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dc.contributor.author김경효-
dc.date.accessioned2017-08-29T04:05:56Z-
dc.date.available2017-08-29T04:05:56Z-
dc.date.issued2015-
dc.identifier.issn2164-5515-
dc.identifier.otherOAK-15197-
dc.identifier.urihttp://dspace.ewha.ac.kr/handle/2015.oak/230662-
dc.description.abstractA 9-valent human papillomavirus (6/11/16/18/31/33/45/52/58) VLP (9vHPV) vaccine has recently been proven highly efficacious in preventing disease associated with vaccine HPV types in a pivotal Phase III study. The demonstration of lot-to-lot consistency to confirm the reliability of the manufacturing process is a regulatory requirement for vaccine licensure in the United States. A randomized trial was conducted to demonstrate that three lots of 9vHPV vaccine elicit equivalent antibody response for all 9 vaccine types. The study required thorough planning because it required success on 27 separate statistical comparisons. An innovative statistical approach was used taking into account between-lot variance for more conservative power calculations. The study demonstrated equivalence of three lots of 9vHPV vaccine for all 9 vaccine types. © 2015, Merck and Co., Inc.-
dc.languageEnglish-
dc.publisherTaylor and Francis Inc.-
dc.subjectHPV-
dc.subjectImmunogenicity-
dc.subjectLot consistency-
dc.subjectNCT# 00943722-
dc.subjectVaccination-
dc.subjectVaccine-
dc.titlePhase III, randomized controlled trial in girls 9-15 years old to evaluate lot consistency of a novel nine-valent human papillomavirus L1 virus-like particle vaccine-
dc.typeArticle-
dc.relation.issue6-
dc.relation.volume11-
dc.relation.indexSCIE-
dc.relation.indexSCOPUS-
dc.relation.startpage1306-
dc.relation.lastpage1312-
dc.relation.journaltitleHuman Vaccines and Immunotherapeutics-
dc.identifier.doi10.1080/21645515.2015.1009819-
dc.identifier.wosidWOS:000356426800015-
dc.identifier.scopusid2-s2.0-84944445804-
dc.author.googleLuxembourg-
dc.author.googleA.-
dc.author.googleMoreira-
dc.author.googleE.D.-
dc.author.googleJr.-
dc.author.googleSamakoses-
dc.author.googleR.-
dc.author.googleKim-
dc.author.googleK.-H.-
dc.author.googleSun-
dc.author.googleX.-
dc.author.googleMaansson-
dc.author.googleMoeller-
dc.author.googleE.-
dc.author.googleChristiano-
dc.author.googleS.-
dc.author.googleChen-
dc.author.googleJ.-
dc.contributor.scopusid김경효(35448653000)-
dc.date.modifydate20180329110334-
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