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 States37,864 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 range18 Years
SexALL
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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
✕. 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.
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 (Cohort 1) and Day 365 (Cohorts 2 and 3)
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 6 months after the last participant dosed in each cohort
. 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.