Safety Study of GSK Biologicals' HPV Vaccine (GSK-580299) in Healthy Female Subjects.
This study will collect safety data of GlaxoSmithKline Biologicals' human papillomavirus (HPV) vaccine in healthy females of Chinese origin who are unable to receive all three doses of commercially available HPV vaccine before they are 25 years, and were placebo recipients in the primary study (NCT00306241).
HPV-16/18 Infections and Associated Cervical Neoplasia.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Safety Study of GSK Biologicals' Human Papillomavirus Vaccine (GSK-580299) in Healthy Female Subjects.|
- Number of Subjects Reporting Any Serious Adverse Event (SAE) and SAE(s) With a Causal Relationship to Vaccination as Assessed by the Investigator. [ Time Frame: During the entire study period (Day 0 up to the telephone contact at Month 12). ] [ Designated as safety issue: No ]SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.
|Study Start Date:||May 2009|
|Study Completion Date:||September 2010|
|Primary Completion Date:||September 2010 (Final data collection date for primary outcome measure)|
|Experimental: Cervarix Group||
Subjects will receive three doses of the HPV vaccine administered intramuscularly according to a 0, 1, 6 month vaccination schedule.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00811798
|GSK Investigational Site|
|Hong Kong, Hong Kong|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|