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Result Summary for 103514

Result Summary

Protocol ID:	103514
Clinical Study ID:	103514
Official Title:	Phase 3, open, age-stratified study to assess immunogenicity & safety of GSK Biologicals' HPV-16/18 vaccine administered intramuscularly according to 3-dose schedule (0,1,6 months) in healthy female subjects aged 15 - 55 years and long term follow-up
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:	Schwarz TF et al. Human papillomavirus (HPV) 16/18 l1 AS04 virus-like particle (VLP) cervical cancer vaccine is immunogenic and well-tolerated 18 months after vaccination in women up to age 55 years. Journal of Clinical Oncology, 2007 ASCO Annual Meeting Proceedings Part I. Vol 25, No. 18S (June 20 Supplement), 2007: 3007. 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. Schwarz TF et al. Long-term persistence of immune response to HPV-16/18 AS04-adjuvanted cervical cancer vaccine in women aged 15-55 years. Abstract presented at the 4th Biennial Meeting of the Asia Oceania research on Genital Infection and Neoplasia (AOGIN). New Delhi, India, 26-28 March 2010. Schwarz TF et al. An AS04-containing human papillomavirus (HPV) 16/18 vaccine for prevention of cervical cancer is immunogenic and well-tolerated in women 15-55 years old. Journal of Clinical Oncology, 2006 ASCO Annual Meeting Proceedings Part I. Vol 24, No. 18S (June 20 Supplement), 2006: 1008. Schwarz TF et al. (2011) Persistence of immune response to HPV-16/18 AS04-adjuvanted cervical cancer vaccine in women aged 15–55 years. Hum Vaccin. 7(9):958-965. Garçon N et al. Vaccines Adjuvanted with Adjuvant Systems – from Concept to Clinical Evidence. Abstract presented at the 13th International Congress on Infectious Diseases (ICID), Kuala Lumpur, Malaysia, 19-22 June 2008. Schwarz TF et al. (2009) Immunogenicity and tolerability of an HPV-16/18 AS04-adjuvanted prophylactic cervical cancer vaccine in women aged 15–55 years. Vaccine. 27(4):581-587. Schwarz TF et al. Immune response in women up to 55 years of age vaccinated with Cervarix, the HPV-16/18 L1 VLP AS04 vaccine candidate. Abstract presented at EUROGIN 2007. Monte Carlo, Monaco, 4-6 October 2007. 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. Poncelet S et al. Induction of cervical mucosal HPV IGG in women 15-55 years old following systemic vaccination with GSK cervical cancer candidate vaccine. Abstract presented at the 25th annual meeting of the European Society of Paediatric Infectious Diseases. Porto, Portugal, 2-4 May 2007. 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.