( ------------------------- Combined...)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,Health

------------------------- Combined Protocols 7858 4 7861 83 95.2 (87.2, 98.7) ====================================================================== HPV 6-, 11-, 16-, or 18-related Genital Warts ---------------------------------------------------------------------- Protocol 007 235 0 233 3 100.0 (-139.5, 100.0) ---------------------------------------------------------------------- FUTURE I 2261 0 2279 29 100.0 (86.4, 100.0) ---------------------------------------------------------------------- FUTURE II 5401 1 5387 59 98.3 (90.2, 100.0) ---------------------------------------------------------------------- Combined Protocols 7897 1 7899 91 98.9 (93.7, 100.0) ---------------------------------------------------------------------- * The PPE population 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). **See Table 2 for analysis of vaccine impact in the general population. ***Evaluated only the HPV 16 L1 VLP vaccine component of GARDASIL. +P-values were computed for pre-specified primary hypothesis tests. All p-values were less than0.001, supporting the following conclusions: efficacy against HPV 16/18-related CIN 2/3 is greater than0% (FUTURE II); efficacy against HPV 16/18-related CIN 2/3 is greater than25% (Combined Protocols); and efficacy against HPV 6/11/16/18-related CIN is greater than20% (FUTURE I). ++Analyses of the combined trials were prospectively planned and included the use of similar study entry criteria. n = Number of subjects with at least 1 follow-up visit after Month 7. Note 1: Point estimates and confidence intervals are adjusted for person-time of follow-up.
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