The median Lollapalooza duration of follow-upwas

The median deduces 1st lollapalooza duration of set lists recalls follow-upwas 4.0, 3.0, 3.0, and 3.0 years for Study 1, Study 2, Study 3, and Study 4,respectively. Subjects received vaccine or AAHS control on the day of enrollmentand 2 and 6 months thereafter. Efficacy was analyzed for each study individuallyand for all studies combined according to a prospective clinical plan. Overall, 73% of subjects were naïve (i.e., PCR [Polymerase Chain Reaction]negative and seronegative for all 4 vaccine HPV types) to all 4 vaccine HPVtypes at enrollment.

A total of 27% of subjects had evidence of prior exposure to or ongoinginfection with at least 1 of the 4 vaccine HPV types about lollapalooza . Among these subjects, 74%had evidence of prior exposure to or ongoing infection with only 1 of the 4vaccine HPV types and were naïve (PCR negative and seronegative) to theremaining 3 types lolla palooza . In subjects who were naïve (PCR negative and seronegative) to all 4 vaccine HPVtypes, CIN, genital warts, VIN, and VaIN caused by any of the 4 vaccine HPVtypes were counted as endpoints perry farrell . Among subjects who were positive (PCR positive and/or seropositive) for avaccine HPV type at Day 1, endpoints related to that type were not included inthe analyses of prophylactic efficacy setlists . Endpoints related to the remaining typesfor which the subject was naïve (PCR negative and seronegative) were counted.

For example, in subjects who were HPV 18 positive (PCR positive and/orseropositive) at Day 1, lesionscaused by HPV 18 were not counted in theprophylactic efficacy evaluations adams lollapalooza . Lesions caused by HPV 6, 11, and 16 wereincluded in the prophylactic efficacy evaluations The same approach was usedfor the other types dealie . 14.1Prophylactic Efficacy - HPV Types 6, 11, 16, and 18 in Women 16 Through 26Years of AgeGARDASIL was administered without prescreening for presence of HPV infection andthe efficacy trials allowed enrollment of subjects regardless of baseline HPVstatus (i.e., PCR status or serostatus) palloza . Subjects with current or prior HPVinfection with an HPV type contained in the vaccine were not eligible forprophylactic efficacy evaluations for that type gawking .

The primary analyses of efficacy with respect to HPV types 6, 11, 16, and 18were conducted in the per-protocol efficacy (PPE) population, consisting ofindividuals who received all 3 vaccinations within 1 year of enrollment, did nothave major deviations from the study protocol, and were naïve (PCR negative incervicovaginal specimens 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 was measured starting after the Month 7 visit . GARDASIL was efficacious in reducing the incidence of CIN (any grade includingCIN 2/3); AIS; genital warts; VIN (any grade); and VaIN (any grade) related tovaccine HPV types 6, 11, 16, or 18 in those who were PCR negative andseronegative at baseline (Table 6) lalapalooza . In addition, individuals who were already infected with 1 or morevaccine-related HPV types prior to vaccination were protected from precancerouscervical lesions and external genital lesions caused by the other vaccine HPVtypes has been cancelled . Table 6 Analysis of Efficacy of GARDASIL in the PPE* Population** of 16- Through 26-Year-Old Women for Vaccine HPV TypesPopulationGARDASIL AAHS Control% Efficacy (95% CI) NNumber of cases NNumber of casesHPV 16- or 18-related CIN 2/3 or AISStudy 1***7550 75012 100.0 (65.1, 100.0)Study 2 2310 2301100.0 (-3744.9, 100.0) Study 3 2201 0 2222 36 100.0 (89.2, 100.0)Study 4 5306 2 5262 63 96.9 (88.2, 99.6)Combined Protocols? 8493 2 8464 11298.2 (93.5, 99.8)HPV 16-related CIN 2/3 or AIS Combined Protocols? 7402 2 7205 93 97.9 (92.3, 99.8)HPV 18-related CIN 2/3 or AIS Combined Protocols? 7382 0 7316 29 100.0 (86.6, 100.0)HPV 16- or 18-related VIN 2/3 Study 2 2310 2300Not calculated Study 3 2219 0 2239 6100.0 (14.4, 100.0)Study 4 5322 0 5275 4100.0 (-50.3, 100.0) Combined Protocols? 7772 0 7744 10 100.0 (55.5, 100.0)HPV 16- or 18-related VaIN 2/3Study 2 2310 2300Not calculated Study 3 2219 0 2239 5100.0 (-10.1, 100.0) Study 4 5322 0 5275 4100.0 (-50.3, 100.0) Combined Protocols? 7772 0 7744 9100.0 (49.5, 100.0)HPV 6-, 11-, 16-, or 18-related CIN (CIN 1, CIN 2/3) or AIS Study 2 2350 2333100.0 (-138.4, 100.0)Study 3 2241 0 2258 77 100.0 (95.1, 100.0)Study 4 5388 9 5374 14593.8 (88.0, 97.2)Combined Protocols? 7864 9 7865 22596.0 (92.3, 98.2)HPV 6-, 11-, 16-, or 18-related Genital Warts Study 2 2350 2333100.0 (-139.5, 100.0)Study 3 2261 0 2279 58 100.0 (93.5, 100.0)Study 4 5404 2 5390 13298.5 (94.5, 99.8)Combined Protocols? 7900 2 7902 19399.0 (96.2, 99.9)HPV 6- and 11-related Genital Warts Combined Protocols? 6932 2 6856 18999.0 (96.2, 99.9)*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 naïve (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 7 for analysis of vaccine impact in the general population***Evaluated only the HPV 16 L1 VLP vaccine component of GARDASIL?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 CI = Confidence Interval 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: Study 1 = Protocol 005; Study 2 = Protocol 007; Study 3 = Protocol 013; and Study 4 = Protocol 015 Note 4: Table 6 does not include cases due to non-vaccine HPV typesAAHS Control = Amorphous Aluminum Hydroxyphosphate SulfateProphylactic efficacy against overall cervical and genital disease related toHPV 6, 11, 16, and 18 in an extension phase of Study 2, that included datathrough month 60, was noted to be 100% (95% CI: 12.3%, 100.0%) among subjects inthe per protocol population naïve to the relevant HPV types.