{"analyses":[{"groupDescription":"This p-value compares HPV16 persistence by study arm.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.89","statisticalMethod":"Chi-squared"},{"groupDescription":"This p-value compares HPV18/45 persistence by study arm.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.65","statisticalMethod":"Chi-squared"},{"groupDescription":"This p-value compares HPV31/33/52/58 persistence by study arm.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.056","statisticalMethod":"Chi-squared"},{"groupDescription":"This p-value compares HPV35/39/51/56/59 persistence by study arm.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.38","statisticalMethod":"Chi-squared"},{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.33","pValueComment":"This p-value compares overall HPV persistence and is not specific to HPV genotype.","statisticalMethod":"Chi-squared"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"9"}],"title":"HPV16 persistence identified"},{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"5"}],"title":"HPV18/45 persistence identified"},{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"11"}],"title":"HPV31/33/52/58 persistence identified"},{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"8"}],"title":"HPV33/39/51/56/59 persistence identified"},{"measurements":[{"groupId":"OG000","value":"13"},{"groupId":"OG001","value":"21"}],"title":"Overall high-risk HPV persistence identified"},{"measurements":[{"groupId":"OG000","value":"23"},{"groupId":"OG001","value":"10"}],"title":"High-risk HPV persistence NOT identified"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"53"},{"groupId":"OG001","value":"64"}],"units":"Participants"}],"description":"Persistence will be measured as two or more consecutive polymerase chain reaction (PCR) positive swabs for the same human papillomavirus (HPV) genotype. Will use Chi-Square test to compare the number of participants with the persistent infection in the vaccinated to unvaccinated group.","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 were included in this analysis if they had 2 or more HPV DNA PCR results from swabs collected after the baseline swab. Of the 185 participants in the baseline population, 117 were included in this analysis.","reportingStatus":"POSTED","timeFrame":"Up to month 36","title":"Persistent High-risk Infection Among Vaccine Compared With Placebo Recipients","type":"PRIMARY","unitOfMeasure":"Participants"}