Safety of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus (HPV)-16/18 Vaccine, Cervarix® When Administered to Healthy Females According to the Prescribing Information in Korea
10 Years
25 Years
Female
HPV-16/18 Infections and Associated Cervical Neoplasia
Trial Information
Safety of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus (HPV)-16/18 Vaccine, Cervarix® When Administered to Healthy Females According to the Prescribing Information in Korea
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
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Number of Subjects Reporting Unsolicited Adverse Events (AEs)
Outcome 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.
Outcome Time Frame:
During the 30-day period (Day 0 to Day 29) following any vaccination (During the 3rd year of surveillance).
Safety Issue:
No
Principal Investigator
GSK Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
GlaxoSmithKline
Authority:
Korea: Korea Food & Drug Administration
Study ID:
112485
NCT ID:
NCT01101542
Start Date:
February 2010
Completion Date:
March 2014
Related Keywords:
- HPV-16/18 Infections and Associated Cervical Neoplasia
- Post-marketing surveillance
- Human papillomavirus
- Korea
- Safety
- Prescribing Information
- Neoplasms
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