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Clinical Trials in Australia / NCT06592794
Active, not recruiting Phase 3

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

NCT06592794 · tracked via the Priya Life Science Australia tracker
Phase
Phase 3
Started
2024-09-24
Last updated
2026-05-13

Condition(s) studied

Acute GastroenteritisNorovirus Acute Gastroenteritis

Investigational drug(s) / intervention(s)

mRNA-1403 →Placebo

mRNA-1403: Intramuscular (IM) injection.

Placebo: 0.9% sodium chloride solution by IM injection.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

Trial sites (283)

FacilityCityRegionStatus
Accel Research Sites - Achieve Clinical Research Birmingham Alabama
Cullman Clinical Trials Cullman Alabama
Alliance for Multispecialty Research, LLC Daphne Alabama
ClinMed, LLC Phoenix Arizona
DM Clinical - Phoenix Phoenix Arizona
HOPE Research Institute Phoenix Arizona
HOPE Research Institute Phoenix Arizona
Abby's Research Institute Phoenix Arizona
Headlands Research Scottsdale Scottsdale Arizona
Scottsdale Clinical Trials Scottsdale Arizona
Hope Research Institute - Tempe Tempe Arizona
Arizona Liver Health Tucson Arizona
Quality of Life Medical and Research Center Tucson Arizona
Del Sol Research Management LLC.- Tucson Tucson Arizona
Lynn Institute of the Ozarks Little Rock Arkansas
Baptist Health Center for Clinical Research Little Rock Arkansas
ARK Clinical Research, LLC Fountain Valley California
ASCADA Research, LLC - Family Medicine Fullerton California
Matrix Clinical Research Huntington Park California
Velocity Clinical Research, San Diego La Mesa California
Ark Clinical Research Long Beach California
Matrix Clinical Research Los Angeles California
Velocity Clinical Research - Westlake Los Angeles California
Paradigm Research Redding California
Artemis Institute for Clinical Research Riverside California
Benchmark Research Riverside California
Peninsula Research Associates (PRA) Rolling Hills Estates California
Apex Clinical Research San Diego California
Artemis Institute for Clinical Research San Diego California
Lynn Institute of Denver Aurora Colorado
Tekton Research - Fort Collins Fort Collins Colorado
Tekton Research, Inc - Longmont Center Longmont Colorado
Imagine Research of Palm Beach County Boynton Beach Florida
Pioneer Clinical Studies Coral Gables Florida
Integrity Clinical Research, LLC (ICR SITES) - Doral Doral Florida
Alliance for multispecialty Research - Florida Doral Florida
AGA Clinical Trials Hialeah Florida
Best Quality Research Inc. Hialeah Florida
Neoclinical Research Hialeah Florida
Research Centers of America Hollywood Florida

+ 243 more sites — see the full list on the official registry below.

More ModernaTX, Inc. trials in Australia

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06592794 on ClinicalTrials.gov ↗ ← All trials in Australia