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 | Completed Results

• 1 other identifier: 208710
• Study Type: observational
• Target: 670
• Locations: 1 country
• Sites: 29

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.

Conditions

Neoplasms, Rectal

Keywords

Human Papillomavirus Vaccine; Adverse events after vaccination; Safety; Serious adverse events after vaccination

Outcome Measures

Primary Outcomes (7)

• 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)

Study Arms (1)

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.

Interventions

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

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.

Cervarix Group

Eligibility Criteria

• Age: 9 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (29)

GSK Investigational Site

Busan, 47863, South Korea

Location

GSK Investigational Site

Chungcheongnam-do, 32580, South Korea

Location

GSK Investigational Site

Daegu, 42274, South Korea

Location

GSK Investigational Site

Gongju-si, Chungcheongnam-do, 32555, South Korea

Location

GSK Investigational Site

Gwangju, 62220, South Korea

Location

GSK Investigational Site

Gyeonggi-do, 11813, South Korea

Location

GSK Investigational Site

Gyeonggi-do, 16334, South Korea

Location

GSK Investigational Site

Gyeongsangbuk-do, 39230, South Korea

Location

GSK Investigational Site

Gyeongsangbuk-do, 39814, South Korea

Location

GSK Investigational Site

Incheon, 22227, South Korea

Location

GSK Investigational Site

Jeollabuk-do, 54154, South Korea

Location

GSK Investigational Site

Jeollabuk-do, 55018, South Korea

Location

GSK Investigational Site

Jeonju-si, Jeollabuk-do, 561-712, South Korea

Location

GSK Investigational Site

Jeonju-si,Jeollabuk-do, 54944, South Korea

Location

GSK Investigational Site

Seoul, 01215, South Korea

Location

GSK Investigational Site

Seoul, 01357, South Korea

Location

GSK Investigational Site

Seoul, 02033, South Korea

Location

GSK Investigational Site

Seoul, 03080, South Korea

Location

GSK Investigational Site

Seoul, 03181, South Korea

Location

GSK Investigational Site

Seoul, 06568, South Korea

Location

GSK Investigational Site

Seoul, 07983, South Korea

Location

GSK Investigational Site

Seoul, 08009, South Korea

Location

GSK Investigational Site

Seoul, 08312, South Korea

Location

GSK Investigational Site

Seoul, 08737, South Korea

Location

GSK Investigational Site

Seoul, 130-709, South Korea

Location

GSK Investigational Site

Seoul, 139-711, South Korea

Location

GSK Investigational Site

Suwon-si, Gyeonggi-do, 16388, South Korea

Location

GSK Investigational Site

Suwon-si, Gyeonggi-do, 16554, South Korea

Location

GSK Investigational Site

Yangju-si, Gyeonggi-do, 11456, South Korea

Location

Related Publications (1)

• Eun BW, Bahar E, Xavier S, Kim H, Borys D. Post-marketing surveillance study of the safety of the HPV-16/18 vaccine in Korea (2017-2021). Hum Vaccin Immunother. 2023 Dec 31;19(1):2184756. doi: 10.1080/21645515.2023.2184756. Epub 2023 Mar 10.

  PMID: 36896702 DERIVED

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Limitations and Caveats

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.

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2018
• First Posted: September 14, 2018
• Study Start: October 2, 2018
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: February 23, 2023
• Results First Posted: February 23, 2023

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (29)