Clinical trial · Observational
Evaluation of Safety of a Vaccine Against Cervical Cancer in Healthy Korean Females
Safety of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus (HPV)-16/18 Vaccine, Cervarix® When Administered to Healthy Females According to the Prescribing Information in Korea
NCT01101542CI-TRIAL-00033907completedResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This Post Marketing Surveillance (PMS) will collect safety data on the use of GSK Biologicals' human papillomavirus (HPV) vaccine in the local target population of females as per the regulations of the Korean Food and Drugs Administration (KFDA).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Infections, Papillomavirus | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cervarix. | Biological | — | UNRESOLVED |
| Data collection | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Cervarix Group
- description
- Subjects received 3 doses of the Cervarix vaccine. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0,1, 6 month vaccination schedule. According to the prescribing information, if flexibility in the vaccination schedule is necessary, the second dose can be administered between 1 month and 2.5 months after the first dose.
- interventionNames
- Biological: Cervarix.
- Other: Data collection
Primary outcomes (10)
- measure
- Number of Subjects Reporting Unsolicited Adverse Events (AEs)
- timeFrame
- During the 30-day period (Day 0 to Day 29) following any vaccination (During the 3rd year of surveillance).
- description
- An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 10 Years
- Maximum age
- 25 Years
Show eligibility criteria text
Inclusion Criteria: * Female subjects aged between and including, 10 to 25 years at the time of the first vaccination. * Subjects who the investigator believes that they or their parents/guardians can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for vaccination visits etc) should be enrolled in the PMS. * Written informed consent obtained from the subject or the subjects' parent/ guardian. * Subjects of childbearing potential must not be pregnant. Absence of pregnancy should be verified (e.g. urine pregnancy test) as per the investigator's clinical judgement. * Subjects with no contraindication according to the local approved prescribing information. * No previous administration of an HPV vaccine other than Cervarix®. * No previous administration of more than two doses of Cervarix®. * No planned administration of an HPV vaccine other than Cervarix® during the PMS
References
Publications (1)
- DERIVEDKim CJ, Song R, Chen J, Tavares Da Silva F, Gopala KB, Kim JH, Bi D, Park JS. Six-year multi-centre, observational, post-marketing surveillance of the safety of the HPV-16/18 AS04-adjuvanted vaccine in women aged 10-25 years in Korea. Pharmacoepidemiol Drug Saf. 2017 Jul;26(7):837-842. doi: 10.1002/pds.4175. Epub 2017 Mar 7. PMID 28266092