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Gardasil Demonstrates Up to 100% Efficacy

Pasteur MSD is the only company in Europe dedicated exclusively to vaccines. Sanofi Pasteur MSD is able to draw on the research expertise of sanofi pasteur and Merck & Co., Inc., together with their teams throughout the world, to focus on the development of new vaccines for Europe, which aim to extend protection to other diseases and perfect existing vaccines in order to improve the acceptability, efficacy and tolerability of vaccination.

Contact
Dr. Arne Näveke
Executive Director, Communication Europe
Sanofi Pasteur MSD
Tel +33 4 37 28 40 40
Fax +33 4 37 28 44 04

Clinical study details
a) 551 16-23 year-old women were enrolled and vaccinated in a randomised, placebo-controlled trial. Subjects received vaccine or placebo at Day 1, Months 2, and 6. At regular intervals through 3 years, subjects underwent serum anti-HPV testing. A subset (241 subjects) underwent 2 additional years of follow up. Subjects who originally received vaccine were given another dose at Month 60, while placebo subjects initiated a 3-dose vaccine regimen. Anti-HPV responses were measured 1 and 4 weeks post-dose 4 (subjects who originally received vaccine) or post-dose 1 (subjects who originally received placebo).
b) FUTURE I and II are phase III, prospective, double-blind, placebo-controlled randomised studies conducted in 16 countries. The women who participated in the trials were aged 16 to 26 and received three doses of either Gardasil® or placebo at day 1, month 2, and month 6. The primary analyses of these trials evaluated the efficacy of Gardasil® compared to placebo in women who were negative to the relevant Human Papillomavirus types (6, 11, 16 and/or 18) when they started the study, remained free of infection with the relevant Human Papillomavirus types through month 7, received all three doses of Gardasil® within one year and had no protocol violations.
FUTURE I evaluated th
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