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Gardasil Demonstrates Up to 100% Efficacy

rved in the placebo group compared to the one case of CIN3 observed in the vaccine group. ,c)

The one case of CIN3 in the vaccine group of FUTURE II involved a woman who had an infection with Human Papillomavirus type 52 at baseline and at five follow-up visits. Type16 was detected in only one of these visits suggesting that this case could have been type 52-related. To be conservative, this case was nevertheless included in the group that received the vaccine.

CIN2/3 is the obligate precursor of cervical cancer and the clinically most relevant endpoint for the US Food and Drug Administration (FDA) and the World Health Organization (WHO) to demonstrate efficacy in the prevention of cervical cancer.

In both studies, Gardasil® was generally well tolerated. The adverse events observed were similar to what has been previously reported.

Notes to editors

High efficacy has already led to vaccination of women in the placebo groups
In light of the high efficacy shown by Gardasil® at licensure, the Data and Safety Monitoring Board of FUTURE I and II had recommended that women in the placebo group should be vaccinated with Gardasil®. The board recommended that the studies should be terminated as soon as feasible in order to provide the benefits of vaccination with Gardasil® to these women rapidly. In Europe, vaccination of women in the placebo groups of FUTURE I and II has already begun in the United Kingdom, Germany, Sweden, Norway, Denmark, Finland and Austria. In other countries, vaccination will start soon with the objective to complete vaccination before the end of the year 2007. In a similar way, vaccination of women in many other countries around the world, including the US, Australia and Canada, has begun or is anticipated to begin soon.

Protection against additional virus types through cross protection
In large phase III clinical stu
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