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GSK Cervical Cancer Candidate Vaccine CERVARIX (R) Demonstrates Long-Term Protection for More Than Six Years
Date:3/10/2008

showed 78 percent efficacy in preventing incident infection caused by virus type 45, and 60 percent efficacy in preventing incident infection caused by virus type 31.

Virus types 18 and 45 are responsible for a significant percentage of a particularly aggressive and deadly form of cervical cancer known as adenocarcinoma. This type of cervical cancer tends to occur in younger women and is not well detected by routine screening methods.

"We specifically designed our cervical cancer vaccine with the goal of providing long-lasting protection from cervical cancer," said James Tursi, MD, Director of Medical Affairs, North America, GlaxoSmithKline. "These study results are important because women remain at risk for infection with cancer- causing virus types throughout their lives, and long-term protection will be an essential component of a successful vaccination strategy."

The results also include safety data from nearly six and a half years, showing that the candidate vaccine had no meaningful differences between the study groups and had a favorable overall safety profile.

These data were presented today at the Society of Gynecologic Oncologists (SGO) annual meeting in Tampa, FL.

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 76 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 can
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SOURCE GlaxoSmithKline
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