A Study to Investigate the Safety and Efficacy of mRNA-1403 in Participants ≥18 Years of Age for the Prevention of Acute Gastroenteritis
← catalyst calendarNCT06592794 · readout in 180 d
Sponsored by ModernaTX, Inc. (industry) · MRNA — their whole pipeline →.
Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Triple · Prevention
Enrollment
37,864actual
Sites
283
Countries
Australia, Canada, Japan +4
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2024-09-24 | actual | When the study began enrolling |
| Primary completion | 2027-02-15 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2027-02-15 | estimated | The whole study's end, after follow-up |
| First posted | 2024-09-19 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-05-13 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Acute Gastroenteritis
- Norovirus Acute Gastroenteritis
Interventions
- Biological: mRNA-1403
- Biological: Placebo
Primary outcomes
what the primary-completion date above is the date OFNumber of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
measured Day 1 up to Day 7 (7 days after study intervention)
Number of Participants with Unsolicited Adverse Events (AEs)
measured Day 1 up to Day 28 (28 days after study intervention)
Number of Participants with Medically Attended Adverse Events (MAAEs)
measured Day 1 through Day 181
Number of Participants with Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), and AEs Leading to Study Withdrawal
measured Day 1 up to Day 546
Vaccine Efficacy (VE) of mRNA-1403 to Prevent First Occurrence of Protocol-defined Moderate or Severe AGE Associated with Vaccine Matched Genotypes
measured Day 15 up to 9 months after last participant dosed
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