PMID- 36896702
OWN - NLM
STAT- MEDLINE
DCOM- 20230316
LR  - 20230330
IS  - 2164-554X (Electronic)
IS  - 2164-5515 (Print)
IS  - 2164-5515 (Linking)
VI  - 19
IP  - 1
DP  - 2023 Dec 31
TI  - Post-marketing surveillance study of the safety of the HPV-16/18 vaccine in Korea 
      (2017-2021).
PG  - 2184756
LID - 10.1080/21645515.2023.2184756 [doi]
LID - 2184756
AB  - Human papillomavirus (HPV) infection is associated with the risk of developing 
      certain cancers, including cancers of the cervix, vulva, vagina, penis, anus, 
      rectum, and oropharynx. In 2016, the bivalent HPV-16/18 vaccine was included in 
      the Korea National Immunization Program. This vaccine protects against HPV types 
      16 and 18 and other oncogenic HPV types predominant in cervical and anal cancers. 
      This post-marketing surveillance (PMS) study assessed the safety of the HPV-16/18 
      vaccine in Korea. The study was conducted in males and females aged between 9 and 
      25 years, from 2017 to 2021. Safety was measured in terms of frequency and 
      intensity of adverse events (AEs), adverse drug reactions (ADRs), and serious 
      adverse events (SAEs) after each vaccine dose. The safety analysis included all 
      participants who were vaccinated as per prescribing information and who completed 
      a 30-day follow-up after at least one dose. Data were collected using individual 
      case report forms. The total safety cohort included 662 participants. A total of 
      220 AEs were reported in 144 subjects (21.75%), and there were 158 ADRs in 111 
      subjects (16.77%), with the most common being injection site pain in all cases. 
      No SAEs or serious ADRs were reported. Most AEs were reported after the first 
      dose and were injection site reactions with mild intensity that recovered. No 
      individuals required hospitalization or an emergency department visit. Safety 
      results showed that the HPV-16/18 vaccine was generally well tolerated in the 
      Korean population, and no safety concerns were identified.ClinicalTrials.gov 
      Identifier: NCT03671369.
FAU - Eun, Byung-Wook
AU  - Eun BW
AUID- ORCID: 0000-0003-3147-9061
AD  - Nowon Eulji University Hospital, Seoul, Republic of Korea.
FAU - Bahar, Enas
AU  - Bahar E
AUID- ORCID: 0000-0003-4827-8311
AD  - GSK, Wavre, Belgium.
FAU - Xavier, Stebin
AU  - Xavier S
AUID- ORCID: 0000-0002-7055-7790
AD  - GSK, Bengaluru, India.
FAU - Kim, Hyungwoo
AU  - Kim H
AD  - GSK, Seoul, Republic of Korea.
FAU - Borys, Dorota
AU  - Borys D
AUID- ORCID: 0000-0001-9704-8462
AD  - GSK, Wavre, Belgium.
LA  - eng
SI  - ClinicalTrials.gov/NCT03671369
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20230310
PL  - United States
TA  - Hum Vaccin Immunother
JT  - Human vaccines & immunotherapeutics
JID - 101572652
RN  - 0 (Papillomavirus Vaccines)
SB  - IM
MH  - Male
MH  - Female
MH  - Humans
MH  - Child
MH  - Adolescent
MH  - Young Adult
MH  - Adult
MH  - Human papillomavirus 16
MH  - *Uterine Cervical Neoplasms/prevention & control
MH  - *Papillomavirus Infections
MH  - Human papillomavirus 18
MH  - *Papillomavirus Vaccines
MH  - *Drug-Related Side Effects and Adverse Reactions/epidemiology
MH  - Injection Site Reaction
MH  - Product Surveillance, Postmarketing
MH  - Republic of Korea
PMC - PMC10026934
OAB - What is the context? Infection with human papillomavirus (HPV) is linked to the 
      development of certain cancers.More specifically, HPV types 16 and 18 are 
      predominant in cervical and anal cancers.In 2016, the HPV-16/18 vaccine was 
      included in the National Immunization Program of Korea.What is new? The objective 
      of this study was to evaluate the safety of the HPV-16/18 vaccine following its 
      introduction in Korea.The study was conducted from 2017 to 2021 in young Korean 
      men and women between 9 and 25 years of age.The study analyzed 662 participants, 
      of whom:  composite function 144 reported 220 adverse events composite function 111 reported 158 adverse drug 
      reactions composite function None reported serious adverse eventsThe safety of the vaccine was 
      measured after each dose as the number and intensity of:  composite function Adverse events, which 
      are side-effects or unwanted reactions that might be associated with the use of 
      the vaccine composite function Adverse drug reactions, which are side-effects or unwanted reactions 
      associated with the use of the vaccine composite function Serious adverse events, which are 
      reactions resulting in death, disability, are life-threatening, or require 
      hospitalization (or prolongation of it).Most adverse events occurred following 
      the first dose, were mild in intensity, and the participants recovered after a 
      few days. Injection site pain was the most common adverse event following 
      vaccination.What is the impact?The study showed that the HPV-16/18 vaccine is 
      safe and generally well tolerated in Korean participants.
OABL- eng
OTO - NOTNLM
OT  - AS04-adjuvanted HPV-16/18 vaccine
OT  - HPV
OT  - HPV-16/18
OT  - Korea
OT  - bivalent vaccine
OT  - post-marketing surveillance
OT  - safety
COIS- EB, SX, HK and DB are employed by GSK. HK and DB hold shares in GSK. All authors 
      declare no other financial and non-financial relationships, activities and no 
      other conflicts of interest.
EDAT- 2023/03/11 06:00
MHDA- 2023/03/17 06:00
PMCR- 2023/03/10
CRDT- 2023/03/10 04:52
PHST- 2023/03/11 06:00 [pubmed]
PHST- 2023/03/17 06:00 [medline]
PHST- 2023/03/10 04:52 [entrez]
PHST- 2023/03/10 00:00 [pmc-release]
AID - 2184756 [pii]
AID - 10.1080/21645515.2023.2184756 [doi]
PST - ppublish
SO  - Hum Vaccin Immunother. 2023 Dec 31;19(1):2184756. doi: 
      10.1080/21645515.2023.2184756. Epub 2023 Mar 10.