Safety Evaluation of the GSK-580299 Vaccine in Women From the Control Group in the Primary NCT00294047 Study
|ClinicalTrials.gov Identifier: NCT01190189|
Recruitment Status : Completed
First Posted : August 27, 2010
Last Update Posted : June 1, 2018
|Condition or disease||Intervention/treatment||Phase|
|Infections, Papillomavirus||Biological: GSK580299 (Cervarix™)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||137 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 Control Subjects From the Primary NCT00294047 Study|
|Study Start Date :||April 1, 2011|
|Actual Primary Completion Date :||November 23, 2017|
|Actual Study Completion Date :||November 23, 2017|
Experimental: Group A
Subjects received control vaccine in the primary study NCT00294047
Biological: GSK580299 (Cervarix™)
3-dose schedule intramuscularly vaccination
- Number of subjects reporting any, Grade 3 and related serious adverse events (SAEs) [ Time Frame: During the entire study period (From Month 0 to 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. A related SAE was defined as an event assessed by the investigator as causally related to the study vaccination.
- Number of subjects reporting any, Grade 3 and related medically significant conditions (MAEs) [ Time Frame: During the entire study period (From Month 0 to Month 12) ]Medically significant conditions were defined as: AEs prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common diseases. Common diseases included: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury.
- Number of subjects with potentially Immune-Mediated Diseases (pIMDs) [ Time Frame: During the entire study period (From Month 0 to Month 12) ]pIMD(s) are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology.
- Number of subjects with pregnancies and their outcomes [ Time Frame: During the entire study period (From Month 0 to Month 12) ]Pregnancy outcomes are live infant, premature live infant, elec-tive termination, ectopic pregnancy, spontaneous abortion, lost to follow-up and pregnancy ongoing. For each category it was specified if the infant presents congenital anomaly (CA) or no apparent congenital anomaly (No ACA).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01190189
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|Study Director:||GSK Clinical Trials||GlaxoSmithKline|