Post-marketing Surveillance of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus (HPV)-16/18 Vaccine, Cervarix When Administered According to the Approved Prescribing Information in Korea
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Neoplasms, Rectal
- Sponsor
- GlaxoSmithKline
- Enrollment
- 670
- Locations
- 1
- Primary Endpoint
- Percentage (%) of Subjects With Adverse Events (AEs) Post Dose 2
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subject or/and subjects whose parent(s)/Legally Acceptable Representative(s) \[LAR(s)\], in the opinion of the investigator, can and will comply with the requirements of the protocol.
- •Korean male or female subjects aged 9-25 years who are eligible for the series of Cervarix according to the locally approved PI.
- •Written informed consent obtained from the subject/from the parent(s)/LAR of the subject.
Exclusion Criteria
- •At the time of PMS entry, the contraindications and precautions of use indicated in the locally approved PI. PI should be checked and the subject must not be included in the PMS if there is any contraindication. Any changes in the locally approved PI must be implemented immediately.
- •Subjects who had previous administration of a HPV vaccine other than Cervarix will not be enrolled into the study.
- •Subjects who are not eligible for vaccination with Cervarix according to the medical judgement of physician.
- •Child in care.
Outcomes
Primary Outcomes
Percentage (%) of Subjects With Adverse Events (AEs) Post Dose 2
Time Frame: From Day 1 up to 30 days (post dose 2 vaccination)
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.
Number of Participants With AEs by Maximum Intensity Post Dose 1
Time Frame: From Day 1 up to 30 days (post dose 1 vaccination)
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.
Number of Participants With AEs by Maximum Intensity Post Dose 2
Time Frame: From Day 1 up to 30 days (post dose 2 vaccination)
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.
Number of Participants With AEs by Maximum Intensity Post Dose 3
Time Frame: From Day 1 up to 30 days (post dose 3 vaccination)
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.
Number of Participants With Serious Adverse Events (SAEs) and Fatal SAEs
Time Frame: From Day 1 to 30 days after the last vaccine dose administered (at Month 0 or Month 2 or Month 6)
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.
Percentage (%) of Subjects With Adverse Events (AEs) Post Dose 1
Time Frame: From Day 1 up to 30 days (post dose 1 vaccination)
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.
Percentage (%) of Subjects With Adverse Events (AEs) Post Dose 3
Time Frame: From Day 1 up to 30 days (post dose 3 vaccination)
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.