Clinical trial NCT03671369: 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
Official title: Post-marketing Surveillance of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus (HPV)-16/18 Vaccine, Cervarix When Administered According to the Approved Prescribing Information in Korea
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neoplasms, Rectal
Keywords: Human Papillomavirus Vaccine
Adverse events after vaccination
Safety
Serious adverse events after vaccination
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2018-09-14
Enrollment: 670
Sex: ALL
Minimum age (years): 9
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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.

Primary outcomes:
measure: Percentage (%) of Subjects With Adverse Events (AEs) Post Dose 1
timeFrame: From Day 1 up to 30 days (post dose 1 vaccination)
measure: Percentage (%) of Subjects With Adverse Events (AEs) Post Dose 2
timeFrame: From Day 1 up to 30 days (post dose 2 vaccination)
measure: Percentage (%) of Subjects With Adverse Events (AEs) Post Dose 3
timeFrame: From Day 1 up to 30 days (post dose 3 vaccination)
measure: Number of Participants With AEs by Maximum Intensity Post Dose 1
timeFrame: From Day 1 up to 30 days (post dose 1 vaccination)
measure: Number of Participants With AEs by Maximum Intensity Post Dose 2
timeFrame: From Day 1 up to 30 days (post dose 2 vaccination)
measure: Number of Participants With AEs by Maximum Intensity Post Dose 3
timeFrame: From Day 1 up to 30 days (post dose 3 vaccination)
measure: Number of Participants With Serious Adverse Events (SAEs) and Fatal SAEs
timeFrame: From Day 1 to 30 days after the last vaccine dose administered (at Month 0 or Month 2 or Month 6)
Secondary outcomes:
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: GSK Investigational Site
city: Chungcheongnam-do
country: Korea, Republic of
facility: GSK Investigational Site
city: Daegu
country: Korea, Republic of
facility: GSK Investigational Site
city: Gongju-si, Chungcheongnam-do
country: Korea, Republic of
facility: GSK Investigational Site
city: Gwangju
country: Korea, Republic of
facility: GSK Investigational Site
city: Gyeonggi-do
country: Korea, Republic of
facility: GSK Investigational Site
city: Gyeonggi-do
country: Korea, Republic of
facility: GSK Investigational Site
city: Gyeongsangbuk-do
country: Korea, Republic of
facility: GSK Investigational Site
city: Gyeongsangbuk-do
country: Korea, Republic of
facility: GSK Investigational Site
city: Incheon
country: Korea, Republic of
facility: GSK Investigational Site
city: Jeollabuk-do
country: Korea, Republic of
facility: GSK Investigational Site
city: Jeollabuk-do
country: Korea, Republic of
facility: GSK Investigational Site
city: Jeonju-si, Jeollabuk-do
country: Korea, Republic of
facility: GSK Investigational Site
city: Jeonju-si,Jeollabuk-do
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Suwon-si, Gyeonggi-do
country: Korea, Republic of
facility: GSK Investigational Site
city: Suwon-si, Gyeonggi-do
country: Korea, Republic of
facility: GSK Investigational Site
city: Yangju-si, Gyeonggi-do
country: Korea, Republic of
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: