Full metadata record
DC Field | Value | Language |
---|---|---|
dc.contributor.author | 김경효 | * |
dc.date.accessioned | 2016-08-29T12:08:15Z | - |
dc.date.available | 2016-08-29T12:08:15Z | - |
dc.date.issued | 2015 | * |
dc.identifier.issn | 2164-5515 | * |
dc.identifier.other | OAK-15197 | * |
dc.identifier.uri | https://dspace.ewha.ac.kr/handle/2015.oak/230662 | - |
dc.description.abstract | A 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.language | English | * |
dc.publisher | Taylor and Francis Inc. | * |
dc.subject | HPV | * |
dc.subject | Immunogenicity | * |
dc.subject | Lot consistency | * |
dc.subject | NCT# 00943722 | * |
dc.subject | Vaccination | * |
dc.subject | Vaccine | * |
dc.title | Phase 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.type | Article | * |
dc.relation.issue | 6 | * |
dc.relation.volume | 11 | * |
dc.relation.index | SCIE | * |
dc.relation.index | SCOPUS | * |
dc.relation.startpage | 1306 | * |
dc.relation.lastpage | 1312 | * |
dc.relation.journaltitle | Human Vaccines and Immunotherapeutics | * |
dc.identifier.doi | 10.1080/21645515.2015.1009819 | * |
dc.identifier.wosid | WOS:000356426800015 | * |
dc.identifier.scopusid | 2-s2.0-84944445804 | * |
dc.author.google | Luxembourg | * |
dc.author.google | A. | * |
dc.author.google | Moreira | * |
dc.author.google | E.D. | * |
dc.author.google | Jr. | * |
dc.author.google | Samakoses | * |
dc.author.google | R. | * |
dc.author.google | Kim | * |
dc.author.google | K.-H. | * |
dc.author.google | Sun | * |
dc.author.google | X. | * |
dc.author.google | Maansson | * |
dc.author.google | Moeller | * |
dc.author.google | E. | * |
dc.author.google | Christiano | * |
dc.author.google | S. | * |
dc.author.google | Chen | * |
dc.author.google | J. | * |
dc.contributor.scopusid | 김경효(35448653000) | * |
dc.date.modifydate | 20240301081003 | * |