Drugs / Cervarix
Cervarix
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Cervarix | — | 2007-09-20 | europa.eu ↗ |
Trials 42
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT04301154 | Feb 2022 → Oct 2023 | HIV infectious disease | Henry M. Jackson Foundation for the Advancement of Military Medicine | Completed | No outcome recorded |
| Phase 1 | NCT02234921 | Oct 2014 → Aug 2018 | prostate adenocarcinoma | UbiVac | Completed | No outcome recorded |
| Phase 1 | NCT00541970 | Oct 2007 → Mar 2013 | human papilloma virus infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 26 trials · 1 met primary | ||||||
| Phase 2 | NCT00586339 | Jan 2008 → Jul 2011 | human papilloma virus infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT00546078 | Jan → Dec 2008 | human papilloma virus infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT00518336 | Nov 2007 → Jul 2008 | human papilloma virus infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT00316693 | Apr 2006 → Feb 2009 | human papilloma virus infection | GlaxoSmithKline | Completed | Met primary |
| Phase 2 | NCT00309166 | Apr 2006 → Jun 2007 | human papilloma virus infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT00689741 | Jan 2001 → Apr 2003 | human papilloma virus infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 325 trials · 4 met primary | ||||||
| Phase 3 | NCT03728881 | Apr 2019 → Sep 2022 | cervical carcinoma | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 3 | NCT02567955 | Sep 2015 → Sep 2016 | — | Laval University | Completed | No outcome recorded |
| Phase 3 | NCT02082639 | Feb → Aug 2015 | human papilloma virus infection | GlaxoSmithKline | Withdrawn | No outcome recorded |
| Phase 3 | NCT01755689 | Jan 2013 → Apr 2014 | meningococcal infection | GlaxoSmithKline | Completed | Mixed |
| Phase 3 | NCT01627561 | Oct 2012 → Apr 2014 | human papilloma virus infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT01462357 | Nov 2011 → Oct 2015 | human papilloma virus infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00811798 | May 2009 → Sep 2010 | human papilloma virus infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00779766 | Oct 2008 → Sep 2011 | human papilloma virus infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT01456715 | Sep 2008 → Dec 2018 | human papilloma virus infection | Laval University | Completed | No outcome recorded |
| Phase 3 | NCT00652938 | Apr 2008 → Aug 2009 | human papilloma virus infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00637195 | Mar → Jun 2008 | human papilloma virus infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00578227 | Dec 2007 → Dec 2008 | human papilloma virus infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00492544 | Jul 2007 → Mar 2008 | human papilloma virus infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00456807 | Apr 2007 → Jan 2008 | human papilloma virus infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00426361 | Feb 2007 → Mar 2008 | human papilloma virus infection | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT00423046 | Jan 2007 → Mar 2008 | human papilloma virus infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00369824 | Sep 2006 → Nov 2007 | human papilloma virus infection | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT00344032 | Jul 2006 → Dec 2007 | human papilloma virus infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00337818 | Jun 2006 | cervical intraepithelial neoplasia, human papilloma virus infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00294047 | Feb 2006 → Jan 2014 | human papilloma virus infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00250276 | Oct 2005 → Mar 2007 | human papilloma virus infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00316706 | Oct 2005 → Jan 2009 | cervical intraepithelial neoplasia, human papilloma virus infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00196937 | Oct 2004 → Dec 2005 | human papilloma virus infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00128661 | Jun 2004 → Dec 2010 | cervical cancer, precancerous condition | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT00122681 | May 2004 → Nov 2006 | human papilloma virus infection | GlaxoSmithKline | Completed | Met primary |
| Phase 48 trials · 2 met primary | ||||||
| Phase 4 | NCT03675256 | Dec 2018 → Feb 2024 | human papilloma virus infection | Massachusetts General Hospital | Unknown | Met primary |
| Phase 4 | NCT03180034 | Nov 2017 → Aug 2025 overdue | cervical carcinoma, human papilloma virus infection | National Cancer Institute (NCI) | Active not recruiting | Met primary |
| Phase 4 | NCT02837926 | May 2016 → Dec 2017 | cervical cancer | Reims University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT01386164 | Aug 2011 → Dec 2012 | HIV infectious disease, human papilloma virus infection | University of Aarhus | Completed | No outcome recorded |
| Phase 4 | NCT01082861 | Sep 2010 → Apr 2011 | human papilloma virus infection | National Institute for Public Health and the Environment (RIVM) | Terminated | No outcome recorded Stop: Business |
| Phase 4 | NCT02296255 | Apr 2010 → May 2011 | cervical cancer | Cancer Prevention and Research Institute, Italy | Completed | No outcome recorded |
| Phase 4 | NCT00730847 | Sep 2008 → Jan 2012 | human papilloma virus infection | GlaxoSmithKline | Terminated | No outcome recorded |
| Phase 4 | NCT00534638 | Oct 2007 → Dec 2014 | human papilloma virus infection | GlaxoSmithKline | Completed | Mixed |
| Comparator or background therapy9 trials | ||||||
| Phase 1 | NCT00478621 Comparator | May 2007 → Jun 2008 | human papilloma virus infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT02834637 Comparator | Feb 2017 → Jan 2020 overdue | human papilloma virus infection | London School of Hygiene and Tropical Medicine | Active not recruiting | No outcome recorded |
| Phase 3 | NCT01190176 Background | Sep 2011 → Sep 2017 | human papilloma virus infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00552279 Comparator | Nov 2007 → Feb 2009 | human papilloma virus infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00481767 Comparator | Oct 2007 → Feb 2010 | human papilloma virus infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 4 | NCT03105856 Comparator | Jan 2017 → Dec 2018 | cervical carcinoma, cervical intraepithelial neoplasia | National Institute of Public Health, Mexico | Completed | No outcome recorded |
| Phase 4 | NCT01914367 Comparator | Jun 2013 → Sep 2015 | human papilloma virus infection | University Hospital, Ghent | Completed | No outcome recorded |
| Phase 4 | NCT00956553 Comparator | Sep 2009 → Sep 2012 | human papilloma virus infection | Public Health England | Completed | No outcome recorded |
| — | NCT03747770 Comparator | Dec 2018 → Dec 2022 | — | International Vaccine Institute | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 13
| Date | Issuer | Release |
|---|---|---|
| 2022-05-27 | GlaxoSmithKline | Regulatory China approves Cervarix two-dose vaccine schedule for girls aged 9 to 14 against certain types of cancer-causing human papillomavirus gsk.com ↗
GSK plc (LSE/NYSE: GSK) announced today that a two-dose schedule for its HPV vaccine Cervarix [Human Papillomavirus bivalent (types 16, 18) Vaccine, Recombinant)] has been approved by China’s NMPA for girls aged 9 to 14. |
| 2013-12-20 | GlaxoSmithKline | Regulatory GSK Cervarix® two-dose schedule receives European marketing authorisation gsk.com ↗
GlaxoSmithKline (GSK) announced today that the European Commission has granted marketing authorisation for its cervical cancer vaccine Cervarix® [Human papillomavirus bivalent (types 16 and 18) vaccine, recombinant] as a two-dose schedule for girls aged 9 to 14. |
| 2013-11-28 | GlaxoSmithKline | Regulatory Regulatory Update - GSK receives positive CHMP opinion for Cervarix™ two-dose schedule gsk.com ↗
Today, GlaxoSmithKline plc (GSK) announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) is recommending marketing authorisation for a two-dose schedule in 9-14 year old girls for its cervical cancer vaccine, Cervarix™ [Human papillomavirus bivalent (types 16 and 18) vaccine, recombinant]. |
| 2013-11-04 | GlaxoSmithKline | Results GSK announces data to support Cervarix® two-dose schedule for the prevention of cervical cancer in 9-14 year old girls gsk.com ↗
These findings consistently suggest that the immune response of the two-dose schedule in girls aged 9 to 14 years with Cervarix is in line with the three-dose schedule. |
| 2013-08-07 | GlaxoSmithKline | Regulatory Regulatory update – GSK announces EU submission for Cervarix® two dose schedule gsk.com ↗ |
| 2011-11-09 | GlaxoSmithKline | Results Data published in The Lancet Oncology support high efficacy previously demonstrated by Cervarix® (HPV 16 and 18 vaccine) against precancerous cervical lesions gsk.com ↗
Results from the largest efficacy trial of a cervical cancer vaccine to date (PATRICIA), show that Cervarix provided 93%† efficacy against CIN3+ irrespective of the HPV type associated with the CIN3+ lesion. |
| 2009-10-15 | GlaxoSmithKline | Regulatory GSK’s Cervarix® becomes the first cervical cancer vaccine to gain approval in Japan gsk.com ↗
GlaxoSmithKline (GSK) today gained approval for Cervarix® in Japan, which becomes the first cervical cancer vaccine to be approved by the Japanese Ministry of Health, Labour and Welfare (MHLW). |
| 2009-10-15 | GlaxoSmithKline | Regulatory FDA approves Cervarix, GlaxoSmithKline’s cervical cancer vaccine gsk.com ↗ |
| 2009-09-29 | GlaxoSmithKline | Regulatory GlaxoSmithKline update on FDA review of Cervarix gsk.com ↗
GlaxoSmithKline (NYSE: GSK) announced today the U.S. Food and Drug Administration (FDA) has not yet completed the review of the Biologics License Application (BLA) for CERVARIX® [Human papillomavirus bivalent (types 16 and 18) vaccine, recombinant], the Company’s candidate cervical cancer vaccine. |
| 2009-09-08 | GlaxoSmithKline | Regulatory FDA Advisory Committee makes favorable recommendation for Cervarix, GlaxoSmithKline’s candidate cervical cancer vaccine gsk.com ↗
The Committee’s favorable recommendation, although not binding, will be considered by the FDA in its final review of the Biologics License Application (BLA) for the candidate vaccine. |
| 2009-07-08 | GlaxoSmithKline | Regulatory WHO grants prequalification to Cervarix®: GSK’s vaccine to help combat cervical cancer in developing nations gsk.com ↗
The World Health Organization (WHO) has awarded prequalification to Cervarix®, GlaxoSmithKline’s cervical cancer vaccine. |
| 2009-07-06 | GlaxoSmithKline | Results Landmark study for GSK’s cervical cancer vaccine published in The Lancet gsk.com ↗
The final analysis of the largest efficacy trial of a cervical cancer vaccine is published today in The Lancet. |
| 2009-03-29 | GlaxoSmithKline | Regulatory Cervarix® U.S. regulatory update gsk.com ↗
GSK has submitted final data from its Phase III pivotal efficacy study, HPV-008, to the FDA. |
All press releases naming this drug 13 releases
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 54 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Cervarix | “Participants were randomly assigned (1:1) to receive an HPV vaccine (Cervarix, GlaxoSmithKline, Rixensart, Belgium) or a control hepatitis A vaccine (modified preparation of...” PMID 21865087 ↗ Aug 201151“This phase IIIb trial compares a single dose of the Cervarix vaccine in girls to 3 doses of the Gardasil vaccine in young women for the prevention of human papillomavirus (HPV)...” NCT03728881 ↗ “Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.” NCT00779766 ↗ “Patients will receive a dose of 0.5-mL CERVARIX at week 1 (Day 4) and week 7 by intramuscular injection at a site distant from the DRibble vaccine.” NCT02234921 ↗ “930 HIV-negative Tanzanian schoolgirls aged 9-14 years were randomised to receive one, two or three doses of Cervarix® or Gardasil®9 (155 per arm)” PMID 42378813 ↗ Jun 2026 “Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.” NCT00369824 ↗ “the 2-valent vaccine (Cervarix, GSK Biologicals, Rixensart, Belgium)” PMID 36113532 ↗ Oct 2022 “Participants receive Cervarix IM at month 0 and Tdap IM at month 6.” NCT03180034 ↗ |
| Known as | 580299 | “Safety and Immunogenicity of GlaxoSmithKline Biologicals' HPV Vaccine 580299 (Cervarix) in HIV Infected Females” NCT00586339 ↗2“the 580299 HPV vaccine (CervarixTM) in a Brazilian cohort of women vaccinated” NCT00518336 ↗ “GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM)” NCT00423046 ↗ |
| Known as | AS04-HPV16/18 | “We assessed co-administration of quadrivalent meningococcal serogroups A, C, W and Y tetanus toxoid-conjugate vaccine (MenACWY-TT), human papillomavirus 16/18 AS04-adjuvanted...” PMID 29789243 ↗ May 2018 |
| Known as | Bivalent HPV vaccine | “Bivalent HPV vaccine CERVARIX®” NCT03747770 ↗ |
| Known as | Cervarix TM | “GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM)” NCT00423046 ↗2“HPV-16/18 VLP/AS04 Vaccine (Cervarix TM)” NCT00344032 ↗ “HPV Vaccine (GSK580299) Cervarix TM” NCT00652938 ↗ |
| Known as | GSK Biologicals HPV-16/18 vaccine | “GSK Biologicals HPV-16/18 vaccine (Cervarix TM )” NCT00316693 ↗ |
| Known as | GSK Biologicals' HPV Vaccine GSK580299 | “GSK Biologicals' HPV Vaccine GSK580299” NCT00546078 ↗ |
| Known as | GSK580299 | “Evaluation of the Effectiveness of Two Vaccination Strategies Using GlaxoSmithKline Biologicals' HPV Vaccine GSK580299 (Cervarix) Administered in Healthy Adolescents” NCT00534638 ↗2“GSK Biologicals' Human Papillomavirus (HPV) Vaccine (Cervarix™) (GSK-580299)” NCT02082639 ↗ “HPV Vaccine (GSK580299) Cervarix TM” NCT00652938 ↗ |
| Known as | HPV-16/18 vaccine | “HPV-16/18 vaccine (Cervarix™)” NCT00316693 ↗ |
| Modality | Vaccine | “the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine (Cervarix(®), GlaxoSmithKline Biologicals)” PMID 21858807 ↗ Oct 2011 |
| Route | Intramuscular | “Intramuscular injection, 3 doses” NCT00122681 ↗ |