CDEK
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hpv 16/18 vaccine

Trade name: Cervarix

Vaccineapproved

Approved

Oct 16, 2009

Cervarix is a vaccine against certain types of cancer-causing human papillomavirus (HPV). — Wikipedia

Clinical trial activity

85 trials · 46 clinical orgs · 1 marketing orgs

Phase 1
9
Phase 2
60
Phase 3
45
Phase 4
16

Earliest trial started Oct 1, 1999 (NCT00693966)

Timeline

1990s

  1. Jan 1, 1999

    Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 1999

    GlaxoSmithKline — Earliest Phase 2 Sponsor(trial)

2000s

  1. Jan 1, 2004

    GlaxoSmithKline — Earliest Phase 3 Sponsor(trial)

  2. Oct 16, 2009

    GlaxoSmithKline — Earliest FDA Approval

  3. Oct 16, 2009

    GlaxoSmithKline — NDA Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedOct 16, 2009

Chemistry & pharmacology

Oral

No

Parenteral

No

Topical

No

Sources

Also known as

  • bivalent hpv vaccine
  • cervarix
  • cervarix
  • cervarix
  • gardasil
  • gsk580299
  • hpv 16/18 vaccine
  • hpv-6/11/16/18 vaccine
  • hpv l1 vaccine, bivalent 16,18
  • hpv vaccine for strains -6, -11, -16, and -18
  • human papillomavirus 16/18 virus-like particle
  • human papillomavirus1 type 16 l1 protein / human papillomavirus type 18 l1 protein
  • human papillomavirus bivalent [types 16 and 18] vaccine
  • human papillomavirus bivalent (types 16 and 18) vaccine, recombinant
  • human papillomavirus vaccine l1 16,18
  • human papillomavirus vaccine, l1 type 16, 18
  • human papillomavirus virus 16/18 bivalent vaccine
  • medi 517
  • medi-517
  • ta-hpv

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07281677Phase 4Dec 20, 2025Government of China
NCT05291845Phase 2Apr 3, 2022Zagazig University
NCT05237947Phase 4Mar 1, 2022National Cancer Institute (NCI)
NCT04965350Phase 3Apr 19, 2021Government of China, Shanghai Zerun Biotechnology Co.,Ltd
NCT04590521Phase 4Dec 31, 2020Murdoch Childrens Research Institute, Murdoch University
NCT04537156Phase 3Sep 5, 2020Beijing Wantai Biological Pharmacy Enterprise Co., Ltd., Government of China, Xiamen University
NCT04301154Phase 1Jun 30, 2020Bambino Gesù Hospital and Research Institute, Case Western Reserve University, Chulalongkorn University, Government of Thailand, Henry M. Jackson Foundation for the Advancement of Military Medicine, Johns Hopkins University, Karolinska Institute, Leidos, PENTA Foundation, United States Army, University of Miami, University of Padova
NCT05426148Phase 4May 1, 2020Beijing Wantai Biological Pharmacy Enterprise Co., Ltd., Government of China
NCT03728881Phase 3Jul 5, 2019National Cancer Institute (NCI)
NCT03747770N/ADec 17, 2018Government of Thailand, International Vaccine Institute
NCT03610581Phase 1/Phase 2 (Phase 2)Sep 24, 2018Bavarian Nordic, Janssen Pharmaceutica NV
NCT03629886Phase 4Aug 22, 2018GlaxoSmithKline
NCT02834637Phase 3Feb 23, 2017Catalan Institute of Oncology, Government of Tanzania, Karolinska Institute, National Cancer Institute (NCI), University of Glasgow, University of London, University of York
NCT03105856Phase 4Jan 3, 2017Government of Mexico
NCT02993757Phase 3Dec 1, 2016Sanofi, Sanofi-Aventis
NCT02979535Phase 3Nov 16, 2016Sanofi, Sanofi-Aventis
NCT02740777Phase 2Feb 1, 2016Government of China, Shanghai Zerun Biotechnology Co.,Ltd
NCT02567955Phase 3Sep 1, 2015Laval University
NCT02082639Phase 3Feb 1, 2015GlaxoSmithKline
NCT02733068Phase 3Nov 1, 2014Government of China, Shanghai Zerun Biotechnology Co.,Ltd
Showing 20 of 85 trials
Page 1 / 5

Organizations

Research & Development (46)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
GlaxoSmithKlineFor profit535241999
Government of ChinaGovernment9142010
Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.For profit4142010
National Cancer Institute (NCI)Government4232008
Shanghai Zerun Biotechnology Co.,LtdFor profit4432012
Xiamen UniversityAcademic/Hospital3332010
Government of MexicoGovernment2212009
Government of ThailandGovernment2022018
Johns Hopkins UniversityAcademic/Hospital2112008
Karolinska InstituteAcademic/Hospital2022017
Laval UniversityAcademic/Hospital2212008
National Institute for Public Health and the Environment, RIVM, HollandGovernment2112009
SanofiFor profit2212016
Sanofi-AventisFor profit2012016
Aarhus UniversityAcademic/Hospital1112011
Adolescent Trials NetworkAcademic/Hospital1012008
Bambino Gesù Hospital and Research InstituteAcademic/Hospital1012020
Bavarian NordicFor profit1012018
Cancer Prevention and Research Institute, ItalyAcademic/Hospital1112010
Case Western Reserve UniversityAcademic/Hospital1012020
46 organizations
Page 1 / 3

Marketing (1)

OrganizationOrg typeRelationshipDate
GlaxoSmithKlineFor profitNDAOct 16, 2009