{"analyses":[{"ciLowerLimit":"0.99","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.06","estimateComment":"GMT ratio = GMT (V503) / GMT (Gardasil)","groupDescription":"Anti-HPV Type 6","groupIds":["OG000","OG001"],"nonInferiorityComment":"Non-inferiority required that the lower bound of the two-sided confidence interval (CI) of the GMT ratio was \\>0.67","nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE","pValue":"<0.001","paramType":"GMT ratio","paramValue":"1.02","statisticalMethod":"ANOVA"},{"ciLowerLimit":"0.77","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.83","estimateComment":"GMT ratio = GMT (V503) / GMT (Gardasil)","groupDescription":"Anti-HPV Type 11","groupIds":["OG000","OG001"],"nonInferiorityComment":"Non-inferiority required that the lower bound of the two-sided CI of the GMT ratio was \\>0.67","nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE","pValue":"<0.001","paramType":"GMT ratio","paramValue":"0.80","statisticalMethod":"ANOVA"},{"ciLowerLimit":"0.96","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.03","estimateComment":"GMT ratio = GMT (V503) / GMT (Gardasil)","groupDescription":"Anti-HPV Type 16","groupIds":["OG000","OG001"],"nonInferiorityComment":"Non-inferiority required that the lower bound of the two-sided CI of the GMT ratio was \\>0.67","nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE","pValue":"<0.001","paramType":"GMT ratio","paramValue":"0.99","statisticalMethod":"ANOVA"},{"ciLowerLimit":"1.14","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.23","estimateComment":"GMT ratio = GMT (V503) / GMT (Gardasil)","groupDescription":"Anti-HPV Type 18","groupIds":["OG000","OG001"],"nonInferiorityComment":"Non-inferiority required that the lower bound of the two-sided CI of the GMT ratio was \\>0.67","nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE","pValue":"<0.001","paramType":"GMT ratio","paramValue":"1.19","statisticalMethod":"ANOVA"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"871.7","upperLimit":"915.1","value":"893.1"},{"groupId":"OG001","lowerLimit":"854.2","upperLimit":"896.8","value":"875.2"}]}],"title":"Anti-HPV Type 6 (n=3993, 3975)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"649.6","upperLimit":"683.4","value":"666.3"},{"groupId":"OG001","lowerLimit":"809.2","upperLimit":"851.4","value":"830.0"}]}],"title":"Anti-HPV Type 11 (n=3995, 3982)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"3057.1","upperLimit":"3206.9","value":"3131.1"},{"groupId":"OG001","lowerLimit":"3082.3","upperLimit":"3232.7","value":"3156.6"}]}],"title":"Anti-HPV Type 16 (n=4032, 4062)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"782.7","upperLimit":"827.1","value":"804.6"},{"groupId":"OG001","lowerLimit":"660.2","upperLimit":"697.7","value":"678.7"}]}],"title":"Anti-HPV Type 18 (n=4539, 4541)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"636.7","upperLimit":"680.9","value":"658.4"},{"groupId":"OG001","lowerLimit":"9.4","upperLimit":"10.1","value":"9.7"}]}],"title":"Anti-HPV Type 31 (n=4466, 4377)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"405.6","upperLimit":"426.4","value":"415.9"},{"comment":"The GMT value was \\<4 milli Merck U/mL","groupId":"OG001","lowerLimit":"NA","upperLimit":"NA","value":"NA"}]}],"title":"Anti-HPV Type 33 (n=4702, 4691)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"246.2","upperLimit":"259.6","value":"252.8"},{"comment":"The GMT value was \\<3 milli Merck U/mL","groupId":"OG001","lowerLimit":"NA","upperLimit":"NA","value":"NA"}]}],"title":"Anti-HPV Type 45 (n=4792, 4750)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"371.6","upperLimit":"388.0","value":"379.7"},{"comment":"The GMT value was \\<3 milli Merck U/mL","groupId":"OG001","lowerLimit":"NA","upperLimit":"NA","value":"NA"}]}],"title":"Anti-HPV Type 52 (n=4455, 4335)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"469.9","upperLimit":"495.3","value":"482.5"},{"comment":"The GMT value was \\<4 milli Merck U/mL","groupId":"OG001","lowerLimit":"NA","upperLimit":"NA","value":"NA"}]}],"title":"Anti-HPV Type 58 (n=4486, 4446)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"6792"},{"groupId":"OG001","value":"6795"}],"units":"Participants"}],"description":"Serum antibodies to HPV types 6/11/16/18/31/33/45/52/58 were measured with a Competitive Luminex Immunoassay. Titers are reported in milli Merck Units/mL. Statistical analysis was performed only for HPV types contained in both vaccines.","dispersionType":"95% Confidence Interval","groups":[{"description":"V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL injection in a 3-dose regimen in the base study. A subset of participants (Cohort 1) received a fourth V503 mid-dose vaccination in the extension study.","id":"OG000","title":"Mid-dose V503"},{"description":"Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study. Participants (Cohort 2) were offered the V503 mid-dose 3-dose regimen in the extension study.","id":"OG001","title":"Gardasil"}],"paramType":"GEOMETRIC_MEAN","populationDescription":"The Per-protocol Immunogenicity population included all participants who were not protocol violators, received all 3 vaccinations of mid-dose V503 or Gardasil within acceptable ranges, were seronegative at Day 1 and PCR negative from Day 1- Month 7 for the relevant HPV types, and had a Month 7 serum sample collected within an acceptable range","reportingStatus":"POSTED","timeFrame":"4 weeks postdose 3 in the base study","title":"Base Study: Geometric Mean Titers (GMTs) to HPV Types 6/11/16/18/31/33/45/52/58","type":"PRIMARY","unitOfMeasure":"milli Merck U/mL"}