Safety Study of GSK Biologicals' Human Papillomavirus Vaccine in 580299/008 Subjects From Canada or the US
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|ClinicalTrials.gov Identifier: NCT00799825|
Recruitment Status : Completed
First Posted : December 1, 2008
Results First Posted : September 20, 2013
Last Update Posted : July 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|Infections, Papillomavirus||Biological: GSK Biological's HPV vaccine GSK580299 (Cervarix™)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||346 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety Study of GSK Biologicals' Human Papillomavirus Vaccine (GSK580299) in Female American and Canadian Subjects Who Had Received Control Vaccine in Study 580299/008|
|Study Start Date :||January 1, 2009|
|Actual Primary Completion Date :||August 2, 2012|
|Actual Study Completion Date :||August 2, 2012|
Experimental: Cervarix group
Female subjects who previously received the active control i.e. Hepatitis A vaccine in the primary study (NCT00122681) and who received the Cervarix vaccine in the current study. The Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1 and 6 months schedule.
Biological: GSK Biological's HPV vaccine GSK580299 (Cervarix™)
All subjects will receive a 0.5 ml dose administered as an intramuscular injection, according to a 0, 1, 6-month schedule.
Other Name: CervarixTM
- Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs) [ Time Frame: Throughout the study (up to Month 12) ]SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Any = Occurrence of any SAE regardless of intensity grade or relation to vaccination. Grade 3 = SAE which prevented normal, everyday activities. Related = SAE assessed by the investigator as related to the vaccination.
- Number of Subjects With Any, Grade 3 and Related Medically Significant Conditions (MSCs) [ Time Frame: Throughout the study (up to Month 12) ]MSCs = Adverse events (AEs) prompting emergency room/physician visits not related to common diseases or routine visits for physical examination/vaccination, or SAEs not related to common diseases. Common diseases include: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury. Any = Occurrence of any MSC regardless of intensity grade or relation to vaccination. Grade 3 = MSC which prevented normal, everyday activities. Related = MSC assessed by the investigator as related to the vaccination.
- Number of Subjects With Pregnancies and Pregnancy Outcomes. [ Time Frame: Throughout the study (up to Month 12) ]
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): NCT00799825
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|Study Director:||GSK Clinical Trials||GlaxoSmithKline|