Safety Profile of the 9-Valent HPV Vaccine: A Combined Analysis of 7 Phase III Clinical Trials

Detalhes bibliográficos
Autor(a) principal: Moreira Júnior, Edson Duarte
Data de Publicação: 2016
Outros Autores: Block, Stan L, Ferris, Daron, Giuliano, Anna R, Iversen, Ole-Erik, Joura, Elmar A, Kosalaraksa, Pope, Schilling, Andrea, Van Damme, Pierre, Bornstein, Jacob, Bosch, F Xavier, Pils, Sophie, Cuzick, Jack, Garland, Suzanne M, Huh, Warner, Kjaer, Susanne K, Qi, Hong, Hyatt, Donna, Martin, Jason, Moeller, Erin, Ritter, Michael, Baudin, Martine, 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/18860
Resumo: Edson D. Moreira Jr, MD, PhD, a Stan L. Block, MD, b Daron Ferris, MD, c Anna R. Giuliano, PhD, d Ole-Erik Iversen, MD, e Elmar A. Joura, MD, f Pope Kosalaraksa, MD, g Andrea Schilling, MD, h Pierre Van Damme, MD, PhD, i Jacob Bornstein, MD, MPA, j F. Xavier Bosch, MD, k Sophie Pils, MD, f Jack Cuzick, PhD, l Suzanne M. Garland, MD, m Warner Huh, MD, n Susanne K. Kjaer, MD, o Hong Qi, MD, MPH, p Donna Hyatt, BA, p Jason Martin, MS, p Erin Moeller, MPH, p Michael Ritter, BA, p Martine Baudin, MD, q Alain Luxembourg, MD, PhDp. aAssociação Obras Sociais Irmã Dulce and Oswaldo Cruz Foundation, Brazilian Ministry of Health, Bahia, Brazil; bKentucky Pediatric/Adult Research, Inc, Bardstown, Kentucky; cDepartment of Medicine, Medical College of Georgia, Augusta University, Augusta, Georgia; dCenter for Infection Research in Cancer, Moffi tt Cancer Center, Tampa, Florida; eDepartment of Gynaecology, University of Bergen, Bergen, Norway; fDepartment of Obstetrics, Medical University of Vienna, Vienna, Austria; gDepartment of Medicine, Khon Kaen University, Khon Kaen, Thailand; hDepartamento de Ginecología y Obstetricia Clínica Alemana, Facultad de Medicina Clínica Alemana— Universidad Del Desarrollo, Santiago, Chile; iCentre for the Evaluation of Vaccination, Vaccine & Infectious Disease Institute, University of Antwerp, Antwerp, Belgium; jDepartment of Obstetrics and Gynecology, Galilee Medical Center and Bar Ilan University Faculty of Medicine, Nahariya, Israel; kCatalan Institute of Oncology/ IDIBELL, Barcelona, Spain; lWolfson Institute of Preventive Medicine, London, United Kingdom; mRoyal Women’s Hospital, University of Melbourne and Murdoch Childrens Research Institute, Parkville, Australia; nDivision of Gynecologic Oncology, University of Alabama Birmingham, Birmingham, Alabama; oDanish Cancer Society Research Center and Department of Gynecology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark; pMerck & Co., Inc., Kenilworth, New Jersey; and qSanofi Pasteur MSD, Lyon, France.
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spelling Moreira Júnior, Edson DuarteBlock, Stan LFerris, DaronGiuliano, Anna RIversen, Ole-ErikJoura, Elmar AKosalaraksa, PopeSchilling, AndreaVan Damme, PierreBornstein, JacobBosch, F XavierPils, SophieCuzick, JackGarland, Suzanne MHuh, WarnerKjaer, Susanne KQi, HongHyatt, DonnaMartin, JasonMoeller, ErinRitter, MichaelBaudin, MartineLuxembourg, Alain2017-05-16T13:01:34Z2017-05-16T13:01:34Z2016MOREIRA JÚNIOR, E. D. Safety Profile of the 9-Valent HPV Vaccine: A Combined Analysis of 7 Phase III Clinical Trials. Pediatrics, v. 138, n. 2, e20154387, 2016.0031-4005https://www.arca.fiocruz.br/handle/icict/1886010.1542/peds.2015-4387Edson D. Moreira Jr, MD, PhD, a Stan L. Block, MD, b Daron Ferris, MD, c Anna R. Giuliano, PhD, d Ole-Erik Iversen, MD, e Elmar A. Joura, MD, f Pope Kosalaraksa, MD, g Andrea Schilling, MD, h Pierre Van Damme, MD, PhD, i Jacob Bornstein, MD, MPA, j F. Xavier Bosch, MD, k Sophie Pils, MD, f Jack Cuzick, PhD, l Suzanne M. Garland, MD, m Warner Huh, MD, n Susanne K. Kjaer, MD, o Hong Qi, MD, MPH, p Donna Hyatt, BA, p Jason Martin, MS, p Erin Moeller, MPH, p Michael Ritter, BA, p Martine Baudin, MD, q Alain Luxembourg, MD, PhDp. aAssociação Obras Sociais Irmã Dulce and Oswaldo Cruz Foundation, Brazilian Ministry of Health, Bahia, Brazil; bKentucky Pediatric/Adult Research, Inc, Bardstown, Kentucky; cDepartment of Medicine, Medical College of Georgia, Augusta University, Augusta, Georgia; dCenter for Infection Research in Cancer, Moffi tt Cancer Center, Tampa, Florida; eDepartment of Gynaecology, University of Bergen, Bergen, Norway; fDepartment of Obstetrics, Medical University of Vienna, Vienna, Austria; gDepartment of Medicine, Khon Kaen University, Khon Kaen, Thailand; hDepartamento de Ginecología y Obstetricia Clínica Alemana, Facultad de Medicina Clínica Alemana— Universidad Del Desarrollo, Santiago, Chile; iCentre for the Evaluation of Vaccination, Vaccine & Infectious Disease Institute, University of Antwerp, Antwerp, Belgium; jDepartment of Obstetrics and Gynecology, Galilee Medical Center and Bar Ilan University Faculty of Medicine, Nahariya, Israel; kCatalan Institute of Oncology/ IDIBELL, Barcelona, Spain; lWolfson Institute of Preventive Medicine, London, United Kingdom; mRoyal Women’s Hospital, University of Melbourne and Murdoch Childrens Research Institute, Parkville, Australia; nDivision of Gynecologic Oncology, University of Alabama Birmingham, Birmingham, Alabama; oDanish Cancer Society Research Center and Department of Gynecology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark; pMerck & Co., Inc., Kenilworth, New Jersey; and qSanofi Pasteur MSD, Lyon, France.Merck & Co., Inc., Kenilworth, New Jersey2017-08-31Associação Obras Sociais Irmã Dulce. Salvador, BA, Brasil / Fundação Oswaldo Cruz. Instituto Gonçalo Moniz. Salvador, BA, BrasilMúltipla - ver em NotasThe overall safety profile of the 9-valent human papillomavirus (9vHPV) vaccine was evaluated across 7 Phase III studies, conducted in males and females (nonpregnant at entry), 9 to 26 years of age. METHODS: Vaccination was administered as a 3-dose regimen at day 1, and months 2 and 6. More than 15 000 subjects received ≥1 dose of 9vHPV vaccine. In 2 of the studies, >7000 control subjects received ≥1 dose of quadrivalent HPV (qHPV) vaccine. Serious and nonserious adverse events (AEs) and new medical conditions were recorded throughout the study. Subjects testing positive for pregnancy at day 1 were not vaccinated; those who became pregnant after day 1 were discontinued from further vaccination until resolution of the pregnancy. Pregnancies detected after study start (n = 2950) were followed to outcome. RESULTS: The most common AEs (≥5%) experienced by 9vHPV vaccine recipients were injection-site AEs (pain, swelling, erythema) and vaccine-related systemic AEs (headache, pyrexia). Injection-site AEs were more common in 9vHPV vaccine than qHPV vaccine recipients; most were mild-to-moderate in intensity. Discontinuations and vaccine-related serious AEs were rare (0.1% and <0.1%, respectively). Seven deaths were reported; none were considered vaccine related. The proportions of pregnancies with adverse outcome were within ranges reported in the general population. CONCLUSIONS: The 9vHPV vaccine was generally well tolerated in subjects aged 9 to 26 years with an AE profile similar to that of the qHPV vaccine; injection-site AEs were more common with 9vHPV vaccine. Its additional coverage and safety profile support widespread 9vHPV vaccination.engAmerican Academy of PediatricsHPVVacina contra HPVPapilomavírus humanoVacinaçãoHumanosHPVHPV vaccineHuman papillomavirusVaccinationHumansHPVVacina contra HPVPapilomavírus humanoVacinaçãoHumanosSafety Profile of the 9-Valent HPV Vaccine: A Combined Analysis of 7 Phase III Clinical Trialsinfo: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/18860/1/license.txt5a560609d32a3863062d77ff32785d58MD51ORIGINALMoreira Jr ED Safety profile of the 9-valent....pdfMoreira Jr ED Safety profile of the 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dc.title.pt_BR.fl_str_mv Safety Profile of the 9-Valent HPV Vaccine: A Combined Analysis of 7 Phase III Clinical Trials
title Safety Profile of the 9-Valent HPV Vaccine: A Combined Analysis of 7 Phase III Clinical Trials
spellingShingle Safety Profile of the 9-Valent HPV Vaccine: A Combined Analysis of 7 Phase III Clinical Trials
Moreira Júnior, Edson Duarte
HPV
Vacina contra HPV
Papilomavírus humano
Vacinação
Humanos
HPV
HPV vaccine
Human papillomavirus
Vaccination
Humans
HPV
Vacina contra HPV
Papilomavírus humano
Vacinação
Humanos
title_short Safety Profile of the 9-Valent HPV Vaccine: A Combined Analysis of 7 Phase III Clinical Trials
title_full Safety Profile of the 9-Valent HPV Vaccine: A Combined Analysis of 7 Phase III Clinical Trials
title_fullStr Safety Profile of the 9-Valent HPV Vaccine: A Combined Analysis of 7 Phase III Clinical Trials
title_full_unstemmed Safety Profile of the 9-Valent HPV Vaccine: A Combined Analysis of 7 Phase III Clinical Trials
title_sort Safety Profile of the 9-Valent HPV Vaccine: A Combined Analysis of 7 Phase III Clinical Trials
author Moreira Júnior, Edson Duarte
author_facet Moreira Júnior, Edson Duarte
Block, Stan L
Ferris, Daron
Giuliano, Anna R
Iversen, Ole-Erik
Joura, Elmar A
Kosalaraksa, Pope
Schilling, Andrea
Van Damme, Pierre
Bornstein, Jacob
Bosch, F Xavier
Pils, Sophie
Cuzick, Jack
Garland, Suzanne M
Huh, Warner
Kjaer, Susanne K
Qi, Hong
Hyatt, Donna
Martin, Jason
Moeller, Erin
Ritter, Michael
Baudin, Martine
Luxembourg, Alain
author_role author
author2 Block, Stan L
Ferris, Daron
Giuliano, Anna R
Iversen, Ole-Erik
Joura, Elmar A
Kosalaraksa, Pope
Schilling, Andrea
Van Damme, Pierre
Bornstein, Jacob
Bosch, F Xavier
Pils, Sophie
Cuzick, Jack
Garland, Suzanne M
Huh, Warner
Kjaer, Susanne K
Qi, Hong
Hyatt, Donna
Martin, Jason
Moeller, Erin
Ritter, Michael
Baudin, Martine
Luxembourg, Alain
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.contributor.author.fl_str_mv Moreira Júnior, Edson Duarte
Block, Stan L
Ferris, Daron
Giuliano, Anna R
Iversen, Ole-Erik
Joura, Elmar A
Kosalaraksa, Pope
Schilling, Andrea
Van Damme, Pierre
Bornstein, Jacob
Bosch, F Xavier
Pils, Sophie
Cuzick, Jack
Garland, Suzanne M
Huh, Warner
Kjaer, Susanne K
Qi, Hong
Hyatt, Donna
Martin, Jason
Moeller, Erin
Ritter, Michael
Baudin, Martine
Luxembourg, Alain
dc.subject.other.pt_BR.fl_str_mv HPV
Vacina contra HPV
Papilomavírus humano
Vacinação
Humanos
topic HPV
Vacina contra HPV
Papilomavírus humano
Vacinação
Humanos
HPV
HPV vaccine
Human papillomavirus
Vaccination
Humans
HPV
Vacina contra HPV
Papilomavírus humano
Vacinação
Humanos
dc.subject.en.pt_BR.fl_str_mv HPV
HPV vaccine
Human papillomavirus
Vaccination
Humans
dc.subject.decs.pt_BR.fl_str_mv HPV
Vacina contra HPV
Papilomavírus humano
Vacinação
Humanos
description Edson D. Moreira Jr, MD, PhD, a Stan L. Block, MD, b Daron Ferris, MD, c Anna R. Giuliano, PhD, d Ole-Erik Iversen, MD, e Elmar A. Joura, MD, f Pope Kosalaraksa, MD, g Andrea Schilling, MD, h Pierre Van Damme, MD, PhD, i Jacob Bornstein, MD, MPA, j F. Xavier Bosch, MD, k Sophie Pils, MD, f Jack Cuzick, PhD, l Suzanne M. Garland, MD, m Warner Huh, MD, n Susanne K. Kjaer, MD, o Hong Qi, MD, MPH, p Donna Hyatt, BA, p Jason Martin, MS, p Erin Moeller, MPH, p Michael Ritter, BA, p Martine Baudin, MD, q Alain Luxembourg, MD, PhDp. aAssociação Obras Sociais Irmã Dulce and Oswaldo Cruz Foundation, Brazilian Ministry of Health, Bahia, Brazil; bKentucky Pediatric/Adult Research, Inc, Bardstown, Kentucky; cDepartment of Medicine, Medical College of Georgia, Augusta University, Augusta, Georgia; dCenter for Infection Research in Cancer, Moffi tt Cancer Center, Tampa, Florida; eDepartment of Gynaecology, University of Bergen, Bergen, Norway; fDepartment of Obstetrics, Medical University of Vienna, Vienna, Austria; gDepartment of Medicine, Khon Kaen University, Khon Kaen, Thailand; hDepartamento de Ginecología y Obstetricia Clínica Alemana, Facultad de Medicina Clínica Alemana— Universidad Del Desarrollo, Santiago, Chile; iCentre for the Evaluation of Vaccination, Vaccine & Infectious Disease Institute, University of Antwerp, Antwerp, Belgium; jDepartment of Obstetrics and Gynecology, Galilee Medical Center and Bar Ilan University Faculty of Medicine, Nahariya, Israel; kCatalan Institute of Oncology/ IDIBELL, Barcelona, Spain; lWolfson Institute of Preventive Medicine, London, United Kingdom; mRoyal Women’s Hospital, University of Melbourne and Murdoch Childrens Research Institute, Parkville, Australia; nDivision of Gynecologic Oncology, University of Alabama Birmingham, Birmingham, Alabama; oDanish Cancer Society Research Center and Department of Gynecology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark; pMerck & Co., Inc., Kenilworth, New Jersey; and qSanofi Pasteur MSD, Lyon, France.
publishDate 2016
dc.date.issued.fl_str_mv 2016
dc.date.accessioned.fl_str_mv 2017-05-16T13:01:34Z
dc.date.available.fl_str_mv 2017-05-16T13:01:34Z
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 JÚNIOR, E. D. Safety Profile of the 9-Valent HPV Vaccine: A Combined Analysis of 7 Phase III Clinical Trials. Pediatrics, v. 138, n. 2, e20154387, 2016.
dc.identifier.uri.fl_str_mv https://www.arca.fiocruz.br/handle/icict/18860
dc.identifier.issn.pt_BR.fl_str_mv 0031-4005
dc.identifier.doi.none.fl_str_mv 10.1542/peds.2015-4387
identifier_str_mv MOREIRA JÚNIOR, E. D. Safety Profile of the 9-Valent HPV Vaccine: A Combined Analysis of 7 Phase III Clinical Trials. Pediatrics, v. 138, n. 2, e20154387, 2016.
0031-4005
10.1542/peds.2015-4387
url https://www.arca.fiocruz.br/handle/icict/18860
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 American Academy of Pediatrics
publisher.none.fl_str_mv American Academy of Pediatrics
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/18860/1/license.txt
https://www.arca.fiocruz.br/bitstream/icict/18860/2/Moreira%20Jr%20ED%20Safety%20profile%20of%20the%209-valent....pdf
https://www.arca.fiocruz.br/bitstream/icict/18860/3/Moreira%20Jr%20ED%20Safety%20profile%20of%20the%209-valent....pdf.txt
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repository.name.fl_str_mv Repositório Institucional da FIOCRUZ (ARCA) - Fundação Oswaldo Cruz (FIOCRUZ)
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