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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

NCT03671369 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 670

Last updated 2023-02-23

Study results available
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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

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.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Eligibility

Min Age
9 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-10-02
Primary Completion
2020-12-01
Completion
2020-12-01

Countries

  • South Korea

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03671369 on ClinicalTrials.gov