title: Six-year multi-centre, observational, post-marketing surveillance of the safety of the HPV-16/18 AS04-adjuvanted vaccine in women aged 10-25 years in Korea.
abstract: OBJECTIVE
  To evaluate the safety of HPV-16/18 AS04-adjuvanted vaccine when administered as per the PI in Korea.
  
  
  METHODS
  A total of 3084 women aged 10-25 years were enrolled in this post-marketing surveillance from 2008 to 2014. Subjects were invited to receive three doses of the vaccine (0, 1 and 6 months), and participants who received at least one dose were included in the analysis. Adverse events (AEs), adverse drug reactions (ADRs) and serious AEs (SAEs) were recorded after each dose. All AEs, ADRs and SAEs were presented with exact 95% confidence intervals (CI) (NCT01101542).
  
  
  RESULTS
  Injection-site pain was the most frequent AE and ADR reported by 322 subjects (10.4% [95%CI: 9.4-11.6]); the local pain was transient and lasted 4-7 days in most cases. Dysmenorrhoea and vaginitis were the most common unexpected AEs reported by 30 (1.0% [95%CI: 0.7-1.4]) and 16 subjects (0.7% [95%CI: 0.3-0.8]), respectively. Pain (toe pain, leg pain and body pain [one case each]; foot pain [two cases]) was the most common unexpected ADR reported by five subjects (0.2% [95%CI: 0.1-0.4]). Four subjects reported a single SAE (one case each of exostosis, gastroenteritis, abortion and tonsillitis); none were fatal. All SAEs were assessed as unlikely to be related to vaccination; gastroenteritis, exostosis and tonsillitis resolved during the study period.
  
  
  CONCLUSIONS
  This is the first post-marketing surveillance study in Korea that provides 6-year safety data for HPV-16/18 AS04-adjuvanted vaccine. The vaccine showed an acceptable safety profile and favourable benefit/risk ratio when given to women aged 10-25 years in Korea. © 2017 The Authors. Pharmacoepidemiology & Drug Safety Published by John Wiley & Sons Ltd.
authors.affiliation: Department of Obstetrics and Gynecology, College of Medicine, Konyang University, Daejeon, Korea.
authors.forename: Chul-Jung
authors.initials: CJ
authors.lastname: Kim
authors.affiliation: GSK Vaccines, Seoul, Korea.
authors.forename: Rok
authors.initials: R
authors.lastname: Song
authors.affiliation: GSK Pte Ltd, Singapore, Singapore.
authors.forename: Jing
authors.initials: J
authors.lastname: Chen
authors.affiliation: GSK Vaccines, Wavre, Belgium.
authors.forename: Fernanda
authors.initials: F
authors.lastname: Tavares Da Silva
authors.affiliation: GSK Pharmaceuticals Ltd, Bangalore, India.
authors.forename: Kusuma B
authors.initials: KB
authors.lastname: Gopala
authors.affiliation: GSK Vaccines, Seoul, Korea.
authors.forename: Joon Hyung
authors.initials: JH
authors.lastname: Kim
authors.affiliation: GSK Vaccines, Wavre, Belgium.
authors.forename: Dan
authors.initials: D
authors.lastname: Bi
authors.affiliation: Department of Obstetrics and Gynecology, Seoul St. Mary's Hospital, The Catholic University of Korea, Seoul, Korea.
authors.forename: Jong Sup
authors.identifier: http://orcid.org/0000-0003-4086-4885
authors.initials: JS
authors.lastname: Park
mesh_terms: D000293:Adolescent; D000328:Adult; D002648:Child; D005260:Female; D052162:Human papillomavirus 16 / Q000276:immunology; D052161:Human papillomavirus 18 / Q000276:immunology; D006801:Humans; D030361:Papillomavirus Infections / Q000453:epidemiology / Q000517:prevention & control*; D053918:Papillomavirus Vaccines / Q000009:adverse effects* / Q000276:immunology*; D011358:Product Surveillance, Postmarketing; D056910:Republic of Korea / Q000453:epidemiology; D055815:Young Adult
chemical_list: D053918:Papillomavirus Vaccines
keywords: HPV-16/18 AS04-adjuvanted vaccine; Korea; post-marketing surveillance; safety