The purpose of this post-marketing surveillance (PMS) study is to collect safety information on the use of Cervarix upon the expanded indication to anal cancer to both women and men (at least 600 Korean women and men) within 30 days after each vaccination dose, when administered according to the approved prescribing information (PI) in Korea in a real health care setting over a period of 4 years.
Study Type
OBSERVATIONAL
Enrollment
670
This study assesses the safety of GSK Biologicals' Human papillomavirus (HPV) vaccine in terms of frequency and intensity of adverse events (AEs) and serious adverse events (SAEs) when administered routinely in male and female subjects aged between 9 and 25 years, according to the approved Prescribing Information in Korea. All AEs reported during the 30-day post-vaccination follow-up period (Day 1 to Day 30) and all SAEs reported through the study period from dose 1 up to 30 days after the last dose administered during the post-marketing surveillance (PMS) were collected as part of safety data in this PMS.
GSK Investigational Site
Busan, South Korea
GSK Investigational Site
Chungcheongnam-do, South Korea
GSK Investigational Site
Daegu, South Korea
GSK Investigational Site
Gongju-si, Chungcheongnam-do, South Korea
GSK Investigational Site
Gwangju, South Korea
GSK Investigational Site
Gyeonggi-do, South Korea
GSK Investigational Site
Gyeonggi-do, South Korea
GSK Investigational Site
Gyeongsangbuk-do, South Korea
GSK Investigational Site
Gyeongsangbuk-do, South Korea
GSK Investigational Site
Incheon, South Korea
...and 19 more locations
Percentage (%) of Subjects With Adverse Events (AEs) Post Dose 1
An adverse event (AE) is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. The percentage of subjects with AEs was calculated by dividing the number of subjects with adverse events by the number of subjects in each total number of Cervarix doses vaccinated in Total Safety Cohort, and multiplied by 100.
Time frame: From Day 1 up to 30 days (post dose 1 vaccination)
Percentage (%) of Subjects With Adverse Events (AEs) Post Dose 2
An adverse event (AE) is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. The percentage of subjects with AEs was calculated by dividing the number of subjects with adverse events by the number of subjects in each total number of Cervarix doses vaccinated in Total Safety Cohort, and multiplied by 100.
Time frame: From Day 1 up to 30 days (post dose 2 vaccination)
Percentage (%) of Subjects With Adverse Events (AEs) Post Dose 3
An adverse event (AE) is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. The percentage of subjects with AEs was calculated by dividing the number of subjects with adverse events by the number of subjects in each total number of Cervarix doses vaccinated in Total Safety Cohort, and multiplied by 100.
Time frame: From Day 1 up to 30 days (post dose 3 vaccination)
Number of Participants With AEs by Maximum Intensity Post Dose 1
An AE with maximum intensity are equivalent to severe AEs category (AEs which prevented normal everyday activities in a young child. Such an AE would, for example, prevent attendance at school/kindergarten/a day-care centre and can cause the parent(s)/Legally Acceptable Representative(s) to seek medical advice). The physician assessed the maximum intensity that occurred over the duration of the event for all AEs recorded during the PMS. The assessment was based on the physician's clinical judgement.
Time frame: From Day 1 up to 30 days (post dose 1 vaccination)
Number of Participants With AEs by Maximum Intensity Post Dose 2
An AE with maximum intensity are equivalent to severe AEs category (AEs which prevented normal everyday activities in a young child. Such an AE would, for example, prevent attendance at school/kindergarten/a day-care centre and can cause the parent(s)/Legally Acceptable Representative(s) to seek medical advice). The physician assessed the maximum intensity that occurred over the duration of the event for all AEs recorded during the PMS. The assessment was based on the physician's clinical judgement.
Time frame: From Day 1 up to 30 days (post dose 2 vaccination)
Number of Participants With AEs by Maximum Intensity Post Dose 3
An AE with maximum intensity are equivalent to severe AEs category (AEs which prevented normal everyday activities in a young child. Such an AE would, for example, prevent attendance at school/kindergarten/a day-care centre and can cause the parent(s)/Legally Acceptable Representative(s) to seek medical advice). The physician assessed the maximum intensity that occurred over the duration of the event for all AEs recorded during the PMS. The assessment was based on the physician's clinical judgement.
Time frame: From Day 1 up to 30 days (post dose 3 vaccination)
Number of Participants With Serious Adverse Events (SAEs) and Fatal SAEs
A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in disability/incapacity, or is a congenital anomaly/birth defect in the offspring of a study subject.
Time frame: From Day 1 to 30 days after the last vaccine dose administered (at Month 0 or Month 2 or Month 6)
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