Last updated: 05/08/2023 07:00:15

A post-marketing surveillance study to assess the safety of Cervarix (GlaxoSmithKline [GSK] Biologicals’ human papillomavirus [HPV] -16/18 vaccine), when administered according to the approved Prescribing Information (PI) in Korea

GSK study ID
208710
See study documents
Clinicaltrials.gov ID
NCT03671369
See results summary
EudraCT ID
Not applicable
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: Post-marketing surveillance of GlaxoSmithKline (GSK) Biologicals’ human papillomavirus (HPV)-16/18 vaccine, Cervarix when administered according to the approved Prescribing Information in Korea
Trial description: The purpose of this post-marketing surveillance (PMS) study is to collect safety information on the use of Cervarix upon the expanded indication to anal cancer to both women and men (at least 600 Korean women and men) within 30 days after each vaccination dose, when administered according to the approved prescribing information (PI) in Korea in a real health care setting over a period of 4 years.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Percentage (%) of subjects with adverse events (AEs) post dose 1

Timeframe: From Day 1 up to 30 days (post dose 1 vaccination)

Percentage (%) of subjects with adverse events (AEs) post dose 2

Timeframe: From Day 1 up to 30 days (post dose 2 vaccination)

Percentage (%) of subjects with adverse events (AEs) post dose 3

Timeframe: From Day 1 up to 30 days (post dose 3 vaccination)

Number of participants with AEs by maximum intensity post dose 1

Timeframe: From Day 1 up to 30 days (post dose 1 vaccination)

Number of participants with AEs by maximum intensity post dose 2

Timeframe: From Day 1 up to 30 days (post dose 2 vaccination)

Number of participants with AEs by maximum intensity post dose 3

Timeframe: From Day 1 up to 30 days (post dose 3 vaccination)

Number of participants with serious adverse events (SAEs) and fatal SAEs

Timeframe: From Day 1 to 30 days after the last vaccine dose administered (at Month 0 or Month 2 or Month 6)

Secondary outcomes:
Not applicable
Interventions:
  • Other: Safety data collection (following routine vaccination) by a continuous surveillance method.
    • Enrollment:
    670
    Primary completion date:
    2020-01-12
    Observational study model:
    Cohort
    Time perspective:
    Prospective
    Clinical publications:
    Eun BW, Bahar E, Xavier S, Kim H, Borys D. Post-marketing surveillance study of the safety of the HPV-16/18 vaccine in Korea (2017–2021). Hum Vaccin Immunother. 2023;1-8. DOI: http://dx.doi.org/ 10.1080/21645515.2023.2184756
    Medical condition
    Neoplasms, Rectal
    Product
    SB580299
    Collaborators
    Not applicable
    Study date(s)
    October 2018 to December 2020
    Type
    Observational
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    9 - 25 years
    Accepts healthy volunteers
    Yes
    • Subject or/and subjects whose parent(s)/Legally Acceptable Representative(s) [LAR(s)], in the opinion of the investigator, can and will comply with the requirements of the protocol.
    • Korean male or female subjects aged 9-25 years who are eligible for the series of Cervarix according to the locally approved PI.
    • At the time of PMS entry, the contraindications and precautions of use indicated in the locally approved PI. PI should be checked and the subject must not be included in the PMS if there is any contraindication. Any changes in the locally approved PI must be implemented immediately.
    • Subjects who had previous administration of a HPV vaccine other than Cervarix will not be enrolled into the study.
    Inclusion and exclusion criteria
    Inclusion criteria:

      Subject or/and subjects whose parent(s)/Legally Acceptable Representative(s) [LAR(s)], in the opinion of the investigator, can and will comply with the requirements of the protocol.

      • Korean male or female subjects aged 9-25 years who are eligible for the series of Cervarix according to the locally approved PI.
      • Written informed consent obtained from the subject/from the parent(s)/LAR of the subject.
    Exclusion criteria:

      At the time of PMS entry, the contraindications and precautions of use indicated in the locally approved PI. PI should be checked and the subject must not be included in the PMS if there is any contraindication. Any changes in the locally approved PI must be implemented immediately.

      • Subjects who had previous administration of a HPV vaccine other than Cervarix will not be enrolled into the study.
      • Subjects who are not eligible for vaccination with Cervarix according to the medical judgement of physician.
      • Child in care.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Gongju-si, Chungcheongnam-do, South Korea, 32555
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Seoul, South Korea, 139-711
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Daegu, South Korea, 42274
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Gyeongsangbuk-do, South Korea, 39230
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Incheon, South Korea, 22227
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Jeonju-si, Jeollabuk-do, South Korea, 561-712
    Status
    Study Complete
    Contact us
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    Study documents

    Study report synopsis
    Available language(s): English
    Download document(s)
    Protocol
    Available language(s): English
    Download document(s)
    Statistical analysis plan
    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
    2020-01-12
    Actual study completion date
    2020-01-12

    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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