Last updated: 03/05/2019 10:40:30

Evaluation of safety of a vaccine against cervical cancer in healthy Korean females

GSK study ID
112485
See study documents
Clinicaltrials.gov ID
NCT01101542
See results summary
EudraCT ID
2011-004872-13
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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
Trial description: 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).
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

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).

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).

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).

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).

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)

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).

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).

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).

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).

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:
Not applicable
Interventions:
Biological/vaccine: Cervarix.
Other: Data collection
Enrollment:
3091
Observational study model:
Cohort
Primary completion date:
2014-20-02
Time perspective:
Prospective
Clinical publications:
Kim CJ et al. (2017) 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. doi: 10.1002/pds.4175.
Medical condition
Infections, Papillomavirus
Product
SB580299
Collaborators
Not applicable
Study date(s)
July 2010 to February 2014
Type
Observational
Phase
4

Participation criteria

Sex
Female
Age
10 - 25 years
Accepts healthy volunteers
Yes
  • Inclusion Criteria:
  • Female subjects aged between and including, 10 to 25 years at the time of the first vaccination.
Inclusion and exclusion criteria
Inclusion 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

Trial location(s)

Location
Status
Contact us
Contact us
Location
GSK Investigational Site
Seoul, South Korea, 138-736
Status
Study Complete
Contact us
Location
GSK Investigational Site
Busan, South Korea, 602-702
Status
Study Complete
Contact us
Location
GSK Investigational Site
Bucheon-si, Gyeonggi-do, South Korea, 420-76
Status
Terminated/Withdrawn
Contact us

Study documents

Scientific result summary
Available language(s): English
Download document(s)
Protocol
Available language(s): English
Download document(s)
Clinical study report
Available language(s): English
Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Refer to study documents

Recruitment status
Finalized
Actual primary completion date
2014-20-02
Actual study completion date
2014-20-02

Plain language summaries

Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

Additional information about the trial

Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website