Who is sponsoring NCT00517309?

NCT00517309 is sponsored by Merck Sharp & Dohme LLC.

What condition does NCT00517309 study?

NCT00517309 studies Cervical Cancer, Genital Warts.

Is NCT00517309 still recruiting?

NCT00517309 is currently completed. Last updated 22 March 2017.

Last reviewed 2017-03-22 · How we verify

NCT00517309: FUTURE

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Study to Test the Safety of HPV Vaccine in Women (V501-011)(COMPLETED)

Completed Phase 3 Last updated 22 March 2017

What this trial tests

Phase 3 trial testing V501, Gardasil, Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine / Duration of Treatment : 4 Years in Cervical Cancer in 1,877 participants. Completed in 11 June 2004.

Timeline

28 December 2001

Primary endpoint
8 June 2004

11 June 2004

Quick facts

Lead sponsor	Merck Sharp & Dohme LLC
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	1,877
Start date	28 December 2001
Primary completion	8 June 2004
Estimated completion	11 June 2004

Drugs / interventions tested

V501, Gardasil, Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine / Duration of Treatment : 4 Years
Comparator: placebo (concomitant-vaccine matched) / Duration of Treatment : 4 Years — full drug profile →

Conditions studied

Cervical Cancer — all drugs for Cervical Cancer →
Genital Warts — all drugs for Genital Warts →

Sponsor

Merck Sharp & Dohme LLC — full company profile →

Who can join

Adults 16 to 23, female only, with Cervical Cancer or Genital Warts. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The primary purpose of the study is to test the safety of HPV Vaccine in Women

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Prophylactic vaccination against human papillomaviruses to prevent cervical cancer and its precursors.
Arbyn M, Xu L, Simoens C, Martin-Hirsch PP. · · 2018 · cited 289× · PMID 29740819 · DOI 10.1002/14651858.cd009069.pub3
Targeting lymph node delivery with nanovaccines for cancer immunotherapy: recent advances and future directions.
Li Y, Li S, Jiang Z, Tan K, et al · · 2023 · cited 21× · PMID 37415161 · DOI 10.1186/s12951-023-01977-1
HPV pathogenesis, various types of vaccines, safety concern, prophylactic and therapeutic applications to control cervical cancer, and future perspective.
Ashique S, Hussain A, Fatima N, Altamimi MA. · · 2023 · cited 14× · PMID 37363362 · DOI 10.1007/s13337-023-00824-z
Think like a Virus: Toward Improving Nanovaccine Development against SARS-CoV-2.
Mohamed NA, Abou-Saleh H, Mohamed HA, Al-Ghouti MA, et al · · 2022 · cited 9× · PMID 35891532 · DOI 10.3390/v14071553

Verify or expand the search:

Other recruiting trials for Cervical Cancer

Currently open trials in the same condition.

NCT07276360 — Hypofractionated Radiotherapy for the Treatment of Locally Advanced Cervical Cancer in Uganda · Phase 2 · recruiting
NCT05570422 — A Study to Evaluate the Safety, Tolerability, Preliminary Efficacy of KRC-01 · Phase 1 · recruiting
NCT07225530 — Implementation of Screen, Treat, and Triage for Women Living With HIV in La Romana (iSTAR) · NA · recruiting
NCT07209917 — Secondary Cervical Cancer Prevention of Vulnerable Women With HPV and HIV Co-infection in India · NA · recruiting
NCT07256236 — SKB264 Plus QL1706 in Recurrent or Metastatic Cervical Cancer · Phase 2 · recruiting

Other Merck Sharp & Dohme LLC trials

Trials by the same sponsor.

NCT07224477 — A Clinical Study of V540A in Healthy Female Participants (V540A-005) · Phase 2 · not yet recruiting
NCT07302347 — A Study of Pembrolizumab in Japanese Pediatric Participants With Solid Tumors or Lymphomas and Japanese Adult Participan · Phase 1, PHASE2 · recruiting
NCT07528508 — A Clinical Trial in Healthy Participants to Study the Effect of a Single Dose of MK-8527 on Levels of Methadone (MK-8527 · Phase 1 · not yet recruiting
NCT07513376 — A Clinical Trial of Adjuvant Intismeran (V940) With or Without Pembrolizumab Coformulated With Berahyaluronidase Alfa (M · Phase 3 · not yet recruiting
NCT07532304 — A Clinical Trial of MK-4646 With Bictegravir/Emtricitabine/Tenofovir Alafenamide and Dolutegravir in Healthy Adult Parti · Phase 1 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00517309 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Merck Sharp & Dohme LLC
Last refreshed: 22 March 2017

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00517309.

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