Safety profile of the 9-valent human papillomavirus vaccine: assessment in prior quadrivalent HPV vaccine recipients and in men 16 to 26 years of age

Detalhes bibliográficos
Autor(a) principal: Moreira Junior, Edson Duarte
Data de Publicação: 2018
Outros Autores: Giuliano, A R, Hoon, J de, Iversen, O-E, Joura, E A, Restrepo, J, Van Damme, P, Vandermeulen, C, Ellison, M C, Krick, A, Shields, C, Heiles, B, Luxembourg, Alain
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Institucional da FIOCRUZ (ARCA)
Texto Completo: https://www.arca.fiocruz.br/handle/icict/25354
Resumo: aCentro de Pesquisa Clınica, Associação Obras Sociais Irmã Dulce and Oswaldo Cruz Foundation, Brazilian Ministry of Health, Salvador, Bahia, Brazil; bDepartment of Cancer Epidemiology, Center for Infection Research (CIRC), Moffitt Cancer Center, Tampa, Florida, USA; cCenter for Clinical Pharmacology, Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium; dDepartment of Clinical Science, University of Bergen/Womens Clinic, Haukeland University Hospital, Bergen, Norway; eDepartment of Gynecology, Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria; fFundaci on Centro de Investigaci on Cl ınica CIC, Medell ın, Colombia; gUniversity of Antwerp, Vaccine & Infectious Disease Institute, Centre for the Evaluation of Vaccination, Antwerp, Belgium; hLeuven University Vaccinology Center, Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium; iMerck & Co. Inc., Kenilworth, New Jersey, USA
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spelling Moreira Junior, Edson DuarteGiuliano, A RHoon, J deIversen, O-EJoura, E ARestrepo, JVan Damme, PVandermeulen, CEllison, M CKrick, AShields, CHeiles, BLuxembourg, Alain2018-03-16T17:42:41Z2018-03-16T17:42:41Z2018MOREIRA JUNIOR, E. D. et al. Safety profile of the 9-valent human papillomavirus vaccine: assessment in prior quadrivalent HPV vaccine recipients and in men 16 to 26 years of age. Human Vaccines and Immunotherapeutics, v. 14, n. 2, p. 396–403, 2018.2164-5515https://www.arca.fiocruz.br/handle/icict/2535410.1080/21645515.2017.1403700aCentro de Pesquisa Clınica, Associação Obras Sociais Irmã Dulce and Oswaldo Cruz Foundation, Brazilian Ministry of Health, Salvador, Bahia, Brazil; bDepartment of Cancer Epidemiology, Center for Infection Research (CIRC), Moffitt Cancer Center, Tampa, Florida, USA; cCenter for Clinical Pharmacology, Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium; dDepartment of Clinical Science, University of Bergen/Womens Clinic, Haukeland University Hospital, Bergen, Norway; eDepartment of Gynecology, Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria; fFundaci on Centro de Investigaci on Cl ınica CIC, Medell ın, Colombia; gUniversity of Antwerp, Vaccine & Infectious Disease Institute, Centre for the Evaluation of Vaccination, Antwerp, Belgium; hLeuven University Vaccinology Center, Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium; iMerck & Co. Inc., Kenilworth, New Jersey, USAMerck & Co., Inc., Kenilworth, NJ USAAssociação Obras Sociais Irmã Dulce. Centro de Pesquisa Clínica. Salvador, BA, Brasil / Fundação Oswaldo Cruz. Instituto Gonçalo Moniz. Salvador, BA, BrasilMúltipla - ver em NotasA 9-valent HPV (9vHPV) vaccine has been developed to protect against HPV type 6/11/16/18/31/33/45/52/58-related infection and disease. Previous safety analyses from 7 clinical trials conducted in 9vHPV vaccine recipients 9-26 years of age, including comparisons of 9vHPV and quadrivalent HPV (qHPV) vaccines in girls and women 16-26 years of age, showed that the 9vHPV vaccine was generally well tolerated. Additional safety analyses were conducted to include the results of new clinical studies. The safety profile of the 9vHPV vaccine in prior qHPV vaccine recipients (n = 3756 from 1 randomized controlled trial and 2 open-label extension studies) and young men (n = 248 9vHPV and n = 248 qHPV vaccine recipients from 1 randomized controlled trial) was evaluated. Vaccine was administered as a 3-dose regimen (at Day 1 and Months 2 and 6), and adverse events (AEs) were monitored. The most common AEs were injection-site events (91.1% and 79.0% in prior qHPV vaccine recipients and young men, respectively), the majority of which were mild. Discontinuations due to an AE were rare (0.2% and 0.0% among prior qHPV vaccine recipients and young men, respectively). In young men, the AE profile of the 9vHPV vaccine was generally similar to that of the qHPV vaccine. Overall, the 9vHPV vaccine was generally well tolerated in prior qHPV vaccine recipients and in young men, with an AE profile generally consistent with that previously reported with the broader clinical program.engTaylor & FrancisHPVPapiloma virus humano - HPVVacinas contra HPV9vHPVCervical canJEL CODEVaccines against HPVSafety profile of the 9-valent human papillomavirus vaccine: assessment in prior quadrivalent HPV vaccine recipients and in men 16 to 26 years of ageinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleinfo: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/25354/1/license.txt5a560609d32a3863062d77ff32785d58MD51ORIGINALMoreira ED Safety profile of the 9-valent human papillomavirus ....pdfMoreira ED Safety profile of the 9-valent human papillomavirus 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dc.title.pt_BR.fl_str_mv Safety profile of the 9-valent human papillomavirus vaccine: assessment in prior quadrivalent HPV vaccine recipients and in men 16 to 26 years of age
title Safety profile of the 9-valent human papillomavirus vaccine: assessment in prior quadrivalent HPV vaccine recipients and in men 16 to 26 years of age
spellingShingle Safety profile of the 9-valent human papillomavirus vaccine: assessment in prior quadrivalent HPV vaccine recipients and in men 16 to 26 years of age
Moreira Junior, Edson Duarte
HPV
Papiloma virus humano - HPV
Vacinas contra HPV
9vHPV
Cervical canJEL CODE
Vaccines against HPV
title_short Safety profile of the 9-valent human papillomavirus vaccine: assessment in prior quadrivalent HPV vaccine recipients and in men 16 to 26 years of age
title_full Safety profile of the 9-valent human papillomavirus vaccine: assessment in prior quadrivalent HPV vaccine recipients and in men 16 to 26 years of age
title_fullStr Safety profile of the 9-valent human papillomavirus vaccine: assessment in prior quadrivalent HPV vaccine recipients and in men 16 to 26 years of age
title_full_unstemmed Safety profile of the 9-valent human papillomavirus vaccine: assessment in prior quadrivalent HPV vaccine recipients and in men 16 to 26 years of age
title_sort Safety profile of the 9-valent human papillomavirus vaccine: assessment in prior quadrivalent HPV vaccine recipients and in men 16 to 26 years of age
author Moreira Junior, Edson Duarte
author_facet Moreira Junior, Edson Duarte
Giuliano, A R
Hoon, J de
Iversen, O-E
Joura, E A
Restrepo, J
Van Damme, P
Vandermeulen, C
Ellison, M C
Krick, A
Shields, C
Heiles, B
Luxembourg, Alain
author_role author
author2 Giuliano, A R
Hoon, J de
Iversen, O-E
Joura, E A
Restrepo, J
Van Damme, P
Vandermeulen, C
Ellison, M C
Krick, A
Shields, C
Heiles, B
Luxembourg, Alain
author2_role author
author
author
author
author
author
author
author
author
author
author
author
dc.contributor.author.fl_str_mv Moreira Junior, Edson Duarte
Giuliano, A R
Hoon, J de
Iversen, O-E
Joura, E A
Restrepo, J
Van Damme, P
Vandermeulen, C
Ellison, M C
Krick, A
Shields, C
Heiles, B
Luxembourg, Alain
dc.subject.other.pt_BR.fl_str_mv HPV
Papiloma virus humano - HPV
Vacinas contra HPV
topic HPV
Papiloma virus humano - HPV
Vacinas contra HPV
9vHPV
Cervical canJEL CODE
Vaccines against HPV
dc.subject.en.pt_BR.fl_str_mv 9vHPV
Cervical canJEL CODE
Vaccines against HPV
description aCentro de Pesquisa Clınica, Associação Obras Sociais Irmã Dulce and Oswaldo Cruz Foundation, Brazilian Ministry of Health, Salvador, Bahia, Brazil; bDepartment of Cancer Epidemiology, Center for Infection Research (CIRC), Moffitt Cancer Center, Tampa, Florida, USA; cCenter for Clinical Pharmacology, Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium; dDepartment of Clinical Science, University of Bergen/Womens Clinic, Haukeland University Hospital, Bergen, Norway; eDepartment of Gynecology, Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria; fFundaci on Centro de Investigaci on Cl ınica CIC, Medell ın, Colombia; gUniversity of Antwerp, Vaccine & Infectious Disease Institute, Centre for the Evaluation of Vaccination, Antwerp, Belgium; hLeuven University Vaccinology Center, Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium; iMerck & Co. Inc., Kenilworth, New Jersey, USA
publishDate 2018
dc.date.accessioned.fl_str_mv 2018-03-16T17:42:41Z
dc.date.available.fl_str_mv 2018-03-16T17:42:41Z
dc.date.issued.fl_str_mv 2018
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 MOREIRA JUNIOR, E. D. et al. Safety profile of the 9-valent human papillomavirus vaccine: assessment in prior quadrivalent HPV vaccine recipients and in men 16 to 26 years of age. Human Vaccines and Immunotherapeutics, v. 14, n. 2, p. 396–403, 2018.
dc.identifier.uri.fl_str_mv https://www.arca.fiocruz.br/handle/icict/25354
dc.identifier.issn.pt_BR.fl_str_mv 2164-5515
dc.identifier.eissn.none.fl_str_mv 10.1080/21645515.2017.1403700
identifier_str_mv MOREIRA JUNIOR, E. D. et al. Safety profile of the 9-valent human papillomavirus vaccine: assessment in prior quadrivalent HPV vaccine recipients and in men 16 to 26 years of age. Human Vaccines and Immunotherapeutics, v. 14, n. 2, p. 396–403, 2018.
2164-5515
10.1080/21645515.2017.1403700
url https://www.arca.fiocruz.br/handle/icict/25354
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language eng
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dc.publisher.none.fl_str_mv Taylor & Francis
publisher.none.fl_str_mv Taylor & Francis
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instname_str Fundação Oswaldo Cruz (FIOCRUZ)
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collection Repositório Institucional da FIOCRUZ (ARCA)
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