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mRNA-1403

Phase 3

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment37,864

FDA Designations

No designations recorded

Clinical trial landscape

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
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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
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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
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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
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Frequently asked questions about mRNA-1403

What is mRNA-1403 used for?

mRNA-1403 is an investigational messenger RNA vaccine being developed to prevent acute gastroenteritis caused by norovirus infection. It is intended for use in healthy adults 18 years of age and older. The vaccine is currently being evaluated in clinical trials for the prevention of norovirus acute gastroenteritis.

How does mRNA-1403 work?

mRNA-1403 is a messenger RNA vaccine that works by instructing cells to produce a viral protein, which triggers an immune response against norovirus. This response is designed to prevent norovirus acute gastroenteritis. The vaccine is administered to healthy adults to stimulate immunity against the virus.

Who is developing mRNA-1403?

mRNA-1403 is being developed by Moderna, Inc., a biotechnology company publicly traded under the ticker symbol MRNA on the NASDAQ stock exchange. Moderna is conducting clinical trials to evaluate the safety and efficacy of mRNA-1403 for the prevention of norovirus acute gastroenteritis in adults.

What phase is mRNA-1403 in?

mRNA-1403 is currently in Phase 3 clinical development. A Phase 3 trial is actively investigating the safety and efficacy of mRNA-1403 in participants 18 years of age and older for the prevention of acute gastroenteritis. The vaccine is investigational and has not been approved by regulatory authorities.

What clinical trials is mRNA-1403 in?

mRNA-1403 is being studied in two clinical trials. NCT06592794 is a Phase 3 trial evaluating safety and efficacy in approximately 37,864 adults for prevention of acute gastroenteritis. NCT05992935 is a Phase 1 trial assessing safety, reactogenicity, and immunogenicity in healthy adults aged 18 to 80 years.

Is mRNA-1403 the same as mRNA-1405?

No, mRNA-1403 and mRNA-1405 are separate investigational vaccines. They are being studied together in a Phase 1 clinical trial (NCT05992935) to evaluate their safety, reactogenicity, and immunogenicity for preventing norovirus acute gastroenteritis in healthy adults aged 18 to 80 years.