th respect to prevalence of HPV infection and disease at enrollment. Analyses were conducted to evaluate the overall impact of GARDASIL with respect to HPV 6-, 11-, 16-, and 18-related cervical and genital disease in the general population. Here, analyses included events arising from HPV infections that were present at the start of vaccination as well as events that arose from infections that were acquired after the start of vaccination. The impact of GARDASIL in the general population is shown in Table 2. Impact was measured starting 1 month Postdose 1. Prophylactic efficacy denotes the vaccine's efficacy in women who are naive (PCR negative and seronegative) to the relevant HPV types at vaccination onset. General population impact denotes vaccine impact among women regardless of baseline PCR status and serostatus. The majority of CIN and genital warts, VIN, and VaIN detected in the group that received GARDASIL occurred as a consequence of HPV infection with the relevant HPV type that was already present at Day 1. Table 2 General Population Impact for Vaccine HPV Types ---------------------------------------------------------------------- GARDASIL or HPV 16 L1 Placebo VLP Vaccine % Reduction Endpoints Analysis ---------------------- (95% CI) N Cases N Cases ====================================================================== Prophylactic Efficacy* 9342 1 9400 81 98.8 (92.9, 100.0) ----------------------------------------------------- HPV 16- or 18- HPV 16 related CIN 2/3 and/or HPV or AIS 18 Positive at Day 1 -- 121 -- 120 -- ----------------------------------
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