{"analyses":[{"groupDescription":"This comparison is specific to the incidence of fever or chills.","groupIds":["OG000","OG001"],"nonInferiorityComment":"Descriptive analysis","nonInferiorityType":"OTHER","pValue":"0.135","statisticalMethod":"Chi-squared"},{"groupDescription":"This comparison is specific to the incidence of headache.","groupIds":["OG000","OG001"],"nonInferiorityComment":"Descriptive analysis","nonInferiorityType":"OTHER","pValue":"0.640","statisticalMethod":"Chi-squared"},{"groupDescription":"This comparison is specific to the incidence of fatigue.","groupIds":["OG000","OG001"],"nonInferiorityComment":"Descriptive analysis","nonInferiorityType":"OTHER","pValue":"0.838","statisticalMethod":"Chi-squared"},{"groupDescription":"This comparison is specific to the incidence of muscle aches.","groupIds":["OG000","OG001"],"nonInferiorityComment":"Descriptive analysis","nonInferiorityType":"OTHER","pValue":"0.917","statisticalMethod":"Chi-squared"},{"groupDescription":"This comparison is specific to the incidence of pain at injection site.","groupIds":["OG000","OG001"],"nonInferiorityComment":"Descriptive analysis","nonInferiorityType":"OTHER","pValue":"0.005","statisticalMethod":"Chi-squared"},{"groupDescription":"This comparison is specific to the incidence of tenderness at injection site.","groupIds":["OG000","OG001"],"nonInferiorityComment":"Descriptive analysis","nonInferiorityType":"OTHER","pValue":"0.001","statisticalMethod":"Chi-squared"},{"groupDescription":"This comparison is specific to the incidence of swelling at injection site.","groupIds":["OG000","OG001"],"nonInferiorityComment":"Descriptive analysis","nonInferiorityType":"OTHER","pValue":"0.004","statisticalMethod":"Chi-squared"},{"groupDescription":"This comparison is specific to the incidence of medical attention/medication required.","groupIds":["OG000","OG001"],"nonInferiorityComment":"Descriptive analysis","nonInferiorityType":"OTHER","pValue":"0.133","statisticalMethod":"Chi-squared"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"2"}],"title":"Fever or chills"},{"measurements":[{"groupId":"OG000","value":"24"},{"groupId":"OG001","value":"22"}],"title":"Headache"},{"measurements":[{"groupId":"OG000","value":"23"},{"groupId":"OG001","value":"25"}],"title":"Fatigue"},{"measurements":[{"groupId":"OG000","value":"17"},{"groupId":"OG001","value":"17"}],"title":"Muscle aches"},{"measurements":[{"groupId":"OG000","value":"33"},{"groupId":"OG001","value":"17"}],"title":"Pain at injection site"},{"measurements":[{"groupId":"OG000","value":"53"},{"groupId":"OG001","value":"31"}],"title":"Tenderness at injection site"},{"measurements":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"2"}],"title":"Swelling at injection site"},{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"11"}],"title":"Medical attention/medication"}]}],"denomUnitsSelected":"Symptom reports","denoms":[{"counts":[{"groupId":"OG000","value":"91"},{"groupId":"OG001","value":"94"}],"units":"Participants"},{"counts":[{"groupId":"OG000","value":"173"},{"groupId":"OG001","value":"127"}],"units":"Symptom reports"}],"description":"Will monitor safety by comparing type and frequency of AEs in the two study arms, graded according to the Food and Drug Administration criteria. Symptoms are reported at least once from any dose.","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_UNITS","populationDescription":"There were 173 incidence of reported symptoms among participants in Arm I (Vaccine) and 127 incidence of reported symptoms among participants in Arm II (Placebo). Overall, there were 91 participants in Arm I (Vaccine) and 94 participants in Arm II (Placebo) reported symptoms at least once for any dose received.","reportingStatus":"POSTED","timeFrame":"Up to month 36","title":"Incidence of Adverse Events (AEs) Via Solicited Vaccine Reactogenicity by Arm","type":"SECONDARY","typeUnitsAnalyzed":"Symptom reports","unitOfMeasure":"Symptom reports"}