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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

StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated April 3, 2026 (before its estimated September 22, 2026 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Trial status changed: Recruiting → Active, Not Recruiting
    • Enrollment target: estimated 1405 to confirmed 1407
    • Site details revised at 16 of 16 sites
    v13
  2. Trial status: Active, Not Recruiting to Recruiting
    • Site details revised at 16 of 16 sites
    v12
  3. Primary endpoints revised (4)v11 Show 7 more changesShow less
    • Enrollment target: 1285 to 1405
    • Study sites: 14 to 16
    • Primary completion date: Apr 14, 2026 to Sep 22, 2026
    • Study completion date: Nov 20, 2026 to Sep 22, 2026
    • Eligibility criteria expanded, about 55 words
    • Secondary endpoints: details revised at 4 of 6 entries
    • Study arms: 15 to 17
  4. Primary completion date: Apr 14, 2025 to Apr 14, 2026
    • Study completion date: Nov 20, 2025 to Nov 20, 2026
    • Eligibility criteria expanded, about 23 words
    v10
  5. Eligibility criteria expanded, about 48 words
    • Secondary endpoints revised (6)
    v9
Show 7 earlier versionsHide 7 earlier versions
  1. Study completion date: Apr 14, 2025 to Nov 20, 2025
    • Eligibility criteria shortened, about 42 words
    v8
  2. Study sites: 15 to 14v7
  3. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 1260 to confirmed 1285
    • Primary and study completion dates: May 7, 2025 to Apr 14, 2025
    • Site details revised at 15 of 15 sites
    v6
  4. Phase: Phase 1 to Phase 1/2v5 Show 9 more changesShow less
    • Trial status: Active, Not Recruiting to Recruiting
    • Enrollment target: 664 to 1260
    • Primary endpoints revised (4)
    • Study sites: 14 to 15
    • Primary and study completion dates: Dec 7, 2024 to May 7, 2025
    • Eligibility criteria expanded, about 51 words
    • Secondary endpoints revised (6)
    • Study title shortened, about 7 words
    • Study arms: 11 to 15
  5. Enrollment target: estimated 660 to confirmed 664
    • Primary completion date: Jan 21, 2025 to Dec 7, 2024
    • Study completion date: May 21, 2025 to Dec 7, 2024
    v4
  6. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 15 to 14
    v3
  7. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Primary endpoints: 5 to 4
    • Primary completion date: Nov 13, 2024 to Jan 21, 2025
    • Study completion date: Feb 3, 2025 to May 21, 2025
    • Site details revised at 15 of 15 sites
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Moderna
49 trials monitored
See 3 trials at risk
The purpose of the Part A Phase 1 of this study is to evaluate the safety, reactogenicity, and immunogenicity of mRNA-1403 and mRNA-1405 in healthy adult participants 18 to 49 years of age and 60 to 80 years of age. The purpose of Part B Phase 2 and Part C Phase 2 is to evaluate the safety, reactogenicity, and immunogenicity of mRNA-1403 in healthy adult participants (18 to 80 years of age).
Trial Details
NCT Number NCT05992935
Lead Sponsor ModernaTX, Inc.
Conditions
(from sponsor)		 Norovirus Acute Gastroenteritis
Enrollment 1,407 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov