Evaluation of Safety of a Vaccine Against Cervical Cancer in Healthy Korean Females
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).
HPV-16/18 Infections and Associated Cervical Neoplasia
Other: Data collection
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Safety of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus (HPV)-16/18 Vaccine, Cervarix® When Administered to Healthy Females According to the Prescribing Information in Korea|
- Number of Subjects Reporting Unsolicited Adverse Events (AEs) [ Time Frame: During the 30-day period (Day 0 to Day 29) following any vaccination (During the 3rd year of surveillance). ] [ Designated as safety issue: No ]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.
- Number of Subjects Reporting Serious Adverse Event (SAEs) and SAE(s) Causally Related to Vaccination. [ Time Frame: During the entire PMS period up to one month after the third vaccine dose (During the 3rd year of surveillance). ] [ Designated as safety issue: No ]SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.
- Number of Subjects Reporting Unsolicited Adverse Events (AEs) [ Time Frame: During the 4th, 5th and 6th year of surveillance ] [ Designated as safety issue: No ]
- Number of Subjects Reporting Serious Adverse Event (SAEs) and SAE(s) Causally Related to Vaccination. [ Time Frame: During the 4th, 5th and 6th year of surveillance ] [ Designated as safety issue: No ]
- Number of Subjects With Medically Significant Conditions. [ Time Frame: During the entire PMS period up to one month after the third vaccine dose (During the 3rd, 4th, 5th and 6th year of surveillance) ] [ Designated as safety issue: No ]
Medically significant conditions were defined as: AEs prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common diseases. Common diseases included: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury.
*Note that the analysis was not performed for this outcome since it was not a requirement of the Korean regulatory authority.
|Study Start Date:||February 2010|
|Estimated Study Completion Date:||March 2014|
|Primary Completion Date:||February 2010 (Final data collection date for primary outcome measure)|
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.
Subjects will receive three doses of the Cervarix vaccine administered intramuscularly according to a 0, 1, 6 month vaccination schedule in routine clinical practice settings.Other: Data collection
All adverse events will be recorded by all subjects or the subject's parents/guardians using diary cards.
|Korea, Republic of|
|GSK Investigational Site|
|Busan, Korea, Republic of, 602-702|
|GSK Investigational Site|
|Seoul, Korea, Republic of, 138-736|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|