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Result Summary for 104820

Result Summary

Protocol ID:	104820
Clinical Study ID:	104820
Official Title:	A study to evaluate safety, immunogenicity and efficacy of GSK Biologicals HPV-16/18 L1/AS04 vaccine administered intramuscularly according to a three-dose schedule (0, 1, 6 month) in healthy adult female subjects aged 26 years and above
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:	Skinner R et al. Baseline characteristics of women over 25 years old in Asia-Pacific region in the phase III Viviane trial of the AS04-adjuvanted HPV-16/18 vaccine. Abstract presented at the Asia-Oceania Research Organization in Genital Infection and Neoplasia (AOGIN), Hong Kong, 13-15 July 2012. Skinner R et al. HPV-16/18 AS04-Adjuvanted vaccine efficacy in ≥26-year-old women after 4-year follow-up. Abstract presented in the 27th International Papillomavirus Conference and Clinical Workshop (IPV). Berlin, Germany, 17-22 September 2011. 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. (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. Skinner R et al. Effect of HPV type on risk of progression from HPV infection to CIN1+ and CIN2+ in women aged 26 years and over. Abstract presented at the 28th International Papillomavirus Conference and Clinical Workshop (IPC & CW), San Juan, Puerto Rico, 30 Nov - 06 Dec 2012. 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 SUBMITTED to the EUROGIN 2008 Joining Forces for Cervical Cancer Prevention Conference, Nice, France, 12-15 November 2008.