Edson D Moreira1, Stan L Block2, Daron Ferris3, Anna R Giuliano4, Ole-Erik Iversen5, Elmar A Joura6, Pope Kosalaraksa7, Andrea Schilling8, Pierre Van Damme9, Jacob Bornstein10, F Xavier Bosch11, Sophie Pils6, Jack Cuzick12, Suzanne M Garland13, Warner Huh14, Susanne K Kjaer15, Hong Qi16, Donna Hyatt16, Jason Martin16, Erin Moeller16, Michael Ritter16, Martine Baudin17, Alain Luxembourg16. 1. Associação Obras Sociais Irmã Dulce and Oswaldo Cruz Foundation, Brazilian Ministry of Health, Bahia, Brazil; edson@bahia.fiocruz.br. 2. Kentucky Pediatric/Adult Research, Inc, Bardstown, Kentucky; 3. Department of Medicine, Medical College of Georgia, Augusta University, Augusta, Georgia; 4. Center for Infection Research in Cancer, Moffitt Cancer Center, Tampa, Florida; 5. Department of Gynaecology, University of Bergen, Bergen, Norway; 6. Department of Obstetrics, Medical University of Vienna, Vienna, Austria; 7. Department of Medicine, Khon Kaen University, Khon Kaen, Thailand; 8. Departamento de Ginecología y Obstetricia Clínica Alemana, Facultad de Medicina Clínica Alemana-Universidad Del Desarrollo, Santiago, Chile; 9. Centre for the Evaluation of Vaccination, Vaccine & Infectious Disease Institute, University of Antwerp, Antwerp, Belgium; 10. Department of Obstetrics and Gynecology, Galilee Medical Center and Bar Ilan University Faculty of Medicine, Nahariya, Israel; 11. Catalan Institute of Oncology/IDIBELL, Barcelona, Spain; 12. Wolfson Institute of Preventive Medicine, London, United Kingdom; 13. Royal Women's Hospital, University of Melbourne and Murdoch Childrens Research Institute, Parkville, Australia; 14. Division of Gynecologic Oncology, University of Alabama Birmingham, Birmingham, Alabama; 15. Danish Cancer Society Research Center and Department of Gynecology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark; 16. Merck & Co., Inc., Kenilworth, New Jersey; and. 17. Sanofi Pasteur MSD, Lyon, France.
Abstract
OBJECTIVES: 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.
OBJECTIVES: 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.
Authors: James G Donahue; Burney A Kieke; Edwin M Lewis; Eric S Weintraub; Kayla E Hanson; David L McClure; Elizabeth R Vickers; Julianne Gee; Matthew F Daley; Frank DeStefano; Rulin C Hechter; Lisa A Jackson; Nicola P Klein; Allison L Naleway; Jennifer C Nelson; Edward A Belongia Journal: Pediatrics Date: 2019-11-18 Impact factor: 7.124
Authors: Tom T Shimabukuro; John R Su; Paige L Marquez; Adamma Mba-Jonas; Jorge E Arana; Maria V Cano Journal: Pediatrics Date: 2019-11-18 Impact factor: 7.124
Authors: Mary Kate Kelly; Robert W Grundmeier; Alisa J Stephens-Shields; Russell Localio; Laura P Shone; Margaret Wright; Jennifer Steffes; Sharon G Humiston; Cynthia Rand; Christina Albertin; Abigail Breck; Dianna E Abney; Greta McFarland; Peter G Szilagyi; Alexander G Fiks Journal: Vaccine Date: 2020-06-12 Impact factor: 3.641