Safety Profile of the 9-Valent HPV Vaccine: A Combined Analysis of 7 Phase III Clinical Trials
| Autor(a) principal: | |
|---|---|
| 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/18198 |
Resumo: | Merck & Co., Inc., Kenilworth, New Jersey |
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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, Alain2017-03-29T17:54:30Z2017-03-29T17:54:30Z2016MOREIRA JUNIOR, E. D. et al. Safety Profile of the 9-Valent HPV Vaccine: A Combined Analysis of 7 Phase III Clinical Trials. Pediatrics, v. 138, n. 2, e2 0154387, 2016.1098-4275https://www.arca.fiocruz.br/handle/icict/1819810.1542/peds.2015-4387Merck & Co., Inc., Kenilworth, New JerseyAssociação Obras Sociais Irmã Dulce. Salvador, BA, Brasil / Fundação Oswaldo Cruz. Centro de Pesquisas Gonçalo Moniz. Salvador, BA, BrasilKentucky Pediatric Adult Research, Inc. Bardstown, KentuckyAugusta University. Medical College of Georgia. Department of Medicine. Augusta, GeorgiaCenter for Infection Research in Cancer, Moffitt Cancer Center. Tampa, FloridaUniversity of Bergen. Department of Gynaecology. Bergen, NorwayMedical University of Vienna. Department of Obstetrics. Vienna, AustriaKhon Kaen University. Department of Medicine. Khon Kaen, ThailandUniversidad Del Desarrollo. Facultad de Medicina Clínica Alemana. Departamento de Ginecología y Obstetricia Clínica Alemana. Santiago, ChileUniversity of Antwerp. Centre for the Evaluation of Vaccination, Vaccine & Infectious Disease Institute. Antwerp, BelgiumJ University Faculty of Medicine. Department of Obstetrics and Gynecology. Galilee Medical Center and BarIlan. Nahariya, IsraelCatalan Institute of Oncology/ IDIBELL. Barcelona, SpainMedical University of Vienna. Department of Obstetrics. Vienna, AustriaWolfson Institute of Preventive Medicine. London, United KingdomUniversity of Melbourne and Murdoch Childrens Research Institute. Royal Women’s Hospital. Parkville, AustraliaUniversity of Alabama Birmingham. Division of Gynecologic Oncology. Birmingham, AlabamaUniversity of Copenhagen. Danish Cancer Society Research Center and Department of Gynecology, Rigshospitalet. Copenhagen, DenmarkMerck & Co., Inc. Kenilworth, New JerseyMerck & Co., Inc. Kenilworth, New JerseyMerck & Co., Inc. Kenilworth, New JerseyMerck & Co., Inc. Kenilworth, New JerseyMerck & Co., Inc. Kenilworth, New JerseyThe 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. OBJECTIVES: The overall safety profile of the 9-valent human papillomavirus (9vHPV) vaccine abstract 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 PediatricsVacinas contra HPVVacinas contra papilomavírus humanoHumanosInfecçãoVacina quadrivalenteHPV vaccinesHuman Papillomavirus VaccinesHumanInfectionQuadrivalent vaccineSafety 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/18198/1/license.txt5a560609d32a3863062d77ff32785d58MD51ORIGINALMorerira JR ED Safety of GARDASIL 9-Combined Analysis of Clinical Trials.pdfMorerira JR ED Safety of GARDASIL 9-Combined Analysis of Clinical Trials.pdfapplication/pdf669279https://www.arca.fiocruz.br/bitstream/icict/18198/2/Morerira%20JR%20ED%20Safety%20of%20GARDASIL%209-Combined%20Analysis%20of%20Clinical%20Trials.pdfd285f342679b856b3ac68d80ecfb0555MD52TEXTMorerira JR ED Safety of GARDASIL 9-Combined Analysis of Clinical Trials.pdf.txtMorerira JR ED Safety of GARDASIL 9-Combined Analysis of Clinical Trials.pdf.txtExtracted texttext/plain70911https://www.arca.fiocruz.br/bitstream/icict/18198/3/Morerira%20JR%20ED%20Safety%20of%20GARDASIL%209-Combined%20Analysis%20of%20Clinical%20Trials.pdf.txt37cc66efbbbee876a7ee08d98eaeac6eMD53icict/181982023-03-15 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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 Vacinas contra HPV Vacinas contra papilomavírus humano Humanos Infecção Vacina quadrivalente HPV vaccines Human Papillomavirus Vaccines Human Infection Quadrivalent vaccine |
| 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 |
Vacinas contra HPV Vacinas contra papilomavírus humano Humanos Infecção Vacina quadrivalente |
| topic |
Vacinas contra HPV Vacinas contra papilomavírus humano Humanos Infecção Vacina quadrivalente HPV vaccines Human Papillomavirus Vaccines Human Infection Quadrivalent vaccine |
| dc.subject.en.pt_BR.fl_str_mv |
HPV vaccines Human Papillomavirus Vaccines Human Infection Quadrivalent vaccine |
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Merck & Co., Inc., Kenilworth, New Jersey |
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2016 |
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2016 |
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2017-03-29T17:54:30Z |
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2017-03-29T17:54:30Z |
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MOREIRA JUNIOR, E. D. et al. Safety Profile of the 9-Valent HPV Vaccine: A Combined Analysis of 7 Phase III Clinical Trials. Pediatrics, v. 138, n. 2, e2 0154387, 2016. |
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https://www.arca.fiocruz.br/handle/icict/18198 |
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1098-4275 |
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10.1542/peds.2015-4387 |
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MOREIRA JUNIOR, E. D. et al. Safety Profile of the 9-Valent HPV Vaccine: A Combined Analysis of 7 Phase III Clinical Trials. Pediatrics, v. 138, n. 2, e2 0154387, 2016. 1098-4275 10.1542/peds.2015-4387 |
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American Academy of Pediatrics |
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American Academy of Pediatrics |
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