{"analyses":[{"ciLowerLimit":"-1.5","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.9","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","paramType":"Difference in Percentages","paramValue":"0.0","statisticalMethod":"Miettinen & Nurminen"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.3"},{"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.","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 14 days after any vaccination - Base Study","title":"Percentage of Participants Who Experience a Serious Adverse Event (SAE) Within 15 Days of Any Vaccination - Base Study","type":"PRIMARY","unitOfMeasure":"Percentage of Participants"}