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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

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
Authors
LuxembourgA.MoreiraE.D.Jr.SamakosesR.KimK.-H.SunX.MaanssonMoellerE.ChristianoS.ChenJ.
Ewha Authors
김경효
SCOPUS Author ID
김경효scopus
Issue Date
2015
Journal Title
Human Vaccines and Immunotherapeutics
ISSN
2164-5515JCR Link
Citation
vol. 11, no. 6, pp. 1306 - 1312
Keywords
HPVImmunogenicityLot consistencyNCT# 00943722VaccinationVaccine
Publisher
Taylor and Francis Inc.
Indexed
SCIE; SCOPUS WOS scopus
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.
DOI
10.1080/21645515.2015.1009819
Appears in Collections:
의학전문대학원 > 의학과 > Journal papers
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