title: Safety Profile of the 9-Valent HPV Vaccine: A Combined Analysis of 7 Phase III Clinical Trials.
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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  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.affiliation: Associação Obras Sociais Irmã Dulce and Oswaldo Cruz Foundation, Brazilian Ministry of Health, Bahia, Brazil; edson@bahia.fiocruz.br.
authors.forename: Edson D
authors.initials: ED
authors.lastname: Moreira
authors.affiliation: Kentucky Pediatric/Adult Research, Inc, Bardstown, Kentucky;
authors.forename: Stan L
authors.initials: SL
authors.lastname: Block
authors.affiliation: Department of Medicine, Medical College of Georgia, Augusta University, Augusta, Georgia;
authors.forename: Daron
authors.initials: D
authors.lastname: Ferris
authors.affiliation: Center for Infection Research in Cancer, Moffitt Cancer Center, Tampa, Florida;
authors.forename: Anna R
authors.initials: AR
authors.lastname: Giuliano
authors.affiliation: Department of Gynaecology, University of Bergen, Bergen, Norway;
authors.forename: Ole-Erik
authors.initials: OE
authors.lastname: Iversen
authors.affiliation: Department of Obstetrics, Medical University of Vienna, Vienna, Austria;
authors.forename: Elmar A
authors.initials: EA
authors.lastname: Joura
authors.affiliation: Department of Medicine, Khon Kaen University, Khon Kaen, Thailand;
authors.forename: Pope
authors.initials: P
authors.lastname: Kosalaraksa
authors.affiliation: Departamento de Ginecología y Obstetricia Clínica Alemana, Facultad de Medicina Clínica Alemana-Universidad Del Desarrollo, Santiago, Chile;
authors.forename: Andrea
authors.initials: A
authors.lastname: Schilling
authors.affiliation: Centre for the Evaluation of Vaccination, Vaccine & Infectious Disease Institute, University of Antwerp, Antwerp, Belgium;
authors.forename: Pierre
authors.initials: P
authors.lastname: Van Damme
authors.affiliation: Department of Obstetrics and Gynecology, Galilee Medical Center and Bar Ilan University Faculty of Medicine, Nahariya, Israel;
authors.forename: Jacob
authors.initials: J
authors.lastname: Bornstein
authors.affiliation: Catalan Institute of Oncology/IDIBELL, Barcelona, Spain;
authors.forename: F Xavier
authors.initials: FX
authors.lastname: Bosch
authors.affiliation: Department of Obstetrics, Medical University of Vienna, Vienna, Austria;
authors.forename: Sophie
authors.initials: S
authors.lastname: Pils
authors.affiliation: Wolfson Institute of Preventive Medicine, London, United Kingdom;
authors.forename: Jack
authors.initials: J
authors.lastname: Cuzick
authors.affiliation: Royal Women's Hospital, University of Melbourne and Murdoch Childrens Research Institute, Parkville, Australia;
authors.forename: Suzanne M
authors.initials: SM
authors.lastname: Garland
authors.affiliation: Division of Gynecologic Oncology, University of Alabama Birmingham, Birmingham, Alabama;
authors.forename: Warner
authors.initials: W
authors.lastname: Huh
authors.affiliation: Danish Cancer Society Research Center and Department of Gynecology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark;
authors.forename: Susanne K
authors.initials: SK
authors.lastname: Kjaer
authors.affiliation: Merck & Co., Inc., Kenilworth, New Jersey; and.
authors.forename: Hong
authors.initials: H
authors.lastname: Qi
authors.affiliation: Merck & Co., Inc., Kenilworth, New Jersey; and.
authors.forename: Donna
authors.initials: D
authors.lastname: Hyatt
authors.affiliation: Merck & Co., Inc., Kenilworth, New Jersey; and.
authors.forename: Jason
authors.initials: J
authors.lastname: Martin
authors.affiliation: Merck & Co., Inc., Kenilworth, New Jersey; and.
authors.forename: Erin
authors.initials: E
authors.lastname: Moeller
authors.affiliation: Merck & Co., Inc., Kenilworth, New Jersey; and.
authors.forename: Michael
authors.initials: M
authors.lastname: Ritter
authors.affiliation: Sanofi Pasteur MSD, Lyon, France.
authors.forename: Martine
authors.initials: M
authors.lastname: Baudin
authors.affiliation: Merck & Co., Inc., Kenilworth, New Jersey; and.
authors.forename: Alain
authors.initials: A
authors.lastname: Luxembourg
mesh_terms: D000293:Adolescent; D000328:Adult; D002648:Child; D017326:Clinical Trials, Phase III as Topic; D004487:Edema / Q000209:etiology; D004890:Erythema / Q000209:etiology; D005260:Female; D005334:Fever / Q000209:etiology; D005500:Follow-Up Studies; D006261:Headache / Q000209:etiology; D006801:Humans; D007115:Immunization Schedule; D008297:Male; D017063:Outcome Assessment, Health Care; D010146:Pain / Q000209:etiology; D053918:Papillomavirus Vaccines / Q000008:administration & dosage / Q000009:adverse effects*; D011247:Pregnancy; D011248:Pregnancy Complications / Q000209:etiology; D011256:Pregnancy Outcome; D055815:Young Adult
chemical_list: D053918:Papillomavirus Vaccines