drugset
Drugs / GSK580299
last change May 2022 re-read 3 minutes ago

GSK580299

also known as Cervarix · Cervarix TM

Vaccine

Developed for
human papilloma virus infection
Investigated by
GlaxoSmithKline

Trials 6

today NCT01190189 · Ph 3 NCT01277042 · Ph 3 NCT01249365 · Ph 3 NCT00849381 · Ph 3 NCT00799825 · Ph 3 NCT00549900 · Ph 1
20082009201020112012201320142015201620172018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT00549900 Dec 2007 → Jul 2008 human papilloma virus infection GlaxoSmithKline Completed No outcome recorded
Phase 35 trials · 1 met primary
Phase 3 NCT01190189 Apr 2011 → Nov 2017 human papilloma virus infection GlaxoSmithKline Completed No outcome recorded
Phase 3 NCT01277042 Feb → Sep 2011 human papilloma virus infection GlaxoSmithKline Completed Met primary
Phase 3 NCT01249365 Jan 2011 → Jan 2017 human papilloma virus infection GlaxoSmithKline Completed No outcome recorded
Phase 3 NCT00849381 Apr 2009 → Dec 2012 human papilloma virus infection GlaxoSmithKline Completed No outcome recorded
Phase 3 NCT00799825 Jan 2009 → Aug 2012 human papilloma virus infection GlaxoSmithKline Completed No outcome recorded

Press releases naming this drug 12 releases

DateIssuerRelease
2022-05-27 GlaxoSmithKline China approves Cervarix two-dose vaccine schedule for girls aged 9 to 14 against certain types of cancer-causing human papillomavirus gsk.com ↗
2013-12-20 GlaxoSmithKline GSK Cervarix® two-dose schedule receives European marketing authorisation gsk.com ↗
2013-11-28 GlaxoSmithKline Regulatory Update - GSK receives positive CHMP opinion for Cervarix™ two-dose schedule gsk.com ↗
2013-11-04 GlaxoSmithKline GSK announces data to support Cervarix® two-dose schedule for the prevention of cervical cancer in 9-14 year old girls gsk.com ↗
2013-08-07 GlaxoSmithKline Regulatory update – GSK announces EU submission for Cervarix® two dose schedule gsk.com ↗
2011-11-09 GlaxoSmithKline Data published in The Lancet Oncology support high efficacy previously demonstrated by Cervarix® (HPV 16 and 18 vaccine) against precancerous cervical lesions gsk.com ↗
2009-10-15 GlaxoSmithKline GSK’s Cervarix® becomes the first cervical cancer vaccine to gain approval in Japan gsk.com ↗
2009-10-15 GlaxoSmithKline FDA approves Cervarix, GlaxoSmithKline’s cervical cancer vaccine gsk.com ↗
2009-09-29 GlaxoSmithKline GlaxoSmithKline update on FDA review of Cervarix gsk.com ↗
2009-09-08 GlaxoSmithKline FDA Advisory Committee makes favorable recommendation for Cervarix, GlaxoSmithKline’s candidate cervical cancer vaccine gsk.com ↗
2009-07-08 GlaxoSmithKline WHO grants prequalification to Cervarix®: GSK’s vaccine to help combat cervical cancer in developing nations gsk.com ↗
2009-03-29 GlaxoSmithKline Cervarix® U.S. regulatory update gsk.com ↗

Evidence & citations 5 cited values

Every value below carries the sentence it was read from. 6 sources stand behind the page.

FieldValueCited text
Known as GSK 580299 “HPV -16/18 L1 VLP AS04 vaccine (GSK 580299, Cervarix TM)” NCT00549900 ↗
7

“Human Papillomavirus Vaccine (GSK-580299)” NCT01190189 ↗

NCT01190189 ↗

NCT01277042 ↗

NCT01249365 ↗

NCT00849381 ↗

NCT00799825 ↗

NCT00549900 ↗
Known as Cervarix “GSK580299 (Cervarix™ , HPV -16/18 L1 VLP AS04 vaccine)” NCT00549900 ↗
3

“GSK580299 (CervarixTM)” NCT01277042 ↗

“GSK580299 (Cervarix)” NCT01190189 ↗

“GSK580299 (Cervarix)” NCT01249365 ↗
Known as Cervarix TM “HPV -16/18 L1 VLP AS04 vaccine (GSK 580299, Cervarix TM)” NCT00549900 ↗
1

“GSK580299 (CervarixTM)” NCT01277042 ↗
Modality Vaccine “HPV -16/18 L1 VLP AS04 vaccine” NCT00549900 ↗
Route Intramuscular “administered intramuscularly” NCT00549900 ↗