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Largest Cervical Cancer Vaccine Efficacy Trial Shows Cervarix,Provides Excellent Protection Against Lesions Caused by Most Common,Cancer-Causing Virus Types

and 18. This strong immune response has been shown to persist for up to 5.5 years in previous studies.

As in previous studies conducted over the past five years and involving over 40,000 women, the candidate vaccine has been shown to be generally well-tolerated.

Notes to Editors

About the Study

These data are interim results from an ongoing Phase III randomized, controlled trial of 18,644 women aged between 15 to 25 years of age from across four continents - Asia-Pacific, Europe, Latin America and North America, in a total of 14 countries.

This interim analysis shows results over an average follow-up time of 15 months after first vaccination, in which a proportion of the women enrolled already had a human papillomavirus infection or abnormal cytology (abnormal Pap smears) at study entry.

The primary objective of the interim analysis was to evaluate the vaccine efficacy against precancerous lesions associated with cancer-causing virus types 16 and 18 among women who were DNA-negative and seronegative for the corresponding vaccine type at study entry. Secondary objectives included efficacy against 6- and 12-month persistent infection with virus types 16, 18 or other cancer-causing virus types, immunogenicity and safety.

About the GSK Cervical Cancer Vaccine

In May, CERVARIX was granted its first license in a major market by the Therapeutic Goods Administration (TGA) of Australia for the prevention of cervical cancer and precancerous lesions caused by human papillomavirus types 16 and 18 for use in females ages 10 to 45 years. This is the first time that a cervical cancer vaccine has been explicitly indicated anywhere in the world for women over the age of 26.

GSK submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for its cervical cancer candidate vaccine in March 2007, following earlier regulatory filings with the European Medicines Agency (EMEA) and regulatory
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