{"analyses":[{"ciLowerLimit":"80.9","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"99.8","estimateComment":"Vaccine efficacy = 100 \\* \\[1 - (incidence rate with V503 / incidence rate with Gardasil)\\]. The pre-specified success criterion was a lower bound of the 95% confidence interval of observed efficacy of \\>25%.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","paramType":"Vaccine efficacy","paramValue":"96.7","statisticalMethod":"Exact test, 1-sided"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.5"},{"groupId":"OG001","value":"15.8"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"6016"},{"groupId":"OG001","value":"6017"}],"units":"Participants"}],"description":"HPV Type 31/33/45/52/58-related high-grade Cervical Intraepithelial Neoplasia (CIN 2/3), Adenocarcinoma in Situ (AIS), Invasive Cervical Carcinoma, high-grade Vulvar Intraepithelial Neoplasia (VIN 2/3), high-grade Vaginal Intraepithelial Neoplasia (VaIN 2/3), vulvar cancer, or vaginal cancer were determined by clinical/pathologic criteria and positive Polymerase Chain Reaction (PCR) assay for virus subtype. This outcome measure reports data based on the protocol-specified plan of conducting hypothesis testing when at least 30 cases had accumulated. The cutoff date for this analysis was 10 April 2013. Disease incidence was defined as the number of primary efficacy cases per 10,000 person-years of follow-up in a treatment arm.","groups":[{"description":"V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL injection in a 3-dose regimen in the base study. A subset of participants (Cohort 1) received a fourth V503 mid-dose vaccination in the extension study.","id":"OG000","title":"Mid-dose V503"},{"description":"Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study. Participants (Cohort 2) were offered the V503 mid-dose 3-dose regimen in the extension study.","id":"OG001","title":"Gardasil"}],"paramType":"NUMBER","populationDescription":"The Per-protocol Efficacy population included all participants who received all 3 vaccinations of mid-dose V503 or Gardasil within acceptable day ranges, were seronegative at Day 1 and PCR negative at Day 1 through Day 7 to the relevant HPV types, and had at least 1 follow-up visit following Month 7.","reportingStatus":"POSTED","timeFrame":"From Day 1 until >=30 cases accumulate, up to Month 54 in the base study","title":"Base Study: Combined Incidence of HPV Type 31/33/45/52/58-related Disease (Test of Hypothesis)","type":"PRIMARY","unitOfMeasure":"Cases per 10,000 person-years follow-up"}