drugset
Drugs / V503
last change Jul 2025 re-read 3 minutes ago

V503

also known as 9vHPV · Gardasil9

Vaccine

Developed for
human papilloma virus infection · cervical cancer · vaginal cancer · vulva cancer · anogenital human papillomavirus infection · anus neoplasm
Investigated by
Merck Sharp & Dohme LLC

Trials 13

today NCT04635423 · Ph 3 NCT03998254 · Ph 3 NCT03903562 · Ph 3 NCT03158220 · Ph 3 NCT02114385 · Ph 3 NCT01984697 · Ph 3 NCT01304498 · Ph 3 NCT01254643 · Ph 3 NCT01073293 · Ph 3 NCT01047345 · Ph 3 NCT00988884 · Ph 3 NCT00943722 · Ph 3 NCT00543543 · Ph 3
200820092010201120122013201420152016201720182019202020212022202320242025202620272028
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 313 trials · 9 met primary · 1 missed
Phase 3 NCT04635423 Nov 2020 → Dec 2023 anogenital human papillomavirus infection, anus neoplasm Merck Sharp & Dohme LLC Completed Met primary
Phase 3 NCT03998254 Jun 2019 → Mar 2028 expected human papilloma virus infection Merck Sharp & Dohme LLC Active not recruiting No outcome recorded
Phase 3 NCT03903562 Apr 2019 → Feb 2025 human papilloma virus infection Merck Sharp & Dohme LLC Completed Met primary
Phase 3 NCT03158220 Sep 2017 → Nov 2018 anogenital human papillomavirus infection, cervical cancer, vaginal cancer, vulva cancer Merck Sharp & Dohme LLC Completed Met primary
Phase 3 NCT02114385 Mar 2014 → Apr 2015 human papilloma virus infection Merck Sharp & Dohme LLC Completed Met primary
Phase 3 NCT01984697 Dec 2013 → Jun 2015 human papilloma virus infection Merck Sharp & Dohme LLC Completed Met primary
Phase 3 NCT01304498 Feb → Dec 2011 human papilloma virus infection Merck Sharp & Dohme LLC Completed Met primary
Phase 3 NCT01254643 Jan 2011 → Aug 2013 human papilloma virus infection Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 3 NCT01073293 Apr 2010 → Jun 2011 human papilloma virus infection Merck Sharp & Dohme LLC Completed Met primary
Phase 3 NCT01047345 Feb 2010 → Jun 2011 cervical cancer, human papilloma virus infection, vaginal cancer, vulva cancer Merck Sharp & Dohme LLC Completed Missed primary

Press releases naming this drug 4 releases

DateIssuerRelease
2020-06-12 Merck Sharp & Dohme LLC FDA Approves Merck’s GARDASIL 9 for the Prevention of Certain HPV-Related Head and Neck Cancers merck.com ↗
2014-02-20 Merck Sharp & Dohme LLC FDA Accepts for Review Merck’s Biologics License Application for V503, Investigational 9-valent Human Papillomavirus Vaccine merck.com ↗
2013-11-04 Merck Sharp & Dohme LLC 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 ↗
2013-10-24 Merck Sharp & Dohme LLC Merck Provides Update on Investigational 9-valent HPV Vaccine V503 to U.S. Advisory Committee on Immunization Practices merck.com ↗

Evidence & citations 5 cited values

Every value below carries the sentence it was read from. 16 sources stand behind the page.

FieldValueCited text
Known as V503 ClinicalTrials.gov intervention name — accepted as the source's own label NCT00943722 ↗
12

NCT00988884 ↗

NCT03158220 ↗

NCT01047345 ↗

NCT00543543 ↗

NCT01073293 ↗

NCT01304498 ↗

NCT01984697 ↗

NCT03998254 ↗

NCT03903562 ↗

NCT04635423 ↗

Show 2 more sources
Known as 9vHPV “subjects who had participated in one of two trials comparing two and three doses (2D, 3D), were given an additional vaccine dose (Gardasil®9, 9vHPV) several years after the...” PMID 39914257 ↗ Feb 2025
2

“V503 (9vHPV) vaccine given as a 0.5 mL intramuscular injection” NCT01047345 ↗

“9-valent human papillomavirus (9vHPV; V503) vaccine” NCT03998254 ↗
Known as Gardasil9 “subjects who had participated in one of two trials comparing two and three doses (2D, 3D), were given an additional vaccine dose (Gardasil®9, 9vHPV) several years after the...” PMID 39914257 ↗ Feb 2025
Modality Vaccine “A 9-valent HPV (9vHPV) vaccine has been developed to protect against HPV type 6/11/16/18/31/33/45/52/58-related infection and disease.” PMID 29211620 ↗ Dec 2017
Route Intramuscular “Participants received the 9vHPV vaccine or the qHPV vaccine in a series of three intramuscular injections on day 1 and at months 2 and 6.” PMID 25693011 ↗ Feb 2015