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
CompletedResults postedLast updated 23 February 2023
What this trial tests
trial testing Safety data collection (following routine vaccination) by a continuous surveillance method. in Neoplasms, Rectal in 670 participants. Completed in 1 December 2020.
Adults 9 to 25, any sex, with Neoplasms, Rectal. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage (%) of Subjects With Adverse Events (AEs) Post Dose 1Primary· From Day 1 up to 30 days (post dose 1 vaccination)
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 o
Group
Value
95% CI
Cervarix Group
17.72
14.33 – 21.54
Percentage (%) of Subjects With Adverse Events (AEs) Post Dose 2Primary· From Day 1 up to 30 days (post dose 2 vaccination)
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 o
Group
Value
95% CI
Cervarix Group
18.77
15.01 – 23.01
Percentage (%) of Subjects With Adverse Events (AEs) Post Dose 3Primary· From Day 1 up to 30 days (post dose 3 vaccination)
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 o
Group
Value
95% CI
Cervarix Group
2.86
0.07 – 14.92
Number of Participants With AEs by Maximum Intensity Post Dose 1Primary· From Day 1 up to 30 days (post dose 1 vaccination)
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.
Group
Value
95% CI
Cervarix Group
0
Number of Participants With AEs by Maximum Intensity Post Dose 2Primary· From Day 1 up to 30 days (post dose 2 vaccination)
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.
Group
Value
95% CI
Cervarix Group
0
Number of Participants With AEs by Maximum Intensity Post Dose 3Primary· From Day 1 up to 30 days (post dose 3 vaccination)
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.
Group
Value
95% CI
Cervarix Group
0
Number of Participants With Serious Adverse Events (SAEs) and Fatal SAEsPrimary· From Day 1 to 30 days after the last vaccine dose administered (at Month 0 or Month 2 or Month 6)
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.
Serious Adverse Events
Group
Value
95% CI
Cervarix Group
0
Fatal Serious Adverse Events
Group
Value
95% CI
Cervarix Group
0
Adverse events — posted to ClinicalTrials.gov
Time frame: Non-serious adverse events: From Day 1 up to 30 days (post dose 1, dose 2 and dose 3 vaccination). SAEs: From Day 1 to 30 days after the last vaccine dose administered (at Month 0 or Month 2 or Month 6)..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
NCT06640049 — A Study of Dostarlimab in Participants With Untreated Locally Advanced Rectal Cancer in China
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NCT05723562 — A Study of Dostarlimab in Untreated dMMR/MSI-H Locally Advanced Rectal Cancer
· Phase 2
· active not recruiting
NCT03573791 — Biomarkers for Predicting Neoadjuvant Chemoradio-resistance for Middle-low Advanced Rectal Cancer
· recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
Last refreshed: 23 February 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03671369.