| Author | Luxembourg, Alain | |
| Author | Moreira Junior, Edson Duarte | |
| Author | Samakoses, Rudiwilai | |
| Author | Kim, Kyung-Hyo | |
| Author | Sun, Xiao | |
| Author | Maansson, Roger | |
| Author | Moeller, Erin | |
| Author | Christiano, Susan | |
| Author | Chen, Joshua | |
| Access date | 2016-05-19T16:52:18Z | |
| Available date | 2016-05-19T16:52:18Z | |
| Document date | 2015 | |
| Citation | 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. | pt_BR |
| ISSN | 2164-5515 | |
| URI | https://www.arca.fiocruz.br/handle/icict/14399 | |
| Language | eng | pt_BR |
| Publisher | Taylor & Francis: STM, Behavioural Science and Public Health Titles | pt_BR |
| Rights | open access | pt_BR |
| 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. | pt_BR |
| Type | Article | pt_BR |
| DOI | /dx.doi.org/10.1080/21645515.2015.1009819 | |
| 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 | pt_BR |
| Affilliation | Merck & Co. Inc. Whitehouse Station. NJ, USA | pt_BR |
| Affilliation | Hospital Santo Antônio. Obras Sociais Irmã Dulce. Salvador, BA, BRasilm/ Fundação Oswaldo Cruz. Centro de Pesquisas Gonçalo Moniz. Salvador, BA, Brasil | pt_BR |
| Affilliation | Phramongkutklao Hospital. Deptartment of Pediatrics. Bangkok, Thailand | pt_BR |
| Affilliation | Ewha Womans University School of Medicine. Department of Pediatrics. Seoul, Korea | pt_BR |
| Affilliation | Merck & Co. Inc. Whitehouse Station. NJ, USA | pt_BR |
| Affilliation | Merck & Co. Inc. Whitehouse Station. NJ, USA | pt_BR |
| Affilliation | Merck & Co. Inc. Whitehouse Station. NJ, USA | pt_BR |
| Affilliation | Merck & Co. Inc. Whitehouse Station. NJ, USA | pt_BR |
| Affilliation | Merck & Co. Inc. Whitehouse Station. NJ, USA | pt_BR |
| Subject | HPV | pt_BR |
| Subject | Immunogenicity | pt_BR |
| Subject | Lot consistency | pt_BR |
| Subject | NCT# 00943722 | pt_BR |
| Subject | Vaccine | pt_BR |
| Subject | Vaccination | pt_BR |
| DeCS | Anticorpos Antivirais/sangue | pt_BR |
| DeCS | Vacinas contra Papillomavirus/administração & dosagem | pt_BR |
| DeCS | Vacinas contra Papillomavirus/imunologia | pt_BR |
| DeCS | Vacinas de Partículas Semelhantes a Vírus/administração & dosagem | pt_BR |
| DeCS | Vacinas de Partículas Semelhantes a Vírus/imunologia | pt_BR |
| DeCS | Adolescente | pt_BR |
| DeCS | Adulto | pt_BR |
| DeCS | Bioestatística/métodos | pt_BR |
| DeCS | Criança | pt_BR |
| DeCS | Feminino | pt_BR |
| DeCS | Humanos | pt_BR |
| DeCS | Masculino | pt_BR |
| DeCS | Resultado do Tratamento | pt_BR |
| DeCS | Estados Unidos | pt_BR |
| DeCS | Adulto | pt_BR |
| DeCS | Jovem | pt_BR |
| xmlui.metadata.dc.subject.ods | 03 Saúde e Bem-Estar | |
