A Study to Investigate the Safety and Efficacy of mRNA-1403 in Participants ≥18 Years of Age for … (NCT06592794) | Clinical Trial Compass
Active — Not RecruitingPhase 3
A Study to Investigate the Safety and Efficacy of mRNA-1403 in Participants ≥18 Years of Age for the Prevention of Acute Gastroenteritis
United States, Australia, Canada37,864 participantsStarted 2024-09-24
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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:
. 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.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
Timeframe: Day 1 up to Day 7 (7 days after study intervention)
2
Number of Participants with Unsolicited Adverse Events (AEs)
Timeframe: Day 1 up to Day 28 (28 days after study intervention)
3
Number of Participants with Medically Attended Adverse Events (MAAEs)
Timeframe: Day 1 through Day 181
4
Number of Participants with Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), and AEs Leading to Study Withdrawal
Timeframe: Day 1 up to Day 546
5
Vaccine Efficacy (VE) of mRNA-1403 to Prevent First Occurrence of Protocol-defined Moderate or Severe AGE Associated with Vaccine Matched Genotypes
Timeframe: Day 15 up to 9 months after last participant dosed
. 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.
. 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.