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Result Summary for 108933

Result Summary

Protocol ID:	108933
Clinical Study ID:	108933
Official Title:	Phase IIIb, Observer-blind Study to Compare Immunogenicity of GSK Biologicals' HPV-16/18 L1/AS04 Vaccine Versus Gardasil® [Quadrivalent Human Papillomavirus (HPV-6,11,16,18 L1 VLP) Recombinant Vaccine Merck & Co., Inc.]
Phase:	phase 3
Study Indications or Diseases:	Infections, Papillomavirus
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:	Katherine A et al. (2012) Adjuvanted human papillomavirus types 16/18 vaccine (Cervarix®): a guide to its use. Adis Drug Eval Drug Prof. 28(3):1-6. Chatterjee A et al. Comparative immunogenicity of two prophylactic human papillomavirus vaccines: results through month 24. Abstract presented at the 26th International Papillomavirus Conference and Clinical Workshop (IPV). Montréal, Canada, 3-8 July 2010. Einstein M et al. Comparative immunology of two prophylactic human papillomavirus cervical cancer vaccines: month 18 schedule. Abstract presented at IDSA. Philadelphia, USA, 29 October-1 November 2009. Einstein M et al. Comparison of immunogenicity of two prophylactic human papillomavirus (HPV) vaccines at month 36. Abstract presented at European Research Organization on Genital Infection and Neoplasia 2011 (EUROGIN). Lisbon, Portugal, 8-11 May 2011. Einstein M et al. Immunogenicity comparison of two prophylactic human papillomavirus (HPV) cervical cancer vaccines at month 24. Abstract presented at European Research Organization on Genital Infection and Neoplasia 2010 (EUROGIN). Monte Carlo, Monaco, 17-20 February 2010. Einstein M et al. Comparison of immunogenicity of two prophylactic Human Papillomavirus (HPV) vaccines at month 48. Abstract presented at the 20th World Congress of Gynecology & Obstetrics (FIGO), Rome, Italy, 7-12 October 2012. 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. Einstein M et al. (2009) Comparison of the immunogenicity and safety of Cervarix™ and Gardasil® human papillomavirus (HPV) cervical cancer vaccines in healthy women aged 18-45 years. Hum Vaccin. 5(10):705-719. Einstein M et al. (2011) Comparative immunogenicity and safety of human papillomavirus (HPV)-16/18 vaccine and HPV-6/11/16/18 vaccine: Follow-up from months 12–24 in a Phase III randomized study of healthy women aged 18–45 years. Hum Vaccin. 7(12):1343-1358. Einstein M et al. Comparative evaluation of immunogenicity of two prophylactic human papillomavirus vaccines. Abstract presented at the 25th International Papillomavirus Conference, Malmö, Sweden, 8-14 May 2009. Dessy F et al. Comparative evaluation of the immunogenicity of two prophylactic HPV cervical cancer vaccines by Merck’s competitive Luminex cLIA) and GSK’s binding ELISA. Abstract presented at European Research Organization on Genital Infection and Neoplasia 2010 (EUROGIN). Monte Carlo, Monaco, 17-20 February 2010. Einstein M et al. Comparative immunogenicity of two prophylactic human papillomavirus cervical cancer vaccines against HPV-31 and -45. Abstract presented at European Research Organization on Genital Infection and Neoplasia 2010 (EUROGIN). Monte Carlo, Monaco, 17-20 February 2010. Moris P et al. CervarixTM (HPV-16/18 AS04 adjuvanted vaccine) induces higher HPV-16/18-specific T Cell repsonses compared to GardasilR (human papillomavirus quadrivalent (types 6,11,16, 18) recombinant vaccine) in healthy women aged 18-45 years. Abstract presented at FIGO 2009 - 19th World Congress of Gynecology & Obstetrics. Cape Town, South Africa, 4-9 October 2009. Einstein MH et al. (2011) Comparison of the immunogenicity of the human papillomavirus (HPV)-16/18 vaccine and the HPV-6/11/16/18 vaccine for oncogenic non-vaccine types HPV-31 and HPV-45 in healthy women aged 18–45 years. Hum Vaccin. 7(12):1359-1373. Coursaget P et al. (2011) Priming as a basis for long-term protection and implications for HPV vaccination. Gynecologic Oncology. 121:S1–S9. Einstein M et al. Comparative immunogenicity of two prophylactic human papillomavirus cervical cancer vaccines: follow-up at month 18. Abstract presented at European Research Organization on Genital Infection and Neoplasia 2010 (EUROGIN). Monte Carlo, Monaco, 17-20 February 2010.