N/A
Completed N=105
Evaluation of Safety of a Vaccine Against Cervical Cancer in Healthy Korean Females
Infections, Papillomavirus
Source: ClinicalTrials.gov NCT01101542 ↗
Enrolled (actual)
105
Serious AEs
0.1%
Results posted
Dec 2011
Primary outcomePrimary: Number of Subjects Reporting Unsolicited Adverse Events (AEs) — 30 Subjects
Summary
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Reporting Unsolicited Adverse Events (AEs) |
620 | — |
| PRIMARY Number of Subjects Reporting Serious Adverse Event (SAEs) and SAE(s) Causally Related to Vaccination. |
3; 0 | — |
| PRIMARY Number of Subjects With Medically Significant Conditions. |
27; 44; 135 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01101542). 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.