{"analyses":[{"ciLowerLimit":"-0.7","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.5","estimateComment":"Percentage Point Difference = 9- to 15-Year-Old Males (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)","groupDescription":"Anti-HPV 6","groupIds":["OG000","OG001"],"nonInferiorityComment":"Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.","nonInferiorityType":"NON_INFERIORITY","pValue":"< 0.001","paramType":"Percentage Point Difference","paramValue":"0.1","statisticalMethod":"Miettinen and Nurminen"},{"ciLowerLimit":"-0.7","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.2","estimateComment":"Percentage Point Difference = 9- to 15-Year-Old Males (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)","groupDescription":"Anti-HPV 11","groupIds":["OG000","OG001"],"nonInferiorityComment":"Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.","nonInferiorityType":"NON_INFERIORITY","pValue":"< 0.001","paramType":"Percentage Point Difference","paramValue":"0.0","statisticalMethod":"Miettinen and Nurminen"},{"ciLowerLimit":"-0.7","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.2","estimateComment":"Percentage Point Difference = 9- to 15-Year-Old Males (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)","groupDescription":"Anti-HPV 16","groupIds":["OG000","OG001"],"nonInferiorityComment":"Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.","nonInferiorityType":"NON_INFERIORITY","pValue":"< 0.001","paramType":"Percentage Point Difference","paramValue":"0.0","statisticalMethod":"Miettinen and Nurminen"},{"ciLowerLimit":"-0.4","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.6","estimateComment":"Percentage Point Difference = 9- to 15-Year-Old Males (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)","groupDescription":"Anti-HPV 18","groupIds":["OG000","OG001"],"nonInferiorityComment":"Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.","nonInferiorityType":"NON_INFERIORITY","pValue":"< 0.001","paramType":"Percentage Point Difference","paramValue":"0.3","statisticalMethod":"Miettinen and Nurminen"},{"ciLowerLimit":"-0.4","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.7","estimateComment":"Percentage Point Difference = 9- to 15-Year-Old Males (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)","groupDescription":"Anti-HPV 31","groupIds":["OG000","OG001"],"nonInferiorityComment":"Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.","nonInferiorityType":"NON_INFERIORITY","pValue":"< 0.001","paramType":"Percentage Point Difference","paramValue":"0.3","statisticalMethod":"Miettinen and Nurminen"},{"ciLowerLimit":"-0.4","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.6","estimateComment":"Percentage Point Difference = 9- to 15-Year-Old Males (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)","groupDescription":"Anti-HPV 33","groupIds":["OG000","OG001"],"nonInferiorityComment":"Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.","nonInferiorityType":"NON_INFERIORITY","pValue":"< 0.001","paramType":"Percentage Point Difference","paramValue":"0.3","statisticalMethod":"Miettinen and Nurminen"},{"ciLowerLimit":"-0.1","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"2.0","estimateComment":"Percentage Point Difference = 9- to 15-Year-Old Males (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)","groupDescription":"Anti-HPV 45","groupIds":["OG000","OG001"],"nonInferiorityComment":"Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.","nonInferiorityType":"NON_INFERIORITY","pValue":"< 0.001","paramType":"Percentage Point Difference","paramValue":"0.5","statisticalMethod":"Miettinen and Nurminen"},{"ciLowerLimit":"-0.4","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.7","estimateComment":"Percentage Point Difference = 9- to 15-Year-Old Males (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)","groupDescription":"Anti-HPV 52","groupIds":["OG000","OG001"],"nonInferiorityComment":"Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.","nonInferiorityType":"NON_INFERIORITY","pValue":"< 0.001","paramType":"Percentage Point Difference","paramValue":"0.3","statisticalMethod":"Miettinen and Nurminen"},{"ciLowerLimit":"-0.7","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.2","estimateComment":"Percentage Point Difference = 9- to 15-Year-Old Males (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)","groupDescription":"Anti-HPV 58","groupIds":["OG000","OG001"],"nonInferiorityComment":"Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.","nonInferiorityType":"NON_INFERIORITY","pValue":"< 0.001","paramType":"Percentage Point Difference","paramValue":"0.0","statisticalMethod":"Miettinen and Nurminen"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"99.0","upperLimit":"100.0","value":"99.8"},{"groupId":"OG001","lowerLimit":"98.3","upperLimit":"100.0","value":"99.7"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"559"},{"groupId":"OG001","value":"328"}],"units":"Participants"}],"title":"Anti-HPV 6 cLIA ≥30 mMU/mL"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"99.3","upperLimit":"100.0","value":"100.0"},{"groupId":"OG001","lowerLimit":"98.9","upperLimit":"100.0","value":"100.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"559"},{"groupId":"OG001","value":"332"}],"units":"Participants"}],"title":"Anti-HPV 11 cLIA ≥16 mMU/mL"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"99.4","upperLimit":"100.0","value":"100.0"},{"groupId":"OG001","lowerLimit":"98.9","upperLimit":"100.0","value":"100.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"569"},{"groupId":"OG001","value":"329"}],"units":"Participants"}],"title":"Anti-HPV 16 cLIA ≥20 mMU/mL"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"99.4","upperLimit":"100.0","value":"100.0"},{"groupId":"OG001","lowerLimit":"98.4","upperLimit":"100.0","value":"99.7"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"567"},{"groupId":"OG001","value":"345"}],"units":"Participants"}],"title":"Anti-HPV 18 cLIA ≥24 mMU/mL"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"99.3","upperLimit":"100.0","value":"100.0"},{"groupId":"OG001","lowerLimit":"98.4","upperLimit":"100.0","value":"99.7"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"564"},{"groupId":"OG001","value":"340"}],"units":"Participants"}],"title":"Anti-HPV 31 cLIA ≥10 mMU/mL"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"99.4","upperLimit":"100.0","value":"100.0"},{"groupId":"OG001","lowerLimit":"98.4","upperLimit":"100.0","value":"99.7"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"567"},{"groupId":"OG001","value":"354"}],"units":"Participants"}],"title":"Anti-HPV 33 cLIA ≥8 mMU/mL"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"99.4","upperLimit":"100.0","value":"100.0"},{"groupId":"OG001","lowerLimit":"98.1","upperLimit":"99.9","value":"99.5"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"570"},{"groupId":"OG001","value":"368"}],"units":"Participants"}],"title":"Anti-HPV 45 cLIA ≥8 mMU/mL"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"99.4","upperLimit":"100.0","value":"100.0"},{"groupId":"OG001","lowerLimit":"98.4","upperLimit":"100.0","value":"99.7"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"568"},{"groupId":"OG001","value":"337"}],"units":"Participants"}],"title":"Anti-HPV 52 cLIA ≥8 mMU/mL"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"99.4","upperLimit":"100.0","value":"100.0"},{"groupId":"OG001","lowerLimit":"98.9","upperLimit":"100.0","value":"100.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"566"},{"groupId":"OG001","value":"332"}],"units":"Participants"}],"title":"Anti-HPV 58 cLIA ≥8 mMU/mL"}],"denoms":[{"counts":[{"groupId":"OG000","value":"570"},{"groupId":"OG001","value":"378"}],"units":"Participants"}],"description":"Serum antibody titers for HPV VLPs, Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined 4 weeks post-vaccination 3 using cLIA. The serostatus cutoffs (milli Merck U/mL) for HPV types were as follows: HPV Type 6: ≥30, HPV Type 11: ≥16; HPV Type 16: ≥20, HPV Type 18: ≥24, HPV Type 31: ≥10, HPV Type 33: ≥8, HPV Type 45: ≥8, HPV Type 52: ≥8, and HPV Type 58: ≥8.","dispersionType":"95% Confidence Interval","groups":[{"description":"9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.","id":"OG000","title":"Base Study: 9- to 15-Year-Old Males (Lot 1)"},{"description":"9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.","id":"OG001","title":"Base Study: 16- to 26-Year-Old Females (Lot 1)"}],"paramType":"NUMBER","populationDescription":"9-15-year-old males and 16-26-year-old females who received 3 vaccinations from Lot 1 and met following criteria for at least 1 of the 9 HPV types: no general protocol violations, received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), and had a Month 7 serum sample collected within an acceptable day range","reportingStatus":"POSTED","timeFrame":"4 weeks post-vaccination 3 (Month 7)","title":"Base Study: Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Males [Lot 1] Versus 16- to 26-Year-Old Females [Lot 1])","type":"SECONDARY","unitOfMeasure":"Percentage of Participants"}