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Efficacy Against Oral Persistent Infection, Immunogenicity and Safety of the 9-valent Human Papillomavirus Vaccine (9vHPV) in Men Aged 20-45 Years (V503-049)

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 58 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Lead sponsor: Merck Sharp & Dohme LLC to Merck Sharp & Dohme LLC Primary endpoints: details revised at 1 of 1 entry · Primary completion moved earlier from Aug 27, 2027 to Jan 15, 2027 · Completion moved earlier from Aug 31, 2028 to Jun 1, 2027 · 3 more Show 6 more changesShow less
    • Primary endpoints: details revised at 1 of 1 entry
    • Primary completion moved earlier from Aug 27, 2027 to Jan 15, 2027
    • Completion moved earlier from Aug 31, 2028 to Jun 1, 2027
    • Eligibility criteria expanded, about 26 words
    • Secondary endpoints: details revised at 8 of 8 entries
    • Site details revised at 5 of 103 sites
  2. Primary completion date: Sep 21, 2026 to Aug 27, 2027 Completion date: Sep 21, 2026 to Aug 31, 2028 · Eligibility criteria shortened, about 1 wordv57 Show 2 more changesShow less
    • Completion date: Sep 21, 2026 to Aug 31, 2028
    • Eligibility criteria shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  3. Re-verified, no change to tracked fieldsv56
  4. Primary and study completion dates: Aug 12, 2026 to Sep 21, 2026v55
  5. Re-verified, no change to tracked fieldsv54
Show 45 earlier versionsHide 45 earlier versions
  1. Primary and study completion dates: Aug 20, 2024 to Aug 12, 2026v53
  2. Enrollment target: estimated 6000 to confirmed 6033v52
  3. 2 versions Re-verified since Aug 17, 2022, no change to tracked fieldsv50-v51
  4. Trial status: Recruiting to Active, Not Recruiting Site details revised at 103 of 103 sitesv49 Show 1 more changeShow less
    • Site details revised at 103 of 103 sites
  5. Site details revised at 2 of 103 sitesv48
  6. Site details revised at 3 of 103 sitesv47
  7. Site details revised at 6 of 103 sitesv46
  8. Primary and study completion dates: Jul 15, 2024 to Aug 20, 2024v45
  9. Site details revised at 5 of 103 sitesv44
  10. Site details revised at 2 of 103 sitesv43
  11. Site details revised at 1 of 103 sitesv42
  12. Site details revised at 6 of 103 sitesv41
  13. Site details revised at 8 of 103 sitesv40
  14. Site details revised at 1 of 103 sitesv39
  15. Study sites revised (103)v38 See this version in full on ClinicalTrials.gov ↗
  16. Site details revised at 3 of 103 sitesv37
  17. Study sites: 102 to 103v36
  18. Site details revised at 1 of 102 sitesv35
  19. Site details revised at 1 of 102 sitesv34
  20. Study sites revised (102)v33 See this version in full on ClinicalTrials.gov ↗
  21. Study sites: 101 to 102v32
  22. Study sites: 99 to 101v31
  23. Study sites: 95 to 99v30
  24. Study sites: 92 to 95v29
  25. Study sites: 91 to 92v28
  26. Study sites: 88 to 91v27
  27. Study sites: 86 to 88v26
  28. Study sites: 82 to 86v25
  29. Study sites: 78 to 82v24
  30. Study sites: 75 to 78v23
  31. Study sites: 71 to 75v22
  32. Study sites: 69 to 71v21
  33. Study sites: 66 to 69v20
  34. Study sites: 57 to 66v19
  35. Study sites: 53 to 57v18
  36. Study sites: 49 to 53v17
  37. Study sites: 45 to 49v16
  38. Study sites: 42 to 45v15
  39. Study sites: 37 to 42v14
  40. Study sites: 36 to 37v13
  41. Study sites: 34 to 36v12
  42. Study sites: 33 to 34v11
  43. Site details revised at 1 of 33 sitesv10
  44. Study sites: 31 to 33v9
  • 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.
Merck (MSD)
407 trials monitored
See 29 trials at risk
The purpose of this study is to evaluate the efficacy, immunogenicity and safety of the 9vHPV vaccine in men 20 to 45 years of age. The primary hypothesis tested after the primary database lock is that administration of a 3-dose regimen of 9vHPV vaccine will reduce the incidence of human papillomavirus (HPV) 16/18/31/33/45/52/58-related oral persistent infection (6 months or longer) compared with placebo. There will also be an Extension Study to offer an opportunity to complete the 3 dose regimen of 9vHPV vaccine for participants who received placebo in the Base Study, or received less than 3 doses of 9vHPV vaccine in the Base Study.
Trial Details
NCT Number NCT04199689
Lead Sponsor Merck Sharp & Dohme LLC
Conditions Papillomavirus Infections
Enrollment 6,033 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov