A Post-marketing Surveillance Study to Assess the Safety of Cervarix

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Clinical Trial 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.

See also
Status	Clinical Trial	Phase
Recruiting	`NCT03573791` - Biomarkers for Predicting Neoadjuvant Chemoradio-resistance for Middle-low Advanced Rectal Cancer
Completed	`NCT02017509` - Immunoscore in Rectal Cancer
Recruiting	`NCT05723562` - A Study of Dostarlimab in Untreated dMMR/MSI-H Locally Advanced Rectal Cancer	Phase 2

NCT number	NCT03671369
Study type	Observational
Source	GlaxoSmithKline
Contact
Status	Completed
Phase
Start date	October 2, 2018
Completion date	December 1, 2020

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms