human papillomavirus 9-valent vaccine, recombinant

Trade name: Gardasil 9

Vaccineapproved

Approved

Dec 10, 2014

Gardasil is an HPV vaccine for use in the prevention of certain strains of human papillomavirus (HPV). It was developed by Merck & Co. High-risk human papilloma virus (hr-HPV) genital infection is the most common sexually transmitted infection among women. The HPV strains that Gardasil protects against are sexually transmitted, specifically HPV types 6, 11, 16 and 18. HPV types 16 and 18 cause an estimated 70% of cervical cancers, and are responsible for most HPV-induced anal, vulvar, vaginal, and penile cancer cases. HPV types 6 and 11 cause an estimated 90% of genital warts cases. HPV type 16 is responsible for almost 90% of HPV-positive oropharyngeal cancers, and the prevalence is higher in males than females. Though Gardasil does not treat existing infection, vaccination is still recommended for HPV-positive individuals, as it may protect against one or more different strains of the disease. — Wikipedia

Clinical trial activity

122 trials · 121 clinical orgs · 1 marketing orgs

Phase 1
16
Phase 2
71
Phase 3
51
Phase 4
36

Earliest trial started Sep 24, 2007 (NCT00543543)

Timeline

2000s

  1. Jan 1, 2007

    Merck — Earliest Phase 3 Sponsor(trial)

  2. Jan 1, 2009

    Earliest Phase 1 Sponsor(trial)

2010s

  1. Jan 1, 2014

    Earliest Phase 2 Sponsor(trial)

  2. Oct 10, 2014

    Merck — First NDA Organization

  3. Oct 10, 2014

    Merck — NDA Organization

  4. Dec 10, 2014

    Earliest FDA Approval

Indications

Studied for

Mechanism of action

Approval history

  • approvedDec 10, 2014

Chemistry & pharmacology

Oral

No

Parenteral

No

Topical

No

Sources

Also known as

  • 9-valent hpv vaccine
  • gardasil 9
  • gardasil 9
  • human papillomavirus 9-valent vaccine, recombinant
  • human papillomavirus 9-valent vaccine, recombinant
  • human papillomavirus vaccine
  • human papillomavirus vaccine [types 6, 11, 16, 18, 31, 33, 45, 52, 58] (recombinant, adsorbed)
  • nonavalent hpv vaccine
  • recombinant human papillomavirus nonavalent vaccine
  • v503

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07303751Phase 2Feb 1, 2026University of Barcelona
NCT06786429Phase 4Jan 31, 2026Eunice Dube, National Cancer Institute (NCI), National University of Science and Technology, Zimbabwe
NCT07256912Phase 4Jan 15, 2026International Agency for Research on Cancer
NCT07281677Phase 4Dec 20, 2025Government of China
NCT07224477Phase 2Dec 5, 2025Merck
NCT07156084Phase 4Sep 23, 2025Canadian Immunization Research Network
NCT06793410Phase 2May 12, 2025Vastra Gotaland Region
NCT06959563Early Phase 1 (Phase 1)Apr 28, 2025Medicine Invention Design, Inc, UnitedHealth Group
NCT06866574Phase 3Apr 11, 2025Beijing Wantai Biological Pharmacy Enterprise Co., Ltd., Fudan University, Government of China, Xiamen University
NCT06799494Phase 4Mar 31, 2025Emory University, Merck
NCT06756269Phase 2Jan 15, 2025Government of China, Shanghai Bovax Biotechnology Co., Ltd.
NCT06681636Phase 2Dec 14, 2024Government of Vietnam, Murdoch University
NCT06688058Phase 1Dec 12, 2024Merck
NCT06623409Phase 1Nov 4, 2024Merck
NCT06624839Phase 2Oct 31, 2024University of Maryland
NCT06658405Phase 2Oct 31, 2024University of Lille
NCT06588257Phase 4Oct 9, 2024Fundacion Huesped, Merck
NCT06436274Phase 4Sep 30, 2024Botswana Harvard Aids Institute, Government of Rwanda, Harvard University, Karolinska Institute, National Cancer Institute (NCI), University of the Witwatersrand, University of Washington
NCT06536855Phase 4Sep 1, 2024Karolinska Institute, Merck, Rwanda Biomedical Centre
NCT06465914Phase 3Jul 11, 2024Fudan University, Government of China, Shanghai Bovax Biotechnology Co., Ltd.
Showing 20 of 122 trials
Page 1 / 7

Organizations

Research & Development (121)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
MerckFor profit432542007
Government of ChinaGovernment17242019
National Cancer Institute (NCI)Government12542016
Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.For profit7142019
Shanghai Bovax Biotechnology Co., Ltd.Government7732018
University of WashingtonAcademic/Hospital6522017
Xiamen UniversityAcademic/Hospital6632019
Beijing Health Guard Biotechnology, IncFor profit5532019
Karolinska InstituteAcademic/Hospital4022017
University of the WitwatersrandAcademic/Hospital3132014
Boston UniversityAcademic/Hospital2222020
Cornell UniversityAcademic/Hospital2122014
Emory UniversityAcademic/Hospital2122023
Fudan UniversityAcademic/Hospital2012024
International Agency for Research on CancerAcademic/Hospital2222023
Laval UniversityAcademic/Hospital2212015
Sanofi-AventisFor profit2112011
Shanghai Zerun Biotechnology Co.,LtdFor profit2222019
Sinocelltech Ltd.For profit2222021
State of TexasGovernment2012019
121 organizations
Page 1 / 7

Marketing (1)

OrganizationOrg typeRelationshipDate
MerckFor profitNDAOct 10, 2014