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.

Luxembourg, Alain; Moreira Junior, Edson Duarte; Samakoses, Rudiwilai; Kim, Kyung-Hyo; Sun, Xiao; Maansson, Roger; Moeller, Erin; Christiano, Susan; Chen, Joshua

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.

Detalhes bibliográficos
Autor(a) principal:	Luxembourg, Alain
Data de Publicação:	2015
Outros Autores:	Moreira Junior, Edson Duarte, Samakoses, Rudiwilai, Kim, Kyung-Hyo, Sun, Xiao, Maansson, Roger, Moeller, Erin, Christiano, Susan, Chen, Joshua
Tipo de documento:	Artigo
Idioma:	eng
Título da fonte:	Repositório Institucional da FIOCRUZ (ARCA)
Texto Completo:	https://www.arca.fiocruz.br/handle/icict/14399
Resumo:	Merck & Co. Inc. Whitehouse Station. NJ, USA

Metadados do item

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spelling	Luxembourg, AlainMoreira Junior, Edson DuarteSamakoses, RudiwilaiKim, Kyung-HyoSun, XiaoMaansson, RogerMoeller, ErinChristiano, SusanChen, Joshua2016-05-19T16:52:18Z2016-05-19T16:52:18Z2015LUXEMBOURG, 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, 2015.2164-5515https://www.arca.fiocruz.br/handle/icict/14399/dx.doi.org/10.1080/21645515.2015.1009819engTaylor & Francis: STM, Behavioural Science and Public Health TitlesPhase 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.info:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleMerck & Co. Inc. Whitehouse Station. NJ, USAHospital Santo Antônio. Obras Sociais Irmã Dulce. Salvador, BA, BRasilm/ Fundação Oswaldo Cruz. Centro de Pesquisas Gonçalo Moniz. Salvador, BA, BrasilPhramongkutklao Hospital. Deptartment of Pediatrics. Bangkok, ThailandEwha Womans University School of Medicine. Department of Pediatrics. Seoul, KoreaMerck & Co. Inc. Whitehouse Station. NJ, USAMerck & Co. Inc. Whitehouse Station. NJ, USAMerck & Co. Inc. Whitehouse Station. NJ, USAMerck & Co. Inc. Whitehouse Station. NJ, USAMerck & Co. Inc. Whitehouse Station. NJ, USAA 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 typesHPVImmunogenicityLot consistencyNCT# 00943722VaccineVaccinationAnticorpos Antivirais/sangueVacinas contra Papillomavirus/administração & dosagemVacinas contra Papillomavirus/imunologiaVacinas de Partículas Semelhantes a Vírus/administração & dosagemVacinas de Partículas Semelhantes a Vírus/imunologiaAdolescenteAdultoBioestatística/métodosCriançaFemininoHumanosMasculinoResultado do TratamentoEstados UnidosAdultoJoveminfo:eu-repo/semantics/openAccessreponame:Repositório Institucional da FIOCRUZ (ARCA)instname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZLICENSElicense.txtlicense.txttext/plain; charset=utf-82991https://www.arca.fiocruz.br/bitstream/icict/14399/1/license.txt5a560609d32a3863062d77ff32785d58MD51ORIGINALLuxembourg A Phase III randomized....pdfLuxembourg A Phase III 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dc.title.pt_BR.fl_str_mv	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.
spellingShingle	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. Luxembourg, Alain HPV Immunogenicity Lot consistency NCT# 00943722 Vaccine Vaccination Anticorpos Antivirais/sangue Vacinas contra Papillomavirus/administração & dosagem Vacinas contra Papillomavirus/imunologia Vacinas de Partículas Semelhantes a Vírus/administração & dosagem Vacinas de Partículas Semelhantes a Vírus/imunologia Adolescente Adulto Bioestatística/métodos Criança Feminino Humanos Masculino Resultado do Tratamento Estados Unidos Adulto Jovem
title_short	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_full	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_fullStr	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_full_unstemmed	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_sort	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.
author	Luxembourg, Alain
author_facet	Luxembourg, Alain Moreira Junior, Edson Duarte Samakoses, Rudiwilai Kim, Kyung-Hyo Sun, Xiao Maansson, Roger Moeller, Erin Christiano, Susan Chen, Joshua
author_role	author
author2	Moreira Junior, Edson Duarte Samakoses, Rudiwilai Kim, Kyung-Hyo Sun, Xiao Maansson, Roger Moeller, Erin Christiano, Susan Chen, Joshua
author2_role	author author author author author author author author
dc.contributor.author.fl_str_mv	Luxembourg, Alain Moreira Junior, Edson Duarte Samakoses, Rudiwilai Kim, Kyung-Hyo Sun, Xiao Maansson, Roger Moeller, Erin Christiano, Susan Chen, Joshua
dc.subject.en.pt_BR.fl_str_mv	HPV Immunogenicity Lot consistency NCT# 00943722 Vaccine Vaccination
topic	HPV Immunogenicity Lot consistency NCT# 00943722 Vaccine Vaccination Anticorpos Antivirais/sangue Vacinas contra Papillomavirus/administração & dosagem Vacinas contra Papillomavirus/imunologia Vacinas de Partículas Semelhantes a Vírus/administração & dosagem Vacinas de Partículas Semelhantes a Vírus/imunologia Adolescente Adulto Bioestatística/métodos Criança Feminino Humanos Masculino Resultado do Tratamento Estados Unidos Adulto Jovem
dc.subject.decs.pt_BR.fl_str_mv	Anticorpos Antivirais/sangue Vacinas contra Papillomavirus/administração & dosagem Vacinas contra Papillomavirus/imunologia Vacinas de Partículas Semelhantes a Vírus/administração & dosagem Vacinas de Partículas Semelhantes a Vírus/imunologia Adolescente Adulto Bioestatística/métodos Criança Feminino Humanos Masculino Resultado do Tratamento Estados Unidos Adulto Jovem
description	Merck & Co. Inc. Whitehouse Station. NJ, USA
publishDate	2015
dc.date.issued.fl_str_mv	2015
dc.date.accessioned.fl_str_mv	2016-05-19T16:52:18Z
dc.date.available.fl_str_mv	2016-05-19T16:52:18Z
dc.type.status.fl_str_mv	info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv	info:eu-repo/semantics/article
format	article
status_str	publishedVersion
dc.identifier.citation.fl_str_mv	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.uri.fl_str_mv	https://www.arca.fiocruz.br/handle/icict/14399
dc.identifier.issn.none.fl_str_mv	2164-5515
dc.identifier.doi.none.fl_str_mv	/dx.doi.org/10.1080/21645515.2015.1009819
identifier_str_mv	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. 2164-5515 /dx.doi.org/10.1080/21645515.2015.1009819
url	https://www.arca.fiocruz.br/handle/icict/14399
dc.language.iso.fl_str_mv	eng
language	eng
dc.rights.driver.fl_str_mv	info:eu-repo/semantics/openAccess
eu_rights_str_mv	openAccess
dc.publisher.none.fl_str_mv	Taylor & Francis: STM, Behavioural Science and Public Health Titles
publisher.none.fl_str_mv	Taylor & Francis: STM, Behavioural Science and Public Health Titles
dc.source.none.fl_str_mv	reponame:Repositório Institucional da FIOCRUZ (ARCA) instname:Fundação Oswaldo Cruz (FIOCRUZ) instacron:FIOCRUZ
instname_str	Fundação Oswaldo Cruz (FIOCRUZ)
instacron_str	FIOCRUZ
institution	FIOCRUZ
reponame_str	Repositório Institucional da FIOCRUZ (ARCA)
collection	Repositório Institucional da FIOCRUZ (ARCA)
bitstream.url.fl_str_mv	https://www.arca.fiocruz.br/bitstream/icict/14399/1/license.txt https://www.arca.fiocruz.br/bitstream/icict/14399/2/Luxembourg%20A%20Phase%20III%20randomized....pdf https://www.arca.fiocruz.br/bitstream/icict/14399/3/Luxembourg%20A%20Phase%20III%20randomized....pdf.txt
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repository.name.fl_str_mv	Repositório Institucional da FIOCRUZ (ARCA) - Fundação Oswaldo Cruz (FIOCRUZ)
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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.

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