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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
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.
Details
| Lead sponsor | GlaxoSmithKline |
|---|---|
| Status | COMPLETED |
| Enrolment | 670 |
| Start date | Tue Oct 02 2018 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Tue Dec 01 2020 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Neoplasms, Rectal
Interventions
- Safety data collection (following routine vaccination) by a continuous surveillance method.
Countries
South Korea