Please use this identifier to cite or link to this item: https://www.arca.fiocruz.br/handle/icict/18198
Title: Safety Profile of the 9-Valent HPV Vaccine: A Combined Analysis of 7 Phase III Clinical Trials
Authors: 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
Affilliation: Associação Obras Sociais Irmã Dulce. Salvador, BA, Brasil / Fundação Oswaldo Cruz. Centro de Pesquisas Gonçalo Moniz. Salvador, BA, Brasil
Kentucky Pediatric Adult Research, Inc. Bardstown, Kentucky
Augusta University. Medical College of Georgia. Department of Medicine. Augusta, Georgia
Center for Infection Research in Cancer, Moffitt Cancer Center. Tampa, Florida
University of Bergen. Department of Gynaecology. Bergen, Norway
Medical University of Vienna. Department of Obstetrics. Vienna, Austria
Khon Kaen University. Department of Medicine. Khon Kaen, Thailand
Universidad Del Desarrollo. Facultad de Medicina Clínica Alemana. Departamento de Ginecología y Obstetricia Clínica Alemana. Santiago, Chile
University of Antwerp. Centre for the Evaluation of Vaccination, Vaccine & Infectious Disease Institute. Antwerp, Belgium
J University Faculty of Medicine. Department of Obstetrics and Gynecology. Galilee Medical Center and BarIlan. Nahariya, Israel
Catalan Institute of Oncology/ IDIBELL. Barcelona, Spain
Medical University of Vienna. Department of Obstetrics. Vienna, Austria
Wolfson Institute of Preventive Medicine. London, United Kingdom
University of Melbourne and Murdoch Childrens Research Institute. Royal Women’s Hospital. Parkville, Australia
University of Alabama Birmingham. Division of Gynecologic Oncology. Birmingham, Alabama
University of Copenhagen. Danish Cancer Society Research Center and Department of Gynecology, Rigshospitalet. Copenhagen, Denmark
Merck & Co., Inc. Kenilworth, New Jersey
Merck & Co., Inc. Kenilworth, New Jersey
Merck & Co., Inc. Kenilworth, New Jersey
Merck & Co., Inc. Kenilworth, New Jersey
Merck & Co., Inc. Kenilworth, New Jersey
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. 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.
Keywords: HPV vaccines
Human Papillomavirus Vaccines
Human
Infection
Quadrivalent vaccine
keywords: Vacinas contra HPV
Vacinas contra papilomavírus humano
Humanos
Infecção
Vacina quadrivalente
Issue Date: 2016
Publisher: American Academy of Pediatrics
Citation: 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.
DOI: 10.1542/peds.2015-4387
ISSN: 1098-4275
Copyright: open access
Appears in Collections:BA - IGM - Artigos de Periódicos

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