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

Infections, Papillomavirus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01101542
• Other study ID #: 112485
• Status: Completed
• Start date: July 1, 2010
• Est. completion date: February 20, 2014

Study information

• Verified date: October 2015
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3091
• Est. completion date: February 20, 2014
• Est. primary completion date: February 20, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 10 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Infections, Papillomavirus

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	GSK Investigational Site	Busan
Korea, Republic of	GSK Investigational Site	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Primary	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).
Primary	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).
Primary	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).
Primary	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)
Primary	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).
Primary	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).
Primary	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).
Primary	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).
Primary	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)