Recent Updates
Recently added Catalysts

mRNA-1403

Phase 3

Acute Gastroenteritis | Monoclonal antibody | Other |Moderna, Inc.|Last Updated: May 13, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment37,864
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06592794A Study to Investigate the Safety and Efficacy of mRNA-1403 in Participants ≥18 Years of Age for the Prevention of Acute GastroenteritisPHASE3 ACTIVE NOT_RECRUITING 37,864 — — Sep 24, 2024Feb 15, 2027May 13, 2026283 United States, Australia +5
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
Day 1 up to Day 7 (7 days after study intervention)
Number of Participants with Unsolicited Adverse Events (AEs)
Day 1 up to Day 28 (28 days after study intervention)
Number of Participants with Medically Attended Adverse Events (MAAEs)
Day 1 through Day 181
Number of Participants with Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), and AEs Leading to Study Withdrawal
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
Day 15 up to 9 months after last participant dosed
Secondary Endpoints
VE of mRNA-1403 to Prevent First Occurrence of Protocol-defined Severe AGE Associated with Vaccine Matched Genotypes
Day 15 up to 9 months after last participant dosed
VE of mRNA-1403 to Prevent First Occurrence of Protocol-defined Severe Norovirus (NoV) AGE Associated with Any Genogroup I or II Norovirus (NoV) Genotype
Day 15 up to 9 months after last participant dosed
VE of mRNA-1403 to Prevent First Occurrence of Protocol-defined Moderate or Severe AGE Associated with Any Genogroup I or II NoV Genotype
Day 15 up to 9 months after last participant dosed
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
mRNA-1403EXPERIMENTALParticipants will receive a single injection of mRNA-1403 on Day 1.
PlaceboPLACEBO_COMPARATORParticipants will receive a single injection of mRNA-1403 matching placebo (0.9% sodium chloride solution) on Day 1.
Interventions
NameTypeDescription
mRNA-1403BIOLOGICALIntramuscular (IM) injection.
PlaceboBIOLOGICAL0.9% sodium chloride solution by IM injection.
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites283

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...

Countries:United StatesAustraliaCanadaJapanPanamaPuerto RicoUnited Kingdom
Unlock Eligibility Criteria
Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06592794primaryCompletionDate: changed
LOWMay 24, 2026NCT06592794studyFirstPostDate: changed