| Author | Moreira Júnior, Edson Duarte | |
| Author | Block, Stan L | |
| Author | Ferris, Daron | |
| Author | Giuliano, Anna R | |
| Author | Iversen, Ole-Erik | |
| Author | Joura, Elmar A | |
| Author | Kosalaraksa, Pope | |
| Author | Schilling, Andrea | |
| Author | Van Damme, Pierre | |
| Author | Bornstein, Jacob | |
| Author | Bosch, F Xavier | |
| Author | Pils, Sophie | |
| Author | Cuzick, Jack | |
| Author | Garland, Suzanne M | |
| Author | Huh, Warner | |
| Author | Kjaer, Susanne K | |
| Author | Qi, Hong | |
| Author | Hyatt, Donna | |
| Author | Martin, Jason | |
| Author | Moeller, Erin | |
| Author | Ritter, Michael | |
| Author | Baudin, Martine | |
| Author | Luxembourg, Alain | |
| Access date | 2017-05-16T13:01:34Z | |
| Available date | 2017-05-16T13:01:34Z | |
| Document date | 2016 | |
| Citation | 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. | pt_BR |
| ISSN | 0031-4005 | pt_BR |
| URI | https://www.arca.fiocruz.br/handle/icict/18860 | |
| 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. | pt_BR |
| Sponsorship | Merck & Co., Inc., Kenilworth, New Jersey | pt_BR |
| Language | eng | pt_BR |
| Publisher | American Academy of Pediatrics | pt_BR |
| Rights | open access | pt_BR |
| Subject in Portuguese | HPV | pt_BR |
| Subject in Portuguese | Vacina contra HPV | pt_BR |
| Subject in Portuguese | Papilomavírus humano | pt_BR |
| Subject in Portuguese | Vacinação | pt_BR |
| Subject in Portuguese | Humanos | pt_BR |
| Title | Safety Profile of the 9-Valent HPV Vaccine: A Combined Analysis of 7 Phase III Clinical Trials | pt_BR |
| Type | Article | pt_BR |
| DOI | 10.1542/peds.2015-4387 | |
| Abstract | The 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. | pt_BR |
| Affilliation | Associação Obras Sociais Irmã Dulce. Salvador, BA, Brasil / Fundação Oswaldo Cruz. Instituto Gonçalo Moniz. Salvador, BA, Brasil | pt_BR |
| Affilliation | Múltipla - ver em Notas | pt_BR |
| Subject | HPV | pt_BR |
| Subject | HPV vaccine | pt_BR |
| Subject | Human papillomavirus | pt_BR |
| Subject | Vaccination | pt_BR |
| Subject | Humans | pt_BR |
| DeCS | HPV | pt_BR |
| DeCS | Vacina contra HPV | pt_BR |
| DeCS | Papilomavírus humano | pt_BR |
| DeCS | Vacinação | pt_BR |
| DeCS | Humanos | pt_BR |
| Embargo date | 2017-08-31 | |
| xmlui.metadata.dc.subject.ods | 03 Saúde e Bem-Estar |
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