dc.creator | Luxembourg, Alain | |
dc.creator | Moreira Junior, Edson Duarte | |
dc.creator | Samakoses, Rudiwilai | |
dc.creator | Kim, Kyung-Hyo | |
dc.creator | Sun, Xiao | |
dc.creator | Maansson, Roger | |
dc.creator | Moeller, Erin | |
dc.creator | Christiano, Susan | |
dc.creator | Chen, Joshua | |
dc.date | 2016-05-19T16:52:18Z | |
dc.date | 2016-05-19T16:52:18Z | |
dc.date | 2015 | |
dc.date.accessioned | 2023-09-26T20:16:49Z | |
dc.date.available | 2023-09-26T20:16:49Z | |
dc.identifier | LUXEMBOURG, 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.identifier | 2164-5515 | |
dc.identifier | https://www.arca.fiocruz.br/handle/icict/14399 | |
dc.identifier | /dx.doi.org/10.1080/21645515.2015.1009819 | |
dc.identifier.uri | https://repositorioslatinoamericanos.uchile.cl/handle/2250/8853197 | |
dc.description | 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 | |
dc.format | application/pdf | |
dc.language | eng | |
dc.publisher | Taylor & Francis: STM, Behavioural Science and Public Health Titles | |
dc.rights | open access | |
dc.subject | HPV | |
dc.subject | Immunogenicity | |
dc.subject | Lot consistency | |
dc.subject | NCT# 00943722 | |
dc.subject | Vaccine | |
dc.subject | Vaccination | |
dc.subject | Anticorpos Antivirais/sangue | |
dc.subject | Vacinas contra Papillomavirus/administração & dosagem | |
dc.subject | Vacinas contra Papillomavirus/imunologia | |
dc.subject | Vacinas de Partículas Semelhantes a Vírus/administração & dosagem | |
dc.subject | Vacinas de Partículas Semelhantes a Vírus/imunologia | |
dc.subject | Adolescente | |
dc.subject | Adulto | |
dc.subject | Bioestatística/métodos | |
dc.subject | Criança | |
dc.subject | Feminino | |
dc.subject | Humanos | |
dc.subject | Masculino | |
dc.subject | Resultado do Tratamento | |
dc.subject | Estados Unidos | |
dc.subject | Adulto | |
dc.subject | Jovem | |
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 | |