Last updated: 10/27/2020 14:30:04

A follow-up extension study to evaluate the persistence of immune response to GSK Biologicals’ HPV vaccine in healthy Chinese female subjects who received three doses of the vaccine in the HPV-058 study

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GSK study ID
207347
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Clinicaltrials.gov ID
NCT03355820
See results summary
EudraCT ID
2017-000255-50
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: Persistence of immune response to GSK Biologicals’ HPV vaccine in healthy Chinese female subjects from the HPV-058 study
Trial description: The purpose of this study is to evaluate the persistence of immune response in subjects who received the HPV-16/18 vaccine, seven to eight years after the last dose of primary vaccination in the HPV-058 study. No new subjects will be enrolled in this extension study.
Primary purpose:
Prevention
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:

Number of seropositive subjects for anti-HPV-16 antibodies at Day 1 in HPV-093 (NCT03355820) study

Timeframe: At Day 1 in HPV-093 (NCT03355820) study (i.e. 7 to 8 years after completion of the vaccination schedule in HPV-058 [NCT00996125] study)

Number of seropositive subjects for anti-HPV-18 antibodies at Day 1 in HPV-093 (NCT03355820) study

Timeframe: At Day 1 in HPV-093 (NCT03355820) study (i.e. 7 to 8 years after completion of the vaccination schedule in HPV-058 [NCT00996125] study)

Anti-HPV-16 antibody concentrations at Day 1 in HPV-093 (NCT03355820) study

Timeframe: At Day 1 in HPV-093 (NCT03355820) study (i.e. 7 to 8 years after completion of the vaccination schedule in HPV-058 [NCT00996125] study)

Anti-HPV-18 antibody concentrations at Day 1 in HPV-093 (NCT03355820) study

Timeframe: At Day 1 in HPV-093 (NCT03355820) study (i.e. 7 to 8 years after completion of the vaccination schedule in HPV-058 [NCT00996125] study)

Secondary outcomes:

Number of seropositive subjects for anti-HPV-16 antibodies at Day 1 in HPV-093 (NCT03355820) and at Year 6 in HPV-039 (NCT00779766) studies

Timeframe: At Day 1 in HPV-093 (NCT03355820) study (i.e. 7 to 8 years after completion of the vaccination schedule in HPV-058 [NCT00996125] study) and at Year 6 in HPV-039 (NCT00779766) study

Number of seropositive subjects for anti-HPV-18 antibodies at Day 1 in HPV-093 (NCT03355820) and at Year 6 in HPV-039 (NCT00779766) studies

Timeframe: At Day 1 in HPV-093 (NCT03355820) study (i.e. 7 to 8 years after completion of the vaccination schedule in HPV-058 [NCT00996125] study) and at Year 6 in HPV-039 (NCT00779766) study

Concentration of antibodies against HPV-16 at Day 1 in HPV-093 (NCT03355820) and at Year 6 in HPV-039 (NCT00779766) studies

Timeframe: At Day 1 in HPV-093 (NCT03355820) study (i.e. 7 to 8 years after completion of the vaccination schedule in HPV-058 [NCT00996125] study) and at Year 6 in HPV-039 (NCT00779766) study

Concentration of antibodies against HPV-18 at Day 1 in HPV-093 (NCT03355820) and at Year 6 in HPV-039 (NCT00779766) studies

Timeframe: At Day 1 in HPV-093 (NCT03355820) study (i.e. 7 to 8 years after completion of the vaccination schedule in HPV-058 [NCT00996125] study) and at Year 6 in HPV-039 (NCT00779766) study

Interventions:
  • Procedure/surgery: Blood sampling for antibody determination
    • Enrollment:
    228
    Primary completion date:
    2018-29-06
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Hu Y, Zhang X, YHe Y, MA Z, Xie Y, Lu X, Xu Y, Zhang Y, Jiang Y, Xiao H, Struyf F, Folschweiller N, Jiang J, Poncelet S, Karkada N, Jastorff A and Borys D. Long-term persistence of immune response to the AS04-adjuvanted HPV-16/18 vaccine in Chinese girls aged 9-17 years: Results from an 8-9-year follow-up phase III open-label study. Asia Pac J Clin Oncol. 2020 Aug 11. doi: 10.1111/ajco.13398. Online ahead of print.
    Medical condition
    Cervical Intraepithelial Neoplasia
    Product
    SB580299
    Collaborators
    Not applicable
    Study date(s)
    February 2018 to June 2018
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female
    Age
    17+ years
    Accepts healthy volunteers
    Yes
    • Subjects/subject’s parents/legally acceptable representative(s) [LAR(s)] who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
    • Written informed consent obtained from the subject or subject’s parents/LAR(s) prior to performing any study specific procedure.
    • Use of any investigational or non-registered product (drug or vaccine which may have an impact on the study objectives) during the period starting 30 days (Day 29 to Day 1) before the study visit.
    • Concurrently participating in another clinical study, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product (pharmaceutical product or device).
    Inclusion and exclusion criteria
    Inclusion criteria:

      Subjects/subject’s parents/legally acceptable representative(s) [LAR(s)] who, in the opinion of the investigator, can and will comply with the requirements of the protocol.

      • Written informed consent obtained from the subject or subject’s parents/LAR(s) prior to performing any study specific procedure.
      • Written informed assent obtained from the subjects below the legal age of consent.
      • Subjects who received all three doses of the HPV-16/18 vaccine in the HPV-058 study.
      • Healthy subjects as established by medical history and clinical examination before entering into the study.
    Exclusion criteria:

      Use of any investigational or non-registered product (drug or vaccine which may have an impact on the study objectives) during the period starting 30 days (Day 29 to Day 1) before the study visit.

      • Concurrently participating in another clinical study, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product (pharmaceutical product or device).
      • Previous vaccination against HPV outside the HPV-058 study.
      • Subjects with contraindications related to blood draw such as blood disorders and anticoagulants use.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Taizhou, Jiangsu, China, 225300
    Status
    Study Complete
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    Study documents

    Clinical study report
    Available language(s): English
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    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

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2018-29-06
    Actual study completion date
    2018-29-06

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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