A Post-marketing Surveillance Study to Assess the Safety of Cervarix (GlaxoSmithKline [GSK] Biologicals' Human Papillomavirus [HPV] -16/18 Vaccine), When Administered According to the Approved Prescribing Information (PI) in Korea

CompletedOBSERVATIONAL
Enrollment

670

Participants

Timeline

Start Date

October 2, 2018

Primary Completion Date

December 1, 2020

Study Completion Date

December 1, 2020

Conditions
Neoplasms, Rectal
Interventions
OTHER

Safety data collection (following routine vaccination) by a continuous surveillance method.

"This study assesses the safety of GSK Biologicals' Human papillomavirus (HPV) vaccine in terms of frequency and intensity of adverse events (AEs) and serious adverse events (SAEs) when administered routinely in male and female subjects aged between 9 and 25 years, according to the approved Prescribing Information in Korea.~All AEs reported during the 30-day post-vaccination follow-up period (Day 1 to Day 30) and all SAEs reported through the study period from dose 1 up to 30 days after the last dose administered during the post-marketing surveillance (PMS) were collected as part of safety data in this PMS."

Trial Locations (29)

11456

GSK Investigational Site, Yangju-si, Gyeonggi-do

11813

GSK Investigational Site, Gyeonggi-do

16334

GSK Investigational Site, Gyeonggi-do

16388

GSK Investigational Site, Suwon-si, Gyeonggi-do

16554

GSK Investigational Site, Suwon-si, Gyeonggi-do

22227

GSK Investigational Site, Incheon

32555

GSK Investigational Site, Gongju-si, Chungcheongnam-do

32580

GSK Investigational Site, Chungcheongnam-do

39230

GSK Investigational Site, Gyeongsangbuk-do

39814

GSK Investigational Site, Gyeongsangbuk-do

42274

GSK Investigational Site, Daegu

47863

GSK Investigational Site, Busan

54154

GSK Investigational Site, Jeollabuk-do

54944

GSK Investigational Site, Jeonju-si,Jeollabuk-do

55018

GSK Investigational Site, Jeollabuk-do

62220

GSK Investigational Site, Gwangju

561-712

GSK Investigational Site, Jeonju-si, Jeollabuk-do

01215

GSK Investigational Site, Seoul

01357

GSK Investigational Site, Seoul

02033

GSK Investigational Site, Seoul

03080

GSK Investigational Site, Seoul

03181

GSK Investigational Site, Seoul

06568

GSK Investigational Site, Seoul

07983

GSK Investigational Site, Seoul

08009

GSK Investigational Site, Seoul

08312

GSK Investigational Site, Seoul

08737

GSK Investigational Site, Seoul

130-709

GSK Investigational Site, Seoul

139-711

GSK Investigational Site, Seoul

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT03671369 - A Post-marketing Surveillance Study to Assess the Safety of Cervarix (GlaxoSmithKline [GSK] Biologicals' Human Papillomavirus [HPV] -16/18 Vaccine), When Administered According to the Approved Prescribing Information (PI) in Korea | Biotech Hunter | Biotech Hunter