Clinical trial NCT01101542: Evaluation of Safety of a Vaccine Against Cervical Cancer in Healthy Korean Females
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infections, Papillomavirus
Keywords: Post-marketing surveillance
Human papillomavirus
Korea
Safety
Prescribing Information
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2010-04-12
Enrollment: 3091
Sex: FEMALE
Minimum age (years): 10
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).


Eligibility criteria: 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

Primary outcomes:
measure: Number of Subjects Reporting Unsolicited Adverse Events (AEs)
timeFrame: During the 30-day period (Day 0 to Day 29) following any vaccination (During the 3rd year of surveillance).
measure: Number of Subjects Reporting Unsolicited Adverse Events (AEs)
timeFrame: During the 30-day period (Day 0 to Day 29) following any vaccination (During the 4th year of surveillance).
measure: Number of Subjects Reporting Serious Adverse Event (SAEs) and SAE(s) Causally Related to Vaccination.
timeFrame: During the entire Post Marketing Surveillance period up to one month after the third vaccine dose (During the 3rd year of surveillance).
measure: Number of Subjects Reporting Serious Adverse Event (SAEs) and SAE(s) Causally Related to Vaccination.
timeFrame: During the entire Post Marketing Surveillance period up to one month after the third vaccine dose (During the 4th year of surveillance).
measure: Number of Subjects With Medically Significant Conditions.
timeFrame: 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)
measure: Number of Subjects Reporting Unsolicited Adverse Events (AEs)
timeFrame: During the 30-day period (Day 0 to Day 29) following any vaccination (During the 5th year of surveillance).
measure: Number of Subjects Reporting Unsolicited Adverse Events (AEs)
timeFrame: During the 30-day period (Day 0 to Day 29) following any vaccination (During the 6th year of surveillance).
measure: Number of Subjects Reporting Serious Adverse Event (SAEs) and SAE(s) Causally Related to Vaccination.
timeFrame: During the entire Post Marketing Surveillance period up to one month after the third vaccine dose (During the 5th year of surveillance).
measure: Number of Subjects Reporting Serious Adverse Event (SAEs) and SAE(s) Causally Related to Vaccination.
timeFrame: During the entire Post Marketing Surveillance period up to one month after the third vaccine dose (During the 6th year of surveillance).
measure: Number of Subjects With Medically Significant Conditions.
timeFrame: 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)
Secondary outcomes:
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.