( y which was maintained over 5.5 years ...)Cervarix, GSK Cervical Cancer Candidate Vaccine, Demonstrates 100,Percent Protection Against Precancerous Lesions Caused By,Cancer-Causing Human Papillomavirus Types 16 & 18 for More Than,Five Years,Health

y, which was maintained over 5.5 years for both virus types 16 and 18. At the end of the 5.5 year observation period, the average level of antibodies against both virus types 16 and 18 was at least 11 times greater than antibody levels associated with natural infection with the virus.

"The results of this study confirm our confidence in our cervical cancer candidate vaccine, which includes a novel proprietary adjuvant system, called AS04, intended to enhance immune response and increase duration of protection," said Dr. Hugues Bogaerts, Vice President of Worldwide Medical Affairs, Human Papillomavirus Vaccines, GSK. "We believe that the best possible prevention of cervical cancer will include routine screening together with a vaccine designed to provide broad and durable protection against the most common cancer-causing virus types."

Notes to editors

About the study

This was an extended follow-up (EFU) analysis of women who participated in the initial efficacy study of GSK's cervical cancer candidate vaccine. The initial study was a double-blind, controlled trial of 1,113 young women between 15-25 years of age, randomized to receive three doses of the GSK candidate vaccine for cervical cancer formulated with the AS04 adjuvant system, or three doses of placebo on a 0, 1 and 6 month schedule.

This extended follow-up study looked at study endpoints for 776 women from the same cohort of women for a period of up to 67 months. The trial was conducted in 28 centers in Brazil, Canada and the U.S. and evaluated the efficacy, safety and immunogenicity of GSK's cervical cancer candidate vaccine for the prevention of infection with cancer causing virus types 16 and/or 18, and other cancer-causing virus types, as well as associated Pap smear abnormalities and cervical precancerous lesions. In the extended follow up study, women were evaluated for the presence of human papillomavirus DNA by PCR using cervical samples and annual cervical cytology
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