Human Papilloma Virus Vaccine Safety and Immunogenicity Trial in Young Adolescent Women With GSK Bio HPV-16/18.
|ClinicalTrials.gov Identifier: NCT00196924|
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : March 23, 2017
|Condition or disease||Intervention/treatment||Phase|
|Infections, Papillomavirus||Biological: HPV-16/18 L1/AS04||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2067 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Evaluate the Safety and Immunogenicity of GSK Biologicals' HPV-16/18 Vaccine Administered Intramuscularly According to a 0,1,6 Month Schedule in Healthy Female Subjects (10 - 14 Years)|
|Study Start Date :||June 2004|
|Actual Primary Completion Date :||March 2006|
|Actual Study Completion Date :||March 2006|
- Demonstration of safety of the HPV vaccine compared to the control (occurrence of SAEs) up to month 7.
- Safety of HPV vaccine in entire study period. Vaccine immunogenicity.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00196924
Show 61 Study Locations
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|