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Result Summary for 580299/012

Result Summary

Protocol ID:	580299/012
Clinical Study ID:	580299/012
Official Title:	Immunogenicity: 3 consecutive lots of GSK Bios’ HPV-16/18 vaccine admnd intramuscularly at 0,1,6 mth schedule in healthy females aged 10–25 y & demonstrate non-inferiority of candidate HPV vaccine manufactured by modified production process
Phase:	phase 3
Study Indications or Diseases:	Human Papillomavirus (HPV)
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:	Petaja T et al. (2011) Long-term persistence of systemic and mucosal immune response to HPV-16/18 AS04-adjuvanted vaccine in preteen/ adolescent girls and young women. Int J Cancer. 129(9):2147-2157. 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. 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. Petaja T et al. Long-term persistence of immune response to HPV-16/18 ASO4-adjuvanted cervical cancer vaccine in preteen/adolescent girls and young women. Abstract presented at European Research Organization on Genital Infection and Neoplasia 2010 (EUROGIN). Monte Carlo, Monaco, 17-20 February 2010. Pedersen C. et al. Long-term persistence of immune response to an AS04 adjuvanted cervical cancer vaccine in preteen/adolescent girls. Abstract presented at the 26th Annual Meeting of the ESPID. Graz, Austria, 13-17 May 2008. Pedersen C et al. (2007) Immunization of early adolescent females with human papillomavirus type 16 and 18 L1 virus-like particle vaccine containing AS04 adjuvant. J Adolesc Health. 40(6):564-571. 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.