{"analyses":[{"ciLowerLimit":"-1.7","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.6","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","paramType":"Difference in Percentages","paramValue":"-0.2","statisticalMethod":"Miettinen & Nurminen"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.2"},{"groupId":"OG001","value":"0.3"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"608"},{"groupId":"OG001","value":"305"}],"units":"Participants"}],"description":"An SAE is one that results in death, disability/incapacity, or hospitalization or is life threatening, a congenital anomaly or birth defect, cancer, an overdose, or otherwise jeopardizes the participant and may require medical intervention. An SAE that is judged by the Investigator to be \"definitely related,\" \"probably related,\" or \"possibly related\" is defined as a vaccine-related SAE.","groups":[{"description":"Blinded 9vHPV vaccine (V503) 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study. Participants will not continue to the Extension Study.","id":"OG000","title":"9vHPV Vaccine - Base Study"},{"description":"Blinded 0.5 mL intramuscular injection of saline placebo at Day 1, Month 2, and Month 6 of the Base Study. After completion of the Base Study, participants will be eligible to receive open-label 9vHPV 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Extension Study.","id":"OG001","title":"Placebo - Base Study"}],"paramType":"NUMBER","populationDescription":"All participants who received at least 1 vaccination and had available follow-up data.","reportingStatus":"POSTED","timeFrame":"Up to 7 months - Base Study","title":"Percentage of Participants Who Experience a Vaccine-related SAE Any Time During Study- Base Study","type":"PRIMARY","unitOfMeasure":"Percentage of Participants"}