CERVARIX(R) Shown to Provide Longest Duration of Sustained Neutralizing Antibodi...(o date. Thehigh and sustained neutralizi...),Health

Date:5/14/2008

o date. The high and sustained neutralizing antibody levels we observe over this same period give us confidence that the vaccine will continue to protect for even longer. This is why we are extending the study follow-up in a sub-set of women for up to 9.5 years, the longest follow-up period for any cervical cancer vaccine."

This trial included more than 700 women aged 15-25 years. During the same period that the candidate vaccine induced sustained high antibody levels for both virus types 16 and 18, the vaccine had been shown to provide 100 percent efficacy against those cancer-causing virus types.

These data were presented today at the European Society for Paediatric Infectious Diseases (ESPID) annual meeting in Graz, Austria.

Notes to the editors:

-- Safety data from 11 trials involving almost 30,000 women ages 10-72

years who received either the candidate vaccine or a control were also

presented at ESPID. During the course of vaccination and after the

completion of the three-dose schedule no differences were observed

between the candidate vaccine and control groups in serious adverse

events, medically significant conditions and new onset of autoimmune

diseases.

-- Compliance with the three-dose schedule was excellent in the 11 trials

of the integrated safety summary.

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 candidate vaccine, 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 6.4 years post-vaccination. The trial
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SOURCE GlaxoSmithKline Copyright©2008 PR Newswire. All rights reserved

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