Safety Study of GSK Biologicals' HPV Vaccine (GSK-580299) in Healthy Female Subjects.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|