Human Papillomavirus 9-valent Vaccine, Recombinant

also known as Gardasil 9 · 9vHPV

Developed for: human papilloma virus infection · cervical intraepithelial neoplasia · cervix disorder · intraepithelial neoplasia · skin disorder caused by infection
Investigated by: Merck Sharp & Dohme LLC · CENTER FOR SUPPORTING COMMUNITY DEVELOPMENT INITIATIVES · Canceropôle Nord Ouest · Centre Oscar Lambret · Hai Phong Center for Disease Control · Instituto de Salud Carlos III
+6 more
· Louisiana State University Health Sciences Center in New Orleans · Murdoch Childrens Research Institute · National Institute of Hygiene and Epidemiology, Vietnam · University Hospital Virgen de las Nieves · University of Utah · Western Institute for Veterans Research

Milestone	Jurisdiction	Brand	Indication	Date	Sentence it was read from
Approved	EU (EMA)	Gardasil 9	—	2015-06-10	europa.eu ↗

today

EU approved 2015

20162017201820192020202120222023202420252026202720282029

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 22 trials
Phase 2	NCT06658405	Jan 2025 → Oct 2028 expected	cervix disorder	Centre Oscar Lambret	Recruiting	No outcome recorded
Phase 2	NCT06681636	Dec 2024 → Oct 2026 expected	cervical cancer, human papilloma virus infection, viral sexually transmitted disease	National Institute of Hygiene and Epidemiology, Vietnam	Not yet recruiting	No outcome recorded
Phase 2/31 trial
Phase 2/3	NCT05625633	Mar 2024 → Dec 2025 overdue	skin disorder caused by infection	Western Institute for Veterans Research	Recruiting	No outcome recorded
Phase 42 trials
Phase 4	NCT05266898	Nov 2022 → Dec 2025 overdue	HIV infectious disease, cervical intraepithelial neoplasia, human papilloma virus infection, intraepithelial neoplasia +1	Louisiana State University Health Sciences Center in New Orleans	Recruiting	No outcome recorded
Phase 4	NCT04270773	Feb 2020 → Sep 2024 overdue	HIV infectious disease, human papilloma virus infection	University Hospital Virgen de las Nieves	Active not recruiting	No outcome recorded
Comparator or background therapy1 trial
Phase 4	NCT02968420 Comparator	Sep 2017 → May 2019	human papilloma virus infection	University of British Columbia	Completed	No outcome recorded

Date	Issuer	Release
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 ↗

Every value below carries the sentence it was read from. 7 sources stand behind the page.

Field	Value	Cited text
Known as	Human Papillomavirus 9-valent Vaccine, Recombinant	ClinicalTrials.gov intervention name — accepted as the source's own label NCT06658405 ↗ 5 NCT04270773 ↗ NCT05266898 ↗ NCT06681636 ↗ NCT02968420 ↗ NCT05625633 ↗
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
Known as	Gardasil 9	“The intervention of a single dose of licensed Gardasil 9 vaccine (Human Papillomavirus 9-valent Vaccine, Recombinant) will be administered at Day 0 of the study.” NCT02968420 ↗ 1 “Gardasil 9” NCT06658405 ↗
Modality	Vaccine	“Human papillomavirus (HPV) vaccines provide excellent protection from infection and disease.” PMID 39914257 ↗ Feb 2025
Route	Intramuscular	“administered as intramuscular injection” NCT05625633 ↗