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

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).

Study Overview

• Status: Completed
• Conditions: Infections, Papillomavirus
• Intervention / Treatment: Biological: Cervarix.; Other: Data collection

• Study Type: Observational
• Enrollment (Actual): 3091

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of, 602-702
    • GSK Investigational Site
  • Seoul, Korea, Republic of, 138-736
    • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 21 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Healthy female subjects aged between and including 10 to 25 years who receive Cervarix® according to the current practice of Korean doctors.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cervarix Group; 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.	Biological: Cervarix.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects Reporting Unsolicited Adverse Events (AEs)	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.	During the 30-day period (Day 0 to Day 29) following any vaccination (During the 3rd year of surveillance).
Number of Subjects Reporting Unsolicited Adverse Events (AEs)	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. Note: Results for the 5th and 6th year of surveillance will be added when they become available.	During the 30-day period (Day 0 to Day 29) following any vaccination (During the 4th year of surveillance).
Number of Subjects Reporting Serious Adverse Event (SAEs) and SAE(s) Causally Related to Vaccination.	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.	During the entire Post Marketing Surveillance period up to one month after the third vaccine dose (During the 3rd year of surveillance).
Number of Subjects Reporting Serious Adverse Event (SAEs) and SAE(s) Causally Related to Vaccination.	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. Note: Results for the 5th and 6th year of surveillance will be added when they become available.	During the entire Post Marketing Surveillance period up to one month after the third vaccine dose (During the 4th year of surveillance).
Number of Subjects With Medically Significant Conditions.	*Note: For Surveillance Year 3 the analysis was not performed for this outcome since it was not a requirement of the Korean regulatory authority.	During the entire Post Marketing Surveillance period up to one month after the third vaccine dose (During the 3rd, 4th, 5th and 6th year of surveillance)
Number of Subjects Reporting Unsolicited Adverse Events (AEs)	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.	During the 30-day period (Day 0 to Day 29) following any vaccination (During the 5th year of surveillance).
Number of Subjects Reporting Unsolicited Adverse Events (AEs)	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.	During the 30-day period (Day 0 to Day 29) following any vaccination (During the 6th year of surveillance).
Number of Subjects Reporting Serious Adverse Event (SAEs) and SAE(s) Causally Related to Vaccination.	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.	During the entire Post Marketing Surveillance period up to one month after the third vaccine dose (During the 5th year of surveillance).
Number of Subjects Reporting Serious Adverse Event (SAEs) and SAE(s) Causally Related to Vaccination.	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.	During the entire Post Marketing Surveillance period up to one month after the third vaccine dose (During the 6th year of surveillance).
Number of Subjects With Medically Significant Conditions.	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.	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)

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

General Publications

• Kim 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): February 20, 2014
• Study Completion (Actual): February 20, 2014

Study Registration Dates

• First Submitted: April 8, 2010
• First Submitted That Met QC Criteria: April 8, 2010
• First Posted (Estimate): April 12, 2010

Study Record Updates

• Last Update Posted (Actual): July 23, 2018
• Last Update Submitted That Met QC Criteria: May 25, 2018
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: Safety; Human papillomavirus; Post-marketing surveillance; Korea; Prescribing Information
• Other Study ID Numbers: 112485