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

h at least 1 follow-up visit after Month 7. Note 1: Point estimates and confidence intervals are adjusted for person-time of follow-up. Note 2: The first analysis in the table (i.e., HPV 16- or 18-related CIN 2/3, AIS or worse) was the primary endpoint of the vaccine development plan. Note 3: FUTURE I refers to Protocol 013; FUTURE II refers to Protocol 015. ---------------------------------------------------------------------- GARDASIL was efficacious against HPV disease caused by each of the 4 vaccine HPV types. In a pre-defined analysis, the efficacy of GARDASIL against HPV 16/18-related disease was 100% (95% CI: 87.9%, 100.0%) for CIN 3 or AIS and 100% (95% CI: 55.5%, 100.0%) for VIN 2/3 or VaIN 2/3. The efficacy of GARDASIL against HPV 6-, 11-, 16-, and 18-related VIN 1 or VaIN 1 was 100% (95% CI: 75.8%, 100.0%). These analyses were conducted in the PPE population that consisted of individuals who received all 3 vaccinations within 1 year of enrollment, did not have major deviations from the study protocol, and were naive (PCR negative and seronegative) to the relevant HPV type(s) (Types 6, 11, 16, and 18) prior to dose 1 and through 1 month Postdose 3 (Month 7). Efficacy in Subjects with Current or Prior Infection GARDASIL is a prophylactic vaccine. There was no clear evidence of protection from disease caused by HPV types for which subjects were PCR positive and/or seropositive at baseline. Individuals who were already infected with 1 or more vaccine-related HPV types prior to vaccination were protected from clinical disease caused by the remaining vaccine HPV types. General Population Impact The general population of young American women includes women who are HPV-naive (PCR negative and seronegative) and women who are HPV-non-naive (PCR positive and/or seropositive), some of whom have HPV-related disease. The clinical trials population approximated the general population of American women wi
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