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
Completed
Completed
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
Observational study model:
Not applicable
Primary completion date:
2018-29-06
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
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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
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If you wish to request for full study report, please contact - [email protected]

Results overview

Results posted on ClinicalTrials.gov

Recruitment status
Completed
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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