Drugs / 9vHPV
9vHPV
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT05372016 | Sep 2020 → Jun 2022 | adenocarcinoma in situ, anogenital human papillomavirus infection, cervical cancer, cervical intraepithelial neoplasia grade 2/3 +2 | Shanghai Bovax Biotechnology Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT01651949 | Oct 2012 → Aug 2014 | anal carcinoma, anogenital human papillomavirus infection, intraepithelial neoplasia | Merck Sharp & Dohme LLC | Completed | Mixed |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2026-03-17 | Merck Sharp & Dohme LLC | Results Merck to Present New Data Reinforcing Long-Term Efficacy of GARDASIL®9 and GARDASIL® at the EUROGIN International Multidisciplinary HPV Congress 2026 merck.com ↗
Data show long-term effectiveness of GARDASIL ® 9 and GARDASIL ® 14 years and 18 years, respectively, following vaccination with 3 doses |
| 2024-09-11 | Merck Sharp & Dohme LLC | Results Merck Announces Positive Top-line Results from Phase 3 Trial Evaluating Efficacy and Safety of GARDASIL®9 in Japanese Males merck.com ↗
The trial met its primary and secondary endpoints demonstrating that administration of a 3-dose regimen of GARDASIL 9 reduced the combined incidence of anogenital persistent infection caused by 9 types of HPV compared with a placebo. |
| 2018-06-13 | Merck Sharp & Dohme LLC | Regulatory FDA Grants Priority Review to Merck’s Supplemental Biologics License Application (sBLA) for GARDASIL®9 in Women and Men Ages 27 to 45 for the Prevention of Certain HPV-Related Cancers and Diseases merck.com ↗
The FDA has granted Priority Review to this sBLA and has set a Prescription Drug User Fee Act (PDUFA), or target action, date of Oct. 6, 2018. |
| 2014-02-20 | Merck Sharp & Dohme LLC | Regulatory FDA Accepts for Review Merck’s Biologics License Application for V503, Investigational 9-valent Human Papillomavirus Vaccine merck.com ↗
Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today that the Biologics License Application for V503, its investigational 9-valent human papillomavirus (HPV) vaccine, has been accepted for standard review by the U.S. Food and Drug Administration. |
| 2013-11-04 | Merck Sharp & Dohme LLC | Results Merck’s Investigational 9-valent HPV Vaccine, V503, Prevented 97 Percent of Cervical, Vaginal and Vulvar Pre-cancers Caused by Five Additional HPV Types, in Phase III Study merck.com ↗
Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today that in the pivotal Phase III efficacy study, its investigational 9-valent HPV vaccine (V503) prevented approximately 97 percent of cervical, vaginal and vulvar pre-cancers caused by HPV types 31, 33, 45, 52, and 58. |
| 2013-10-24 | Merck Sharp & Dohme LLC | Results Merck Provides Update on Investigational 9-valent HPV Vaccine V503 to U.S. Advisory Committee on Immunization Practices merck.com ↗
Merck said that the pivotal efficacy trial is complete, the primary endpoints have been met and the company expects to submit a Biologics License Application for V503 to the U.S. Food and Drug Administration in 2013. |
All press releases naming this drug 7 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | 9vHPV | “9vHPV vaccine ,0.5mL, three doses, 0,2,6 months” NCT05372016 ↗ |
| Known as | 9-valent HPV vaccine | “This study is designed to evaluate the immunogenicity and tolerability of 9vHPV (9-valent HPV vaccine, V503) in 16- to 26-year old men and women.” NCT01651949 ↗ |
| Known as | V503 | “9vHPV, V503 (9-valent HPV [Types 6, 11, 16, 18, 31, 33, 45, 52, and 58] L1 virus-like particle vaccine), 0.5 mL injection in 3-dose regimen” NCT01651949 ↗ |
| Modality | Vaccine | “a Multivalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine” NCT01651949 ↗ |
| Route | Intramuscular | “0.5 mL intramuscular injection” NCT01651949 ↗ |