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A Study of Vaccination With 9-valent Extraintestinal Pathogenic Escherichia Coli Vaccine (ExPEC9V) in the Prevention of Invasive Extraintestinal Pathogenic Escherichia Coli Disease in Adults Aged 60 Years And Older With a History of Urinary Tract Infection in the Past 2 Years

StatusCompleted
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 63 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Results posted: Sep 28, 2026 Lead sponsor: Janssen Research & Development, LLC to Janssen Research & Development, LLC · Eligibility criteria expanded, about 8 words · Secondary endpoints revised (33) · 2 more Show 5 more changesShow less
    • Lead sponsor: Janssen Research & Development, LLC to Janssen Research & Development, LLC
    • Eligibility criteria expanded, about 8 words
    • Secondary endpoints revised (33)
    • Study description revised
    • Site details revised at 17 of 374 sites
  2. Primary endpoint revised Secondary endpoints: 30 to 33v62 Show 1 more changeShow less
    • Secondary endpoints: 30 to 33

    See this version in full on ClinicalTrials.gov ↗

  3. Enrollment target: 17935 to 17797v61
  4. 3 versions Re-verified since Dec 4, 2025, no change to tracked fieldsv58-v60
  5. Study sites: 373 to 374v57
Show 43 earlier versionsHide 43 earlier versions
  1. Re-verified, no change to tracked fieldsv56
  2. Trial status: Active, Not Recruiting to Completedv55
  3. 2 versions Re-verified since Aug 14, 2025, no change to tracked fieldsv53-v54
  4. Study sites: 374 to 373v52
  5. 4 versions Re-verified since Apr 25, 2025, no change to tracked fieldsv48-v51
  6. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 19800 to confirmed 17935 · Study sites: 375 to 374v47 Show 2 more changesShow less
    • Enrollment target: estimated 19800 to confirmed 17935
    • Study sites: 375 to 374
  7. Primary completion date: May 19, 2025 to Aug 27, 2025 Completion date: Jul 31, 2027 to Aug 27, 2025v46 Show 1 more changeShow less
    • Completion date: Jul 31, 2027 to Aug 27, 2025
  8. Study sites: 371 to 375v45
  9. Completion date: Jun 29, 2029 to Jul 31, 2027v44
  10. Study sites: 369 to 371v43
  11. Study sites: 367 to 369v42
  12. Re-verified, no change to tracked fieldsv41
  13. Study sites: 364 to 367v40
  14. Re-verified, no change to tracked fieldsv39
  15. Site details revised at 8 of 364 sitesv38
  16. Study sites: 362 to 364 Completion date: Mar 29, 2028 to Jun 29, 2029v37 Show 1 more changeShow less
    • Completion date: Mar 29, 2028 to Jun 29, 2029
  17. Primary endpoints: 2 to 1 Enrollment target: 18556 to 19800 · Study sites: 359 to 362 · Completion date: Nov 22, 2027 to Mar 29, 2028 · 2 morev36 Show 5 more changesShow less
    • Enrollment target: 18556 to 19800
    • Study sites: 359 to 362
    • Completion date: Nov 22, 2027 to Mar 29, 2028
    • Secondary endpoints: 28 to 30
    • Study description revised

    See this version in full on ClinicalTrials.gov ↗

  18. Study sites: 358 to 359v35
  19. Study sites: 353 to 358v34
  20. Study sites: 346 to 353v33
  21. Study sites: 339 to 346v32
  22. Study sites: 328 to 339v31
  23. Study sites: 318 to 328v30
  24. Completion date: May 14, 2028 to Nov 22, 2027 Study sites revised (318)v29 Show 1 more changeShow less
    • Study sites revised (318)

    See this version in full on ClinicalTrials.gov ↗

  25. Study sites: 313 to 318v28
  26. Study sites: 296 to 313v27
  27. Study sites: 283 to 296v26
  28. Site details revised at 1 of 283 sitesv25
  29. Study sites: 271 to 283 Eligibility criteria shortened, about 46 words · Study description expanded, about 1 wordv24 Show 2 more changesShow less
    • Eligibility criteria shortened, about 46 words
    • Study description expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  30. Study sites: 261 to 271v23
  31. Study sites: 252 to 261v22
  32. Study sites: 250 to 252v21
  33. Study sites: 398 to 250 Completion date: Oct 1, 2027 to May 14, 2028v20 Show 1 more changeShow less
    • Completion date: Oct 1, 2027 to May 14, 2028
  34. Study sites: 390 to 398v19
  35. Study sites: 347 to 390v18
  36. Study sites: 344 to 347 Completion date: Oct 7, 2027 to Oct 1, 2027v17 Show 1 more changeShow less
    • Completion date: Oct 7, 2027 to Oct 1, 2027
  37. Study sites: 320 to 344 Completion date: Jul 31, 2027 to Oct 7, 2027v16 Show 1 more changeShow less
    • Completion date: Jul 31, 2027 to Oct 7, 2027
  38. Study sites: 316 to 320 Completion date: May 31, 2027 to Jul 31, 2027v15 Show 1 more changeShow less
    • Completion date: May 31, 2027 to Jul 31, 2027
  39. Study sites: 282 to 316v14
  • 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.
The purpose of this study is to demonstrate the efficacy of 9-valent extraintestinal pathogenic Escherichia coli vaccine (ExPEC9V) compared to placebo in the prevention of the first invasive extraintestinal pathogenic Escherichia coli disease (IED) event caused by ExPEC9V O-serotypes.
Trial Details
NCT Number NCT04899336
Lead Sponsor Janssen Research & Development, LLC
Conditions Invasive Extraintestinal Pathogenic Escherichia Coli Disease (IED) Prevention
Enrollment 17,797 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov