A Post-marketing Surveillance Study to Assess the Safety of Cervarix (GlaxoSmithKline [GSK] Biolo… (NCT03671369) | Clinical Trial Compass
CompletedNot Applicable
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
South Korea670 participantsStarted 2018-10-02
Plain-language 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.
Who can participate
Age range
9 Years – 25 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage (%) of Subjects With Adverse Events (AEs) Post Dose 1
Timeframe: From Day 1 up to 30 days (post dose 1 vaccination)
2
Percentage (%) of Subjects With Adverse Events (AEs) Post Dose 2
Timeframe: From Day 1 up to 30 days (post dose 2 vaccination)
3
Percentage (%) of Subjects With Adverse Events (AEs) Post Dose 3
Timeframe: From Day 1 up to 30 days (post dose 3 vaccination)
4
Number of Participants With AEs by Maximum Intensity Post Dose 1
Timeframe: From Day 1 up to 30 days (post dose 1 vaccination)
5
Number of Participants With AEs by Maximum Intensity Post Dose 2
Timeframe: From Day 1 up to 30 days (post dose 2 vaccination)
6
Number of Participants With AEs by Maximum Intensity Post Dose 3
Timeframe: From Day 1 up to 30 days (post dose 3 vaccination)
7
Number of Participants With Serious Adverse Events (SAEs) and Fatal SAEs