{"analyses":[{"ciLowerLimit":"98.9","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"100.0","groupDescription":"Anti-HPV 31","groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"statistical criterion of acceptability required that the lower bound of the 95% confidence interval (CI) for the proportion of participants seroconverting be greater than 90%","paramType":"Seroconversion rate","paramValue":"99.8","statisticalMethod":"Clopper-Pearson"},{"ciLowerLimit":"98.9","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"100.0","groupDescription":"Anti-HPV 33","groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"statistical criterion of acceptability required that the lower bound of the 95% CI for the proportion of subjects seroconverting be greater than 90%","paramType":"Seroconversion Rate","paramValue":"99.8","statisticalMethod":"Clopper-Pearson"},{"ciLowerLimit":"96.7","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"99.2","groupDescription":"Anti-HPV 45","groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"statistical criterion of acceptability required that the lower bound of the 95% CI for the proportion of subjects seroconverting be greater than 90%","paramType":"Seroconversion Rate","paramValue":"98.3","statisticalMethod":"Clopper-Pearson"},{"ciLowerLimit":"98.6","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"100.0","groupDescription":"Anti-HPV 52","groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"statistical criterion of acceptability required that the lower bound of the 95% CI for the proportion of subjects seroconverting be greater than 90%","paramType":"Seroconversion Rate","paramValue":"99.6","statisticalMethod":"Clopper-Pearson"},{"ciLowerLimit":"98.9","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"100.0","groupDescription":"Anti-HPV 58","groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"statistical criterion of acceptability required that the lower bound of the 95% CI for the proportion of subjects seroconverting be greater than 90%","paramType":"Seroconversion Rate","paramValue":"99.8","statisticalMethod":"Clopper-Pearson"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"99.3","upperLimit":"100.0","value":"100.0"},{"groupId":"OG001","lowerLimit":"98.5","upperLimit":"100.0","value":"100.0"}]}],"title":"Anti-HPV 6 (n=511; n=251)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"99.3","upperLimit":"100.0","value":"100.0"},{"groupId":"OG001","lowerLimit":"97.9","upperLimit":"100.0","value":"99.6"}]}],"title":"Anti-HPV 11 (n=515; n=261)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"99.3","upperLimit":"100.0","value":"100.0"},{"groupId":"OG001","lowerLimit":"98.6","upperLimit":"100.0","value":"100.0"}]}],"title":"Anti-HPV 16 (n=515; n=261)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"99.3","upperLimit":"100.0","value":"100.0"},{"groupId":"OG001","lowerLimit":"80.6","upperLimit":"89.5","value":"85.4"}]}],"title":"Anti-HPV 18 (n=515; n=261)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"98.9","upperLimit":"100.0","value":"99.8"},{"groupId":"OG001","lowerLimit":"18.7","upperLimit":"29.4","value":"23.8"}]}],"title":"Anti-HPV 31 (n=515; n=261)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"98.9","upperLimit":"100.0","value":"99.8"},{"groupId":"OG001","lowerLimit":"5.0","upperLimit":"12.0","value":"8.0"}]}],"title":"Anti-HPV 33 (n=515; n=261)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"96.7","upperLimit":"99.2","value":"98.3"},{"groupId":"OG001","lowerLimit":"1.6","upperLimit":"6.4","value":"3.4"}]}],"title":"Anti-HPV 45 (n=515; n=261)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"98.6","upperLimit":"100.0","value":"99.6"},{"groupId":"OG001","lowerLimit":"1.9","upperLimit":"6.9","value":"3.8"}]}],"title":"Anti-HPV 52 (n=515; n=261)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"98.9","upperLimit":"100.0","value":"99.8"},{"groupId":"OG001","lowerLimit":"6.0","upperLimit":"13.4","value":"9.2"}]}],"title":"Anti-HPV 58 (n=515; n=261)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"515"},{"groupId":"OG001","value":"261"}],"units":"Participants"}],"description":"Serum antibody titers for HPV virus-like particles (VLPs), Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined 4 weeks post-vaccination 3 using competitive luminex immunoassay (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":"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":"Participants who received all 3 vaccinations within an acceptable day range, had Month 7 serology sample collected within an acceptable range and had no other protocol violations that could interfere with immunes response to the vaccine. Statistical testing performed only within the 9vHPV arm and only for HPV types 31, 33, 45, 52, and 58.","reportingStatus":"POSTED","timeFrame":"4 weeks post-vaccination 3 (Month 7; End of Base Study)","title":"Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine - Base Study","type":"SECONDARY","unitOfMeasure":"Percentage of Participants"}