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PHILADELPHIA (AFX) - GlaxoSmithKline said it started a head-to-head study comparing the immunogenicity of its cervical cancer candidate vaccine, CERVARIX, against Sanofi-Aventis' and Merck & Co Inc's Gardasil, claiming this is the first study of its kind.
The primary objective of the head-to-head trial is to compare the immune responses to human papillomavirus (HPV) types 16 and 18 in US women 18 to 26-years-old. Secondary objectives include evaluating the immune responses to HPV 16 and 18 in women 27 to 35-years-old and 36 to 45-years-old. In addition, the study will compare immune responses to other cancer-causing HPV types.
Initial study results are anticipated 12 months after study enrolment is completed, and extended follow up will continue for another 17 months.
This is a Phase III, randomized, observer-blind, multicenter study, to be conducted among 1,042 patients in the US. There will be two arms of the study, one arm receiving GSK's cervical cancer candidate vaccine, one arm receiving Gardasil. newsdesk@afxnews.com lam/lam COPYRIGHT Copyright AFX News Limited 2006. All rights reserved. The copying, republication or redistribution of AFX News Content, including by framing or similar means, is expressly prohibited without the prior written consent of AFX News. AFX News and AFX Financial News Logo are registered trademarks of AFX News Limited
Copyright 2007 AFX News Limited. All Rights Reserved.
