Who is sponsoring NCT00378560?

NCT00378560 is sponsored by Merck Sharp & Dohme LLC.

What condition does NCT00378560 study?

NCT00378560 studies HPV Infections.

Is NCT00378560 still recruiting?

NCT00378560 is currently completed. Last updated 17 April 2017.

Are results published for NCT00378560?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2017-04-17 · How we verify

NCT00378560

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

V501 Efficacy Study in Women Aged 18 to 26 (V501-027)

Completed Phase 2 Results posted Last updated 17 April 2017

What this trial tests

Phase 2 trial testing Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine in HPV Infections in 1,021 participants. Completed in 16 September 2009.

Timeline

12 June 2006

Primary endpoint
16 September 2009

16 September 2009

Quick facts

Lead sponsor	Merck Sharp & Dohme LLC
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	1,021
Start date	12 June 2006
Primary completion	16 September 2009
Estimated completion	16 September 2009

Drugs / interventions tested

Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine
Comparator: Placebo — full drug profile →

Conditions studied

HPV Infections — all drugs for HPV Infections →

Sponsor

Merck Sharp & Dohme LLC — full company profile →

Who can join

Adults 18 to 26, female only, with HPV Infections. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Combined Incidence of Persistent Human Papillomavirus (HPV) 6, 11, 16 and 18 Infection or HPV 6, 11, 16 and 18 Related-Disease as Determined by Clinical/Pathologic Criteria and Positive Polymerase Chain Reaction (PCR) Assay for Virus Subtype Primary · Over 30 months

Participants with HPV 6, 11, 16 or 18 persistent infection, and genital disease (e.g., cervical, vaginal or vulval intraepithelial neoplasia, or cancer, adenocarcinoma in situ and genital warts) per 100 person-years of follow up.

Group	Value	95% CI
V501	0.4	61.2 – 97.7
Placebo	3.1	0.0 – 0.0

Vaccine Type Serum Antibody Titer at One Month After Completed Vaccination Series (Anti-HPV 6) Secondary · At one month after completed vaccination series (Month 7)

Month 7 HPV Competitive Luminex immunoassay (cLIA) Geometric Mean Titers (GMTs) by vaccine group. The limit of detection of the assay was 7 mMU/ml. GMTs and confidence limits below the limit of detection are shown as "7.0".

Group	Value	95% CI
V501	390.8	357.7 – 426.9
Placebo	7.0	7.0 – 7.0

Vaccine Type Serum Antibody Titer at One Month After Completed Vaccination Series (Anti-HPV 11) Secondary · At one month after completed vaccination series (Month 7)

Month 7 HPV cLIA Geometric Mean Titers by vaccine group. The limit of detection of the assay was 8 mMU/ml. GMTs and confidence limits below the limit of detection are shown as "8.0".

Group	Value	95% CI
V501	579.8	538.1 – 624.8
Placebo	8.0	8.0 – 8.0

Vaccine Type Serum Antibody Titer at One Month After Completed Vaccination Series (Anti-HPV 16) Secondary · At one month after completed vaccination series (Month 7)

Month 7 HPV cLIA Geometric Mean Titers by vaccine group. The limit of detection of the assay was 11 mMU/ml. GMTs and confidence limits below the limit of detection are shown as "11.0".

Group	Value	95% CI
V501	2396.4	2201.3 – 2608.8
Placebo	11.0	11.0 – 11.0

Vaccine Type Serum Antibody Titer at One Month After Completed Vaccination Series (Anti-HPV 18) Secondary · At one month after completed vaccination series (Month 7)

Month 7 HPV cLIA Geometric Mean Titers by vaccine group. The limit of detection of the assay was 10 mMU/ml. GMTs and confidence limits below the limit of detection are shown as "10.0".

Group	Value	95% CI
V501	369.0	335.9 – 405.4
Placebo	10.0	10.0 – 10.0

Adverse events — posted to ClinicalTrials.gov

Time frame: Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

V501

Serious: 39/480 (8%)

Deaths: —

Placebo

Serious: 65/468 (14%)

Deaths: —

Serious adverse events (34 terms)

Reaction	System	V501	Placebo
Cervical dysplasia	Reproductive system and breast disorders	—	—
Abortion induced	Surgical and medical procedures	—	—
Appendicitis	Infections and infestations	—	—
Gastroenteritis	Infections and infestations	—	—
Pneumonia	Infections and infestations	—	—
Ovarian neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Lymphadenitis	Blood and lymphatic system disorders	—	—
Vertigo	Ear and labyrinth disorders	—	—
Ascites	Gastrointestinal disorders	—	—
Enterocolitis	Gastrointestinal disorders	—	—
Peritonitis	Gastrointestinal disorders	—	—
Hernia	General disorders	—	—
Herpes simplex	Infections and infestations	—	—
Meningitis aseptic	Infections and infestations	—	—
Ovarian abscess	Infections and infestations	—	—
Pyelonephritis	Infections and infestations	—	—
Pyelonephritis acute	Infections and infestations	—	—
Tonsillitis	Infections and infestations	—	—
Drug toxicity	Injury, poisoning and procedural complications	—	—
Facial bones fracture	Injury, poisoning and procedural complications	—	—
Hand fracture	Injury, poisoning and procedural complications	—	—
Ligament injury	Injury, poisoning and procedural complications	—	—
Neck injury	Injury, poisoning and procedural complications	—	—
Depressed level of consciousness	Nervous system disorders	—	—
Myasthenia gravis	Nervous system disorders	—	—

Other adverse events (160 terms — click to expand)

Reaction	System	V501	Placebo
Injection site pain	General disorders	—	—
Injection site erythema	General disorders	—	—
Injection site swelling	General disorders	—	—
Headache	Nervous system disorders	—	—
Nasopharyngitis	Infections and infestations	—	—
Pyrexia	General disorders	—	—
Dysmenorrhoea	Reproductive system and breast disorders	—	—
Injection site pruritus	General disorders	—	—
Malaise	General disorders	—	—
Injection site haemorrhage	General disorders	—	—
Nausea	Gastrointestinal disorders	—	—
Diarrhoea	Gastrointestinal disorders	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—
Injection site discomfort	General disorders	—	—
Abdominal pain	Gastrointestinal disorders	—	—
Cystitis	Infections and infestations	—	—
Constipation	Gastrointestinal disorders	—	—
Stomach discomfort	Gastrointestinal disorders	—	—
Stomatitis	Gastrointestinal disorders	—	—
Alanine aminotransferase increased	Investigations	—	—
Protein urine present	Investigations	—	—
Dizziness	Nervous system disorders	—	—
Pharyngolaryngeal pain	Respiratory, thoracic and mediastinal disorders	—	—
Abdominal pain lower	Gastrointestinal disorders	—	—
Haemoglobin decreased	Investigations	—	—
White blood cell count increased	Investigations	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	—	—
Metrorrhagia	Reproductive system and breast disorders	—	—
Dry skin	Skin and subcutaneous tissue disorders	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—
Toothache	Gastrointestinal disorders	—	—
Vomiting	Gastrointestinal disorders	—	—
Injection site anaesthesia	General disorders	—	—
Injection site bruising	General disorders	—	—
Injection site warmth	General disorders	—	—
Tonsillitis	Infections and infestations	—	—
Arthropod sting	Injury, poisoning and procedural complications	—	—
Haematocrit decreased	Investigations	—	—
Platelet count increased	Investigations	—	—

Most-reported serious reactions: Cervical dysplasia, Abortion induced, Appendicitis, Gastroenteritis, Pneumonia, Ovarian neoplasm, Lymphadenitis, Vertigo.

Data from ClinicalTrials.gov NCT00378560 adverse events section.

Sponsor's own description

A study to evaluate the efficacy, immunogenicity, safety and tolerability of V501 in adult 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
Systematic drug repositioning through mining adverse event data in ClinicalTrials.gov.
Su EW, Sanger TM. · · 2017 · cited 23× · PMID 28348935 · DOI 10.7717/peerj.3154
Will HPV vaccination prevent cervical cancer?
Rees CP, Brhlikova P, Pollock AM. · · 2020 · cited 16× · PMID 31962050 · DOI 10.1177/0141076819899308
Post-hoc analysis of injection-site reactions following vaccination with quadrivalent human papillomavirus vaccine in Japanese female clinical trial participants.
Murata S, Shirakawa M, Sugawara Y, Shuto M, et al · · 2020 · cited 2× · PMID 32827835 · DOI 10.1016/j.pvr.2020.100205

Verify or expand the search:

Other trials of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine

Trials testing the same drug.

NCT00733122 — Tolerability and Immunogenicity of Gardasil in Females Between 16 and 23 Years of Age in India (V501-034) · Phase 3 · withdrawn
NCT00834106 — Prevention of Human Papillomavirus (HPV) in 20 to 45 Year Old Chinese Women (V501-041) · Phase 3 · completed
NCT00380367 — Safety, Tolerability and Immunogenicity of HPV (Human Papilloma Virus) Vaccine in Healthy Females 9 to 15 Years of Age i · Phase 3 · completed
NCT00090220 — A Study to Evaluate the Safety, Immune Response, and Efficacy of Gardasil (V501, qHPV) in Mid-Adult Women (V501-019) · Phase 3 · completed

Other recruiting trials for HPV Infections

Currently open trials in the same condition.

NCT05027776 — Immunogenicity and Safety of Quadrivalent HPV Vaccine in Healthy Chinese Female Subjects Aged 9 to 19 Years · Phase 3 · 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 NCT00378560 (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: 17 April 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/NCT00378560.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing