Evaluation of Safety of a Vaccine Against Cervical Cancer in Healthy Korean Females

Completed

• Conditions: Infections, Papillomavirus
• Interventions: Biological: Cervarix.; Other: Data collection

• Registration Number: NCT01101542
• Lead Sponsor: GlaxoSmithKline

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-04-08
• Study First Submitted QC: 2010-04-08
• Study First Posted: 2010-04-12
• Study Start: 2010-07-01
• Results First Submitted: 2011-11-10
• Results First Submitted QC: 2011-11-10
• Results First Posted: 2011-12-19
• Primary Completion: 2014-02-20
• Study Completion: 2014-02-20
• Status Verified: 2015-10
• Last Update Submitted: 2018-05-25
• Last Update Posted: 2018-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 3091

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cervarix Group	Cervarix.	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.
Cervarix Group	Data collection	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.

Primary Outcome Measures

Name	Time	Method
Number of Subjects Reporting Unsolicited Adverse Events (AEs)	During the 30-day period (Day 0 to Day 29) following any vaccination (During the 6th year of surveillance).	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.	During the entire Post Marketing Surveillance period up to one month after the third vaccine dose (During the 6th year of surveillance).	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 With Medically Significant Conditions.	During the entire Post Marketing Surveillance period up to one month after the third vaccine dose (During the 4th, 5th and 6th year of surveillance)	MSC include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.

Trial Locations

Locations (1)

GSK Investigational Site; 🇰🇷 Seoul, Korea, Republic of