Home > Result Summaries: Compounds > Human Papillomavirus Types 16 and 18 Vaccine > Result Summary for 580299/001

Result Summary for 580299/001

Result Summary

Protocol ID:	580299/001
Clinical Study ID:	580299/001
Official Title:	A double-blind, placebo-controlled, randomised study of the efficacy of an HPV-16/18 VLP vaccine in the prevention of HPV-16 and/or HPV-18 cervical infection in healthy adolescent and young adult women in North America and Brazil.
Phase:	Phase 2
Study Indications or Diseases:	Papillomavirus Vaccines
Generic Name:	Human Papillomavirus Types 16 and 18 Vaccine
Trade/Product Name:	Cervarix
Approved Drug Label:	http://www.gsk.com/products.html
Results Summary:	Click here to download result summary.
Citations:	Rombo L et al. Tolerability of HPV-16/18 AS04-adjuvanted cervical cancer vaccine. Abstract presented at the European Research Organization on Genital Infection and Neoplasia (EUROGIN) International Multidisciplinary Conference. Nice, France, 12-15 November 2008. Descamps D et al. (2009) Safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine for cervical cancer prevention: A pooled analysis of 11 clinical trials. Hum Vaccin. 5(5):51-59. David M-P et al. Modeling of long-term persistence of anti-HPV-16 and anti-HPV-18 antibodies induced by an AS04-adjuvanted cervical cancer vaccine. Abstract presented at the European Research Organization on Genital Infection and Neoplasia (EUROGIN) International Multidisciplinary Conference. Nice, France, 12-15 November 2008. Verstraeten T et al. (2008) Analysis of adverse events of potential autoimmune aetiology in a large integrated safety database of AS04 adjuvanted vaccines. Vaccine. 26(51):6630–6638. Descamps D et al. Safety of human papillomavirus (HPV)-16/18 AS04 adjuvanted vaccine for cervical cancer prevention: integrated summary of 11 clinical trials. Abstract presented at the 26th Annual Meeting of the ESPID. Graz, Austria, 13-17 May 2008. David MP et al (2009) Long-term persistence of anti-HPV-16 and -18 antibodies induced by vaccination with the AS04-adjuvanted cervical cancer vaccine: Modeling of sustained antibody responses. Gynecol Oncol. doi:10.1016/j.ygyno.2009.01.011 Harper DM et al. (2004) Efficacy of a bivalent L1 virus-like particle vaccine in prevention of infection with human papillomavirus types 16 and 18 in young women: a randomised controlled trial. Lancet. 364(9447): 1757-1765. David MP et al. Long-term persistence of detectable anti-HPV-16 and anti-HPV-18 antibodies induced by CervarixTM: modelling of sustained antibody responses. Abstract presented at the 26th Annual Meeting of the ESPID. Graz, Austria, 13-17 May 2008.