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
Trial overview
Percentage (%) of subjects with adverse events (AEs) post dose 1
Timeframe: From Day 1 up to 30 days (post dose 1 vaccination)
Percentage (%) of subjects with adverse events (AEs) post dose 2
Timeframe: From Day 1 up to 30 days (post dose 2 vaccination)
Percentage (%) of subjects with adverse events (AEs) post dose 3
Timeframe: From Day 1 up to 30 days (post dose 3 vaccination)
Number of participants with AEs by maximum intensity post dose 1
Timeframe: From Day 1 up to 30 days (post dose 1 vaccination)
Number of participants with AEs by maximum intensity post dose 2
Timeframe: From Day 1 up to 30 days (post dose 2 vaccination)
Number of participants with AEs by maximum intensity post dose 3
Timeframe: From Day 1 up to 30 days (post dose 3 vaccination)
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)
Participation 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.
- 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.
- 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.
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.
- 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.
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.
Trial location(s)
Study documents
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.