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New England Journal of Medicine Publishes New Data on Gardasil,,Merck's Cervical Cancer Vaccine

ause a large number of "abnormal" Pap test results and low-grade cervical lesions.

"My fellow investigators around the world are proud of these data and their contribution to our understanding of the impact of GARDASIL on risk for development of cervical, vulvar, and vaginal diseases caused by HPV 6, 11, 16, and 18," said Eliav Barr, M.D., executive director of Biologics Clinical Research and head of the HPV Vaccine Program, Merck Research Laboratories. "In women not infected with the four HPV types targeted by GARDASIL, GARDASIL reduced cervical disease caused by the relevant HPV types. And, across the larger study population, GARDASIL also reduced the overall burden of cervical, vulvar, and vaginal HPV diseases caused by HPV types targeted by the vaccine and by other HPV types."

GARDASIL was approved by the FDA on June 8, 2006, and is recommended for use by girls and women ages 11 to 26 by the U.S. Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices. GARDASIL is indicated for the prevention of HPV types 16- and 18- related cervical cancer, non-invasive cervical cancer (cervical intraepithelial neoplasia (CIN) grade 3 and adenocarcinoma in situ (AIS)), cervical pre-cancers (cervical intraepithelial neoplasia (CIN) grade 2), vulvar pre-cancers (vulvar intraepithelial neoplasia (VIN) 2/3)) and vaginal pre-cancers (vaginal intraepithelial neoplasia (VaIN) 2/3), and for the prevention of genital warts and low-grade cervical lesions (CIN 1) caused by HPV types 6, 11, 16 and 18. GARDASIL is contraindicated in individuals who are hypersensitive to the active substances or to any of the excipients of the vaccine.

Studies assessed CIN 2/3, the most meaningful efficacy measure

The studies, FUTURE I and FUTURE II, are phase III, prospective, double-blind, placebo-controlled randomized studies conducted in 29 countries. The women who participated in the trials were 15 to 26 years old at enrollment; they received
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