Neoplasms

Digestive System Diseases

All Conditions

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

All Drugs and Chemicals

Vaccines

The study group comprised of 9-25 year-old male and female subjects who were administered with 3 doses of Cervarix vaccine, according to a 0, 1, and 6 months schedule, as per locally approved prescribing information (PI) in Korea. The 9-14 years old subjects were vaccinated with 2 doses, according to a 0 and 6-12 months schedule. In the 2-dose schedule, if the second dose was administered before 5 months after the first dose, the third dose vaccination was required. In the 3 doses schedule, if the vaccination schedule required flexibility, the second dose was administered between 1 and 2.5 months and the third dose was administered between 5 and 12 months after the first dose.

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.

Safety data collection (following routine vaccination) by a continuous surveillance method.

GSK Clinical Trials

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.

A Post-marketing Surveillance Study to Assess the Safety of Cervarix (GlaxoSmithKline [GSK] Biologicals' Human Papillomavirus [HPV] -16/18 Vaccine), When Administered According to the Approved Prescribing Information (PI) in Korea

Post-marketing Surveillance of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus (HPV)-16/18 Vaccine, Cervarix When Administered According to the Approved Prescribing Information in Korea

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.

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.

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.

GlaxoSmithKline

Data was collected based on the Total Vaccinated Cohort.

Cervarix Group

Age, Continuous

Male

Female

Sex/Gender, Customized

Korean

Non-Korean

Race/Ethnicity, Customized

Statistical significance of AEs incidence proportion by baseline background factor wasn't planned in statistical analysis plan. As per Ministry of Food and Drug Safety regulation, additional analysis was done to determine what factors may affect AEs incidence in Korea routine clinical practice. Study design didn't include stratification or adjustment to account for baseline factors in analysis. Study findings are to be interpreted with caution considering clinical plausibility and significance.

GSK Response Center

The analysis was performed on Total Safety cohort, which included all subjects with data available at the specified time point who received at least one dose of vaccine as per the protocol and who reported adverse events even though they have not completed 30-days follow-up period after vaccination.

Percentage (%) of Subjects With Adverse Events (AEs) Post Dose 1

The analysis was performed on Total Safety cohort, which included all subjects with data available at the specified time point who received two doses of vaccine as per the protocol and who reported adverse events even though they have not completed 30-days follow-up period after vaccination.

Percentage (%) of Subjects With Adverse Events (AEs) Post Dose 2

The analysis was performed on Total Safety cohort, which included all subjects with data available at the specified time point who received three doses of vaccine as per the protocol and who reported adverse events even though they have not completed 30-days follow-up period after vaccination.

Percentage (%) of Subjects With Adverse Events (AEs) Post Dose 3

The analysis was performed on Total Safety cohort, which included all participants with data available at the specified time point who received at least one dose of vaccine as per the protocol and who reported adverse events even though they have not completed 30-days follow-up period after vaccination.

Number of Participants With AEs by Maximum Intensity Post Dose 1

The analysis was performed on Total Safety cohort, which included all participants with data available at the specified time point who received two doses of vaccine as per the protocol and who reported adverse events even though they have not completed 30-days follow-up period after vaccination.

Number of Participants With AEs by Maximum Intensity Post Dose 2

The analysis was performed on Total Safety cohort, which included all participants with data available at the specified time point who received three doses of vaccine as per the protocol and who reported adverse events even though they have not completed 30-days follow-up period after vaccination.

Number of Participants With AEs by Maximum Intensity Post Dose 3

Serious Adverse Events

Fatal Serious Adverse Events

The analysis was performed on the Total Safety cohort, which included all participants who received at least one dose of vaccine as per the protocol and who reported adverse events even though they have not completed 30 days follow up period after vaccination.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Post-marketing Surveillance Study to Assess the Safety of Cervarix (GlaxoSmithKline [GSK] Biologicals' Human Papillomavirus [HPV] -16/18 Vaccine), When Administered According to the Approved Prescribing Information (PI) in Korea	NCT03671369	Neoplasms, Rect...	Safety data col...	9 Years - 25 Years	GlaxoSmithKline
A Post-marketing Surveillance Study to Assess the Safety of Cervarix (GlaxoSmithKline [GSK] Biologicals' Human Papillomavirus [HPV] -16/18 Vaccine), When Administered According to the Approved Prescribing Information (PI) in Korea	NCT03671369	Neoplasms, Rect...	Safety data col...	9 Years - 25 Years	GlaxoSmithKline

Spots Global Cancer Trial Database for safety data collection (following routine vaccination) by a continuous surveillance method.