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Comparing One or Two Doses of the Human Papillomavirus Vaccine for the Prevention of Human Papillomavirus Infection, ESCUDDO Study

Study acronym: ESCUDDO
StatusActive, Not Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 446 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Enrollment target: estimated 28000 to confirmed 27945 Primary completion date changed from estimate of Aug 1, 2025 to Aug 21, 2025 · Completion date: Aug 1, 2025 to Aug 1, 2028v446 Show 2 more changesShow less
    • Primary completion date changed from estimate of Aug 1, 2025 to Aug 21, 2025
    • Completion date: Aug 1, 2025 to Aug 1, 2028
  2. Primary endpoints revised (3) Secondary endpoints: 1 to 2 · Study description expanded, about 34 wordsv445 Show 2 more changesShow less
    • Secondary endpoints: 1 to 2
    • Study description expanded, about 34 words

    See this version in full on ClinicalTrials.gov ↗

  3. Re-verified, no change to tracked fieldsv444
  4. Secondary endpoint revised Study description expanded, about 74 wordsv443 Show 1 more changeShow less
    • Study description expanded, about 74 words

    See this version in full on ClinicalTrials.gov ↗

  5. 6 versions Re-verified since Dec 20, 2024, no change to tracked fieldsv437-v442
Show 40 earlier versionsHide 40 earlier versions
  1. Trial status: Enrolling by Invitation to Active, Not Recruitingv436
  2. 4 versions Re-verified since Sep 22, 2022, no change to tracked fieldsv432-v435
  3. Primary endpoints: 2 to 3 Enrollment target: 25000 to 28000 · Eligibility criteria expanded, about 197 words · Secondary endpoints: 5 to 1 · 1 morev431 Show 4 more changesShow less
    • Enrollment target: 25000 to 28000
    • Eligibility criteria expanded, about 197 words
    • Secondary endpoints: 5 to 1
    • Study description expanded, about 168 words

    See this version in full on ClinicalTrials.gov ↗

  4. Trial status: Active, Not Recruiting to Enrolling by Invitation Primary and study completion dates: Aug 1, 2024 to Aug 1, 2025v430 Show 1 more changeShow less
    • Primary and study completion dates: Aug 1, 2024 to Aug 1, 2025
  5. 3 versions Re-verified since Apr 22, 2022, no change to tracked fieldsv427-v429
  6. Site details revisedv426
  7. 2 versions Re-verified since Dec 11, 2020, no change to tracked fieldsv424-v425
  8. Primary and study completion dates: Oct 14, 2020 to Aug 1, 2024 Primary endpoints: 4 to 2 · Trial status: Completed to Active, Not Recruiting · Enrollment target: 22089 to 25000 · 6 morev423 Show 9 more changesShow less
    • Primary endpoints: 4 to 2
    • Trial status: Completed to Active, Not Recruiting
    • Enrollment target: 22089 to 25000
    • Interventions: Cervarix (Biological), Gardasil 9 (Biological) to Diphtheria Toxoid/Tetanus Toxoid/Acellular Pertussis Vaccine Adsorbed (Biological), Questionnaire Administration (Other), Recombinant Human…
    • Eligibility criteria shortened, about 25 words
    • Secondary endpoints: 6 to 5
    • Study description shortened, about 273 words
    • Study site revised
    • Study title expanded, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  9. Trial status: Active, Not Recruiting to Completed Primary completion date changed from estimate of Dec 31, 2022 to Oct 14, 2020 · Study completion date changed from estimate of Dec 31, 2024 to Oct 14, 2020v422 Show 2 more changesShow less
    • Primary completion date changed from estimate of Dec 31, 2022 to Oct 14, 2020
    • Study completion date changed from estimate of Dec 31, 2024 to Oct 14, 2020
  10. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 25000 to confirmed 22089 · Site details revisedv421 Show 2 more changesShow less
    • Enrollment target: estimated 25000 to confirmed 22089
    • Site details revised
  11. Re-verified, no change to tracked fieldsv420
  12. Secondary endpoints: details revised at 6 of 6 entriesv419
  13. 2 versions Re-verified since Apr 4, 2019, no change to tracked fieldsv417-v418
  14. Eligibility criteria expanded, about 46 words Secondary endpoints revised (6)v416 Show 1 more changeShow less
    • Secondary endpoints revised (6)

    See this version in full on ClinicalTrials.gov ↗

  15. Re-verified, no change to tracked fieldsv415
  16. Start date changed from estimate of Apr 2, 2019 to Nov 29, 2017v414
  17. Start date: Apr 1, 2019 to Apr 2, 2019v413
  18. Start date: Mar 29, 2019 to Apr 1, 2019v412
  19. Start date: Mar 28, 2019 to Mar 29, 2019v411
  20. Start date: Mar 27, 2019 to Mar 28, 2019v410
  21. Start date: Mar 26, 2019 to Mar 27, 2019v409
  22. Start date: Mar 25, 2019 to Mar 26, 2019v408
  23. Start date: Mar 22, 2019 to Mar 25, 2019v407
  24. Start date: Mar 21, 2019 to Mar 22, 2019v406
  25. Start date: Mar 20, 2019 to Mar 21, 2019v405
  26. Start date: Mar 19, 2019 to Mar 20, 2019v404
  27. Start date: Mar 18, 2019 to Mar 19, 2019v403
  28. Start date: Mar 15, 2019 to Mar 18, 2019v402
  29. Start date: Mar 14, 2019 to Mar 15, 2019v401
  30. Start date: Mar 13, 2019 to Mar 14, 2019v400
  31. Start date: Mar 12, 2019 to Mar 13, 2019v399
  32. Start date: Mar 11, 2019 to Mar 12, 2019v398
  33. Start date: Mar 8, 2019 to Mar 11, 2019v397
  • 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.
This phase IV trial investigates whether one dose of a human papillomavirus vaccine works as well as two doses in preventing human papillomavirus (HPV) infection. Certain types of HPV cause almost all cases of cervical cancer. Vaccines that protect against infection with these types of human papillomavirus may reduce the risk of cervical cancer. Both Gardasil-9 and Cervarix protect against HPV 16 and 18, which cause 70% of all cervical cancers. However, HPV vaccination rates are too low, especially in countries with very high rates of cervical cancer. HPV vaccines are expensive-many countries cannot afford them-more than one dose is needed, and giving multiple doses is difficult. Researchers want to find out if one dose prevents HPV infection. If it does, more people might get the vaccine.
Trial Details
NCT Number NCT03180034
Lead Sponsor National Cancer Institute (NCI)
Collaborators: Bill and Melinda Gates Foundation
Conditions Human Papillomavirus Infection, Human Papillomavirus-Related Cervical Carcinoma
Enrollment 27,945 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov