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Data Published in The Lancet Show Gardasil was 100 Percent,Effective in Preventing High-Grade Vulvar and Vaginal Lesions,Caused by HPV Types 16 and 18

a 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.

High grade vulvar and vaginal lesions indicators for possible development of cancer

The studies used for this analysis combine findings from one phase II study and two phase III studies - Protocol 007, Protocol 013 (FUTURE I) and Protocol 015 (FUTURE II), respectively. All three studies were double-blind, placebo-controlled randomized studies and were conducted at 157 sites in 24 countries. More than 18,000 women participated in the three trials and were between the ages of 16 to 26 at the time of enrollment. They received three doses of either GARDASIL or placebo at day one, month two and month six. The combined analysis evaluated the impact of GARDASIL on the incidence of high-grade vulvar and vaginal pre-cancers (VIN 2/3 and VaIN 2/3), common precursors to vulvar and vaginal cancers in younger women, caused by HPV types 16 and 18.

In the per-protocol population of this combined analysis, GARDASIL was 100 percent effective in preventing HPV 16- and 18-related VIN 2/3 and VaIN 2/3 in women who were not exposed to the relevant HPV types until at least one month after completing the vaccination series; no cases were observed in the vaccine group (n=7,811) compared to 15 cases in the placebo group (n=7,785).

In the unrestricted population of this combined analysis, GARDASIL was 97 percent effective in preventing HPV 16- and 18-related VIN 2/3 and VaIN 2/3 in women who may have been exposed to the relevant HPV types before completing the vaccination series; one case was o
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