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Result Summary for 109616 (Y7)

Result Summary

Protocol ID:	109616 (Y7)
Clinical Study ID:	109616
Official Title:	Follow-up study to evaluate the long-term efficacy of a HPV vaccine (580299) in healthy young adult women in Brazil
Phase:	phase 2
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:	Roteli-Martins C et al. Sustained immunogenicity and efficacy of the HPV-16/18 AS04-adjuvanted vaccine: Follow-up to 8.4 years. Abstract presented at the 28th Annual Meeting of the European Society for Pediatric Infectious Diseases (ESPID). Nice, France, 4-8 May 2010. De Carvalho N et al. Sustained immunogenicity and efficacy of the HPV-16/18 AS04-adjuvanted vaccine up to 7.3 years. Abstract presented at the 4th Biennial Meeting of Asia Oceania Research Organisation in Genital Infections and Neoplasia (AOGIN). New Delhi, India, 26-28 March 2010. Carvalho De N et al. (2010) Sustained efficacy and immunogenicity of the HPV-16/18 AS04-adjuvanted vaccine up to 7.3 years in young adult women. Vaccine. 28(38):6247-6255. Romanowski B et al. Immunogenicity/efficacy over 9.4 years and immunogenicity after 2 doses. Abstract presented at the Public Health Association of Australia (PHAA), Darwin, Australia. 19-21 June 2012. De Carvalho N et al. Sustained immunogenicity and efficacy of the HPV-16/18 AS04-adjuvanted vaccine (CervarixTM): follow-up to 7.3 years. Abstract presented at the 16th International Meeting of European Society of Gynaecological Oncology (ESGO). Belgrade, Serbia, 11-14 October 2009. De Carvalho N et al. Sustained immunogenicity and efficacy of the HPV-16/18 AS04-adjuvanted vaccine up to 7.3 years. Abstract presented at 58th Annual Clinical Meeting of American College of Obstetricians and Gynecologists (ACOG). San Fransisco, USA, 15-19 May 2010. Naud P et al. Sustained immunogenicity and efficacy of the HPV-16/18 vaccine in women aged 15-25 years: follow-up to 9.4 years. Abstract presented at the 27th International Papillomavirus Conference and Clinical Workshop (IPCCW). Berlin, Germany, 17-21 September 2011. De Carvalho N et al. Immunogenicity and safety of HPV-16/18 AS04-adjuvanted vaccine up to 7.3y – Abstract presented at the 25th International Papillomavirus Conference (IPC) and Clinical Workshop. Malmö, Sweden, 8-14 May 2009. De Carvalho N et al. Sustained levels of total and neutralising antibodies and favourable long term safety with the HPC-16/18 AS04-adjuvanted vaccine (CervarixTM): follow-up to 7.3 years. Abstract presented at FIGO 2009 - 19th World Congress of Gynecology & Obstetrics. Cape Town, South Africa, 4-9 October 2009.