Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1403 and mRNA-1405 to Prevent Norovirus Acute Gastroenteritis in Healthy Adults 18 to 80 Years of Age
← catalyst calendarNCT05992935 · readout in 34 d
Sponsored by ModernaTX, Inc. (industry) · MRNA — their whole pipeline →.
Phase
Phase 1/2
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Triple · Prevention
Enrollment
1,407actual
Sites
16
Countries
Australia, United States
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 | 2023-08-25 | actual | When the study began enrolling |
| Primary completion | 2026-09-22 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-09-22 | estimated | The whole study's end, after follow-up |
| First posted | 2023-08-15 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-04-03 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Norovirus Acute Gastroenteritis
Interventions
- Biological: mRNA-1403
- Biological: mRNA-1405
- Biological: Placebo
Primary outcomes
what the primary-completion date above is the date OFNumber of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)
measured Up to a maximum of Day 36 (7 days after each study injection)
Number of Participants with Unsolicited Adverse Events (AEs)
measured Up to a maximum of Day 57 (28 days after each study injection)
Number of Participants with Medically Attended AEs (MAAEs)
measured Day 1 up to a maximum of Day 546
Number of Participants with Any Serious Adverse Events (SAEs), AEs Leading to Withdrawal From Study, and Adverse Events of Special Interest (AESIs)
measured Day 1 up to a maximum of Day 730
Permalink · MRNA's whole pipeline · Catalyst calendar · Every registered study · What changed