{"analyses":[{"ciLowerLimit":"2.07","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"2.59","estimateComment":"GMT ratio = GMT for 9- to 15-Year-Old males (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)","groupDescription":"Anti-HPV 6","groupIds":["OG000","OG001"],"nonInferiorityComment":"non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67","nonInferiorityType":"NON_INFERIORITY","pValue":"< 0.001","pValueComment":"one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group","paramType":"GMT ratio","paramValue":"2.31","statisticalComment":"model with a response of log individual titers and a fixed effect for comparison group","statisticalMethod":"ANOVA"},{"ciLowerLimit":"1.88","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"2.36","estimateComment":"GMT ratio = GMT for 9- to 15-Year-Old Males (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)","groupDescription":"Anti-HPV 11","groupIds":["OG000","OG001"],"nonInferiorityComment":"non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67","nonInferiorityType":"NON_INFERIORITY","pValue":"< 0.001","pValueComment":"one-sided tests of non-inferiority conducted at the alpha=0.025 level; 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model with a response of log individual titers and a fixed effect for comparison group","paramType":"GMT ratio","paramValue":"2.47","statisticalComment":"model with a response of log individual titers and a fixed effect for comparison group","statisticalMethod":"ANOVA"},{"ciLowerLimit":"2.37","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"2.98","estimateComment":"GMT ratio = GMT for 9- to 15-Year-Old Males (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)","groupDescription":"Anti-HPV 58","groupIds":["OG000","OG001"],"nonInferiorityComment":"non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67","nonInferiorityType":"NON_INFERIORITY","pValue":"< 0.001","pValueComment":"one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group","paramType":"GMT ratio","paramValue":"2.66","statisticalComment":"model with a response of log individual titers and a fixed effect for comparison group","statisticalMethod":"ANOVA"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1944.0","upperLimit":"2235.7","value":"2084.7"},{"groupId":"OG001","lowerLimit":"822.3","upperLimit":"986.9","value":"900.8"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"559"},{"groupId":"OG001","value":"328"}],"units":"Participants"}],"title":"Anti-HPV 6"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1386.5","upperLimit":"1595.0","value":"1487.1"},{"groupId":"OG001","lowerLimit":"645.2","upperLimit":"773.8","value":"706.6"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"559"},{"groupId":"OG001","value":"332"}],"units":"Participants"}],"title":"Anti-HPV 11"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"8065.9","upperLimit":"9231.3","value":"8628.9"},{"groupId":"OG001","lowerLimit":"3223.5","upperLimit":"3849.5","value":"3522.6"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"569"},{"groupId":"OG001","value":"329"}],"units":"Participants"}],"title":"Anti-HPV 16"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"2602.8","upperLimit":"3061.5","value":"2822.8"},{"groupId":"OG001","lowerLimit":"795.4","upperLimit":"979.5","value":"882.7"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"567"},{"groupId":"OG001","value":"345"}],"units":"Participants"}],"title":"Anti-HPV 18"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"2056.1","upperLimit":"2399.5","value":"2221.2"},{"groupId":"OG001","lowerLimit":"682.5","upperLimit":"832.7","value":"753.9"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"564"},{"groupId":"OG001","value":"340"}],"units":"Participants"}],"title":"Anti-HPV 31"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1117.1","upperLimit":"1286.2","value":"1198.7"},{"groupId":"OG001","lowerLimit":"426.9","upperLimit":"510.3","value":"466.8"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"567"},{"groupId":"OG001","value":"354"}],"units":"Participants"}],"title":"Anti-HPV 33"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"830.2","upperLimit":"991.0","value":"907.0"},{"groupId":"OG001","lowerLimit":"243.8","upperLimit":"303.9","value":"272.2"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"570"},{"groupId":"OG001","value":"368"}],"units":"Participants"}],"title":"Anti-HPV 45"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"964.4","upperLimit":"1116.9","value":"1037.8"},{"groupId":"OG001","lowerLimit":"381.4","upperLimit":"461.5","value":"419.6"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"568"},{"groupId":"OG001","value":"337"}],"units":"Participants"}],"title":"Anti-HPV 52"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1460.2","upperLimit":"1683.1","value":"1567.7"},{"groupId":"OG001","lowerLimit":"538.2","upperLimit":"647.9","value":"590.5"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"566"},{"groupId":"OG001","value":"332"}],"units":"Participants"}],"title":"Anti-HPV 58"}],"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 a competitive luminex immunoassay (cLIA). Titers were reported in milli Merck Units/mL.","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":"GEOMETRIC_MEAN","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: GMTs for Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Males [Lot 1] and 16- to 26-Year-Old Females [Lot 1])","type":"PRIMARY","unitOfMeasure":"milli Merck Units/mL"}