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Evaluation of Safety of a Vaccine Against Cervical Cancer in Healthy Korean Females

NCT01101542 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 3091

Last updated 2018-07-23

Study results available
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Summary

This Post Marketing Surveillance (PMS) will collect safety data on the use of GSK Biologicals' human papillomavirus (HPV) vaccine in the local target population of females as per the regulations of the Korean Food and Drugs Administration (KFDA).

Conditions

  • Infections, Papillomavirus

Interventions

BIOLOGICAL

Cervarix.

Subjects will receive three doses of the Cervarix vaccine administered intramuscularly according to a 0, 1, 6 month vaccination schedule in routine clinical practice settings.

OTHER

Data collection

All adverse events will be recorded by all subjects or the subject's parents/guardians using diary cards.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Eligibility

Min Age
10 Years
Max Age
25 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-07-01
Primary Completion
2014-02-20
Completion
2014-02-20

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 NCT01101542 on ClinicalTrials.gov