A Study to Investigate the Safety and Efficacy of mRNA-1403 in Participants ≥18 Years of Age for the Prevention of Acute Gastroenteritis
Launched by MODERNATX, INC. · Sep 9, 2024
Trial Information
Current as of June 06, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new vaccine called mRNA-1403, which aims to prevent acute gastroenteritis caused by norovirus in adults aged 18 and older. Norovirus is a common virus that can lead to severe stomach problems, including vomiting and diarrhea. The trial will assess how safe the vaccine is and how well it works in preventing moderate to severe cases of norovirus-related gastroenteritis.
To participate in this study, individuals should be generally healthy, able to follow study procedures, and not currently experiencing any serious illnesses. Key criteria include being free from recent norovirus infections and having stable medical conditions. Participants can expect to receive the vaccine and will be monitored for any side effects and their overall health throughout the trial. It’s important to note that certain medical histories or conditions may exclude individuals from joining, such as recent surgeries, severe allergic reactions to vaccines, or unstable medical conditions.
Gender
ALL
Eligibility criteria
- 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.
About Modernatx, Inc.
ModernaTX, Inc. is a pioneering biotechnology company focused on developing transformative medicines based on messenger RNA (mRNA) technology. Established with a commitment to addressing unmet medical needs, Moderna leverages its proprietary platform to create innovative therapies and vaccines for a variety of diseases, including infectious diseases and cancer. The company gained global recognition for its rapid development of an mRNA-based COVID-19 vaccine, showcasing its agility and expertise in the biopharmaceutical landscape. Through robust clinical trials and a commitment to scientific excellence, ModernaTX aims to redefine the future of medicine and enhance patient outcomes worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
New Port Richey, Florida, United States
Leicester, , United Kingdom
Columbus, Ohio, United States
Honolulu, Hawaii, United States
Austin, Texas, United States
Fort Worth, Texas, United States
Savannah, Georgia, United States
Metairie, Louisiana, United States
Metairie, Louisiana, United States
Troy, Michigan, United States
Newport News, Virginia, United States
Missoula, Montana, United States
Rochester, New York, United States
Minneapolis, Minnesota, United States
Bristol, Tennessee, United States
Hialeah, Florida, United States
Houston, Texas, United States
Tucson, Arizona, United States
Aberdeen, , United Kingdom
Exeter, , United Kingdom
Edinburgh, , United Kingdom
Hialeah, Florida, United States
Carrollton, Texas, United States
Maroubra, New South Wales, Australia
Phoenix, Arizona, United States
Hartsdale, New York, United States
Atlanta, Georgia, United States
Pompano Beach, Florida, United States
Orlando, Florida, United States
Plano, Texas, United States
Charlottesville, Virginia, United States
Koshigaya, Saitama, Japan
Little Rock, Arkansas, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Tomball, Texas, United States
Idaho Falls, Idaho, United States
Miami, Florida, United States
Glasgow, , United Kingdom
Jupiter, Florida, United States
Jacksonville, Florida, United States
Newcastle Upon Tyne, , United Kingdom
Lenexa, Kansas, United States
Peoria, Illinois, United States
Lakeland, Florida, United States
Redding, California, United States
Meridian, Idaho, United States
East Syracuse, New York, United States
Chesterfield, Missouri, United States
Hollywood, Florida, United States
Manchester, , United Kingdom
Port Saint Lucie, Florida, United States
Cullman, Alabama, United States
Aurora, Colorado, United States
Sunrise, Florida, United States
Salt Lake City, Utah, United States
Miami, Florida, United States
Little Rock, Arkansas, United States
Miami, Florida, United States
Coffs Harbour, New South Wales, Australia
Riverside, California, United States
Boynton Beach, Florida, United States
Richmond, Virginia, United States
Lexington, Kentucky, United States
Huntington Park, California, United States
Los Angeles, California, United States
Duncansville, Pennsylvania, United States
Kanwal, New South Wales, Australia
Albany, Georgia, United States
Tucson, Arizona, United States
Saint Augustine, Florida, United States
Miami, Florida, United States
Plano, Texas, United States
Southfield, Michigan, United States
Valparaiso, Indiana, United States
Scottsdale, Arizona, United States
La Mesa, California, United States
Miami, Florida, United States
East Greenwich, Rhode Island, United States
Adelaide, South Australia, Australia
Bruce, Australian Capital Territory, Australia
Sudbury, , Canada
Spartanburg, South Carolina, United States
Tempe, Arizona, United States
Port Orange, Florida, United States
Wilmington, North Carolina, United States
Houston, Texas, United States
Greenville, South Carolina, United States
Naples, Florida, United States
Columbus, Ohio, United States
Dallas, Texas, United States
Nagoya, Aichi, Japan
Los Angeles, California, United States
Rolling Hills Estates, California, United States
Bountiful, Utah, United States
Kelowna, , Canada
Levis, , Canada
London, , Canada
Trois Rivieres, , Canada
Philadelphia, Pennsylvania, United States
Coventry, , United Kingdom
Anderson, South Carolina, United States
Canberra, Australian Capital Territory, Australia
Kanwal, New South Wales, Australia
Brisbane, Queensland, Australia
Phoenix, Arizona, United States
Warren, New Jersey, United States
Long Beach, California, United States
Decatur, Georgia, United States
Longmont, Colorado, United States
River Forest, Illinois, United States
Brownsville, Texas, United States
Southfield, Michigan, United States
Daphne, Alabama, United States
Fort Collins, Colorado, United States
Stockbridge, Georgia, United States
Springfield, Missouri, United States
Charleston, South Carolina, United States
Yukon, Oklahoma, United States
Kingwood, West Virginia, United States
Miami, Florida, United States
Houston, Texas, United States
Covington, Louisiana, United States
Gulfport, Mississippi, United States
Weymouth, , United Kingdom
Hialeah, Florida, United States
Wichita, Kansas, United States
Brookline, Massachusetts, United States
Springfield, Missouri, United States
Norfolk, Nebraska, United States
Tulsa, Oklahoma, United States
Hendersonville, Tennessee, United States
Morehead City, North Carolina, United States
Beachwood, Ohio, United States
Albuquerque, New Mexico, United States
Scottsdale, Arizona, United States
Southfield, Michigan, United States
North Charleston, South Carolina, United States
Binghamton, New York, United States
Fayetteville, Georgia, United States
Austin, Texas, United States
Hampton, Virginia, United States
Fountain Valley, California, United States
Corby, Northamptonshire, United Kingdom
Fullerton, California, United States
Conroe, Texas, United States
Durham, North Carolina, United States
Vestal, New York, United States
Brooklyn, New York, United States
Tomball, Texas, United States
San Diego, California, United States
Las Vegas, Nevada, United States
Sugar Land, Texas, United States
London, , United Kingdom
Jersey City, New Jersey, United States
Birmingham, Alabama, United States
Phoenix, Arizona, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
Riverside, California, United States
San Diego, California, United States
Coral Gables, Florida, United States
Doral, Florida, United States
Doral, Florida, United States
Inverness, Florida, United States
Lake Mary, Florida, United States
Leesburg, Florida, United States
Maitland, Florida, United States
Saint Petersburg, Florida, United States
Saint Petersburg, Florida, United States
Atlanta, Georgia, United States
Savannah, Georgia, United States
Chicago, Illinois, United States
Gurnee, Illinois, United States
Naperville, Illinois, United States
Sioux City, Iowa, United States
Overland Park, Kansas, United States
Baton Rouge, Louisiana, United States
Annapolis, Maryland, United States
Gaithersburg, Maryland, United States
Rockville, Maryland, United States
Silver Spring, Maryland, United States
Burlington, Massachusetts, United States
Lincoln, Nebraska, United States
Omaha, Nebraska, United States
Carson City, Nevada, United States
Las Vegas, Nevada, United States
Albuquerque, New Mexico, United States
Albuquerque, New Mexico, United States
Brooklyn, New York, United States
Charlotte, North Carolina, United States
Charlotte, North Carolina, United States
Raleigh, North Carolina, United States
Winston Salem, North Carolina, United States
Cincinnati, Ohio, United States
Cincinnati, Ohio, United States
Cincinnati, Ohio, United States
Cincinnati, Ohio, United States
Edmond, Oklahoma, United States
Memphis, Tennessee, United States
Beaumont, Texas, United States
El Paso, Texas, United States
Irving, Texas, United States
Prosper, Texas, United States
San Antonio, Texas, United States
San Antonio, Texas, United States
San Antonio, Texas, United States
Norfolk, Virginia, United States
Portsmouth, Virginia, United States
Seattle, Washington, United States
Calgary, , Canada
Chicoutimi, , Canada
Guelph, , Canada
Halifax, , Canada
Halifax, , Canada
Mirabel, , Canada
Pointe Claire, , Canada
Quebec, , Canada
Québec, , Canada
Red Deer, , Canada
Richmond, , Canada
Sarnia, , Canada
Sherbrooke, , Canada
Toronto, , Canada
Toronto, , Canada
Truro, , Canada
Ponce, , Puerto Rico
San Juan, , Puerto Rico
San Juan, , Puerto Rico
Nagoya, Aichi, Japan
Hiroshima Shi, Hirosima [Hiroshima], Japan
Sapporo, Hokkaidô [Hokkaido], Japan
Fukuoka Shi, Hukuoka [Fukuoka], Japan
Kawasaki Shi, Kanagawa, Japan
Kyoto Shi, Kyôto [Kyoto], Japan
Minoh, Osaka, Japan
Kawagoe Shi, Saitama, Japan
Yabasecho, Shiga, Japan
Chiyoda Ku, Tôkyô [Tokyo], Japan
Chuo Ku, Tôkyô [Tokyo], Japan
Minato Ku, Tôkyô [Tokyo], Japan
Minato Ku, Tôkyô [Tokyo], Japan
Ota, Tôkyô [Tokyo], Japan
Shinjuku Ku, Tôkyô [Tokyo], Japan
Suginami, Tôkyô [Tokyo], Japan
Hachioji, Tôkyô, Japan
Hyogo, , Japan
Kanazawa Shi, , Japan
Kochi, , Japan
Sapporo Shi, , Japan
Takatsuki Shi, , Japan
High Wycombe, Buckinghamshire, United Kingdom
Runcorn, Cheshire, United Kingdom
Truro, Cornwall, United Kingdom
London, England, United Kingdom
Orpington, Kent, United Kingdom
Blackpool, Lancashire, United Kingdom
Rochdale, Manchester, United Kingdom
Salford, Manchester, United Kingdom
Witney, Oxfordshire, United Kingdom
Birmingham, , United Kingdom
Bournemouth, , United Kingdom
Bristol, , United Kingdom
Cardiff, , United Kingdom
Enfield Town, , United Kingdom
Glasgow, , United Kingdom
Glasgow, , United Kingdom
Liverpool, , United Kingdom
London, , United Kingdom
Newcastle Upon Tyne, , United Kingdom
Nottingham, , United Kingdom
Plymouth, , United Kingdom
Portsmouth, , United Kingdom
Sheffield, , United Kingdom
Shipley, , United Kingdom
Wansford, , United Kingdom
Witney, , United Kingdom
Wrexham, , United Kingdom
York, , United Kingdom
Guelph, , Canada
Norwood, South Australia, Australia
Bayswater, Victoria, Australia
Darlinghurst, New South Wales, Australia
Coffs Harbour, New South Wales, Australia
Maroubra, New South Wales, Australia
Sydney, New South Wales, Australia
Southport, Queensland, Australia
Bayswater, Victoria, Australia
Camberwell, Victoria, Australia
North Melbourne, Victoria, Australia
David, Chiriquí, Panama
Ciudad De Panamá, , Panama
La Chorrera, , Panama
Panama City, , Panama
Red Deer, Alberta, Canada
Herston, Queensland, Australia
Southport, Queensland, Australia
Camberwell, Victoria, Australia
North Melbourne, Victoria, Australia
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported