Safety Study of GSK Biologicals' HPV Vaccine (GSK-580299) in Healthy Female Subjects.
|ClinicalTrials.gov Identifier: NCT00811798|
Recruitment Status : Completed
First Posted : December 19, 2008
Results First Posted : October 13, 2011
Last Update Posted : October 20, 2016
|Condition or disease||Intervention/treatment||Phase|
|Infections, Papillomavirus||Biological: Cervarix||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||92 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety Study of GSK Biologicals' Human Papillomavirus Vaccine (GSK-580299) in Healthy Female Subjects.|
|Study Start Date :||May 2009|
|Actual Primary Completion Date :||September 2010|
|Actual Study Completion Date :||September 2010|
|Experimental: Cervarix Group||
Subjects will receive three doses of the HPV vaccine administered intramuscularly according to a 0, 1, 6 month vaccination schedule.
- 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). ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00811798
|GSK Investigational Site|
|Hong Kong, Hong Kong|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|