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

dc.creatorMoreira Júnior, Edson Duarte
dc.creatorBlock, Stan L
dc.creatorFerris, Daron
dc.creatorGiuliano, Anna R
dc.creatorIversen, Ole-Erik
dc.creatorJoura, Elmar A
dc.creatorKosalaraksa, Pope
dc.creatorSchilling, Andrea
dc.creatorVan Damme, Pierre
dc.creatorBornstein, Jacob
dc.creatorBosch, F Xavier
dc.creatorPils, Sophie
dc.creatorCuzick, Jack
dc.creatorGarland, Suzanne M
dc.creatorHuh, Warner
dc.creatorKjaer, Susanne K
dc.creatorQi, Hong
dc.creatorHyatt, Donna
dc.creatorMartin, Jason
dc.creatorMoeller, Erin
dc.creatorRitter, Michael
dc.creatorBaudin, Martine
dc.creatorLuxembourg, Alain
dc.date2017-05-16T13:01:34Z
dc.date2017-05-16T13:01:34Z
dc.date2016
dc.date.accessioned2023-09-26T23:33:05Z
dc.date.available2023-09-26T23:33:05Z
dc.identifierMOREIRA 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.identifier0031-4005
dc.identifierhttps://www.arca.fiocruz.br/handle/icict/18860
dc.identifier10.1542/peds.2015-4387
dc.identifier.urihttps://repositorioslatinoamericanos.uchile.cl/handle/2250/8891786
dc.descriptionEdson 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.
dc.descriptionMerck & Co., Inc., Kenilworth, New Jersey
dc.descriptionThe 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.
dc.description2017-08-31
dc.formatapplication/pdf
dc.languageeng
dc.publisherAmerican Academy of Pediatrics
dc.rightsopen access
dc.subjectHPV
dc.subjectVacina contra HPV
dc.subjectPapilomavírus humano
dc.subjectVacinação
dc.subjectHumanos
dc.subjectHPV
dc.subjectHPV vaccine
dc.subjectHuman papillomavirus
dc.subjectVaccination
dc.subjectHumans
dc.subjectHPV
dc.subjectVacina contra HPV
dc.subjectPapilomavírus humano
dc.subjectVacinação
dc.subjectHumanos
dc.titleSafety Profile of the 9-Valent HPV Vaccine: A Combined Analysis of 7 Phase III Clinical Trials
dc.typeArticle


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