Human Papilloma Virus Vaccine Safety and Immunogenicity Trial in Young Adolescent Women With GSK Bio HPV-16/18.
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|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.
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): NCT00196924
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|