{"analyses":[{"ciLowerLimit":"7.5","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"13.1","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","paramType":"Difference in Percentages","paramValue":"10.2","statisticalMethod":"Miettinen & Nurminen"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"11.2"},{"groupId":"OG001","value":"1.0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"608"},{"groupId":"OG001","value":"305"}],"units":"Participants"}],"description":"An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Participants were instructed to estimate the severity of AEs such as pain at injection site as mild (awareness of symptom, but easily tolerated), moderate (discomfort enough to cause interference with usual activities), or severe (incapacitating with inability to work or do usual activity). Additionally, participants were instructed to measure any swelling and/or erythema at its greatest width. Swelling or erythema with diameter \\>2 inches (\\>5 cm) was recorded as severe. All AEs associated with the injection site and reported as severe were summarized.","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 5 days after any vaccination - Base Study","title":"Percentage of Participants Who Experience a Severe Injection-site AE - Base Study","type":"PRIMARY","unitOfMeasure":"Percentage of Participants"}