N/A
Completed N=669
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
Neoplasms, Rectal
Source: ClinicalTrials.gov NCT03671369 ↗
Enrolled (actual)
669
Serious AEs
0.0%
Results posted
Feb 2023
Primary outcomePrimary: Percentage (%) of Subjects With Adverse Events (AEs) Post Dose 1 — 17.72 Percentage of subjects
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage (%) of Subjects With Adverse Events (AEs) Post Dose 1 |
17.72 | — |
| PRIMARY Percentage (%) of Subjects With Adverse Events (AEs) Post Dose 2 |
18.77 | — |
| PRIMARY Percentage (%) of Subjects With Adverse Events (AEs) Post Dose 3 |
2.86 | — |
| PRIMARY Number of Participants With AEs by Maximum Intensity Post Dose 1 |
— | — |
| PRIMARY Number of Participants With AEs by Maximum Intensity Post Dose 2 |
— | — |
| PRIMARY Number of Participants With AEs by Maximum Intensity Post Dose 3 |
— | — |
| PRIMARY Number of Participants With Serious Adverse Events (SAEs) and Fatal SAEs |
0; 0 | — |
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.
Data sourced from ClinicalTrials.gov (NCT03671369). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.