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

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 Overview

• Status: Completed
• Conditions: Neoplasms, Rectal
• Intervention / Treatment: Other: Safety data collection (following routine vaccination) by a continuous surveillance method.

• Study Type: Observational
• Enrollment (Actual): 670

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of, 47863
    • GSK Investigational Site
  • Chungcheongnam-do, Korea, Republic of, 32580
    • GSK Investigational Site
  • Daegu, Korea, Republic of, 42274
    • GSK Investigational Site
  • Gongju-si, Chungcheongnam-do, Korea, Republic of, 32555
    • GSK Investigational Site
  • Gwangju, Korea, Republic of, 62220
    • GSK Investigational Site
  • Gyeonggi-do, Korea, Republic of, 11813
    • GSK Investigational Site
  • Gyeonggi-do, Korea, Republic of, 16334
    • GSK Investigational Site
  • Gyeongsangbuk-do, Korea, Republic of, 39230
    • GSK Investigational Site
  • Gyeongsangbuk-do, Korea, Republic of, 39814
    • GSK Investigational Site
  • Incheon, Korea, Republic of, 22227
    • GSK Investigational Site
  • Jeollabuk-do, Korea, Republic of, 54154
    • GSK Investigational Site
  • Jeollabuk-do, Korea, Republic of, 55018
    • GSK Investigational Site
  • Jeonju-si, Jeollabuk-do, Korea, Republic of, 561-712
    • GSK Investigational Site
  • Jeonju-si,Jeollabuk-do, Korea, Republic of, 54944
    • GSK Investigational Site
  • Seoul, Korea, Republic of, 130-709
    • GSK Investigational Site
  • Seoul, Korea, Republic of, 03080
    • GSK Investigational Site
  • Seoul, Korea, Republic of, 139-711
    • GSK Investigational Site
  • Seoul, Korea, Republic of, 01215
    • GSK Investigational Site
  • Seoul, Korea, Republic of, 01357
    • GSK Investigational Site
  • Seoul, Korea, Republic of, 02033
    • GSK Investigational Site
  • Seoul, Korea, Republic of, 03181
    • GSK Investigational Site
  • Seoul, Korea, Republic of, 06568
    • GSK Investigational Site
  • Seoul, Korea, Republic of, 07983
    • GSK Investigational Site
  • Seoul, Korea, Republic of, 08009
    • GSK Investigational Site
  • Seoul, Korea, Republic of, 08312
    • GSK Investigational Site
  • Seoul, Korea, Republic of, 08737
    • GSK Investigational Site
  • Suwon-si, Gyeonggi-do, Korea, Republic of, 16388
    • GSK Investigational Site
  • Suwon-si, Gyeonggi-do, Korea, Republic of, 16554
    • GSK Investigational Site
  • Yangju-si, Gyeonggi-do, Korea, Republic of, 11456
    • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 25 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Korean male and female subjects aged 9-25 years, who are eligible for the series of Cervarix vaccination, according to the locally approved PI.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Cervarix Group; 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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	From Day 1 to 30 days after the last vaccine dose administered (at Month 0 or Month 2 or Month 6)

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2018
• Primary Completion (Actual): December 1, 2020
• Study Completion (Actual): December 1, 2020

Study Registration Dates

• First Submitted: August 30, 2018
• First Submitted That Met QC Criteria: September 13, 2018
• First Posted (Actual): September 14, 2018

Study Record Updates

• Last Update Posted (Estimate): February 23, 2023
• Last Update Submitted That Met QC Criteria: May 20, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Safety; Human Papillomavirus Vaccine; Adverse events after vaccination; Serious adverse events after vaccination
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: 208710

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No