{"analyses":[{"groupDescription":"This p-value compares HSIL recurrence and presence of HPV16, in Arm I (Vaccine)","groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY","pValue":"0.93","statisticalMethod":"Log Rank"},{"groupDescription":"This p-value compares HSIL recurrence and presence of HPV18, in Arm I (Vaccine)","groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY","pValue":"0.77","statisticalMethod":"Log Rank"},{"groupDescription":"This p-value compares HSIL recurrence and presence of HPV31, in Arm I (Vaccine)","groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY","pValue":"0.57","statisticalMethod":"Log Rank"},{"groupDescription":"This p-value compares HSIL recurrence and presence of HPV33, in Arm I (Vaccine)","groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY","pValue":"0.73","statisticalMethod":"Log Rank"},{"groupDescription":"This p-value compares HSIL recurrence and presence of HPV45, in Arm I (Vaccine)","groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY","pValue":"0.998","statisticalMethod":"Log Rank"},{"groupDescription":"This p-value compares HSIL recurrence and presence of HPV52, in Arm I (Vaccine)","groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY","pValue":"0.93","statisticalMethod":"Log Rank"},{"groupDescription":"This p-value compares HSIL recurrence and presence of HPV58, in Arm I (Vaccine)","groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY","pValue":"0.95","statisticalMethod":"Log Rank"},{"groupDescription":"This p-value compares HSIL recurrence and presence of any HPV type, in Arm I (Vaccine)","groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY","pValue":"0.91","statisticalMethod":"Log Rank"},{"groupDescription":"This p-value compares HSIL recurrence and presence of HPV16, in Arm II (Placebo)","groupIds":["OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.22","statisticalMethod":"Log Rank"},{"groupDescription":"This p-value compares HSIL recurrence and presence of HPV18, in Arm II (Placebo)","groupIds":["OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.27","statisticalMethod":"Log Rank"},{"groupDescription":"This p-value compares HSIL recurrence and presence of HPV31, in Arm II (Placebo)","groupIds":["OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.72","statisticalMethod":"Log Rank"},{"groupDescription":"This p-value compares HSIL recurrence and presence of HPV33, in Arm II (Placebo)","groupIds":["OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.71","statisticalMethod":"Log Rank"},{"groupDescription":"This p-value compares HSIL recurrence and presence of HPV45, in Arm II (Placebo)","groupIds":["OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.11","statisticalMethod":"Log Rank"},{"groupDescription":"This p-value compares HSIL recurrence and presence of HPV52, in Arm II (Placebo)","groupIds":["OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.58","statisticalMethod":"Log Rank"},{"groupDescription":"This p-value compares HSIL recurrence and presence of HPV58, in Arm II (Placebo)","groupIds":["OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.81","statisticalMethod":"Log Rank"},{"groupDescription":"This p-value compares HSIL recurrence and presence of any HPV type, in Arm II (Placebo)","groupIds":["OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.73","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"33"},{"groupId":"OG001","value":"49"}],"title":"Negative, No event"},{"measurements":[{"groupId":"OG000","value":"22"},{"groupId":"OG001","value":"13"}],"title":"Positive, no event"},{"measurements":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"12"}],"title":"Negative, HSIL"},{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"6"}],"title":"Positive, HSIL"}],"title":"HPV16"},{"categories":[{"measurements":[{"groupId":"OG000","value":"32"},{"groupId":"OG001","value":"48"}],"title":"Negative, No event"},{"measurements":[{"groupId":"OG000","value":"23"},{"groupId":"OG001","value":"14"}],"title":"Positive, no event"},{"measurements":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"12"}],"title":"Negative, HSIL"},{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"6"}],"title":"Positive, HSIL"}],"title":"HPV18"},{"categories":[{"measurements":[{"groupId":"OG000","value":"28"},{"groupId":"OG001","value":"48"}],"title":"Negative, No event"},{"measurements":[{"groupId":"OG000","value":"27"},{"groupId":"OG001","value":"14"}],"title":"Positive, no event"},{"measurements":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"13"}],"title":"Negative, HSIL"},{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"5"}],"title":"Positive, HSIL"}],"title":"HPV31"},{"categories":[{"measurements":[{"groupId":"OG000","value":"30"},{"groupId":"OG001","value":"47"}],"title":"Negative, No event"},{"measurements":[{"groupId":"OG000","value":"25"},{"groupId":"OG001","value":"15"}],"title":"Positive, no event"},{"measurements":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"15"}],"title":"Negative, HSIL"},{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"3"}],"title":"Positive, HSIL"}],"title":"HPV33"},{"categories":[{"measurements":[{"groupId":"OG000","value":"33"},{"groupId":"OG001","value":"41"}],"title":"Negative, No event"},{"measurements":[{"groupId":"OG000","value":"22"},{"groupId":"OG001","value":"21"}],"title":"Positive, no event"},{"measurements":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"16"}],"title":"Negative, HSIL"},{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"2"}],"title":"Positive, HSIL"}],"title":"HPV45"},{"categories":[{"measurements":[{"groupId":"OG000","value":"27"},{"groupId":"OG001","value":"42"}],"title":"Negative, No event"},{"measurements":[{"groupId":"OG000","value":"28"},{"groupId":"OG001","value":"20"}],"title":"Positive, no event"},{"measurements":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"14"}],"title":"Negative, HSIL"},{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"4"}],"title":"Positive, HSIL"}],"title":"HPV52"},{"categories":[{"measurements":[{"groupId":"OG000","value":"28"},{"groupId":"OG001","value":"44"}],"title":"Negative, No event"},{"measurements":[{"groupId":"OG000","value":"27"},{"groupId":"OG001","value":"18"}],"title":"Positive, no event"},{"measurements":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"13"}],"title":"Negative, HSIL"},{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"5"}],"title":"Positive, HSIL"}],"title":"HPV58"},{"categories":[{"measurements":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"20"}],"title":"Negative, No event"},{"measurements":[{"groupId":"OG000","value":"39"},{"groupId":"OG001","value":"42"}],"title":"Positive, no event"},{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"6"}],"title":"Negative, HSIL"},{"measurements":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"12"}],"title":"Positive, HSIL"}],"title":"Any HPV"}],"denoms":[{"counts":[{"groupId":"OG000","value":"68"},{"groupId":"OG001","value":"80"}],"units":"Participants"}],"description":"Will evaluate placebo and vaccine recipients separately. Will assess whether presence and amount of HPV antibody, detected at baseline in the placebo arm, is protective against recurrence. For the vaccine arm, will assess whether magnitude of vaccine antibody levels month 1 following the third vaccination in the vaccine arm affects recurrence.","groups":[{"description":"Patients receive recombinant human papillomavirus nonavalent vaccine IM at baseline, 2 months, and 6 months.\n\nLaboratory Biomarker Analysis: Correlative studies\n\nQuestionnaire Administration: Ancillary studies\n\nRecombinant Human Papillomavirus Nonavalent Vaccine: Given IM","id":"OG000","title":"Arm I (Recombinant Human Papillomavirus Nonavalent Vaccine)"},{"description":"Patients receive placebo IM at baseline, 2 months, and 6 months.\n\nLaboratory Biomarker Analysis: Correlative studies\n\nPlacebo Administration: Given IM\n\nQuestionnaire Administration: Ancillary studies","id":"OG001","title":"Arm II (Placebo)"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Participants with usable serology samples from at least one timepoint are included in this analysis.","reportingStatus":"POSTED","timeFrame":"Up to month 36","title":"HPV Antibody Level","type":"SECONDARY","unitOfMeasure":"Participants"}