{"analyses":[{"ciLowerLimit":"94.6","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"97.1","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","paramType":"Vaccine efficacy","paramValue":"96.0"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"21.5"},{"groupId":"OG001","value":"538.8"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"5941"},{"groupId":"OG001","value":"5955"}],"units":"Participants"}],"description":"Combined Incidence of HPV Type 31/33/45/52/58-related persistent infection as determined by clinical/pathologic criteria and positive Polymerase Chain Reaction (PCR) assay for virus subtype. Persistent infection was defined as infection detected in samples from \\>=2 consecutive visits 6 months (+/-1 month visit window) or longer apart. Incidence was defined as the number of cases of persistent infection 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":"Up to Month 54 in the base study","title":"Base Study: Combined Incidence of HPV Type 31/33/45/52/58-related Persistent Infection","type":"SECONDARY","unitOfMeasure":"Cases per 10,000 person-years follow-up"}