Safety Profile of the 9-Valent HPV Vaccine: A Combined Analysis of 7 Phase III Clinical Trials
Autor(a) principal: | |
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Data de Publicação: | 2016 |
Outros Autores: | , , , , , , , , , , , , , , , , , , , , , |
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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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. |
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2016 |
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2016 |
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2017-05-16T13:01:34Z |
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2017-05-16T13:01:34Z |
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info:eu-repo/semantics/publishedVersion |
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info:eu-repo/semantics/article |
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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 |
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eng |
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info:eu-repo/semantics/openAccess |
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dc.publisher.none.fl_str_mv |
American Academy of Pediatrics |
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American Academy of Pediatrics |
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