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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 670 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 9 Years – 25 Years
• Healthy volunteers: Accepted

Summary

The purpose of this post-marketing surveillance (PMS) study is to collect safety information on the use of Cervarix upon the expanded indication to anal cancer to both women and men (at least 600 Korean women and men) within 30 days after each vaccination dose, when administered according to the approved prescribing information (PI) in Korea in a real health care setting over a period of 4 years.

Conditions

• Neoplasms, Rectal

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-10-02
• Primary completion: 2020-12-01
• Completion: 2020-12-01
• First posted: 2018-09-14
• Last updated: 2023-02-23
• Results posted: 2023-02-23

Locations

29 sites across 1 country: South Korea