human papillomavirus quadrivalent (types 6, 11, 16 and 18) vaccine, recombinant

Trade name: Gardasil

Vaccineapproved

Approved

Jun 8, 2006

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

125 trials · 132 clinical orgs · 1 marketing orgs

Phase 1
12
Phase 2
76
Phase 3
50
Phase 4
22

Earliest trial started May 1, 2000 (NCT00365716)

Timeline

2000s

  1. Jan 1, 2000

    Merck — Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2001

    Merck — Earliest Phase 3 Sponsor(trial)

  3. Jan 1, 2006

    Merck — Earliest Phase 1 Sponsor(trial)

  4. Jun 8, 2006

    Merck — Earliest FDA Approval

  5. Jun 8, 2006

    Merck — NDA Organization

Indications

Studied for

Mechanism of action

Approval history

  • approvedJun 8, 2006

Chemistry & pharmacology

Oral

No

Parenteral

No

Topical

No

Sources

Also known as

  • 4-valent hpv vaccine
  • both doses late
  • garaisil
  • gardasil
  • gardasil
  • gardasil
  • hpv vaccine
  • human papillomavirus 6,11,16,18 vaccine
  • human papillomavirus quadrivalent (types 6, 11, 16 and 18) vaccine, recombinant
  • human papillomavirus quadrivalent vaccine
  • human papillomavirus type 11 l1 protein /human papillomavirus type 16 l1 protein /human papillomavirus type 18 l1 protein/human papillomavirus type 6 l1 protein
  • human papillomavirus type 6 l1 protein / human papillomavirus type 11 l1 protein / human papillomavirus type 16 l1 protein / human papillomavirus type 18 l1 protein
  • human papillomavirus vaccine l1, type 6,11,16,18
  • human papillomavirus vaccine l1, type 6,11,16,18
  • quadrivalen human papillomavirus vaccine
  • quadrivalent human papillomavirus vaccine
  • silgard
  • silgard
  • tetravalent vaccine
  • v501

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06650956N/ANov 30, 2024Health Poverty Action
NCT06632912Phase 3Oct 31, 2024Chengdu Institute of Biological Products Co.,Ltd., National Vaccine and Serum Institute, China
NCT06281119Phase 3Jun 30, 2024Bill and Melinda Gates Foundation, Serum Institute of India Pvt. Ltd.
NCT06142461Phase 2Jan 31, 2024National Cancer Institute (NCI), National Institutes of Health (NIH), PharmaJet, Inc.
NCT05672966Phase 1Aug 1, 2023Government of China, Novotech, Wuhan BravoVax Co., Ltd.
NCT05799144Phase 2May 16, 2023Vanderbilt University
NCT05584332Phase 3Nov 15, 2022Shanghai Bovax Biotechnology Co., Ltd.
NCT05761002N/AJun 1, 2022Zagazig University
NCT05435209Phase 4May 25, 2022Merck, University of Washington
NCT05031078Phase 4Nov 30, 2021Emory University
NCT04953130Phase 4Nov 30, 2021Government of Tanzania, Institut Català d'Oncologia, Karolinska Institute, University of Cambridge, University of London, University of York
NCT05060484Phase 2Oct 19, 2021Government of China, Sinocelltech Ltd.
NCT04921111Phase 1Jul 2, 2021Sinocelltech Ltd.
NCT04508309Phase 3Dec 31, 2020Agogo Presbyterian Hospital, Ghana, Beijing Wantai Biological Pharmacy Enterprise Co., Ltd., International Center for Diarrheal Disease Research, Leidos, PATH, The EMMES Corporation
NCT05668572Phase 3Dec 5, 2020Beijing Health Guard Biotechnology, Inc
NCT05383625Phase 3Sep 1, 2020Zagazig University
NCT04425291Phase 3May 28, 2020Shanghai Bovax Biotechnology Co., Ltd.
NCT05694728Phase 2May 23, 2020Beijing Health Guard Biotechnology, Inc, Government of China
NCT04422366Phase 3Apr 28, 2020Shanghai Bovax Biotechnology Co., Ltd.
NCT04096911Phase 2Jul 31, 2019Innovent Biologics (Suzhou) Co. Ltd., Nanjing Medical University
Showing 20 of 125 trials
Page 1 / 7

Organizations

Research & Development (132)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
MerckFor profit513052000
GlaxoSmithKlineFor profit8832005
National Cancer Institute (NCI)Government8232007
Government of ChinaGovernment7022013
Government of MexicoGovernment4322009
Shanghai Bovax Biotechnology Co., Ltd.Government4422016
The EMMES CorporationFor profit4032007
University of California, San FranciscoAcademic/Hospital4022007
AIDS Malignancy ConsortiumAcademic/Hospital3322007
Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.For profit3032015
Laval UniversityAcademic/Hospital3212007
National Institute of Allergy and Infectious Diseases (NIAID)Government3322006
University of LondonAcademic/Hospital3322009
University of PittsburghAcademic/Hospital3222007
Beijing Health Guard Biotechnology, IncFor profit2222020
Bill and Melinda Gates FoundationAcademic/Hospital2012018
Cornell UniversityAcademic/Hospital2022007
International Center for Diarrheal Disease ResearchAcademic/Hospital2022018
Johns Hopkins UniversityAcademic/Hospital2222008
National Autonomous University of MexicoAcademic/Hospital2112015
132 organizations
Page 1 / 7

Marketing (1)

OrganizationOrg typeRelationshipDate
MerckFor profitNDAJun 8, 2006