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A Study to Investigate the Safety and Efficacy of mRNA-1403 in Participants ≥18 Years of Age for the Prevention of Acute Gastroenteritis

Study acronym: Nova 301
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Secondary endpoints: 14 to 16v18
  2. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 28000 to confirmed 37864
    • Site details revised at 283 of 283 sites
    v17
  3. Site details revised at 22 of 283 sitesv16
  4. Site details revised at 69 of 283 sitesv15
  5. Trial status: Active, Not Recruiting to Recruitingv14 Show 4 more changesShow less
    • Enrollment target: 27776 to 28000
    • Primary and study completion dates: May 31, 2027 to Feb 15, 2027
    • Secondary endpoints revised (14)
    • Site details revised at 283 of 283 sites
Show 12 earlier versionsHide 12 earlier versions
  1. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 25000 to confirmed 27776
    • Site details revised at 283 of 283 sites
    v13
  2. Study sites: 282 to 283v12
  3. Study sites: 283 to 282v11
  4. Eligibility criteria revisedv10
  5. Re-verified, no change to tracked fieldsv9
  6. Study sites: 268 to 283v8
  7. Site details revised at 8 of 268 sitesv7
  8. Site details revised at 25 of 268 sitesv6
  9. Site details revised at 42 of 268 sitesv5
  10. Study sites: 270 to 268v4
  11. Study sites: 208 to 270v3
  12. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Study sites: 210 to 208
    • Start date changed from estimate of Sep 25, 2024 to Sep 24, 2024
    • Eligibility criteria expanded, about 43 words
    • Secondary endpoints revised (14)
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 primary objectives of this study are to evaluate the safety and reactogenicity of mRNA-1403, and to demonstrate the efficacy of mRNA-1403 to prevent protocol-defined moderate or severe norovirus acute gastroenteritis (AGE) associated with vaccine matched genotypes.
Trial Details
NCT Number NCT06592794
Lead Sponsor ModernaTX, Inc.
Conditions
(from sponsor)		 Acute Gastroenteritis, Norovirus Acute Gastroenteritis
Enrollment 37,864 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov