Research - Baton Rouge
Baton Rouge, Louisiana, 70809
United States
Velocity Clinical Research - Covington
Covington, Louisiana, 70433
United States
Benchmark Research
Metairie, Louisiana, 70006
United States
Clinical Trials Management, LLC
Metairie, Louisiana, 70006
United States
Privia Medical Group
Annapolis, Maryland, 27101
United States
Cenexel CBH (CBH Health)
Gaithersburg, Maryland, 20877
United States
Velocity Clinical Research-Rockville
Rockville, Maryland, 20854
United States
Javara Inc/Privia Medical Group, LLC
Silver Spring, Maryland, 20901
United States
DM Clinical Research - Brookline
Brookline, Massachusetts, 02445
United States
Skylight Health Research - Burlington
Burlington, Massachusetts, 02721
United States
Headlands Research - Detroit
Southfield, Michigan, 48034
United States
Great Lakes Research Institute
Southfield, Michigan, 48075
United States
DM Clinical Research - Southfield
Southfield, Michigan, 48076
United States
Oakland Medical Research Center
Troy, Michigan, 48085
United States
Clinical Research Institute, Inc.
Minneapolis, Minnesota, 55402
United States
Velocity Clinical Research, Gulfport
Gulfport, Mississippi, 39503
United States
Clinical Research Professionals
Chesterfield, Missouri, 63005
United States
Clinvest Headlands LLC
Springfield, Missouri, 65807
United States
Delricht Research
Springfield, Missouri, 65807
United States
Montana Medical Research, Inc
Missoula, Montana, 59808
United States
Velocity Clinical Research-Lincoln
Lincoln, Nebraska, 68510
United States
Velocity Clinical Research-Norfolk
Norfolk, Nebraska, 68701
United States
Velocity Clinical Research-Omaha
Omaha, Nebraska, 38134
United States
Javara Inc. / Nevada Health Centers, Ind
Carson City, Nevada, 89706
United States
Vector Clinical Trials
Las Vegas, Nevada, 89074
United States
Oasis Clinical Research
Las Vegas, Nevada, 89121
United States
DM Clinical Research - New Jersey
Jersey City, New Jersey, 07306
United States
IMA Clinical Research Warren
Warren Township, New Jersey, 07059
United States
Albuquerque Clinical Trials (ACT)
Albuquerque, New Mexico, 87102
United States
DM Clinical Research
Albuquerque, New Mexico, 87106
United States
Velocity Clinical Research- Albuquerque
Albuquerque, New Mexico, 87107
United States
Velocity Clinical Research - Binghamton
Binghamton, New York, 13905
United States
DM Clinical - Brooklyn
Brooklyn, New York, 11220
United States
Brooklyn Clinical Research
Brooklyn, New York, 11226
United States
Velocity Clinical Research - Syracuse
East Syracuse, New York, 13057
United States
Drug Trials America
Hartsdale, New York, 10530
United States
Rochester Clinical Research, Inc
Rochester, New York, 14609
United States
Velocity Clinical Research-Vestal
Vestal, New York, 13850
United States
DelRicht Research, LLC
Charlotte, North Carolina, 28205
United States
Javara Inc. - Tryon Medical-South Park
Charlotte, North Carolina, 28287
United States
Velocity Clinical Research, Durham
Durham, North Carolina, 27701
United States
West Clinical Research
Morehead City, North Carolina, 28557
United States
Accellacare Raleigh
Raleigh, North Carolina, 27609
United States
Accellacare of Wilmington
Wilmington, North Carolina, 28401
United States
Javara - Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27101
United States
Velocity Clinical Research, Cleveland
Beachwood, Ohio, 44122
United States
Velocity Clinical Research-Mt. Auburn
Cincinnati, Ohio, 45219
United States
CTI Clinical Research Center
Cincinnati, Ohio, 45241
United States
Velocity Clinical Reseach - Blue Ash
Cincinnati, Ohio, 45242
United States
Velocity Clinical Research - Cincinnati OH
Cincinnati, Ohio, 45246
United States
Centricity Research
Columbus, Ohio, 43213
United States
Remington-Davis Clinical Research
Columbus, Ohio, 43215
United States
Tekton Research, Inc - Edmond
Edmond, Oklahoma, 73013
United States
Delricht Tate
Tulsa, Oklahoma, 74133
United States
Tekton Research, Inc - Yukon Location
Yukon, Oklahoma, 73099
United States
Altoona Center for Clinical Research - Research
Duncansville, Pennsylvania, 16635
United States
DM Clinical Research
Philadelphia, Pennsylvania, 19107
United States
Velocity Clinical Research - Providence
East Greenwich, Rhode Island, 02818
United States
Velocity Clinical Research - Anderson
Anderson, South Carolina, 29621
United States
DelRicht Research
Charleston, South Carolina, 29407
United States
Coastal Carolina Research Center - North Charleston
North Charleston, South Carolina, 29405
United States
Velocity Clinical Research, Spartanburg
Spartanburg, South Carolina, 29303
United States
PMG Research of Bristol, LLC
Bristol, Tennessee, 37620
United States
Delricht Moyer
Hendersonville, Tennessee, 37075
United States
CNS Healthcare DBA Clinical Neuroscience Solutions, INC
Memphis, Tennessee, 38119
United States
Benchmark Research
Austin, Texas, 78705
United States
IMA Clinical Research Austin
Austin, Texas, 78745
United States
Tekton Research, Inc. - Beaumont
Beaumont, Texas, 77706
United States
Headlands Research Brownsville
Brownsville, Texas, 78526
United States
Family Medicine Associates of Texas
Carrollton, Texas, 75010
United States
Javara Inc (Conroe)
Conroe, Texas, 77384
United States
WR-Global Medical Research, LLC
Dallas, Texas, 75224
United States
El Paso Research
El Paso, Texas, 79936
United States
Benchmark Research
Fort Worth, Texas, 76135
United States
West Houston Clinical Research Service
Houston, Texas, 77055
United States
DM Clinical Research - CyFair
Houston, Texas, 77065
United States
DM Clinical Research - Bellaire
Houston, Texas, 77081
United States
DM Clinical Research - Irving
Irving, Texas, 75061
United States
ACRC Trials
Plano, Texas, 75024
United States
Research Your Health
Plano, Texas, 75093
United States
Delricht Research At Zomnir Family Medicine
Prosper, Texas, 75078
United States
DM Clinical Research - San Antonio
San Antonio, Texas, 78207
United States
IMA Clinical Research
San Antonio, Texas, 78229
United States
Tekton Research Inc - San Antonio
San Antonio, Texas, 78229
United States
DM Clinical Research - Sugarland
Sugar Land, Texas, 77478
United States
DM Clinical Research - Tomball
Tomball, Texas, 77375
United States
DM Clinical Research
Tomball, Texas, 77375
United States
Cope Family Medicine
Bountiful, Utah, 84010
United States
JBR Clinical Research
Salt Lake City, Utah, 84107
United States
Charlottesville Medical Research Center, LLC
Charlottesville, Virginia, 22911
United States
Velocity Clinical Research - Hampton
Hampton, Virginia, 23666
United States
Health Research of Hampton Roads
Newport News, Virginia, 23606
United States
AMR Norfolk
Norfolk, Virginia, 37920
United States
Velocity Clinical Research-Portsmouth
Portsmouth, Virginia, 23703
United States
Clinical Research Partners, LLC
Richmond, Virginia, 23226
United States
DM Clinical Research - Seattle
Seattle, Washington, 98122
United States
Frontier Clinical Research, LLC
Kingwood, West Virginia, 26537
United States

Collaborators and Investigators

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 Registration Dates

Study Start Date2024-09-24
Study Completion Date2027-02-15

Study Record Updates

Study Start Date2024-09-24
Study Completion Date2027-02-15

Terms related to this study

Keywords Provided by Researchers

  • Acute Gastroenteritis
  • Norovirus Acute Gastroenteritis
  • mRNA-1403
  • Viral Gastroenteritis

Additional Relevant MeSH Terms

  • Acute Gastroenteritis
  • Norovirus Acute Gastroenteritis