dc.creatorLuxembourg, Alain
dc.creatorMoreira Junior, Edson Duarte
dc.creatorSamakoses, Rudiwilai
dc.creatorKim, Kyung-Hyo
dc.creatorSun, Xiao
dc.creatorMaansson, Roger
dc.creatorMoeller, Erin
dc.creatorChristiano, Susan
dc.creatorChen, Joshua
dc.date2016-05-19T16:52:18Z
dc.date2016-05-19T16:52:18Z
dc.date2015
dc.date.accessioned2023-09-26T20:16:49Z
dc.date.available2023-09-26T20:16:49Z
dc.identifierLUXEMBOURG, A. et al. 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. Human Vaccines & Immunotherapeutics, v. 11, n. 6, p. 1306-1312, 2015.
dc.identifier2164-5515
dc.identifierhttps://www.arca.fiocruz.br/handle/icict/14399
dc.identifier/dx.doi.org/10.1080/21645515.2015.1009819
dc.identifier.urihttps://repositorioslatinoamericanos.uchile.cl/handle/2250/8853197
dc.descriptionA 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
dc.formatapplication/pdf
dc.languageeng
dc.publisherTaylor & Francis: STM, Behavioural Science and Public Health Titles
dc.rightsopen access
dc.subjectHPV
dc.subjectImmunogenicity
dc.subjectLot consistency
dc.subjectNCT# 00943722
dc.subjectVaccine
dc.subjectVaccination
dc.subjectAnticorpos Antivirais/sangue
dc.subjectVacinas contra Papillomavirus/administração & dosagem
dc.subjectVacinas contra Papillomavirus/imunologia
dc.subjectVacinas de Partículas Semelhantes a Vírus/administração & dosagem
dc.subjectVacinas de Partículas Semelhantes a Vírus/imunologia
dc.subjectAdolescente
dc.subjectAdulto
dc.subjectBioestatística/métodos
dc.subjectCriança
dc.subjectFeminino
dc.subjectHumanos
dc.subjectMasculino
dc.subjectResultado do Tratamento
dc.subjectEstados Unidos
dc.subjectAdulto
dc.subjectJovem
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


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