Merck & Co., Inc. Release: The New England Journal of Medicine Publishes Additional Efficacy and Safety Data for GARDASIL® in Males

WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Merck (known as MSD outside the United States and Canada) announced today that data from a sub-study of the pivotal Phase III clinical trial with GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant] in males were published in the October 27 issue of the New England Journal of Medicine (NEJM). In this study of 602 healthy men who have sex with men (MSM), ages 16 to 26 years, GARDASIL was 77.5 percent effective in the per-protocol efficacy population in reducing the rates of anal intraepithelial neoplasia (AIN) associated with human papillomavirus (HPV) types 6, 11, 16 and 18. The efficacy of GARDASIL against HPV-related anal disease was studied in a population of MSM because of the known high risk of anal infection and disease that occurs in this group.

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