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
Study complete
Study complete
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
    Primary completion date:
    2014-20-02
    Observational study model:
    Cohort
    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
    Study complete
    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
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    Access to clinical trial data by researchers
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