Recent Updates
Recently added Catalysts

mRNA-1403

Phase 3

Acute Gastroenteritis | Vaccine | Infectious Disease |Moderna, Inc.|Trials Updated: May 13, 2026

mRNA-1403 development status

Highest phase Phase 3
Registered trials 2 across 1 sponsor since Aug 2023

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials2
Total Enrollment39,271

FDA Designations

No designations recorded

mRNA-1403 clinical trials

mRNA-1403 · 2 trials · 2 indications

Phase 3 1Phase 1 1
NCT06592794A Study to Investigate the Safety and Efficacy of mRNA-1403 in Participants ≥18 Years of Age for the Prevention of Acute GastroenteritisAcute Gastroenteritis
ACTIVE NOT_RECRUITING37,864 Analytics
PHASE3ACTIVE NOT_RECRUITING
A Study to Investigate the Safety and Efficacy of mRNA-1403 in Participants ≥18 Years of Age for the Prevention of Acute Gastroenteritis
Acute Gastroenteritis
NCT0659279437,864
Unlock trial analytics

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
Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)
Up to a maximum of Day 36 (7 days after each study injection)
Number of Participants with Medically Attended AEs (MAAEs)
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)
Day 1 up to a maximum of Day 730

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.
Phase 1 Part A: mRNA-1403 Dose Level 1EXPERIMENTALParticipants will receive 2 intramuscular (IM) injections of mRNA-1403 at Dose Level 1.
Phase 1 Part A: mRNA-1403 Dose Level 2EXPERIMENTALParticipants will receive 2 IM injections of mRNA-1403 at Dose Level 2.
Phase 1 Part A: mRNA-1403 Dose Level 3EXPERIMENTALParticipants will receive 2 IM injections of mRNA-1403 at Dose Level 3.
Phase 1 Part A: mRNA-1403 Dose Level 4 Regimen 1EXPERIMENTALParticipants will receive 2 IM injections of mRNA-1403 at Dose Level 4.
Phase 1 Part A: mRNA-1403 Dose Level 4 Regimen 2EXPERIMENTALParticipants will receive 1 IM injection of mRNA-1403 at Dose Level 4 and 1 IM injection of study vaccine-matching placebo.
Phase 1 Part A: mRNA-1405 Dose Level 1EXPERIMENTALParticipants will receive 2 IM injections of mRNA-1405 at Dose Level 1.
Phase 1 Part A: mRNA-1405 Dose Level 2EXPERIMENTALParticipants will receive 2 IM injections of mRNA-1405 at Dose Level 2.
Phase 1 Part A: mRNA-1405 Dose Level 3EXPERIMENTALParticipants will receive 2 IM injections of mRNA-1405 at Dose Level 3.
Phase 1 Part A: mRNA-1405 Dose Level 4 Regimen 1EXPERIMENTALParticipants will receive 2 IM injections of mRNA-1405 at Dose Level 4.
Phase 1 Part A: mRNA-1405 Dose Level 4 Regimen 2EXPERIMENTALParticipants will receive 1 IM injections of mRNA-1405 at Dose Level 4 and 1 IM injection of study vaccine-matching placebo.
Phase 1 Part A: PlaceboPLACEBO_COMPARATORParticipants will receive 2 IM injections of study vaccine-matching placebo.
Phase 2 Part B: mRNA-1403 Dose Level 1EXPERIMENTALParticipants will receive 1 IM injection of mRNA-1403 at Dose Level 1.
Phase 2 Part B: mRNA-1403 Dose Level 2EXPERIMENTALParticipants will receive 1 IM injection of mRNA-1403 at Dose Level 2 and if participating in the booster extension will receive a second dose of study vaccine-matching placebo 12-15 months after first dose.
Phase 2 Part B: mRNA-1403 Dose Level 3EXPERIMENTALParticipants will receive 1 IM injection of mRNA-1403 at Dose Level 3 and if participating in the booster extension will receive a second dose of mRNA-1403 at Dose Level 3 12-15 months after first dose.
Phase 2 Part B: PlaceboPLACEBO_COMPARATORParticipants will receive 1 IM injection of study vaccine-matching placebo.
Phase 2 Part C: mRNA-1403 Dose Level 3EXPERIMENTALParticipants will receive 1 IM injection of mRNA-1403 at Dose Level 3.
Phase 2 Part C: PlaceboPLACEBO_COMPARATORParticipants will receive 1 IM injection of study vaccine-matching placebo.

Interventions

NameTypeDescription
mRNA-1403BIOLOGICALIntramuscular (IM) injection.
PlaceboBIOLOGICAL0.9% sodium chloride solution by IM injection.
mRNA-1405BIOLOGICALSterile liquid for injection
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 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

Frequently asked questions about mRNA-1403

What is mRNA-1403?

mRNA-1403 is an investigational mRNA vaccine developed by Moderna, Inc. (ticker MRNA) for the prevention of acute gastroenteritis, including norovirus acute gastroenteritis. It is in Phase 3 clinical development and is designed to be given to healthy adults 18 years of age and older.

What is mRNA-1403 used for?

mRNA-1403 is being developed to prevent acute gastroenteritis, specifically norovirus acute gastroenteritis, in healthy adults. It is an investigational vaccine and has not been approved for use. The Phase 3 trial enrolls participants 18 years of age and older across the United States, Australia, Canada, Japan, Panama, Puerto Rico, and the United Kingdom.

Who makes mRNA-1403?

mRNA-1403 is developed by Moderna, Inc., which trades on the Nasdaq under the ticker MRNA. Moderna is the sponsor of the clinical program evaluating the vaccine for prevention of acute gastroenteritis, including norovirus acute gastroenteritis.

What phase is mRNA-1403 in?

mRNA-1403 is in Phase 3 clinical development. It is an investigational vaccine and is not approved. The Phase 3 study, NCT06592794, is active but not recruiting, and an earlier Phase 1 study, NCT05992935, evaluated the vaccine in healthy adults 18 to 80 years of age.

What clinical trials is mRNA-1403 in?

mRNA-1403 has been studied in two clinical trials. The Phase 3 trial NCT06592794 is a randomized, double-blind, placebo-controlled study with 37,864 participants evaluating prevention of acute gastroenteritis. The Phase 1 trial NCT05992935 evaluated safety, reactogenicity, and immunogenicity in 1,407 healthy adults aged 18 to 80.

How is the Phase 3 trial of mRNA-1403 designed?

The Phase 3 trial NCT06592794 is a randomized, double-blind, placebo-controlled study of mRNA-1403 in participants 18 years of age and older for prevention of acute gastroenteritis. It has enrolled 37,864 participants across the United States, Australia, Canada, Japan, Panama, Puerto Rico, and the United Kingdom, and is currently active but not recruiting.

Explore more on BiopharmaWatch

Moderna, Inc. (MRNA)Pipeline, catalysts, financials, insiders and newsBiotech disease mapWho is developing what in each indication, and how crowded it isFDA calendarUpcoming PDUFA dates, AdComs and approval oddsPDUFA calendarEvery scheduled FDA decision date, month by monthHistorical FDA calendarPast decisions and how the stock moved on eachCatalyst SyncUpcoming readouts and decisions, screened by runway and phaseBiotech stock screenerFilter by clinical phase, cash runway and market capDrugs A to ZEvery drug page starting with MCompanies A to ZEvery biotech and pharma company we track